[Federal Register Volume 75, Number 169 (Wednesday, September 1, 2010)]
[Notices]
[Pages 53643-53660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21646]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2010-0055]
Examination Guidelines Update: Developments in the Obviousness
Inquiry After KSR v.Teleflex
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice.
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SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) is issuing an update (2010 KSR Guidelines Update) to its
obviousness guidelines for its personnel to be used when applying the
law of obviousness under
[[Page 53644]]
35 U.S.C. 103. This 2010 KSR Guidelines Update highlights case law
developments on obviousness under 35 U.S.C. 103 since the 2007 decision
by the United States Supreme Court (Supreme Court) in KSR Int'l Co. v.
Teleflex Inc. These guidelines are intended to be used by Office
personnel in conjunction with the guidance in the Manual of Patent
Examining Procedure when applying the law of obviousness under 35
U.S.C. 103. Members of the public are invited to provide comments on
the 2010 KSR Guidelines Update. The Office is especially interested in
receiving suggestions of recent decisional law in the field of
obviousness that would have particular value as teaching tools.
DATES: Effective Date: This 2010 KSR Guidelines Update is effective
September 1, 2010.
ADDRESSES: Comments concerning this 2010 KSR Guidelines Update may be
sent by electronic mail message over the Internet addressed to [email protected], or submitted by mail addressed to: Mail Stop
Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria,
VA 22313-1450. Although comments may be submitted by mail, the Office
prefers to receive comments via the Internet.
FOR FURTHER INFORMATION CONTACT: Kathleen Kahler Fonda or Pinchus M.
Laufer, Legal Advisors, Office of Patent Legal Administration, Office
of the Associate Commissioner for Patent Examination Policy, by
telephone at (571) 272-7754 or (571) 272-7726; by mail addressed to:
Mail Stop Comments Patents, Commissioner for Patents, P.O. Box 1450,
Alexandria, VA 22313-1450; or by facsimile transmission to (571) 273-
7754, marked to the attention of Kathleen Kahler Fonda.
SUPPLEMENTARY INFORMATION:
1. Introduction. The purpose of this 2010 KSR Guidelines Update is
to remind Office personnel of the principles of obviousness explained
by the Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S 398
(2007) (KSR), and to provide additional guidance in view of decisions
by the United States Court of Appeals for the Federal Circuit (Federal
Circuit) since KSR. This body of case law developed over the past three
years provides additional examples that will be useful to Office
personnel as well as practitioners during the examination process.
Although every question of obviousness must be decided on its own
facts, these cases begin to clarify the contours of the obviousness
inquiry after KSR, and help to show when a rejection on this basis is
proper and when it is not.
This 2010 KSR Guidelines Update does not constitute substantive
rule making and hence does not have the force and effect of law. It has
been developed as a matter of internal Office management and is not
intended to create any right or benefit, substantive or procedural,
enforceable by any party against the Office. Rejections will continue
to be based upon the substantive law, and it is these rejections that
are appealable. Consequently, any failure by Office personnel to follow
this 2010 KSR Guidelines Update is neither appealable nor petitionable.
After a review of the principles of obviousness and Office policy
as reflected in the Manual of Patent Examining Procedure (MPEP), this
2010 KSR Guidelines Update addresses a number of issues that arise when
Office personnel consider whether or not a claimed invention is
obvious. The concepts discussed are grounded in Federal Circuit cases,
and correlated with existing Office policy as appropriate. A number of
cases which have been selected for their instructional value on the
issue of obviousness will be discussed in detail.
The law of obviousness will continue to be refined, and Office
personnel are encouraged to maintain an awareness of precedential case
law from the Federal Circuit and precedential decisions of the Board of
Patent Appeals and Interferences (Board) in this area. The Office will
train Office personnel and update the MPEP as necessary to reflect the
current state of the law.
2. Principles of Obviousness and the Guidelines. In response to the
Supreme Court's April 2007 decision in KSR, the Office developed
guidelines for patent examiners to follow when determining obviousness
of a claimed invention and published these guidelines in the Federal
Register and Official Gazette. See Examination Guidelines for
Determining Obviousness Under 35 U.S.C. 103 in View of the Supreme
Court Decision in KSR International Co. v. Teleflex Inc., 72 FR 57526
(Oct. 10, 2007), 1324 Off. Gaz. Pat. Office 23 (Nov. 6, 2007) (2007 KSR
Guidelines). The 2007 KSR Guidelines have been incorporated in the
MPEP. See MPEP Sec. 2141 (8th ed. 2001) (Rev. 6, Sept. 2007). The
purpose of the 2007 KSR Guidelines was to give Office personnel
practical guidance on how to evaluate obviousness issues under 35
U.S.C. 103(a) in accordance with the Supreme Court's instruction in
KSR. The 2007 KSR Guidelines also alerted Office personnel to the
importance of considering rebuttal evidence submitted by patent
applicants in response to obviousness rejections.
The 2007 KSR Guidelines pointed out, as had the Supreme Court in
KSR, that the factual inquiries announced in Graham v. John Deere, 383
U.S. 1, 17-18 (1966) (scope and content of the prior art; differences
between the claimed invention and the prior art; level of ordinary
skill in the art; and secondary indicia of nonobviousness), remain the
foundation of any determination of obviousness. It remains true that
``[t]he determination of obviousness is dependent on the facts of each
case.'' Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1089 (Fed.
Cir. 2008) (citing Graham, 383 U.S. at 17-18 (1966)). As for the
reasoning required to support an obviousness determination, the 2007
KSR Guidelines noted that the teaching-suggestion-motivation (TSM) test
was but one possible approach. The 2007 KSR Guidelines identified six
other rationales gleaned from the KSR decision as examples of
appropriate lines of reasoning that could also be used. The six other
rationales identified in the 2007 KSR Guidelines are: (1) Combining
prior art elements according to known methods to yield predictable
results; (2) simple substitution of one known element for another to
obtain predictable results; (3) use of a known technique to improve
similar devices, methods, or products in the same way; (4) applying a
known technique to a known device, method, or product ready for
improvement to yield predictable results; (5) obvious to try--choosing
from a finite number of identified, predictable solutions, with a
reasonable expectation of success; and (6) known work in one field of
endeavor may prompt variations of it for use in either the same field
or a different one based on design incentives or other market forces if
the variations are predictable to one of ordinary skill in the art. Any
rationale employed must provide a link between the factual findings and
the legal conclusion of obviousness.
It is important for Office personnel to recognize that when they do
choose to formulate an obviousness rejection using one of the
rationales suggested by the Supreme Court in KSR and discussed in the
2007 KSR Guidelines, they are to adhere to the instructions provided in
the MPEP regarding the necessary factual findings. However, the 2007
KSR Guidelines also stressed that while the Graham inquiries and the
associated reasoning are crucial to a proper obviousness determination,
the Supreme Court in KSR did not place any limit on the particular
approach to be taken to formulate the line of reasoning.
[[Page 53645]]
In other words, the KSR decision is not to be seen as replacing a
single test for obviousness--the TSM test--with the seven rationales
listed in the 2007 KSR Guidelines. See MPEP Sec. Sec. 2141 and 2143
(8th ed. 2001) (Rev. 8, July 2010) (references to the MPEP are to
Revision 8 of the 8th Edition of the MPEP unless otherwise indicated).
It remains Office policy that appropriate factual findings are required
in order to apply the enumerated rationales properly. If a rejection
has been made that omits one of the required factual findings, and in
response to the rejection a practitioner or inventor points out the
omission, Office personnel must either withdraw the rejection, or
repeat the rejection including all required factual findings.
3. The Impact of the KSR Decision. KSR's renewed emphasis on the
foundational principles of Graham coupled with its abrogation of the
strict TSM test have clearly impacted the manner in which Office
personnel and practitioners carry out the business of prosecuting
patent applications with regard to issues of obviousness. However,
Office personnel as well as practitioners should also recognize the
significant extent to which the obviousness inquiry has remained
constant in the aftermath of KSR.
In footnote 2 of the 2007 KSR Guidelines, the Office acknowledged
that ongoing developments in the law of obviousness were to be expected
in the wake of the KSR decision. That footnote also stated that it was
``not clear which Federal Circuit decisions will retain their
viability'' after KSR. See 2007 KSR Guidelines, 72 FR at 57,528 n.2.
The edition of the MPEP that was current when the KSR decision was
handed down had made the following statement in Sec. 2144:
The rationale to modify or combine the prior art does not have
to be expressly stated in the prior art; the rationale may be
expressly or impliedly contained in the prior art or it may be
reasoned from knowledge generally available to one of ordinary skill
in the art, established scientific principles, or legal precedent
established by prior case law.
MPEP Sec. 2144 (8th ed. 2001) (Rev. 5, Aug. 2006) (citing five
pre-KSR Federal Circuit opinions and two decisions of the Board). The
KSR decision has reinforced those earlier decisions that validated a
more flexible approach to providing reasons for obviousness. However,
the Supreme Court's pronouncement in KSR has at the same time clearly
undermined the continued viability of cases such as In re Lee, 277 F.3d
1338 (Fed. Cir. 2002), insofar as Lee appears to require a strict basis
in record evidence as a reason to modify the prior art.
The Supreme Court's flexible approach to the obviousness inquiry is
reflected in numerous pre-KSR decisions, as can be seen in a review of
MPEP Sec. 2144. This section provides many lines of reasoning to
support a determination of obviousness based upon earlier legal
precedent that had condoned the use of particular examples of what may
be considered common sense or ordinary routine practice (e.g., making
integral, changes in shape, making adjustable). Thus, the type of
reasoning sanctioned by the opinion in KSR has long been a part of the
patent examination process. See MPEP Sec. 2144.
Although the KSR approach is flexible with regard to the line of
reasoning to be applied, the 2007 KSR Guidelines and MPEP Sec. 2143
state: ``The Supreme Court in KSR noted that the analysis supporting a
rejection under 35 U.S.C. 103 should be made explicit.'' MPEP Sec.
2143. In Ball Aerosol v. Limited Brands, 555 F.3d 984 (Fed. Cir. 2009),
the Federal Circuit offered additional instruction as to the need for
an explicit analysis. The Federal Circuit explained, as is consistent
with the 2007 KSR Guidelines, that the Supreme Court's requirement for
an explicit analysis does not require record evidence of an explicit
teaching of a motivation to combine in the prior art.
[T]he analysis that ``should be made explicit'' refers not to
the teachings in the prior art of a motivation to combine, but to
the court's analysis * * *. Under the flexible inquiry set forth by
the Supreme Court, the district court therefore erred by failing to
take account of ``the inferences and creative steps,'' or even
routine steps, that an inventor would employ and by failing to find
a motivation to combine related pieces from the prior art.
Ball Aerosol, 555 F.3d at 993. The Federal Circuit's directive in
Ball Aerosol was addressed to a lower court, but it applies to Office
personnel as well. When setting forth a rejection, Office personnel are
to continue to make appropriate findings of fact as explained in MPEP
Sec. Sec. 2141 and 2143, and must provide a reasoned explanation as to
why the invention as claimed would have been obvious to a person of
ordinary skill in the art at the time of the invention. This
requirement for explanation remains even in situations in which Office
personnel may properly rely on intangible realities such as common
sense and ordinary ingenuity.
When considering obviousness, Office personnel are cautioned
against treating any line of reasoning as a per se rule. MPEP Sec.
2144 discusses supporting a rejection under 35 U.S.C. 103 by reliance
on scientific theory and legal precedent. In keeping with the flexible
approach and the requirement for explanation, Office personnel may
invoke legal precedent as a source of supporting rationale when
warranted and appropriately supported. See MPEP Sec. 2144.04. So, for
example, automating a manual activity, making portable, making
separable, reversal or duplication of parts, or purifying an old
product may form the basis of a rejection. However, such rationales
should not be treated as per se rules, but rather must be explained and
shown to apply to the facts at hand. A similar caveat applies to any
obviousness analysis. Simply stating the principle (e.g., ``art
recognized equivalent,'' ``structural similarity'') without providing
an explanation of its applicability to the facts of the case at hand is
generally not sufficient to establish a prima facie case of
obviousness.
Many basic approaches that a practitioner may use to demonstrate
nonobviousness also continue to apply in the post-KSR era. Since it is
now clear that a strict TSM approach is not the only way to establish a
prima facie case of obviousness, it is true that practitioners have
been required to shift the emphasis of their nonobviousness arguments
to a certain degree. However, familiar lines of argument still apply,
including teaching away from the claimed invention by the prior art,
lack of a reasonable expectation of success, and unexpected results.
Indeed, they may have even taken on added importance in view of the
recognition in KSR of a variety of possible rationales.
At the time the KSR decision was handed down, some observers
questioned whether the principles discussed were intended by the
Supreme Court to apply to all fields of inventive endeavor. Arguments
were made that because the technology at issue in KSR involved the
relatively well-developed and predictable field of vehicle pedal
assemblies, the decision was relevant only to such fields. The Federal
Circuit has soundly repudiated such a notion, stating that KSR applies
across technologies:
This court also declines to cabin KSR to the ``predictable
arts'' (as opposed to the ``unpredictable art'' of biotechnology).
In fact, this record shows that one of skill in this advanced art
would find these claimed ``results'' profoundly ``predictable.''
In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). Thus, Office
personnel should not withdraw any rejection solely on the basis that
the invention lies in a technological area ordinarily considered to be
unpredictable.
The decisions of the Federal Circuit discussed in this 2010 KSR
Guidelines
[[Page 53646]]
Update provide Office personnel as well as practitioners with
additional examples of the law of obviousness. The purpose of the 2007
KSR Guidelines was, as stated above, to help Office personnel to
determine when a claimed invention is not obvious, and to provide an
appropriate supporting rationale when an obviousness rejection is
appropriate. Now that a body of case law is available to guide Office
personnel and practitioners as to the boundaries between obviousness
and nonobviousness, it is possible in this 2010 KSR Guidelines Update
to contrast situations in which the subject matter was found to have
been obvious with those in which it was determined not to have been
obvious. Thus, Office personnel may use this 2010 KSR Guidelines Update
in conjunction with the 2007 KSR Guidelines (incorporated into MPEP
Sec. Sec. 2141 and 2143) to provide a more complete view of the state
of the law of obviousness.
This 2010 KSR Guidelines Update provides a ``teaching point'' for
each discussed case. The ``teaching point'' may be used to quickly
determine the relevance of the discussed case, but should not be used
as a substitute for reading the remainder of the discussion of the case
in this 2010 KSR Guidelines Update. Nor should any case in this 2010
KSR Guidelines Update be applied or cited in an Office action solely on
the basis of what is stated in the ``teaching point'' for the case.
4. Obviousness Examples from Federal Circuit Cases. The impact of
the Supreme Court's decision in KSR can be more readily understood in
the context of factual scenarios. The cases in this 2010 KSR Guidelines
Update are broadly grouped according to obviousness concepts in order
to provide persons involved with patent prosecution with ready access
to the examples that are most pertinent to the issue at hand. The first
three groups correspond directly with three of the rationales
identified in the 2007 KSR Guidelines. These rationales--combining
prior art elements, substituting one known element for another, and
obvious to try--have each been the subject of a significant number of
post-KSR obviousness decisions. The fourth group focuses on issues
concerning consideration of evidence during prosecution. Office
personnel as well as practitioners are reminded of the technology-
specific obviousness examples previously posted on the Office's Web
site at http://www.uspto.gov/web/offices/pac/dapp/opla/ksr/ksr_training_materials.htm.
Although the other rationales discussed in the 2007 KSR Guidelines
are not the focus of separate discussions in this 2010 KSR Guidelines
Update, it will be noted that obviousness concepts such as applying
known techniques, design choice, and market forces are addressed when
they arise in the selected cases. The cases included in this 2010 KSR
Guidelines Update reinforce the idea, presented in the 2007 KSR
Guidelines, that there may be more than one line of reasoning that can
properly be applied to a particular factual scenario. The selected
decisions also illustrate the overlapping nature of the lines of
reasoning that may be employed to establish a prima facie case of
obviousness. Although the 2007 KSR Guidelines presented the rationales
as discrete, self-contained lines of reasoning, and they may indeed be
employed that way, it is useful to recognize that real-world situations
may require analyses that may not be so readily pigeon-holed into
distinct categories.
A. Combining Prior Art Elements. In discussing the obviousness
rationale concerning combining prior art elements, identified as
Rationale A, the 2007 KSR Guidelines quoted KSR and noted that ``it can
be important to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way
the claimed new invention does.'' KSR, 550 U.S. at 401. In view of the
cases decided since KSR, one situation when it is important to identify
a reason to combine known elements in a known manner to obtain
predictable results is when the combination requires a greater
expenditure of time, effort, or resources than the prior art teachings.
Even though the components are known, the combining step is technically
feasible, and the result is predictable, the claimed invention may
nevertheless be nonobvious when the combining step involves such
additional effort that no one of ordinary skill would have undertaken
it without a recognized reason to do so. When a combination invention
involves additional complexity as compared with the prior art, the
invention may be nonobvious unless an examiner can articulate a reason
for including the added features or steps. This is so even when the
claimed invention could have been readily implemented.
Example 4.1. In re Omeprazole Patent Litigation, 536 F.3d 1361
(Fed. Cir. 2008). Teaching point: Even where a general method that
could have been applied to make the claimed product was known and
within the level of skill of the ordinary artisan, the claim may
nevertheless be nonobvious if the problem which had suggested use of
the method had been previously unknown.
The case of In re Omeprazole Patent Litigation is one in which the
claims in question were found to be nonobvious in the context of an
argument to combine prior art elements. The invention involved applying
enteric coatings to a drug in pill form for the purpose of ensuring
that the drug did not disintegrate before reaching its intended site of
action. The drug at issue was omeprazole, the generic name for gastric
acid inhibitor marketed as Prilosec[reg]. The claimed formulation
included two layers of coatings over the active ingredient.
The district court found that Astra's patent in suit was infringed
by defendants Apotex and Impax. The district court rejected Apotex's
defense that the patents were invalid for obviousness. Apotex had
argued that the claimed invention was obvious because coated omeprazole
tablets were known from a prior art reference, and because secondary
subcoatings in pharmaceutical preparations generally were also known.
There was no evidence of unpredictability associated with applying two
different enteric coatings to omeprazole. However, Astra's reason for
applying an intervening subcoating between the prior art coating and
omeprazole had been that the prior art coating was actually interacting
with omeprazole, thereby contributing to undesirable degradation of the
active ingredient. This degradation of omeprazole by interaction with
the prior art coating had not been recognized in the prior art.
Therefore, the district court reasoned that based on the evidence
available, a person of ordinary skill in the art would have had no
reason to include a subcoating in an omeprazole pill formulation.
The Federal Circuit affirmed the district court's decision that the
claimed invention was not obvious. Even though subcoatings for enteric
drug formulation were known, and there was no evidence of undue
technical hurdles or lack of a reasonable expectation of success, the
formulation was nevertheless not obvious because the flaws in the prior
art formulation that had prompted the modification had not been
recognized. Thus there would have been no reason to modify the initial
formulation, even though the modification could have been done.
Moreover, a person of skill in the art likely would have chosen a
different modification even if he or she had recognized the problem.
Office personnel should note that in this case the modification of
the prior art that had been presented as an
[[Page 53647]]
argument for obviousness was an extra process step that added an
additional component to a known, successfully marketed formulation. The
proposed modification thus amounted to extra work and greater expense
for no apparent reason. This is not the same as combining known prior
art elements A and B when each would have been expected to contribute
its own known properties to the final product. In the Omeprazole case,
in view of the expectations of those of ordinary skill in the art,
adding the subcoating would not have been expected to confer any
particular desirable property on the final product. Rather, the final
product obtained according to the proposed modifications would merely
have been expected to have the same functional properties as the prior
art product.
The Omeprazole case can also be analyzed in view of the discovery
of a previously unknown problem by the patentee. If the adverse
interaction between active agent and coating had been known, it might
well have been obvious to use a subcoating. However, since the problem
had not been previously known, there would have been no reason to incur
additional time and expense to add another layer, even though the
addition would have been technologically possible. This is true because
the prior art of record failed to mention any stability problem,
despite the acknowledgment during testimony at trial that there was a
known theoretical reason that omeprazole might be subject to
degradation in the presence of the known coating material.
Example 4.2. Crocs, Inc. v. U.S. International Trade Commission,
598 F.3d 1294 (Fed. Cir. 2010). Teaching point: A claimed combination
of prior art elements may be nonobvious where the prior art teaches
away from the claimed combination and the combination yields more than
predictable results.
The case of Crocs, Inc. v. U.S. International Trade Commission is a
decision in which the claimed foam footwear was held by the Federal
Circuit to be nonobvious over a combination of prior art references.
The claims involved in the obviousness issue were from Crocs' U.S.
Patent No. 6,993,858, and were drawn to footwear in which a one-piece
molded foam base section formed the top of the shoe (the upper) and the
sole. A strap also made of foam was attached to the foot opening of the
upper, such that the strap could provide support to the Achilles
portion of the wearer's foot. The strap was attached via connectors
that allowed it to be in contact with the base section, and to pivot
relative to the base section. Because both the base portion and the
strap were made of foam, friction between the strap and the base
section allowed the strap to maintain its position after pivoting. In
other words, the foam strap did not fall under the force of gravity to
a position adjacent to the heel of the base section.
The International Trade Commission (ITC) determined that the claims
were obvious over the combination of two pieces of prior art. The first
was the Aqua Clog, which was a shoe that corresponded to the base
section of the footwear of the `858 patent. The second was the Aguerre
patent, which taught heel straps made of elastic or another flexible
material. In the ITC's view, the claimed invention was obvious because
the prior art Aqua Clog differed from the claimed invention only as to
the presence of the strap, and a suitable strap was taught by Aguerre.
The Federal Circuit disagreed. The Federal Circuit stated that the
prior art did not teach foam heel straps, or that a foam heel strap
should be placed in contact with a foam base. The Federal Circuit
pointed out that the prior art actually counseled against using foam as
a material for the heel strap of a shoe.
The record shows that the prior art would actually discourage
and teach away from the use of foam straps. An ordinary artisan in
this field would not add a foam strap to the foam Aqua Clog because
foam was likely to stretch and deform, in addition to causing
discomfort for a wearer. The prior art depicts foam as unsuitable
for straps.
Id. at 1309.
The Federal Circuit continued, stating that even if--contrary to
fact--the claimed invention had been a combination of elements that
were known in the prior art, the claims still would have been
nonobvious. There was testimony in the record that the loose fit of the
heel strap made the shoe more comfortable for the wearer than prior art
shoes in which the heel strap was constantly in contact with the
wearer's foot. In the claimed footwear, the foam heel strap contacted
the wearer's foot only when needed to help reposition the foot properly
in the shoe, thus reducing wearer discomfort that could arise from
constant contact. This desirable feature was a result of the friction
between the base section and the strap that kept the strap in place
behind the Achilles portion of the wearer's foot. The Federal Circuit
pointed out that this combination ``yielded more than predictable
results.'' Id. at 1310. Aguerre had taught that friction between the
base section and the strap was a problem rather than an advantage, and
had suggested the use of nylon washers to reduce friction. Thus the
Federal Circuit stated that even if all elements of the claimed
invention had been taught by the prior art, the claims would not have
been obvious because the combination yielded more than predictable
results.
The Federal Circuit's discussion in Crocs serves as a reminder to
Office personnel that merely pointing to the presence of all claim
elements in the prior art is not a complete statement of a rejection
for obviousness. In accordance with MPEP Sec. 2143 A(3), a proper
rejection based on the rationale that the claimed invention is a
combination of prior art elements also includes a finding that results
flowing from the combination would have been predictable to a person of
ordinary skill in the art. MPEP Sec. 2143 A(3). If results would not
have been predictable, Office personnel should not enter an obviousness
rejection using the combination of prior art elements rationale, and
should withdraw such a rejection if it has been made.
Example 4.3. Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d
1356 (Fed. Cir. 2008). Teaching point: A claimed invention is likely to
be obvious if it is a combination of known prior art elements that
would reasonably have been expected to maintain their respective
properties or functions after they have been combined.
Sundance involved a segmented and mechanized cover for trucks,
swimming pools, or other structures. The claim was found to be obvious
over the prior art applied.
A first prior art reference taught that a reason for making a
segmented cover was ease of repair, in that a single damaged segment
could be readily removed and replaced when necessary. A second prior
art reference taught the advantages of a mechanized cover for ease of
opening. The Federal Circuit noted that the segmentation aspect of the
first reference and the mechanization function of the second perform in
the same way after combination as they had before. The Federal Circuit
further observed that a person of ordinary skill in the art would have
expected that adding replaceable segments as taught by the first
reference to the mechanized cover of the other would result in a cover
that maintained the advantageous properties of both of the prior art
covers.
Thus, the Sundance case points out that a hallmark of a proper
obviousness rejection based on combining known prior art elements is
that one of ordinary skill in the art would reasonably have expected
the elements to maintain their respective properties or functions after
they have been combined.
[[Page 53648]]
Example 4.4. Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed Cir.
2009). Teaching point: A combination of known elements would have been
prima facie obvious if an ordinarily skilled artisan would have
recognized an apparent reason to combine those elements and would have
known how to do so.
In the case of Ecolab, Inc. v. FMC Corp., an ``apparent reason to
combine'' in conjunction with the technical ability to optimize led to
the conclusion that the claimed invention would have been obvious.
The invention in question was a method of treating meat to reduce
the incidence of pathogens, by spraying the meat with an antibacterial
solution under specified conditions. The parties did not dispute that a
single prior art reference had taught all of the elements of the
claimed invention, except for the pressure limitation of ``at least 50
psi.''
FMC had argued at the district court that the claimed invention
would have been obvious in view of the first prior art reference
mentioned above in view of a second reference that had taught the
advantages of spray-treating at pressures of 20 to 150 psi when
treating meat with a different antibacterial agent. The district court
did not find FMC's argument to be convincing, and denied the motion for
judgment as a matter of law that the claim was obvious.
Disagreeing with the district court, the Federal Circuit stated
that ``there was an apparent reason to combine these known elements--
namely to increase contact between the [antibacterial solution] and the
bacteria on the meat surface and to use the pressure to wash additional
bacteria off the meat surface.'' Id. at 1350. The Federal Circuit
explained that because the second reference had taught ``using high
pressure to improve the effectiveness of an antimicrobial solution when
sprayed onto meat, and because an ordinarily skilled artisan would have
recognized the reasons for applying [the claimed antibacterial
solution] using high pressure and would have known how to do so,
Ecolab's claims combining high pressure with other limitations
disclosed in FMC's patent are invalid as obvious.'' Id.
When considering the question of obviousness, Office personnel
should keep in mind the capabilities of a person of ordinary skill. In
Ecolab, the Federal Circuit stated:
Ecolab's expert admitted that one skilled in the art would know
how to adjust application parameters to determine the optimum
parameters for a particular solution. The question then is whether
it would have been obvious to combine the high pressure parameter
disclosed in the Bender patent with the PAA methods disclosed in
FMC's `676 patent. The answer is yes.
Id. If optimization of the application parameters had not been within
the level of ordinary skill in the art, the outcome of the Ecolab case
may well have been different.
Example 4.5. Wyers v. Master Lock Co., No. 2009-1412, --F.3d--,
2010 WL 2901839 (Fed. Cir. July 22, 2010). Teaching point: The scope of
analogous art is to be construed broadly and includes references that
are reasonably pertinent to the problem that the inventor was trying to
solve. Common sense may be used to support a legal conclusion of
obviousness so long as it is explained with sufficient reasoning.
In the case of Wyers v. Master Lock Co., the Federal Circuit held
that the claimed barbell-shaped hitch pin locks used to secure trailers
to vehicles were obvious.
The court discussed two different sets of claims in Wyers, both
drawn to improvements over the prior art hitch pin locks. The first
improvement was a removable sleeve that could be placed over the shank
of the hitch pin lock so that the same lock could be used with towing
apertures of varying sizes. The second improvement was an external flat
flange seal adapted to protect the internal lock mechanism from
contaminants. Wyers had admitted that each of several prior art
references taught every element of the claimed inventions except for
the removable sleeve and the external covering. Master Lock had argued
that these references, in combination with additional references
teaching the missing elements, would have rendered the claims obvious.
The court first addressed the question of whether the additional
references relied on by Master Lock were analogous prior art. As to the
reference teaching the sleeve improvement, the court concluded that it
dealt specifically with using a vehicle to tow a trailer, and was
therefore in the same field of endeavor as Wyers' sleeve improvement.
The reference teaching the sealing improvement dealt with a padlock
rather than a lock for a tow hitch. The court noted that Wyers'
specification had characterized the claimed invention as being in the
field of locking devices, thus at least suggesting that the sealed
padlock reference was in the same field of endeavor. However, the court
also observed that even if sealed padlocks were not in the same field
of endeavor, they were nevertheless reasonably pertinent to the problem
of avoiding contamination of a locking mechanism for tow hitches. The
court explained that the Supreme Court's decision in KSR ``directs [it]
to construe the scope of analogous art broadly.'' Wyers, slip. op. at
12. For these reasons, the court found that Master Lock's asserted
references were analogous prior art, and therefore relevant to the
obviousness inquiry.
The court then turned to the question of whether there would have
been adequate motivation to combine the prior art elements as had been
urged by Master Lock. The court recalled the Graham inquiries, and also
emphasized the ``expansive and flexible'' post-KSR approach to
obviousness that must not ``deny factfinders recourse to common
sense.'' Wyers, slip op. at 13 (quoting KSR, 550 U.S. at 415 and 421).
The court stated:
KSR and our later cases establish that the legal determination
of obviousness may include recourse to logic, judgment, and common
sense, in lieu of expert testimony * * *.
Thus, in appropriate cases, the ultimate inference as to the
existence of a motivation to combine references may boil down to a
question of ``common sense,'' appropriate for resolution on summary
judgment or JMOL.
Id. at 15 (citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d
1324, 1329 (Fed. Cir. 2009); Ball Aerosol, 555 F.3d at 993).
After reviewing these principles, the court proceeded to explain
why adequate motivation to combine had been established in this case.
With regard to the sleeve improvement, it pointed out that the need for
different sizes of hitch pins was well known in the art, and that this
was a known source of inconvenience and expense for users. The court
also mentioned the marketplace aspect of the issue, noting that space
on store shelves was at a premium, and that removable sleeves addressed
this economic concern. As to the sealing improvement, the court pointed
out that both internal and external seals were well-known means to
protect locks from contaminants. The court concluded that the
constituent elements were being employed in accordance with their
recognized functions, and would have predictably retained their
respective functions when combined as suggested by Master Lock. The
court cited In re O'Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988) for the
proposition that a reasonable expectation of success is a requirement
for a proper determination of obviousness.
Office personnel should note that although the Federal Circuit
invoked the idea of common sense in support of a conclusion of
obviousness, it did not end its explanation there. Rather, the
[[Page 53649]]
court explained why a person of ordinary skill in the art at the time
of the invention, in view of the facts relevant to the case, would have
found the claimed inventions to have been obvious. As stated in the
MPEP:
The key to supporting any rejection under 35 U.S.C. 103 is the
clear articulation of the reason(s) why the claimed invention would
have been obvious. The Supreme Court in KSR noted that the analysis
supporting a rejection under 35 U.S.C. 103 should be made explicit.
The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329,
1336 (Fed. Cir. 2006), stated that ``[R]ejections on obviousness
cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning
to support the legal conclusion of obviousness.''
MPEP Sec. 2141 III. Office personnel should continue to provide a
reasoned explanation for every obviousness rejection.
Example 4.6. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
567 F.3d 1314 (Fed. Cir. 2009). Teaching point: Predictability as
discussed in KSR encompasses the expectation that prior art elements
are capable of being combined, as well as the expectation that the
combination would have worked for its intended purpose. An inference
that a claimed combination would not have been obvious is especially
strong where the prior art's teachings undermine the very reason being
proffered as to why a person of ordinary skill would have combined the
known elements.
The claim in DePuy Spine was directed to a polyaxial pedicle screw
used in spinal surgeries that included a compression member for
pressing a screw head against a receiver member. A prior art reference
(Puno) disclosed all of the elements of the claim except for the
compression member. Instead, the screw head in Puno was separated from
the receiver member to achieve a shock absorber effect, allowing some
motion between receiver member and the vertebrae. The missing
compression member was readily found in another prior art reference
(Anderson), which disclosed an external fracture immobilization splint
for immobilizing long bones with a swivel clamp capable of polyaxial
movement until rigidly secured by a compression member. It was asserted
during trial that a person of ordinary skill would have recognized that
the addition of Anderson's compression member to Puno's device would
have achieved a rigidly locked polyaxial pedicle screw covered by the
claim.
In conducting its analysis, the Federal Circuit noted that the
``predictable result'' discussed in KSR refers not only to the
expectation that prior art elements are capable of being physically
combined, but also that the combination would have worked for its
intended purpose. In this case, it was successfully argued that Puno
``teaches away'' from a rigid screw because Puno warned that rigidity
increases the likelihood that the screw will fail within the human
body, rendering the device inoperative for its intended purpose. In
fact, the reference did not merely express a general preference for
pedicle screws having a ``shock absorber'' effect, but rather expressed
concern for failure and stated that the shock absorber feature
``decrease[s] the chance of failure of the screw of the bone-screw
interface'' because ``it prevent[s] direct transfer of load from the
rod to the bone-screw interface.'' Thus, the alleged reason to combine
the prior art elements of Puno and Anderson--increasing the rigidity of
the screw--ran contrary to the prior art that taught that increasing
rigidity would result in a greater likelihood of failure. In view of
this teaching and the backdrop of collective teachings of the prior
art, the Federal Circuit determined that Puno teaches away from the
proposed combination such that a person of ordinary skill would have
been deterred from combining the references as proposed. Secondary
considerations evaluated by the Federal Circuit relating to failure by
others and copying also supported the view that the combination would
not have been obvious at the time of the invention.
B. Substituting One Known Element for Another. As explained in the
2007 KSR Guidelines, the substitution rationale applies when the
claimed invention can be viewed as resulting from substituting a known
element for an element of a prior art invention. The rationale applies
when one of ordinary skill in the art would have been technologically
capable of making the substitution, and the result obtained would have
been predictable. See MPEP Sec. 2143(B).
Example 4.7. In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed.
Cir. 2007). Teaching point: When determining whether a reference in a
different field of endeavor may be used to support a case of
obviousness (i.e., is analogous), it is necessary to consider the
problem to be solved.
The claimed invention in ICON was directed to a treadmill with a
folding tread base that swivels into an upright storage position,
including a gas spring connected between the tread base and the upright
structure to assist in stably retaining the tread base in the storage
position. On reexamination, the examiner rejected the claims as obvious
based on a combination of references including an advertisement
(Damark) for a folding treadmill demonstrating all of the claim
elements other than the gas spring, and a patent (Teague) with a gas
spring. Teague was directed to a bed that folds into a cabinet using a
novel dual-action spring that reverses force as the mechanism passes a
neutral position, rather than a single-action spring that would provide
a force pushing the bed closed at all times. The dual-action spring
reduced the force required to open the bed from the closed position,
while reducing the force required to lift the bed from the open
position.
The Federal Circuit addressed the propriety of making the
combination since Teague comes from a different field than the
application. Teague was found to be reasonably pertinent to the problem
addressed in the application because the folding mechanism did not
require any particular focus on treadmills, but rather generally
addressed problems of supporting the weight of such a mechanism and
providing a stable resting position.
Other evidence was considered concerning whether one skilled in the
art would have been led to combine the teachings of Damark and Teague.
Appellant argued that Teague teaches away from the invention because it
directs one skilled in the art not to use single-action springs and
does not satisfy the claim limitations as the dual-action springs would
render the invention inoperable. The Federal Circuit considered the
arguments and found that while Teague at most teaches away from using
single-action springs to decrease the opening force, it actually
instructed that single-action springs provide the result desired by the
inventors, which was to increase the opening force provided by gravity.
As to inoperability, the claims were not limited to single-action
springs and were so broad as to encompass anything that assists in
stably retaining the tread base, which is the function that Teague
accomplished. Additionally, the fact that the counterweight mechanism
from Teague used a large spring, which appellant argued would overpower
the treadmill mechanism, ignores the modifications that one skilled in
the art would make to a device borrowed from the prior art. One skilled
in the art would size the components from Teague appropriately for the
application.
ICON is another useful example for understanding the scope of
analogous art. The art applied concerned retaining mechanisms for
folding beds, not treadmills. When determining whether a
[[Page 53650]]
reference may properly be applied to an invention in a different field
of endeavor, it is necessary to consider the problem to be solved. It
is certainly possible that a reference may be drawn in such a way that
its usefulness as a teaching is narrowly restricted. However, in ICON,
the ``treadmill'' concept was too narrow a lens through which to view
the art in light of the prior art teachings concerning the problem to
be solved. The Teague reference was analogous art because ``Teague and
the current application both address the need to stably retain a
folding mechanism,'' id. at 1378, and because ``nothing about ICON's
folding mechanism requires any particular focus on treadmills,'' id. at
1380.
ICON is also informative as to the relationship between the problem
to be solved and existence of a reason to combine. ``Indeed, while
perhaps not dispositive of the issue, the finding that Teague, by
addressing a similar problem, provides analogous art to ICON's
application goes a long way towards demonstrating a reason to combine
the two references. Because ICON's broad claims read on embodiments
addressing that problem as described by Teague, the prior art here
indicates a reason to incorporate its teachings.'' Id. at 1380-81.
The Federal Circuit's discussion in ICON also makes clear that if
the reference does not teach that a combination is undesirable, then it
cannot be said to teach away. An assessment of whether a combination
would render the device inoperable must not ``ignore the modifications
that one skilled in the art would make to a device borrowed from the
prior art.'' Id. at 1382.
Example 4.8. Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed.
Cir. 2008). Teaching point: Analogous art is not limited to references
in the field of endeavor of the invention, but also includes references
that would have been recognized by those of ordinary skill in the art
as useful for applicant's purpose.
Agrizap involved a stationary pest control device for electrocution
of pests such as rats and gophers, in which the device is set in an
area where the pest is likely to encounter it. The only difference
between the claimed device and the prior art stationary pest control
device was that the claimed device employed a resistive electrical
switch, while the prior art device used a mechanical pressure switch. A
resistive electrical switch was taught in two prior art patents, in the
contexts of a hand-held pest control device and a cattle prod.
In determining that the claimed invention was obvious, the Federal
Circuit noted that ``[t]he asserted claims simply substitute a
resistive electrical switch for the mechanical pressure switch''
employed in the prior art device. Id. at 1344. In this case, the prior
art concerning the hand-held devices revealed that the function of the
substituted resistive electrical switch was well known and predictable,
and that it could be used in a pest control device. According to the
Federal Circuit, the references that taught the hand-held devices
showed that ``the use of an animal body as a resistive switch to
complete a circuit for the generation of an electric charge was already
well known in the prior art.'' Id. Finally, the Federal Circuit noted
that the problem solved by using the resistive electrical switch in the
prior art hand-held devices--malfunction of mechanical switches due to
dirt and dampness--also pertained to the prior art stationary pest
control device.
The Federal Circuit recognized Agrizap as ``a textbook case of when
the asserted claims involve a combination of familiar elements
according to known methods that does no more than yield predictable
results.'' Id. Agrizap exemplifies a strong case of obviousness based
on simple substitution that was not overcome by the objective evidence
of nonobviousness offered. It also demonstrates that analogous art is
not limited to the field of applicant's endeavor, in that one of the
references that used an animal body as a resistive switch to complete a
circuit for the generation of an electric charge was not in the field
of pest control.
Example 4.9. Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318
(Fed. Cir. 2008). Teaching point: Because Internet and Web browser
technologies had become commonplace for communicating and displaying
information, it would have been obvious to adapt existing processes to
incorporate them for those functions.
The invention at issue in Muniauction was a method for auctioning
municipal bonds over the Internet. A municipality could offer a package
of bond instruments of varying principal amounts and maturity dates,
and an interested buyer would then submit a bid comprising a price and
interest rate for each maturity date. It was also possible for the
interested buyer to bid on a portion of the offering. The claimed
invention considered all of the noted parameters to determine the best
bid. It operated on conventional Web browsers and allowed participants
to monitor the course of the auction.
The only difference between the prior art bidding system and the
claimed invention was the use of a conventional Web browser. At trial,
the district court had determined that Muniauction's claims were not
obvious. Thomson argued that the claimed invention amounted to
incorporating a Web browser into a prior art auction system, and was
therefore obvious in light of KSR. Muniauction rebutted the argument by
offering evidence of skepticism by experts, copying, praise, and
commercial success. Although the district court found the evidence to
be persuasive of nonobviousness, the Federal Circuit disagreed. It
noted that a nexus between the claimed invention and the proffered
evidence was lacking because the evidence was not coextensive with the
claims at issue. For this reason, the Federal Circuit determined that
Muniauction's evidence of secondary considerations was not entitled to
substantial weight.
The Federal Circuit analogized this case to Leapfrog Enterprises,
Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007), cited in
the 2007 KSR Guidelines. The Leapfrog case involved a determination of
obviousness based on application of modern electronics to a prior art
mechanical children's learning device. In Leapfrog, the court had noted
that market pressures would have prompted a person of ordinary skill to
use modern electronics in the prior art device. Similarly in
Muniauction, market pressures would have prompted a person of ordinary
skill to use a conventional Web browser in a method of auctioning
municipal bonds.
Example 4.10. Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d
1293 (Fed. Cir. 2007). Teaching point: A chemical compound would have
been obvious over a mixture containing that compound as well as other
compounds where it was known or the skilled artisan had reason to
believe that some desirable property of the mixture was derived in
whole or in part from the claimed compound, and separating the claimed
compound from the mixture was routine in the art.
In Aventis, the claims were drawn to the 5(S) stereoisomer of the
blood pressure drug ramipril in stereochemically pure form, and to
compositions and methods requiring 5(S) ramipril. The 5(S) stereoisomer
is one in which all five stereocenters in the ramipril molecule are in
the S rather than the R configuration. A mixture of various
stereoisomers including 5(S) ramipril had been taught by the prior art.
The question before the court was whether the purified single
stereoisomer
[[Page 53651]]
would have been obvious over the known mixture of stereoisomers.
The record showed that the presence of multiple S stereocenters in
drugs similar to ramipril was known to be associated with enhanced
therapeutic efficacy. For example, when all of the stereocenters were
in the S form in the related drug enalapril (SSS enalapril) as compared
with only two stereocenters in the S form (SSR enalapril), the
therapeutic potency was 700 times as great. There was also evidence to
indicate that conventional methods could be used to separate the
various stereoisomers of ramipril.
The district court saw the issue as a close case, because, in its
view, there was no clear motivation in the prior art to isolate 5(S)
ramipril. However, the Federal Circuit disagreed, and found that the
claims would have been obvious. The Federal Circuit cautioned that
requiring such a clearly stated motivation in the prior art to isolate
5(S) ramipril ran counter to the Supreme Court's decision in KSR. The
court stated:
Requiring an explicit teaching to purify the 5(S) stereoisomer
from a mixture in which it is the active ingredient is precisely the
sort of rigid application of the TSM test that was criticized in
KSR.
Id. at 1301. The Aventis court also relied on the settled principle
that in chemical cases, structural similarity can provide the necessary
reason to modify prior art teachings. The Federal Circuit also
addressed the kind of teaching that would be sufficient in the absence
of an explicitly stated prior art-based motivation, explaining that an
expectation of similar properties in light of the prior art can be
sufficient, even without an explicit teaching that the compound will
have a particular utility.
In the chemical arts, the cases involving so-called ``lead
compounds'' form an important subgroup of the obviousness cases that
are based on substitution. The Federal Circuit has had a number of
opportunities since the KSR decision to discuss the circumstances under
which it would have been obvious to modify a known compound to arrive
at a claimed compound. The following cases explore the selection of a
lead compound, the need to provide a reason for any proposed
modification, and the predictability of the result.
Example 4.11. Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d
1353 (Fed. Cir. 2008). Teaching point: A claimed compound would not
have been obvious where there was no reason to modify the closest prior
art lead compound to obtain the claimed compound and the prior art
taught that modifying the lead compound would destroy its advantageous
property. Any known compound may serve as a lead compound when there is
some reason for starting with that lead compound and modifying it to
obtain the claimed compound.
Eisai concerns the pharmaceutical compound rabeprazole. Rabeprazole
is a proton pump inhibitor for treating stomach ulcers and related
disorders. The Federal Circuit affirmed the district court's summary
judgment of nonobviousness, stating that no reason had been advanced to
modify the prior art compound in a way that would destroy an
advantageous property.
Co-defendant Teva based its obviousness argument on the structural
similarity between rabeprazole and lansoprazole. The compounds were
recognized as sharing a common core, and the Federal Circuit
characterized lansoprazole as a ``lead compound.'' The prior art
compound lansoprazole was useful for the same indications as
rabeprazole, and differed from rabeprazole only in that lansoprazole
has a trifluoroethoxy substituent at the 4-position of the pyridine
ring, while rabeprazole has a methoxypropoxy substituent. The trifluoro
substituent of lansoprazole was known to be a beneficial feature
because it conferred lipophilicity to the compound. The ability of a
person of ordinary skill to carry out the modification to introduce the
methoxypropoxy substituent, and the predictability of the result were
not addressed.
Despite the significant similarity between the structures, the
Federal Circuit did not find any sufficient reason to modify the lead
compound. According to the Federal Circuit:
Obviousness based on structural similarity thus can be proved by
identification of some motivation that would have led one of
ordinary skill in the art to select and then modify a known compound
(i.e. a lead compound) in a particular way to achieve the claimed
compound. * * * In keeping with the flexible nature of the
obviousness inquiry, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
127 S.Ct. 1727, 1739, 167 L.Ed.2d 705 (2007), the requisite
motivation can come from any number of sources and need not
necessarily be explicit in the art. See Aventis Pharma Deutschland
GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007). Rather
``it is sufficient to show that the claimed and prior art compounds
possess a `sufficiently close relationship * * * to create an
expectation,' in light of the totality of the prior art, that the
new compound will have `similar properties' to the old.'' Id.
(quoting Dillon, 919 F.2d at 692).
Eisai, 533 F.3d at 1357. The prior art taught that introducing a
fluorinated substituent was known to increase lipophilicity, so a
skilled artisan would have expected that replacing the trifluoroethoxy
substituent with a methoxypropoxy substituent would have reduced the
lipophilicity of the compound. Thus, the prior art created the
expectation that rabeprazole would be less useful than lansoprazole as
a drug for treating stomach ulcers and related disorders because the
proposed modification would have destroyed an advantageous property of
the prior art compound. The compound was not obvious as argued by Teva
because, upon consideration of all of the facts of the case, a person
of ordinary skill in the art at the time of the invention would not
have had a reason to modify lansoprazole so as to form rabeprazole.
Office personnel are cautioned that the term ``lead compound'' in a
particular opinion can have a contextual meaning that may vary from the
way a pharmaceutical chemist might use the term. In the field of
pharmaceutical chemistry, the term ``lead compound'' has been defined
variously as ``a chemical compound that has pharmacological or
biological activity and whose chemical structure is used as a starting
point for chemical modifications in order to improve potency,
selectivity, or pharmacokinetic parameters;'' ``[a] compound that
exhibits pharmacological properties which suggest its development;''
and ``a potential drug being tested for safety and efficacy.'' See,
e.g.,http://en.wikipedia.org/wiki/Lead_compound, accessed January 13,
2010; http://www.combichemistry.com/glossary_k.html, accessed January
13, 2010; and http://www.buildingbiotechnology.com/glossary4.php,
accessed January 13, 2010.
The Federal Circuit in Eisai makes it clear that from the
perspective of the law of obviousness, any known compound might
possibly serve as a lead compound: ``Obviousness based on structural
similarity thus can be proved by identification of some motivation that
would have led one of ordinary skill in the art to select and then
modify a known compound (i.e. a lead compound) in a particular way to
achieve the claimed compound.'' Eisai, 533 F.3d at 1357. Thus, Office
personnel should recognize that a proper obviousness rejection of a
claimed compound that is useful as a drug might be made beginning with
an inactive compound, if, for example, the reasons for modifying a
prior art compound to arrive at the claimed compound have nothing to do
with pharmaceutical activity. The inactive compound would not be
considered to be a lead
[[Page 53652]]
compound by pharmaceutical chemists, but could potentially be used as
such when considering obviousness. Office personnel might also base an
obviousness rejection on a known compound that pharmaceutical chemists
would not select as a lead compound due to expense, handling issues, or
other business considerations. However, there must be some reason for
starting with that lead compound other than the mere fact that the
``lead compound'' merely exists. See Altana Pharma AG v. Teva
Pharmaceuticals USA, Inc., 566 F.3d 999, 1007 (Fed. Cir. 2009) (holding
that there must be some reason ``to select and modify a known
compound''); Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520
F.3d 1358, 1364 (Fed. Cir. 2008).
Example 4.12. Procter & Gamble Co. v. Teva Pharmaceuticals USA,
Inc., 566 F.3d 989 (Fed. Cir. 2009). Teaching point: It is not
necessary to select a single compound as a ``lead compound'' in order
to support an obviousness rejection. However, where there was reason to
select and modify the lead compound to obtain the claimed compound, but
no reasonable expectation of success, the claimed compound would not
have been obvious.
A chemical compound was also found to be nonobvious in Procter &
Gamble. The compound at issue was risedronate--the active ingredient of
Procter & Gamble's osteoporosis drug Actonel[reg]. Risedronate is an
example of a bisphosphonate, which is a class of compounds known to
inhibit bone resorption.
When Procter & Gamble sued Teva for infringement, Teva defended by
arguing invalidity for obviousness over one of Procter & Gamble's
earlier patents. The prior art patent did not teach risedronate, but
instead taught thirty-six other similar compounds including 2-pyr EHDP
that were potentially useful with regard to osteoporosis. Teva argued
obviousness on the basis of structural similarity to 2-pyr EHDP, which
is a positional isomer of risedronate.
The district court found no reason to select 2-pyr EHDP as a lead
compound in light of the unpredictable nature of the art, and no reason
to modify it so as to obtain risedronate. In addition, there were
unexpected results as to potency and toxicity. Therefore the district
court found that Teva had not made a prima facie case, and even if it
had, it was rebutted by evidence of unexpected results.
The Federal Circuit affirmed the district court's decision. The
Federal Circuit did not deem it necessary in this case to consider the
question of whether 2-pyr EHDP had been appropriately selected as a
lead compound. Rather, the Federal Circuit stated that if 2-pyr EHDP is
presumed to be an appropriate lead compound, there must be both a
reason to modify it so as to make risedronate, and a reasonable
expectation of success. Here there was no evidence that the necessary
modifications would have been routine, so there would have been no
reasonable expectation of success.
Procter & Gamble is also informative in its discussion of the
treatment of secondary considerations of non-obviousness. Although the
court found that no prima facie case of obviousness had been presented,
it proceeded to analyze Procter & Gamble's proffered evidence
countering the alleged prima facie case in some detail, thus shedding
light on the proper treatment of such evidence.
The Federal Circuit noted in dicta that even if a prima facie case
of obviousness had been established, sufficient evidence of unexpected
results was introduced to rebut such a showing. At trial, the witnesses
consistently testified that the properties of risedronate were not
expected, offering evidence that researchers did not predict either the
potency or the low dose at which the compound was effective, and that
the superior properties were unexpected and could not be predicted.
Tests comparing risedronate to a compound in the prior art reference
showed that risedronate outperformed the other compound by a
substantial margin, could be administered in a greater amount without
an observable toxic effect, and was not lethal at the same levels as
the other compound. The weight of the evidence and the credibility of
the witnesses were sufficient to show unexpected results that would
have rebutted an obviousness determination. Thus, nonobviousness can be
shown when a claimed invention is shown to have unexpectedly superior
properties when compared to the prior art.
The court then addressed the evidence of commercial success of
risedronate and the evidence that risedronate met a long-felt need. The
court pointed out that little weight was to be afforded to the
commercial success because the competing product was also assigned to
Procter & Gamble. However, the Federal Circuit affirmed the district
court's conclusion that risedronate met a long-felt, unsatisfied need.
The court rejected Teva's contention that because the competing drug
was available before Actonel[supreg], there was no unmet need that the
invention satisfied. The court emphasized that whether there was a
long-felt unsatisfied need is to be evaluated based on the
circumstances as of the filing date of the challenged invention--not as
of the date that the invention is brought to market.
It should be noted that the lead compound cases do not stand for
the proposition that identification of a single lead compound is
necessary in every obviousness rejection of a chemical compound. For
example, one might envision a suggestion in the prior art to formulate
a compound having certain structurally defined moieties, or moieties
with certain properties. If a person of ordinary skill would have known
how to synthesize such a compound, and the structural and/or functional
result could reasonably have been predicted, then a prima facie case of
obviousness of the claimed chemical compound might exist even without
identification of a particular lead compound. As a second example, it
could be possible to view a claimed compound as consisting of two known
compounds attached via a chemical linker. The claimed compound might
properly be found to have been obvious if there would have been a
reason to link the two, if one of ordinary skill would have known how
to do so, and if the resulting compound would have been the predictable
result of the linkage procedure. Thus, Office personnel should
recognize that in certain situations, it may be proper to reject a
claimed chemical compound as obvious even without identifying a single
lead compound.
Example 4.13. Altana Pharma AG v. Teva Pharmaceuticals USA, Inc.,
566 F.3d 999 (Fed. Cir. 2009). Teaching point: Obviousness of a
chemical compound in view of its structural similarity to a prior art
compound may be shown by identifying some line of reasoning that would
have led one of ordinary skill in the art to select and modify a prior
art lead compound in a particular way to produce the claimed compound.
It is not necessary for the reasoning to be explicitly found in the
prior art of record, nor is it necessary for the prior art to point to
only a single lead compound.
Although the decision reached by the Federal Circuit in Altana
involved a motion for preliminary injunction and did not include a
final determination of obviousness, the case is nevertheless
instructive as to the issue of selecting a lead compound.
The technology involved in Altana was the compound pantoprazole,
which is the active ingredient in Altana's antiulcer drug
Protonix[supreg]. Pantoprazole belongs to a class of compounds known
[[Page 53653]]
as proton pump inhibitors that are used to treat gastric acid disorders
in the stomach.
Altana accused Teva of infringement. The district court denied
Altana's motion for preliminary injunction for failure to establish a
likelihood of success on the merits, determining that Teva had
demonstrated a substantial question of invalidity for obviousness in
light of one of Altana's prior patents. Altana's patent discussed a
compound referred to as compound 12, which was one of eighteen
compounds disclosed. The claimed compound pantoprazole was structurally
similar to compound 12. The district court found that one of ordinary
skill in the art would have selected compound 12 as a lead compound for
modification, and the Federal Circuit affirmed.
Obviousness of a chemical compound in view of its structural
similarity to a prior art compound may be shown by identifying some
line of reasoning that would have led one of ordinary skill in the art
to select and modify the prior art compound in a particular way to
produce the claimed compound. The necessary line of reasoning can be
drawn from any number of sources and need not necessarily be explicitly
found in the prior art of record. The Federal Circuit determined that
ample evidence supported the district court's finding that compound 12
was a natural choice for further development. For example, Altana's
prior art patent claimed that its compounds, including compound 12,
were improvements over the prior art; compound 12 was disclosed as one
of the more potent of the eighteen compounds disclosed; the patent
examiner had considered the compounds of Altana's prior art patent to
be relevant during the prosecution of the patent in suit; and experts
had opined that one of ordinary skill in the art would have selected
the eighteen compounds to pursue further investigation into their
potential as proton pump inhibitors.
In response to Altana's argument that the prior art must point to
only a single lead compound for further development, the Federal
Circuit stated that a ``restrictive view of the lead compound test
would present a rigid test similar to the teaching-suggestion-
motivation test that the Supreme Court explicitly rejected in KSR * *
*. The district court in this case employed a flexible approach--one
that was admittedly preliminary--and found that the defendants had
raised a substantial question that one of skill in the art would have
used the more potent compounds of [Altana's prior art] patent,
including compound 12, as a starting point from which to pursue further
development efforts. That finding was not clearly erroneous.'' Id. at
1008.
C. The ``Obvious to Try'' Rationale. The question of whether a
claimed invention can be shown to be obvious based on an ``obvious to
try'' line of reasoning has been explored extensively by the Federal
Circuit in several cases since the KSR decision. The 2007 KSR
Guidelines explain, in view of the Supreme Court's instruction, that
this rationale is only appropriate when there is a recognized problem
or need in the art; there are a finite number of identified,
predictable solutions to the recognized need or problem; and one of
ordinary skill in the art could have pursued these known potential
solutions with a reasonable expectation of success. The case law in
this area is developing quickly in the chemical arts, although the
rationale has been applied in other art areas as well.
Some commentators on the KSR decision have expressed a concern that
because inventive activities are always carried out in the context of
what has come before and not in a vacuum, few inventions will survive
scrutiny under an obvious to try standard. The cases decided since KSR
have proved this fear to have been unfounded. Courts appear to be
applying the KSR requirement for ``a finite number of identified
predictable solutions'' in a manner that places particular emphasis on
predictability and the reasonable expectations of those of ordinary
skill in the art.
In a recent Federal Circuit decision, the court pointed out the
challenging nature of the task faced by the courts--and likewise by
Office personnel--when considering the viability of an obvious to try
argument: ``The evaluation of the choices made by a skilled scientist,
when such choices lead to the desired result, is a challenge to
judicial understanding of how technical advance is achieved in the
particular field of science or technology.'' Abbott Labs. v. Sandoz,
Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008). The Federal Circuit
cautioned that an obviousness inquiry based on an obvious to try
rationale must always be undertaken in the context of the subject
matter in question, ``including the characteristics of the science or
technology, its state of advance, the nature of the known choices, the
specificity or generality of the prior art, and the predictability of
results in the area of interest.'' Id.
Example 4.14. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009). Teaching
point: A claimed polynucleotide would have been obvious over the known
protein that it encodes where the skilled artisan would have had a
reasonable expectation of success in deriving the claimed
polynucleotide using standard biochemical techniques, and the skilled
artisan would have had a reason to try to isolate the claimed
polynucleotide. KSR applies to all technologies, rather than just the
``predictable'' arts.
The Federal Circuit's decision in In re Kubin was an affirmance of
the Board's decision in Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. App. &
Interf. 2007), and the Board in turn had affirmed the examiner's
determination that the claims in question would have been obvious over
the prior art applied. A discussion of Ex parte Kubin was included in
the 2007 KSR Guidelines. See 2007 KSR Guidelines, 72 FR at 57532. The
claimed invention in Kubin was an isolated nucleic acid molecule. The
claim stated that the nucleic acid encoded a particular polypeptide.
The encoded polypeptide was identified in the claim by its partially
specified sequence, and by its ability to bind to a specified protein.
A prior art patent to Valiante taught the polypeptide encoded by the
claimed nucleic acid, but did not disclose either the sequence of the
polypeptide, or the claimed isolated nucleic acid molecule. However,
Valiante did disclose that by employing conventional methods, such as
those disclosed by a prior art laboratory manual by Sambrook, the
sequence of the polypeptide could be determined, and the nucleic acid
molecule could be isolated. In view of Valiante's disclosure of the
polypeptide, and of routine prior art methods for sequencing the
polypeptide and isolating the nucleic acid molecule, the Board found
that a person of ordinary skill in the art would have had a reasonable
expectation that a nucleic acid molecule within the claimed scope could
have been successfully obtained.
Relying on In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), Appellant
argued that it was improper for the Office to use the polypeptide of
the Valiante patent together with the methods described in Sambrook to
reject a claim drawn to a specific nucleic acid molecule without
providing a reference showing or suggesting a structurally similar
nucleic acid molecule. Citing KSR, the Board stated that ``when there
is motivation to solve a problem and there are a finite number of
identified, predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her technical grasp.
If this leads to anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense.'' The Board noted
that
[[Page 53654]]
the problem facing those in the art was to isolate a specific nucleic
acid, and there were a limited number of methods available to do so.
The Board concluded that the skilled artisan would have had reason to
try these methods with the reasonable expectation that at least one
would be successful. Thus, isolating the specific nucleic acid molecule
claimed was ``the product not of innovation but of ordinary skill and
common sense.'' The Board's reasoning was substantially adopted by the
Federal Circuit. However, it is important to note that in the Kubin
decision, the Federal Circuit held that ``the Supreme Court in KSR
unambiguously discredited'' the Federal Circuit's decision in Deuel,
insofar as it ``implies the obviousness inquiry cannot consider that
the combination of the claim's constituent elements was `obvious to
try.' '' Kubin, 561 F.3d at 1358. Instead, Kubin stated that KSR
``resurrects'' the Federal Circuit's own wisdom in O'Farrell, in which
``to differentiate between proper and improper applications of `obvious
to try,' '' the Federal Circuit ``outlined two classes of situations
where `obvious to try' is erroneously equated with obviousness under
Sec. 103.'' Kubin, 561 F.3d at 1359. These two classes of situations
are: (1) When what would have been ``obvious to try'' would have been
to vary all parameters or try each of numerous possible choices until
one possibly arrived at a successful result, where the prior art gave
either no indication of which parameters were critical or no direction
as to which of many possible choices is likely to be successful; and
(2) when what was ``obvious to try'' was to explore a new technology or
general approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance as to
the particular form of the claimed invention or how to achieve it. Id.
(citing O'Farrell, 853 F.2d at 903).
Example 4.15. Takeda Chemical Industries, Ltd. v. Alphapharm Pty.,
Ltd., 492 F.3d 1350 (Fed. Cir. 2007). Teaching point: A claimed
compound would not have been obvious where it was not obvious to try to
obtain it from a broad range of compounds, any one of which could have
been selected as the lead compound for further investigation, and the
prior art taught away from using a particular lead compound, and there
was no predictability or reasonable expectation of success in making
the particular modifications necessary to transform the lead compound
into the claimed compound.
Takeda is an example of a chemical case in which the Federal
Circuit found that the claim was not obvious. The claimed compound was
pioglitazone, a member of a class of drugs known as thiazolidinediones
(TZDs) marketed by Takeda as a treatment for Type 2 diabetes. The
Takeda case brings together the concept of a ``lead compound'' and the
obvious-to-try argument.
Alphapharm had filed an Abbreviated New Drug Application with the
Food and Drug Administration, which was a technical act of infringement
of Takeda's patent. When Takeda brought suit, Alphapharm's defense was
that Takeda's patent was invalid due to obviousness. Alphapharm argued
that a two-step modification--involving homologation and ring-walking--
of a known compound identified as ``compound b'' would have produced
pioglitazone, and that it was therefore obvious.
The district court found that there would have been no reason to
select compound b as a lead compound. There were a large number of
similar prior art TZD compounds; fifty-four were specifically
identified in Takeda's prior patent, and the district court observed
that ``hundreds of millions'' were more generally disclosed. Although
the parties agreed that compound b represented the closest prior art,
one reference had taught certain disadvantageous properties associated
with compound b, which according to the district court would have
taught the skilled artisan not to select that compound as a lead
compound. The district court found no prima facie case of obviousness,
and stated that even if a prima facie case had been established, it
would have been overcome in this case in view of the unexpected lack of
toxicity of pioglitazone.
The Federal Circuit affirmed the decision of the district court,
citing the need for a reason to modify a prior art compound. The
Federal Circuit quoted KSR, stating:
The KSR Court recognized that ``[w]hen there is a design need or
market pressure to solve a problem and there are a finite number of
identified, predictable solutions, a person of ordinary skill has
good reason to pursue the known options within his or her technical
grasp.'' KSR, 127 S.Ct. at 1732. In such circumstances, ``the fact
that a combination was obvious to try might show that it was obvious
under Sec. 103.'' Id. That is not the case here. Rather than
identify predictable solutions for antidiabetic treatment, the prior
art disclosed a broad selection of compounds any one of which could
have been selected as a lead compound for further investigation.
Significantly, the closest prior art compound (compound b, the 6-
methyl) exhibited negative properties that would have directed one
of ordinary skill in the art away from that compound. Thus, this
case fails to present the type of situation contemplated by the
Court when it stated that an invention may be deemed obvious if it
was ``obvious to try.'' The evidence showed that it was not obvious
to try.
Takeda, 492 F.3d at 1359.
Accordingly, Office personnel should recognize that the obvious to
try rationale does not apply when the appropriate factual findings
cannot be made. In Takeda, there was a recognized need for treatment of
diabetes. However, there was no finite number of identified,
predictable solutions to the recognized need, and no reasonable
expectation of success. There were numerous known TZD compounds, and
although one clearly represented the closest prior art, its known
disadvantages rendered it unsuitable as a starting point for further
research, and taught the skilled artisan away from its use.
Furthermore, even if there had been reason to select compound b, there
had been no predictability or reasonable expectation of success
associated with the particular modifications necessary to transform
compound b into the claimed compound pioglitazone. Thus, an obviousness
rejection based on an obvious to try rationale was not appropriate in
this situation.
Example 4.16. Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs,
Inc., 520 F.3d 1358 (Fed. Cir. 2008). Teaching point: Where the claimed
anti-convulsant drug had been discovered somewhat serendipitously in
the course of research aimed at finding a new anti-diabetic drug, it
would not have been obvious to try to obtain a claimed compound where
the prior art did not present a finite and easily traversed number of
potential starting compounds, and there was no apparent reason for
selecting a particular starting compound from among a number of
unpredictable alternatives.
The Ortho-McNeil case provides another example in which a chemical
compound was determined not to be obvious. The claimed subject matter
was topiramate, which is used as an anti-convulsant. As in DePuy Spine,
whether the combination would predictably be effective for its intended
purpose is part of the obviousness analysis.
In the course of working toward a new anti-diabetic drug, Ortho-
McNeil's scientist had unexpectedly discovered that a reaction
intermediate had anti-convulsant properties. Mylan's defense of
invalidity due to obviousness rested on an obvious to try argument.
However, Mylan did not explain why it would have been obvious to begin
with an anti-diabetic drug precursor, especially the specific one that
led to
[[Page 53655]]
topiramate, if one had been seeking an anti-convulsant drug. The
district court ruled on summary judgment that Ortho-McNeil's patent was
not invalid for obviousness.
The Federal Circuit affirmed. The Federal Circuit pointed out that
there was no apparent reason why a person of ordinary skill would have
chosen the particular starting compound or the particular synthetic
pathway that led to topiramate as an intermediate. Furthermore, there
would have been no reason to test that intermediate for anticonvulsant
properties if treating diabetes had been the goal. The Federal Circuit
recognized an element of serendipity in this case, which runs counter
to the requirement for predictability. Summarizing their conclusion
with regard to Mylan's obvious to try argument, the Federal Circuit
stated:
[T]his invention, contrary to Mylan's characterization, does not
present a finite (and small in the context of the art) number of
options easily traversed to show obviousness * * *. KSR posits a
situation with a finite, and in the context of the art, small or
easily traversed, number of options that would convince an
ordinarily skilled artisan of obviousness* * * . [T]his clearly is
not the easily traversed, small and finite number of alternatives
that KSR suggested might support an inference of obviousness.
Id. at 1364. Thus, Ortho-McNeil helps to clarify the Supreme
Court's requirement in KSR for ``a finite number'' of predictable
solutions when an obvious to try rationale is applied: Under the
Federal Circuit's case law ``finite'' means ``small or easily
traversed'' in the context of the art in question. As taught in Abbott,
discussed above, it is essential that the inquiry be placed in the
context of the subject matter at issue, and each case must be decided
on its own facts.
Example 4.17. Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575
F.3d 1341 (Fed. Cir. 2009). Teaching point: A claimed compound would
have been obvious where it was obvious to try to obtain it from a
finite and easily traversed number of options that was narrowed down
from a larger set of possibilities by the prior art, and the outcome of
obtaining the claimed compound was reasonably predictable.
In Bayer the claimed invention was an oral contraceptive containing
micronized drospirenone marketed as Yasmin[reg].
The prior art compound drospirenone was known to be a poorly water-
soluble, acid-sensitive compound with contraceptive effects. It was
also known in the art that micronization improves the solubility of
poorly water soluble drugs.
Based on the known acid sensitivity, Bayer had studied how
effectively an enteric-coated drospirenone tablet delivered a
formulation as compared to an intravenous injection of the same
formulation to measure the ``absolute bioavailability'' of the drug.
Bayer added an unprotected (normal) drospirenone tablet and compared
its bioavailability to that of the enteric-coated formulation and the
intravenous delivery. Bayer expected to find that the enteric-coated
tablet would produce a lower bioavailability than an intravenous
injection, while the normal pill would produce an even lower
bioavailability than the enteric-coated tablet. However, they found
that despite observations that drospirenone would quickly isomerize in
a highly acidic environment (supporting the belief that an enteric
coating would be necessary to preserve bioavailability), the normal
pill and the enteric-coated pill resulted in the same bioavailability.
Following this study, Bayer developed micronized drospirenone in a
normal pill, the basis for the disputed patent.
The district court found that a person having ordinary skill in the
art would have considered the prior art result that a structurally
related compound, spirorenone, though acid-sensitive, would
nevertheless absorb in vivo, would have suggested the same result for
drospirenone. It also found that while another reference taught that
drospirenone isomerizes in vitro when exposed to acid simulating the
human stomach, a person of ordinary skill would have been aware of the
study's shortcomings, and would have verified the findings as suggested
by a treatise on the science of dosage form design, which would have
then showed that no enteric coating was necessary.
The Federal Circuit held that the patent was invalid because the
claimed formulation was obvious. The Federal Circuit reasoned that the
prior art would have funneled the formulator toward two options. Thus,
the formulator would not have been required to try all possibilities in
a field unreduced by the prior art. The prior art was not vague in
pointing toward a general approach or area of exploration, but rather
guided the formulator precisely to the use of either a normal pill or
an enteric-coated pill.
It is important for Office personnel to recognize that the mere
existence of a large number of options does not in and of itself lead
to a conclusion of nonobviousness. Where the prior art teachings lead
one of ordinary skill in the art to a narrower set of options, then
that reduced set is the appropriate one to consider when determining
obviousness using an obvious to try rationale.
Example 4.18. Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075
(Fed. Cir. 2008). Teaching point: A claimed isolated stereoisomer would
not have been obvious where the claimed stereoisomer exhibits
unexpectedly strong therapeutic advantages over the prior art racemic
mixture without the correspondingly expected toxicity, and the
resulting properties of the enantiomers separated from the racemic
mixture were unpredictable.
The case of Sanofi also sheds light on the obvious to try line of
reasoning. The claimed compound was clopidogrel, which is the
dextrorotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-
c)thienopyridyl)(2-chlorophenyl)-acetate. Clopidogrel is an anti-
thrombotic compound used to treat or prevent heart attack or stroke.
The racemate, or mixture of dextrorotatory and levorotatory (D- and L-)
isomers of the compound, was known in the prior art. The two forms had
not previously been separated, and although the mixture was known to
have anti-thrombotic properties, the extent to which each of the
individual isomers contributed to the observed properties of the
racemate was not known and was not predictable.
The district court assumed that in the absence of any additional
information, the D-isomer would have been prima facie obvious over the
known racemate. However, in view of the evidence of unpredicted
therapeutic advantages of the D-isomer presented in the case, the
district court found that any prima facie case of obviousness had been
overcome. At trial, the experts for both parties testified that persons
of ordinary skill in the art could not have predicted the degree to
which the isomers would have exhibited different levels of therapeutic
activity and toxicity. Both parties' experts also agreed that the
isomer with greater therapeutic activity would most likely have had
greater toxicity. Sanofi witnesses testified that Sanofi's own
researchers had believed that the separation of the isomers was
unlikely to have been productive, and experts for both parties agreed
that it was difficult to separate isomers at the time of the invention.
Nevertheless, when Sanofi ultimately undertook the task of separating
the isomers, it found that they had the ``rare characteristic of
`absolute stereoselectivity,' '' whereby the D-isomer provided all of
the favorable therapeutic activity but no significant toxicity, while
the L-isomer produced no therapeutic activity but
[[Page 53656]]
virtually all of the toxicity. Based on this record, the district court
concluded that Apotex had not met its burden of proving by clear and
convincing evidence that Sanofi's patent was invalid for obviousness.
The Federal Circuit affirmed the district court's conclusion.
Office personnel should recognize that even when only a small
number of possible choices exist, the obvious to try line of reasoning
is not appropriate when, upon consideration of all of the evidence, the
outcome would not have been reasonably predictable and the inventor
would not have had a reasonable expectation of success. In Bayer, there
were art-based reasons to expect that both the normal pill and the
enteric-coated pill would be therapeutically suitable, even though not
all prior art studies were in complete agreement. Thus, the result
obtained was not unexpected. In Sanofi, on the other hand, there was
strong evidence that persons of ordinary skill in the art, prior to the
separation of the isomers, would have had no reason to expect that the
D-isomer would have such strong therapeutic advantages as compared with
the L-isomer. In other words, the result in Sanofi was unexpected.
Example 4.19. Rolls-Royce, PLC v. United Technologies Corp., 603
F.3d 1325 (Fed. Cir. 2010). Teaching point: An obvious to try rationale
may be proper when the possible options for solving a problem were
known and finite. However, if the possible options were not either
known or finite, then an obvious to try rationale cannot be used to
support a conclusion of obviousness.
In Rolls-Royce the Federal Circuit addressed the obvious to try
rationale in the context of a fan blade for jet engines. The case had
arisen out of an interference proceeding. Finding that the district
court had correctly determined that there was no interference-in-fact
because Rolls-Royce's claims would not have been obvious in light of
United's application, the Federal Circuit affirmed.
The Federal Circuit described the fan blade of the count as
follows:
Each fan blade has three regions--an inner, an intermediate, and
an outer region. The area closest to the axis of rotation at the hub
is the inner region. The area farthest from the center of the engine
and closest to the casing surrounding the engine is the outer
region. The intermediate region falls in between. The count defines
a fan blade with a swept-forward inner region, a swept-rearward
intermediate region, and forward-leaning outer region.
Id. at 1328.
United had argued that it would have been obvious for a person of
ordinary skill in the art to try a fan blade design in which the sweep
angle in the outer region was reversed as compared with prior art fan
blades from rearward to forward sweep, in order to reduce endwall
shock. The Federal Circuit disagreed with United's assessment that the
claimed fan blade would have been obvious based on an obvious to try
rationale. The Federal Circuit pointed out that in a proper obvious to
try approach to obviousness, the possible options for solving a problem
must have been ``known and finite.'' Id. at 1339, citing Abbott, 544
F.3d at 1351. In this case, there had been no suggestion in the prior
art that would have suggested that changing the sweep angle as Rolls-
Royce had done would have addressed the issue of endwall shock. Thus,
the Federal Circuit concluded that changing the sweep angle ``would not
have presented itself as an option at all, let alone an option that
would have been obvious to try.'' Rolls-Royce, 603 F.3d at 1339. The
decision in Rolls-Royce is a reminder to Office personnel that the
obvious to try rationale can properly be used to support a conclusion
of obviousness only when the claimed solution would have been selected
from a finite number of potential solutions known to persons of
ordinary skill in the art.
Example 4.20. Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587
F.3d 1324, 1328-29 (Fed. Cir. 2009). Teaching point: Where there were a
finite number of identified, predictable solutions and there is no
evidence of unexpected results, an obvious to try inquiry may properly
lead to a legal conclusion of obviousness. Common sense may be used to
support a legal conclusion of obviousness so long as it is explained
with sufficient reasoning.
The Perfect Web case provides an example in which the Federal
Circuit held that a claimed method for managing bulk e-mail
distribution was obvious on the basis of an obvious to try argument. In
Perfect Web, the method required selecting the intended recipients,
transmitting the e-mails, determining how many of the e-mails had been
successfully received, and repeating the first three steps if a pre-
determined minimum number of intended recipients had not received the
e-mail.
The Federal Circuit affirmed the district court's determination on
summary judgment that the claimed invention would have been obvious.
Failure to meet a desired quota of e-mail recipients was a recognized
problem in the field of e-mail marketing. The prior art had also
recognized three potential solutions: Increasing the size of the
initial recipient list; resending e-mails to recipients who did not
receive them on the first attempt; and selecting a new recipient list
and sending e-mails to them. The last option corresponded to the fourth
step of the invention as claimed.
The Federal Circuit noted that based on ``simple logic,'' selecting
a new list of recipients was more likely to result in the desired
outcome than resending to those who had not received the e-mail on the
first attempt. There had been no evidence of any unexpected result
associated with selecting a new recipient list, and no evidence that
the method would not have had a reasonable likelihood of success. Thus,
the Federal Circuit concluded that, as required by KSR, there were a
``finite number of identified, predictable solutions,'' and that the
obvious to try inquiry properly led to the legal conclusion of
obviousness.
The Federal Circuit in Perfect Web also discussed the role of
common sense in the determination of obviousness. The district court
had cited KSR for the proposition that ``[a] person of ordinary skill
is also a person of ordinary creativity, not an automaton,'' and found
that ``the final step [of the claimed invention] is merely the logical
result of common sense application of the maxim `try, try again.' '' In
affirming the district court, the Federal Circuit undertook an extended
discussion of common sense as it has been applied to the obviousness
inquiry, both before and since the KSR decision.
The Federal Circuit pointed out that application of common sense is
not really an innovation in the law of obviousness when it stated,
``Common sense has long been recognized to inform the analysis of
obviousness if explained with sufficient reasoning.'' Perfect Web, 587
F.3d at 1328 (emphasis added). The Federal Circuit then provided a
review of a number of precedential cases that inform the understanding
of common sense, including In re Bozek, 416 F.2d 1385, 1390 (CCPA 1969)
(explaining that a patent examiner may rely on ``common knowledge and
common sense of the person of ordinary skill in the art without any
specific hint or suggestion in a particular reference'') and In re
Zurko, 258 F.3d 1379, 1383, 1385 (Fed. Cir. 2001) (clarifying that a
factual foundation is needed in order for an examiner to invoke ``good
common sense'' in a case in which ``basic knowledge and common sense
was not based on any evidence in the record'').
[[Page 53657]]
The Federal Circuit implicitly acknowledged in Perfect Web that the
kind of strict evidence-based teaching, suggestion, or motivation
required in In re Lee, 277 F.3d 1338, 1344 (Fed. Cir. 2002), is not an
absolute requirement for an obviousness rejection in light of the
teachings of KSR. The Federal Circuit explained that ``[a]t the time
[of the Lee decision], we required the PTO to identify record evidence
of a teaching, suggestion, or motivation to combine references.''
However, Perfect Web went on to state that even under Lee, common sense
could properly be applied when analyzing evidence relevant to
obviousness. Citing DyStar Textilfarben GmbH v. C.H. Patrick Co., 464
F.3d 1356 (Fed. Cir. 2006), and In re Kahn, 441 F.3d 977 (Fed. Cir.
2006), two cases decided shortly before the Supreme Court's decision in
KSR, the Federal Circuit noted that although ``a reasoned explanation
that avoids conclusory generalizations'' is required to use common
sense, identification of a ``specific hint or suggestion in a
particular reference'' is not.
5. Federal Circuit Cases Discussing Consideration of Evidence.
Office personnel should consider all rebuttal evidence that is timely
presented by the applicants when reevaluating any obviousness
determination. In the case of a claim rendered obvious by a combination
of prior art references, applicants may submit evidence or argument to
demonstrate that the results of the claimed combination were
unexpected.
Another area that has thus far remained consistent with pre-KSR
precedent is the consideration of rebuttal evidence and secondary
considerations in the determination of obviousness. As reflected in the
MPEP, such evidence should not be considered simply for its
``knockdown'' value; rather, all evidence must be reweighed to
determine whether the claims are nonobvious.
Once the applicant has presented rebuttal evidence, Office
personnel should reconsider any initial obviousness determination in
view of the entire record. See, e.g., In re Piasecki, 745 F.2d 1468,
1472, 223 USPQ 785, 788 (Fed. Cir. 1984); In re Eli Lilly & Co., 90
F.2d 943, 945, 14 USPQ2d 1741, 1743 (Fed. Cir. 1990). All the
rejections of record and proposed rejections and their bases should
be reviewed to confirm their continued viability.
MPEP Sec. 2141.
Office personnel should not evaluate rebuttal evidence for its
``knockdown'' value against the prima facie case, Piasecki, 745 F.2d
at 1473, 223 USPQ at 788, or summarily dismiss it as not compelling
or insufficient. If the evidence is deemed insufficient to rebut the
prima facie case of obviousness, Office personnel should
specifically set forth the facts and reasoning that justify this
conclusion.
MPEP Sec. 2145. The following cases exemplify the continued
application of these principles both at the Federal Circuit and within
the Office. Note that these principles were at issue in some of the
cases previously discussed, and have been addressed there in a more
cursory fashion.
Example 5.1. PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491
F.3d 1342 (Fed. Cir. 2007). Teaching point: Even though all evidence
must be considered in an obviousness analysis, evidence of
nonobviousness may be outweighed by contradictory evidence in the
record or by what is in the specification. Although a reasonable
expectation of success is needed to support a case of obviousness,
absolute predictability is not required.
The claims at issue in PharmaStem were directed to compositions
comprising hematopoietic stem cells from umbilical cord or placental
blood, and to methods of using such compositions for treatment of blood
and immune system disorders. The composition claims required that the
stem cells be present in an amount sufficient to effect hematopoietic
reconstitution when administered to a human adult. The trial court had
found that PharmaStem's patents were infringed and not invalid on
obviousness or other grounds. On appeal, the Federal Circuit reversed
the district court, determining that the claims were invalid for
obviousness.
The Federal Circuit discussed the evidence presented at trial. It
pointed out that the patentee, PharmaStem, had not invented an entirely
new procedure or new composition. Rather, PharmaStem's own
specification acknowledged that it was already known in the prior art
that umbilical cord and placental blood-based compositions contained
hematopoietic stem cells, and that hematopoietic stem cells were useful
for the purpose of hematopoietic reconstitution. PharmaStem's
contribution was to provide experimental proof that umbilical cord and
placental blood could be used to effect hematopoietic reconstitution in
mice. By extrapolation, one of ordinary skill in the art would have
expected this reconstitution method to work in humans as well.
The court rejected PharmaStem's expert testimony that hematopoietic
stem cells had not been proved to exist in cord blood prior to the
experiments described in PharmaStem's patents. The court explained that
the expert testimony was contrary to the inventors' admissions in the
specification, as well as prior art teachings that disclosed stem cells
in cord blood. In this case, PharmaStem's evidence of nonobviousness
was outweighed by contradictory evidence.
Despite PharmaStem's useful experimental validation of
hematopoietic reconstitution using hematopoietic stem cells from
umbilical cord and placental blood, the Federal Circuit found that the
claims at issue would have been obvious. There had been ample
suggestion in the prior art that the claimed method would have worked.
Absolute predictability is not a necessary prerequisite to a case of
obviousness. Rather, a degree of predictability that one of ordinary
skill would have found to be reasonable is sufficient. The Federal
Circuit concluded that ``[g]ood science and useful contributions do not
necessarily result in patentability.'' Id. at 1364.
Example 5.2. In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007).
Teaching point: All evidence, including evidence rebutting a prima
facie case of obviousness, must be considered when properly presented.
It was found to be an error in Sullivan for the Board to fail to
consider evidence submitted to rebut a prima facie case of obviousness.
The claimed invention was directed to an antivenom composition
comprising F(ab) fragments used to treat venomous rattlesnake bites.
The composition was created from antibody molecules that include three
fragments, F(ab)2, F(ab) and F(c), which have separate
properties and utilities. There have been commercially available
antivenom products that consisted of whole antibodies and
F(ab)2 fragments, but researchers had not experimented with
antivenoms containing only F(ab) fragments because it was believed that
their unique properties would prevent them from decreasing the toxicity
of snake venom. The inventor, Sullivan, discovered that F(ab) fragments
are effective at neutralizing the lethality of rattlesnake venom, while
reducing the occurrence of adverse immune reactions in humans. On
appeal of the examiner's rejection, the Board held that the claim was
obvious because all the elements of the claimed composition were
accounted for in the prior art, and that the composition taught by that
prior art would have been expected by a person of ordinary skill in the
art at the time the invention was made to neutralize the lethality of
the venom of a rattlesnake.
Rebuttal evidence had not been considered by the Board because it
[[Page 53658]]
considered the evidence to relate to the intended use of the claimed
composition as an antivenom, rather than the composition itself.
Appellant successfully argued that even if the Board had shown a prima
facie case of obviousness, the extensive rebuttal evidence must be
considered. The evidence included three expert declarations submitted
to show that the prior art taught away from the claimed invention, an
unexpected property or result from the use of F(ab) fragment antivenom,
and why those having ordinary skill in the art expected antivenoms
comprising F(ab) fragments to fail. The declarations related to more
than the use of the claimed composition. While a statement of intended
use may not render a known composition patentable, the claimed
composition was not known, and whether it would have been obvious
depends upon consideration of the rebuttal evidence. Appellant did not
concede that the only distinguishing factor of its composition is the
statement of intended use and extensively argued that its claimed
composition exhibits the unexpected property of neutralizing the
lethality of rattlesnake venom while reducing the occurrence of adverse
immune reactions in humans. The Federal Circuit found that such a use
and unexpected property cannot be ignored--the unexpected property is
relevant and thus the declarations describing it should have been
considered.
Nonobviousness can be shown when a person of ordinary skill in the
art would not have reasonably predicted the claimed invention based on
the prior art, and the resulting invention would not have been
expected. All evidence must be considered when properly presented.
Example 5.3. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357
(Fed. Cir. 2010). Teaching point: Evidence that has been properly
presented in a timely manner must be considered on the record. Evidence
of commercial success is pertinent where a nexus between the success of
the product and the claimed invention has been demonstrated.
The case of Hearing Components involved a disposable protective
covering for the portion of a hearing aid that is inserted into the ear
canal. The covering was such that it could be readily replaced by a
user as needed.
At the district court, Shure had argued that Hearing Components'
patents were obvious over one or more of three different combinations
of prior art references. The jury disagreed, and determined that the
claims were nonobvious. The district court upheld the jury verdict,
stating that in view of the conflicting evidence presented by the
parties as to the teachings of the references, motivation to combine,
and secondary considerations, the nonobviousness verdict was
sufficiently grounded in the evidence.
Shure appealed to the Federal Circuit, but the Federal Circuit
agreed with the district court that the jury's nonobviousness verdict
had been supported by substantial evidence. Although Shure had argued
before the jury that the Carlisle reference taught an ear piece
positioned inside the ear canal, Hearing Components' credible witness
countered that only the molded duct and not the ear piece itself was
taught by Carlisle as being inside the ear canal. On the issue of
combining references, Shure's witness had given testimony described as
``rather sparse, and lacking in specific details.'' Id. at 1364. In
contradistinction, Hearing Components' witness ``described particular
reasons why one skilled in the art would not have been motivated to
combine the references.'' Id. Finally, as to secondary considerations,
the Federal Circuit determined that Hearing Components had shown a
nexus between the commercial success of its product and the patent by
providing evidence that ``the licensing fee for a covered product was
more than cut in half immediately upon expiration'' of the patent.
Although the Hearing Components case involves substantial evidence
of nonobviousness in a jury verdict, it is nevertheless instructive for
Office personnel on the matter of weighing evidence. Office personnel
routinely must consider evidence in the form of prior art references,
statements in the specification, or declarations under 37 CFR 1.131 or
1.132. Other forms of evidence may also be presented during
prosecution. Office personnel are reminded that evidence that has been
presented in a timely manner should not be ignored, but rather should
be considered on the record. However, not all evidence need be accorded
the same weight. In determining the relative weight to accord to
rebuttal evidence, considerations such as whether a nexus exists
between the claimed invention and the proffered evidence, and whether
the evidence is commensurate in scope with the claimed invention, are
appropriate. The mere presence of some credible rebuttal evidence does
not dictate that an obviousness rejection must always be withdrawn. See
MPEP Sec. 2145. Office personnel must consider the appropriate weight
to be accorded to each piece of evidence. An obviousness rejection
should be made or maintained only if evidence of obviousness outweighs
evidence of nonobviousness. See MPEP Sec. 706(I) (``The standard to be
applied in all cases is the `preponderance of the evidence' test. In
other words, an examiner should reject a claim if, in view of the prior
art and evidence of record, it is more likely than not that the claim
is unpatentable.''). MPEP Sec. 716.01(d) provides further guidance on
weighing evidence in making a determination of patentability.
Example 5.4. Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310
(Fed. Cir. 2008). Teaching point: Evidence of secondary considerations
of obviousness such as commercial success and long-felt need may be
insufficient to overcome a prima facie case of obviousness if the prima
facie case is strong. An argument for nonobviousness based on
commercial success or long-felt need is undermined when there is a
failure to link the commercial success or long-felt need to a claimed
feature that distinguishes over the prior art.
The claims at issue in Asyst concerned a processing system for
tracking articles such as silicon wafers which move from one processing
station to the next in a manufacturing facility. The claims required
that each processing station be in communication with a central control
unit. The Federal Circuit agreed with the district court that the only
difference between the claimed invention and the prior art to Hesser
was that the prior art had taught the use of a bus for this
communication, while the claims required a multiplexer. At trial, the
jury had concluded that Hesser was not relevant prior art, but the
district court overturned that conclusion and issued a judgment as a
matter of law (JMOL) that the claims would have been obvious in view of
Hesser. Because the evidence showed that persons of ordinary skill in
the art would have been familiar with both the bus and the multiplexer,
and that they could have readily selected and employed one or the other
based on known considerations, the Federal Circuit affirmed the
district court's conclusion that the claims were invalid for
obviousness.
The Federal Circuit also discussed arguments that the district
court had failed to consider the objective evidence of nonobviousness
presented by Asyst. Asyst had offered evidence of commercial success of
its invention. However, the Federal Circuit pointed out that Asyst had
not provided the required nexus between the commercial success and the
claimed invention, emphasizing that ``Asyst's failure to link that
commercial success to the features
[[Page 53659]]
of its invention that were not disclosed in Hesser undermines the
probative force of the evidence * * *.'' Id. at 1316. Asyst had also
offered evidence from others in the field praising the invention as
addressing a long-felt need. Once again, the Federal Circuit found the
argument to be unavailing in view of the prior art, stating that
``[w]hile the evidence shows that the overall system drew praise as a
solution to a felt need, there was no evidence that the success * * *
was attributable to the substitution of a multiplexer for a bus, which
was the only material difference between Hesser and the patented
invention.'' Id. The Federal Circuit also reiterated, citing pre-KSR
decisions, that ``as we have often held, evidence of secondary
considerations does not always overcome a strong prima facie showing of
obviousness.'' Id. (citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1372 (Fed. Cir. 2007); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714,
719-20 (Fed. Cir. 1991); Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757,
768 (Fed. Cir. 1988)).
When considering obviousness, Office personnel should carefully
weigh any properly presented objective evidence of nonobviousness
against the strength of the prima facie case. If the asserted evidence,
such as commercial success or satisfaction of a long-felt need, is
attributable to features already in the prior art, the probative value
of the evidence is reduced.
6. Conclusion. This 2010 KSR Guidelines Update is intended to be
used by Office personnel in conjunction with the guidance provided in
MPEP Sec. Sec. 2141 and 2143 (which incorporates the 2007 KSR
Guidelines) to clarify the contours of obviousness after KSR. It
addresses a number of issues that arise when Office personnel consider
whether or not a claimed invention is obvious. While Office personnel
are encouraged to make use of these tools, they are reminded that every
question of obviousness must be decided on its own facts. The Office
will continue to monitor the developing law of obviousness, and will
provide additional guidance and updates as necessary.
Dated: August 20, 2010.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
Appendix
The following table contains the cases set out as examples in
this 2010 KSR Guidelines Update and the teaching points of the case.
------------------------------------------------------------------------
Case Teaching point
------------------------------------------------------------------------
Combining Prior Art Elements
------------------------------------------------------------------------
In re Omeprazole Patent Even where a general method that
Litigation, 536 F.3d 1361 (Fed. could have been applied to make the
Cir. 2008). claimed product was known and
within the level of skill of the
ordinary artisan, the claim may
nevertheless be nonobvious if the
problem which had suggested use of
the method had been previously
unknown.
Crocs, Inc. v. U.S. Int'l Trade A claimed combination of prior art
Comm'n., 598 F.3d 1294 (Fed. Cir. elements may be nonobvious where
2010). the prior art teaches away from the
claimed combination and the
combination yields more than
predictable results.
Sundance, Inc. v. DeMonte A claimed invention is likely to be
Fabricating Ltd., 550 F.3d 1356 obvious if it is a combination of
(Fed. Cir. 2008). known prior art elements that would
reasonably have been expected to
maintain their respective
properties or functions after they
have been combined.
Ecolab, Inc. v. FMC Corp., 569 A combination of known elements
F.3d 1335 (Fed. Cir. 2009). would have been prima facie obvious
if an ordinarily skilled artisan
would have recognized an apparent
reason to combine those elements
and would have known how to do so.
Wyers v. Master Lock Co., No. 2009- The scope of analogous art is to be
1412, --F.3d--, 2010 WL 2901839 construed broadly and includes
(Fed. Cir. July 22, 2010). references that are reasonably
pertinent to the problem that the
inventor was trying to solve.
Common sense may be used to support
a legal conclusion of obviousness
so long as it is explained with
sufficient reasoning.
DePuy Spine, Inc. v. Medtronic Predictability as discussed in KSR
Sofamor Danek, Inc., 567 F.3d encompasses the expectation that
1314 (Fed. Cir. 2009). prior art elements are capable of
being combined, as well as the
expectation that the combination
would have worked for its intended
purpose. An inference that a
claimed combination would not have
been obvious is especially strong
where the prior art's teachings
undermine the very reason being
proffered as to why a person of
ordinary skill would have combined
the known elements.
------------------------------------------------------------------------
Substituting One Known Element for Another
------------------------------------------------------------------------
In re ICON Health & Fitness, Inc., When determining whether a reference
496 F.3d 1374 (Fed. Cir. 2007). in a different field of endeavor
may be used to support a case of
obviousness (i.e., is analogous),
it is necessary to consider the
problem to be solved.
Agrizap, Inc. v. Woodstream Corp., Analogous art is not limited to
520 F.3d 1337 (Fed. Cir. 2008). references in the field of endeavor
of the invention, but also includes
references that would have been
recognized by those of ordinary
skill in the art as useful for
applicant's purpose.
Muniauction, Inc. v. Thomson Because Internet and Web browser
Corp., 532 F.3d 1318 (Fed. Cir. technologies had become commonplace
2008). for communicating and displaying
information, it would have been
obvious to adapt existing processes
to incorporate them for those
functions.
Aventis Pharma Deutschland v. A chemical compound would have been
Lupin, Ltd., 499 F.3d 1293 (Fed. obvious over a mixture containing
Cir. 2007). that compound as well as other
compounds where it was known or the
skilled artisan had reason to
believe that some desirable
property of the mixture was derived
in whole or in part from the
claimed compound, and separating
the claimed compound from the
mixture was routine in the art.
Eisai Co. Ltd. v. Dr. Reddy's A claimed compound would not have
Labs., Ltd., 533 F.3d 1353 (Fed. been obvious where there was no
Cir. 2008). reason to modify the closest prior
art lead compound to obtain the
claimed compound and the prior art
taught that modifying the lead
compound would destroy its
advantageous property. Any known
compound may serve as a lead
compound when there is some reason
for starting with that lead
compound and modifying it to obtain
the claimed compound.
Procter & Gamble Co. v. Teva It is not necessary to select a
Pharmaceuticals USA, Inc., 566 single compound as a ``lead
F.3d 989 (Fed. Cir. 2009). compound'' in order to support an
obviousness rejection. However,
where there was reason to select
and modify the lead compound to
obtain the claimed compound, but no
reasonable expectation of success,
the claimed compound would not have
been obvious.
[[Page 53660]]
Altana Pharma AG v. Teva Pharms. Obviousness of a chemical compound
USA, Inc., 566 F.3d 999 (Fed. in view of its structural
Cir. 2009). similarity to a prior art compound
may be shown by identifying some
line of reasoning that would have
led one of ordinary skill in the
art to select and modify a prior
art lead compound in a particular
way to produce the claimed
compound. It is not necessary for
the reasoning to be explicitly
found in the prior art of record,
nor is it necessary for the prior
art to point to only a single lead
compound.
------------------------------------------------------------------------
The Obvious To Try Rationale
------------------------------------------------------------------------
In re Kubin, 561 F.3d 1351 (Fed. A claimed polynucleotide would have
Cir. 2009). been obvious over the known protein
that it encodes where the skilled
artisan would have had a reasonable
expectation of success in deriving
the claimed polynucleotide using
standard biochemical techniques,
and the skilled artisan would have
had a reason to try to isolate the
claimed polynucleotide. KSR applies
to all technologies, rather than
just the ``predictable'' arts.
Takeda Chem. Indus. v. Alphapharm A claimed compound would not have
Pty., Ltd., 492 F.3d 1350 (Fed. been obvious where it was not
Cir. 2007). obvious to try to obtain it from a
broad range of compounds, any one
of which could have been selected
as the lead compound for further
investigation, and the prior art
taught away from using a particular
lead compound, and there was no
predictability or reasonable
expectation of success in making
the particular modifications
necessary to transform the lead
compound into the claimed compound.
Ortho-McNeil Pharmaceutical, Inc. Where the claimed anti-convulsant
v. Mylan Labs, Inc., 520 F.3d drug had been discovered somewhat
1358 (Fed. Cir. 2008). serendipitously in the course of
research aimed at finding a new
anti-diabetic drug, it would not
have been obvious to try to obtain
a claimed compound where the prior
art did not present a finite and
easily traversed number of
potential starting compounds, and
there was no apparent reason for
selecting a particular starting
compound from among a number of
unpredictable alternatives.
Bayer Schering Pharma A.G. v. Barr A claimed compound would have been
Labs., Inc., 575 F.3d 1341 (Fed. obvious where it was obvious to try
Cir. 2009). to obtain it from a finite and
easily traversed number of options
that was narrowed down from a
larger set of possibilities by the
prior art, and the outcome of
obtaining the claimed compound was
reasonably predictable.
Sanofi-Synthelabo v. Apotex, Inc., A claimed isolated stereoisomer
550 F.3d 1075 (Fed. Cir. 2008). would not have been obvious where
the claimed stereoisomer exhibits
unexpectedly strong therapeutic
advantages over the prior art
racemic mixture without the
correspondingly expected toxicity,
and the resulting properties of the
enantiomers separated from the
racemic mixture were unpredictable.
Rolls-Royce, PLC v. United An obvious to try rationale may be
Technologies Corp., 603 F.3d 1325 proper when the possible options
(Fed. Cir. 2010). for solving a problem were known
and finite. However, if the
possible options were not either
known or finite, then an obvious to
try rationale cannot be used to
support a conclusion of
obviousness.
Perfect Web Techs., Inc. v. Where there were a finite number of
InfoUSA, Inc., 587 F.3d 1324 identified, predictable solutions
(Fed. Cir. 2009). and there is no evidence of
unexpected results, an obvious to
try inquiry may properly lead to a
legal conclusion of obviousness.
Common sense may be used to support
a legal conclusion of obviousness
so long as it is explained with
sufficient reasoning.
------------------------------------------------------------------------
Consideration of Evidence
------------------------------------------------------------------------
PharmaStem Therapeutics, Inc. v. Even though all evidence must be
ViaCell, Inc., 491 F.3d 1342 considered in an obviousness
(Fed. Cir. 2007). analysis, evidence of
nonobviousness may be outweighed by
contradictory evidence in the
record or by what is in the
specification. Although a
reasonable expectation of success
is needed to support a case of
obviousness, absolute
predictability is not required.
In re Sullivan, 498 F.3d 1345 All evidence, including evidence
(Fed. Cir. 2007). rebutting a prima facie case of
obviousness, must be considered
when properly presented.
Hearing Components, Inc. v. Shure Evidence that has been properly
Inc., 600 F.3d 1357 (Fed. Cir. presented in a timely manner must
2010). be considered on the record.
Evidence of commercial success is
pertinent where a nexus between the
success of the product and the
claimed invention has been
demonstrated.
Asyst Techs., Inc. v. Emtrak, Evidence of secondary considerations
Inc., 544 F.3d 1310 (Fed. Cir. of obviousness such as commercial
2008). success and long-felt need may be
insufficient to overcome a prima
facie case of obviousness if the
prima facie case is strong. An
argument for nonobviousness based
on commercial success or long-felt
need is undermined when there is a
failure to link the commercial
success or long-felt need to a
claimed feature that distinguishes
over the prior art.
------------------------------------------------------------------------
[FR Doc. 2010-21646 Filed 8-31-10; 8:45 am]
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