[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32639-32645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15777]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office
[Docket No. 980605148-8148-01]


Request for Comments on Interim Guidelines for Examination of 
Patent Applications Under the 35 U.S.C. 112 para. 1 ``Written 
Description'' Requirement

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice and request for public comments.

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SUMMARY: The Patent and Trademark Office (PTO) requests comments from 
any interested member of the public on the following interim 
guidelines. These guidelines will be used by PTO personnel in their 
review of biotechnological patent applications for compliance with the 
``written description'' requirement of 35 U.S.C. 112 para. 1. Although 
the guidelines are directed primarily to written descriptions of 
biotechnological inventions, they reflect the current understanding of 
the PTO and apply across the board to all relevant technologies.

DATES: Written comments on the interim guidelines will be accepted by 
the PTO until September 14, 1998.

ADDRESSES: Written comments should be addressed to Box 8, Commissioner 
of Patents and Trademarks, Washington, D.C. 20231, marked to the 
attention of Scott A. Chambers, Associate Solicitor or to Box Comments, 
Assistant Commissioner for Patents, Washington, D.C. 20231 marked to 
the attention of Linda S. Therkorn. Alternatively, comments may be 
submitted to Scott Chambers via facsimile at (703) 305-9373 or by 
electronic mail addressed to ``[email protected]'' or to Linda 
Therkorn via facsimile at (703) 305-8825 or by electronic mail 
addressed at ``[email protected].''

FOR FURTHER INFORMATION CONTACT: Scott Chambers by telephone at (703) 
305-9035, by facsimile at (703) 305-9373, by mail to his attention 
addressed to Box 8, Commissioner of Patents and Trademarks, Washington, 
D.C. 20231, or by electronic mail at ``[email protected]'; or 
Linda Therkorn by telephone at (703) 305-8800, by facsimile at (703) 
305-8825, by mail addressed to Box Comments, Assistant Commissioner for 
Patents, Washington, D.C. 20231, or by electronic mail at 
``[email protected].''

SUPPLEMENTARY INFORMATION: The PTO requests comments from any 
interested member of the public on the following interim guidelines. 
These guidelines will be used by PTO personnel in their review of 
biotechnological patent applications for compliance with the ``written 
description'' requirement of 35 U.S.C. 112 para. 1. Although the 
guidelines are directed primarily to written descriptions of 
biotechnological inventions, they reflect the current understanding of 
the PTO and apply across the board to all relevant technologies. 
Because these guidelines govern internal practices, they are exempt 
from notice and comment rulemaking under 5 U.S.C. 553(b)(A).
    Written comments should include the following information: (1) name 
and affiliation of the individual responding; and (2) an indication of 
whether the comments offered represent views of the respondent's 
organization or are they respondent's personal views. The PTO is 
particularly interested in comments relating to: (1) the accuracy of 
the methodology; (2) relevant factors to consider in determining 
whether the written description requirement of 35 U.S.C. 112 para. 1 is 
satisfied; (3) whether the scope of these guidelines should be limited 
to certain technologies, such as biotechnology, or even a particular 
area of biotechnology such as nucleic acids, or encompass all 
technologies generally; (4) whether the scope of these guidelines 
should be expanded to include processes and/or product-by-process 
claims; and (5) the impact these guidelines may have on currently 
pending applications as well as future applications.
    Parties presenting written comments are requested, where possible, 
to provide their comments in machine-readable format in addition to a 
paper copy. Such submissions may be provided by electronic mail 
messages sent over the Internet, or on a 3.5'' floppy disk formatted 
for use in either a Macintosh, Windows, Windows for Workgroups, Windows 
95, Windows NT, or MS-DOS based computer.
    Written comments will be available for public inspection on or 
about September 14, 1998, in Suite 918, Crystal Park 2, 2121 Crystal 
Drive, Arlington, Virginia. In addition, comments provided in machine-
readable format will be available through anonymous file transfer 
protocol (ftp) via the Internet (address: comments.uspto.gov) and 
through the World Wide Web (address: www.uspto.gov).

Interim Guidelines for the Examination of Patent Applications Under 
The 35 U.S.C. 112 para. 1 ``Written Description'' Requirement

    These ``Written Description Guidelines'' are intended to assist 
Office personnel in the examination of patent applications for 
compliance with the written description requirement of 35 U.S.C. 112, 
para. 1, in view of University of California v. Eli Lilly 1 
and the earlier cases Fiers v. Revel 2 and Amgen, Inc. v. 
Chugai Pharmaceutical Co. 3 These Interim Guidelines are 
directed primarily to determining whether there is written description 
support for product claims and are not intended to specifically address 
the description necessary to support process or product-by-process 
claims. Similarly, these Guidelines are not intended to directly 
address the question of new matter, which is currently addressed in the 
Manual of Patent Examining Procedure Secs. 2163.06-.07. The Final 
Guidelines may address these additional issues if public comment 
suggests they should be addressed. These guidelines are based on the 
Office's current understanding of the law and are believed to be fully 
consistent with binding precedent of the Supreme Court, the Federal 
Circuit, and the Federal Circuit's predecessor courts.
    These guidelines do not constitute substantive rulemaking and hence 
do not have the force and effect of law. They are designed to assist 
Office personnel in analyzing claimed subject matter for compliance 
with substantive law. Rejections will be based upon the substantive 
law, and it is these rejections which are appealable. Consequently, any 
failure by Office personnel to follow the guidelines is neither 
appealable nor petitionable.

[[Page 32640]]

    These guidelines are intended to form part of the normal 
examination process. Thus, where Office personnel establish a prima 
facie case of lack of written description for a claim, a thorough 
review of the prior art and examination on the merits for compliance 
with the other statutory requirements, including those of 35 U.S.C. 
101, 102, 103, and 112, is to be conducted prior to completing an 
Office action which includes a rejection for lack of written 
description.
    Office personnel are to rely on these guidelines in the event of 
any inconsistent treatment of issues involving the written description 
requirement between these guidelines and any earlier guidance provided 
from the Office. Although these guidelines address examples principally 
drawn from the biotechnological arts, they are intended to be equally 
applicable to all fields of invention.

I. General Principles Governing Compliance with the ``Written 
Description'' Requirement for Applications

    The first paragraph of 35 U.S.C. 112 requires that the 
``specification shall contain a written description of the invention * 
* *'' This requirement is separate and distinct from the enablement 
requirement. 4 This written description requirement has 
several policy objectives. ``[T]he ``essential goal'' of the 
description of the invention requirement is to clearly convey the 
information that an applicant has invented the subject matter which is 
claimed.'' 5 Another objective is to put the public in 
possession of what the applicant claims as the invention. The written 
description requirement prevents an applicant from claiming subject 
matter that was not described in the specification as filed, and the 
proscription against the introduction of new matter in a patent 
application 6 serves to prevent an applicant from adding 
information that goes beyond the subject matter originally filed.
    To satisfy the written description requirement, a patent 
specification must describe the claimed invention in sufficient detail 
that one skilled in the art can reasonably conclude that the inventor 
had possession of the claimed invention. 7 This requirement 
of the Patent Act promotes the progress of the useful arts by ensuring 
that patentees adequately describe their inventions in their patent 
specifications for the benefit of the public in exchange for the right 
to exclude others from practicing the invention for the duration of the 
patent's term. 8

II. Evaluate Whether The Application Complies With the ``Written 
Description'' Requirement

    The inquiry into whether the description requirement is met must be 
determined on a case-by-case basis and is a question of fact. 
9 The examiner has the initial burden of presenting evidence 
or reasons why a person skilled in the art would not recognize in an 
applicant's disclosure a description of the invention defined by the 
claims. 10 Office personnel should adhere to the following 
procedures when reviewing patent applications for compliance with the 
written description requirement of 35 U.S.C. 112, para. 1.

A. Review the Entire Application To Determine What Applicant has 
Invented, the Field of the Invention and the Level of Predictability in 
the Art

    Prior to determining whether the claims satisfy the written 
description requirement, Office personnel should review the entire 
specification, including the specific embodiments, figures, sequence 
listings, and the claims, to understand what applicant has invented and 
the correspondence between what applicant has described, i.e., has 
possession of, and what applicant is claiming. Such a review should be 
conducted from the standpoint of one of skill in the art at the time 
the application was filed and should include a determination of the 
field of the invention and, thus, the level of predictability in the 
art. Predictability of the structure of a species can be premised upon:
    (1) Whether the level of skill in the art leads to a predictability 
of structure; and/or
    (2) Whether teachings in the application or prior art lead to a 
predictability of structure.
    There is an inverse correlation between the level of predictability 
in the art and the amount of disclosure necessary to satisfy the 
written description requirement. For example, if there is a well-
established correlation between structure and function in the art, one 
skilled in the art will be able to reasonably predict the complete 
structure of the claimed invention from its function. Thus, in some 
factual situations, the written description requirement may be 
satisfied through disclosure of function alone when there is a well-
established correlation between structure and function. In contrast, 
without such a correlation, prediction of structure from function is 
highly unlikely. In this latter case, disclosure of function alone will 
not satisfy the written description requirement. 11

B. For Each Claim, Determine What the Claim as a Whole Covers

    Each claim must be separately analyzed and given its broadest 
reasonable interpretation. 12 The entire claim, including 
its preamble language and transitional phrase, must be considered. 
``Preamble language'' is that language in a claim appearing before a 
transitional phase, e.g., before ``comprising,'' ``consisting 
essentially of,'' or ``consisting of''. The transitional term 
``comprising'' (and other comparable terms, e.g., ``containing'' and 
``including'') is ``open-ended''--it covers the expressly recited 
subject matter alone or in combination with other unstated subject 
matter. 13 There must be adequate written description to 
support the claimed invention including the preamble. 14 The 
claim as a whole, including all limitations found in the preamble, the 
transitional phrase, and the body of the claim, must be described 
sufficiently to satisfy the written description requirement. 
15 For claims of the form ``A [structure] comprising SEQ ID 
NO: 1'' there may be a written description problem if the claim as a 
whole, including its preamble and transitional phrase, is directed to 
an invention of unpredictable structure that is not fully described.
    For example, when the term ``gene,'' ``mRNA,'' or ``cDNA'' is 
recited in the preamble, it implies a specific structure (or a small 
genus of specific structures) when used in the traditional sense, i.e., 
to mean the structure having the naturally occurring sequence. Thus, 
``A gene comprising SEQ ID NO: 1''; ``A mRNA comprising SEQ ID NO: 1''; 
and ``A cDNA comprising SEQ ID NO: 1'' implicitly recite specific 
structures such as promoters, enhancers, coding regions, and other 
regulatory elements in the preamble which must be sufficiently 
described in the specification so as to show the applicant was in 
possession of the claimed inventions.
    In contrast, use of less specific, generic preamble language, such 
as ``composition,'' ``nucleic acid,'' ``DNA,'' and ``RNA,'' does not 
typically present a written description problem. These terms are 
sufficiently general that one skilled in the art can readily envision a 
sufficient number of members of the claimed genus to provide written 
description support for the genus.
    A claim such as ``A gene comprising SEQ ID NO: 1,'' can be viewed 
as a species claim in which the preamble recites a combination and the 
body of the claim recites a subcombination: The ``gene'' is the 
combination and ``SEQ ID

[[Page 32641]]

NO: 1'' (which is a fragment of the gene) is the subcombination. 
Written description of only the subcombination (in this example the 
fragment SEQ ID NO: 1) normally does not put one in possession of the 
combination (in this example the gene).
    Likewise, generic claims to sequences can be viewed as a genus of 
such combination-subcombination claims. For example, a claim such as 
``A nucleic acid comprising SEQ ID NO: 1'' can be viewed as a genus 
claim in which each member of the genus (each species) is itself a 
combination-subcombination: Each member of the genus ``nucleic acid'' 
is a combination containing the subcombination ``SEQ ID NO: 1'' (which 
is a fragment of the nucleic acid). Again, the generic term ``nucleic 
acid'' does not typically present a written description problem because 
one skilled in the art can readily envision a sufficient number of 
members of the claimed genus to provide written description support for 
the genus. 16

C. For Each Claimed Species, Determine Whether There is Sufficient 
Written Description To Inform a Skilled Artisan That Applicant was in 
Possession of the Claimed Invention at the Time the Application was 
Filed

    Written description may be satisfied through disclosure of relevant 
identifying characteristics, i.e., structure, other physical and/or 
chemical characteristics, functional characteristics when coupled with 
a known or disclosed correlation between function and structure, or 
some combination of such characteristics. What is well known to one 
skilled in the art need not be disclosed. If a skilled artisan would 
have understood the inventor to be in possession of the claimed 
invention at the time of filing, even if every nuance of the claims is 
not explicitly described in the specification, then the adequate 
description requirement is met.
    For each claimed species:
    (1) Determine whether a complete structure is disclosed. The 
complete structure of a species typically satisfies the requirement 
that the description be set forth in ``such full, clear, concise and 
exact terms'' to show possession of the claimed invention. If a 
complete structure is disclosed, the written description requirement is 
satisfied for that species, and a rejection under 35 U.S.C. 112 para. 1 
for lack of written description must not be made.
    For example, consider the following claim:

    A probe for use in detecting nucleic acid sequences coding for 
enzyme Q from the genus Bacillus consisting of SEQ ID NO: 16.

    Considering the claim as a whole, it is a species claim covering 
the probe SEQ ID NO: 16. The specification discloses the complete 
sequence for SEQ ID NO: 16. Thus, this claim falls into the ``safe 
harbor'' described under C(1).
    (2) If the complete structure is not disclosed, determine whether 
the specification discloses other relevant identifying characteristics, 
i.e., physical and/or chemical characteristics and/or functional 
characteristics coupled with a known or disclosed correlation between 
function and structure, sufficient to describe the claimed invention in 
such full, clear, concise and exact terms that a skilled artisan would 
recognize applicant was in possession of the claimed invention. 
Disclosure of any combination of such identifying characteristics that 
would lead one of skill in the art to the conclusion that the applicant 
was in possession of the claimed species is sufficient. In such a case, 
a rejection for lack of written description under 35 U.S.C. 112 para. 1 
must not be made.
    For example, consider the following claim:

    An isolated double-stranded DNA consisting of (1) a single-
stranded DNA which has a molecular size of 2.57 Kb and is derived 
from golden mosaic virus, and (2) a DNA complementary to said 
single-stranded DNA, giving the restriction endonuclease cleavage 
map shown in FIG.2(a) and having no Mbo I restriction endonuclease 
site.

    Although the specification does not disclose the complete structure 
for the claimed DNA, it does disclose sufficient identifying 
characteristics, i.e., size, cleavage map, and source from which the 
DNA is derived. Thus, while this claim does not meet the C(1) criteria 
because the complete sequence is not disclosed, it does meet the C(2) 
criteria because one skilled in the art would recognize from the 
characteristics, e.g., size, map, source, that applicant was in 
possession of the claimed material at the time of filing.
    The following protein claim also falls within the C(2) criteria:

    An isolated alginate lyase enzyme wherein said enzyme lyses 
alginate in the mucous substance produced in a patient with cystic 
fibrosis and wherein said enzyme has the N-terminal amino acid 
sequence SEQ ID No. 1, obtained from Flavobacterium pepermentium and 
has the following physicochemical properties: (1) Activity: lyses 
alginate to saccharides having a non-reducing end C4-
C5 double bond and ultimately to 4-deoxy-5-ketouronic 
acid; (2) Molecular weight: 60,000 daltons; (3) Optimal pH: 8.0; (4) 
Stable pH: 6.0-8.0; (5) Optimal temperature: 70 degrees C; and (6) 
Substrate specificity: alginate.

    In this example, the specification discloses the molecular weight, 
origin, activity, and specificity but does not disclose the complete 
structure for the claimed enzyme. Thus, this claim would not meet the 
C(1) criteria because the complete sequence is not disclosed. However, 
the claim meets the C(2) criteria because, although the complete 
structure is not disclosed, one skilled in the art would recognize from 
the disclosed physical characteristics--e.g., molecular weight, origin, 
activity, and specificity--that applicant was in possession of the 
claimed material at the time of filing.
    In contrast, consider the following claim:

    An isolated nucleotide sequence consisting of the sequence of the 
reverse transcript of a human mRNA, which mRNA encodes insulin.

    The specification in this example provides the coding sequence for 
rat insulin but not that for human insulin. The description for the 
reverse transcript of human mRNA is limited to its function, encoding 
human insulin, and to a method for isolating the claimed sequence from 
its natural source. A sequence described only by a purely functional 
characteristic, without any known or disclosed correlation between that 
function and the structure of the sequence, normally is not a 
sufficient identifying characteristic for written description purposes, 
even when accompanied by a method of obtaining the claimed species. In 
this case, even though a genetic code table would correlate a known 
insulin amino acid sequence with a genus of coding nucleic acids, the 
same table cannot predict the native, naturally occurring nucleic acid 
sequence of human mRNA or its corresponding cDNA. Thus, the 
specification in this example does not provide adequate written 
description, either under the C(1) or C(2) criteria.
    Any claim to a species that does not meet the test described under 
C(1) or C(2)must be rejected as lacking adequate written description 
under 35 U.S.C. 112 para. 1.

[[Page 32642]]

D. For Each Claimed Genus, Determine Whether There is Sufficient 
Written Description to Inform a Skilled Artisan That Applicant was in 
Possession of the Claimed Genus at the Time the Application was Filed

    The written description requirement for a claimed genus may be 
satisfied through sufficient description of a representative number of 
species by relevant identifying characteristics, i.e., structure or 
other physical and/or chemical characteristics, by functional 
characteristics coupled with a known or disclosed correlation between 
function and structure, or by a combination of such identifying 
characteristics, sufficient to show the applicant was in possession of 
the claimed genus. A ``representative number of species'' requires that 
the species which are expressly described be representative of the 
entire genus. Thus, when there is substantial variation within the 
genus, it may require a description of the various species which 
reflect the variation within the genus. For example, a broadly drawn 
claim to a specific gene from ruminant mammals may require a 
representative species from cattle, buffalo, bison, goat, deer, 
antelope, camel, giraffe and llama.
    What constitutes a ``representative number'' is an inverse function 
of the predictability of the art, as determined in IIA above. The 
number must be sufficient to reasonably identify the other members of 
genus. In an unpredictable art, adequate written description of a genus 
cannot be achieved by disclosing only one species within the genus. In 
fact, if the members of the genus are expected to vary widely in their 
identifying characteristics, such as structure and activity, written 
description for each member within the genus may be necessary.
    Generalized descriptions alone, such as ``vertebrate insulin cDNA'' 
or ``mammalian insulin cDNA,'' fail to satisfy the written description 
requirement because they do not describe any members of the genus 
except by function without any known or disclosed correlation between 
function and structure.24 If the correlation between 
structure and function in the art would not have been known to one 
skilled in the art and the specification does not describe the 
correlation, the written descriptive support cannot depend on that 
correlation.
    For each claim to a genus:
    (1) Determine whether a representative number of species have been 
described by complete structure as in C(1) above. If a representative 
number have been so described, then the applicant has written 
description support for the claimed genus and a rejection under 112 
para. 1 for lack of written description must not be made.
    For example, consider the following claim to a genus:

    An isolated DNA probe for detecting HIV-X, wherein said DNA 
probe hybridizes to the nucleotide sequence set forth in SEQ ID NO:1 
under the following conditions: hybridization in 7% sodium dodecyl 
sulfate (SDS), 0.5M NaPO 4 pH 7.0, 1mM EDTA at 50 deg. 
C.; and washing with 1% SDS at 42 deg. C.

    In this case, the specification discloses the sequence of the 
isolated DNA molecule consisting of SEQ ID NO: 1 and discloses several 
sequences that hybridize to SEQ ID NO: 1. Hybridization under the 
stringent conditions specified here requires that the claimed nucleic 
acid probes be structurally similar to the complement of the nucleic 
acid sequence disclosed as SEQ ID NO: 1. In this case, the description 
as a whole is sufficient to evidence possession of the claimed genus 
because the genus is defined by relation to the structure of the 
sequence provided as SEQ ID NO: 1, and because several species are 
disclosed that possess the hybridization property which further defines 
the genus. Thus, this claim to a genus meets the D(1) criteria.
    (2) For each claim to a genus not supported as described under 
D(1), determine whether there is a representative number of adequately 
described species, as analyzed under C(2). The representative number 
must permit one skilled in the art to reasonably identify the remaining 
members of the genus. If a representative number are so described, then 
the written description requirement is satisfied and, again, a 
rejection under 112 para. 1 for lack of written description must not be 
made.
    For example, consider the following claim to a genus:

    A monoclonal antibody which specifically binds to the novel 
cancer associated TAG-31 antigen but which does not substantially 
bind normal adult human tissues, wherein said monoclonal antibody 
has a binding affinity of greater than 3 times 10 \9\ M-
-\1\ for TAG-31.

    Considering the claim as a whole, it is drawn to a genus of 
monoclonal antibodies. Although the specification does not disclose the 
complete structure of a representative number of species to support the 
claimed genus of antibodies, it does disclose multiple monoclonal 
antibodies which have the isotype claimed as well as the binding 
specificity and binding affinity characteristics recited in the claims. 
In this well-developed art, additional identifying characteristics for 
a substantial portion of the genus are well-known (e.g., number of 
chains, disulfide bonds, constant and variable regions, etc.). Thus, 
applicant's disclosure combined with what was known in the art are 
sufficient to describe the claimed genus of monoclonal antibodies in 
such full, clear, concise and exact terms to show applicant was in 
possession of the claimed antibodies. Thus, the claim meets the D(2) 
criteria.
    As another example, consider the following claim to a genus:

    An isolated mutanase enzyme produced by Bacillus having the 
following physicochemical properties (1) to (9): (1) action: an 
ability to cleave alpha-1,3-glucosidic links of mutan; (2) substrate 
specificity: an ability to effectively decompose mutan; (3) optimum 
pH: pH 4 to 4.5 when reacting on a mutan substrate at 35 degrees C 
for 10 minutes; (4) pH range for stability: pH 4 to 10 when kept at 
25 degrees C for 24 hours; (5) optimum temperature: 50 degrees to 65 
degrees C when reacted at pH 5 with mutan as a substrate; (6) 
thermal stability: enzyme activity remains stable below 50 degrees C 
after incubation at pH 5 for 10 minutes; (7) effect of metal ions: 
mercury and silver show inhibitory effect on a mutan substrate; (8) 
effect of inhibitors: p-chloromercurybenzoic acid shows inhibitory 
effect on a mutan substrate; and (9) molecular weight: about 140,000 
to about 160,000 as determined by SDS-polyacrylamide gel 
electrophoresis.

    Considering the claim as a whole, it covers a genus of mutanase 
enzymes. Although the specification does not disclose the complete 
structure of a representative number of species to support the claimed 
genus of enzyme compositions, it does disclose 3 mutanase species 
produced by different strains of Bacillus (mutanases A, B and C) which 
are identified by multiple relevant identifying characteristics, i.e., 
molecular weight, substrate specificity, optimum and ranges of 
temperature and pH for mutan cleavage activity, etc. In this well-
developed art, these identifying characteristics are sufficient for a 
skilled artisan to recognize applicant had possession of the species 
from the identifying characteristics of the three mutanase species, to 
reasonably predict sufficient identifying characteristics of the other 
members of the genus and, thus, establish possession of the genus. 
Thus, the claim meets the D(2) criteria.
    As another example, consider the following claim to a genus:


[[Page 32643]]


    A DNA comprising a novel DF3 enhancer and DNA encoding a 
heterologous gene but not encoding DF3 wherein said DF3 enhancer 
consists of SEQ ID NO: 1.

    Considering the claim as a whole, it covers a genus of DNA. The 
specification does not describe a representative number of members of 
the genus by complete structure. Thus, the claim does not meet the D(1) 
criteria. However, there is sufficient disclosure of identifying 
characteristics common to the members of the genus, i.e., DF3 enhancer, 
to meet the D(2) criteria. Because of the nature of the generic term 
``DNA,'' one skilled in the art could envision a sufficient number of 
the members of the genus to describe the invention in such full, clear 
and concise terms as to show possession of the invention at the time of 
filing.
    In contrast, consider the claim:

    An isolated nucleic acid comprising the structure of the reverse 
transcript of a mammalian mRNA, which mRNA encodes insulin.

    Considering the claim as a whole, the claim covers the genus of 
nucleotide sequences encoding mammalian insulin. The specification only 
provides the coding sequence for rat insulin cDNA and a method to 
isolate the coding sequence from its natural source.25 This 
description does not meet the criteria of D(1) or D(2) and thus does 
not satisfy the written description requirement.
    Also contrast the claim ``A gene comprising SEQ ID NO: 1.'' 
Although all genes encompassed by this claim share the characteristic 
of comprising SEQ ID NO: 1, and as such might appear to meet the D(2) 
criteria, there is insufficient description of the characteristics 
(e.g., promoters, enhancers, coding regions, and other regulatory 
elements) which identify the genes, as opposed to any DNA comprising 
SEQ ID NO: 1.
    If sufficient identifying characteristics are not disclosed for a 
given genus, as described in D(1) or D(2), the claim to that genus must 
be rejected as lacking adequate written description under 35 U.S.C. 112 
para. 1.

III. Complete Patentability Determination Under All Statutory 
Requirements and Clearly Communicate Findings, Conclusions and 
Their Bases

    The above only describes how to determine whether the written 
description requirement of 35 U.S.C. 112 para. 1 is satisfied. 
Regardless of the outcome of that determination, Office personnel must 
complete the patentability determination under all the relevant 
statutory provisions of the Patent Act.
    Once Office personnel have concluded analysis of the claimed 
invention under all the statutory provisions, including 35 U.S.C. 101, 
112, 102 and 103, they should review all the proposed rejections and 
their bases to confirm their correctness. Only then should any 
rejection be imposed in an Office action. The Office action should 
clearly communicate the findings, conclusions and reasons which support 
them.
    Specific to these guidelines:

A. For Each Claim Lacking Written Description Support, Reject the Claim 
Under Section 112, para. 1, for Lack of Adequate Written Description

    In rejecting a claim, set forth express findings of fact regarding 
the above analysis which support the lack of written description 
conclusion. These findings should:
    (1) identify the claim limitation not described; and
    (2) provide reasons why a person skilled in the art at the time the 
application was filed would not have recognized the description of this 
limitation in view of the disclosure of the application as filed.
    When appropriate, suggest amendments to the claims which would 
bring the claims into compliance with the written description in the 
specification, bearing in mind the prohibition against new matter in 
the claims and corresponding description set forth in 35 U.S.C. 112 and 
132.

B. Upon Reply by Applicant, Again Determine the Patentability of the 
Claimed Invention, Including Whether the Written Description 
Requirement is Satisfied by Performing the Analysis Described Above in 
View of the Whole Record

    Upon reply by applicant, before repeating any rejection under 
Section 112 para. 1 for lack of written descriptive basis, review the 
basis for the rejection in view of the record as a whole, including 
amendments, arguments and any evidence submitted by applicant. If the 
whole record now demonstrates that the written description requirement 
is satisfied, do not repeat the rejection in the next Office action. If 
the record still does not demonstrate that written description is 
adequate to support the claim(s), repeat the rejection under 35 U.S.C. 
112 para. 1, fully respond to applicant's rebuttal arguments, and 
properly treat any further showings submitted by applicant in the 
reply. Any affidavits, including those relevant to the 112 para. 1 
written description requirement, must be thoroughly analyzed and 
discussed in the Office action.

Endnotes

    1. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).
    2. 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993).
    3. 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
    4. E.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 
USPQ2d 1111, 1115 (Fed. Cir. 1991).
    5. In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 
(CCPA 1977).
    6. 35 U.S.C. Secs. 132 & 251.
    7. E.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 
USPQ2d 1111, 1116 (Fed. Cir. 1991). Much of the written description 
case law addresses whether the specification as originally filed 
supports claims not originally in the application. The issue raised 
in the cases is most often phrased as whether the original 
application provides ``adequate support'' for the claims at issue or 
whether the material added to the specification incorporates ``new 
matter'' in violation of 35 U.S.C. Sec. 132. The ``written 
description'' question similarly arises in the interference context, 
where the issue is whether the specification of one party to the 
interference can support the newly added claims corresponding to the 
count at issue, i.e., whether that party can ``make the claim'' 
corresponding to the interference count. E.g., see Martin v. Mayer, 
823 F.2d 500, 502, 3 USPQ2d 1333, 1335 (Fed. Cir. 1987).
    In addition, early opinions suggest the Patent and Trademark 
Office was unwilling to find written descriptive support when the 
only description was found in the claims; however, this viewpoint 
was rejected. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 
1980) (original claims constitute their own description); In re 
Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973) (accord); In re 
Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (accord). It is now 
well-accepted that a satisfactory description can be mined from the 
claims or any other portion of the originally filed specification. 
    These early opinions did not address the quality or specificity 
of particularity that was required in the description, i.e., how 
much description is enough.
    8. See Eli Lilly, 119 F.3d at 1566, 43 USPQ2d at 1404.
    9. See In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 
1972) (``Precisely how close [to the claimed invention] the 
description must come to comply with Sec. 112 must be left to a 
case-by-case development.''); In re Wertheim, 541 F.2d 257, 262, 191 
USPQ 90, 96 (CCPA 1976) (inquiry is primarily factual and depends on 
the nature of the invention and the amount of knowledge imparted to 
those skilled in the art by the disclosure).
    10. Wertheim, 541 F.2d at 262, 191 USPQ at 96.
    11. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written 
description requirement not satisfied by merely providing ``a result 
that one might achieve if one made that invention''); In re Wilder, 
736 F.2d 1516, 1521, 222 USPQ 369, 372-73

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(Fed. Cir. 1984) (affirming a rejection for lack of written 
description because the specification does ``little more than 
outline goals appellants hope the claimed invention achieves and the 
problems the invention will hopefully ameliorate'').
    12. See, e.g., In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d 
1023, 1027 (Fed. Cir. 1997).
    13. See, e.g., Ex parte Davis, 80 USPQ 448, 450 (1948) 
(``comprising'' leaves the ``claim open for the inclusion of 
unspecified ingredients even in major amounts''.), quoted with 
approval in Moleculon Research Corp v. CBS, Inc., 793 F.2d 1261, 
1271, 229 USPQ 805, 812 (Fed. Cir. 1986).
    14. See Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, 14 
USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that preamble 
language that constitutes a structural limitation is actually part 
of the claimed invention).
    15. An applicant shows possession of the claimed invention by 
describing the claimed invention with all of its limitations. 
Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 
1961, 1966 (Fed. Cir. 1997).
    16. E.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06.
    17. A ``relevant identifying characteristic'' is one that would 
provide evidence that applicant was in possession of what is 
claimed. For example, the presence of a restriction enzyme map of a 
gene may be relevant to a statement that the gene has been isolated. 
One skilled in the art could determine whether the gene disclosed 
was the same as or different than a gene isolated by another by 
comparing the restriction enzyme map. In contrast, evidence that the 
gene could be digested with a nuclease would not normally represent 
a relevant characteristic since any gene would be digested with a 
nuclease.
    Examples of identifying characteristics include a sequence, 
structure, binding affinity, binding specificity, molecular weight 
and length. Although structural formulas provide a convenient method 
of demonstrating possession of specific molecules, other identifying 
characteristics can demonstrate the requisite possession. For 
example, unique cleavage by particular enzymes, isoelectric points 
of fragments, detailed restriction enzyme maps, a comparison of 
enzymatic activities, or antibody cross reactivity may be sufficient 
to show possession of the claimed invention to one of skill in the 
art. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 
41 USPQ2d 1961, 1966 (1997) (``written description'' requirement may 
be satisfied by using ``such descriptive means as words, structures, 
figures, diagrams, formulas, etc. that fully set forth the claimed 
invention'').
    However, a definition by function alone ``does not suffice'' to 
sufficiently describe a coding sequence ``because it is only an 
indication of what the gene does, rather than what it is.'' Eli 
Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d 
at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen).
    18. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 
1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).
    19. See, e.g., Vas-Cath, 935 F.2d at 1563, 19 USPQ2d at 1116; 
Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ 391, 395 (CCPA 1972) 
(stating ``the description need not be in ipsis verbis to be 
sufficient'').
    20. 35 U.S.C. Sec. 112 para. 1. Cf. Fields v. Conover, 443 F.2d 
1386, 1392, 170 USPQ 276, 280 (CCPA 1971) (finding a lack of written 
description because the specification lacked the ``full, clear, 
concise, and exact written description'' which is necessary to 
support the claimed invention).
    21. The examples contained within these guidelines are not 
intended to represent the minimum requirements necessary to comply 
with 35 U.S.C. Sec. 112 para. 1.
    22. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
    23. See id. at 1568, 43 USPQ2d at 1406.
    24. Cf. Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at 1405 (stating 
that ``The name cDNA is not itself a written description of that 
DNA; it conveys no distinguishing information concerning itself.'').
    25. See id. 1568, 43 USPQ2d at 1406.

    Dated: June 9, 1998.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.

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