[Federal Register Volume 77, Number 3 (Thursday, January 5, 2012)]
[Proposed Rules]
[Pages 448-457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33811]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
37 CFR Part 1
[Docket No. PTO-P-2011-0073]
RIN 0651-AC67
Changes To Implement the Preissuance Submissions by Third Parties
Provision of the Leahy-Smith America Invents Act
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (Office) is
proposing changes to the rules of patent practice to implement the
preissuance submissions by third parties provision of the Leahy-Smith
America Invents Act. This provision provides a mechanism for third
parties to contribute to the quality of issued patents by submitting to
the Office, for consideration and inclusion in the record of patent
applications, any patents, published patent applications, or other
printed publications of potential relevance to the examination of the
applications. A preissuance submission may be made in any non-
[[Page 449]]
provisional utility, design, and plant application, as well as in any
continuing or reissue application. A third-party preissuance submission
must include a concise description of the asserted relevance of each
document submitted and be submitted within a certain statutorily
specified time period. The third party must submit a fee as prescribed
by the Director and a statement that the submission complies with all
of the statutory requirements. The third-party preissuance submission
provision of the Leahy-Smith America Invents Act is effective on
September 16, 2012, and applies to any application filed before, on, or
after September 16, 2012.
Comment Deadline: Written comments must be received on or before
March 5, 2012.
ADDRESSES: Comments should be sent by electronic mail message over the
Internet addressed to: [email protected]. Comments may
also be submitted by postal mail addressed to: Mail Stop Comments--
Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313
1450, marked to the attention of Nicole D. Haines, Legal Advisor,
Office of Patent Legal Administration, Office of the Associate
Commissioner for Patent Examination Policy.
Comments may also be sent by electronic mail message over the
Internet via the Federal eRulemaking Portal. See the Federal
eRulemaking Portal Web site (http://www.regulations.gov) for additional
instructions on providing comments via the Federal eRulemaking Portal.
Although comments may be submitted by postal mail, the Office
prefers to receive comments by electronic mail message over the
Internet because sharing comments with the public is more easily
accomplished. Electronic comments are preferred to be submitted in
plain text, but also may be submitted in ADOBE[supreg] portable
document format or MICROSOFT WORD[supreg] format. Comments not
submitted electronically should be submitted on paper in a format that
facilitates convenient digital scanning into ADOBE[supreg] portable
document format.
The comments will be available for public inspection at the Office
of the Commissioner for Patents, currently located in Madison East,
Tenth Floor, 600 Dulany Street, Alexandria, Virginia. Comments also
will be available for viewing via the Office's Internet Web site
(http://www.uspto.gov). Because comments will be made available for
public inspection, information that the submitter does not desire to
make public, such as an address or phone number, should not be included
in the comments.
FOR FURTHER INFORMATION CONTACT: Nicole D. Haines, Legal Advisor ((571)
272 7717), Pinchus M. Laufer, Senior Legal Advisor ((571) 272-7726), or
Hiram H. Bernstein, Senior Legal Advisor ((571) 272-7707), Office of
Patent Legal Administration, Office of the Associate Commissioner for
Patent Examination Policy.
SUPPLEMENTARY INFORMATION: The Leahy-Smith America Invents Act was
enacted into law on September 16, 2011. See Public Law 112-29, 125
Stat. 284 (2011). This notice proposes changes to the rules of practice
to implement Section 8 of the Leahy-Smith America Invents Act, which
provides a mechanism for third parties to submit to the Office, for
consideration and inclusion in the record of a patent application, any
patents, published patent applications, or other printed publications
of potential relevance to the examination of the application.
Section 8 of the Leahy-Smith America Invents Act amends 35 U.S.C.
122 by adding 35 U.S.C. 122(e), which enumerates certain conditions
that apply to a third-party preissuance submission to the Office in a
patent application. Pursuant to 35 U.S.C. 122(e), third-party
preissuance submissions of patents, published patent applications, or
other printed publications must be made in patent applications before
the earlier of: (a) The date a notice of allowance under 35 U.S.C. 151
is given or mailed in the application; or (b) the later of (i) six
months after the date on which the application is first published under
35 U.S.C. 122 by the Office, or (ii) the date of the first rejection
under 35 U.S.C. 132 of any claim by the examiner during the examination
of the application. 35 U.S.C. 122(e) also requires a concise
description of the asserted relevance of each document submitted, a fee
as prescribed by the Director, and a statement by the person making the
third-party preissuance submission that the submission was made in
compliance with 35 U.S.C. 122(e). A preissuance submission by a third
party may be made in any non-provisional utility, design, or plant
application, as well as in any continuing or reissue application.
The preissuance submissions by third parties provision of the
Leahy-Smith America Invents Act takes effect on September 16, 2012.
This provision applies to any patent application filed before, on, or
after September 16, 2012.
The Office plans to permit third-party preissuance submissions to
be filed via the Office electronic filing system (EFS-Web). However,
third-party preissuance submissions, whether submitted in paper or
electronically via EFS-Web, would not be automatically entered into the
electronic image file wrapper (IFW) for an application. Instead,
preissuance submissions submitted by third parties would be reviewed to
determine compliance with 35 U.S.C. 122(e) and new 37 CFR 1.290 before
being entered into the IFW. Third parties filing preissuance
submissions electronically via EFS-Web, will receive immediate,
electronic acknowledgment of the Office's receipt of the submission,
instead of waiting for the Office to mail a return postcard.
The current EFS-Web Legal Framework prohibits third-party
submissions under 37 CFR 1.99 and 37 CFR 1.291 in patent applications
because electronically filed documents are instantly loaded into the
IFW. See Legal Framework for Electronic Filing System--Web (EFS-Web),
74 FR 55200, 55202, 55206-7 (October 27, 2009). Because third-party
preissuance submissions would be permitted to be filed electronically
under the proposed rule, the Office intends to protect applicants by
establishing procedures to determine whether a third-party preissuance
submission is in compliance with the requirements of new 37 CFR 1.290
before entering the submission into the IFW of an application or making
the submission available to an examiner for consideration. The Office
intends to complete such determination, for both paper and electronic
submissions, promptly following receipt of the submission so that
compliant preissuance submissions would be quickly entered into the IFW
and made available to the examiner for consideration. Non-compliant
third-party preissuance submissions would not be entered into the IFW
of an application or considered and would be discarded. Also, no refund
of the required fees would be provided in the event a preissuance
submission is determined to be non-compliant. If an electronic mail
message address is provided with a third party preissuance submission,
the Office may attempt to notify the third party submitter of such non-
compliance; however, the statutory time period for making a preissuance
submission would not be tolled by the initial non-compliant submission.
The Office does not plan to require that the third party serve the
applicant with a copy of the third-party's preissuance submission. Nor
does the
[[Page 450]]
Office intend to directly notify the applicant upon entry of a third-
party preissuance submission. However, the contents of a compliant
third-party preissuance submission will be made available to the
applicant via its entry in the IFW of the patent application. By not
requiring service of third-party preissuance submissions on the
applicant, the Office is underscoring that such third-party submissions
will not create a duty on the part of the applicant to independently
file the submitted documents with the Office in an information
disclosure statement (IDS). Additionally, challenges regarding whether
service of a third-party preissuance submission was proper could
negatively impact the pendency of the application.
35 U.S.C. 122(e) does not limit third-party preissuance submissions
to pending applications. A third-party preissuance submission made
within the statutory time period, and otherwise compliant, would be
entered even if the application to which the submission is directed has
been abandoned. An examiner would not consider such preissuance
submission unless the application resumes a pending status (e.g., the
application is revived, the notice of abandonment is withdrawn, etc.).
The abandonment of an application will not, however, toll the statutory
time period for making a preissuance submission. Additionally, a third-
party preissuance submission made within the statutory time period, and
otherwise compliant, would be entered even if the application to which
the submission is directed has not been published.
Compliant third-party preissuance submissions would be considered
by the examiner when the examiner next takes up the application for
action following the entry of the preissuance submission into the IFW.
An examiner would consider the documents and concise descriptions
submitted in a compliant third-party preissuance submission in the same
manner that the examiner considers information and concise explanations
of relevance submitted as part of an IDS. Generally with the next
Office action, a copy of the third party's listing of documents, with
an indication of which documents were considered by the examiner, would
be provided to the applicant. Documents considered by the examiner
would be printed on the patent. Accordingly, an applicant would not
need to file an IDS to have the same documents that were previously
submitted by a third party as part of a compliant preissuance
submission considered by the examiner in the application.
The Office plans to have examiners acknowledge in the record of the
patent application the examiner's consideration of the documents
submitted. This will be done in a manner similar to that of the
examiner's consideration of applicant-submitted documents filed as part
of an IDS. For example, the examiner would indicate at the bottom of
each page of a preissuance submission ``All documents considered except
where lined through,'' along with the examiner's electronic initials
and the examiner's electronic signature on the final page of the
submission. See, e.g., Manual of Patent Examining Procedure (MPEP)
Sec. 609.05(b) (8th ed. 2001) (Rev. 8, July 2010). Such indication by
the examiner placed at the bottom of each page of a preissuance
submission would mean that the examiner has considered the listed
documents and their accompanying concise descriptions. Striking through
a document would mean that the examiner did not consider either the
document or its accompanying concise description (e.g., because the
document was listed improperly, a copy of the document was not
submitted, or a concise description was not provided for that
document).
Since it would be advantageous for examiners to have the best art
before them prior to issuing the first Office action on the merits, and
because a first action allowance in the application could close the
time period for making a preissuance submission under 35 U.S.C. 122(e),
third parties should consider providing any preissuance submission at
the earliest opportunity. Additionally, because highly relevant
documents can be obfuscated by voluminous submissions, third parties
should limit any preissuance submission to the most relevant documents
and should avoid submitting documents that are cumulative in nature.
Third parties need not submit documents that are cumulative of each
other or that are cumulative of information already under consideration
by the Office. Third parties are reminded that 35 U.S.C. 122(e)
requires that the documents submitted be ``of potential relevance to
the examination of the application'' and that the relevance of each
document submitted must be provided in an accompanying concise
description.
The Director is proposing to set the fees for third-party
preissuance submissions to recover costs to the Office for third-party
preissuance submissions to the Office. 35 U.S.C. 122(e) expressly
provides for ``such fee as the Director may prescribe.'' The Office is
setting fees for third-party preissuance submissions in this rulemaking
pursuant to its authority under 35 U.S.C. 41(d)(2), which provides that
fees for all processing, services, or materials relating to patents not
specified in 35 U.S.C. 41 are to be set at amounts to recover the
estimated average cost to the Office of such processing, services, or
materials. See 35 U.S.C. 41(d)(2). The current rules of practice (37
CFR 1.99) provide for a third-party submission of up to ten documents
for the fee set forth in 37 CFR 1.17(p) (currently $180.00). The Office
expects the processing costs to the Office for third-party preissuance
submissions under new 37 CFR 1.290 to be equivalent to the processing
costs to the Office for submissions under 37 CFR 1.99. Accordingly, the
Office has determined that the fee set forth in 37 CFR 1.17(p) would
also be applicable to third-party preissuance submissions under 37 CFR
1.290 and proposes to require the fee set forth in 37 CFR 1.17(p) for
every ten documents, or fraction thereof, listed in each third-party
preissuance submission.
The Office proposes to provide an exemption from this fee
requirement where a preissuance submission lists three or fewer total
documents and is the first preissuance submission submitted in an
application by a third party or a party in privity with the third
party. The Office is providing this fee exemption for the first
preissuance submission in an application by a third party containing
three or fewer total documents because the submission of a limited
number of documents is more likely to assist in the examination process
and thus offset the cost of processing the submission. Moreover,
keeping the size of the fee exempted submission to three or fewer total
documents will help to focus the attention of third parties on finding
and submitting only the most relevant art to the claims at hand. Where
one third party takes advantage of the fee exemption in an application,
another third party is not precluded from also taking advantage of the
fee exemption in the same application provided that the third parties
are not in privity with each other.
The Office proposes to implement 35 U.S.C. 122(e) in a new rule 37
CFR 1.290 and to eliminate Sec. 1.99. While current Sec. 1.99
provides for third-party submissions of patents, published patent
applications, or printed publications, it does not permit an
accompanying concise description of relevance of each document and
limits the time period for such submissions to up to two months after
the date of the patent application publication, or the
[[Page 451]]
mailing of a notice of allowance, whichever is earlier. By contrast,
new 35 U.S.C. 122(e) and proposed 37 CFR 1.290 permit third parties to
submit the same types of documents, but with an accompanying concise
description of relevance of each document submitted and provide third
parties with the same or more time to file preissuance submissions with
the Office when compared with current 37 CFR 1.99. Accordingly, the
Office proposes to eliminate 37 CFR 1.99 in favor of new 37 CFR 1.290.
The Office also plans to eliminate the public use proceeding
provisions of 37 CFR 1.292. Because Section 6 of the Leahy-Smith
America Invents Act makes available a post-grant review proceeding in
which prior public use may be raised, the pre-grant public use
proceeding set forth in 37 CFR 1.292 is no longer considered necessary.
Additionally, information on prior public use may be submitted by third
parties by way of a protest in a pending application when the
requirements of 37 CFR 1.291 have been met, and utilization of 37 CFR
1.291 would promote Office efficiency with respect to treatment of
these issues. Requests for a public use proceeding under 37 CFR 1.292
are also very rare. The few public use proceedings conducted each year
are a source of considerable delay in the involved applications and
seldom lead to the rejection of claims.
In view of the proposed elimination of 37 CFR 1.99 and 37 CFR
1.292, the Office proposes to amend 37 CFR 1.17 to eliminate the
document submission fees pertaining to 37 CFR 1.99 and 37 CFR 1.292.
The Office also proposes to amend 37 CFR 1.17 to add the document
submission fees pertaining to new 37 CFR 1.290.
For ease of compliance, the Office proposes to amend 37 CFR 1.291
to make the requirements for submitting protests against pending patent
applications more clear and, where appropriate, more consistent with
the proposed requirements of new 37 CFR 1.290.
Discussion of Specific Rules
Title 37 of the Code of Federal Regulations, Part 1, is proposed to
be amended as follows:
Section 1.99: Section 1.99 is proposed to be removed and reserved.
Section 1.99 is unnecessary because proposed Sec. 1.290 provides for
third-party preissuance submissions of patents, published patent
applications, and other printed publications to the Office for
consideration and inclusion in the record of a patent application, with
a concise description of the relevance of each document being submitted
and within time periods that are the same or greater than those
permitted under Sec. 1.99.
Section 1.290: Section 1.290(a) as proposed provides that a third
party may submit, for consideration and entry in the record of a patent
application, any patents, published patent applications, or other
printed publications of potential relevance to the examination of the
application if the submission complies with 35 U.S.C. 122(e) and the
requirements of Sec. 1.290, and provides that the submission will not
be entered or considered by the Office if the submission is not in
compliance with 35 U.S.C. 122(e) and Sec. 1.290. Because Sec.
1.290(a) as proposed requires preissuance submissions be directed to
patent applications, the Office would not accept preissuance
submissions directed to issued patents. Such submissions should be
filed in accordance with Sec. 1.501. Section 1.290(a) as proposed does
not require that the application be published. For example, the Office
would accept a compliant preissuance submission directed to an
application in which a nonpublication request has been filed pursuant
to 35 U.S.C. 122(b)(2)(B)(i) and Sec. 1.213. Preissuance submissions
under Sec. 1.290 as proposed may be directed to non-provisional
utility, design, and plant applications, as well as to continuing and
reissue applications.
Also, Sec. 1.290(a) as proposed limits the type of information
that may be submitted to patent publications, which include patents and
published patent applications, and other printed publications of
potential relevance to the examination of a patent application. For
example, a submission under Sec. 1.290 could not include unpublished
internal documents or other non-patent documents which do not qualify
as ``printed publications.'' See MPEP Sec. 2128. In the case of a
preissuance submission that includes a lengthy document, a third party
could submit the relevant portion of the document (e.g., one chapter of
a book) in lieu of the entire document where it is practical to do so.
Because 35 U.S.C. 122(e) does not limit the type of information that
may be submitted to prior art, there is no requirement in Sec.
1.290(a) as proposed that the information submitted be prior art
documents in order to be considered by the examiner. Further, in those
situations where a third party is asserting that a document submitted
is prior art, the third party bears the burden of establishing the date
of the document where the date is not apparent from the document
regardless whether the document is in paper or electronic format. In
such situations, the third party may submit evidence in the form of
affidavits, declarations, or other evidence. Such evidence will not be
counted toward the document count, unless the document is in the form
of a patent document or other printed publication and the document,
itself, is listed and submitted for consideration by the examiner.
Section 1.290(b) as proposed sets forth the time periods in which a
third party may file a preissuance submission. Under Sec. 1.290(b) as
proposed, any third-party submission under this section must be filed
before the earlier of: (1) The date a notice of allowance under Sec.
1.311 is given or mailed in the application; or (2) the later of: (i)
six months after the date on which the application is first published
by the Office under 35 U.S.C. 122(b) and Sec. 1.211, or (ii) the date
the first rejection under Sec. 1.104 of any claim by the examiner is
given or mailed during the examination of the application.
The time periods provided for in Sec. 1.290(b) are statutory and
cannot be waived. Thus, the Office cannot grant any request for
extension of the Sec. 1.290(b) time periods. Also, preissuance
submissions must be filed before, not on, the dates identified in Sec.
1.290(b)(i), (b)(2)(i), and (b)(2)(ii). A preissuance submission under
Sec. 1.290 is filed on its date of receipt in the Office as set forth
in Sec. 1.6 (the provisions of Sec. 1.8 do not apply to a preissuance
submission under Sec. 1.290). Third-party preissuance submissions that
are not timely filed would not be entered or considered and would be
discarded.
Proposed Sec. 1.290(b)(2)(i) highlights a distinction in the
statutory language of 35 U.S.C. 122(c) and (e) with respect to
publication of the application. 35 U.S.C. 122(c) broadly refers to
``publication of the application,'' whereas new 35 U.S.C. 122(e) refers
to an application ``first published under section 122 by the Office.''
The Sec. 1.290(b)(2)(i) time period would be initiated only by
publications by the Office under 35 U.S.C. 122(b) and Sec. 1.211, and
would not be initiated by a publication by the World Intellectual
Property Organization (WIPO). Thus, an earlier publication by WIPO of
an international application designating the U.S. filed on or after
November 29, 2000, would not be considered a publication that would
initiate the Sec. 1.290(b)(2)(i) time period for an application which
entered the national stage from the international application after
compliance with 35 U.S.C. 371. Further, where the Office republishes an
application due to material mistake of the Office pursuant to 37 CFR
1.221(b), the date on which the application is
[[Page 452]]
republished will be considered the date the application is ``first
published by the Office'' under Sec. 1.290(b)(2)(i).
The proposed new Sec. 1.290(b)(2)(ii) time period would be
initiated by the date the first rejection under Sec. 1.104 of any
claim by the examiner is given or mailed during the examination of the
application. The Sec. 1.290(b)(2)(ii) time period would not be
initiated, for example, by a first Office action that only contains a
restriction requirement or where the first Office action is an action
under Ex parte Quayle, 1935 Dec. Comm'r Pat. 11 (1935).
Section 1.290(c) as proposed requires a preissuance submission to
be made in writing. For a paper filing, the third party may include a
self-addressed postcard with the preissuance submission to receive an
acknowledgment by the Office that the preissuance submission has been
received. For an electronic filing, the third party will receive
immediate, electronic acknowledgment of the Office's receipt of the
submission. In either case, the third party will not receive any
communications from the Office relating to the submission other than
the self-addressed postcard or electronic acknowledgment of receipt.
Section 1.290(c) as proposed also requires that the application to
which the third-party submission is directed be identified on each page
of the submission by application number (i.e., the series code and
serial number), except for the copies of the documents that are being
submitted pursuant to Sec. 1.290(d)(3). By requiring identification by
application number, third-party preissuance submissions could be timely
matched with the application file and routed to the examiner.
Section 1.290(d)(1) as proposed provides that any third-party
submission under Sec. 1.290 must include a list of the documents being
submitted, and the listing must include a heading that identifies the
listing as a third-party preissuance submission under Sec. 1.290.
Proposed Sec. 1.290(e) also sets forth the requirements for
identifying the documents being submitted and listed pursuant to Sec.
1.290(d)(1). The Office proposes to provide a form similar to forms
PTO/SB/08A and 08B to assist third parties in preparing the listing of
documents in accordance with Sec. Sec. 1.290(d)(1) and (e) and to
ensure that the documents are properly made of record in the
application file.
Section 1.290(d)(2) as proposed requires a concise description of
the asserted relevance of each listed document. 35 U.S.C. 122(e)
requires that each third-party preissuance submission be accompanied by
a ``concise description of the asserted relevance of each document
submitted.'' The concise description should explain why the respective
document has been submitted and how it is of potential relevance to the
examination of the application in which the preissuance submission has
been filed. Unless there is no concise description provided for a
document that is listed, or the concise description is merely a bare
statement that the document is relevant and thus does not amount to a
meaningful concise description, the Office does not propose to
otherwise evaluate the sufficiency of the concise description. It would
be a best practice that each concise description point out the relevant
pages or lines of the respective document, particularly where the
document is lengthy and complex and the third party can identify a
highly relevant section, such as a particular figure or paragraph. The
third party may present the concise description in a format that would
best explain to the examiner the relevance of the accompanying
document, such as in a narrative description or a claim chart. Third
parties should refrain from submitting a verbose description of
relevance not only because the statute calls for a ``concise''
description but also because a focused description is more effective in
drawing the examiner's attention to the relevant issues.
Section 1.290(d)(3) as proposed requires submission of a legible
copy of each listed document. See Sec. 1.98(a)(2) and MPEP Sec.
609.04(a). Where only the relevant portion of a document is listed, the
third party could submit only a copy of that portion (e.g., where a
particular chapter of a book is listed and not the entire book). When a
copy of only a relevant portion of a document is submitted, the third
party should also submit copies of pages of the document that provide
identifying information (e.g., a copy of the cover, the title page, the
copyright information page, etc.). Under Sec. 1.290(d)(3) as proposed,
a third party need not submit copies of U.S. patents and U.S. patent
application publications, unless required by the Office, as such
documents are readily accessible to examiners.
Section 1.290(d)(4) as proposed requires an English language
translation of all relevant portions of any listed non-English language
document to be considered by the examiner.
Section 1.290(d)(5)(i) as proposed requires a statement by the
party making the submission that the party is not an individual who has
a duty to disclose information with respect to the application (i.e.,
each individual associated with the filing and prosecution of the
patent application) under Sec. 1.56. Such statement is intended to
avoid potential misuse of preissuance submissions by applicants (e.g.,
by employing a third party ``straw man'') to attempt to circumvent the
IDS rules.
Section 1.290(d)(5)(ii) as proposed requires a statement by the
party making the submission that the submission complies with the
requirements of 35 U.S.C. 122(e) and Sec. 1.290. To facilitate
compliance by third parties, the Office proposes to provide a form for
third-party preissuance submissions under Sec. 1.290 that includes the
statements required by Sec. Sec. 1.290(d)(5)(i) and (ii).
Section 1.290(e) as proposed sets forth the requirements for
identifying the documents submitted and listed pursuant to Sec.
1.290(d)(1). Section 1.290(e) requires that U.S. patents and U.S.
patent application publications be listed in a separate section from
other documents. Separating the listing of U.S. patents and U.S. patent
application publications from the listing of other documents would
facilitate printing the U.S. patents and U.S. patent application
publications considered by the examiner in a third-party preissuance
submission on the face of the patent.
Section 1.290(e)(1) as proposed requires that each U.S. patent be
identified by patent number, first named inventor, and issue date.
Section 1.290(e)(2) as proposed requires that each U.S. patent
application publication be identified by patent application publication
number, first named inventor, and publication date. Section 1.290(e)(3)
as proposed requires that each foreign patent or published foreign
patent application be identified by the country or patent office that
issued the patent or published the application, an appropriate document
number, first named inventor, and the publication date indicated on the
patent or published application. Requiring U.S. and foreign patent and
published patent application documents to be identified by the first
named inventor should aid in identifying the listed documents in the
event the application number, publication number, or other appropriate
document number data is inadvertently transposed or otherwise
misidentified. Section 1.290(e)(4) as proposed requires that each non-
patent publication be identified by publisher, author, title, pages
being submitted, publication date, and place of publication, where such
information is available. The qualifier ``where available'' applies to
each item of information specified in Sec. 1.290(e)(4). Thus, if an
item of information is not available for a particular non-patent
[[Page 453]]
publication (e.g., publisher information), the third party need not
provide that information, and the citation of the non-patent
publication would not be improper as a result of not providing that
information. Further, Sec. 1.290(e)(4) as proposed does not preclude
additional information not specified in Sec. 1.290(e)(4) from being
provided (e.g., journal title and volume/issue information for a
journal article). Section 1.290(e)(4) as proposed also provides that
the third party bears the burden of establishing the date of a non-
patent publication where the non-patent publication is asserted by the
third party to be prior art and the date is not apparent from the
document, regardless whether the document is in paper or electronic
form.
Section 1.290(f) as proposed requires payment of the fee set forth
in Sec. 1.17(p) for every ten documents or fraction thereof being
submitted, except where the submission is accompanied by the statement
set forth in proposed Sec. 1.290(g). The Office proposes to determine
the document count based on the Sec. 1.290(d)(1) listing of documents.
Thus, if a document is listed but a copy of the document is not
submitted, the listed document would be counted toward the document
count. If a copy of a document is submitted but the document is not
listed, the document would not be counted or considered and would be
discarded. A third party would be permitted to cite less than an entire
publication in the Sec. 1.290(d)(1) listing, which would be counted as
one document. Further, while a third party would be permitted to cite
different publications that are all available from the same electronic
source, such as a Web site, each such publication would be counted as a
separate document.
Section 1.290(g) as proposed provides an exemption from the Sec.
1.290(f) fee requirement where a preissuance submission listing three
or fewer total documents is the first preissuance submission submitted
in an application by a third party, or a party in privity with the
third party. Where one third party takes advantage of the fee exemption
in an application, another third party is not precluded from also
taking advantage of the fee exemption in the same application as long
as the third parties are not in privity with each other. For example,
applying the current 37 CFR 1.17(p) fee of $180.00 in accordance with
proposed Sec. Sec. 1.290(f) and (g): (1) No fee would be required for
the first preissuance submission by a third party containing three or
fewer total documents; (2) a $180.00 fee would be required for the
first preissuance submission by a third party containing more than
three, but ten or fewer total documents: and (3) a $360.00 fee would be
required for the first preissuance submission by a third party
containing more than ten, but twenty or fewer total documents. For a
second or subsequent preissuance submission by the same third party:
(1) A $180.00 fee would be required where the second or subsequent
preissuance submission by the third party contains ten or fewer total
documents; and (2) a $360.00 fee would be required where the second or
subsequent preissuance submission by the same third party contains more
than ten, but twenty or fewer total documents.
To implement the fee exemption in Sec. 1.290(g) and avoid
potential misuse of such exemption, the Office proposes to require that
exemption-eligible preissuance submissions be accompanied by a
statement of the third party that, to the knowledge of the person
signing the statement after making reasonable inquiry, the submission
is the first and only preissuance submission submitted in the
application by the third party or a party in privity with the third
party. To preclude a third party from making multiple preissuance
submissions in the same application on the same day and asserting that
each such submission is the first preissuance submission being
submitted in the application by the third party, the Sec. 1.290(g)
statement would require that the submission be the ``first and only''
preissuance submission. This statement would not, however, preclude the
third party from making more than one preissuance submission in an
application, where the need for the subsequent submissions was not
known at the time the earlier submission including the Sec. 1.290(g)
statement was filed with the Office. Such additional submissions would
not be exempt from the Sec. 1.290(f) fee requirement.
The Office does not propose to entertain challenges to the accuracy
of such third-party statements because, pursuant to Sec. 11.18(b),
whoever knowingly and willfully makes any false, fictitious, or
fraudulent statements or representations to the Office shall be subject
to the penalties set forth under 18 U.S.C. 1001. Section 11.18(b)
applies to any paper presented to the Office, whether by a practitioner
or non-practitioner.
Additionally, the Office does not propose to require an explicit
identification of a real party in interest because such identification
might discourage some third parties from making a preissuance
submission or invite challenges based on allegations of
misidentification.
Section 1.290(h) as proposed provides that in the absence of a
request by the Office, an applicant has no duty to, and need not, reply
to a submission under Sec. 1.290. Likewise, because the prosecution of
a patent application is an ex parte proceeding, no further response
from a third party with respect to an examiner's treatment of the third
party's preissuance submission would be permitted or considered.
Section 1.290(i) as proposed provides that the provisions of Sec.
1.8 do not apply to the time periods set forth in Sec. 1.290.
Section 1.291: The Office proposes to amend portions of Sec. 1.291
for clarity and also for consistency with new 35 U.S.C. 122(e) and
proposed Sec. 1.290.
Section 1.291(b) is proposed to be amended to clarify that the
application publication date is the date the application was published
under 35 U.S.C. 122(b), and Sec. 1.211 and is also proposed to be
amended by including ``given or'' before ``mailed'' to provide for
electronic notification of the notice of allowance (i.e., e-Office
action).
Section 1.291(b)(1) is proposed to be amended to more clearly
define the time period for submitting protests under Sec. 1.291 that
are accompanied by applicant consent. Specifically, Sec. 1.291(b)(1)
is proposed to be amended to provide that, if a protest is accompanied
by the written consent of the applicant, the protest will be considered
if the protest is filed before a notice of allowance under Sec. 1.311
is given or mailed in the application. This amendment would provide a
definite standard for both the Office and third parties and would give
more certainty as to when a protest under Sec. 1.291 that is
accompanied by applicant consent would or would not be accepted by the
Office. Moreover, it is reasonable that the time period for submission
ends when a notice of allowance is given or mailed in the application
in view of the current publication process.
Under the current publication process, final electronic capture of
information to be printed in a patent will begin as soon as an allowed
application is received in the Office of Patent Publication,
immediately after the notice of allowance has been given or mailed. See
MPEP Sec. 1309.
Section 1.291(c)(1) is proposed to be amended to set forth the
requirements for identifying the information being submitted and
listed, consistent with proposed Sec. 1.290(e). Section 1.291(c)(1)(i)
as proposed to be amended requires that each U.S. patent be identified
by patent number, first named inventor, and issue date. Section
[[Page 454]]
1.291(c)(1)(ii) as proposed to be amended requires that each U.S.
patent application publication be identified by patent application
publication number, first named inventor, and publication date. Section
1.291(c)(1)(iii) as proposed to be amended requires that each foreign
patent or published foreign patent application be identified by the
country or patent office that issued the patent or published the
application, an appropriate document number, first named inventor, and
the publication date indicated on the patent or published application.
Section 1.291(c)(1)(iv) as proposed to be amended requires that each
non-patent publication be identified by publisher, author, title, pages
being submitted, publication date, and place of publication, where such
information is available. The qualifier ``where such information is
available'' applies to each item of information specified in Sec.
1.291(c)(1)(iv). Thus, if an item of information is not available for a
particular non-patent publication (e.g., publisher information), the
protestor need not provide that information, and the citation of the
non-patent publication would not be improper as a result of not
providing that information. Further, Sec. 1.291(c)(1)(iv) as proposed
to be amended does not preclude additional information not specified in
Sec. 1.291(c)(1)(iv) from being provided (e.g., journal title and
volume/issue information for a journal article). Section 1.291(c)(1)(v)
as proposed to be amended requires that each item of other information
be identified by date, if known. Requiring U.S. and foreign patent and
published patent application documents to be identified by the first
named inventor should aid in identifying the listed documents in the
event the application number, publication number, or other appropriate
document number data is inadvertently transposed or otherwise
misidentified.
Section 1.291(c)(2) is proposed to be amended to change
``explanation'' to ``description'' to conform to proposed Sec.
1.290(d)(2). This amendment would clarify that there is no difference
between the concise description of relevance for a third-party
preissuance submission and the concise description of relevance for a
protest.
Section 1.291(c)(3) is proposed to be amended to clarify that
copies of information submitted must be legible. See Sec. 1.98(a)(2)
and MPEP Sec. 609.04(a). Section 1.291(c)(3) is also proposed to be
amended to provide that copies of U.S. patents and U.S. patent
application publications would not need to be submitted, unless
required by the Office, as such documents are readily accessible to
examiners.
Section 1.292: Section 1.292 is proposed to be removed and
reserved. The practice of providing a pre-grant public use proceeding
as set forth in Sec. 1.292 is no longer considered necessary, and is
inefficient as compared to alternative mechanisms available to third
parties for raising prior public use; for example, as provided for by
Sec. 1.291 protests, where appropriate, and also by Section 6 of the
Leahy-Smith America Invents Act which makes available a post-grant
review proceeding.
Sections 1.17 and 41.202: Sections 1.17 and 41.202 would also be
amended to change or remove references to Sec. Sec. 1.99 and 1.292,
for consistency with the proposed addition of new Sec. 1.290 and
removal of Sec. Sec. 1.99 and 1.292. Section 1.17(i) would also be
amended to correct a misidentification of Sec. 1.53(b)(3) to Sec.
1.53(c)(3) concerning the fee for converting a provisional application
filed under Sec. 1.53(c) into a nonprovisional application under Sec.
1.53(b).
Rulemaking Considerations
A. Administrative Procedure Act: This notice proposes changes to
the rules of practice concerning the procedure for filing third party
preissuance submissions. The changes proposed in this notice do not
change the substantive criteria of patentability. Therefore, the
changes in this proposed rule are merely procedural and/or
interpretive. See Bachow Communs., Inc. v. FCC, 237 F.3d 683, 690 (DC
Cir. 2001) (rules governing an application process are procedural under
the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala,
244 F.3d 242, 350 (4th Cir. 2001) (rules for handling appeals were
procedural where they did not change the substantive standard for
reviewing claims); Nat'l Org. of Veterans' Advocates v. Sec'y of
Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that
clarifies interpretation of a statute is interpretive).
Accordingly, prior notice and opportunity for public comment are
not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law) and
thirty-day advance publication is not required pursuant to 5 U.S.C.
553(d) (or any other law). See Cooper Techs. Co. v. Dudas, 536 F.3d
1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35
U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for
``interpretative rules, general statements of policy, or rules of
agency organization, procedure, or practice.'') (quoting 5 U.S.C.
553(b)(A)). The Office, however, is publishing these changes and the
Regulatory Flexibility Act certification discussion below, for comment
as it seeks the benefit of the public's views on the Office's proposed
implementation of this provision of the Leahy-Smith America Invents
Act.
B. Regulatory Flexibility Act: For the reasons set forth herein,
the Deputy General Counsel for General Law of the United States Patent
and Trademark Office has certified to the Chief Counsel for Advocacy of
the Small Business Administration that changes proposed in this notice
will not have a significant economic impact on a substantial number of
small entities. See 5 U.S.C. 605(b). This notice proposes changes to
the rules of practice to implement section 8 of the Leahy-Smith America
Invents Act, which provides a mechanism for third parties to submit to
the Office, for consideration and inclusion in the record of a patent
application, any patents, published patent applications, or other
printed publications of potential relevance to the examination of the
application.
The changes proposed in this notice concern requirements for third
parties submitting patents, published patent applications, or other
printed publications in a patent application. The burden to all
entities, including small entities, imposed by these rules is a minor
addition to that of the current regulations for third-party submissions
under Sec. 1.99. Consistent with the current regulations, the Office
will continue to require third parties filing submissions to, for
example, file a listing of the documents submitted along with a copy of
each document, with minor additional formatting requirements.
Additional requirements proposed in this notice are requirements of
statute (e.g., the concise explanation) and thus the sole means of
accomplishing the purpose of the statute. Because of the expanded scope
of submissions under this rulemaking and additional requirements by
statute, the Office believes this will take a total of 10 hours at a
cost of $3,400.00 per submission. Furthermore, the Office estimates
that no more than 730 small entity third parties will make preissuance
submissions per year. Therefore, the changes proposed in this notice
will not have a significant economic impact on a substantial number of
small entities.
C. Executive Order 12866 (Regulatory Planning and Review): This
rulemaking has been determined to be not significant for purposes of
Executive Order 12866 (Sept. 30, 1993).
[[Page 455]]
D. Executive Order 13563 (Improving Regulation and Regulatory
Review): The Office has complied with Executive Order 13563.
Specifically, the Office has, to the extent feasible and applicable:
(1) Made a reasoned determination that the benefits justify the costs
of the rule; (2) tailored the rule to impose the least burden on
society consistent with obtaining the regulatory objectives; (3)
selected a regulatory approach that maximizes net benefits; (4)
specified performance objectives; (5) identified and assessed available
alternatives; (6) involved the public in an open exchange of
information and perspectives among experts in relevant disciplines,
affected stakeholders in the private sector and the public as a whole,
and provided on-line access to the rulemaking docket; (7) attempted to
promote coordination, simplification, and harmonization across
government agencies and identified goals designed to promote
innovation; (8) considered approaches that reduce burdens and maintain
flexibility and freedom of choice for the public; and (9) ensured the
objectivity of scientific and technological information and processes.
E. Executive Order 13132 (Federalism): This rulemaking does not
contain policies with federalism implications sufficient to warrant
preparation of a Federalism Assessment under Executive Order 13132
(Aug. 4, 1999).
F. Executive Order 13175 (Tribal Consultation): This rulemaking
will not: (1) Have substantial direct effects on one or more Indian
tribes; (2) impose substantial direct compliance costs on Indian tribal
governments; or (3) preempt tribal law. Therefore, a tribal summary
impact statement is not required under Executive Order 13175 (Nov. 6,
2000).
G. Executive Order 13211 (Energy Effects): This rulemaking is not a
significant energy action under Executive Order 13211 because this
rulemaking is not likely to have a significant adverse effect on the
supply, distribution, or use of energy. Therefore, a Statement of
Energy Effects is not required under Executive Order 13211 (May 18,
2001).
H. Executive Order 12988 (Civil Justice Reform): This rulemaking
meets applicable standards to minimize litigation, eliminate ambiguity,
and reduce burden as set forth in sections 3(a) and 3(b)(2) of
Executive Order 12988 (Feb. 5, 1996).
I. Executive Order 13045 (Protection of Children): This rulemaking
does not concern an environmental risk to health or safety that may
disproportionately affect children under Executive Order 13045 (Apr.
21, 1997).
J. Executive Order 12630 (Taking of Private Property): This
rulemaking will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630 (Mar. 15, 1988).
K. Congressional Review Act: Under the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the
United States Patent and Trademark Office will submit a report
containing the final rule and other required information to the United
States Senate, the United States House of Representatives, and the
Comptroller General of the Government Accountability Office. The
changes in this notice are not expected to result in an annual effect
on the economy of 100 million dollars or more, a major increase in
costs or prices, or significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States-based enterprises to compete with foreign-based
enterprises in domestic and export markets. Therefore, this notice is
not expected to result in a ``major rule'' as defined in 5 U.S.C.
804(2).
L. Unfunded Mandates Reform Act of 1995: The changes proposed in
this notice do not involve a Federal intergovernmental mandate that
will result in the expenditure by State, local, and tribal governments,
in the aggregate, of 100 million dollars (as adjusted) or more in any
one year, or a Federal private sector mandate that will result in the
expenditure by the private sector of 100 million dollars (as adjusted)
or more in any one year, and will not significantly or uniquely affect
small governments. Therefore, no actions are necessary under the
provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C.
1501 et seq.
M. National Environmental Policy Act: This rulemaking will not have
any effect on the quality of environment and is thus categorically
excluded from review under the National Environmental Policy Act of
1969. See 42 U.S.C. 4321 et seq.
N. National Technology Transfer and Advancement Act: The
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because
this rulemaking does not contain provisions which involve the use of
technical standards.
O. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) requires that the Office consider the impact of
paperwork and other information collection burdens imposed on the
public. This rulemaking proposes changes to the rules of practice that
would impact existing information collection requirements previously
approved by the Office of Management and Budget (OMB) under OMB Control
Number 0651-0062. Accordingly, the Office will submit to the OMB a
proposed revision to the information collection requirements under
0651-0062. The proposed revision will be available at the OMB's
Information Collection Review Web site (www.reginfo.gov/public/do/PRAMain).
Needs and Uses: This information collection is necessary so that
the public may submit patents, published patent applications, and other
printed publications to the Office for consideration in a patent
application. The Office will use this information, as appropriate,
during the patent examination process to assist in evaluating the
patent application. The Office will provide a form (PTO/SB/429) to
assist the public in making a submission of patents, published patent
applications, and other printed publications for consideration in a
patent application.
Title of Collection: Third-Party Submissions and Protests.
OMB Control Number: 0651-0062.
Form Numbers: PTO/SB/429.
Method of Collection: By mail, facsimile, hand delivery, or
electronically to the Office.
Affected Public: Individuals or households; businesses or other
for-profits; and not-for-profit institutions.
Estimated Number of Respondents: 1,030 responses filed per year.
Estimated Time per Response: The Office estimates that the
responses in this collection will take the public 10 hours.
Estimated Total Annual Respondent Burden Hours: 10,300 hours per
year.
Estimated Total Annual Respondent Cost Burden: $3,502,000 per year.
Estimated Total Annual Non-hour Respondent Cost Burden: $185,400
per year in the form of filing fees.
The Office is soliciting comments to: (1) Evaluate whether the
proposed information requirement is necessary for the proper
performance of the functions of the Office, including whether the
information will have practical utility; (2) evaluate the accuracy of
the Office's estimate of the burden; (3) enhance the quality, utility,
and clarity of the information to be collected; and (4) minimize the
burden of collecting the information on those who are to respond,
including by using appropriate automated, electronic, mechanical or
[[Page 456]]
other technological collection techniques or other forms of information
technology.
Please send comments on or before March 5, 2012 to Mail Stop
Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria,
VA 22313-1450, marked to the attention of Raul Tamayo, Legal Advisor,
Office of Patent Legal Administration, Office of the Associate
Commissioner for Patent Examination Policy. Comments should also be
submitted to the Office of Information and Regulatory Affairs, Office
of Management and Budget, New Executive Office Building, Room 10202,
725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for
the Patent and Trademark Office.
Notwithstanding any other provision of law, no person is required
to respond to, nor shall a person be subject to a penalty for failure
to comply with, a collection of information subject to the requirements
of the Paperwork Reduction Act, unless that collection of information
displays a currently valid OMB control number.
List of Subjects in 37 CFR Part 1
Administrative practice and procedure, Courts, Freedom of
Information, Inventions and patents, Reporting and record keeping
requirements, Small Businesses.
For the reasons set forth in the preamble, 37 CFR part 1 is
proposed to be amended as follows:
PART 1--RULES OF PRACTICE IN PATENT CASES
1. The authority citation for 37 CFR part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
2. Section 1.99 is removed and reserved.
Sec. 1.99 [Reserved]
3. Section 1.290 is added as follows:
Sec. 1.290 Submissions by third parties in applications.
(a) A third party may submit, for consideration and entry in the
record of a patent application, any patents, published patent
applications, or other printed publications of potential relevance to
the examination of the application if the submission is in compliance
with 35 U.S.C. 122(e) and this section. A third-party submission in an
application will not be entered or considered by the Office if the
submission is not in compliance with 35 U.S.C. 122(e) and this section.
(b) Any third-party submission under this section must be filed
before the earlier of:
(1) The date a notice of allowance under Sec. 1.311 is given or
mailed in the application; or
(2) The later of:
(i) Six months after the date on which the application is first
published by the Office under 35 U.S.C. 122(b) and Sec. 1.211, or
(ii) The date the first rejection under Sec. 1.104 of any claim by
the examiner is given or mailed during the examination of the
application.
(c) Any third-party submission under this section must be made in
writing, and identify on each page of the submission, except for copies
required by paragraph (d)(3) of this section, the application to which
the submission is directed by application number.
(d) Any third-party submission under this section must include:
(1) A list of the documents being submitted;
(2) A concise description of the asserted relevance of each listed
document;
(3) A legible copy of each listed document, or the portion which
caused it to be listed, other than U.S. patents and U.S. patent
application publications, unless required by the Office;
(4) An English language translation of all relevant portions of any
listed non-English language document to be considered by the examiner;
and
(5) A statement by the party making the submission that:
(i) The party is not an individual who has a duty to disclose
information with respect to the application under Sec. 1.56; and
(ii) The submission complies with the requirements of 35 U.S.C.
122(e) and this section.
(e) The list of documents required by paragraph (d)(1) of this
section must list U.S. patents and U.S. patent application publications
in a separate section from other documents, include a heading that
identifies the listing as a third-party preissuance submission under
Sec. 1.290, and identify each:
(1) U.S. patent by patent number, first named inventor, and issue
date;
(2) U.S. patent application publication by patent application
publication number, first named inventor, and publication date;
(3) Foreign patent or published foreign patent application by the
country or patent office that issued the patent or published the
application, first named inventor, an appropriate document number, and
the publication date indicated on the patent or published application;
and
(4) Non-patent publication by publisher, author, title, pages being
submitted, publication date, and place of publication, where available.
If not apparent from the document, the third party bears the burden of
establishing the date of a non-patent publication where asserted to be
prior art.
(f) Any third-party submission under this section must be
accompanied by the fee set forth in Sec. 1.17(p) for every ten
documents or fraction thereof being submitted.
(g) The fee otherwise required by paragraph (f) of this section is
not required for a submission listing three or fewer total documents
that is accompanied by a statement by the party making the submission
that, to the knowledge of the person signing the statement after making
reasonable inquiry, the submission is the first and only submission
under 35 U.S.C. 122(e) submitted in the application by the party or a
party in privity with the party.
(h) In the absence of a request by the Office, an applicant has no
duty to, and need not, reply to a submission under this section.
(i) The provisions of Sec. 1.8 do not apply to the time periods
set forth in this section.
4. Section 1.291 is amended by revising the introductory text of
paragraph (b) and paragraphs (b)(1) and (c) to read as follows:
Sec. 1.291 Protests by the public against pending applications.
* * * * *
(b) The protest will be entered into the record of the application
if, in addition to complying with paragraph (c) of this section, the
protest has been served upon the applicant in accordance with Sec.
1.248, or filed with the Office in duplicate in the event service is
not possible; and, except for paragraph (b)(1) of this section, the
protest was filed prior to the date the application was published under
35 U.S.C. 122(b) and Sec. 1.211, or a notice of allowance under Sec.
1.311 was given or mailed, whichever occurs first.
(1) If a protest is accompanied by the written consent of the
applicant, the protest will be considered if the protest is filed
before a notice of allowance under Sec. 1.311 is given or mailed in
the application.
* * * * *
(c) In addition to compliance with paragraphs (a) and (b) of this
section, a protest must include:
(1) A listing of the patents, publications, or other information
relied upon identifying:
(i) Each U.S. patent by patent number, first named inventor, and
issue date;
[[Page 457]]
(ii) Each U.S. patent application publication by patent application
publication number, first named inventor, and publication date;
(iii) Each foreign patent or published foreign patent application
by the country or patent office that issued the patent or published the
application, an appropriate document number, first named inventor, and
the publication date indicated on the patent or published application;
(iv) Each printed publication is identified by publisher, author,
title, pages being submitted, publication date, and place of
publication, where available; and
(vi) Each item of other information by date, if known.
(2) A concise description of the relevance of each item listed
pursuant to paragraph (c)(1) of this section;
(3) A legible copy of each listed patent, publication, or other
item of information in written form, or at least the pertinent portions
thereof, other than U.S. patents and U.S. patent application
publications, unless required by the Office;
* * * * *
5. Section 1.292 is removed and reserved.
Sec. 1.292 [Reserved]
Dated: December 30, 2011.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2011-33811 Filed 1-4-12; 8:45 am]
BILLING CODE 3510-16-P