Errata
Page 76, column one, of the Official Gazette of November 2, 1999
(volume 1228) should be replaced with the following:
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56. Section 1.173 is proposed to be revised to read as follows:
1.173 Reissue specification, drawings, and amendments.
(a) Contents of a reissue application. An application for reissue
must contain the entire specification, including the claims, and the
drawings of the patent. No new matter shall be introduced into the
application.
(1) Specification, including claims. The entire specification, including
the claims, of the patent for which reissue is requested must be
furnished in the form of a copy of the printed patent, but with only a
single column of the printed patent securely mounted, or otherwise
reproduced in permanent form, on a single page. If an amendment of the
reissue application is to be included, it must be made pursuant to
paragraph (b) of this section.
(2) Drawings. Applicant must submit a clean copy of each drawing sheet
of the printed patent at the time the reissue application is filed. If
such copy complies with 1.84, no further drawings will be required.
Where a drawing of the reissue application is to include any changes
relative to the patent being reissued, the changes to the drawing must
be made in accordance with paragraph (b)(3) of this section. The Office
will not transfer the drawings from the patent file to the reissue
application.
(b) Making amendments in a reissue application. An amendment in a
reissue application is made either upon filing, by incorporating the
changes physically within the specification, including the claims, using
markings pursuant to paragraph (d) of this section, or by filing an
amendment paper as a preliminary amendment or during prosecution
directing that specified changes be made to the application
specification, including the claims, or to the drawings.
(1) Specification other than the claims. Changes to the specification,
other than to the claims, must be made by submission of the entire text
of an added or rewritten paragraph, including markings pursuant to
paragraph (d) of this section, except that an entire paragraph may be
deleted by a statement deleting the paragraph without presentation of
the text of the paragraph. The precise point in the specification must
be identified where any added or rewritten paragraph is located.
(2) Claims. An amendment paper must include the entire text of each
claim being changed by such amendment paper and of each claim being
added by such amendment paper. For any claim changed by the amendment
paper, a parenthetical expression "amended," "twice amended," etc.,
should follow the claim number. Each changed patent claim and each added
claim must include markings pursuant to paragraph (d) of this section,
except that a patent claim or added claim should be canceled by a
statement canceling the claim without presentation of the text of the
claim.
(3) Drawings. Any change to the patent drawings must be submitted as a
sketch on a separate paper showing the proposed changes in red for
approval by the examiner. Upon approval by the examiner, new drawings in
compliance with 1.84 including the approved changes must be filed.
Amended figures must be identified as "Amended," and any added figure
must be identified as "New." In the event that a figure is canceled, the
figure must be surrounded by brackets and identified as "Canceled."
(c) Status of claims and support for claim changes. Whenever there is an
amendment to the claims pursuant to paragraph (b) of this section, there
must also be supplied, on pages separate from the pages containing the
changes, the status (ie., pending or canceled), as of the date of the
amendment, of all patent claims and of all added claims, and an
explanation of the support in the disclosure of the patent for the
changes to the claims made by the amendment paper.
(d) Changes shown by markings. Any changes relative to the patent being
reissued which are made to the specification, including the claims, upon
filing, or by an amendment paper in the reissue application, must
include the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets; and
(2) The matter to be added by reissue must be underlined.
(e) Numbering of patent claims preserved. Patent claims may not be
renumbered. The numbering of any claims added in the reissue application
must follow the number of the highest numbered patent claim.
(f) Amendment of disclosure may be required. The disclosure must be
amended, when required by the Office, to correct inaccuracies of
description and definition, and to secure substantial correspondence
between the claims, the remainder of the specification, and the drawings.
(g) Amendments made relative to patent. All amendments must be made
relative to the patent specification, including the claims, and
drawings, which are in effect as of the date of filing of the reissue
application.
1.174 [Removed and Reserved]
57. Section 1.174 is proposed to be removed and reserved.
58. Section 1.176 is proposed to be revised to read as follows:
1.176 Examination of reissue.
(a) A reissue application will be examined in the same manner as a
non-reissue nonprovisional application, and will be subject to all the
requirements of the rules related to non- reissue applications.
Restriction between subject matter of the original patent claims and
previously unclaimed subject matter may be required.
(b) The examiner will act on applications for reissue in advance of
other nonprovisional applications. An application for reissue, other
than a continued prosecution application under 1.53(d), will not be
acted on sooner than two months after the announcement of the filing of
the reissue application in the Official Gazette.
59. Section 1.177 is proposed to be revised to read as follows:
1.177 Issuance of multiple reissue patents.
(a) The Office may reissue a patent as multiple reissue patents. If
applicant files more than one application for the reissue of a single
patent, each such application must contain or be amended to contain in
the first sentence of the specification a notice stating that more than
one reissue application has been filed and identifying each of the
reissue applications by relationship, application number and filing
date. The Office may correct any reissue patent resulting from an
application to which this paragraph applies and not containing the
required notice by certificate of correction under 1.322.
(b) If applicant files more than one application for the reissue of a
single patent, each claim of the patent being reissued must be presented
in each of the reissue applications as an amended, unamended, or
canceled (shown in brackets) claim, with each such claim bearing the
same number as in the patent being reissued. The same claim of the
patent being reissued may not be presented in its original unamended
form for examination in more than one of such multiple reissue
applications. The numbering of any added claims in any of the multiple
reissue applications must follow the number of the highest numbered
original patent claim.
(c) If any one of the several reissue applications by itself fails to
correct an error in the original patent as required by 35 U.S.C. 251,
but is otherwise in condition for allowance, the Office may suspend
action in the allowable application until all issues are resolved as to
at least one of the remaining reissue applications. The Office may also
merge two or more of the multiple reissue applications into a single
reissue application. No reissue application containing only unamended
patent claims and not correcting an error in the original patent will be
passed to issue by itself.
60. Section 1.178 is proposed to be revised to read as follows:
1.178 Original patent.
The application for a reissue should be accompanied by an offer to
surrender the original patent. The application should also be
accompanied by the original patent, or if the original is
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Page 78, column one, of the Official Gazette of November 2, 1999 (volume
1228) should be replaced with the following:
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(2) If the person making the oath or declaration or any supplemental
oath or declaration is not the inventor ( 1.42, 1.43, or 1.47), the
oath or declaration shall state the relationship of the person to the
inventor, and, upon information and belief, the facts which the inventor
would have been required to state. If the person signing the oath or
declaration is the legal representative of a deceased inventor, the oath
or declaration shall also state that the person is a legal
representative and the citizenship, residence and mailing address of the
legal representative.
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(d) If the oath or declaration filed pursuant to 35 U.S.C. 371(c)(4)
and this section names an inventive entity different from the inventive
entity set forth in the international stage, the oath or declaration
must be accompanied by:
(1) A statement from each person being added as an inventor and from
each person being deleted as an inventor that any error in inventorship
in the international stage occurred without deceptive intention on his
or her part;
(2) The processing fee set forth in 1.17(i); and
(3) If an assignment has been executed by any of the original named
inventors, the written consent of the assignee (see 3.73(b) of this
chapter).
73. Section 1.510 is proposed to be amended by revising paragraph (b)(4)
to read as follows:
1.510 Request for reexamination.
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(b) ***
(4) The entire specification, including the claims, of the patent for
which reexamination is requested, in the form of a copy of the printed
patent, but with only a single column of the printed patent securely
mounted, or otherwise reproduced in permanent form, on a single sheet. A
clean copy of each drawing sheet of the printed patent must also be
furnished. Additionally, a copy of any disclaimer, certificate of
correction, or reexamination certificate issued in the patent must be
included.
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74. Section 1.530 and its heading are proposed to be amended by revising
its heading and paragraph (d), and adding paragraphs (e) through (1) to
read as follows:
1.530 Statement; amendment by patent owner; inventorship change.
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(d) Making amendments in a reexamination proceeding. A proposed
amendment in a reexamination proceeding is made by filing a paper
directing that proposed specified changes be made to the patent
specification, including the claims, or to the drawings. An amendment
paper directing that proposed specified changes be made in a
reexamination proceeding may be submitted as an accompaniment to a
request filed by the patent owner in accordance with 1.510(e), as
part of a patent owner statement in accordance with paragraph (b) of
this section, or, where permitted, during the conduct of the
reexamination proceeding pursuant to 1.550(a).
(1) Specification other than the claims. Changes to the specification,
other than to the claims, must be made by submission of the entire text
of an added or rewritten paragraph including markings pursuant to
paragraph (f) of this section, except that an entire paragraph may be
deleted by a statement deleting the paragraph, without presentation of
the text of the paragraph. The precise point in the specification must
be identified where any added or rewritten paragraph is located.
(2) Claims. An amendment paper must include the entire text of each
patent claim which is being proposed to be changed by such amendment
paper and of each new claim being proposed to be added by such amendment
paper. For any claim changed by the amendment paper, a parenthetical
expression "amended," "twice amended." etc., should follow the claim
number. Each patent claim proposed to be changed and each proposed added
claim must include markings pursuant to paragraph (f) of this section,
except that a patent claim or proposed added claim should be canceled by
a statement canceling the claim, without presentation of the text of the
claim.
(3) Drawings. Any change to the patent drawings must be submitted as a
sketch on a separate paper showing the proposed changes in red for
approval by the examiner. Upon approval of the changes by the examiner,
only new sheets of drawings including the changes and in compliance with
1.84 must be filed. Amended figures must be identified as "Amended,"
and any added figure must be identified as "New." In the event a figure
is canceled, the figure must be surrounded by brackets and identified as
"Canceled."
(e) Status of claims and support for claim changes. Whenever there is an
amendment to the claims pursuant to paragraph (d) of this section, there
must also be supplied, on pages separate from the pages containing the
changes, the status (i.e., pending or canceled), as of the date of the
amendment, of all patent claims and of all added claims, and an
explanation of the support in the disclosure of the patent for the
changes to the claims made by the amendment paper.
(f) Changes shown by markings. Any changes relative to the patent being
reexamined which are made to the specification, including the claims,
must include the following markings:
(1) The matter to be omitted by the reexamination proceeding must be
enclosed in brackets; and
(2) The matter to be added by the reexamination proceeding must be
underlined.
(g) Numbering of patent claims preserved. Patent claims may not be
renumbered. The numbering of any claims added in the reexamination
proceeding must follow the number of the highest numbered patent claim.
(h) Amendment of disclosure may be required. The disclosure must be
amended, when required by the Office, to correct inaccuracies of
description and definition, and to secure substantial correspondence
between the claims, the remainder of the specification, and the drawings.
(i) Amendments made relative to patent. All amendments must be made
relative to the patent specification, including the claims, and
drawings, which are in effect as of the date of filing the request for
reexamination.
(j) No enlargement of claim scope. No amendment may enlarge the scope of
the claims of the patent or introduce new matter. No amendment may be
proposed for entry in an expired patent. Moreover, no amendment, other
than the cancellation of claims, will be incorporated into the patent by
a certificate issued after the expiration of the patent.
(k) Amendments not effective until certificate. Although the Office
actions will treat proposed amendments as though they have been entered,
the proposed amendments will not be effective until the reexamination
certificate is issued.
(l) Correction of inventorship in reexamination proceedings.
(1) When it appears that the correct inventor or inventors were not
named in a patent being reexamined through error without deceptive
intention on the part of the actual inventor or inventors, the
Commissioner may, on petition of all the parties and the assignees and
satisfactory proof of the facts and payment of the fee set forth in
1.20(b), or on order of a court before which such matter is called in
question, include in the reexamination certificate to be issued under
1.570 an amendment naming only the actual inventor or inventors. The
petition must be submitted as part of the reexamination proceeding, and
must satisfy the requirements of 1.324.
(2) Notwithstanding paragraph (l)(1) of this section, if a petition to
correct inventorship satisfying the requirements of 1.324 is filed in
a reexamination proceeding, and the reexamination proceeding is
terminated other than in a reexamination certificate under 1.570, a
certificate of correction indicating the change of inventorship stated
in the petition will be issued upon request by the patentee.
75. Section 1.550 is proposed to be amended by revising paragraphs (a)
through (c) to read as follows:
1.550 Conduct of reexamination proceedings.
(a) All reexamination proceedings, including any appeals to the Board
of Patent Appeals and Interferences, will be conducted with special
dispatch within the Office. After issuance of the reexamination order
and expiration of the time for submitting any responses thereto, the
examination will be conducted in accordance with 1.104, 1.105,
1.110-1.113, 1.115, and 1.116 and will result in the issuance of a
reexamination certificate under 1.570.
(b) The patent owner will be given at least thirty days to respond to
any Office action. Such response may include further statements in
response to any rejections and/or proposed amendments or new claims to
place the patent in a condition where all claims, if amended as
proposed, would be patentable.
(c)(1) On or before the day on which an action by the patent owner is
due in a reexamination proceeding, the time for taking action by a
patent owner will be extended only for sufficient cause, and for a
reasonable time specified. Any request for such extension must be filed
on or before the day on which action by the patent owner is due, but in
no case will the mere filing of a request effect any extension. See
1.304(a) for extensions of time for filing a notice of appeal to the
U.S. Court of Appeals for the Federal Circuit or for commencing a civil
action.
(2) After the day on which an action by the patent owner is due in a
reexamination proceeding, the time for taking action by a patent owner
will be extended only upon the granting of a petition for extension of
time to accept late papers on the grounds that submission of the papers
was unintentionally delayed. A petition must be:
(i) Accompanied by papers effecting the action by the patent owner
required to continue prosecution of the reexamination proceeding;
(ii) Accompanied by the petition fee as set forth in 1.17(h);
(iii) Accompanied by a statement that the delay was unintentional. The
Commissioner may require additional information where there is a
question whether the delay was unintentional; and
(iv) Filed as a complete petition within the full statutory time period
for submission of the papers that were unintentionally delayed.
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76. Section 1.666 is proposed to be amended by revising paragraph (b) to
read as follows:
1.666 Filing of interference settlement agreements.
(b) If any party filing the agreement or understanding under
paragraph (a) of this section so requests, the copy will be kept
separate from the file of the interference, and made available only to
Government agencies on written request, or to any person upon petition
accompanied by the fee set forth in 1.17(h) and on a showing of good
cause.
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77. Section 1.720 is proposed to be amended by revising paragraphs (b)
and (g) to read as follows:
1.720 Conditions for extension of patent term.
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(b) The term of the patent has never been previously extended, except
for extensions issued pursuant to 1.701, 1.760, or 1.790;
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(g) The term of the patent, including any interim extension issued
pursuant to 1.790, has not expired before the submission of an
application in compliance with 1.741; and
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78. Section 1.730 is proposed to be revised to read as follows:
1.730 Applicant for extension of patent term; signature requirements.
(a) Any application for extension of a patent term must be submitted
by the owner of record of the patent or its agent and must comply with
the requirements of 1.740.
(b) If the application is submitted by the patent owner, the application
must be signed either by:
(1) The patent owner in compliance with 3.73(b) of this chapter; or
(2) A registered practitioner on behalf of the patent owner.
(c) If the application is submitted on behalf of the patent owner by an
agent of the patent owner (e.g., a licensee of the patent owner), the
application must be signed by a registered practitioner on behalf of the
agent. The Office may require proof that the agent is authorized to act
on behalf of the patent owner.
(d) If the application is signed by a registered practitioner, the
Office may require proof that the practitioner is authorized to act on
behalf of the patent owner or agent of the patent owner.
79. Section 1.740 is proposed to be amended by revising its heading, the
introductory text of paragraph (a), and paragraphs (a)(9), (a)(10),
(a)(14), (a)(15), (b) and (c) to read as follows:
1.740 Formal requirements for application for extension of patent
term; correction of informalities.
(a) An application for extension of patent term must be made in
writing to the Commissioner. A formal application for the extension of
patent term must include:
***
(9) A statement that the patent claims the approved product or a
method of using or manufacturing the approved product, and a showing
which lists each applicable patent claim and demonstrates the manner in
which at least one such patent claim reads on:
(i) The approved product, if the listed claims include any claim to the
approved product;
(ii) The method of using the approved product, if the listed claims
include any claim to the method of using the approved product; and
(iii) The method of manufacturing the approved product, if the listed
claims include any claim to the method of manufacturing the approved
product;
(10) A statement beginning on a new page, of the relevant dates and
information pursuant to 35 U.S.C. 156(g) in order to enable the
Secretary of Health and Human Services or the Secretary of Agriculture,
as appropriate, to determine the applicable regulatory review period as
follows:
(i) For a patent claiming a human drug, antibiotic, or human biological
product:
(A) The effective date of the investigational new drug (IND) application
and the IND number;
(B) The date on which a new drug application (NDA) or Product License
Application (PLA) was initially submitted and the NDA or PLA number; and
(C) The date on which the NDA was approved or the Product License issued;
(ii) For a patent claiming a new animal drug:
(A) The date a major health or environmental effects test on the drug
was initiated, and any available substantiation of that date, or the
date of an exemption under subsection (j) of section 512 of the Federal
Food, Drug, and Cosmetic Act became effective for such animal drug;
(B) The date on which a new animal drug application (NADA) was initially
submitted and the NADA number; and
(C) the date on which the NADA was approved;
(iii) For a patent claiming a veterinary biological product:
(A) The date the authority to prepare an experimental biological product
under the Virus-Serum-Toxin Act became effective;
(B) The date an application for a license was submitted under the
Virus-Serum-Toxin Act; and
(C) The date the license issued;
(iv) For a patent claiming a food or color additive:
(A) The date a major health or environmental effects test on the
additive was initiated and any available substantiation of that date;
(B) The date on which a petition for product approval under the Federal
Food, Drug and Cosmetic Act was initially submitted and the petition
number; and
(C) The date on which the FDA published a Federal Register notice
listing the additive for use;
(v) For a patent claiming a medical device:
(A) The effective date of the investigational device exemption (IDE) and
the IDE number, if applicable, or the date on which the applicant began
the first clinical investigation involving the device if no IDE was
submitted and any available substantiation of that date;
(B) The date on which the application for product approval or notice of
completion of a product development protocol under section 515 of the
Federal Food, Drug and Cosmetic Act was initially submitted and the
number of the application; and
(C) The date on which the application was approved or the protocol
declared to be completed;
***
(14) The prescribed fee for receiving and acting upon the application
for extension (see 1.200(j)); and
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