United States Patent and Trademark Office OG Notices: 08 February 2005

                            DEPARTMENT OF COMMERCE
                  United States Patent and Trademark Office
                             37 CFR Parts 1 and 3
                           [Docket No.: 2004-P-034]
                                RIN 0651-AB76

              Changes to Implement the Cooperative Research and
                      Technology Enhancement Act of 2004

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Interim rule.

SUMMARY: The Cooperative Research and Technology Enhancement Act of 2004
(CREATE Act) amends the patent laws to provide that subject matter
developed by another person shall be treated as owned by the same person
or subject to an obligation of assignment to the same person for purposes
of determining obviousness if three conditions are met: the claimed
invention was made by or on behalf of parties to a joint research
agreement that was in effect on or before the date the claimed invention
was made; the claimed invention was made as a result of activities
undertaken within the scope of the joint research agreement; and the
application for patent for the claimed invention discloses or is amended
to disclose the names of the parties to the joint research agreement. The
United States Patent and Trademark Office (Office) is revising the rules
of practice in patent cases to implement the CREATE Act.

DATES: EFFECTIVE DATE: December 10, 2004.
COMMENT DEADLINE DATE: To be ensured of consideration, written comments
must be received on or before February 10, 2005. No public hearing will
be held.

ADDRESSES: Comments should be sent by electronic mail message over the
Internet addressed to: ab76comments@uspto.gov. Comments may also be
submitted by mail addressed to: Box Comments-Patents, Commissioner for
Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, or by facsimile to
(571) 273-7735, marked to the attention of Robert A. Clarke. Although
comments may be submitted by mail or facsimile, the Office prefers to
receive comments via the Internet. If comments are submitted by mail,
the Office prefers that the comments be submitted on a DOS formatted
3 1/2 inch disk accompanied by a paper copy.

   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.

   The comments will be available for public inspection at the Office of
the Commissioner for Patents, located in Madison East, Tenth Floor, 600
Dulany Street, Alexandria, Virginia, and will be available through
anonymous file transfer protocol (ftp) via the Internet (address:
http://www.uspto.gov). Because comments will be made available for public
inspection, information that is not desired to be made public, such as an
address or phone number, should not be included in the comments.

FOR FURTHER INFORMATION CONTACT: Robert A. Clarke, or Jeanne M. Clark,
Senior Legal Advisors, Office of Patent Legal Administration, Office of
the Deputy Commissioner for Patent Examination Policy, by telephone at
(571) 272-7704, by mail addressed to: Box Comments-Patents, Commissioner
for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, or by facsimile to
(571) 273-7735, marked to the attention of Robert A. Clarke.

SUPPLEMENTARY INFORMATION: The CREATE Act amends 35 U.S.C. 103(c) to
provide that subject matter developed by another person shall be treated
as owned by the same person or subject to an obligation of assignment to
the same person for purposes of determining obviousness if three
conditions are met: (1) the claimed invention was made by or on behalf of
parties to a joint research agreement that was in effect on or before the
date the claimed invention was made; (2) the claimed invention was made as
a result of activities undertaken within the scope of the joint research
agreement; and (3) the application for patent for the claimed invention
discloses or is amended to disclose the names of the parties to the joint
research agreement. See Pub. L. 108-453, 118 Stat. 3596 (2004). Section 2
of the CREATE Act specifically amends 35 U.S.C. 103(c) to provide that:

   (c)(1) Subject matter developed by another person, which qualifies as
prior art only under one or more of subsections (e), (f), and (g) of
section 102 of this title, shall not preclude patentability under this
section where the subject matter and the claimed invention were, at the
time the claimed invention was made, owned by the same person or subject
to an obligation of assignment to the same person.

   (2) For purposes of this subsection, subject matter developed by
another person and a claimed invention shall be deemed to have been owned
by the same person or subject to an obligation of assignment to the same
person if-

   (A) the claimed invention was made by or on behalf of parties to a
joint research agreement that was in effect on or before the date the
claimed invention was made;

   (B) the claimed invention was made as a result of activities undertaken
within the scope of the joint research agreement; and

   (C) the application for patent for the claimed invention discloses or
is amended to disclose the names of the parties to the joint research
agreement.

   (3) For purposes of paragraph (2), the tern "joint research
agreement" means a written contract, grant, or cooperative agreement
entered into by two or more persons or entities for the performance of
experimental, developmental, or research work in the field of the
claimed invention.

   Section 3 of the CREATE Act provides that its amendments shall
apply to any patent (including any reissue patent) granted on or after
December 10, 2004. The CREATE Act provides that its amendments shall
not affect any final decision of a court or the Office rendered before
December 10, 2004, and shall not affect the right of any party in any
action pending before the Office or a court on December 10, 2004, to
have that party's rights determined on the basis of the provisions of
title 35, United States Code, in effect on December 9, 2004. Since the
CREATE Act also includes the amendment to 35 U.S.C. 103(c) made by Sec.
4807 of the American Inventors Protection Act of 1999 (see
Pub. L. 106-113, 113 Stat. 1501, 1501A-591 (1999)), the change of
"subsection (f) or (g)" to "one or more of subsections (e), (f),
or (g)" in 35 U.S.C. 103(c) is now also applicable to applications
filed prior to December 29, 1999, that were pending on December 10,
2004.

   This interim rule revises the rules of practice in title 37 of
the Code of Federal Regulations (CFR) to implement the CREATE Act.

   Once an examiner has established a prima facie case
of obviousness under 35 U.S.C. 103(a), the burden of overcoming the
rejection by invoking 35 U.S.C. 103(c) as amended by the CREATE Act is
on the applicant. To overcome a rejection under 35 U.S.C. 103(a) based
upon subject matter (whether a patent document, publication, or other
evidence) which qualifies as prior art under only one or more of 35
U.S.C. 102(e), (f) or (g) via the CREATE Act, the applicant must
provide a statement to the effect that the prior art and the claimed
invention were made by or on the behalf of parties to a joint research
agreement within the meaning of 35 U.S.C. 103(c)(3), and that the
claimed invention was made as a result of activities undertaken within
the scope of the joint research agreement. 35 U.S.C. 103(c)(3) defines
a "joint research agreement" as a written contract, grant, or
cooperative agreement entered into by two or more persons or entities
for the performance of experimental, developmental, or research work in
the field of the claimed invention, that was in effect on or before the
date the claimed invention (under examination or reexamination) was
made. The statement must be or begin on a separate sheet and must not
also be directed to other matters (Sec. 1.4(c)). The statement must be
signed either by the applicant or by the assignee of the entire
interest (as provided for under Sec. 3.71(b)).

   In addition to providing a statement, the applicant must also:
(1) amend the specification to disclose the names of the parties to the
joint research agreement; and (2) either amend the specification to
either set forth the date the joint research agreement was executed and
a concise statement of the field of the claimed invention, or specify
where (i.e., by reel and frame number) this information is
recorded in the assignment records of the Office. If the applicant
disqualifies the subject matter relied upon by the examiner in
accordance with 35 U.S.C. 103(c) as amended by the CREATE Act and the
procedures set forth in this interim rule, the examiner will treat the
application under examination and the 35 U.S.C. 102(e), (f), or (g)
prior art as if they are commonly owned for purposes of 35 U.S.C. 103. 

   35 U.S.C. 103(c), as amended by the CREATE Act, continues to
apply only to subject matter which qualifies as prior art under 35
U.S.C. 102(e), (f) or (g), and which is being relied upon in a
rejection under 35 U.S.C. 103. If the rejection is anticipation under
35 U.S.C. 102(e), (f), or (g), 35 U.S.C. 103(c) cannot be relied upon
to disqualify the subject matter in order to overcome the anticipation
rejection. 

   Because the CREATE Act applies only to patents granted on or
after December 10, 2004, the recapture doctrine may prevent the
presentation of claims in reissue applications that had been amended or
cancelled (e.g., to avoid a rejection under 35 U.S.C. 103(a)
based upon subject matter that may now be disqualified under the CREATE
Act) during the prosecution of the application which resulted in the
patent being reissued. See H.R. Rep. No. 108-425, at 6-7 (2003).

Discussion of Specific Rules:

Section 1.71: Section 1.71 is amended to add new Sec.
1.71(g). Section 1.71(g) provides that the specification may disclose
or be amended to disclose the names of the parties to a joint research
agreement. The application must disclose or be amended to
disclose the names of the parties to a joint research agreement to
invoke the "safe harbor" provision of 35 U.S.C. 103(c) as amended
by the CREATE Act. See 35 U.S.C. 103(c)(2)(C). Section
1.71(g)(1) specifically provides that if the specification discloses
(or is amended to disclose) the names of the parties to a joint
research agreement for purposes of 35 U.S.C. 103(c)(2), the
specification must also provide certain information necessary to
determine the applicability of the "safe harbor" provision of 35
U.S.C. 103(c) (or specify where such information is recorded by reel
and frame number in the assignment records of the Office). The
specification must also include the name of each party to the joint
research agreement because this information is required by 35 U.S.C.
103(c)(2)(C). The date the joint research agreement was executed must
also be provided because this information is necessary to determine
whether the "joint research agreement . . . was in effect
on or before the date the claimed invention was made" as required by
35 U.S.C. 103(c)(2)(A). If a joint research agreement was amended to be
in compliance with 35 U.S.C. 103(c) as amended by the CREATE Act, the
date the amended joint research agreement was executed is the date the
joint research agreement was executed for purposes of 35 U.S.C.
103(c)(2)(A) and is the date that must be provided to comply with Sec.
1.71(g). A concise statement of the field of the claimed invention must
also be provided because this information is necessary to determine
whether "the claimed invention was made as a result of activities
undertaken within the scope of the joint research agreement" as
required by 35 U.S.C. 103(c)(2)(B).

   Section 1.71(g)(2) provides that an amendment under Sec. 1.71(g)(1)
must be accompanied by the processing fee set forth in Sec. 1.17(i) if it is
not filed within one of the following time periods: (1) within three
months of the filing date of a national application; (2) within three
months of the date of entry of the national stage as set forth in Sec.
1.491 in an international application; (3) before the mailing of a
first Office action on the merits; or (4) before the mailing of a first
Office action after the filing of a request for continued examination
under Sec. 1.114.

   Section 1.71(g)(3) provides that an amendment under Sec. 1.71(g)(1) filed
after the date the issue fee is paid must also be accompanied by the
processing fee set forth Sec. 1.17(i), and that the patent may not
include the names of the parties to the joint research agreement.
Section 1.71(g)(3) also provides that if the patent does not include
the names of the parties to the joint research agreement, the amendment
to include the names of the parties to the joint research agreement
will not be effective unless the patent is corrected by a certificate
of correction under 35 U.S.C. 255 and Sec. 1.322. The requirements of Sec.
1.71(g)(3) (payment of the processing fee set forth in Sec. 1.17(i) and
correction of the patent by a certificate of correction under 35 U.S.C.
255 and Sec. 1.322) also apply in the situation in which such an
amendment is not filed until after the date the patent was granted (in
a patent granted on or after December 10, 2004). It is unnecessary to
file a reissue application or request for reexamination of the patent
to submit the amendment and other information necessary to take
advantage of 35 U.S.C. 103(c) as amended by the CREATE Act. See
H.R. Rep. No. 108-425, at 9 ("[t]he omission of the names of
parties to the agreement is not an error that would justify
commencement of a reissue or reexamination proceeding").

   The submission of such an amendment remains subject to the rules of
practice: e.g., Secs. 1.116, 1.121, and 1.312. For example,
if an amendment under Sec. 1.71(g) is submitted in an application under
final rejection to overcome a rejection under 35 U.S.C. 103(a) based
upon a U.S. patent which qualifies as prior art only under 35 U.S.C.
102(e), the examiner may refuse to enter the amendment under Sec. 1.71(g)
if it is not accompanied by an appropriate terminal disclaimer (Sec.
1.321(d)). Such an amendment may necessitate the reopening of
prosecution and entry of a double patenting rejection (Sec. 1.116).

   If an amendment under Sec. 1.71(g) is submitted to overcome a rejection
under 35 U.S.C. 103(a) based upon a U.S. patent or U.S. patent
application publication which qualifies as prior art only under 35
U.S.C. 102(e), and the examiner withdraws the rejection under 35 U.S.C.
103(a), but issues an Office action containing a new double patenting
rejection based upon the disqualified patent or patent application
publication, the Office action can be made final (provided that the
examiner introduces no other new ground of rejection that was not
necessitated by either amendment or an information disclosure statement
filed during the time period set forth in 1.97(c) with the fee set
forth in Sec. 1.17(p)). The Office action is properly made final because
the new double patenting rejection was necessitated by amendment of the
application by applicant. This is the case regardless of whether the
claims themselves have been amended.

Section 1.77: Section 1.77 is amended to provide for
the names of the parties to a joint research agreement in the preferred
arrangement of the specification. 

Section 1.104: Section 1.104(c)(4) is amended for consistency with the
amendment to 35 U.S.C. 103(c).

Section 1.109: Section 1.109 is added to set forth the conditions under
which the Office will make a double patenting rejection. Section 1.109(a)
contains the provisions of Sec. 1.130(b) (with a few changes for clarity).
Section 1.130(b) is being removed from Sec. 1.130 (see discussion of
Sec. 1.130).

Section 1.109(b) provides for double patenting situations which may
arise as a result of the CREATE Act. Congress recognized that this
amendment to 35 U.S.C. 103(c) would result in situations in which there
would be double patenting between applications not owned by the same
party. See H.R. Rep. No. 108-425, at 5-6 (2003). Therefore,
Sec. 1.109(b) provides that a double patenting rejection will be made in
an application or patent under reexamination if: (1) the application or
patent under reexamination claims an invention that is not patentably
distinct from an invention claimed in a non-commonly owned patent; (2)
the application or patent and the non-commonly owned patent are by or
on behalf of parties to a joint research agreement; and (3) the
inventions claimed in the application or patent and in the non-commonly
owned patent were made as a result of activities undertaken within the
scope of the joint research agreement. Thus, the application or patent
and the subject matter disqualified under 35 U.S.C. 103(c) as amended
by the CREATE Act will be treated as commonly owned for purposes of
double patenting analysis. Section 1.109(b) also provides that this
double patenting rejection will be made regardless of whether the
application or patent and the non-commonly owned patent have the same
or a different inventive entity. Section 1.109(b) also provides that
this double patenting rejection may be obviated by filing a terminal
disclaimer in accordance with Sec. 1.321(d).

Section 1.130: Section 1.130 is amended to remove and reserve
Sec. 1.130(b).

Section 1.321: Section 1.321(d) is added to provide the terminal
disclaimer requirements for the double patenting situations which arise
as a result of the CREATE Act. See H.R. Rep. No. 108-425, at 6 (the
Office may require a terminal disclaimer when double patenting is
determined to exist for two or more claimed inventions for any
application for which the applicant takes advantage of the "safe harbor"
provision in 35 U.S.C. 103(c) as amended by the CREATE Act). The
legislative history of the CREATE Act specifically states that:

   Congress intends that parties who seek to benefit from
   this Act to waive the right to enforce any patent separately from any
   earlier patent that would otherwise have formed the basis for an
   obviousness-type double patenting rejection. Further, Congress intends
   that parties with an interest in a patent that is granted solely on the
   basis of the amendments made pursuant to this Act to waive requirements
   for multiple licenses. In other words, the requirements under current
   law for parties to terminally disclaim interests in patents that would
   otherwise be invalid on "obviousness-type" double patenting grounds
   are to apply, mutatis mutandis, to the patents that may be
   issued in circumstances made possible by this Act.

See id.

   Section 1.321(d) specifically sets forth the requirements for a
terminal disclaimer that is filed in a patent application or in a
reexamination proceeding to obviate a double patenting rejection based
upon a U.S. patent or application that is not commonly owned but was
disqualified under 35 U.S.C. 103(c). First, the terminal disclaimer
must comply with the provisions of Secs. 1.321(b)(2) through (b)(4).
Second, the terminal disclaimer must be signed by the applicant in
accordance with Sec. 1.321(b)(1) if filed in a patent application, or be
signed by the patentee in accordance with Sec. 1.321(a)(1) if filed in a
reexamination proceeding. Third, the terminal disclaimer must also be
signed by the patentee or by the applicant, or an attorney or agent of
record, of the disqualified patent or application. Fourth, the terminal
disclaimer must also include a provision that the owner of the rejected
application or patent and the owner of the disqualified patent or
application each: (1) waive the right to separately enforce and license
the rejected application or patent and the disqualified patent or
application; (2) agree that the rejected application or patent and the
disqualified patent or application shall be enforceable during the
period that the rejected patent or application and the disqualified
patent or application are not separately enforced and are not
separately licensed; and (3) agree that such waiver and agreement shall
be binding upon the owner of the rejected application or patent, its
successors, or assigns, and the owner of the disqualified patent or
application, its successors, or assigns.

Section 3.11: Section 3.11(c) is added to provide that
the Office will record a joint research agreement or an excerpt of a
joint research agreement as provided in 37 CFR part 3. Section 3.11(c)
also provides that such a joint research agreement or excerpt of a
joint research agreement must include the name of each party to the
joint research agreement, the date the joint research agreement was
executed, and a concise statement of the field of invention (see Sec.
1.71(g)). 

Section 3.31: Section 3.31(g) is added to set forth
the requirements for the cover sheet required by Sec. 3.28 seeking to
record a joint research agreement or an excerpt of a joint research
agreement as provided by Sec. 3.11(c). First, the cover sheet must
identify the document as a "joint research agreement" (preferably,
in the space provided for the description of the interest conveyed or
transaction to be recorded in box 3 (under "other") of Office form
PTO-1595 (June 2004)). Second, the cover sheet must indicate the name
of the owner of the application or patent (preferably, in the space
provided for the name and address of the party receiving the interest
in box 2 of Office form PTO-1595). Third, the cover sheet must indicate
the name of every other party to the joint research agreement party
(preferably, in the space provided for the name of the party conveying
the interest in box 1 (providing additional names on an attached sheet
if necessary) of Office form PTO-1595). Fourth, the cover sheet must
indicate the date the joint research agreement was executed
(preferably, in the space provided for the execution date in box 1 of
Office form PTO-1595). 

Rule Making Considerations:

Administrative Procedure Act: Pursuant to authority at
5 U.S.C. 553(b)(B), the Under Secretary of Commerce for Intellectual
Property and Director of the United States Patent and Trademark Office
finds good cause to adopt the changes made in this interim rule without
prior notice and opportunity for public comment, as such prior notice
and comment procedures are contrary to the public interest in this
situation. The amendments to 35 U.S.C. 103(c) in the CREATE Act apply
to any patent granted on or after December 10, 2004, and thus apply to
applications currently pending before the Office. The rules of
practice, however, do not currently provide for the amendment of an
application or the recording of joint research agreements (or excerpts
of joint research agreements) to invoke the "safe harbor" provision
of 35 U.S.C. 103(c) as amended by the CREATE Act, and do not permit the
filing of the type of terminal disclaimer necessary to overcome the
double patenting rejection that may arise as a result of the CREATE
Act. Delay in the promulgation of the changes in this rule to provide
notice and comment procedures might cause harm to those applicants
whose applications are currently under a 35 U.S.C. 103 rejection which
could be overcome by invoking the "safe harbor" provision of 35
U.S.C. 103(c) as amended by the CREATE Act. Put simply, delay in the
implementation of the CREATE Act might cause harm to those applicants
who need to invoke its provisions promptly to avoid a loss of patent
rights.

   In addition, the changes in this interim rule relate solely to the
procedures to be followed in prosecuting a patent application:
i.e., submitting the amendment necessary to invoke the
"safe harbor" provision of 35 U.S.C. 103(c) as amended by the
CREATE Act, filing of the type of terminal disclaimer necessary to
overcome the double patenting rejection that may arise as a result of
the CREATE Act, and submitting joint research agreements or excerpts of
joint research agreements for recording by the Office. Therefore, these
rule changes involve interpretive rules, or rules of agency practice
and procedure under 5 U.S.C. 553(b)(A), and prior notice and an
opportunity for public comment were not required pursuant to 5 U.S.C.
553(b)(A) (or any other law). See Bachow Communications Inc. v.
FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an
application process are "rules of agency organization, procedure, or
practice" and are exempt from the Administrative Procedure Act's
notice and comment requirement); see also Merck & Co., Inc. v.
Kessler, 80 F.3d 1543, 1549-50, 38 USPQ2d 1347, 1351 (Fed. Cir.
1996) (the rules of practice promulgated under the authority of former
35 U.S.C. 6(a) (now in 35 U.S.C. 2(b)(2)) are not substantive rules (to
which the notice and comment requirements of the Administrative
Procedure Act apply)), and Fressola v. Manbeck, 36 USPQ2d
1211, 1215 (D.D.C. 1995) ("it is doubtful whether any of the rules
formulated to govern patent and trade-mark practice are other than
`interpretative rules, general statements of policy, . . .
procedure, or practice.'") (quoting C.W. Ooms, The United
States Patent Office and the Administrative Procedure Act, 38
Trademark Rep. 149, 153 (1948)). Accordingly, prior notice and an
opportunity for public comment were not required pursuant to 5 U.S.C.
553(b)(A) (or any other law), and thirty-day advance publication is not
required pursuant to 5 U.S.C. 553(d) (or any other law). 

Regulatory Flexibility Act: As discussed previously,
the changes in this interim rule involve rules of agency practice and
procedure under 5 U.S.C. 553(b)(A), and prior notice and an opportunity
for public comment were not required pursuant to 5 U.S.C. 553(b)(A) (or
any other law). As prior notice and an opportunity for public comment
were not required pursuant to 5 U.S.C. 553 (or any other law) for the
changes in this interim rule, a regulatory flexibility analysis under
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) is not
required for the changes in this interim rule. See 5 U.S.C. 603.


Executive Order 13132: This rule making does not
contain policies with federalism implications sufficient to warrant
preparation of a Federalism Assessment under Executive Order 13132
(Aug. 4, 1999). 

Executive Order 12866: This rule making has been
determined to be significant for purposes of Executive Order 12866
(Sept. 30, 1993). 

Paperwork Reduction Act: This rule making involves
information collection requirements which are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.). The collections of
information involved in this interim rule have been reviewed and
previously approved by OMB under the following control numbers:
0651-0027, 0651-0031, 0651-0032, and 0651-0033. The United States
Patent and Trademark Office is not resubmitting the information
collections listed above to OMB for its review and approval because the
changes in this notice do not affect the information collection
requirements associated with these information collections.

   The title, description and respondent description of each of the
information collections is shown below with an estimate of the annual
reporting burdens. Included in the estimate is the time for reviewing
instructions, gathering and maintaining the data needed, and completing
and reviewing the collection of information. The principal impacts of
the changes in this rule making are to implement the CREATE Act. 

   OMB Number: 0651-0027.
   Title: Recording Assignments.
   Form Numbers: PTO-1594 and PTO-1595.
   Type of Review: Approved through June of 2005.
   Affected Public: Individuals or Households, Business or Other
For-Profit Institutions, Not-For-Profit Institutions, Farms, Federal
Government, and State, Local, or Tribal Governments.
   Estimated Number of Respondents: 240,345.
   Estimated Time Per Response: 30 minutes.
   Estimated Total Annual Burden Hours: 120,173 hours.
   Needs and Uses: The Office records over 200,000 assignments or
documents related to ownership of patent and trademark cases each year.
The Office requires a cover sheet to expedite the processing of these
documents and to ensure that they are properly recorded. 

   OMB Number: 0651-0031.
   Title: Patent Processing (Updating).
   Form Numbers: PTO/SB/08A, PTO/SB/08B, PTO/SB/17i, PTO/SB/17p,
PTO/SB/21-27, PTO/SB/30-37, PTO/SB/42-43, PTO/SB/61-64, PTO/SB/64A,
PTO/SB/67-68, PTO/SB/91-92, PTO/SB/96-97, PTO-2053-A/B, PTO-2054-A/B,
PTO-2055-A/B, PTOL-413A.

   Type of Review: Approved through July of 2006.
   Affected Public: Individuals or Households, Business or Other
For-Profit Institutions, Not-for-Profit Institutions, Farms, Federal
Government and State, Local and Tribal Governments.
   Estimated Number of Respondents: 2,281,439.
   Estimated Time Per Response: 1 minute and 48 seconds to 8 hours.
   Estimated Total Annual Burden Hours: 2,731,841 hours.

   Needs and Uses: During the processing for an application for a patent,
the applicant/agent may be required or desire to submit additional
information to the United States Patent and Trademark Office concerning
the examination of a specific application. The specific information
required or which may be submitted includes: information disclosure
statements and citations, requests for extensions of time, the
establishment of small entity status; abandonment and revival of
abandoned applications, disclaimers, requests for expedited examination
of design applications, transmittal forms, requests to inspect, copy
and access patent applications, nonpublication requests, certificates
of mailing or transmission, submission of priority documents and
amendments. 

   OMB Number: 0651-0032.
   Title: Initial Patent Application.
   Form Number: PTO/SB/01-07, PTO/SB/13PCT, PTO/SB/16-19, PTO/SB/29 and
29A, PTO/SB/101-110.
   Type or Review: Approved through July of 2006.
   Affected Public: Individuals or Households, Business or Other
For-Profit Institutions, Not-For-Profit Institutions, Farms, Federal
Government, and State, Local, or Tribal Governments.
   Estimated Number of Respondents: 454,287.
   Estimated Time Per Response: 22 minutes to 10 hours and 45 minutes.
   Estimated Total Annual Burden Hours: 4,171,568 hours.
   Needs and Uses: The purpose of this information collection is to permit
the Office to determine whether an application meets the criteria set
forth in the patent statute and regulations. The standard Fee
Transmittal form, New Utility Patent Application Transmittal form, New
Design Patent Application Transmittal form, New Plant Patent
Application Transmittal form, Declaration, Provisional Application
Cover Sheet, and Plant Patent Application Declaration will assist
applicants in complying with the requirements of the patent statute and
regulations, and will further assist the USPTO in processing and
examination of the application. 

   OMB Number: 0651-0033.
   Title: Post Allowance and Refiling.
   Form Numbers: PTO/SB/44, PTO/SB/50-51, PTO/SB/51S, PTO/SB/52-53,
PTO/SB/56-58, PTOL-85B.
   Type of Review: Approved through April of 2007.
   Affected Public: Individuals or Households, Business or Other
For-Profit Institutions, Not-For-Profit Institutions, Farms, Federal
Government, and State, Local or Tribal Governments.
   Estimated Number of Respondents: 223,411.
   Estimated Time Per Response: 1.8 minutes to 2 hours.
   Estimated Total Annual Burden Hours: 67,261 hours.
   Needs and Uses: This collection of information is required to
administer the patent laws pursuant to Title 35, U.S.C., concerning the
issuance of patents and related actions including correcting errors in
printed patents, refiling of patent applications, requesting
reexamination of a patent, and requesting a reissue patent to correct
an error in a patent. The affected public includes any individual or
institution whose application for a patent has been allowed or who
takes action as covered by the applicable rules. 

   Comments are invited on: (1) whether the collection of
information is necessary for proper performance of the functions of the
agency; (2) the accuracy of the agency's estimate of the burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information to respondents.

   Interested persons are requested to send comments regarding these
information collections, including suggestions for reducing this
burden, to Robert J. Spar, Director, Office of Patent Legal
Administration, Commissioner for Patents, P.O. Box 1450, Alexandria, VA
22313-1450, or to the Office of Information and Regulatory Affairs,
OMB, 725 17th Street, N.W., Washington, D.C. 20503, (Attn: PTO Desk
Officer).

   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

37 CFR Part 1

   Administrative practice and procedure, Courts, Freedom of Information,
Inventions and patents, Reporting and record keeping requirements,
Small Businesses. 

37 CFR Part 3

   Administrative practice and procedure, Inventions and patents,
Reporting and record keeping requirements.

   For the reasons set forth in the preamble, 37 CFR Parts 1 and 3 are
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 1.71 is amended by adding a new paragraph (g) to read as
follows:

Sec. 1.71 Detailed description and specification of the invention.

* * * * *

   (g) The specification may disclose or be amended to disclose
the names of the parties to a joint research agreement (35 U.S.C.
103(c)(2)(C)).

   (1) If the specification discloses or is amended to disclose the names
of the parties to a joint research agreement for purposes of 35 U.S.C.
103(c)(2), the specification must also provide or be amended to provide
the following information, or the location where (i.e., by
reel and frame number) such information is recorded in the assignment
records of the Office:

   (i) The date the joint research agreement was executed; and

   (ii) A concise statement of the field of the claimed invention.

   (2) An amendment under paragraph (g)(1) of this section must be
accompanied by the processing fee set forth 1.17(i) if not filed within
one of the following time periods:

   (i) Within three months of the filing date of a national application;

   (ii) Within three months of the date of entry of the national stage as
set forth in Sec. 1.491 in an international application;

   (iii) Before the mailing of a first Office action on the merits; or

   (iv) Before the mailing of a first Office action after the filing of a
request for continued examination under Sec. 1.114.

   (3) An amendment under paragraph (g)(1) of this section filed after the
date the issue fee is paid must be accompanied by the processing fee
set forth Sec. 1.17(i), and the patent may not include the names of the
parties to the joint research agreement. If the patent does not include
the names of the parties to the joint research agreement, the amendment
to include the names of the parties to the joint research agreement
will not be effective unless the patent is corrected by a certificate
of correction under 35 U.S.C. 255 and Sec. 1.322.

   3. Section 1.77 is amended by redesignating paragraphs (b)(4)
through (b)(11) as paragraphs (b)(5) through (b)(12), adding a new
paragraph (b)(4), and revising paragraph (c) to read as follows:

Sec. 1.77 Arrangement of application elements.

* * * * *

   (b) * * *
   (4) The names of the parties to a joint research agreement.

* * * * *

(c) The text of the specification sections defined in
paragraphs (b)(1) through (b)(12) of this section, if applicable,
should be preceded by a section heading in uppercase and without
underlining or bold type. 

   4. Section 1.104 is amended by revising paragraph (c)(4) to
read as follows: 

Sec. 1.104 Nature of examination.

* * * * *

   (c) * * *
   (4) Subject matter which is developed by another person which qualifies
as prior art only under 35 U.S.C. 102(e), (f) or (g) may be used as
prior art under 35 U.S.C. 103 against a claimed invention unless the
entire rights to the subject matter and the claimed invention were
commonly owned by the same person or organization or subject to an
obligation of assignment to the same person or organization at the time
the claimed invention was made.

   (i) Subject matter developed by another person and a claimed invention
shall be deemed to have been commonly owned by the same person or
organization, or subject to an obligation of assignment to the same
person or organization in any application and in any patent granted on
or after December 10, 2004, if:

   (A) The claimed invention was made by or on behalf of parties to a
joint research agreement that was in effect on or before the date the
claimed invention was made;

   (B) The claimed invention was made as a result of activities undertaken
within the scope of the joint research agreement; and

   (C) The application for patent for the claimed invention discloses or
is amended to disclose the names of the parties to the joint research
agreement.

   (ii) For purposes of paragraph (c)(4)(i) of this section, the term
"joint research agreement" means a written contract, grant, or
cooperative agreement entered into by two or more persons or entities
for the performance of experimental, developmental, or research work in
the field of the claimed invention. 

* * * * *

5. Section 1.109 is added to read as follows:

Sec. 1.109 Double patenting.

   (a) A double patenting rejection will be made in an application or
patent under reexamination if the application or patent under
reexamination claims an invention that is not patentably distinct from
an invention claimed in a commonly owned patent. This double patenting
rejection will be made regardless of whether the application or patent
under reexamination and the commonly owned patent have the same or a
different inventive entity. A judicially created double patenting
rejection may be obviated by filing a terminal disclaimer in accordance
with 1.321(c).

   (b) A double patenting rejection will be made in an application or
patent under reexamination if the application or patent under
reexamination claims an invention that is not patentably distinct from
an invention claimed in a non-commonly owned patent by or on behalf of
parties to a joint research agreement in which the inventions claimed
in the application or patent under reexamination and in the other
patent were made as a result of activities undertaken within the scope
of the joint research agreement. This double patenting rejection will
be made regardless of whether the application or patent under
reexamination and the non-commonly owned patent have the same or a
different inventive entity. This double patenting rejection may be
obviated by filing a terminal disclaimer in accordance with Sec.
1.321(d). 

   6. Section 1.130 is amended by removing and reserving paragraph
(b). 

   7. Section 1.321 is amended by adding a new paragraph (d) to
read as follows: 

Sec. 1.321 Statutory disclaimers, including terminal disclaimers.

* * * * *

   (d) A terminal disclaimer, when filed in a patent application (rejected
application) or in a reexamination proceeding (rejected patent) to
obviate a double patenting rejection based upon a patent (disqualified
patent) or application (disqualified application) that is not commonly
owned but was disqualified under 35 U.S.C. 103(c) as resulting from
activities undertaken within the scope of a joint research agreement,
must:

   (1) Comply with the provisions of paragraphs (b)(2) through (b)(4) of
this section;

   (2) Be signed in accordance with paragraph (b)(1) of this section if
filed in a patent application or be signed in accordance with paragraph
(a)(1) of this section if filed in a reexamination proceeding;

   (3) Be signed by the patentee or by the applicant, or an attorney or
agent of record, of the disqualified patent or application; and

   (4) Include a provision that the owner of the rejected application or
patent and the owner of the disqualified patent or application each:

   (i) Waive the right to separately enforce and the right to separately
license the rejected application or patent and the disqualified patent
or application;

   (ii) Agree that the rejected application or patent and the disqualified
patent or application shall be enforceable only for and during such
period that the rejected patent or application and the disqualified
patent or application are not separately enforced and are not
separately licensed; and

   (iii) Agree that such waiver and agreement shall be binding upon the
owner of the rejected application or patent, its successors, or
assigns, and the owner of the disqualified patent or application, its
successors, or assigns. 

PART 3-ASSIGNMENT, RECORDING AND RIGHTS OF ASSIGNEE

8. The authority citation for 37 CFR Part 3 continues to read as follows:

Authority: 15 U.S.C. 1123; 35 U.S.C. 2(b)(2).

9. Section 3.11 is amended by adding a new paragraph (c) to read as
follows:

Sec. 3.11 Documents which will be recorded.

* * * * *

  (c) A joint research agreement or an excerpt of a joint research
agreement will also be recorded as provided in this part. A joint
research agreement or excerpt of a joint research agreement submitted
for recording by the Office must include the name of each party to the
joint research agreement, the date the joint research agreement was
executed, and a concise statement of the field of invention. 

10. Section 3.31 is amended by adding a new paragraph (g) to read as
follows:

Sec. 3.31 Cover sheet content.

* * * * *

   (g) The cover sheet required by Sec. 3.28 seeking to record a joint
research agreement or an excerpt of a joint research agreement as
provided by Sec. 3.11(c) must:

   (1) Identify the document as a "joint research agreement" (in the
space provided for the description of the interest conveyed or
transaction to be recorded if using an Office-provided form);

   (2) Indicate the name of the owner of the application or patent (in the
space provided for the name and address of the party receiving the
interest if using an Office-provided form);

   (3) Indicate the name of each other party to the joint research
agreement party (in the space provided for the name of the party
conveying the interest if using an Office-provided form); and

   (4) Indicate the date the joint research agreement was executed.

January 4, 2005                                                JON W. DUDAS
                                            Under Secretary of Commerce for
                                                  Intellectual Property and
                                              Director of the United States
                                                Patent and Trademark Office