Changes To Implement the Cooperative Research and Technology Enhancement Act of 2004, 1818-1824 [05-461]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 70, Number 7 (Tuesday, January 11, 2005)]
[Rules and Regulations]
[Pages 1818-1824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-461]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

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

[[Page 1819]]

Portal Web site (https://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: 
https://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 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.
    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 
section 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).

[[Page 1820]]

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., Sec. Sec.  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 Sec.  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).

[[Page 1821]]

    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 Sec. Sec.  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,

[[Page 1822]]

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 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, 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.

[[Page 1823]]

    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, NW., Washington, DC 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 recordkeeping 
requirements, Small businesses.

37 CFR Part 3

    Administrative practice and procedure, Inventions and patents, 
Reporting and recordkeeping requirements.


0
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

0
1. The authority citation for 37 CFR part 1 continues to read as 
follows:

    Authority: 35 U.S.C. 2(b)(2).


0
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 Sec.  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.

0
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.

0
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.
* * * * *

0
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 Sec.  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

[[Page 1824]]

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).


Sec.  1.130  [Amended]

0
6. Section 1.130 is amended by removing and reserving paragraph (b).

0
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

0
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).


0
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.

0
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.

    Dated: January 4, 2005.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 05-461 Filed 1-10-05; 8:45 am]
BILLING CODE 3510-16-P