[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Rules and Regulations]
[Pages 54259-54267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18217]


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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: Final rule.

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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: September 14, 2005.

[[Page 54260]]

    Applicability Date: The changes in this final rule apply to any 
patent granted on or after December 10, 2004.

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 amended 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 
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 November 29, 1999, which were pending on December 10, 2004.
    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 for which 
reissue is sought. See H.R. Rep. No. 108-425, at 6-7 (2003).
    The Office published an interim rule to revise the rules of 
practice in title 37 of the Code of Federal Regulations (CFR) to 
implement the CREATE Act. See Changes to Implement the Cooperative 
Research and Technology Enhancement Act of 2004, 70 FR 1818 (Jan. 11, 
2005), 1291 Off. Gaz. Pat. Office 58 (Feb. 8, 2005) (interim rule). 
This final rule further revises the rules of practice in title 37, CFR, 
to implement the CREATE Act.

Discussion of Specific Rules

    Section 1.17: Section 1.17(i) is amended in this final rule to add 
the processing fee required by Sec.  1.71(g)(2) (see the discussion 
regarding Sec.  1.71(g)(2)).
    Section 1.52: Section 1.52(e)(5) is amended in this final rule to 
change ``Sec.  1.77(b)(4)'' to ``Sec.  1.77(b)(5)'' for consistency 
with the change to Sec.  1.77(b).
    Section 1.71: Section 1.71 was amended in the interim rule to add 
new Sec.  1.71(g). An 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) provides 
for the situation in which an application discloses or is 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. Section 1.71(g)(1) specifically provides that the 
specification may disclose or be amended to disclose the name of each 
party to the joint research agreement because this information is 
required by 35 U.S.C. 103(c)(2)(C). This final rule eliminates the 
requirements for: (1) The date the joint research agreement was 
executed; and (2) a concise statement of the field of the claimed 
invention.
    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 if an amendment under Sec.  
1.71(g)(1) is filed after the date the issue fee is paid, the patent as 
issued may not necessarily include the names of the parties to the 
joint research agreement. Section 1.71(g)(3) also provides that if the 
patent as issued does not include the names of the parties to the joint 
research agreement, the patent must be corrected to include the names 
of the parties to the joint research agreement by a certificate of 
correction under 35 U.S.C. 255 and 37 CFR 1.323 for the amendment to be 
effective. The requirements of Sec.  1.71(g)(3) (correction of the 
patent by a certificate of correction under 35 U.S.C. 255 and 37

[[Page 54261]]

CFR 1.323) 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'').
    Section 1.71(g)(3) is amended in this final rule to eliminate the 
provision that the processing fee under Sec.  1.17(i) is required if an 
amendment under Sec.  1.71(g)(1) is submitted after payment of the 
issue fee. The processing fee under Sec.  1.17(i) is required for an 
amendment under Sec.  1.71(g)(1) submitted after the time periods set 
forth in Sec.  1.71(g)(2), even if the amendment under Sec.  1.71(g)(1) 
is also submitted after payment of the issue fee or after a patent is 
granted.
    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)). This is because such an amendment may necessitate the 
reopening of prosecution (e.g., for entry of a double patenting 
rejection).
    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), the examiner may need to issue an Office action 
containing a new double patenting rejection based upon the disqualified 
patent or patent application publication. In these situations, such 
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 1.76: Section 1.76(b)(5) is amended in this final rule to 
change ``Sec.  1.78(a)(4)'' to ``Sec.  1.78(a)(5)'' to correct a 
typographic error.
    Section 1.77: Section 1.77 was amended in the interim rule to 
provide for the names of the parties to a joint research agreement in 
the preferred arrangement of the specification. No further amendment to 
Sec.  1.77 is made in this final rule.
    Section 1.96: Section 1.96(c) is amended in this final rule to 
change ``Sec.  1.77(b)(4)'' to ``Sec.  1.77(b)(5)'' for consistency 
with the change to Sec.  1.77(b).
    Section 1.104: Section 1.104(c)(4) is amended for consistency with 
the amendment to 35 U.S.C. 103(c) and to include the requirements for 
the statement to invoke the prior art disqualification under the CREATE 
Act. Section 1.104 is also amended to change ``same person or 
organization'' to ``same person'' for consistency with 35 U.S.C. 103(c) 
(no change in substance).
    Once an examiner has established a prima facie case of obviousness 
under 35 U.S.C. 103(a), the burden is on the applicant to overcome the 
rejection by invoking 35 U.S.C. 103(c) as amended by the CREATE Act. 
Such a rejection under 35 U.S.C. 103(a) may be 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). To overcome such a rejection via the CREATE Act, 
the applicant must provide a statement in compliance with Sec.  
1.104(c)(4) 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), which was in effect on or 
before the date the claimed invention was made, 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 should either be on or begin on a separate sheet 
and must not be directed to other matters (Sec.  1.4(c)). The statement 
must be signed in accordance with Sec.  1.33(b).
    In addition to providing a statement, the applicant must also amend 
the specification to disclose the names of the parties to the joint 
research agreement in compliance with Sec.  1.71(g)(1). If the 
applicant disqualifies the subject matter relied upon by the examiner 
in accordance with the CREATE Act and the procedures set forth in this 
final 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.
    Section 1.109: Section 1.109 was added in the interim rule, but is 
removed and reserved in this final rule. This final rule sets forth 
guidelines for double patenting rejections based upon a patent or 
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 and other double patenting rejections in 
the Manual of Patent Examining Procedure (MPEP) rather than in the 
rules of practice. MPEP 804 sets forth the Office's guidelines for 
double patenting rejections.
    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, the Office is providing the following guidelines 
for double patenting rejections based upon a patent or 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, which will be incorporated into the next revision 
of the MPEP. A double patenting rejection will be made in an 
application or patent under reexamination (assuming that the applicant 
or patentee has not already filed the appropriate terminal disclaimer) 
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 application or patent; (2) the application or 
patent and the non-commonly owned application or patent are by or on 
behalf of parties to a joint research agreement; and (3) a statement 
has been filed under Sec.  1.104(c)(4)(iii) to disqualify the non-
commonly owned application or patent under 35 U.S.C. 103(c)(2). 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. Such a double 
patenting rejection will be made regardless of whether the

[[Page 54262]]

application or patent and the non-commonly owned patent or application 
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).
    Section 1.130: Section 1.130 was amended in the interim rule to 
remove and reserve Sec.  1.130(b). No further amendment to Sec.  1.130 
is made in this final rule.
    Section 1.321: Section 1.321(c) is amended to change ``judicially 
created double patenting rejection'' to ``judicially created double 
patenting'' because double patenting may exist regardless of whether a 
double patenting rejection has been made.
    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 H.R. Rep. No. 108-425, at 6.
    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 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 include a provision that the owner of the application or 
patent waives the right to separately enforce any patent granted on 
that application or any patent subject to the reexamination proceeding 
and the disqualified patent or any patent granted on the disqualified 
application, and that any patent granted on that application or any 
patent subject to the reexamination proceeding shall be enforceable 
only for and during such period that said patent and the disqualified 
patent, or any patent granted on the disqualified application are not 
separately enforced. Section 1.321(d) does not include a provision that 
the applicant or patentee agrees that such waiver and agreement shall 
be binding upon the owner of the rejected application or patent, its 
successors, or assigns because this is provided for in Sec.  1.321(b).
    This final rule eliminates the following requirements: (1) That the 
owner of the disqualified patent or application must sign the terminal 
disclaimer; (2) that there be a waiver of the right to separately 
license the application or patent and the disqualified patent or 
application; and (3) that the agreement that the application or patent 
and the disqualified patent or application shall be enforceable only 
during the period that the patent or application and the disqualified 
patent or application are not separately licensed.
    Section 3.11: Section 3.11(c) was added in the interim rule 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) as adopted in the interim rule provided 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. This final rule eliminates the 
requirements that such a joint research agreement, or excerpt of a 
joint research agreement, 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 discussion of 
the changes to Sec.  1.71(g) in this final rule). Thus, Sec.  3.11(c) 
as amended in this final rule simply provides 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 3.31: Section 3.31(g) was added in the interim rule 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, by checking the joint research agreement checkbox in box 3 
of Office form PTO-1595 (March 2005)). 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 (preferably, in the space provided for the 
name of the party conveying the interest in box 1 of Office form PTO-
1595). Additional names may be provided on an attached sheet if 
necessary. 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 3 of Office form PTO-1595). No further 
amendment to Sec.  3.31 is made in this final rule.
    Response to comments: The Office published an interim rule 
providing changes to the Office's practice for implementing the CREATE 
Act and requesting public comment on these changes, See Changes to 
Implement the Cooperative Research and Technology Enhancement Act of 
2004, 70 FR at 1818, 1291 Off. Gaz. Pat. Office at 59. The Office 
received twenty-four written comments (from intellectual property 
organizations, patent practitioners, and the general public) in 
response to this interim rule. The comments and the Office's responses 
to the comments follow:
    Comment 1: Several comments suggested that the effective date 
provisions of the CREATE Act did not alter the effective date of the 
amendments to 35 U.S.C. 103(c) by the American Inventors Protection Act 
of 1999 (AIPA) (see Pub. L. 106-113, 113 Stat. 1501, 1501A-591 (1999)). 
Accordingly, the comments argued that only applications filed on or 
after November 29, 1999 (the effective date of the AIPA amendments to 
35 U.S.C. 103(c)) can disqualify 102(e) prior art used in a rejection 
under 35 U.S.C. 103(c) based on common ownership.
    Response: The Office's interpretation is based on the plain 
language of the Act. Section 3 of the CREATE Act provides that ``[t]he 
amendments made by this Act shall apply to any patent granted on or 
after the date of enactment of this Act.'' The CREATE Act rewrote 35 
U.S.C. 103(c) in its entirety and included the amendment to 35 U.S.C. 
103(c) made by Sec.  4807 of the American Inventors Protection Act of 
1999. The

[[Page 54263]]

legislative history of the CREATE Act does not elaborate further on 
this issue. The comments do not provide any authority for any 
alternative interpretation. Accordingly, the effective date provision 
of the CREATE Act applies to 35 U.S.C. 103(c) in its entirety.
    In addition, the alternative interpretation presented by the 
comments would lead to an anomalous application of the prior art 
exclusion under 35 U.S.C. 103(c), in that in applications filed prior 
to November 29, 1999, but pending on or after December 10, 2004, prior 
art available under only 35 U.S.C. 102(e) could not be excluded by 
common owners under 35 U.S.C. 103(c), but could be excluded by parties 
to a joint research agreement under 35 U.S.C. 103(c)(2).
    In any event, applicants currently still have the option of 
refiling any pending application that was filed before November 29, 
1999, to avoid any possible challenge to the application of the AIPA 
amendments to 35 U.S.C. 103(c) to their application.
    Comment 2: One comment expressed disagreement with the Office's 
position that 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.
    Response: The statement concerning the recapture doctrine in the 
interim rule is simply a restatement of what is stated in the 
legislative history of the CREATE Act concerning the recapture 
doctrine. See H.R. Rep. No. 108-425, at 6-7 (2003).
    Comment 3: Several comments suggested that the requirements for the 
statement to invoke the prior art exclusion under the CREATE Act should 
be put into a regulation. In addition, the comments objected to the 
requirement that the applicant or the assignee must sign the statement. 
Furthermore, the comments expressed concern over filing a statement 
that might be perceived as making an admission that the disqualified 
reference is ``prior art.''
    Response: The requirements for the statement have been placed into 
Sec.  1.104(c)(4), and the requirement for signature for the statement 
is now the same as for any other correspondence as set forth in Sec.  
1.33(b). Therefore, a registered practitioner will be allowed to sign 
the statement in accordance with Sec.  1.33.
    With respect to the use of the term ``prior art'' in the statement, 
it is noted that 35 U.S.C. 103(c)(1) uses the term ``prior art'' in its 
first sentence. Thus, Sec.  1.104(c)(4) uses terminology consistent 
with 35 U.S.C. 103(c)(1).
    Comment 4: Several comments questioned whether an interim rule was 
necessary or justified to implement the CREATE Act. The comments 
suggested that the statutory language was clear and there was no need 
to implement regulations.
    Response: The Office believes that implementing regulations were 
necessary, for example, to: (1) Advise applicants on how to amend an 
application to name the parties to a joint research agreement; (2) 
permit a terminal disclaimer by a party who does not also own the 
application or patent forming the basis of the double patenting 
rejection; and (3) provide for the recordation of a joint research 
agreement in the Office's assignment records.
    Comment 5: Several comments were critical of the requirements of 
Sec.  1.71(g)(1) as added in the interim rule. Some comments stated 
that the requirements are unnecessarily complicated and suggested 
deleting those not required by statute. Other comments requested 
clarification of the requirements or suggested alternative 
requirements.
    Response: Section 1.71(g)(1) has been amended to require only the 
names of the parties to the joint research agreement, which is required 
by 35 U.S.C. 103(c)(2)(C). Comments pertaining to requirements not 
recited in the statute (e.g., the execution date or the concise 
statement of the claimed invention) are moot in view of the amendment 
to Sec.  1.71(g)(1) in this final rule.
    Comment 6: Several comments requested the definition of terms such 
as ``joint research agreement,'' ``execution date,'' ``invention 
made,'' and ``not patently distinct.''
    Response: The term ``joint research agreement'' is defined in 35 
U.S.C. 103(c)(3) and is further discussed in the legislative history of 
the CREATE Act. The term ``execution date'' is no longer used in Sec.  
1.71(g)(1), and therefore, there is no need to define it in the rules 
of practice. The terms ``invention made'' and ``not patently distinct'' 
are defined by case law. See e.g., In re Katz., 687 F.2d 450, 215 USPQ 
14 (CCPA 1982) (``invention made'' ); and In re Bratt, 937 F.2d 589, 19 
USPQ2d 1289 (Fed. Cir. 1991) (``not patently distinct'') and In re 
Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985) (same). Accordingly, 
there is no need to provide explicit definitions for these terms in 
this final rule.
    Comment 7: One comment requested that the Office impose a 
requirement that a party invoking the CREATE Act prior art exclusion 
must notify the other parties to the joint research agreement prior to 
invoking the prior art exclusion. In addition, the comment also 
requested a requirement that parties to a joint research agreement be 
disclosed in the disqualified reference.
    Response: A requirement that a party invoking the CREATE Act prior 
art exclusion must notify the other parties to the joint research 
agreement prior to invoking the prior art exclusion is a requirement 
that could be a part of the joint research agreement if it is desired 
by one or more parties to the joint research agreement. This type of 
requirement is better dealt with during the bargaining stage between 
the parties to the joint research agreement. In addition, 35 U.S.C. 
103(c)(2) does not include such a requirement to invoke the prior art 
exclusion. Likewise, the requirement that the parties to the joint 
research agreement be named in the disqualified reference could also be 
set forth in the joint research agreement if desired. Furthermore, 35 
U.S.C. 103(c)(2) does not require that the parties to the joint 
research agreement be disclosed in the disqualified reference.
    Comment 8: One comment requested that the Office impose a 
requirement that the joint research agreement must be disclosed in the 
specification prior to a patent issuing to invoke the CREATE Act prior 
art exclusion. The comment stated such a change is necessary to allow a 
competitor to easily know whether the patentee can disqualify prior art 
that the competitor may use to support an invalidity defense.
    Response: This comment goes against the great weight of the 
comments submitted and is not adopted. In addition, 35 U.S.C. 103(c)(2) 
does not require entry into the specification prior to a patent issuing 
in order to invoke the prior art exclusion under the CREATE Act.
    Comment 9: Several comments suggested that the processing fee 
required by Sec.  1.71(g)(2) is unnecessary. The comments requested 
that the fee be eliminated, or alternatively, that the time period for 
invoking the CREATE Act exclusion without a fee be extended until after 
the first time a rejection using prior art owned by a party to the 
joint research agreement is applied.
    Response: The processing fee required by Sec.  1.71(g)(2) furthers 
the Office's compact prosecution goals by encouraging applicants to 
disqualify

[[Page 54264]]

prior art under the CREATE Act before examination begins. The 
processing fee helps recover the cost of any additional work that may 
be required by applicant's failure to notify the Office of prior art 
that could have been disqualified before the examination process has 
begun.
    Comment 10: Several comments requested that Sec.  1.71(g)(3) be 
rewritten to be more consistent with the requirements of Sec.  
1.71(g)(1).
    Response: The requirements in Sec.  1.71(g)(3) are consistent with 
the requirements of Sec.  1.71(g)(1) because of the amendments made to 
Sec.  1.71(g)(1) in this final rule.
    Comment 11: Several comments suggested Sec.  1.71(g)(3) should be 
rewritten to be more clear by stating this rule is ``notwithstanding 
Sec.  1.312'' and by stating that a certificate of correction is 
effective upon submission as opposed to when it is granted.
    Response: Section 1.71(g)(3) is not in conflict with Sec.  1.312. 
Section 1.312 does not allow for amendments filed after payment of the 
issue fee, and Sec.  1.71(g)(3) does not provide that an amendment 
under Sec.  1.71(g)(1) submitted after payment of the issue fee will be 
entered. Rather, Sec.  1.71(g)(3) advises applicants that the patent as 
issued may not necessarily include the names of the parties to the 
joint research agreement if an amendment under Sec.  1.71(g)(1) is 
submitted after payment of the issue fee (because the rules of practice 
do not permit an amendment to an application after payment of the issue 
fee), and that if the patent as issued does not include the names of 
the parties to the joint research agreement, the patent must be 
corrected to include the names of the parties to the joint research 
agreement by a certificate of correction under 35 U.S.C. 255 and Sec.  
1.323 for the amendment to be effective.
    The request to revise the rule to include the statement that the 
certificate of correction is effective upon submission would not be 
consistent with the case law concerning certificates of correction. 
See, e.g., Southwest Software, Inc. v. Harlequin Inc., 226 F.3d 1280, 
56 USPQ2d 1161 (Fed. Cir. 2000).
    Comment 12: One comment requested clarification concerning when an 
examiner can make an obvious double patenting rejection final if there 
are common inventors or assignees.
    Response: 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 regardless 
of whether there are common inventors or assignees (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)).
    Comment 13: Several comments requested that the processing fee 
stated in Sec.  1.71(g)(2) be added to Sec.  1.17(i).
    Response: The processing fee is added to Sec.  1.17(i) in this 
final rule.
    Comment 14: One comment objected that Sec.  1.71(g) requires more 
than the CREATE Act, and argued that the CREATE Act requires only the 
names of the parties to the joint research agreement who are the owners 
of an application or patent invoking the CREATE Act and the names of 
the owners of the disqualified application or patent.
    Response: This comment goes against the clear statutory requirement 
that the names of the parties to the joint research agreement must be 
disclosed in order to invoke the prior art exclusion under the CREATE 
Act. The statute did not limit the required disclosure to just the 
owners of the patent rights involved.
    Comment 15: One comment stated that Sec.  1.104 uses inconsistent 
terminology.
    Response: Section 1.104 has been amended to include the 
requirements for the statement to invoke the CREATE Act prior art 
exclusion. In addition, Sec.  1.104 has been revised to be consistent 
with the terminology used in 35 U.S.C. 103(c), which uses both terms 
``persons'' and ``parties.''
    Comment 16: Many comments requested clarification of Sec.  1.109, 
including clarification of when double patenting under Sec.  1.109(b) 
would apply.
    Response: Section 1.109 has been removed and this final rule 
includes guidelines concerning double patenting involving CREATE Act 
situations. The guidelines provided in this final rule were made after 
consideration of the comments submitted regarding Sec.  1.109, with 
many of the comments being adopted. For example, the guidelines clearly 
set forth that double patenting rejections based on applications or 
patents to parties of a joint research agreement will only be made 
after the CREATE Act exclusion has been invoked. In addition, the 
guidelines do not require that the invention of the disqualified patent 
be made as a result of the activities within the scope of the joint 
research agreement as Sec.  1.109(b) required in the interim rule.
    Comment 17: Several comments questioned whether the Office has the 
authority to restrict licensing practice in the provisions of Sec.  
1.321(d) introduced in the interim rule. In addition, the comments 
expressed concern that the provisions of Sec.  1.321(d) went beyond 
what is required by the CREATE Act and its legislative history.
    Response: Section 1.321(d) has been amended in this final rule to 
remove several requirements set forth in the interim rule. First, 
terminal disclaimers no longer are required to have any restriction on 
licensing to overcome an obvious double patenting rejection based on 
prior art of a party to a joint research agreement. Second, the 
requirement that the owner of the disqualified application or patent 
sign the terminal disclaimer is removed. Therefore, the removal of 
these requirements from the provisions of Sec.  1.321(d) has simplified 
the process of filing the terminal disclaimer while still maintaining 
the goals of the CREATE Act and its legislative history. Furthermore, 
the removal of these requirements of Sec.  1.321(d) render moot many of 
the comments pertaining to this section.
    Comment 18: Several Comments stated that the assignment rules in 
Sec.  3.11 and Sec.  3.31 should be more consistent with the 
requirements of Sec.  1.71(g)(1).
    Response: These comments are moot in view of the changes to Sec.  
1.71(g)(1) in this final rule. Section 1.71(g)(1) no longer requires 
the execution date and concise statement of the claimed invention and 
is limited to the statutory requirement of the names of the parties to 
the joint research agreement.
    Comment 19: One comment suggested that the Office should consider 
requiring recordation of a notice that a terminal disclaimer has been 
filed to overcome a double patenting rejection to assist the public in 
finding such a terminal disclaimer.
    Response: There is no need to require a separate recordation of a 
terminal disclaimer because any patent in which a terminal disclaimer 
has been filed has such a notation on the front page of the patent. In 
addition, any terminal disclaimer in the file of an issued patent can 
be reviewed by viewing the patent image file wrapper via the Patent 
Application Information Retrieval (PAIR) system.

Rule Making Considerations

    Administrative Procedure Act: The changes in this final rule relate 
solely to the procedures to be followed in

[[Page 54265]]

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 extremely doubtful whether any of the rules formulated to 
govern patent or trade-mark practice are other than `interpretive 
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 final 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 final 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 final 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 final 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.
    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 record keeping 
requirements, Small Businesses.

37 CFR Part 3

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

0
For the reasons set forth in the preamble, the interim rule amending 37 
CFR Parts 1 and 3 which was published at 70 FR 1818-1824 on January 11, 
2005, is adopted as final with the following changes:

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 1.17 is amended by revising paragraph (i) to read as 
follows:


Sec.  1.17  Patent application and reexamination processing fees.

* * * * *
    (i) Processing fee for taking action under one of the following 
sections which refers to this

paragraph...............................$130.00.
    Sec.  1.28(c)(3)--for processing a non-itemized fee deficiency 
based on an error in small entity status.
    Sec.  1.41--for supplying the name or names of the inventor or 
inventors after the filing date without an oath or declaration as 
prescribed by Sec.  1.63, except in provisional applications.
    Sec.  1.48--for correcting inventorship, except in provisional 
applications.
    Sec.  1.52(d)--for processing a nonprovisional application filed 
with a specification in a language other than English.
    Sec.  1.53(b)(3)--to convert a provisional application filed under 
Sec.  1.53(c) into a nonprovisional application under Sec.  1.53(b).
    Sec.  1.55--for entry of late priority papers.
    Sec.  1.71(g)(2)--for processing a belated amendment under Sec.  
1.71(g).
    Sec.  1.99(e)--for processing a belated submission under Sec.  
1.99.
    Sec.  1.103(b)--for requesting limited suspension of action, 
continued prosecution application for a design patent (Sec.  1.53(d)).
    Sec.  1.103(c)--for requesting limited suspension of action, 
request for continued examination (Sec.  1.114).
    Sec.  1.103(d)--for requesting deferred examination of an 
application.
    Sec.  1.217--for processing a redacted copy of a paper submitted in 
the file of an application in which a redacted copy was submitted for 
the patent application publication.
    Sec.  1.221--for requesting voluntary publication or republication 
of an application.

[[Page 54266]]

    Sec.  1.291(c)(5)--for processing a second or subsequent protest by 
the same real party in interest.
    Sec.  1.497(d)--for filing an oath or declaration pursuant to 35 
U.S.C. 371(c)(4) naming an inventive entity different from the 
inventive entity set forth in the international stage.
    Sec.  3.81--for a patent to issue to assignee, assignment submitted 
after payment of the issue fee.
* * * * *

0
3. Section 1.52 is amended by revising paragraph (e)(5) to read as 
follows:


Sec.  1.52  Language, paper, writing, margins, compact disc 
specifications.

* * * * *
    (e) * * *
    (5) The specification must contain an incorporation-by-reference of 
the material on the compact disc in a separate paragraph (Sec.  
1.77(b)(5)), identifying each compact disc by the names of the files 
contained on each of the compact discs, their date of creation and 
their sizes in bytes. The Office may require applicant to amend the 
specification to include in the paper portion any part of the 
specification previously submitted on compact disc.
* * * * *

0
4. Section 1.71 is amended by revising paragraph (g) to read as 
follows:


Sec.  1.71  Detailed description and specification of the invention.

* * * * *
    (g)(1) 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)).
    (2) An amendment under paragraph (g)(1) of this section must be 
accompanied by the processing fee set forth in 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) If an amendment under paragraph (g)(1) of this section is filed 
after the date the issue fee is paid, the patent as issued may not 
necessarily include the names of the parties to the joint research 
agreement. If the patent as issued does not include the names of the 
parties to the joint research agreement, the patent must be corrected 
to include the names of the parties to the joint research agreement by 
a certificate of correction under 35 U.S.C. 255 and Sec.  1.323 for the 
amendment to be effective.

0
5. Section 1.76 is amended by revising paragraph (b)(5) to read as 
follows:


Sec.  1.76  Application data sheet.

* * * * *
    (b) * * *
    (5) Domestic priority information. This information includes the 
application number, the filing date, the status (including patent 
number if available), and relationship of each application for which a 
benefit is claimed under 35 U.S.C. 119(e), 120, 121, or 365(c). 
Providing this information in the application data sheet constitutes 
the specific reference required by 35 U.S.C. 119(e) or 120, and Sec.  
1.78(a)(2) or Sec.  1.78(a)(5), and need not otherwise be made part of 
the specification.
* * * * *

0
6. Section 1.96 is amended by revising the introductory text of 
paragraph (c) to read as follows:


Sec.  1.96  Submission of computer program listings.

* * * * *
    (c) As an appendix which will not be printed: Any computer program 
listing may, and any computer program listing having over 300 lines (up 
to 72 characters per line) must, be submitted on a compact disc in 
compliance with Sec.  1.52(e). A compact disc containing such a 
computer program listing is to be referred to as a ``computer program 
listing appendix.'' The ``computer program listing appendix'' will not 
be part of the printed patent. The specification must include a 
reference to the ``computer program listing appendix'' at the location 
indicated in Sec.  1.77(b)(5).
* * * * *

0
7. 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 subject to an 
obligation of assignment to the same person 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 subject to an obligation of assignment to the same person in 
any application and in any patent granted on or after December 10, 
2004, if:
    (A) The claimed invention and the subject matter 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.
    (iii) To overcome a rejection under 35 U.S.C. 103(a) based upon 
subject matter which qualifies as prior art under only one or more of 
35 U.S.C. 102(e), (f) or (g) via 35 U.S.C. 103(c)(2), 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 
paragraph (c)(4)(ii) of this section, that was in effect on or before 
the date the claimed invention was made, and that the claimed invention 
was made as a result of activities undertaken within the scope of the 
joint research agreement.
* * * * *


Sec.  1.109  [Removed and reserved]

0
8. Section 1.109 is removed and reserved.

0
9. Section 1.321 is amended by revising paragraphs (c) and (d) to read 
as follows:


Sec.  1.321  Statutory disclaimers, including terminal disclaimers.

* * * * *
    (c) A terminal disclaimer, when filed to obviate judicially created 
double patenting in a patent application or in a reexamination 
proceeding except as provided for in paragraph (d) of this section, 
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 in accordance with paragraph (a)(1) 
of this section if filed in a reexamination proceeding; and

[[Page 54267]]

    (3) Include a provision that any patent granted on that application 
or any patent subject to the reexamination proceeding shall be 
enforceable only for and during such period that said patent is 
commonly owned with the application or patent which formed the basis 
for the judicially created double patenting.
    (d) A terminal disclaimer, when filed in a patent application or in 
a reexamination proceeding to obviate double patenting based upon a 
patent or 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; and
    (3) Include a provision waiving the right to separately enforce any 
patent granted on that application or any patent subject to the 
reexamination proceeding and the patent or any patent granted on the 
application which formed the basis for the double patenting, and that 
any patent granted on that application or any patent subject to the 
reexamination proceeding shall be enforceable only for and during such 
period that said patent and the patent, or any patent granted on the 
application, which formed the basis for the double patenting are not 
separately enforced.

PART 3--ASSIGNMENT, RECORDING AND RIGHTS OF ASSIGNEE

0
10. 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
11. Section 3.11 is amended by revising 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.

    Dated: September 7, 2005.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 05-18217 Filed 9-13-05; 8:45 am]
BILLING CODE 3510-16-P