| Examination Instructions and Guidelines |
Referenced Items (251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 261, 262) |
(256) 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.
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.
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 -
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(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
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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
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. 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.
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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)
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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
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. 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
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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
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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 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
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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 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.
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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
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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
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
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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,
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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.
. 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
. 1. The authority citation for 37 CFR Part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
. 2. Section 1.17 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.
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Sec. 1.221 - for requesting voluntary publication or republication
of an application.
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.
* * * * *
. 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.
* * * * *
. 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.
. 5. Section 1.76 is amended by revising paragraph (b)(5) to read as
follows:
Sec. 1.76 Application data sheet.
* * * * *
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(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.
* * * * *
. 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).
* * * * *
. 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
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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]
. 8. Section 1.109 is removed and reserved.
. 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
(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
. 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).
. 11. Section 3.11 is amended by revising paragraph (c) to read as
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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.
September 7, 2005 JON W. DUDAS
Under Secretary of Commerce for
Intellectual Property and Director of the
United States Patent and Trademark Office
[1300 OG 70]