37 cfr parts 1ff: changes to implement the cooperative research and technology enhancement act of 2004

Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
(3) Limitations. Do not use in horses DEPARTMENT OF COMMERCE
Patent and Trademark Office
Stephen F. Sundlof,
37 CFR Parts 1 and 3
Director, Center for Veterinary Medicine. [FR Doc. 05–523 Filed 1–10–05; 8:45 am] Management (HFA–305), Food and Drug [Docket No.: 2004–P–034]
Administration, 5630 Fishers Lane, rm.
BILLING CODE 4160–01–S
RIN 0651–AB76
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Changes To Implement the
DEPARTMENT OF HEALTH AND
Cooperative Research and Technology
HUMAN SERVICES
Enhancement Act of 2004
25.33(a)(1) that this action is of a type Food and Drug Administration
AGENCY: United States Patent and
21 CFR Part 520
cumulatively have a significant effect on ACTION: Interim rule.
Oral Dosage Form New Animal Drugs;
SUMMARY: The Cooperative Research and
Lincomycin Hydrochloride Soluble
(CREATE Act) amends the patent laws to provide that subject matter developed AGENCY: Food and Drug Administration,
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because ACTION: Final rule.
it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to SUMMARY: The Food and Drug
obviousness if three conditions are met: List of Subjects in 21 CFR Part 520
on behalf of parties to a joint research agreement that was in effect on or before authority delegated to the Commissioner within the scope of the joint research of Food and Drugs and redelegated to the names of the parties to the joint research DATES: This rule is effective January 11,
PART 520—ORAL DOSAGE FORM
Trademark Office (Office) is revising the NEW ANIMAL DRUGS
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary
■ 1. The authority citation for 21 CFR DATES: Effective Date: December 10,
Authority: 21 U.S.C. 360b.
Rockville, MD 20855, 301–827–8549, e- SUPPLEMENTARY INFORMATION: Cross
revising paragraph (b) to read as follows: § 520.1263c
Lincomycin hydrochloride
soluble powder.
ADDRESSES: Comments should be sent
§ 510.600(c) of this chapter for use as in by facsimile to (571) 273–7735, marked Stephen F. Sundlof,
Director, Center for Veterinary Medicine. by mail or facsimile, the Office prefers [FR Doc. 05–524 Filed 1–10–05; 8:45 am] to receive comments via the Internet. If BILLING CODE 4160–01–S
submitted on a DOS formatted 31⁄2 inch Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
meaning of 35 U.S.C. 103(c)(3), and that research agreement that was in effect on or before the date the claimed invention agreement. 35 U.S.C. 103(c)(3) defines a ‘‘joint research agreement’’ as a written Street, Alexandria, Virginia, and will be transfer protocol (ftp) via the Internet research work in the field of the claimed invention, that was in effect on or before parties to the joint research agreement. term ‘‘joint research agreement’’ means on a separate sheet and must not also be a written contract, grant, or cooperative directed to other matters (§ 1.4(c)). The FOR FURTHER INFORMATION CONTACT:
applicant or by the assignee of the entire research work in the field of the claimed Box Comments—Patents, Commissioner granted on or after December 10, 2004. VA 22313–1450, or by facsimile to (571) amendments shall not affect any final specification to either set forth the date rendered before December 10, 2004, and executed and a concise statement of the SUPPLEMENTARY INFORMATION: The
shall not affect the right of any party in CREATE Act amends 35 U.S.C. 103(c) to any action pending before the Office or specify where (i.e., by reel and frame the assignment records of the Office. If basis of the provisions of title 35, United the applicant disqualifies the subject obviousness if three conditions are met: procedures set forth in this interim rule, or on behalf of parties to a joint research American Inventors Protection Act of agreement that was in effect on or before 1999 (see Pub. L. 106–113, 113 Stat. 1501, 1501A–591 (1999)), the change of 102(e), (f), or (g) prior art as if they are ‘‘subsection (f) or (g)’’ to ‘‘one or more made as a result of activities undertaken of subsections (e), (f), or (g)’’) in 35 applications filed prior to December 29, art under 35 U.S.C. 102(e), (f) or (g), and names of the parties to the joint research which is being relied upon in a rejection agreement. See Pub. L. 108–453, 118 under 35 U.S.C. 103. If the rejection is Federal Regulations (CFR) to implement 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 prima facie case of obviousness under another person, which qualifies as prior subsections (e), (f), and (g) of section amended or cancelled (e.g., to avoid a invention was made, owned by the same publication, or other evidence) which qualifies as prior art under only one or more of 35 U.S.C. 102(e), (f) or (g) via provide a statement to the effect that the application which resulted in the patent prior art and the claimed invention were being reissued. See H.R. Rep. No. 108– Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
Discussion of Specific Rules
time period set forth in § 1.97(c) with Section 1.71: Section 1.71 is amended amendment under § 1.71(g)(1) filed after the fee set forth in § 1.17(p)). The Office the date the issue fee is paid must also set forth § 1.17(i), and that the patent names of the parties to a joint research parties to the joint research agreement. Section 1.71(g)(3) also provides that if names of the parties to a joint research Section 1.77: Section 1.77 is amended agreement to invoke the ‘‘safe harbor’’ amended by the CREATE Act. See 35 research agreement will not be effective Section 1.104: Section 1.104(c)(4) is specification discloses (or is amended to certificate of correction under 35 U.S.C. joint research agreement for purposes of § 1.71(g)(3) (payment of the processing Section 1.109: Section 1.109 is added fee set forth in § 1.17(i) and correction necessary to determine the applicability rejection. Section 1.109(a) contains the § 1.322) also apply in the situation in of the ‘‘safe harbor’’ provision of 35 changes for clarity). Section 1.130(b) is granted (in a patent granted on or after December 10, 2004). It is unnecessary to file a reissue application or request for this information is required by 35 U.S.C. necessary to take advantage of 35 U.S.C. 103(c)(2)(C). The date the joint research U.S.C. 103(c) would result in situations See H.R. Rep. No. 108–425, at 9 (‘‘[t]he owned by the same party. See H.R. Rep. ‘‘joint research agreement * * * was in No. 108–425, at 5–6 (2003). Therefore, effect on or before the date the claimed invention was made’’ as required by 35 U.S.C. 103(c)(2)(A). If a joint research of practice: e.g., §§ 1.116, 1.121, and reexamination if: (1) The application or invention that is not patentably distinct claimed in the application or patent and because this information is necessary to necessitate the reopening of prosecution undertaken within the scope of the joint and entry of a double patenting rejection research agreement. Thus, the of the joint research agreement’’ as submitted to overcome a rejection under 103(c) as amended by the CREATE Act publication which qualifies as prior art Section 1.109(b) also provides that this forth in § 1.17(i) if it is not filed within examiner withdraws the rejection under regardless of whether the application or three months of the date of entry of the national stage as set forth in § 1.491 in disqualified patent or patent application provides that this double patenting an international application; (3) before the mailing of a first Office action on the made final (provided that the examiner merits; or (4) before the mailing of a first introduces no other new ground of Office action after the filing of a request Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
Section 1.321: Section 1.321(d) is licensed; and (3) agree that such waiver the owner of the rejected application or research agreements (or excerpts of joint result of the CREATE Act. See H.R. Rep. the owner of the disqualified patent or research agreements) to invoke the ‘‘safe application, its successors, or assigns. harbor’’ provision of 35 U.S.C. 103(c) as Section 3.11: Section 3.11(c) is added to provide that the Office will record a joint research agreement or an excerpt of terminal disclaimer necessary to takes advantage of the ‘‘safe harbor’’ that may arise as a result of the CREATE agreement or excerpt of a joint research Congress intends that parties who seek to benefit from this Act to waive the right to statement of the field of invention (see overcome by invoking the ‘‘safe harbor’’ earlier patent that would otherwise have formed the basis for an obviousness-type Section 3.31: Section 3.31(g) is added double patenting rejection. Further, Congress intends that parties with an interest in a cover sheet required by § 3.28 seeking to patent that is granted solely on the basis of the amendments made pursuant to this Act excerpt of a joint research agreement as to waive requirements for multiple licenses. provided by § 3.11(c). First, the cover current law for parties to terminally disclaim interests in patents that would otherwise be ‘‘joint research agreement’’ (preferably, invalid on ‘‘obviousness-type’’ double patenting grounds are to apply, mutatis mutandis, to the patents that may be issued prosecuting a patent application: i.e., in circumstances made possible by this Act.
(under ‘‘other’’) of Office form PTO– invoke the ‘‘safe harbor’’ provision of 35 Section 1.321(d) specifically sets forth sheet must indicate the name of the receiving the interest in box 2 of Office that may arise as a result of the CREATE form PTO–1595). Third, the cover sheet agreements or excerpts of joint research party (preferably, in the space provided the provisions of §§ 1.321(b)(2) through names on an attached sheet if necessary) 553(b)(A), and prior notice and an accordance with § 1.321(b)(1) if filed in a patent application, or be signed by the 553(b)(A) (or any other law). See Bachow Communications Inc. v. FCC, § 1.321(a)(1) if filed in a reexamination 237 F.3d 683, 690 (D.C. Cir. 2001) (rules Rule Making Considerations
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 of the rejected application or patent and Director of the United States Patent and application each: (1) Waive the right to Procedure Act apply)), and Fressola v. (D.D.C. 1995) (‘‘it is doubtful whether patent and trade-mark practice are other and thus apply to applications currently than ‘interpretative rules, general Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
or practice.’ ’’) (quoting C.W. Ooms, The Title: Initial Patent Application. United States Patent Office and the Form Numbers: PTO–1594 and PTO– households, business or other for-profit 553(b)(A) (or any other law), and thirty- institutions, not-for-profit institutions, households, business or other for-profit institutions, not-for-profit institutions, pursuant to 5 U.S.C. 553(d) (or any other Local, or Tribal Governments. this interim rule involve rules of agency Needs and Uses: The Office records Needs and Uses: The purpose of this application meets the criteria set forth changes in this interim rule, a regulatory ensure that they are properly recorded.
flexibility analysis under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) is Title: Patent Processing (Updating). regulations, and will further assist the Paperwork Reduction Act: This rule households, business or other for-profit Title: Post Allowance and Refiling. institutions, not-for-profit institutions, review by the Office of Management and Local and Tribal Governments. et seq.). The collections of information households, business or other for-profit institutions, not-for-profit institutions, numbers: 0651–0027, 0651–0031, 0651– 0032, and 0651–0033. The United States processing for an application for a resubmitting the information collections required or desire to submit additional Needs and Uses: This collection of burdens. Included in the estimate is the correct an error in a patent. The affected principal impacts of the changes in this Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
Comments are invited on: (1) Whether purposes of 35 U.S.C. 103(c)(2), the prior art only under 35 U.S.C. 102(e), (f) functions of the agency; (2) the accuracy information, or the location where (i.e., or (g) may be used as prior art under 35 of the agency’s estimate of the burden; (3) ways to enhance the quality, utility, organization or subject to an obligation (ii) A concise statement of the field of suggestions for reducing this burden, to Robert J. Spar, Director, Office of Patent forth § 1.17(i) if not filed within one of Legal Administration, Commissioner for the following time periods: organization, or subject to an obligation (ii) Within three months of the date of organization in any application and in entry of the national stage as set forth in Washington, DC 20503, (Attn: PTO Desk § 1.491 in an international application; (iii) Before the mailing of a first Office of law, no person is required to respond (iv) Before the mailing of a first Office research agreement that was in effect on action after the filing of a request for or before the date the claimed invention collection of information subject to the (g)(1) of this section filed after the date forth § 1.17(i), and the patent may not List of Subjects
parties to the joint research agreement. 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, the patent is corrected by a certificate of ■ 5. Section 1.109 is added to read as Double patenting.
Arrangement of application
PART 1—RULES OF PRACTICE IN
elements.
PATENT CASES
invention that is not patentably distinct ■ 1. The authority citation for 37 CFR Authority: 35 U.S.C. 2(b)(2).
■ 2. Section 1.71 is amended by adding regardless of whether the application or Detailed description and
specification of the invention.
be amended to disclose the names of the revising paragraph (c)(4) to read as parties to a joint research agreement (35 (1) If the specification discloses or is Nature of examination.
parties to a joint research agreement for invention that is not patentably distinct Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
ENVIRONMENTAL PROTECTION
commonly owned patent by or on behalf agreement shall be binding upon the of parties to a joint research agreement 40 CFR Part 52
application, its successors, or assigns.
[R05–OAR–2004–IL–0003; FRL–7861–1]
were made as a result of activities
undertaken within the scope of the joint PART 3—ASSIGNMENT, RECORDING
Approval and Promulgation of Air
AND RIGHTS OF ASSIGNEE
Quality Implementation Plans; Illinois;
Withdrawal of Direct Final Rule
regardless of whether the application or ■ 8. The authority citation for 37 CFR AGENCY: Environmental Protection
Authority: 15 U.S.C. 1123; 35 U.S.C.
ACTION: Withdrawal of direct final rule.
This double patenting rejection may be obviated by filing a terminal disclaimer ■ 9. Section 3.11 is amended by adding SUMMARY: Due to the receipt of an
adverse comment, the EPA is
[Amended]
Documents which will be recorded.
FR 65378), direct final rule approving a removing and reserving paragraph (b).
■ 7. Section 1.321 is amended by adding will also be recorded as provided in this Illinois. The State of Illinois submitted Statutory disclaimers, including
terminal disclaimers.
executed, and a concise statement of the proceeding (rejected patent) to obviate a ■ 10. Section 3.31 is amended by adding therefore, EPA is withdrawing the direct Cover sheet content.
paragraphs (b)(2) through (b)(4) of this DATES: The direct final rule published at
(1) Identify the document as a ‘‘joint paragraph (b)(1) of this section if filed FOR FURTHER INFORMATION CONTACT:
accordance with paragraph (a)(1) of this Engineer, Criteria Pollutant Section, Air the party receiving the interest if using of the rejected application or patent and List of Subjects in 40 CFR Part 52
name of the party conveying the interest (4) Indicate the date the joint research Authority: 42 U.S.C. 7401 et seq.
(ii) Agree that the rejected application or patent and the disqualified patent or Norman Niedergang,
application shall be enforceable only for Jon W. Dudas,
Acting Regional Administrator, Region 5. and during such period that the rejected Under Secretary of Commerce for Intellectual patent or application and the Property and Director of the United States CFR 52.720 published in the Federal
[FR Doc. 05–461 Filed 1–10–05; 8:45 am] Register on November 12, 2004 (69 FR
BILLING CODE 3510–16–P

Source: http://www.nacua.org/documents/CREATEActChanges.pdf