DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Applicant’s amendment filed on August 25, 2023 is acknowledged.
Claims 2-8 have been canceled.
Claim 1 is pending and currently under consideration.
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "said parent Fc polypeptide" in line 2. There is insufficient antecedent basis for this limitation in the claim.
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the US Patents listed below:
claims 1-10 of US 8,188,231 (the ‘231 Patent, claims are drawn to a protein comprising an Fc variant of a parent Fc polypeptide comprising an amino acid modification at position 243). The ‘231 Patent is in the same chain of continuity as the instant application. The specification of the ‘231 Patent (identical to the instant application) discloses parent Fc polypeptide can be SEQ ID NO:1 which is the amino acid sequence of the Fc region of human IgG1.
claims 2-15 of US 7,662,925 (the ‘925 Patent, claims are drawn to a protein comprising an Fc variant of a parent Fc polypeptide comprising amino acid substitutions in position 332 and 243). Dependent claim 7 further recites a human antibody.
claims 1-8 of US 8,735,547 (the ‘547 Patent, claims are drawn to a protein comprising an Fc variant of a human IgG1 Fc polypeptide, wherein said Fc variant comprises an amino acid modification in the Fc region of said parent Fc polypeptide at position 243 including 243L).
claims 1-8 of US 9,193,798 (the ‘798 Patent, claims are drawn to a protein comprising an Fc variant of a human parent IgG1 Fc polypeptide comprising a first amino acid substitution at position 243 and a second amino acid substitution at position 264),
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims in the US Patents listed above are drawn to the same or nearly the same Fc variant of a human IgG1 Fc comprising amino acid substitution in the same position of 243. Therefore, the claims in the US Patents listed above would anticipate the instant claims.
7. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
8. Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim1 of prior US 8,735,547 (the ‘547 Patent). This is a statutory double patenting rejection.
The instant claim 1 is drawn to a protein comprising an Fc variant of a human IgG1 Fc polypeptide, wherein the said Fc variant comprises an amino acid modification inf the Fc region of said parent Fc polypeptide at position 243, wherein said protein exhibits altered binding affinity to an Fcγ receptor as compared to a parent polypeptide, wherein numbering is according to the EU index.
The claim 1 in the ‘547 Patent is drawn to a protein comprising an Fc variant of a human IgG1 Fc polypeptide, wherein said Fc variant comprises an amino acid modification in the Fc region of said parent Fc polypeptide at position 243, wherein said protein exhibits altered binding affinity to an Fcγ receptor as compared to a parent polypeptide, wherein the numbering is according to the EU index.
Given that the instant claim 1 and the claim 1 in the ‘547 Patent are identical, instant claim 1 is rejected under 35 USC 101.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641