Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendment
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.
Applicant’s amendments of the claims filed 13 August 2025 has been entered. Applicant’s remarks filed 13 August 2025 are acknowledged.
Claims 1-18, 21-22, 28-29, 33-34 and 36-50 are cancelled. Claims 19-20, 23-27, 30-32, 35 and 51-55 are pending and under examination.
Claim Rejections Maintained
Double Patenting
Claims 19-20, 23-27, 30-32, 35 and 51-55 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-12 and 26 of U.S. Patent No. 12,029,788.
Applicant argues that according to MPEP 806.05(h), the instant claims are patentably distinct over the claims of the ’788 patent, because the product as presently claimed can be used in a materially different process than the claims of the reference patent, and further, the process claimed in the reference patent can be practiced with a materially different product than the instant claims. Applicant argues that the instant specification discloses that the anti-GDF8 antibody “1A2” encompassed in the present claims can be used in a materially different process, for example, increasing tibialis anterior (TA) muscle weight, gastrocnemius (GA) muscle weight, and quadriceps (Quad) muscle weight in 9-weeks old young mice without resistance training (p. 40, Table 14); further, the process of the reference patent claim 1 can be practiced with a materially different antibody or antigen-binding fragment that specifically binds GDF-8, such as “H4H1657N2”.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
The claims of the ‘788 patent recite an antibody or antigen-binding fragment thereof that specifically binds GDF-8, wherein the antibody or antigen-binding fragment thereof comprises the three heavy chain CDRs (HCDR1, HCDR2, HCDR3) of SEQ ID NOs: 228/230/232 and the three light chain CDRs (LCDR1, LCDR2, LCDR3) of SEQ ID NOs: 236/238/240, or the antibody or antigen-binding fragment thereof comprises the heavy chain variable region and light chain variable region pair (HCVR/LCVR) of SEQ ID NOs: 226/234. The presently claimed antibody or antigen-binding fragment thereof is recited in the claims of the ‘788 patent, i.e., the claims of the ‘788 patent anticipate the instant claims.
MPEP 804 states: “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 determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate. To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences. Then the examiner should determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis. See Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008).” (emphasis added). In the instant case, the claims of the present application are anticipated by the claims of the reference patent, thus, a nonstatutory double patenting rejection is appropriate.
MPEP 806.05 describes that “Where two or more related inventions are claimed, the principal question to be determined in connection with a requirement to restrict or a rejection on the ground of double patenting is whether or not the inventions as claimed are distinct. If they are distinct, restriction may be proper. If they are not distinct, restriction is never proper. If nondistinct inventions are claimed in separate applications or patents, double patenting must be held, except where the additional applications were filed consonant with a requirement to restrict.” The present application is not related to the application of the ‘788 patent, because Application No. 17/149,540 (issued as the ‘788 patent) is not in the continuing data in the present application. The MPEP 806.05(h) section (cited by Applicant) teaches that when claims are presented to both the product and process of using the product, they can be shown to be patently distinct inventions, and a restriction can be made. Where restriction is required by the Office, double patenting cannot be held. However, such scenario does not apply to the instant case, as the present application is NOT a divisional application of the ‘788 patent as a result of restriction requirement, and the safe harbor protection of 35 U.S.C. 121 against nonstatutory double patenting does not apply in the instant case.
For reasons set forth above, the nonstatutory double patenting rejection is maintained.
Conclusion
NO CLAIM IS ALLOWED.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674 September 30, 2025