DEATAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
RESPONSE TO AMENDMENT
The response, substitute specification, sequence listing, request under 37 CFR 1.48 and amendment filed 6-2-2026 have been entered into the record. Claims 1-6 are pending and under examination.
The request under 37 CFR 1.48 has been accepted, Applicant’s attention is drawn to the communication of record mailed 6-15-2026.
The substitute specification, including replacement sheets for Figures 1 and 2 have been entered as resolving the sequence requirements set forth on page 2 of the Office Action mailed 3-6-2026.
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
Rejections Withdrawn
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al (KR20230062390A, published 5-9-2023) is withdrawn in view of the correction of inventorship leading to the exclusion under 35 USC 102(b)(1)(A).
Rejections Maintained
Claims 1, 2, 5 and 6 stand rejected under 35 U.S.C. 103 as being unpatentable over Gromada et al (US2015/003739) in view of Halkier et al (WO 01/05820 January 25, 2001), Sung et al (Int. J. Mol. Sci. 23:9059 pages 1-15, published August 13, 2022), KR20210081196A (published 7-1-2021) and GenBank inhibin βA nucleotide sequence M13436.1; 1995 for reasons made of record in the Office Action mailed 3-6-2026.
Applicant’s arguments have been carefully considered but are not persuasive. Applicant argues that the claims are drawn to methods. The claims are in fact products per se as drawn to pharmaceutical compositions. Methods/processes are not claimed. The recitation of “composition for alleviation, treatment and prevention of sarcopenia” is intended use of the composition per se and does not convert the product claim to a process claim. As such, arguments drawn to processes are not persuasive as the product can be made by and intended for other purposes. Applicant argues that the introduction of activin A and myostatin by delivering intentionally to a subject is different that intentional delivery for the purpose of making antibodies. This is not persuasive as the product does not differ in any materially different manner. Applicant argues that there is nothing in the prior art about generating antibodies to activin A. This is not persuasive as Gromada teaches activin A antibodies can be made successfully and as such demonstrates that an immune response could produce antibodies to activin A. Applicant asserts that the therapeutic benefit of any immune response is extremely unpredictable. This is not persuasive as this assertion by Counsel is an unsupported allegation and fails to take place of evidence in the record. Statements of this nature are clearly unpersuasive in accordance with guidance provided at MPEP 2145, which states, "The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602 145 USPQ 716, 178 (CCPA 1965); In re Geisler 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)." Applicant asserts that the method would not have been derived from the teachings of the applied references. This is again not persuasive as Gromada et al in fact teaches the use of the antibodies against myostatin and activin A for treating and prevention and/or amelioration of a disease or disorder characterized by decreased muscle mass or strength. The disease or disorders include sarcopenia. Consequently, Applicant’s arguments that the product was not derivable from the references is not persuasive as Sung et al teach surface display expression of myostatin provides for immune response providing for a reasonable expectation of success for making and using the combination as set forth in the Office Action mailed 36-2026. "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Finally, Applicant is reminded that obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Here given the teachings of Sung demonstrating generation of antibodies using surface display in Lactobacillus, the art has a reasonable expectation of success in combining the teachings as set forth in the prior office action to arrive at the claimed product.
Applicant further argues that teachings of the specification with respect to efficacy in a mouse model of strength and reiterates the teachings of the specification as filed. This is not persuasive as the claims are drawn to products and not processes of use.
Status of Claims
Claims 1, 2, 5 and 6 stand rejected. Claims 3 and 4 are objected to as depending from a rejected base claim.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 7:30 am to 5:30 pm M-Th.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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