DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 04/16/2026 has been entered.
Applicant’s amendment, filed 04/16/2026, has been entered.
Claims 2-4, 12, 18 have been canceled.
Claims 1, 5-11, 13-17, 19-20 are pending.
Claims 8-9, 11, 13-15, 19-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 5-7, 10, 16-17 are currently under examination as they read on a method of treating or preventing FTD, ALS and/or ALS-FTD comprising administering to a subject with C9orf72 repeat expansion a polypeptide consisting of dipeptide repeats (Gly-Ala)a wherein a is an integer of 4-25.
The previous rejection under 35 U.S.C. 112(b) has been withdrawn in view of applicant’s amendment, filed 04/16/2026.
The previous rejection under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Edbauer et al. has been withdrawn in view of Applicant’s amendment, filed 04/16/2026.
Edbauer et al. disclosed treating or preventing FTD, ALS and/or ALS-FTD caused by C9orf72 repeat expansion comprising administering the same polypeptides consisting of dipeptide-repeats as recited in the present claims (e.g., (Gly-Ala)a) (see, e.g., Background of the Invention; paragraphs 0014, 0041; claim 38). Given that Edbauer disclosed providing the polypeptide for prophylaxis of said diseases, the subject would be presymptomatic or prodromal (paragraph 0041). Edbauer further taught prime-boost regiment (paragraphs 0109, 0110). Moreover, Edbauer disclosed adjuvants which reads on an immunogenic carrier protein and pharmaceutically acceptable carrier and/or suitable excipients (see paragraphs 0161, 0159).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-7, 10, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Edbauer et al. (US 2015/0361166 A1) in view of Kaushik et al. (Anaerobe 2018 53:50-55).
Edbauer et al. disclosed treating or preventing FTD, ALS and/or ALS-FTD caused by C9orf72 repeat expansion comprising administering the same polypeptides consisting of dipeptide-repeats as recited in the present claims (e.g., (Gly-Ala)a) (see, e.g., Background of the Invention; paragraphs 0014, 0041; claim 38). Given that Edbauer disclosed providing the polypeptide for prophylaxis of said diseases, the subject would be presymptomatic or prodromal (paragraph 0041). Edbauer further taught prime-boost regiment (paragraphs 0109, 0110).
Edbauer did not disclose tetanus toxoid (TT) as an immunogenic carrier protein. However, it would have been obvious to one of ordinary skill in the art to use TT as a carrier protein because TT was a well-known carrier for peptide vaccine before the effective filing date of the claimed invention. For example, Kaushik et al. disclosed that immunization of TT covalent linked to Etx peptides elicited robust antibody response to Etx (see entire document). Moreover, Kaushik taught a SPDP crosslinker linking TT to the peptides, which reads on a spacer (page 52, right column, second paragraph). Given that Edbauer taught both passive and active immunization providing antibodies against the dipeptide-repeats (paragraphs 0109, 0110, claims 38 and 42), one of ordinary skill in the art would have been motivated to use TT-conjugated dipeptide repeats to elicit antibody production against the dipeptide repeats. The ordinary skill in the art would have reasonable expectation of success using a TT-conjugated dipeptide repeat as making such conjugate was known in the art as taught by Kaushik.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Applicant’s argument
Applicant argues that using an immunogenic carrier protein to enhancing antibody titer by 3000-fold increase was unexpected and therefore a POSITA would not expect active immunization against dipeptide DPRs to be successful. However, the evidence presented is insufficient to overcome the prima facie case of obviousness.
In vaccine and immunology art, using an immunogenic carrier protein such as TT to dramatically enhance antibody response to a weak antigen is a well-established and expected principle. A large increase in titer is often viewed as a quantitative optimization of a known mechanism rather than a qualitatively unexpected property.
As evidenced by Edbauer, the prior art already recognized the desirability of generating immune response against the DPRs and taught vaccine-related composition for eliciting such responses. Kaushik further teaches the use of immunogenic carrier proteins to enhance antibody production against weakly immunogenic antigens. Thus, one of ordinary skill in the art would have reasonably expected that conjugation of the DPR to a carrier protein would substantially enhance the antibody response.
Furthermore, one of ordinary skill in the art would have recognized carrier protein selection and resulting antibody titer as result-effective variables affecting the magnitude of the immune response. Because the prior art already taught that carrier proteins increase immunogenicity, optimization resulting in higher antibody titer would have been within the ordinary skill in the art. Therefore, the alleged 3000-fold increase represents an optimized degree of a known result rather than an unexpected property different in kind from the teachings of the prior art. Accordingly, the evidence of unexpected results is insufficient to overcome the prima facie case of obviousness.
Therefore, the rejection is maintained as it applies to amended claims.
Double Patenting
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.
Claims 1, 5-7, 10, 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 10,066,007 in view of Edbauer et al. (US 2015/0361166 A1) and Kaushik et al. (Anaerobe 2018 53:50-55).
The patent claim disclosed a method of treating ALS, FTD or ALS-FTD in a subject with genomic hexanucleotide repeat expansions comprising administering an antibody that binds dipeptide repeats of Gly-Ala. Although the claim does not teach administering the dipeptide repeats, it would have been obvious to one of ordinary in the art to actively immunize the subject with the dipeptide repeat in order to elicit production of antibodies that binds Gly-Ala dipeptide repeat in view of the teachings by Edbauer and Kaushik as discussed above (see 102 and 103). As such, the patent claim would render obvious of the present claims in view of Edbauer and Kaushik.
Applicant's request to hold the rejection in abeyance has been noted. The rejection is maintained.
Conclusion
No claim is allowed.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
