DETAILED 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 .
The amendments of 12/01/2025 have been entered in full. Claims 1, 2, 4, 6-10, 13-18, 22-24, and 28-33 are pending.
All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicants’ amendment and/or arguments filed 12/01/2025.
Claim Rejections - 35 USC § 112
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.
Claim 22 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 22 is unclear as it recites dependency from a canceled claim. For purposes of further examination, claim 22 will be interpreted as depending from claim 1. On this basis, claim 22 recites the limitation "the PMO" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
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, 2, 4, 6-10, 13-18, 22-24, and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190022167 (Wilson; of record), taken together with US 20110082084 (Szeto; of record), US 20230038956 (Kaye), US 20200078465 (Passini).
Wilson teaches compositions and methods for preventing, ameliorating or treating Duchenne muscular dystrophy by administering aromatic-cationic peptides conforming to the formulas of pending claims 1, 2, and 4 [0002][0007]. The signs or symptoms of DMD to be treated or ameliorated include cardiomyopathy, congestive heart failure, or arrhythmia [0008]. In some embodiments, in addition to the administration of the aromatic-cationic peptide, the method further comprises separately, sequentially or simultaneously administering to the subject one or more additional therapeutic agents such as corticosteroids, ACE inhibitors, beta-blockers, angiotensin receptor blockers (ARBs) (as in pending claims 24 and 28) or AVI-4658 phosphorodiamidate morpholino oligomer ([0015]; claims 10 and 22). AVI-4658 is also known as Eteplirsen, which is a drug known increase or correct the production of dystrophin, as generically recited in all pending claims. Thus, Wilson teaches administering the same peptides and additional agents as in the pending claims, which would inherently produce all of the same effects as recited in claims 6-10, and 28.
Wilson further teaches that the peptides may be formulated as pharmaceutically acceptable salts, such as acetate, tartrate, or trifluoroacetate salts, as in claim 29 [0007][0023]. The peptides are administered orally, topically, systemically, intravenously, subcutaneously, transdermally, iontophoretically, intranasally, intraperitoneally, or intramuscularly, as in claims 13-15, and 22 [0026]. Wilson teaches sustained release formulations [0352-0353], which are types of depot formulation as recited in claim 30.
US 20110082084 (Szeto) discloses aromatic-cationic peptides conforming to the formulas of pending claims 1, 2, 4, and 54, e.g. D-Arg-2',6'-Dmt-Lys-Phe-NH2 [0015]. Szeto teaches that these peptides treat or prevent heart failure by enhancing mitochondrial function in cardiac tissues [0007]. In certain embodiments, the heart failure results from hypertrophic cardiomyopathy ([0053] claim 5). The treatment increases cardiac output compared to that of an untreated patient [0054], attenuates Ang-II induced cardiac hypertrophy and fibrosis [0061]. Like Wilson, Szeto teaches that aromatic-cationic peptides and be administered separately, sequentially or simultaneously with known cardiovascular agents, including corticosteroids, ACE inhibitors, beta-blockers, angiotensin receptor blockers (ARBs), as in pending claims 24 and 28 [0055]. Also like Wilson, Szeto teaches that the peptides are administered orally, topically, systemically, intravenously, subcutaneously, transdermally, iontophoretically, intranasally, intraperitoneally, or intramuscularly, as in claims 13-15, and 22. Given the known cardiac effects of aromatic-cationic peptides disclosed in Szeto, one of skill in the art would expect administering aromatic-cationic peptides to patients with muscular dystrophy, as taught in Wilson would be effective for treating the associated cardiomyopathy.
As noted above, Wilson teaches the administration of aromatic-cationic peptides separately, sequentially or simultaneously with the phosphorodiamidate morpholino oligomer (PMO) AVI-4658, also known as Eteplirsen, Neither Wilson nor Szeto specifically teaches other PMOs such as Golodirsen or Casimersen, or a peptide-conjugated PMO (PPMO), as recited in amended claim 1.
US 20230038956 (Kaye) teaches a method of treating muscular dystrophy by administering Golodirsen (Abstact)[0011]. US 20200078465 (Passini) teaches numerous PMO and PPMO compounds for the treatment of muscular dystrophy. These include Casimersen (PMO #1) and a PPMO derived from Casimersen, (PPMO#1) [0039], [0399]. In view of Kaye and Passini, it is clear that the all of the agents recited in claim 1 are known in the prior art as being effective for treating muscular dystrophy. Consequently, one of skill in the art prior to the filing of the instant application would expect to successfully use any of these compounds together with aromatic-cationic peptides as suggested in Wilson for AVI-4658/ Eteplirsen. Therefore, the methods of claims 1, 2, 4, 6-10, 13-18, 22-24, and 28-33 are prima facie obvious over the combined teachings of the cited references.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647