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 .
Applicant’s amendments to the claims and arguments filed on April 27, 2026 have been received and entered. Claims 1 and 9 have been amended, while claims 2-8, 10-11, 16-28, 33-38 have been canceled. Applicants’ cancellation of claims 2-8, 19-25 renders their objection moot. Claims 1, 9, 12-15, 29-32, 39 and 40 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of claims 1-9, 18-26 (group I) in the reply filed on July 9, 2025 is acknowledged.
Claims 12-15, 29-32, 39 and 40 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 9, 2025.
Priority
This application is a 371 of PCT/US2020/050411 filed on 09/11/2020 that claims priority from US provisional application no 62/898,958 filed on 09/11/2019.
Claims 1 and 9 are under consideration.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 1 and 9 were rejected under 35 U.S.C. 103 as being unpatentable over Patel et al (WO2016134293, dated 08/25/2016)/ Meis (US20140328825, dated 11/06/2014), Srivastava et al (WO2017/173137, 10/5/2017, Lu et al (PNAS, 2011, 15876-15880), Lopez (Mol. Cell Bio. 1992, 1674-1679) in view of Sultana et al (Molecular Therapy, 2017, 1306-1315) as evidenced by McGrath et al (J. Vis. Exp. (141), e58687, 1-13). Applicant’s amendments to the claims and arguments are found persuasive, therefore, previous rejection of claims is hereby withdrawn. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
Withdrawn-Claim Rejections - 35 USC § 112
Claims 1, 9, 18 and 26 were 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. Applicant’s amendment to the claims limiting the scope of the of G, M, T, H, A, dnT, and dnW in a specific molar ratio obviates the basis of the rejection. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
Withdrawn-Claim Rejections - 35 USC § 112
Claims 1-9, 18 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. Applicant’s amendment to the claims limiting the scope of the of G, M, T, H, A, dnT, and dnW in a specific molar ratio obviates the basis of the rejection. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
New-Claim Rejections - 35 USC § 112- necessitated by amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the recitation of limitation “..modRNA encode: GATA Binding Protein 4 (G), Myocyte Enhancer Factor 2C (M), T-box 5 (T), Heart- and neural crest derivatives-expressed protein 2 (H), ceramidase (A), dominant negative transforming growth factor beta (dnT), and- dominant negative Wingless-related integration site 8 (dnW), said molecules of modRNAs are present in said composition in a molar ratio of G:M:T:H:A:dnT:dnW of 1:1:1:2:07:0.7:0.7, respectively” (claim 1) is considered new matter. Upon further review of the instant specification, examiner could not find explicit or implicit support for a mod RNA encoding all the seven proteins (G:M:T:H:A:dnT:dnW) in the indicated molar ratio of 1:1:1:2:07:0.7:0.7. The specification further fails to teach indicated ratio of G:M:T:H:A:dnT: dnW from a single mod RNA. Thus, at the time the application was filed, an Artisan of skill would not recognize from the disclosure that Applicant was in possession of the composition, as claimed. In case if applicants have evidence to support otherwise, applicants are invited to indicate page and line number for the written support specifically for a modRNA encode: GATA Binding Protein 4 (G), Myocyte Enhancer Factor 2C (M), T-box 5 (T), Heart- and neural crest derivatives-expressed protein 2 (H), ceramidase (A), dominant negative transforming growth factor beta (dnT), and- dominant negative Wingless-related integration site 8 (dnW), said molecules of modRNAs are present in said composition in a molar ratio of of 1:1:1:2:07:0.7:0.7, as recited in claims of the instant application.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph-written description requirement”. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981) Claim 9 is included in the rejection because it directly depends from the rejected base claim. This is a new matter rejection.
Examiner’s note: Applicant’s representative is requested to contact Examiner to resolve the pending issues to put instant application in condition for allowance and also make necessary changes for the withdrawn method claims for rejoinder.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ifkovits et al (PLoS One 2014, 9, e89678, 1-11) teaches TGFb inhibitor, SB431542 (SB), was identified as a small molecule capable of increasing the conversion of both mouse embryonic fibroblasts and adult cardiac fibroblasts to iCMs up to 5-fold (abstract).
Hadas (Circulation, 2020, 141, 11, 916-930) teaches enhancing AC activity reduced cell death under hypoxia conditions in vitro or during MI in vivo.
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 ANOOP K. SINGH whose telephone number is (571)272-3306. The examiner can normally be reached Monday-Friday, 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571)272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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