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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to drawn to a method of treating a patient having a heart failure using an rAAV in the reply filed on Dec 10, 2025 is acknowledged. Claims 129, 133-138, 140-143, and 145 are pending and under exam. Claims 146-151 are withdrawn.
Claim Interpretation
For the purposes of this examination the protein phosphatase inhibitor-1 or “I-1” as recited in the claims is interpreted to encompass both the endogenous wild-type inhibitor-1 and the engineered constitutively active variants thereof, including I-1c. This interpretation is supported by [0076] of the specification.
WITHDRAWN REJECTIONS AND CLAIM OBJECTIONS
Claim Objections
Objection to claim 135 is withdrawn following claim amendments.
Claim Rejections - 35 USC § 112
Claims 129-145 were 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.
Regarding claim 139: The rejection is withdrawn following cancellation of claim 131 and cancellation of language pertinent to 80% sequence identity to SEQ ID NO: 385-412 as recited previously in claim 141 ii)
Regarding claim 141: The rejection is withdrawn following amendment of claim 141 to cancel the language reciting T is replaced by any amino acid that is not T.
Claims 129, 130, 133-134, 139, and 143-144 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Rejection of claim 129 is withdrawn following cancellation of terms “a classification of.”
Rejection of claims 133-134, and 144 is withdrawn following cancellation of claim 144, and amendment to indicate what constitutes a baseline.
The rejection of claim 139 is withdrawn following cancellation.
The rejection of claims 130 and 144 are withdrawn following cancellation.
Claim Rejections - 35 USC § 102
Claims 129, 131, 133-134, 136-139, 142 and 144-145 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishikawa et al (Mol Ther. 2014 Dec; hereinafter "Ishikawa;" See IDS filed Mar 06, 2025) ; further as evidenced by various references cited herein.
The rejections are withdrawn following claim amendments.
Claim Rejections - 35 USC § 103
Claims 130, 132 and 135 were rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al (Mol Ther. 2014 Dec; hereinafter "Ishikawa;" See IDS filed Mar 06, 2025) and cited evidentiary references above, in view of Yee et al (; hereinafter “Yee;” See PTO-892).
The rejections are withdrawn following claim amendments.
MAINTAINED REJECTIONS AND CLAIM OBJECTIONS
Claim Rejections - 35 USC § 112
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 129, 133-138, 140-143, and 145 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.
Regarding claims 129 and 133: The specification does not demonstrate possession of full scope of the claimed invention. The specification provides support for manufacturing and stably expressing the I-1 gene in viral rAAV vectors. (See Example 4). However, instant specification only demonstrated treatment of heart failure using I-1c gene. (See Examples 5-7). It is noted that methods of manufacturing cannot be equivalent to the methods of treatment or therapeutic efficacy. It is also noted that as evidenced by Carr I-1 is structurally distinct from I-1c, as I-1c is the constitutively active form. (See Carr abstract, See PTO-892 of 01/26/2026).
In view of the above, it is submitted that Applicants were not in possession of the full scope of the claimed invention at the time of filing of the instant invention.
It is noted that “wherein the I-1 protein comprises at least amino acid residues 1-54 of SEQ ID NO: 1” encompasses the entire I-1 protein.
Claims 133-138, 140-143, and 145 are rejected for their dependencies on the rejected claim.
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.
Claims 143 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
The rejection of claim 143 is maintained as it still recites types of Limb-girdle muscular dystrophy, Glycogen storage diseases and progressive familial heart block in parenthesis. The metes and bounds of this phrase are indefinite since it is unclear how these limitations relate to the scope of the claimed invention.
Response to Affidavit Submitted on 06/16/2026
Applicant submitted a 37 C.F.R. 1.132 declaration presenting experimental data and evidence that the claimed dosing regimen results in approximately a 30-fold increase in protein expression in cardiac cells relative to the comparative administration protocol in Ishikawa. (See Declaration #3 and #9) The declaration has fully been considered and it is found that the presented evidence is sufficient to demonstrate an unexpected property attributable to the claimed dosing regimen. Specifically, the declaration stated that “a series of 5 sub-doses results in a superior yield of cardiac expression compared with transduction in a porcine model of heart failure shown in Ishikawa et al. These data are included in a manuscript published in Nature Medicine on October 21, 2025” (See Declaration #5).
The declaration provides objective evidence that the claimed administration protocol produces a substantially greater level of cardiac protein expression than would have been expected from the teachings of prior art. Such evidence is reasonably commensurate in scope with the claimed dosing regimen and is sufficient to rebut the prima facie case of obviousness with respect to the claims directed to the claimed administration regimen.
Accordingly, the Declaration is persuasive and rejections under 35 U.S.C. § 103 and additional cited references are withdrawn.
Double patenting issues:
Applicant’s claims and declaration was also considered against claims of U.S. Patent No. 9,114,148 (reference patent). The claims of the Reference Patent do not recite the claimed dosage regimen (i.e. wherein the at least one total dose is administered in a series of five sub-doses, in which each sub-dose is to be administered over a period of time of about 1 minute to about 5 minutes). It is noted initially that the SEQ ID NO: 1 of instant application has a R8Q mutation compared to the claimed SEQ ID NO: 2 of the Reference Patent. It is additionally noted that the claims of the reference patent do not recite the claimed dosage. As such it is submitted that the evidence submitted in the instant declaration is sufficient to rebut the prima facie case of obviousness type double patenting.
Similar analysis applies to U.S. Patent Nos.: 11,213,534; and 12,343,353
Conclusion
Claim 129, 133-138, 140-143, and 145 appear free of art in view of sequence search results and declaration.
In view of the 112(a) issues, no claim is allowed.
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 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 JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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