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 .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 23 October 2024, in which applicant has amended claims 2, 8, 14, 16, 18, 26, 32, 35, 43, 48, 49, 55, 56, 77, 86, 88; canceled claims 9-13, 15, 17, 19-25, 28-31, 33-34, 36-40, 44-47, 50-54, 57-76, 78-85, and 87.
Therefore, claims 1-2, 8, 14, 16, 18, 26-27, 32, 35, 41-43, 48, 49, 55, 56, 77, 86, and 88 are pending in the application.
Election/Restrictions
Applicants’ election of Group 1, claims 1-2, 8, 14, 16, 18, 26, and 27, drawn to a recombinant nucleic acid comprising a nucleotide sequence encoding a micro-dystrophin protein comprising a utrophin N-terminus in the reply filed on 08 July 2026 is acknowledged.
In the reply filed on 08 July 2026, applicants did not distinctly and specifically point out the supposed errors in the restriction requirement with an election that mailed on 05/08/2026. Therefore, the election response filed on 08 July 2026 will be treated without traverse (MPEP § 818.01(a)).
Claims 32, 35, 41-43, 48, 49, 55, 56, 77, 86, and 88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Regarding an election of species, Applicant elects, SEQ ID NOs: 177. Claims 1, 2, 16, 18, 26, and 27 of the elected Group I read on the above species.
The species election requirement among nucleotide sequence SEQ ID Nos, as set forth in the Office action mailed on 05/08/2026, has been reconsidered in view of the prior art search for nucleotide sequence that is at least 80% identical to any one of SEQ ID NOs: 85-92, 135-148, or 176-185 of claim 8. The species election has been reconsidered to pursue MPEP 803.02. Therefore, the Species election of nucleotide sequence comprising SEQ ID NOs: 70, 72, and 207-247 of claim 14 is hereby withdrawn as to any claim that requires all the limitations of an allowable claim and has been rejoined.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-2, 8, 14, 16, 18, 26, and 27 are under current examination.
Priority
This application was filed 03/27/2024 and is a 371 application of PCT/US2022/077199 filed on 09/28/2022, which claims benefit to the Provisional Application 63303499, filed 01/26/2022 and 63249511, filed 09/28/2021. Thus, the earliest possible priority for the instant application is 09/28/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/23/2024 and 07/08/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and the signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Anticipated by Chamberlain’488
Claim 1-2, 16, 18 and 26-27 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chamberlain et al. (US20180148488A1; cited in IDS filed 10/23/2024; hereinafter “Chamberlain’488”).
Regarding Claims 1, 26-27, Chamberlain’488 discloses a nucleotide sequences including a micro-dystrophin gene operatively linked to a regulatory cassette and a utrophin at n-terminus ([0124], Fig. 21) for treating a subject having, or at risk of developing, Duchenne muscular dystrophy (DMD), sarcopenia, heart disease. This method may include administering a pharmaceutical composition including the micro-dystrophin gene and a delivery vehicle (rAAV particle comprising the rAAV vector encapsidated in an AAV capsid) to a subject (abstract, [0044]). Chamberlain’488 further discloses the delivery vehicle includes a recombinant adeno-associated virus vector [0032] expresses the micro-dystrophin gene, such that the protein encoded by the micro-dystrophin gene [0033] and delivery vehicle is a rAAV particle comprising the rAAV vector encapsidated in an AAV9 capsid [0044], [0178].
Regarding Claim 2, Chamberlain’488 teaches that the nucleotide sequence encodes dystrophin spectrin-like repeats and the juxta-position with hinge domains comprises N-terminus to spectrin-like repeat 1 ([0124] FIG. 21).
Regarding claims 16 and 18, Chamberlain’488 teaches that a cardiac-specific promoter is operably linked to the nucleotide sequence encoding the micro- dystrophin protein, wherein the promoter is cardiac troponin T (cTnT) promoter [0229].
Accordingly, Chamberlain’488 anticipates the instant claims 1-2, 16, 18 and 26-27.
Anticipated by Chamberlain’281
[AltContent: textbox ([img-media_image1.png]
Fig. 12 of Chamberlain)]Claim 1-2, 26-27 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chamberlain et al. (US20050158281A1; cited in IDS filed 10/23/2024; hereinafter “Chamberlain’281”).
Regarding Claims 1-2, 26 and 27, Chamberlain’281 discloses a recombinant nucleic acid comprising a nucleotide sequence encoding a microdystrophin protein comprising a utrophin N-terminus [0043], [0149], Fig. 12; the micro proteins comprise other elements (e.g. from utrophin) such as an actin binding amino-terminal domain [0045]; and a chimeric protein comprising an amino acid sequence (i.e., the dystrophin-like proteins are selected from the group consisting of micro-dystrophin/utrophin chimera proteins) [0043]. Chamberlain’281 further teaches that the the rAAV vector encapsidated in an AAV6 capsid [0175]. Chamberlain’281 further discloses the delivery composition includes a recombinant adeno-associated virus vector [0080] expresses the micro-dystrophin gene, such that the protein encoded by the micro-dystrophin gene [0153] and the tropism of rAAV vectors is derived from the nature of the capsid gene used for growth and encapsidation of the AAV6 [0116], [0182].
Accordingly, Chamberlain’281 anticipates the instant claims 1-2, 26-27.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-2, 14, 16, 18 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Chamberlain et al. (US20180148488A1; cited in IDS filed 10/23/2024; hereinafter “Chamberlain’488”), in view of Duan et al., (US7892824B2; cited in IDS filed 10/23/2024; hereinafter “Duan”).
As discussed previously, regarding claims 1-2, 16, 18 and 26-27 Chamberlain’488 teaches a nucleotide sequences including a micro-dystrophin gene operatively linked to a regulatory cassette and a utrophin at n-terminus ([0124], Fig. 21) for treating a subject having, or at risk of developing, Duchenne muscular dystrophy (DMD), sarcopenia, heart disease. Chamberlain’488 further discloses the delivery vehicle includes a recombinant adeno-associated virus vector [0032] expresses the micro-dystrophin gene, such that the protein encoded by the micro-dystrophin gene [0033] and delivery vehicle is a rAAV particle comprising the rAAV vector encapsidated in an AAV9 capsid [0044], [0178].
Although regarding claim 14, Chamberlain’488 does not specifically teach nucleotide sequence comprises one or more nucleotide sequences of any one of SEQ ID NOs: 70, 72, and 207-247. However, such was known in the prior art.
Regarding claim 14, Duan teaches dystrophin mini/micro genes that retain the essential biological functions of a full-length dystrophin gene and pharmaceutical composition for treatment of Duchenne Muscular Dystrophy (DMD) (abstract). The N-terminal domain of a human dystrophin protein includes nucleic acid sequence SEQ ID NO 47 having 100% sequence identity to instant claim SEQ ID NO: 72 (see ABSS search report filed 26 Aug. 2026).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to practice the nucleotide sequences including a micro-dystrophin gene of Chamberlain’488 and include the nucleic acid sequence of the micro-dystrophin gene as taught by Duan with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Duan because micro-dystrophin gene, or a series thereof, with the ability to restore nNOS to the sarcolennna, and to be used for gene therapy in the treatment of DMD (Col. 3 lns 11-14 of Duan). The POSITA would have a reasonable expectation of success in combining the teachings of Chamberlain’488 and Duan because each of these teachings successfully generated AAV vector system contains a part of the nucleic acid molecule micro gene of the present invention. Therefore, the products as taught by Chamberlain’488 et al. in view of Duan et al. would have been prima facie obvious over the products of the instant application. In regard to the reasonable expectation of success in doing so, substitute the nucleotide sequences of 47 of Duan had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Subject Matter Free of Art
Claim 8 is objected because art does not teach or reasonably suggest the SEQ ID NO: 177 (elected) as well as SEQ ID Nos: 89-92, 135-148, 176, 178-185 (see ABSS report filed Aug. 21, 2026). Since claim 8 depends on rejected base independent claim 1. Claim 8 would be free of the art, if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
To expedite the prosecution, according to ABSS search report, examiners noticed that SEQ ID Nos; 208, 210, 212, 214, 219, 221, 223, 225, 235, 237, 239, 241, 245 and 247 of claim 14 is free of prior art (see ABSS search report filed 08/26/2026).
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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