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 .
Priority
The instant application is a national stage entry of PCT application PCT/US2022/028832, filed 11/06/2023 under 35 USC 371. Acknowledgement is made of the applicant’s claim for benefit to prior-filed U.S. provisional patent applications 63/187,349, which was filed 05/11/2021.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See i.e., pages 155 and 156 of Specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 2 and 65 are objected to because of the following informalities:
Claim 1 recites “amino-terminus to the carboxy terminus”, the phrase is recommended to be amended to “amino-terminus to the carboxy-terminus” to enhance consistence and clarity;
Claim 1 recites “ABD- H1-R1-R2-R3-H3-R24-H4-CR-CT”, wherein the abbreviation “CT”, unlike other abbreviations, has no full name or description. It is recommended to add the full name of the abbreviation “CT”;
claim 2 recites “the method of claim 2”, the phrase needs to be amended to “the method of claim 1” to show correct dependency;
Claim 65 recites “at dose of”, it needs to be amended to “at a dose of”.
Claim Rejections - 35 USC § 112(b)
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 2-4, 7, 9-10, 32-35, 41 and 66 are 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.
Claims 2, 3, 7, 9, 10, 32-34 recite that the second therapeutic is a “therapy”, renders instant claims indefinite. Without a definition regarding the terms “therapeutic” and “therapy”, they are interpreted under broadest reasonable interpretation that “therapeutic” refers to a pharmaceutical composition (a product), while “therapy” refers to a process of using a product (i.e., a pharmaceutic composition) or a method (i.e., physical therapy) for treatment of a disease. Giving the recitation that “a therapeutic” is “a therapy” as in instant claims, an ordinary skill in the art would not have been readily appraised of the scope of instant claims.
Claims 4, 35 and 41 depend from, at least, claim 2, and thus inherit the deficiency and are rejected on the same basis.
Claim 66 recites “at least the proximal portion of the C-terminus corresponding to human dystrophin amino acid residues 3361-3554 of SEQ ID NO:95 (UniProtKB-P11532)”, the term in parentheses renders instant claims indefinite. It is not clear whether “UniProtKB-P11532” refers to SEQ ID NO:95 or the amino acid residues 3361-3554 of SEQ ID NO:95. Therefore the scope of instant claim is not clear.
Related Prior Art
Instant claims are directed to a method comprising administering to a subject a first therapeutic and a second therapeutic which is different from said first therapeutic. The claims limit the first therapeutic is a microdystrophin pharmaceutical composition comprising a therapeutically effective amount of a recombinant adeno-associated vector (rAAV) particle and a pharmaceutically acceptable carrier, wherein the rAAV particle comprises a transgene that encodes a microdystrophin protein consisting of dystrophin domains arranged from amino-terminus to the carboxy-terminus: ABD-H1-R1-R2-R3-H3-R24-H4-CR-CT. The transitional phrase “consist of” excludes any element, step or ingredient not specified in the claim. In instant case, it is interpreted that the microdystrophin protein is arranged exactly in the order of ABD-H1-R1-R2-R3-H3-R24-H4-CR-CT from amino-terminus to the carboxy-terminus without any extra components. Banks (WO 2020/086844 A1) and Chamberlain et al. (WO 2016115543 A2) are considered as the closet prior arts. Banks teaches nucleic acid molecules, polypeptides, cells, vectors, and pharmaceutical compositions relating to miniaturized dystrophin (Abstract). Banks teaches miniaturized dystrophin polypeptide (see p2, L11-28). Chamberlain et al. teach micro-dystrophin gene and methods of treating dystrophinopathy comprising administering a pharmaceutical composition including the micro-dystrophin gene (Abstract). Chamberlain et al. teach micro-dystrophin gene encoding proteins comprising ABD, hinge domain and spectrin-like repeats (see i.e., claims 15-25). However, neither of them teaches the microdystrophin protein consisting of dystrophin domains arranged from amino-terminus to the carboxy-terminus: ABD- H1-R1-R2-R3-H3-R24-H4-CR-CT, as recited in instant claims. Therefore instant claim is considered novel and art-free.
Allowable Subject Matter
Claims 67, 68, 72, 75 and 83-84 are objected to as being dependent upon an objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699