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 .
Claims 24-53 are pending,.
This office action is in response to a response filed 6/23/2026.
The application is a continuation of International Application No. PCT/US2024/044341. filed August 29, 2024, which claims the benefit of U.S. Provisional Application No. 63/644,785, filed May 09, 2024, and U.S. Provisional Application No. 63/585,343, filed September 26, 2023.
Election/Restrictions
Applicant's election without traverse of Group I (claims 24-52) in the reply filed 6/23/2026 is acknowledged. Claim 53 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Information Disclosure Statement
An IDS filed 2/12/2026 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action.
Claim Objections
Claims 51 and 52 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 49 (sic 50). When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The properties recited in claims 51 and 52 simply reiterate properties inherent in the vector as set forth in the disclosure. The capsid is designed and shown, absent evidence to the contrary, to increase muscle tropism and decrease liver tropism.
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 28 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 28 is rejected to for recitation that the X1NX2X3X4 and RGDRX5X6L are each from “Table 1b”. Where possible, claims are to be complete in themselves and as such the claims are objected to because they reference table II (see MPEP 2173.05(s)). It would be remedial to insert the contents of table 1b into the claim.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 51 and 52 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 51 and 52 are drawn to an AAV comprising the modified AAV capsid provided for in the claims. Claims 51 and 52 attempt to advance the scope of the claims by providing properties of the AAV. However, considering the disclosure, these properties are inherent in an AAV comprising the capsid.
[0016] Advantageously, viral vectors comprising an amino acid sequence of the invention exhibit muscle tropism as compared to a wild-type AAV vector.
[0017] In aspects of the invention, the capsid protein further comprises a deletion of G267 in reference to an AAV9 capsid or equivalent position in another AAV capsid. Advantageously, the vector may exhibit reduced liver tropism as compared to a wild-type AAV vector.
Hence, claims 51 and 52 are not described outside of subject matter already claimed. The claims lack adequate description to link additional structure to these required functions. The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure. Structural features that could distinguish the compounds of the claimed genus from others not encompassed by the genus are missing from the disclosure. In this case, there are specific elements referenced but the claims reference these structures with broad generic functional terms that represent a large and diverse genus of elements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 24-28, 30, 32, 34, 36, 44 and 50-52 are rejected under 35 U.S.C. 103 as being unpatentable over Albright et al (WO 2024040193) in view of Nonnemacher et al (WO 2024229125) and McGovern et al (WO 2020219988).
Albright et al teach AAV9 comprising sequences corresponding to those claimed. Specifically, use of RGDR see e.g. ¶0098) as a base insert is shown in ¶0071. X2-X3-X4 matching the format in i.e. SEQ ID NO:191, 215, 550, 198 and 199 of ASI, AST, ASV and ASM. As well, X5-X6-L is found in a number of sequences and is found specifically aw RGDRQAL (SEQ ID NO:26951), RGDRQSL (SEQ ID NO 6206) and RGDRQAL (page 377,m SEQ I DNO:4625). Amino acid 451is naturally an N (see Nonnemacher et al, SEQ ID NO:138).
Hence, the only missing explicit sequence is 451. The claims require that it be L or S. As well, the insertion is such that the RGRD peptide is at amino acid 456, after 455.
Both of these are known in the art.
First, amino acid 451 is meant to be leucine or serine (¶0154 or page 26 of Nonnemacher). This reference teaches muscle tropism for AAV9.
Secondly, insertion after 455 in AAV9 was known in the art. McGovern teaches that for muscle tropism, insertion for AAV9 is known to be at 455. Hence, combined with the insertion peptides and modified amino acids noted in the art, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate modifications of 451 and insertion into 455 as known modifications for muscle tropism. Such a modification would have resulted in a method encompassed by claims 24-28, 30, 32, 34, 36, 44 and 50-52. As noted above: 1) all of the references teach modification for AAV9 tropism to muscle wherein the modifications are known in the art 2) Albright teaches RGDR insertions 3) wherein insertion at amino acid 455 was known in the art (McGovern) and 4) modification at 451 to leucine or serine also know (Nonnemacher). Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the modifications were known in the art and would have predictable been used to modify an AAV9 vector for muscle tropism.
Conclusion
Claims 29, 31, 33, 35, 37-43 and 46-49 are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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