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 .
Status of Application/Claims/Election
Applicant’s election without traverse of Group I (Claims 1-7) on 1/22/2026 is acknowledged.
Claims 1-16, 22, 44 and 47-52 are pending. Claims 8-16, 22, 44 and 47-52 are withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-7 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 63/155,624 and 371 of PCT/US2022/018543 filed on 3/2/2021 and 3/2/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 3/2/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/4/2024 and 1/22/2026 were received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Duplicate Claims, Warning
Applicant is advised that should claim 1 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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).
Claim Rejections - 35 USC § 112b
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 4 is 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 pre-AIA the applicant regards as the invention.
Claim 4 describes said VP3 comprising an amino acid segment at a position within three amino acid residues of an amino acid residue corresponding to positions 452 or position 588 of a reference VP1 polypeptide set forth in SEQ ID NO: 2. It is unclear how positions 452 or position 588 of a reference VP1 polypeptide set forth in SEQ ID NO: 2 relate to the position of the heterologous amino acid segment within VP3. Applicant uses the term “corresponding to”, however SEQ ID NO: 2 and the polypeptide sequence of VP3 are different sequences entirely. Furthermore, it is unclear if the reference VP1 polypeptide is the same VP1 polypeptide in the claimed AAV described in claim 1. Please note that the language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds", see MPEP 2173.
Claim Interpretation
Given the 112b issues identified above, claim 4 is broadly interpreted as the VP3 polypeptide comprising said heterologous amino acid sequence within three amino acid residues of any amino acid position within the VP3 polypeptide.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sabin et al. US 2022/0241430, published 8/4/2022, priority date 5/24/2019 (hereinafter Sabin).
Claims 1, 3, 4 and 6: Sabin describes compositions and methods for modifying the VP1, VP2 and VP3 capsid proteins of AAV particles to achieve targeted delivery (Sabin, para 3, 96, 111-112). In particular, Sabin describes modifications to the H1 loop of VP3 to include a Spytag sequence, which would then allow for the covalent, post-assembly attachment of a SpyCatcher-fused targeting ligands (Sabin, para 112 and 130).
Claim 2: Sabin provides preferred embodiments towards the use of AAV2 viral vectors (Sabin, para 134).
Claim 7: Sabin describes using qPCR to measure vector titers (number of genomes per milliliter or vg/mL) greater than 1011 (Sabin, example 3).
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sabin (supra) as applied to claims 1-4 and 6-7 above in further view of Guenther et al. "Protease-activatable adeno-associated virus vector for gene delivery to damaged heart tissue." Molecular Therapy 27.3 (2019): 611-622 (hereinafter Guenther). A description of Sabin can be found above. Sabine does not describe the incorporation of a protease cleavage site in the VP3 polypeptide.
Claim 5: However, the incorporation of protease cleavage sites into VP3 proteins of AAV vectors are well understood in the art and is commonly used to engineer protease-activatable vector delivery systems. For example, Guenther describes how specific disease environments rich in proteases like matrix metalloproteinases in tumors or diseased tissues can activate AAV vectors which contain protease cleavage sites (Guenther, abstract). Guenther describes this as a strategy to reduce off-target toxicity and improved targeting.
It would have been prima facie obvious to one of ordinary skill in the art to incorporate a protease cleavage site as described by Guenther into the VP3 polypeptide of an AAV vector comprising a Spytag sequence as described by Sabin to improve vector targeting. It would have been a matter of combining prior art elements according to known methods to yield predictable results for one of ordinary skill in the art to include incorporate a protease cleavage site. One would have been motivated to make this combination in order to reduce off-target toxicity and improved targeting since certain target tissues may contain protease rich environments which would then activate the AAV vectors providing tissue specificity. One would have a reasonable expectation of success given that both the Spytag sequence and protease cleavage site could result in improved AAV vector targeting and possible synergistic targeting effects. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1633
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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