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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 38, 47, 49, 52, 53 and 57 in the reply filed on 12/9/2025 is acknowledged.
Claims 1, 2, 5, 7, 10, 11, 15, 18-21, 23 and 28-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/9/2025.
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.
Claims 38, 47, 49, 52, 53 and 57 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.
Regarding claim 38, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 49 recites the limitation "the promoter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The recitation of a promoter first occurs in claim 47.
Claim 52 recites the limitation "the expression cassette" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The recitation of an expression cassette first occurs in claim 47.
Claim 53 recites the limitation "the expression cassette" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The recitation of an expression cassette first occurs in claim 47.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 38, 47, 49, 52, 53 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keravala et al. (WO 2020/014523, published 1/16/2020).
Regarding claims 38 and 49, Keravala et al. teach pharmaceutical composition for treating Danon disease comprising an AAV comprising CAG promoter and a nucleotide sequence encoding a LAMP2B protein, wherein the therapeutic amount is less than 1 x 1012 vg/kg (see Abstract, Fig. 1A, reproduced below, pg. 1 lines 26-28 and pg. 35 lines 5-16).
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783
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Regarding claim 47 and SEQ ID NO: 1, Keravala teaches that their encoded LAMP2B protein (SEQ ID NO: 2) is 100% identical to instantly recited SEQ ID NO: 1.
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Regarding claim 52, Keravala teaches:
SEQ ID NO: 22 which is 100% identical instantly recited SEQ ID NO: 22
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SEQ ID NO: 3 which is 100% identical to instantly recited SEQ ID NO: 3
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SEQ ID NO: 75 which is 100% identical to instantly recited SEQ ID NO: 27
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SEQ ID NO: 42 which is 100% identical to instantly recited SEQ ID NO: 7
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Regarding claim 53, Keravala teaches:
SEQ ID NO: 11 which is 100% identical to instantly recited SEQ ID NO: 11
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SEQ ID NO: 12, which is 100% identical to instantly recited SEQ ID NO: 12
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Regarding claim 57, with respect to the term kit, the claimed kit is not accorded any patentable weight, as it is directed to a composition comprising the pharmaceutical composition of the invention. Regarding instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product).
Thus, the teachings of Keravala clearly anticipate the invention of claims 38, 47, 49, 52, 53 and 57.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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