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 with traverse of Group I in the reply filed on 7/30/2026 is acknowledged. The traversal is on the ground(s) that examination of all of the claims would not impose a serious burden. This is not found persuasive because Applicant did not provide any reason explaining why there would not be a serious burden.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 15, 16, 18, 20, 23 and 24 are withdrawn from consideration for being directed to non-elected subject matter. Claims 1-8, 32-37 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/25/2026 has been considered by the examiner.
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 1, 5-8, 32 and 36-37 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 1 and 32, the recitation of “at least about 90% identity” renders the claim indefinite because the specification does not provide a limiting definition regarding “about.” The specification any numerical values, are to be understood as being modified in all instances by the term “about.” The specification further states a numerical value typically includes +/- 10% pf the recited value (see paragraph [0064]). However, it is unclear whether “at least about 90% identity” includes only at least 81%-99% identity or other value because “typically” means “in most case; usually” according to online dictionary (see OA appendix). As such, the metes and bounds of the claim cannot be established.
Dependent claims 6-8, and 37 are rejected for same reason because they depend on claim 1 and 32 but does not remedy the infiniteness.
Regarding claim 5 and 36, the recitation of “a sequence of SEQ ID NO: 2 or SEQ ID NO: 3” renders the claim indefinite because it is unclear whether the claimed sequence is the full length sequence of SEQ ID NO: 2 or SEQ ID NO: 3, or also encompasses “a sequence” (fragments thereof) within SEQ ID NO: 2 or 3.
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.
(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.
Claim(s) 1, 5-8, 32 and 36-37 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Briggs (WO 2021/242903).
The following rejection is based on the interpretation that PINK1 claimed in claim 1 and 32 encompasses nucleic acid having at least 78% homology with SEQ ID NO: 2 or 3.
Briggs teaches polynucleotides that encodes PINK1 polypeptide, SEQ ID NO: 49, and AAV vectors that comprises said polynucleotide (page 22, paragraph [009], page 26, lines 26-31, Table 8). SEQ ID NO: 49 is the wild type PINK1, which has at least 78% homology with SEQ ID NO: 2 or 3.
Regarding claim 32 and 36, the recitation of “a sequence of SEQ ID NO: 2 or SEQ ID NO: 3” is interpreted as having a segment of SEQ ID NO: 2 or SEQ ID NO: 3, for example, AGA, therefore, SEQ ID NO: 49 from ‘903 application meet this limitation.
Regarding claim 6, Briggs teaches the AAV vector may be serotype 1, AAV1 (page 22, paragraph [009], line 10).
Regarding claim 7, Briggs teaches vector comprises CMV promoter (paragraph [0022]).
Regarding claim 8, Briggs teaches regulating by use base editing in 5’ UTR (page 237, embodiment 43).
Regarding claim 37, Briggs teaches plasmid comprising polynucleotide that encodes PINK1 (paragraph [00153]).
Claim Rejections - 35 USC § 101
Claim 32 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claim(s) recite(s) a polynucleotide encoding PINK1 has at least about 90% identity to SEQ ID NO: 2 or 3. As discussed above in the 112 2nd rejection, since the claimed range of “about” is indefinite, the scope is interpreted as comprising at least 78%. As such the wild type PINK1 polynucleotide meets this limitation. Regarding claim 36, the wild type polynucleotide encoding PINK1 also meets the limitation of a polynucleotide has a sequence of SEQ ID NO: 2 or 3. Therefore, the wild type polynucleotide encoding PINK1 is a product of nature. This judicial exception is not integrated into a practical application because there is no further limitation recited in claims. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not further limit the polynucleotide with additional elements.
Allowable Subject Matter
Claims 2-4, 33-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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/CELINE X QIAN/Primary Examiner, Art Unit 1637
