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 .
DETAILED ACTION
Claim status
Claims 1-19 are pending
Claims 11-19 are withdrawn
Claims 1-10 are under examination
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 2/17/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-16, drawn to compositions comprising one or more AAV vectors encoding PCCA and/or PCCB transgenes operably linked to promoters.
Claims 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following species without traverse is acknowledged.
Claims 1-5, drawn to a composition comprising AAVrh10 and either a PCCA or PCCB gene operably linked to the Cbh promoter.
Rejoinder
The use of the transitional phrase “comprising” and the disjunctive term “or” encompasses both PCCA and PCCB, therefore the species election between PCCA or PCCB (Claims 1-5) with PCCA and PCCB (Claims 6-10) is withdrawn. Claims 6-10 are rejoined.
However, Claims 11-16 (directed to two different AAV vectors) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/06/2025 and 9/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: instant claim uses the abbreviation “Cbh”, which has not been spelled out upon first use. Although claims are allowed abbreviations, if an abbreviation is not spellout upon first use in a claim, Applicant should only use abbreviations that are well known and would be clear to someone who had not read the invention description.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(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 6-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fuller et al., (US 2023/0129893, filed 3/30/2021, published 4/27/2023, with priority to US provisional 63/002,541, filed 3/31/2020).
In regard to claims 1, 6 and 9, Fuller claims an AAVrh10 vector comprising a nucleic acid that encodes either propionyl-CoA carboxylase alpha (PCCA) or fragment thereof or beta (PCCB) or fragment thereof, operably linked to a CMV enhancer/chicken beta-actin (CAG) hybrid promoter (alias Cbh promoter) (Claims 1, 2, and 9 of 2023/0129893, see Claims 1, 2 and 9 of Fuller’s provisional document). Note in regard to claim 6, because Fuller claims use the transitional phrase “comprising” and the disjunctive term “or”, the Examiner has interpreted the claims of Fuller to encompass both PCCA and PCCB.
In regard to claims 2 and 7, Fuller claims the PCCA and/or PCCB nucleotide sequence or fragments thereof, are codon-optimized for humans (Claims 31-32 and 35-36 of 2023/0129893, see Claims 31-32 and 35-36 of Fuller’s provisional document).
In regard to claims 3 and 8, Fuller claims the 2,184 base nucleic acid sequence of SEQ ID NO:2 (Claim 30 of 2023/0129893, see Claim 30 of Fuller’s provisional document), which when translated is identical to the 728 human PCCA amino acid sequence of SEQ ID NO:3.
In regard to claims 4 and 8, Fuller claims the 1,617 base nucleic acid sequence of SEQ ID NO:8 (Claim 34 of 2023/0129893, see Claim 34 of Fuller’s provisional document), which when translated is identical to the 539 human PCCB amino acid sequence of SEQ ID NO:6.
Accordingly, Fuller anticipates instant claims.
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller et al., (US 2023/0129893), in view of Chua (US 2015/0074847, filed 3/13/2013) and Heessen et al. (Mol Cell, 2005, 18:225-235)
As discussed previously, Fuller anticipates an AAVrh10 vector comprising PCCA or PCCB gene operably linked to a Cbh promoter.
However, although Fuller suggests the vector further comprise “sequences that enhance protein stability” ([0106] of 2023/0129893, see [0096] of provisional document), they are silent with respect to further including a portion of Rad23 to increase the stability of the PCC transgene.
With respect to claims 5 and 10, Chua teaches and claims a nucleic acid constructs comprising a fusion protein of a transgene of interest and the ubiquitin-like (Ubl) domain of Rad23 in order to prevent ubiquitination and improve the stability of the transgene in a plant cell (Abstract, Summary of the Invention, see Claim 1 of Chua).
However in regard to claim 5, Chua is directed to using the domain of Rad23 to enhance the transgenic protein in plants (see Title of Chua). Nevertheless, Chua discloses that similar experiments have done in mammalian cells and cites the prior art of Heessen et al. (2005) [0007, 0104-0105, 0119].
Heessen et al. teaches that the Ubl domain of Rad23 is a “cis-acting transferable stabilization signal” (Abstract, Introduction, last para.), and demonstrates the Rad23 domain works in mammalian cells when fused to a transgene of interest (see HeLa experiments expressing a GFP-Rad23 domain fusion (p. 231, last para. of Results).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the AAV vector comprising the PCCA and/or PCCB transgene as taught by Fuller and combine a portion of the Rad23 protein as taught by Chua and Heessen with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Heessen because this domain would improve the stability of the PCC transgene by protecting the protein from proteasomal degradation (Abstract, Introduction, last para.).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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