Prosecution Insights
Last updated: August 17, 2026
Application No. 18/024,806

NOVEL ENGINEERED CAPSID SEROTYPE OF RECOMBINANT ADENO-ASSOCIATED VIRAL VECTOR WITH ENHANCED TRANSDUCTION EFFICIENCY AND WIDESPREAD DISTRIBUTION IN THE BRAIN

Non-Final OA §102§103§112§DOUBLEPATENT
Filed
Mar 06, 2023
Priority
Sep 04, 2020 — provisional 63/074,548 +2 more
Examiner
TINSLEY, BRENDAN THOMAS
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Ohio State University
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allowance Rate
26 granted / 42 resolved
+1.9% vs TC avg
Strong +70% interview lift
Without
With
+70.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
17 currently pending
Career history
74
Total Applications
across all art units

Statute-Specific Performance

§101
5.5%
-34.5% vs TC avg
§103
29.0%
-11.0% vs TC avg
§102
12.5%
-27.5% vs TC avg
§112
39.0%
-1.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 42 resolved cases

Office Action

§102 §103 §112 §DOUBLEPATENT
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 . Claim Status Claims 1-12 are pending. Applicant's election with traverse of the invention of group I drawn to an engineered adeno-associated virus vector in the reply filed on 14 January, 2026 is acknowledged. The traversal is on the grounds that “the special technical feature of group I is present and in common with each of claims 6-12” (Remarks, page 2). Applicant further argues that claims to different categories of invention are considered to have unity of invention if the claims are drawn to only one of the combinations listed in 37 C.F.R. § 1.475 (Remarks, page 2). This is not found persuasive because the inventions of groups I-III do not share a special technical feature. The shared technical feature between the inventions of groups I-III is an engineered AAV vector comprising recombinant 2 (Rec2) capsid comprising one or more substitutions in the heparin binding loci (See Requirement for Restriction, page 4). This shared technical feature is not a special technical feature because Siu discloses an engineered AAV capsid having these exact characteristics (Siu, page 105, full paragraph). This is the first step in the analysis set forth in 37 C.F.R. § 1.475(a). The inventions are not “so linked as to form a single general inventive concept” because the inventions do not involve “one or more of the same or corresponding special technical features” (See 37 C.F.R. § 1.475(a)). There is no need to proceed to the categories of inventions listed in 37 C.F.R. § 1.475(b) because “unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features.” The requirement is still deemed proper and is therefore made FINAL. Claims 6-12 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 January, 2026. Therefore, claims 1-5 are pending and under consideration in the present Official Action. Priority The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2021/049081, filed 03 September, 2021, which claims priority to United States Provisional Application No. 63/074,548, filed 04 September, 2020. Acknowledgment is made of applicant’s claim for priority. The earliest possible priority for the instant application is 04 September, 2020. Information Disclosure Statement The information disclosure statements (IDS) submitted on 06 March, 2023 and 12 December, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Drawings The drawings are objected to because FIG. 5I is out of focus and illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Examiner’s Comment Throughout the present Official Action, where reference is made to the instant specification, the Examiner will be referencing the publication of the instant application (US2023/0330267). Claim Objections Claim 1 is objected to because of the following informalities: The recitation of “recombinant” requires a definite article (e.g. “a”) immediately preceding it. Appropriate correction is required. 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 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. Claim 1 recites the limitation "the substitution" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “one or more substitutions” before reciting “the substitution”. Claim 1 should instead recite “the one or more substitutions”. Claims 2-5 are further rejected for their dependency on a rejected base claim. Claims 2 and 3 each recite “and/or”. It is unclear whether the scopes of claims 2 and 3 are intended to encompass all of the recited amino acid residues/mutations or whether they are instead intended to encompass each in the alternative. For example, it is unclear how an AAV vector can comprise both a Q589L and a Q589I mutation simultaneously. Further, it is unclear how “one” substitution can occur at positions 588, 589, and 594. Accordingly, the metes and bounds of claims 2-3 cannot be determined and a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought. 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. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: 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 of carrying out his invention. Claims 4-5 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 claims 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 4 recites “a first expression cassette comprising a regulatory element and a transgene operatively linked to a promoter and a second expression cassette comprising a tissue specific promoter operatively linked to a RNA silencing element that targets the regulatory element in the first expression cassette.” Claim 4 requires the RNA silencing element of the second cassette to have the functional property of “targets the regulatory element in the first expression cassette.” Claim 5 further specifies the regulatory element to be a WPRE. In addition, as broadly recited, claim 4 requires any element that could be considered to have the property of “silencing” RNA. The instant specification recites “silencing” three times. The all three recitations are in relation to “RNA silencing element”, however, none provide any further structure or definition which would allow the RNA element to have the “silencing” functional activity (Specification, [0005], [0049], claim 4). The exact same amount of description is given for the functional property of the RNA silencing element of “targets the regulatory element in the first expression cassette” (Specification, [0005], [0049], claim 4). There is no elaboration on these functional properties anywhere they are recited. The working examples provided in the instant disclosure describe the generation of engineered AAV capsids (Example 1) and the packaging of a GFP reporter vector into the engineered capsids (Example 2). Nowhere in either working example is there a description of expression cassettes, let alone a first and a second expression cassette where each comprises the elements claimed. The working examples are similarly lacking in any description of RNA silencing elements that target a regulatory element. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021). Further, A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). See MPEP 2163(II)(A)(3)(a)(ii). In the instant case, there isn’t a single example given for the expression cassettes claimed nor is there an example of the elements claimed to be within said expression cassettes and having the claimed functional properties. The closest description of an expression system matching the instantly claimed expression cassettes comes from Siu, Diss. The Ohio State University, 2018., hereinafter “Siu”, Of Record in the IDS filed: 06 March, 2023. Siu discloses an engineered AAV vector comprising two expression cassettes wherein the first comprises a cytomegalovirus enhancer plus chicken beta-actin promoter (CBA), a woodchuck posttranscriptional regulatory element (WPRE), a BDNF sequence and a polyA tail and the second cassette comprises an Agrp minimal promoter driving miR-Bdnf (Siu, page 84, second paragraph). Siu discloses that the miR-bdnf is a microRNA and that the Agrp minimal promoter is activated in the hypothalamus following weight loss and that the miR-bdnf is “against” bdnf (Siu, page 55, first partial paragraph). The miR of Sui is does not target the WPRE in the first cassette. In fact, only one publication has been found which teaches a miRNA targeting a WPRE (See US 2011/0288160, published 24 November, 2011, hereinafter “During”). During teaches a miRNA targeting WPRE as part of an autoregulatory cassette (During, Figure 14, [0123]). The miRNAs used by During were a miR-WPRE74 and a miR-WPRE155 (During, [0123]). Thus, RNA elements that have the functional property of silencing a regulatory element by targeting that regulatory element were not well known at the time of filing and only a few examples could be identified from a single publication. Because Applicant has given no written support in the specification or working examples for a structure associated with the functions of silencing and of targeting a regulatory element for the RNA element, let alone any examples of RNA elements at all, and because such a structure/function relationship can not be determined to be well known to skilled artisans at the time of filing, Applicant has not provided adequate written description of the invention claimed in instant claims 4-5. 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siu, Diss. The Ohio State University, 2018., hereinafter “Siu”, Of Record in the IDS filed: 06 March, 2023. Siu discloses an AAV vector comprising a Rec2 capsid (Siu, page 27, “Abstract”). Siu also discloses a mutated Rec2 capsid having mutations in the heparin binding domain (Siu, page 105, full paragraph). Siu also discloses that the mutated AAV is able to transduce a variety of cell types including neurons (Siu, page 105, full paragraph). Therefore, Siu anticipates the invention of instant claim 1. 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, 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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Siu, Diss. The Ohio State University, 2018., hereinafter “Siu”, Of Record in the IDS filed: 06 March, 2023 in view of US 2019/0085358, published 21 March, 2019, hereinafter “Ovid”, US 2017/0096683, published 06 April, 2017, hereinafter “Genzyme”, and US 2011/0288160, published 24 November, 2011, hereinafter “During”. Siu discloses an AAV vector comprising a Rec2 capsid (Siu, page 27, “Abstract”). Siu also discloses a mutated Rec2 capsid having mutations in the heparin binding domain (Siu, page 105, full paragraph). Siu also discloses that the mutated AAV is able to transduce a variety of cell types including neurons (Siu, page 105, full paragraph). Siu specifically teaches that three different amino acid residues in the heparin binding domain were mutated but Siu does not teach the actual residues (Siu, page 105, full paragraph). Siu also teaches that their mutant Rec2 AAV had enhanced transduction of brain tissue (Siu, page 105, full paragraph). Siu does not disclose the precise locations of the one or more substitutions being at residues 588, 589, and/or 594 of SEQ ID NO: 1. Ovid teaches a Rec2 AAV2 capsid having an amino acid sequence having 100% identity to instant SEQ ID NO: 1 (Ovid, FIG1A, [0004]). The 588th residue in the amino acid sequence of Ovid and instant SEQ ID NO: 1 is a glutamine (Q). Ovid also teaches that Rec2 AAV2 particles have specific tropism for the central nervous system (Ovid, Abstract). Genzyme claims an AAV2 vector with a substitution at position 588 which is in the heparin binding region (Genzyme, claim 1). Genzyme teaches mutating residues in the heparin binging region of AAV2 capsids to prevent binding to heparin (Genzyme, [0315]). Genzyme also teaches that their disclosed vectors can enhance gene therapy of disorders of the central nervous system (Genzyme, Abstract). Thus, a person having ordinary skill in the art would have known from the teachings of Ovid and Genzyme that mutating the 588th residue in a Rec2 AAV2 capsid would reduce heparin binding to produce enhanced gene therapy vectors for the central nervous system. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have mutated the 588th residue of the Rec2 AAV2 capsid of Siu according to the teachings of Ovid and Genzyme to arrive at the invention claimed in instant claim 2 with a reasonable expectation of success because they would have been motivated to do so to reduce heparin binding and to enhance the therapeutic effects of their vector for the central nervous system. They would have had a reasonable expectation of success in doing so considering the shared objectives of Siu, Ovid, and Genzyme in providing therapeutic AAV vectors that transduce nervous tissue and the demonstrated success of mutating position 588 to reduce heparin binding by AAV2-based vectors. Regarding claim 3, Ovid teaches that the amino acid at position 588 of Rec2 AAV2 (instant SEQ ID NO: 1) is a glutamine (Q) and Genzyme teaches to mutate the 588th residue of AAV2 capsids to proline (P) (Genzyme, [0156]). Regarding claims 4-5, Siu discloses that the AAV vector comprises two expression cassettes wherein the first comprises a cytomegalovirus enhancer plus chicken beta-actin promoter (CBA), a woodchuck posttranscriptional regulatory element (WPRE), a BDNF sequence and a polyA tail and the second cassette comprises an Agrp minimal promoter driving miR-Bdnf (Siu, page 84, second paragraph). Siu discloses that the miR-bdnf is a microRNA and that the Agrp minimal promoter is activated in the hypothalamus following weight loss and that the miR-bdnf is “against” bdnf (Siu, page 55, first partial paragraph). Therefore, Siu discloses the engineered AAV comprises a first expression cassette comprising a regulatory element (WPRE) and a transgene (BDNF) operably linked to a promoter (downstream of a CBA promoter), and a second cassette comprising a tissue specific promoter (Agrp minimal promoter) operatively linked to a RNA silencing element (driving expression of miR-Bdnf). Sui does not teach an RNA silencing element that targets the regulatory element in the first expression cassette. During teaches a miRNA targeting WPRE as part of an autoregulatory cassette (During, Figure 14, [0123]). The miRNAs used by During were a miR-WPRE74 and a miR-WPRE155 (During, [0123]). The invention of During is drawn to therapeutic delivery of BDNF just as delivery of BDNF was the goal in Siu (During, [0008]). During teaches that using the WPRE targeting miR inhibited BDNF expression by at least 90% (During, [0123]). It is noted that During and Siu share an inventor and an applicant in common. Thus, a person having ordinary skill in the art would have reasonably expected the miR targeting WPRE of During to have had the same or similar properties of autoregulating BDNF expression in the Rec2 AAV expression context of Siu. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have replaced the miR-Bdnf of Siu with the miR-WPRE of During and to have arrived at the invention claimed in instant claims 4-5 with a reasonable expectation of success because they would have known the miR-WPRE to be a suitable option for the autoregulation of BDNF in the dual cassette system of Siu and they would have reasonably expected the miR-WPRE to predictably have the same or similar properties in the cassette of Siu. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 6-13 of copending Application No. 16/497,326 in view of Siu, Diss. The Ohio State University, 2018., hereinafter “Siu”, Of Record in the IDS filed: 06 March, 2023 in view of US 2019/0085358, published , hereinafter “Ovid” and US 2017/0096683, published, hereinafter “Genzyme”. Copending claim 1 recites: An engineered adeno-associated virus (AAV) vector comprising two expression cassettes; wherein the first cassette comprises a regulatory element and a transgene operatively linked to a promoter; and wherein the second cassette comprises a liver specific promoter operatively linked to a RNA silencing element that targets the regulatory element in the first expression cassette; wherein the RNA silencing element is a microRNA. Pending claim 1 recites: An engineered adeno-associated virus (AAV) vector comprising recombinant 2 (Rec2) capsid comprising one or more substitutions in the heparin binding loci; wherein the substitution confers tropism for neural tissue to the vector. Pending claim 1 is both broader and narrower than copending claim 1. Pending claim 1 is broader in that it does not require expression cassettes and it is narrower in that it is drawn to a Rec2 AAV capsid. With regard to the expression cassettes required by copending claim 1, it is well established that a species of a claimed invention renders the genus obvious. In re Schaumann , 572 F.2d 312, 197 USPQ 5 (CCPA 1978). With regard to the Rec2 capsid, note that MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for ODP rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. The court in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). In the instant case, the supporting specification for the copending application teaches that the AAV capsids are Rec2 capsids (See copending Specification, Examples 1-4). Therefore, the invention instantly claimed is an obvious variant of the copending invention. With regard to the specific mutations claimed in the instant invention, Siu, Ovid, and Genzyme teach and provide motivation to modify the heparin binding domain of the Rec2 AAV as claimed (See above 103 rejection). This is a provisional nonstatutory double patenting rejection. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634 /MARIA MARVICH/Primary Examiner, Art Unit 1634
Read full office action

Prosecution Timeline

Mar 06, 2023
Application Filed
Apr 02, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
62%
Grant Probability
99%
With Interview (+70.5%)
3y 10m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 42 resolved cases by this examiner. Grant probability derived from career allowance rate.

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