Prosecution Insights
Last updated: October 01, 2026
Application No. 18/757,357

GENE THERAPY STRATEGY TO RESTORE ELECTRICAL AND CARDIAC FUNCTION, AND CARDIAC STRUCTURE, IN ARRHYTHMOGENIC RIGHT VENTRICULAR CARDIOMYOPATHY

Non-Final OA §102§103§112§DP
Filed
Jun 27, 2024
Priority
Sep 20, 2017 — provisional 62/560,989 +2 more
Examiner
SALVOZA, M FRANCO G
Art Unit
Tech Center
Assignee
The Regents of the University of California
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
10m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allowance Rate
427 granted / 624 resolved
+8.4% vs TC avg
Strong +30% interview lift
Without
With
+30.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
52 currently pending
Career history
661
Total Applications
across all art units

Statute-Specific Performance

§101
9.8%
-30.2% vs TC avg
§103
27.8%
-12.2% vs TC avg
§102
9.2%
-30.8% vs TC avg
§112
29.1%
-10.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 624 resolved cases

Office Action

§102 §103 §112 §DP
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 1. Claims 1, 27-40 are under consideration. Information Disclosure Statement 2. The information disclosure statement (IDS) was submitted on 1/8/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections 3. Claim 27 is objected to because of the following informalities: The claim appears to be missing a comma after “(JUP)”. Further, plakophilin 2 appears to be misspelled (See Joshi-Mukherjee et al. cited below.) 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. 4. Claims 1, 27-40 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. See claims 1, 27-40 as submitted 1/8/2025. As to claim 1, the claim recites a “structural-based cardiovascular disease or condition”. It is not clear what the metes and bounds of a “structural-based cardiovascular disease or condition” are. Claims 27-40 depend on this claim. Further as to claims 27, 28, the claims recite “the desmosome”. There is insufficient antecedent basis for this limitation in the claim. Further, claim 27 recites “optionally wherein the component is desmoplakin (DSP), plakoglobin (JUP) plakophillin 2 (PKP2) and desmoglein 2 (DSG2).” It is not clear if such a component comprises all such components or if they are intended to be recited in the alternative or not (“and/or desmoglein 2” or “or desmoglein 2”). 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. 5. Claims 1, 27-29, 31-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating arrhythmogenic right ventricular cardiomyopathy, right ventricular dysfunction, left ventricular dysfunction, fibro-fatty replacement of the myocardium, hypertrophic cardiomyopathy, or cardiac electrical and physiological dysfunction in arrhythmogenic disease, does not reasonably provide enablement for treating any structural-based cardiovascular disease or condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. See claims 1, 27-29, 31-40 as submitted 1/8/2025. See also the 35 U.S.C. 112(b) rejection above. In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantityof experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6)the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) thebreadth of the claims. Id. While it is not essential that every factor be examined in detail, thosefactors deemed most relevant should be considered. In the present case, the factors deemedrelevant are those of: the breadth of the claims; the (un)predictability of the art; the amount of direction and the working examples provided, and the quantity of experimentation necessary. Breadth of the claims: Claim 1 recites treating any “structural-based cardiovascular disease or condition” (see also the 35 U.S.C. 112(b) rejection above). Such a recitation reads on therapeutic effect as well as any “structural-based cardiovascular disease or condition”. State of the art: The art at the time of filing teaches many challenges with respect to using therapy to treat cardiovascular diseases. For example, Rincon et al. (“Gene therapy for cardiovascular disease: advances in vector development, targeting, and delivery for clinical translation,” Cardiovascular Research 108: 4-20 (2015))(See PTO-892: Notice of References Cited) teaches: initial clinical results yielded only modest or no improvement in clinical endpoints; the presence of neutralizing antibodies and cellular immune responses directed against the viral vector … the insufficient gene expression levels, and the limited gene transduction efficiencies accounted for the overall limited clinical improvements (abstract); disadvantages include superficial transgene expression, restricted area of vector delivery (table 2). The amount of direction and the working examples provided: The present specification only teaches 2 examples, wherein Example 1 teaches increased connexin 43 expression restored normal cardiomyocyte rhythm in an ARVC patient; as well as Example 2 in mice. However, in view of the breadth of the claims, the limited teachings in the art and the specification, the skilled artisan would be required to conduct undue amount of experimentation in order to use the instantly claimed method to treat any “structural-based cardiovascular disease or condition”. As discussed above undue experimentation would be required to practice the claimedinvention commensurate with the scope of the claims. Reasonable correlation must exist betweenthe scope of the claims and scope of enablement set forth. In view of the quantity ofexperimentation necessary, the limited working examples, the unpredictability of the art, the lackof sufficient guidance in specification, and the breadth of the claims, it would take undue trialsand errors to practice the claimed invention. 6. Claim 31 is 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 claim(s) 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. See claim 31 as submitted 1/8/2025. Claim 31 recites the method according to claim 1, wherein the connexin 43 polypeptide sequence comprises a 382 amino acid sequence of P17302 (CXA_1HUMAN; UniProtKB) (SEQ ID NO. 1), or a functional fragment thereof. Thus, the claim is drawn to a genus of fragments or functional fragments. The following quotation from section 2163 of the Manual of Patent ExaminationProcedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112written description requirement for a generic claim covering several distinct inventions: The written description requirement for a claimed genus may be satisfied throughsufficient description of a representative number of species by actual reduction topractice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics,i.e., structure or other physical and/or chemical properties, by functional characteristicscoupled with a known or disclosed correlation between function and structure, or by acombination of such identifying characteristics, sufficient to show the applicant was inpossession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A"representative number of species" means that the species which are adequately describedare representative of the entire genus. Thus, when there is substantial variation within thegenus, one must describe a sufficient variety of species to reflect the variation within thegenus. Thus, when a claim covers a genus of inventions, the specification must provide writtendescription support for the entire scope of the genus. Support for a genus is generally foundwhere the applicant has provided a number of examples sufficient so that one in the art wouldrecognize from the specification the scope of what is being claimed. The specification teaches: SEQ ID NOs: 3-6, 9, 12. However, it is known in the art that that protein structure determines protein function, and even minor changes can alter function. For example, Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982))(See PTO-892: Notice of References Cited) teaches: that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (p. 1979). Further, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References Cited) teaches: a single amino acid change may alter the immunological information of a peptide (title). Thus, while the specification as indicated above identifies specific fragments, in view of challenges known in the art and the breadth of the claims as indicated above, it does not identify a representative sample of functional fragments. Thus, the application does not identify a representative sample of functional fragments as claimed clearly within the breadth of the claimed genus. There is no apparent common conserved structure to the different functional fragments that distinguishes those that that are functional as compared to those that are not. There is therefore a high level of uncertainty as to which functional fragments fall within the scope of the indicated genus. Further, the specification has identified fragments only by function. The specification does not provide a specific structure of any functional fragment within the genus that correlates with the required function. Because there is no identification of structures common to each functional fragment, nor sufficient representative examples of the functional fragment by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of functional fragments through identification of a structure and function. While the fragments are required to be functional, this is not alone sufficient structure to correlate. This is because the mere presence of a fragment does not demonstrate that a fragment would be able to show function. For the reasons above, and in view of the uncertainty as to which fragments would be able to show function, the application has not provided sufficient written description support for the genus of fragments identified in claim 31. Claim Rejections - 35 USC § 102/103 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 (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. 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. 7. Claims 1, 30, 33, 35, 36, 38-40 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cohen et al. (US20110256112)(cited in applicant’s IDS submitted 1/28/2025). See claims 1, 30, 33, 35, 36, 38-40 as submitted 1/8/2025. See also the 35 U.S.C. 112(b) rejection above. Cohen et al. teaches: use of nucleic acid encoding gap junction protein (title); treating disorder associated with impaired atrioventricular conduction in a subject's heart (interpreted as reading on structural-based cardiovascular disease as recited in claim 1) [0012]; nucleic acid encoding connexin, including connexin 43 [0034](a recited in claim 1); use of vector [0035](as recited in claim 1); use of any promoter known in the art [0049](as recited in claim 1); improving function of the heart's electrical system [0010]; introducing into cells of AV node [0013]; injection into AV node or His bundle [0013] (interpreted as teaching or suggesting promoter active in cardiac tissue); preventing or alleviating arrhythmias caused by AV block [0031](interpreted as reading upon cardiac electrical and physiological dysfunction in arrhythmogenic disease as recited in claim 30); administering vector [0016](as recited in claim 1); viral vector [0027](as recited in claim 33); AAV [0027](as recited in claim 6); systemic administration [0075](as recited in claim 35); mammal (abstract)(as recited in claim 36); human [0049](as recited in claim 36). As to claims 1, 38-40, the recitations following the "wherein" clause are considered to flow from the composition and step as recited in claim 1 (See also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin V. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"); In Hoffer V. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "whereby' clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton V. Nat'l Ass'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In view of the foregoing, all the claimed limitations are found in one reference and are taught to be variations to a method they exemplify. As such, the claimed method is within the scope of Cohen et al., and thus Cohen et al. renders the method prima facie obvious. The rationale to support this conclusion of obviousness is that Cohen et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art. Thus, Cohen et al. anticipates or renders obvious the 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, 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. 8. Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. as applied to claims 1, 30, 33, 35, 36, 38-40 above. See claim 37 as submitted 1/8/2025. See teachings of Cohen et al. above. As to claim 37, such parameters are considered to be those determined by routine optimization according to one of ordinary skill in the art in view of the teachings or suggestions of Cohen et al. absent unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical."[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 9. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. as applied to claims 1, 30, 33, 35, 36, 38-40 above, and further in view of Becker et al. (WO2006134494)(cited in applicant’s IDS submitted 1/28/2025). See claim 3 as submitted 1/8/2025. See the teachings of Cohen et al. above. Cohen et al. does not teach SEQ ID NO: 1. Becker et al. teaches: 382 amino acids of SEQ ID NO: 63, which has 100% identity with instant SEQ ID NO: 1 (See Duplicate 10 of Result 1 of STIC Sequence Search Result 2026-0807_193036_us-18-757-357-1.rag in Supplemental Content Tab); for use in treatment of cardiovascular indications (abstract). One of ordinary skill in the art would have been motivated to use connexin 43 as taught by Becker et al. with method as taught by Cohen et al. Cohen et al. teaches using connexin 43, and Becker et al., which also teaches using connexin 43, teaches such connexin 43 (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for using connexin 43 as taught by Becker et al. with method as taught by Cohen et al. There would have been a reasonable expectation of success given the underlying materials (connexin 43 as taught by Cohen et al and Becker et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 10. Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. in view of Becker et al. as applied to claim 31 above, and further in view of Stokes et al. (WO9802150-A1)(cited in applicant’s IDS submitted 1/28/2025). See claim 32 as submitted 1/8/2025. See the teachings of Cohen et al. in view of Becker et al. above. Cohen et al. does not teach SEQ ID NO: 2. Stokes et al. teaches: connexin 43; Accession number AAV04682, which comprises sequence with 100% identity to SEQ ID NO: 2 (See Result 1 of STIC Sequence Search Result 20260807_193111_us-18-757-357-2.rng in Supplemental Content Tab). SEQ ID NO: 2 is considered to be taught or suggested in view of Cohen et al. in view of Becker et al. and further in view of Stokes et al., as Becker et al., Cohen et al. and Stokes et al. all teach connexin 43 and nucleic acid encoding it and amino acid sequence thereof (See MPEP 2144.06: Substituting equivalents known for the same purpose). Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 11. Claims 33, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. as applied to claims 1, 30, 33, 35, 36, 38-40 above, and further in view of Boink et al. (US20110077702)(cited in applicant’s IDS submitted 1/28/2025). See claims 33, 34 as submitted 1/8/2025. See the teachings of Cohen et al. above. Cohen et al. does not teach; AAV; troponin-T promoter. Boink et al. teaches: use of viral vector [0022]; AAV-9 [0022]; use of troponin T promoter [0106]; treating cardiovascular disorder [0065]. One of ordinary skill in the art would have been motivated to use components as taught by Boink et al. with method as taught by Cohen et al. Cohen et al. teaches use of viral vector and treating cardiovascular disorder, and Boink et al., which also teaches viral vectors and treating cardiovascular disorder, teaches components known and used as and with viral vectors (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for using components as taught by Boink et al. with method as taught by Cohen et al. There would have been a reasonable expectation of success given the underlying materials (vectors as taught by Cohen et al. and Boink et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 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. 12. Claims 1, 30-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12186369. See claims 1, 30-40 as submitted 1/8/2025. Claims 1-12 of U.S. Patent No. 12186369 recite a method for treating arrhythmogenic right ventricular cardiomyopathy (ARVC) in a subject in need thereof, comprising systemically administering to the subject an adeno-associated virus (AAV) vector encoding a connexin 43 polypeptide sequence operably linked to a promoter that is active in cardiac muscle tissue such that connexin 43 polypeptide levels in at least a portion of the heart of the subject are increased; wherein the connexin 43 polypeptide sequence comprises a 382 amino acid sequence of SEQ ID NO: 1, or a functional fragment thereof; wherein the sequence encoding the connexin 43 polypeptide is SEQ ID NO: 2; wherein the AAV vector is from the group of an AAV1, AAV2 or an AAV9 serotype; wherein the promoter is a cardiac-specific promoter; wherein the promoter is a troponin-T promoter; wherein the subject is a mammal; wherein the subject is a human; wherein the effective amount is from about 2×10.sup.11 to about 2×10.sup.14 viral genomes of the AAV vector per kg of body weight of the subject; wherein as a result of the administration, cardiac electrical dysfunction is reduced; wherein as a result of the administration, cardiac physiologic dysfunction is reduced; wherein as a result of the administration, cardiac structural integrity is improved. Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 30-40 and claims 1-12 of U.S. Patent No. 12186369 recite a method for treating a structural-based cardiovascular disease or condition in a subject in need thereof, comprising administering to the subject a vector encoding a connexin 43 polypeptide sequence operably linked to a promoter that is active in cardiac muscle tissue, wherein, as a result of the administration of an effective amount of the vector, connexin 43 levels in at least a portion of the heart of the subject are increased. The patented subgenus claims anticipate the instant genus claims and a patent to the instant genus claims would, necessarily, extend the rights of the already patented sub-genus claims should the instant genus claims issue as a patent. Conclusion 13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. A. Joshi-Mukherjee et al. (“Characterization of the molecular phenotype of two ARVC-related PKP2 mutations,” Heart Rhythm, 5(12): 1715-1723 (2008))(See PTO-892: Notice of References Cited) teaches: wherein ARVC has been linked to mutations in desmosomal proteins, including plakophilin 2 (abstract). 14. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 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, Thomas Visone can be reached at 571-270-0684. 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. /M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
Read full office action

Prosecution Timeline

Jun 27, 2024
Application Filed
Aug 12, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
68%
Grant Probability
98%
With Interview (+30.0%)
3y 1m (~10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 624 resolved cases by this examiner. Grant probability derived from career allowance rate.

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