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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-6, 8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herzog et al (US 11,883,506, efd 8/7/2020) as evidenced by Chamberlain et al (Curr. Opin. Cardiol., 2017) in view of Holzmeister et al (WO 2021/038291,3/4/2021, cited by applicants) as evidenced by Rickelt (Cell Tissue Res., 2012). This rejection is maintained for reasons made of record in the Office Action dated 8/27/2025 and for reasons set forth below.
The claims have been amended to recite that the gene therapy vector, when delivered to cardiomyocytes, upregulates “…one or more desmosomal proteins selected from…” several specific desmosomal proteins. Herzog et al teaches that PKP2 localizes to desmosomes and nuclei, binds to desmoplakins and plakoglobin facilitating cell-to-cell contact, and controls transcription processes (col 8, lines 7-14). Rickelt teaches that PKP2 is a regulatory component in cytoplasmic junctions, such as desmosomes, and regulates the normal distribution of desmoplakin in cardiomyocyte junctions (abstract, Discussion ¶ linking first and second cols, p. 289). Thus it appears that to “upregulate” desmoplakins or plakoglobins is a natural feature, or inherent property, of PKP2 by increasing the ability of such to form cellular junctions. According to MPEP § 2112.01, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Further, the “upregulate” limitations are intended results limitations and are not required, positive method steps of the claimed methods. Such limitations are given little patentable weight as they describe a result of a process, not a method step. See MPEP 2111.04:
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))
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) Herzog et al do not teach the amended claims; 2) the intended result limitation of “…delivery of the gene therapy vector…results in…” should be considered as specifying what the claimed method achieves.
Regarding 1), the explanation of the amended limitations as taught by the cited art is found above.
Regarding 2), such is not convincing for reasons of record. The disputed phrase clearly requires a “…results in…” feature. How this further limits the claim is unexplained by applicants. It does not recite an active method step performed by the skilled artisan, i.e. the skilled artisan cannot themselves increase PKP2 expression is desmosomes; and, the limitation does not add any further structure to the claimed gene therapy vector. Thus, the claims are properly interpreted as reciting an intended result, the limitations of which have been addressed in the record.
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, 3-6, 8, 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 24-28, 30 of copending Application No. 19/023,648 in view of Chamberlain et al (Curr. Opin. Cardiol., 2017) and Holzmeister et al (WO 2021/038291,3/4/2021, cited by applicants).
Claims 1, 3-6, 8, 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 11-15 of copending Application No. 17/761,677 in view of Chamberlain et al (Curr. Opin. Cardiol., 2017) and Holzmeister et al (WO 2021/038291,3/4/2021, cited by applicants).
These rejections are maintained for reasons made of record in the Office Actions dated 4/10/2024, 2/21/2025, 8/27/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive. Applicants ask that these rejections be held in abeyance. Hence, the rejections stand.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638