DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/4/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 3/4/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-6 and 8-15 are pending and have been examined on the merits.
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 1-6 and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 of U.S. Patent No. 11,717,596.
Although the claims at issue are not identical, they are not patentably distinct from each other because whereas the instant claims are drawn to a composition comprising amounts of (i) fibroblast-derived chondrocyte-like cells and (ii) PEO, PVA, PAA, and/or P(PF-co-EG) hydrogel scaffolding (claims 1-14) or alginate beads (claim 15), the reference claims are drawn to providing or using the same, for example 11,717,596 recites a “composition comprising chondrocyte-like cells derived from fibroblasts” (‘596 at claim 1). Additionally, ‘596 (at claims 1-5) is not distinguished from similarly phrased instant claims 2-6 respectively, specifically drawn to wherein said chondrocyte-like cells produce Sox-9 protein and one or more of aggrecan, type II collagen, cartilage link protein, perlecan, and sulfated proteoglycan (‘596 at claim 1 vs. instant claim 2), sourced from dermal fibroblasts, tendon fibroblasts, synovial fibroblasts, or ligament fibroblasts (‘596 claim 2; instant claim 3), autologous or allogeneic (‘596 claim 3; instant claim 4), (‘596 claim 2; instant claim 3). Additionally, ‘596 recites wherein the fibroblasts are autologous or allogeneic (at claim 3; instant claim 4), autologous human dermal fibroblasts (HDFs) or neonatal HDFs (at claim 4; instant claim 5), and a kit comprising thereof (at claim 5; instant claim 6). Whereby ‘596 and the instant claims may not be identical, they are not patentably distinguished, because each of the reference ‘596 and instant claims are broad generics and include under the broad “comprising” phrasing the additional elements, as the shared disclosures evidence that such arrangement of the materials are and may be incorporated therewith in the composition, and the claims as drafted remain inclusive of (do not preclude) the other patent as claimed. Accordingly practicing at least one of the instant or conflicting reference ‘596 patent’s claims would have likely at least rendered obvious the other invention as claimed.
Claims 1-6 and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 of U.S. Patent No. 9,565,432.
Although the claims at issue are not identical, they are not patentably distinct from each other because whereas the instant claims are drawn to a composition comprising amounts of (i) fibroblast-derived chondrocyte-like cells and (ii) PEO, PVA, PAA, and/or P(PF-co-EG) hydrogel scaffolding (claims 1-14) or alginate beads (claim 15), the reference claims are drawn to providing or using the same, for example 9,565,432 recites in a method a composition comprising chondrocyte-like cells derived from fibroblasts (‘432 at claims 1,3). Additionally, ‘423 recites providing a scaffold (at claim 3; instant claim 1 for example), and which are human dermal fibroblasts (HDFs) (at claims 1,3; instant claim 5). Whereby the ‘432 reference patent and the instant claims may not be identical (with respect to the dependent claims and additional features in the independent claims, method vs. composition), they are not patentably distinguished, because each of the reference patent and instant claims are broad generics, and each include under the broad “comprising” phrasing the additional elements, as the shared disclosures evidence that such arrangement of the materials are, and may be incorporated therewith, in the compositions and used in the methods as claimed and mutually disclosed - and thus the claims as drafted remain inclusive of (do not preclude) the other patent as claimed. Accordingly practicing at least one of the instant or conflicting reference ‘432 patent’s claims would have likely at least rendered obvious the other invention as claimed.
Claims 1-6 and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of U.S. Patent No. 9,138,460.
Although the claims at issue are not identical, they are not patentably distinct from each other because whereas the instant claims are drawn to a composition comprising amounts of (i) fibroblast-derived chondrocyte-like cells and (ii) PEO, PVA, PAA, and/or P(PF-co-EG) hydrogel scaffolding (claims 1-14) or alginate beads (claim 15), the reference claims are drawn to providing or using the same (and the specifications further support that the claims support a breadth inclusive of the specifically claimed materials under the broad, generic claims), for example 9,138,460 recites in a method a composition comprising chondrocyte-like cells derived from fibroblasts (‘460 at claims 1+,18+). Additionally, ‘460 recites that the cells may be in a 3D matrix construct, optionally comprising PEO, PVA, PAA, and/or P(PF-co-EG) hydrogel scaffolding (‘460 e.g. at claim 4,5,9; see instant claims e.g. at clm. 1, 8, 9), and may comprise collagen, hyaluronic acid, alginate, agarose, chitosan, fibrin, gelatin, or a copolymer thereof (‘460 claim 8; see instant claim 13) and is not distinguished from similarly phrased instant claims. Whereby the ‘460 reference patent and the instant claims may not be identical (with respect to the dependent claims and additional features in the independent claims, method vs. composition), they are not patentably distinguished, because each of the reference ‘460 and instant claims are broad generics and include under the broad “comprising” phrasing the additional elements, as the shared disclosures evidence that such arrangement of the materials are and may be incorporated therewith in the composition, and the claims as drafted remain inclusive of (do not preclude) the other patent as claimed. Accordingly practicing at least one of the instant or conflicting reference ‘460 patent’s claims would have likely at least rendered obvious the other invention as claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655