DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Response to Amendments
Applicant's reply filed 11/24/2025 has been entered. The claims were not amended. Claims 1-16 remain pending, and are considered on their merits. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Affidavit/Declaration
The Declaration under 37 CFR 1.132 filed 11/12/2025 is sufficient to overcome the rejection of claims 1-16 based upon Chen. The Declaration persuasively sets forth that the claimed composition comprising normal human dermal fibroblasts (NHDFs) appears to have an unexpected effect of preventing tumor formation when administered to subjects as compared to J2 mouse fibroblasts based upon the instant disclosure.
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, 7, and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-23 of U.S. Patent No. US 11,338,065 (provided in the IDS dated 8/02/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because dependent claim 22 of the ‘065 patent is directed towards an ex vivo engineered tissue seed composition comprising patterned endothelial cell cords patterned embedded in a biocompatible hydrogel scaffold, hepatocyte aggregates not in direct contact with the endothelial cell cords, and human fibroblasts. There is no evidence at this time that the product-by-process limitations of instant claim 1 (b) otherwise impart any structural difference to the claimed composition as compared to the composition of the ‘065 patent, and so claim 22 of the ‘065 patent reasonably anticipates instant claim 1 absent any persuasive showing to the contrary (See M.P.E.P. § 2113).
Claim 18 of the ‘065 patent reads on instant claim 5. Claim 20 of the ‘065 patent reads on instant claim 7. Claim 23 of the ‘065 patent reads on instant claim 14. Claim 21 of the ‘065 patent reads on instant claim 15. Claim 19 of the ‘065 patent reads on instant claim 16.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. U.S. Patent No. US 11,338,065 (provided in the IDS dated 8/02/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘065 patent is an ex vivo engineered tissue seed composition comprising patterned endothelial cell cords patterned embedded in a biocompatible hydrogel scaffold, hepatocyte aggregates not in direct contact with the endothelial cell cords, and human fibroblasts, and so anticipates instant claim 1.
In the same order as presented, claims 2-16 of the ‘065 patent read on instant claims 2-16.
Response to Arguments
Applicant’s arguments on pages have been fully considered, but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653