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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/21/2025 has been entered.
Claims 23-42 have been amended. No claims have been newly added or newly canceled.
Claims 23-42 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Drawings
The petition for color drawings filed 09/09/2025 has been granted as per the decision in papers filed 11/18/2025.
Claim Objections
Claims 23, 30, and 37 are objected to because of the following informalities:
The phrase “wherein the viable cultured gingival fibroblasts are cultured by a process comprising the steps of:” in lines 8-9 of independent claims 23, 31, and 39 is not the best form for a product by process claim. It would be more appropriate for the phrase to state “wherein the viable cultured gingival fibroblasts are produced cultured by a process comprising the steps of:”.
The phrase “wherein by completion of the fifth passage the gingival fibroblast cells correspond to cell phenotypes cultivated so that at least about” in lines 18-19 of independent claims 23, 30 and 37 is not the best form for a product by process claim. It would be more appropriate for the phrase to state “wherein by completion of the fifth passage the gingival fibroblast cells correspond to the viable cultured gingival fibroblast cells having phenotypes such that cell phenotypes cultivated so that”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 23-42 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 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.
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.
Applicants have entered the limitation “monotonically increases” in claims 23, 30 and 37. There is insufficient support in the disclosure as originally filed for this limitation; thus it is being considered new matter. The disclosure as originally filed does not describe a monotonic increase.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
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 23-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-15 and 23-31 of copending Application No. 19/037,555 (now allowed as of 01/13/2026 and renumbered claims 1-18) in view of LaFont et al (US 2020/0268805).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are drawn to gingival fibroblast cell compositions and methods with the same CD and mRNA expression and method steps except they include human gingival fibroblast cells instead of equine. LaFont teach wherein gingival fibroblasts for cosmetic or pharmaceutical use can be human or equine (page 5 para 76-79).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use equine gingival fibroblasts in the composition of the copending application because LaFont suggest that these products from gingival fibroblasts are both suitable for cosmetic and pharmaceutical use.
This is a provisional nonstatutory double patenting rejection.
Claims 23-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-36 and 38-45 of copending Application No. 19/181,809 in view of LaFont et al (US 2020/0268805).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are drawn to gingival fibroblast cell compositions and methods with the same CD and mRNA expression and method steps except they include domestic animals such as canine instead of equine.
LaFont teach wherein gingival fibroblasts for pharmaceutical use can be equine or canine (page 1 para 25).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use equine gingival fibroblasts in the composition of the copending application because LaFont suggest that these products from gingival fibroblasts are both suitable for pharmaceutical use.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not fully persuasive.
Applicant’s arguments with regard to the claim objections and rejections of claims 23-42 under 35 USC 101, 35 USC 103, obviousness-type double patenting over patents US 12,258,579 and US 12,351,823 are found persuasive due to the amendments of the claims.
Applicant’s arguments regarding the provisional obviousness-type double patenting rejections over US Applications 19/037555 and 19/181809 have not been found persuasive.
Applicant argues that because of the amendments and the restriction in the parent application that the obviousness-type double patenting rejections are no longer appropriate.
This is not found persuasive as the same amendments have been made in the US Applications 19/037555 and 19/181809. Also, the restriction in the parent application only precludes double patenting rejections over the parent patent and those cases filed as divisionals of the parent patent and this does not apply to US Applications 19/037555 and 19/182163.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631