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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-19 and 23-27, in the reply filed on 12/17/2025 is acknowledged. The traversal is on the ground(s) that searching and examining both groups of inventions could be made “without serious burden”. This is not found persuasive because the scope difference between the product and the method of use such that the product as claimed can be used in a materially different process of use such as pericardial repair in cardiac surgical applications, opposed to topical wound treatment methods. Moreover, searching both inventions would span multiple classes and subclasses. Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/17/2025.
Accordingly, claims 1-19, and 23-27 are pending and under current examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/17/25 and 9/8/25 have been considered by the examiner.
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 1-19 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 7, and 9-14 of U.S. Patent No. 12144831. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a product which is a sterile human placental allograft comprising amnion, intermediate spongy, and chorion layers as well as at least two agents which may be interleukin-1 receptor antagonist and where claimed an additional functional agents in combination in the allograft. The issued claims are also in parallel drawn to configuration for dental, cosmetic, and/or wound healing applications; sized and shaped and planer, in kind; and may further comprise VEGFR1 and additional functional agents in amounts the same and/or overlapping those instantly claimed. All instantly claimed limitations are recited in form and/or some combination in the issued product claims with the wash, sterilization, beam irradiation, and repetition steps of instant claims 23-27 being defined in the specification as filed as the same process of making the product of the issued claims.
Claims 1-19 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-18, and 20-25 of U.S. Patent No. 12285445. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a product which is a sterile human placental allograft comprising amnion, intermediate spongy, and chorion layers as well as at least two agents which may be interleukin-1 receptor antagonist and where claimed an additional functional agents in combination in the allograft. The issued claims are also in parallel drawn to configuration for dental, cosmetic, and/or wound healing applications; sized and shaped and planer, in kind; and may further comprise VEGFR1 and additional functional agents in amounts the same and/or overlapping those instantly claimed. All instantly claimed limitations are recited in form and/or some combination in the issued product claims with the wash, sterilization, beam irradiation, and repetition steps of instant claims 23-27 being defined in the specification as filed as the same process of making the product of the issued claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19, and 23-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a product of nature which is a composition of matter that is an allograft which is intact in a cross-section and comprising a human amnion layer, a human chorion layer, and an intact human intermediate spongy layer positioned therebetween as further specified in the claims. Specifically, this combination of elements including amnion, chorion, and intermediate spongy layer and including an IL-1 receptor antagonist is naturally occurring and does not appear to be markedly different from its naturally occurring counterpart prior to removal from a naturally occurring placental environment because the structure and functional components of claim 1 in combination are present in nature. This judicial exception is not integrated into a practical application because the claims recite no additional elements which would structurally or functionally differentiate the claimed combination elements from their layered combination in a naturally occurring placental environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is recited in claim 1 no additional element differentiating the claimed combination from a section of amnion, chorion, intact intermediate spongy layer, and naturally occurring interleukin-1 receptor antagonist in a naturally occurring placental environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617