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 .
Election/Restrictions
1. Applicant’s election without traverse of Group I in the reply filed on July 29, 2026, is acknowledged.
2. Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 29, 2026.
3. Claims 1, 2, 4, 5, 7-12, 15, 17-22, 24 and 25 are under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claim(s) 1, 2, 4, 5, 7-12, 15, 17-22, 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soret et al., 2020, (reference 20), in view of Heuckeroth et al., 1998, (reference 11), Corfas, 2016, (reference 1), Soret et al., 2010, (reference 21), and Suply et al., 2012, (reference 22); all references of IDS filed on 12/18/2023.
Claims 1, 2, 4, 5, 7-12, 15, 17-22, 24 and 25 are directed to methods of treating enteric neuropathy by administering a combination therapy comprising Glial cell line derived Neurotrophic Factor (GDNF) and a short-chain fatty acid (SCFA). The Soret et al., 2020, publication teaches that GDNF induces enteric neurogenesis and improves colon structure in experimental mouse model of enteric neuropathy, specifically Hirschsprung Disease, see title, abstract and the whole paper. Further, Heuckeroth et al. disclose that GDNF promotes proliferation and survival of enteric neurons and glia, see title, abstract and the whole paper. Corfas published patent application establishes benefits of GDNF treatment for neuropathy in general, and further teaches combination therapy for neuropathy, GDNF and XIB4035, see abstract and the whole text. The three cited prior art documents do not describe treatment of enteric neuropathy by administration of combination of GDNF and SCFA.
Soret et al., 2010, describe beneficial effects of SCFA, specifically butyrate, on colonic mucosa homeostasis, colonic motility and neuronal excitability, see background and the whole paper. Suply et al. specifically teach that butyrate enemas increased distal colonic transit time and induced neuroplastic changes in myenteric and submucosal neurons so to improve gastrointestinal functions in general, see abstract and the whole paper.
It would have been obvious for one of ordinary skill in the art at the time of filing of the instant patent application to use a combination therapy for the treatment of enteric neuropathies, and specifically Hirschsprung disease, by administration of GDNF, as fully established by Soret et al., 2020 and combined knowledge in the art represented by Heuckeroth et al. and Corfas, and SCFA, as taught by Soret et al., 2010 and Suply et al.. Combining known therapeutic drugs is a common strategy in a modern medicine. The goal is often to simplify treatment regimens, address multiple symptoms or disease pathways or to achieve a cumulative effect.
One of ordinary skill in the art would have been motivated to combine GDNF and SCFA as a treatment for enteric neuropathy because at the time filing the prior art disclosed a number of identified, predictable solutions for treatment of the same pathology by administering GDNF and SCFA individually, thus, giving a person of ordinary skill in the art a good reason to pursue the known options within his or her technical grasp, use common sense and reasonably anticipate a successful outcome. This renders the instant invention obvious over the cited prior art of 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.
5. Claims 1, 2, 4, 5, 7-12, 15, 17-22, 24 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8, 10, 12, 15-18, 24 and 27-30 of copending Application No. 17/757,570 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘570 patent application encompass the same method of treating the same pathology by administration of the same factor—GDNF— and use the open language “comprising,” which reasonably includes a combination therapy, such as the invention of the instant pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
6. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
August 26, 2026
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