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
Applicant elected Group V, drawn to a method for reducing GI mucositis. Claims 20 and 26-30 are hereby examined on the merits. In response to species election requirement, Applicant elects ‘elsiglutide’ as the specific species of GLP-2 analog and elects ‘human’ as the specific species of mammal for examination. Claims 20 and 26-30 encompass the elected species.
Claims 1-19 and 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20th March 2026.
Claim status
The claim listing filed 03/20/2026 is pending. Claims 1-19 and 21-25 are withdrawn from consideration. Claims 26-30 are new. Claims 20 and 26-30 are drawn to an election requirement and under examination.
Priority
This application filed 07/18/2023 is a Continuation of PCT/US2022/013075, filed 01/20/2022
PCT/US2022/013075 and claims priority from provisional application 63139490, filed on 01/20/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 09-11-2023 complies with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 20, 26 and 27 are rejected under pre-AIA 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hannelouise Kissow et al., hereinafter Kissow (Hannelouise Kissow et al., Glucagon-like peptide-1 as a treatment for chemotherapy-induced mucositis, Gut 2012; 00: 1-10).
Regarding claim 20, Kissow teaches mice treated with NNC-GLP-2 (i.e., GLP-2 analog) from day -2 until sacrifice on day 2 (i.e. after chemotherapy), when intestinal injury is expected to be at its maximum. The 5-FU injection (i.e., chemotherapy) is given on day 0 at noon (see Study 2). Also see Study 1. In the experimental protocol for the mouse study, Kissow specifically teaches that in each experiment, one chemotherapy-injected group (chemo) and one saline-injected group (no chemo) are treated with a test solution and vehicle (i.e. after chemotherapy). The test solutions are extendin (9-39) and GLP-2 (3-33) (i.e. GLP-2 agonist).
Regarding claims 26 and 27, Kissow teaches the method of administering GLP-2 analog in mice (i.e., mammal; veterinary animal).
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.
Claim(s) 20 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ruben Giorgino et al., hereinafter Giorgino (Ruben Giorgino et al., US20160067311A1; published 2016-03-10; EFD 2015-09-01).
Giorgino teaches elsiglutide to protect against and prevent gastrointestinal organ-specific toxicities induced by chemotherapeutic agents. In particular, Giorgino teaches the use of elsiglutide to prevent and reduce the occurrence or severity of gastrointestinal mucositis (see Field of invention). Giorgino teaches administration of elsiglutide performed by any suitable route -subcutaneous, intravenous intraperitoneal and intramuscular [0051]. Notably, Giorgino teaches that elsiglutide and chemotherapeutic agents are administered concurrently; initiate elsiglutide administration before the administration of the chemotherapeutic agent beings; or administer elsiglutide after the administration of the chemotherapeutic agent concludes (i.e., during the days of the chemotherapy cycle when the chemotherapeutic agent is no longer administered) [0043]. In Examples I and II Giorgino teaches the initial clinical characterization of elsiglutide performed in healthy subjects and cancer patients; study TIDE-11-10 (phase II) are cancer patients receiving chemotherapy [0057]. Giorgino teaches that for the overall trial, i.e. Stage 1 and Stage 2, (69 patients in each treatment group), superiority of elsiglutide to placebo is concluded. More patients were responders, i.e. had no diarrhea, in the elsiglutide group (43 patients) than in the placebo group (39 patients) [0090] (see Fig 2 and TABLE-US-00004).
Although Giorgino teaches elsiglutide (i.e. a GLP-2 analog) for gastrointestinal mucositis and suggests administration of the elsigludtie after the administration of the chemotherapeutic agents concludes, the reference does not exemplify the instant embodiments.
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Regarding claims 20 and 26-28, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to, administer elsiglutide to a subject in need thereof after completion of chemotherapy and/or radiotherapy as specifically suggested in Giorgino as Giorgino teaches administration before, during, and after treatment to reduce gastrointestinal mucostisis (see [0041]-[0043]). One motivated to do so would have a reasonable expectation of success, as Giorgino teaches that Gastrointestinal (GI) damage and dysfunction are well-known side effects of cancer-chemotherapy treatments, and chemotherapy administration is frequently associated with mucositis, diarrhea (chemotherapy-induced diarrhea (CID), etc [0002]. Notably, Giorgino teaches that CID is absent in more people in the elsiglutide-treated group versus placebo [0090].
Thus, one would have recognized that applying the teaching of Giorgino, would have yielded predictable results and improved the clinical end-points of elsiglutide, as claimed (See MPEP § 2143 I(A)(D)).
Regarding claims 29 and 30, Giorgino specifically teaches the GLP-2 analog elsiglutide.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US7745403B2 is directed to a method of treating a patient having chemotherapy-induced diarrhea/mucositis (CID) comprising administering GLP-2 analogs.
US7563770 is directed to a method of treating or preventing a side effect of chemotherapy comprising administering an effective amount of GLP-2 analog.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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