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's election with traverse of:
(i-c) prevention and treatment of celiac disease;
(ii-a) a person suffering from increased intestinal permeability;
(ii-a-1) suffering from low grade inflammation of the gut wall, claim 6;
(iv) tablet from claims 12, 17 & suppositories from claims 12, 17,
Claims 1, 2, 6, 12 and 15-19 reading on the elected species, in the reply filed on 8/18/2025 is acknowledged. Examiner notes that (i-c), elected, is no longer a species within amended claim 1. Examination is shifted to alternate specie (i-b) treatment of celiac disease, from claim 1.
Claims 3, 5, 7-11, 13-14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/18/2025.
Claims 4, 16-19 have been canceled
Response to Arguments
Applicants' arguments, filed 12/9/2025, have been fully considered and are persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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) 1-2, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fatheree et al. (US 2018/0311255 A1; 2018); in view of Adams (“Intestinal Permeability in Patients with Celiac Disease on a Gluten-free Diet”; 2005; Dig Dis Sci. 2005 Apr;50(4):785-90; https://www.celiac.com/celiac-disease/intestinal-permeability-in-patients-with-celiac-disease-on-a-gluten-free-diet-r895/); and Diao et al. (“Rebamipide suppressed diclofenac-induced intestinal permeability via mitochondrial protection in mice”; 2012; World J. Gastroenterol.; 14; 18(10): 1059-1066; doi:10.3748/wjg.v18.i10.105)
This rejection is necessitated by the claim amendment.
Fatheree teaches a JAK kinase inhibitor compound useful for the treatment of multiple diseases [0002]. These include Gastrointestinal Diseases [0164]; which specifically includes celiac disease [0164]. In a combination the JAK kinase inhibitor compound may be combined with agents, that include rebamipide [0171], rendering obvious treatment of celiac disease with a combination that includes rebamipide.
Regarding the person suffering from increased intestinal permeability the Adams article describes intestinal permeability in patients with celiac disease on a gluten-free diet. Three groups were tested, Patients newly diagnosed less than 1 month, patients taking the gluten free diet after diagnosis 1 month to 1 year, and the third group, with celiac, on gluten free diet for more than one year. The first two groups had elevated intestinal permeability, or individuals with diets contaminated with gluten. Researchers concluded that intestinal permeability normalizes in most people with celiac disease on a gluten-free diet. Adams establishes that newly diagnoses with celiac disease, and those on a gluten-free diet less than 1 year tend to have increased intestinal permeability. For these two subpopulations, it would have been obvious to extend the treatment of celiac, with, inter alia, rebamipide, taught by Fatheree, to individuals suffering from increased intestinal permeability, including to a person adhering to gluten-free diet taught by Adams, giving the methods of claims 1 & 2.
Regarding claim 6, the examiner construes the Adams group suffering from increased intestinal permeability to also experience low grade inflammation of the gut wall, absent evidence to the contrary.
Examiner further notes the teachings of Diao et al., which teaches rebamipide suppresses diclofenac-induced intestinal permeability via mitochondrial protecton in mice. Diao supports an expectation that administration of rebamipide to a patient suffering from increased intestinal permeability is likely to experience mitigation of the intestinal permeability by repamipide, in a similar manner to the Diao mice subject to NSAIDs (such as diclofenac).
Claim(s) 12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fatheree et al. (US 2018/0311255 A1; 2018); in view of Adams (“Intestinal Permeability in Patients with Celiac Disease on a Gluten-free Diet”; 2005; Dig Dis Sci. 2005 Apr;50(4):785-90; https://www.celiac.com/celiac-disease/intestinal-permeability-in-patients-with-celiac-disease-on-a-gluten-free-diet-r895/); and Diao et al. (“Rebamipide suppressed diclofenac-induced intestinal permeability via mitochondrial protection in mice”; 2012; World J. Gastroenterol.; 14; 18(10): 1059-1066; doi:10.3748/wjg.v18.i10.105), as applied to claims 1-2, 6 above, and further in view of MedixLife (“Rebamipid (Tablets) Instructions for Use”; 2015; www.medixlife.com/rebamipid-instructions).
This rejection is necessitated by the claim amendment
The rejection of, inter alia, claim 1, is set forth above. Regarding claims 12, 15, the teachings of Fatheree, Adams and Diao do not teach Applicant elected tablet form of rebamipide, required by claim 12, nor the daily doses recited in claim 15. MedixLife teaches a series of tablet forms, which include 100 mg tablets, which render obvious administration of repamipide via tablet formulation. The standard adult dosage is 100 mg three times daily, rendering obvious a dose of 300 mg per day, reading on the range of claim 15 when repamipide is administered to treat celiac and mitigate increased intestinal permeability.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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