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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/30/25 has been entered.
Maintained rejection
Rejection of claims 1-18 under 35USC 103 over Choe in view of Mesateru is maintained. Applicant’s remarks are addressed following the repeated text of the rejection of record.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al (Inflamm. Res, 2010, 59, 1019-1026; submitted by applicant on 12/12/24) in view of Mesateru (WO 2008015959; google translation.
Scope of prior art
Choe teaches that rebamipide may be an important therapeutic drug for vascular inflammation and other inflammatory diseases by inhibition of IL-8 production, which important in endothelial inflammation (page 1019 “conclusion”, page 1025, right column).
Ascertaining the difference
Choe does not recite treatment or prevention of arterial stiffness.
Choe does not recite the therapeutically active amount
Choe does not identify the subject population other than subjects in need of reduction of vascular inflammation.
Obviousness
Regarding subject population:
Choe suggests treating vascular inflammation by administration of rebamipide. Subjects with vascular inflammation are at risk for peripheral arterial disease and arterial stiffening. This is evidenced by Hayden et al (Journal of vascular diseases, 2025, 4(21) 1-44), In the abstract Hayden teaches that VAS is associated with endothelial cell activation and dysfunction that results in proinflammatory endothelium. In view of teaching, treatment of subjects for vascular inflammation is also treatment of subjects who are at risk for peripheral arterial disease and arterial stiffening.
Regarding arterial stiffness: treatment of vascular inflammation by administration of administration of rebamipide also prevents development of arterial stiffness and increases arterial elasticity.
Regarding effective amount: A skilled artisan would find it obvious to determine the optimal amount rebamipide to administer in order to achieve the goal of reducing vascular inflammation. Rebamipide is a known therapeutic agent and it would be obvious to administer an amount that is within the established safe therapeutic parameters.
Regarding specific route of administration, the claimed enteric oral composition is taught by Mesateru (WO 2008015959; google translation; cited in the previous office action). On page 6, Example 1 Maseteru teaches preparation of enteric capsule comprising rebamipide.
A person of ordinary skill in the art would have found obvious to try treating a subject in need of treatment for arterial inflammation by administering a pharmaceutically effective amount of rebamipide. As discussed above, treatment of a subject for arterial inflammation meets the limitation directed to prevention of arterial stiffness and administration to a person suffering or at risk of suffering from peripheral arterial disease. It would be obvious to treat arterial inflammation because Choe suggests it based on the evidence from prior literature (page 1025, Sjorgen sybdrome treated via anti-inflammatory activity of rebamipide) and on assays performed to elucidate the anti-inflammatory activity of rebamipide in endothelial inflammation. The data presented provide expectation of success because with regards to Sjogren syndrome it has already been shown that anti-inflammatory activity of rebamipide is responsible for its therapeutic effect. It is reasonable to expect the anti-inflammatory activity in endothelial cells demonstrated by Choe, will provide therapeutic efficacy in treatment of vascular inflammation.
Reply to Applicant’s remarks
Remarks filed on 10/30/25 have been fully considered and found to be not persuasive. Applicants argue that neither reference relied upon in the rejection of record suggests administration of rebamipide for treatment of arterial stiffness. Applicants also provide data that indicates efficacy of rebamipide in lowering indicators of arterial stiffness. Examiner agrees with the applicants regarding this point. However, the claims encompass prophylactic administration of rebamipide and for the reasons detailed in the rejection of record, the subject population in need of treatment for arterial inflammation represents subjects who are at risk of developing arterial stiffness. Administration of rebamipide to this subject population meets the limitation of the claims directed to prevention of arterial stiffness in a subject in need thereof.
The rejection of record focuses on treatment of arterial inflammation and thereby preventing arterial stiffness.
Rebamipide is also known in treatment of atherosclerosis. Subjects with atherosclerosis are also within the scope the currently claimed population. Same argument as applied for arterial inflammation can also be applied for treatment of atherosclerosis thereby preventing development of arterial stiffness.
Rebamipide at claimed doses has also been administered to subjects with chronic glomerular disease. The subjects to whom rebamipide was administered inherently benefited from prevention of arterial stiffness (see Nakagawa Yuko et al, cited in the IDS on 12/12/24).
Applicants can overcome the rejection of record by limiting the subject population to whom rebamipide is administered. This can be done by deleting the term “prevention”. The art cited in the rejection does not render obvious a method of treating arterial stiffness by administering rebamipide to a subject is experiencing arterial stiffness.
Conclusion
Claims 1-18 are pending
Claims 1-18 are rejected
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628