CLAIMS 44-67 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s response/amendment filed August 22, 2025 has been received and entered into the application.
Claim Rejection - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 68-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chai et al., (WO 2009/065169; already of record, see Applicant’s IDS dated 10/26/23).
Chai teaches formulations comprising an inhibitor of IRAP activity, (pg. 24, line 24 – pg. 25, line 4) which may have a physiologically acceptable excipient present, (e.g., pg. 7, lines 24-26), and which may be presented in the various dosage form types as in present claims 69-70, (pg. 30, line 30 – pg. 31, line 15).
The functional, i.e., intended use, language “for treating kidney fibrosis” in claim 67 does not impart a patentable distinction to the formulation of claim 67 because it does not serve to define a physical characteristic present in the claim 67 formulation not present in the formulation of Chai. Also, it is noted that 71-74 recite physiological activities of the active agent which are inherent to the active agent. Being necessarily present, such activities would also be in the formulations of Chai, whether recited therein or not, because the same active agent, i.e., an inhibitor of IRAP, is present.
Double Patenting
Non-Statutory
Claims 44-68 and 71-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over (a) claims 1-23 of U.S. Patent No. 11,834,663 or (b) claims 1-20 of U.S. Patent No. 10,787,668 or (c) claims 1-23 of U.S. Patent No. 10,100,311, (each cited by Applicant), each of record, for the reasons of record set forth in the previous Office action dated November 07, 2024, as applied to claims 44-67, which reasons are here incorporated by reference.
Newly added claims 68 and 71-74 are properly rejected. Claim 68 corresponds to previously presented claim 67. The functional language “for treating kidney fibrosis” in claim 67 does not impart a patentable distinction to the formulation of claim 67 because it does not serve to define a physical characteristic present in the claim 67 formulation not present in the claim 68 formulation.
Newly added claims 71-74 recite physiological activities of the active agent which are inherent to the active agent. Being necessarily present, such activities would also be in the formulation of claim 68, whether recited therein or not, because the same active agent, i.e., an inhibitor of IRAP, is present.
Applicant’s arguments have been carefully considered, but fail to persuade the Examiner of error in his determination of nonstatutory double patenting. In particular, Applicant has argued that claim 67, directed not to a method but to a formulation, was not addressed in the Examiner’s rejection.
In response, it is noted that the formulation claim was not specifically addressed by the Examiner. However, insofar as the claimed formulation is employed in the methods which were addressed by the Examiner, it is clear that one of ordinary skill in the art would have necessarily appreciated that the references also teach the formulation invention of present claim 67. As such, claim 67 was correctly included in the claim grouping subject to rejection, even if not expressly identified in the body of the Examiner’s rejection.
Accordingly, for the above reasons, the claims are deemed to remain properly rejected and none are currently in condition for allowance.
Applicant's amendment necessitated the new grounds 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 RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached on M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 November 24, 2025