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 .
DETAILED ACTION
Preliminary amendment filed on 08/30/2023 is acknowledged. Claim 3 was amended, claims 4-8 were cancelled and claim 11 was newly added. Claims 1-3 and 9-11 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/CA2022/050297, filed on 03/03/2022 and claims benefit of 63/156,537 filed on 03/04/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 05/31/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS document has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 103
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.
Claims 1-3 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Depaoli et al. (WO 2020/214753 A1, published 10/22/2020, see IDS dated 05/31/2024).
Depaoli is drawn to a method of modulating bile or treating a bile acid-related or associated disorder, comprising administering a chimeric peptide sequence and administering at least one additional agent effective in modulating bile acid homeostasis or treating a bile acid-related or associated disorder (claim 1). Depaoli teaches that the bile acid related or associated disorders include inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis (claim 60). The at least one additional agent may be empagliflozin (claim 97). Depaoli teaches that the additional agent(s) are present in a therapeutically acceptable amount (paragraph 00319).
Regarding instant claims 3 and 11, Depaoli teaches the method may delay, slow or inhibit progression of a bile acid-related or associated disorder in a subject and the subject may be human (paragraphs 00184-00185).
Regarding instant claims 9 and 10, Depaoli teaches kits that include peptide sequences and one or more additional agents for the treatment of a bile acid-related disease, disorder or condition, or a composition comprising the foregoing, and one or more pharmaceutically acceptable or physiologically acceptable diluents, carriers or excipients, packaged into suitable packaging material. Exemplary instructions include instructions for treatment and/or prevention of a bile acid related or associated disorder, such as Crohn’s disease and ulcerative colitis (paragraph 00360). The kit may additionally include other components such as a container (paragraph 00366).
Depaoli does not exemplify the treatment of Crohn’s disease or ulcerative colitis by administering a therapeutically effective amount of empagliflozin. Depaoli does not exemplify a kit comprising empagliflozin.
It would have been prima facie obvious before the effective filing date of the claimed invention to select empagliflozin as the additional agent administered in the method of treating Crohn’s disease or ulcerative colitis in a subject as taught by Depaoli to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select empagliflozin as the additional agent administered in the method of treating Crohn’s disease or ulcerative colitis in a subject because Depaoli teaches that empagliflozin may be selected as the additional agent. One of ordinary skill in the art would have a reasonable expectation of success because Depaoli teaches a method of treating Crohn’s disease or ulcerative colitis that comprises the administration of an additional agent such as empagliflozin.
Regarding instant claims 9 and 10, it would have been prima facie obvious before the effective filing date of the claimed invention to prepare a kit based on the prior art of Depaoli to arrive at the claimed invention. It would have been prima facie obvious to one of ordinary skill in the art to prepare a kit based on the prior art because Depaoli teaches a kit and further, the grouping together of various objects or compositions directed to a common purpose (i.e. forming a kit) when all the individual objects or compositions are prima facie obvious over the prior art does not make the kit patentable. The idea of preparing a kit based on a prima facie obvious composition flows logically from the perspective of providing organization, convenience and quality control. See In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Conclusion
No claims allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693