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
This Office Action is responsive to Applicant’s remarks filed on 06/11/2026 wherein no amendments to the claims were filed. 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.
Maintained Grounds of Rejection
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). 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). 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).
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered, but they are not persuasive.
Applicant argues Depaoli is a combination therapy and does not suggest empagliflozin would be therapeutic on its own. The argument is unpersuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., empagliflozin as a monotherapy) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that Depaoli lists an extremely broad, heterogeneous set of optional co-agents and disease indications. In Depaoli, empagliflozin appears only as one optional "additional agent" among numerous unrelated classes of possible adjunctive compounds. Depaoli provides no direction to isolate empagliflozin from that broad menu and use it as monotherapy. The argument is unpersuasive. The instantly claimed invention does not exclude additional actives that would be included in a combination therapy. Depaoli discloses the method of treating a bile acid-related or associated disorder comprising administering a chimeric peptide sequence and administering at least one additional agent effective in treating a bile acid-related or associated disorder (Depaoli claim 1). Depaoli discloses that the additional agent may be an SGLT-2 inhibitor (Depaoli claim 96) and further narrows the SGLT-2 inhibitor to only eight possible SGLT-2 inhibitors including empagliflozin (Depaoli claim 97). Applicant argues that IBD is clinically distinct from bile acid disorders. Inflammatory bowel disease is not ordinarily understood or described as a primary bile acid disorder and cannot be swept into the definition given by Depaoli as "bile acid-related or associated" disorders, nor does it create a reasoned expectation that empagliflozin alone would treat ulcerative colitis or Crohn's disease. The argument is unpersuasive. Depaoli teaches a method of treating a bile acid-related or associated disorder and further defines ulcerative colitis as a bile acid associated disorder. Therefore, Depaoli teaches the treatment of ulcerative colitis.
Applicant argues unexpected results in the present inventors were the first to show that empagliflozin unexpectedly provides robust therapeutic benefit in the treatment of ulcerative colitis and Crohn's disease. The argument is unpersuasive. While Depaoli does not exemplify the use of empagliflozin as a monotherapy to treat ulcerative colitis, it would have been obvious to one of ordinary skill in the art to treat a bile acid-related or associated disorder such as ulcerative colitis with a combination therapy including the SGLT-2 inhibitor, empagliflozin, because Depaoli discloses the method of treating a bile acid-related or associated disorder with a combination therapy including the SGLT-2 inhibitor, empagliflozin, and discloses that a bile acid-related or associated disorder could be ulcerative colitis. Further, regarding instant claims 9 and 10, unexpected results would not overcome the obviousness of a kit comprising the known compound empagliflozin as the properties of the compound are inherent to the compound (see MPEP 2112.01 at II.) The discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer (see MPEP 2112 at I.)
Conclusion
No claims are allowed.
No new grounds of rejection were provided 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.
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/S.L.S./Examiner, Art Unit 1693
/JONATHAN S LAU/Primary Examiner, Art Unit 1693
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