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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claim appears to be missing the phrase “are administered”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kley et al (US 10,603,300) in view of Hadd et al (WO2021/092341).
Scope of prior art
Claim 1: Kley teaches a method of treating diabetes mellitus in a canine animal by administering to the animal one or more SGLT2 inhibitors (abstract; col 3, lines 52-59; col 5, lines 26-29).
Claim 2: Kley teaches that various forms of diabetes can be treated including where beta cell destruction is caused by an autoimmune reaction, which corresponds to human type 1 diabetes mellitus (col 1, lines 59-67; col 2, lines 1-5).
Claims 3-8: With regards to dose and administration, Kley teaches doses encompassing the claimed dose and also teaches that a practitioner skilled in the art can determine suitable dose and prepare the dose for administration (col 27, lines 35-56). Kley also teaches prolonged administration for up to 2 years (Examples 3, 4 columns 30-31).
Claims 9, 10 and 13: Kley also teaches combination therapy with insulin which provides a benefit of a decreased dose of insulin that is required, compared with monotherapy (col 5, lines 10-14). Insulin is a therapeutic agent for type I diabetes mellitus.
Claim 11: Kley teaches oral administration (Col 4, lines 21-24).
Claim 1: Kley teaches treatment of hyperglycemia (Example 5, column 31).
Ascertaining the difference
Kley teaches administration of SGLT2 inhibitor, but does not recite the currently claimed enavogliflozin.
Secondary reference
Hadd teaches treatment of canine comprising administration of enavogliflozin wherein the animal has diabetes (page 77, claims 1, 5; page 84, line 22).
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application would have found it obvious to practice the method of treating diabetes in an canine by administering SGLT2 inhibitor. Such a method is taught by Kley. While Kley teaches SGLT2 inhibitor, he does not teach enavogliflozin. However, Hadd teaches administration of enavogliflozin, an inhibitor of SGLT2, to canine including those with diabetes. It would have been obvious to use an alternative SGLT2 inhibitor in the method of Kley, with an expectation that the alternative inhibitor will also be effective in treatment of diabetes in canines.
Conclusion
Claim(s) 1-11 and 13-14 are pending
Claim(s) 1-11 and 13-14 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628