CLAIMS 1-10 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 Preliminary Amendment filed July 07, 2023 and Information Disclosure Statement filed December 28, 2022 have been received and entered into the application. Accordingly, the application papers have been amended as directed. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
Claim Rejection - 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.
Claims 1-4 are 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.
In claim 1, the term “application” recites a function to be performed, but the claim fails to recite sufficient structure, material, or acts to perform that function, e.g., a substrate upon which something is applied and what is being applied to what material.
Also, it is unclear if the limitation following the exemplary term “preferably” in claim 2 represents a controlling limitation.
Claim Rejection - 35 USC § 102
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 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 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bei Zhang, "The role of KATP on Glomerular mesangial cells Proliferation and Excessive extracellular matrix Synthesis induced by High glucose", Doctoral dissertation, Naval Medical University, May 2017, pp. 1-116, (cited by Applicant; hereinafter “Zhang”).
Zhang discloses that the potassium ATP channel openers diazoxide and nicorandil (equivalent to nicorandil) are capable of treating diabetic nephropathy. Zhang further discloses type 2 diabetes, (e.g., abstract., pages 63-64 and page 76-77). Further, a drug administration dosage is a treatment method and would be encompassed by the unduly broad term "Application" of the present claims". Also, the diabetic nephropathy staging in claim 8 is an intended function of the composition and does have any effect in limiting the claims which are drawn to a composition of matter.
Claim Rejection - 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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, as above, for the reasons set forth above as applied to claims 1-6 and 8, which reasons are here incorporated by reference.
The differences between the above and the claimed subject matter lies in that Zhang et al. fail to specifically teach potassium ATP channel regulators or openers in general and does not teach the particular dosage forms of present claim 9 or the active agents in association with the auxiliary agents as in present claim 10.
However, 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 because Zhang discloses 2 species of the genus of drugs presently claimed. Therefore, a person of ordinary skill in the art would, have been motivated to choose other species of drugs to perform the same function as those disclosed in the reference. Adding an active ingredient to any one of the different excipients for preparing any of the different dosage forms as claimed are regular skills of a person of ordinary skilled in the art in the absence of any evidence to the contrary.
Accordingly, for the above reasons, the claims are deemed properly rejected and none of the claims are currently in condition for allowance.
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 M-F 6-2:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 October 06, 2025