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
STATUS OF THE CLAIMS: Claims 1-11 are pending in this application.
Response to Arguments & Amendment Under
Claim Rejections - 35 USC § 101 and § 112, 1st paragraph
Applicant’s arguments and amendment filed November 20, 2025, with respect to the rejections of claims under 35 USC § 101 and § 112, 1st paragraph have been fully considered and are persuasive. Therefore, the rejections has been withdrawn.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 (including claims dependent thereon or claims that relate back) are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for specific compounds disclosed in the specification, does not reasonably provide enablement for esters of those compounds and composition containing same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 1 and the claims dependent thereon are rejected because claim 1 recites specific compounds and esters of said compounds. However, the specification fails to teach the preparation or identity of esters. Therefore, the specification is not adequately enabled for making and/or using esters.
Identifying an ester requires knowledge of in vivo regeneration pathways of instant compounds and short of extensive experimentation, would be the skilled artisan would need much more data to determine esters of the instant compounds and compositions.
Applicants have not provided any clear guidance that would provide esters of the instant compounds that will regenerate in vivo to the instant compounds by one or more biological processes or methods for preparing esters. It is not the norm that one can predict with any accuracy whether a particular ester form of an active compound will be more soluble, more easily handled in formulations or more bioavailable without art recognized data to support same. The specification provides no guidance as to what type(s) of esters are suitable for the instant compounds. Generally, esters themselves are not considered to be therapeutically active but only to provide the active compound in vivo.
For rejections under 35 U.S.C. 112, first paragraph, the following factors must be considered (In re Wands, 8 USPQ2d 1400, 1404 (CAFC, 1988)):
1) Nature of invention.
2) State of prior art.
3) Quantity of experimentation needed
4) Level of predictability in the art.
5) Amount of direction and guidance provided by the inventor.
6) Existence of working examples.
7) Breadth of claims.
8) Level of ordinary skill in the art.
Nature of the invention
The nature of the invention is the preparation of compounds and compositions under the genus of a structural formula in claim 1. As stated, however, esters are also intended. The nature of esters is not set forth nor is the manner in which the esters are to be prepared or the core compounds modified into esters.
State of the prior art
The state of the prior art is that esters are known in the pharmaceutical industry. Esters in related compounds are not modified.
Quantity of experimentation needed
The quantity of experimentation needed is undue. The skilled artisan would need to regenerate in vivo the instant compounds by one or more biological processes. All of which require undue experimentation. Applicant has not postulated a metabolic pathway or mechanism, which facilitate conversion of the esters into an active agent.
Level of predictability in the art
The art pertaining to the preparation and use of esters is high as esters are compound specific and not all esters have the ability to regenerate in vivo. (See “Wolff, M.E., “Burger’s Medicinal Chemistry”, pp. 975-977, and Banker et al., “Modern Pharmaceuticals”, p. 596).
Amount of direction and guidance provided by the inventor
There is no guidance provided as all the examples in the specification are drawn to the preparation of compounds disclosed in the specification and not to esters. The lack of guidance to prepare any esters is not provided by the inventor.
Existence of working examples
As discussed above, working examples are drawn to the preparation of compounds disclosed in the specification and not to esters. The lack of guidance to prepare any esters is telling. There is no direction or guidance provided by Applicant to prepare esters of the instant invention.
Breadth of claims
The breath of the recited compounds and compositions in the claims includes esters for which there have been provided no specific examples or procedural steps to prepare esters. Failure to teach how to make the instant compounds makes teaching how to use the compounds unduly difficult, if not impossible.
Level of ordinary skill in the art
The level of ordinary skill in the art is high due to the unpredictability in the chemical art.
Hence, as discussed above, to practice the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation to test which ester can be used in the instant claim, with no assurance of success. Therefore, applicant must show that the specification teach the preparation of esters or limit the claims accordingly.
Claim Rejections - 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 1-11 are rejected under 35 U.S.C. 102 as being anticipated by Huan Xiong et al. (Euro J’nal of Med. Chem.’2018).
Applicant claims an antidiabetic medicament comprising the following:
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281
729
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This reference discloses Applicant’s antidiabetic and metabolism medicament on pages 740-741, 743-744, Figure 1 and Table I. (See Abstract, and entire document).
The medicament reads on the instant claims. Since this reference teaches the exact medicament, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Conclusion
Claims 1-11 are pending. Claims 1-11 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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