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 .
STATUS OF THE CLAIMS: Claims 1, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127 are pending in this application.
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, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127 (including claims dependent thereon and claims that relate back to independent claim) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127 (including claims dependent thereon and claims that relate back to independent claim) 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 tautomers 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.
The claims are rejected because the claims recite specific compounds and tautomers of said compounds. However, the specification fails to teach the preparation or identity of tautomers. Therefore, the specification is not adequately enabled for making and/or using tautomer.
Identifying a tautomer 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 tautomers of the instant compounds and compositions.
Applicants have not provided any clear guidance that would provide tautomers of the instant compounds that will regenerate in vivo to the instant compounds by one or more biological processes or methods for preparation. 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 prodrugs are suitable for the instant compounds. Generally, tautomers 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 (Ia) or (Ib). As stated, however, tautomers are also intended. The nature of tautomer is not set forth nor is the manner in which it is to be prepared or the core compounds modified.
State of the prior art
The state of the prior art is that tautomer are known in the pharmaceutical industry. Tautomer 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 tautomer into an active agent.
Level of predictability in the art
The art pertaining to the preparation and use of tautomers are compound specific and not all tautomers 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 tautomer. The lack of guidance to prepare any tautomer 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 tautomers. The lack of guidance to prepare any tautomer is telling. There is no direction or guidance provided by Applicant to prepare tautomer of the instant invention.
Breadth of claims
The breath of the recited compounds and compositions in the claims includes tautomer for which there have been provided no specific examples or procedural steps to prepare tautomers. 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 tautomer can be used in the instant claim, with no assurance of success. Therefore, applicant must show that the specification teach the preparation of tautomers or limit the claims accordingly.
Double Patenting
Claims 1, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of co-pending Application No. 19/587,226.
This is a provisional non-statutory double patenting rejection.
Allowable Subject Matter
Claims 1, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127will be allowed if: (1) amended to overcome the rejections under 35 USC § 112, first paragraph (i.e., delete “tautomer” from the claims); and (2) a terminal disclaimer is filed and approved to obviate the provisional non-statutory double patenting rejection. The composition and compounds were not found to be obvious or anticipated by the prior art of record. The prior art (i.e., WO 2019/226931) does not teach or suggest the composition and compounds substituted in the manner claimed by the Applicant. Thus, these claims will be allowed if amended to overcome the rejections under 35 USC § 112, first paragraph.
Conclusion
Claims 1, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127are pending. Claims 1, 16, 24, 29-32, 34, 39, 43, 96-97, 99, 102, 106, 109, 111, 116-118 and 126-127 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
