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 1-7 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 1-7 (including claims dependent thereon and claims that relate back to the independent claims) 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 1-7 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for pharmaceutically acceptable salts or salts, does not reasonably provide enablement for making any solvates, co-crystals or polymorphs. 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 the invention commensurate in scope with these claims.
The claims are drawn to solvates, co-crystals or polymorphs. But the numerous examples presented all failed to produce a solvate and hydrates. These cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190, “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However…there is no evidence that such compounds exist…the examples of the '881 patent [U.S. Patent # 4,062,881] to not produce the postulated compounds…there is…no evidence that such compounds even exist.” The same circumstance appears to be true here: there is no evidence that solvates and hydrates of these compounds actually exist; if they did, they would have formed.
Additionally, 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 thus use the invention commensurate in scope with these claims. Solvates and hydrates are non-enabled since generally not all solvents can form solvates and hydrates with all compounds. There is no process enabling such a scope in the specification. Note Vippagunta provided herein who flatly states on p. 18, section 3.4 the following: “Predicting the formation of solvates or hydrates of a compound…Is complex and difficult.” Applicants’ own specification confirms this despite numerous examples presented, none of the final products were obtained as solvates or hydrates. The skill in the art of solvates, co-crystals or polymorphs preparation is quite high.
Hence, applicants must show that solvates and hydrates of the compounds can be made, 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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Narvartis Institutes for BioMedical Research (Clinical Trial Protocol CSAF312X2201’2017).
Applicant claims the following methods for treating chronic ocular surface:
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This reference discloses Applicant methods on pages 18-44. (See Abstract, and entire document). The methods read on the instant claim. Since this reference teaches the exact methods, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Narvartis Institutes for BioMedical Research (Biostatitistics & Statistical Programming CSAF312X2201’2018).
Applicant claims the following methods for treating chronic ocular surface:
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This reference discloses Applicant methods on pages 1-14. (See entire document). The methods read on the instant claim. Since this reference teaches the exact methods, Applicant’s claims are anticipated, and thus, rejected under 35 U.S.C. 102.
Conclusion
Claims 1-7 are pending. Claims 1-7 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
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