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 .
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 3/25/ is acknowledged. The traversal is on the ground(s) that Novitskaya is a review of purinergic signaling in cardiac fibrosis - it is primarily focused on purine nucleotides, their receptors, and ectonucleotidases in the context of fibroblast function. Novitskaya does not teach or suggest measuring pyrimidine nucleotide levels (e.g., uridine, UMP, UTP, cytidine, CMP, CTP, orotate, deoxyuridine, or orotidine), nor measuring levels of any nucleotide in the serum as a clinical biomarker. Novitskaya is silent as to using
nucleotide levels as an indicator of ENPP1 activity or identifying candidate ENPP1 inhibitors based on purine-to-pyrimidine ratios. This is not found persuasive because applicant’s arguments are not commensurate in scope with the claimed inventions in that in the broadest interpretation include practically only the measuring of the pyrimidine or purines. See MPEP 2106.04(b) regarding the implications of claims drawn to the correlation of an assay and a condition.
The requirement is still deemed proper and is therefore made FINAL.
Claims 35, 58, 65, 70, 79 & 82 are considered on the merits.
Claim Rejections - 35 USC § 112
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 35, 58, 65, 70, 79 & 82 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.
Applicant ultimately claims treating myocardial infarction, promoting cardiac wound healing, enhancing cardiac repair, inhibiting ENPP1 activity, and/or preventing heart failure, cardiac cell death, ectopic calcification of cardiac tissue, scarring of cardiac tissue, dilated cardiomyopathy, and/or release of one or more pro-inflammatory molecules from cardiac myocytes in a subject by administering a simple pyrimidine or purine to the subject. The claimed invention cannot be considered to be enabled given the limited showing in the specification. First there is no clear reduction to practice of the claimed invention as no disclosed embodiment appear to have actually treated myocardial infarction, promoting cardiac wound healing, enhancing cardiac repair, inhibiting ENPP1 activity, and/or preventing heart failure, cardiac cell death, ectopic calcification of cardiac tissue, scarring of cardiac tissue, dilated cardiomyopathy, and/or release of one or more pro-inflammatory molecules from cardiac myocytes in the indicated patients. Applicant’s discovery of the correlation between ENPP1 activity and purine and pyrimidine levels does not enable the treating of myocardial infarction, promoting cardiac wound healing, enhancing cardiac repair, inhibiting ENPP1 activity, and/or preventing heart failure, cardiac cell death, ectopic calcification of cardiac tissue, scarring of cardiac tissue, dilated cardiomyopathy, and/or release of one or more pro-inflammatory molecules from cardiac myocytes simply by administering the compounds particularly where the claims require no threshold amount for treatment.
Applicant’s assertion that administering simple naturally occurring compounds to treat myocardial infarction, promoting cardiac wound healing, enhancing cardiac repair, inhibiting ENPP1 activity, and/or preventing heart failure, cardiac cell death, ectopic calcification of cardiac tissue, scarring of cardiac tissue, dilated cardiomyopathy, and/or release of one or more pro-inflammatory molecules from cardiac myocytes in the claimed manner is not enabled by the specification as filed. Even if the administration of the compounds would inhibiting ENPP1 activity there is no clear indication that said treatment would also treat myocardial infarction, promoting cardiac wound healing, enhancing cardiac repair, and/or preventing heart failure, cardiac cell death, ectopic calcification of cardiac tissue, scarring of cardiac tissue, dilated cardiomyopathy, and/or release of one or more pro-inflammatory molecules from cardiac myocytes
"Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable ....Tossing out the mere germ of an idea does not constitute enabling disclosure." Genentech Inc. v. Novo Nordisk A/S , 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997).
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/ Primary Examiner, Art Unit 1657
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