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 .
Claim Rejections - 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over WO18/039207.
The claims of the present application are drawn to methods of treating depression and/or anxiety related to Parkinsonism comprising administering various nicotinamide derivatives or compositions comprising the same. Dependent claims limit the drug administered, provide the Parkinsonism is various diseases including Parkinson’s disease, and to also administer an additional Parkinson’s disease treating drug.
‘207 teaches methods of treating Parkinson’s disease with the same nicotinamide compounds claimed herein (see page 3, lines 11-14). ‘207 also teaches methods of treating, reducing the risk of, and/or reducing the prevalence of indicia of Parkinson’s disease wherein the indicia may be depression (see page 3, lines 15-29). ‘207 teaches their formula I is the same as compound I-G herein (see pages 21-23) and also teaches to optionally administer nicotinamide mononucleotide, which is the same as formula I-A herein (see pages 24-27 – it is noted that the structure on the top of page 25 should have hydroxy groups at the 2’ and 3’-position of the sugar). ‘207 teaches that NMN will be given to patients having Parkinson’s disease and the symptoms will be monitored and their indicia, such as depression, will be improved (see example 4).
Thus, while ‘207 did not specifically administer their compositions to patients having Parkinson’s disease wherein the results of decreased depression were shown, the art clearly suggest this is an event to happen and it would at the minimum be an “obvious to try” situation. That is, it would be prima facia obvious to administer the same drugs as in ‘207 to patients having Parkinson’s disease as in ‘207 and arrive at the present results of treating depression with NMN-drugs in Parkinson’s patients because ‘207 clearly states this as a result of their methods of administering the same. Applicants have shown one example in which a single patient was administered NMN (beta) (compound IA of the present claims and also disclosed as applicable in ‘207), for 6 months wherein their UMSARS questionary before and after the six months showed a score changing from “Often” to “sometimes” for question 19 which is “Do you feel depressed”. This showing of administering 1 of the compounds claimed herein, in one study, on one patient, which changed their results from “often” to “sometimes” cannot be construed as unexpected or surprising results for the entirety of the scope claimed herein, if for any portion at all. One patients’ result is not necessarily effective to prove the clinical effectiveness of the entirety of the scope being claimed herein, and certainly cannot be considered to be sufficient to show any form of unexpected properties when the art actually suggests the properties claimed to occur upon administration of the same drug to the same patient population. Regarding the claimed combination therapy, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). The additional agents claimed herein such as levodopa have been known to be anti-Parkinson’s drugs for years and combination therapy with the same is also known (see US 4,190,672 for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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