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 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.
Claims 1-2, 4-8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Horrobin (European Patent 0 003 407 A1, Published 08/08/1979; cited in a prior Office action) in view of Novak et al. (US 2018/0055879 A1, Published 03/01/2018; cited in a prior Office action).
Claims 3, 3-9, and 12-19 have been canceled.
The claims are directed to a method of preventing overweightness or obesity comprising administering a composition comprising 64Zne in the form of zinc sulfate or zinc aspartate.
Horrobin teaches capsules comprising 20 mg zinc sulfate may be administered in the treatment of obesity (page 11, lines 27-29).
Horrobin lacks a teaching wherein the composition comprises 64Zne.
Novak et al. teach a composition in the form of a solution (for any appropriate route of administration, including by injection) may be prepared in which the solvent is water; in a preferred embodiment, the water is enriched with 16O and/or depleted of 2H, both with respect to the isotopes' natural abundance … In a preferred embodiment, the at least one light isotope that the composition is enriched for is one or more of 64Zn … in a solution as described above, 64Zne is present at a concentration of from 10 µg/ml to 10 mg/ml, most preferably from 100 µg/ml to 2 mg/ml; in these embodiments, 64Zne is present in the form of a chelate of an amino acid, preferably a chelate of aspartate or asparaginate (paragraph 0032). When the enriched-for light isotope is 64Zn, the 64Zn preferably constitutes at least about 80% 64Zn of the zinc on a mole fraction basis (that is, 80% of the zinc atoms are 64Zn atoms), more preferably at least about 90% 64Zn, such as at least 90%, at least 95%, or at least 99% 64Zn, or between about 90% and about 99.9% 64Zn (all on a mole fraction basis) (paragraph 0033). The chemical compounds of the pharmaceutical composition include the isotopes such as at least one of oxides, sulfates, citrates, gluconate, and a chelate (paragraph 0030). In preferred embodiments, the composition is suitable for various routes of administration, such as topical or oral administration or administration by injection (paragraph 0031). A pharmaceutical composition of the present invention is used for improving health, cure abnormalities and degenerative disease; achieve anti-aging effect of therapy and therapeutic effect on mammals (abstract).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to use 64Zn in the compound of Horrobin et al. and have a reasonable expectation of success. One would have been motivated to do so since a composition comprises 64Zn also provides health improving properties. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Applicant previously argued that Novak discloses at Example 8, Table 4 and [0506]-[0507] that in these experiments administration to mice of an agent comprising enriched amount of zinc-64 led to “insignificant changes in weight of the experimental animals. Accordingly, a POSITA would hesitate to substitute zinc-64 for zinc to lower weight in an animal, and would not have had a reasonable expectation of success. This argument is not completely accurate, because the 2nd row clearly shows statistically significant reduction of body weight between Days 4-24. This is consistent with a reasonable expectation that zinc-64 of Novak is obvious to substitute for the zinc compounds taught by Horrobin.
Examiner requests clarification as to Example 8 of Novak, and whether it comprises “a subject in need of preventing/treating overweightness or obesity”, in which case this example would anticipate the claims.
However, in the instant case, the current Examiner is of the view that the tumor model mouse L1210 leukemia of this experiment is different from a model to prevent or treat overweightness or obesity; such as feeding regimen of a high fat diet, with excessive calories compared to normal calorie amount provided. The obesity/risk of obesity involves different model, and would have a likely difference in the Zinc-64 treatment.
Regarding a prior amendment to claim 1, Examiner noted that the obvious method would characteristically involve increasing the amount of 64Zn by dosing a compound that is a salt of Zn in the Zn-64 isotope. Accordingly, the isotope ratio of zinc in a subject will be expected to increase the amount of zinc-64. Additionally, the result will be greater 64Zn in the subject.
Applicant argues:
Horrobin, published 46 years ago, has not resulted in zinc supplementation as therapy for obesity.
This is not persuasive. Horrobin clearly teaches this method of therapy for obesity by using zinc supplementation. Examiner notes that reliance on Abdollahi et al is improper for evaluation of the instant claims, because it is post-filing art. The study makes clear that some overweight/obese patients had reduced body weight (abstract). Thus, the reference does not establish what is argued.
Applicant further argues that, if Horrobin is correct, why would a person of ordinary skill in the art go to the trouble to substitution 64Zn for Zn, arguing for impermissible hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The rejection clearly sets forth rational that renders the claims prima facie obvious.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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