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 .
Status of the Application
This Office Action is in response to applicant’s arguments filed on 3/17/26. Claims 13-18, 25 have been cancelled. Claims 1-12, 19-24, 26-27 are pending. Claim 27 has been amended. Claim 19 has been withdrawn. Claims 1-12, 20-24, 26-27 are examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejections of the last Office Action are maintained for reasons of record and modified below due to the claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 27, there is no support for the limitation “wherein the individual experiences a decrease of at least 2 percentage points in body fat percentage at four weeks and said decrease is maintained through eight weeks” in Applicant’s originally filed disclosure.
Response to Arguments
Applicant argues that this claim amendment is supported by Examples 1-2 of the specification.
This is not persuasive because Examples 1-2 are directed to a decrease of 2.1% (29.1 - 27.0) and 2.4% (29.0 – 27.1) specifically, which does not support the claimed range of “at least 2 percentage points”.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 1-12, 20-24, 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Rathmacher (US 2016/0346238, of record) in view of Devinci (“Fasted Training and HMB”, 2016, of record).
Rathmacher teaches a method of administering HMB to enhance or promote lipolysis, increase adipocyte fat oxidation, induce adipocyte and muscle mitochondrial biogenesis, increase energy expenditure, decrease total body weight and increase body fat loss. These effects are seen with or without caloric restriction and without requiring exercise [0040].
Rathmacher teaches HMB in any form may be incorporated into the delivery and/or administration form in a fashion so as to result in a typical dosage range of about 0.5 grams HMB to about 30 grams HMB [0049].
Rathmacher teaches while any form of HMB can be used HMB is selected from the group comprising a free acid, a salt, an ester, and a lactone. HMB esters include methyl and ethyl esters. HMB lactones include isovalaryl lactone. HMB salts include sodium salt, potassium salt, chromium salt, calcium salt, magnesium salt, alkali metal salts, and earth metal salts [0042].
Rathmacher does not specifically teach wherein the patient population is intermittently fasting.
Devinci teaches intermittent fasting assists with fat loss (1st paragraph).
Devinci teaches the intake of HMB capsules (500mg) in combination with fasted training days (last paragraph of blog).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that the administration of HMB is useful in enhancing fat loss with and without caloric restriction as taught by Rathmacher. The skilled artisan would have expected, with a reasonable degree of success, that intermittent fasting is considered a type of caloric restriction. Moreover, Devinci provides further motivation that intermittent fasting assists with fat loss and teaches the combination of HMB with that of fasting.
It is noted that the limitations of claims 20-24, 26-27 regarding “loss of additional fat” and “fat loss is accelerated” and “decrease of at least 2 percentage points in body fat percentage at four weeks and said decrease is maintained through eight weeks” are obvious to occur. The reason is because all elemental steps of the claimed method (active agent, dosage, and patient population) have been taught by the cited prior art. Therefore, the limitations of claims 20-24, 26-27 will obviously occur since they are a product of individual undergoing intermittent fasting being administered HMB at the claimed dosage.
Response to Arguments
Applicant argues that Rathmacher does not disclose an intermittent fasting regimen.
This is not persuasive because Applicant is reminded that the rejection is not over Rathmacher alone but in combination with Devinci, which teaches intermittent fasting. In response to applicant’s arguments against the references, one cannot show nonobviousness by attacking references individually where the rejections are based on the combination of references. See In re Keller, 642 F. 2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F. 2d 1091, 231 USPQ 375 (Fed. Cir. 1986). F
Applicant argues that the cited prior art fails any quantitative results, let alone that the combination of HMB and fasting produces a durable, synergistic effect on fat loss sustained beyond four weeks.
This is not persuasive because the limitation regarding “decrease of at least 2 percentage points in body fat percentage at four weeks and said decrease is maintained through eight weeks” will obviously occur since every step or limitation of the claims have been taught by the cited prior art.
Applicant argues that the inherency argument is not supported because the specification shows that neither HMB alone nor intermittent fasting alone produces durable fat loss.
This is not persuasive because it is in direct contrast to what is taught by the cited prior art references. Rathmacher clearly teaches that administering HMB increases body fat loss. What’s more, these effects are seen with caloric restriction, which is a form of fasting. Therefore, a definitive statement on the state of the art with regard to HMB alone or with intermittent fasting producing durable fat loss cannot be made in the face of contradicting evidence. Since both HMB and intermittent fasting is expected to produce durable fat loss, there can be no argument made for unexpected results or synergism.
Regarding the establishment of unexpected results or synergism, a few notable principles are well settled. The Applicant has the initial burden to explain any proffered data and establish how any results therein should be taken to be unexpected and significant. See MPEP 716.02 (b). It is applicant’s burden to present clear and convincing factual evidence of nonobviousness or unexpected results, i.e., side-by-side comparison with the closest prior art in support of nonobviousness for the instant claimed invention over the prior art. The claims must be commensurate in the scope with any evidence of unexpected results. See MPEP 716.02 (d). With regard to synergism, a prima facie case of synergism has not been established if the data or result is not obvious. The synergism should be sufficient to overcome the obviousness, but must also be commensurate with the scope of the claims. Further, if the Applicant provides a DECLARATION UNDER 37 CFR 1.132, it must compare the claimed subject matter with the closest prior art in order to be effective to rebut a prima facie case of obviousness. See MPEP 716.02 (e).
Conclusion
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 extension fee 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 Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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