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 12/18/25. Claims 2, 4-40, 43, 45, 47, 49, 51, 54, 60, 62, 64, 68-126 have been cancelled. Claims 1, 3, 41-42, 44, 46, 48, 50, 52-53, 55-59, 61, 63, 65-67 are pending. Claims 1 and 41 have been amended. Claim 67 has been withdrawn. Claims 1, 3, 41-42, 44, 46, 48, 50, 52-53, 55-59, 61, 63, 65-66 are examined herein.
The claim amendments have rendered the 102 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with respect to the 103 rejection have been fully considered but found not persuasive, therefore 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 second paragraph of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 41-42, 44, 46, 48, 50, 52-53, 55-59, 61, 63, 65-66 are rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Specifically, claim 1 recites the limitation "the compound". There is insufficient antecedent basis for this limitation in the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham vs John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 3, 41-42, 44, 46, 48, 50, 52-53, 55-59, 61, 63, 65-66 are rejected under 35 U.S.C. 103(a) as being obvious over Amato (US Patent Application 2011/0064712 A1, of record) in view of Horrobin et al. (US Patent 6,630,157 B1, of record).
The instant claims are directed to a formulation comprising a combination of five agents selected from lipoic acid, nicotinamide, thiamine, piperine, and pyridoxamine.
Amato teaches a dietary supplement (abstract) for use in weight loss (paragraph 0033). Active agents include 25 or 100 mg of lipoic acid (Table 5 or 17), 5 mg of piperine (Table 17), 25 or 50 mg of pyridoxine HCL (Table 3 or 13), 50 mg of thiamine (Table 7), and silicon dioxide (Table 2). Inactive ingredients include the metallic salt, magnesium stearate, and the binder, microcrystalline cellulose (paragraph 0110). The dietary supplement composition can be formulated into a powder, tablet, or capsule (paragraph 0038).
However, Amato fails to disclose nicotinamide and wherein said formulation does not contain additional vitamins or dietary supplements.
Horrobin et al. teach compositions of gamma-linolenic acid (GLA) with alpha lipoic acid, also known as thioctic acid (TA) for their use in preparation of composition for therapy or nutrition, especially in diabetic complications (abstract), such as obesity (col. 5, lines 25-27). Other actives may also be provided in nutritional supplements, or nutraceuticals together with other essential nutrients including vitamin B, pyridoxine, and nicotinamide (col. 6, lines 20-25). Examples show soft or hard gelatin capsules containing 50, 100, or 200 mg of lipoic acid.
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to have combined 100 mg of nicotinamide, as taught by Horrobin et al., with the dietary supplement comprising lipoic acid, piperine, pyridoxine, and thiamine, as taught by Amato, in the claimed amounts.
A person of ordinary skill in the art would have been motivated to combine nicotinamide with lipoic acid, piperine, pyridoxine, and thiamine, in the claimed amounts, because each active agent has been identified as being useful in treating obesity or for losing weight. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating obesity or losing weight by the therapeutically additive effect of combining multiple active agents for the same purpose.
Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382; lt has been held that it is within the skills in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. In re Boesch, 205 USPQ 215 (CCPA 1980) MPEP 2114.04
Response to Arguments
Applicant argues that Amato does not teach or suggest that any of lipoic acid, thiamine, piperine, or pyridoxamine are individually or collectively useful for weight loss. The only mention of weight loss is listed merely as one of several hypothesized benefits of aspartic acid. Similarly, Horrobin does not teach or suggest nicotinamide is useful for treating obesity or weight loss. Instead, Horrobin is expressly directed to the treatment of complications of diabetes. The only mention of nicotinamide is its inclusion as an optional “essential nutrient” or vitamin, not as required or active therapeutic agent for weight loss or obesity. Finally, there is no motivation to combine the references because Amato is drawn to a general dietary supplementation for performance and recovery, while Horrobin is directed to a two agent composition for diabetic complications.
This is not persuasive because both Amato and Horrobin clearly teach a dietary composition that can be used for weight loss or obesity. The motivation to combine comes from both compositions being known and useful as dietary compositions. Applicant is reminded that the instant claims are drawn to a composition and not a method of inducing weight loss or treating obesity. This limitation of weight loss is given little patentable weight since it is considered preamble or intended use of a composition claim.
It is respectfully pointed out that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from each other. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus, the intended use of a composition claim will be given no patentable weight.
It is further respectfully pointed out that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). See MPEP 2111.02.
Applicants argue unexpected superior results in the form of synergism as shown in paragraph 0295 and Figure 5 of the instant specification.
This is not persuasive because Applicant has not clearly or properly explained how the results in Figure 5 can be construed as unexpected or synergistic. In the absence of this information, it appears that the results are merely showing that the invention works as intended.
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