DETAILED ACTION
The receipt is acknowledged of applicant’s election filed 02/11/2026, and IDS filed 08/15/2023.
Claims 1-22 are pending.
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 without traverse of invention III, claims 13-22, in the reply filed on 02/11/2026 is acknowledged. Claims 13-22 are examined on the merit.
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions I and II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Claim Rejections - 35 USC § 112 (a)
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 13-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for nutritional supplement composition administered in conjunction with protein supplement, does not reasonably provide enablement for any form of composition administered otherwise. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims: The claims are directed to a method of burning fat in the body by administering a composition consisting of dihydrocapsiate; African mango seed extract; citrus peel extract; Coleus forskohlii root extract; and red pepper fruit extract. The enabling disclosure must teach the skilled artisan how to burn fat in the body using the claimed plant composition. Further, it is well established that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513.
With regard to scope, the specification placed clear boundaries on the composition embraced by the claims used to burn fat, and makes clear that only nutritional supplement composition administered in conjunction with protein supplement is contemplated (paragraphs [0003], [001] of the published application). The examples provided administering the claimed composition as supplement in conjunction with protein supplement. Given the divergent nature of the compositions contemplated, one would conclude that the genus “composition” embraces essentially all formulations including oral, food, injection, topical, transdermal, implant, etc. Thus, it is incumbent upon the disclosure to teach the skilled artisan how to burn fat in the body by administering the claimed composition such that it can be formulated in the vast array of compositions embraced by the claims without undue experimentation.
Amount of direction provided by the inventor and existence of working examples: At the outset, it is noted that the instant disclosure does not provide a working example wherein method to burn fat in the body achieved by any composition other than nutritional supplement. Although, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), lack of a working example is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. Pharmaceutical and nutritional arts are generally viewed as unpredictable and achieving a useful therapeutic outcome in burning fat is highly unpredictable. Thus, the relevant question in light of the failure of the application to provide a working example of using any form of composition, is whether the manner and process of burning fat is otherwise disclosed such that the skilled artisan would be able to use the invention commensurate with the full scope of what is claimed.
The instant disclosure describes only nutritional supplement comprising the claimed plants/extracts in conjunction with protein supplement to burn body fat, and makes clear that the claimed composition is formulated as nutritional supplement.
State of the prior art and level of predictability in the art: The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.
The pharmaceutical and nutritional art using natural plants arts are recognized as unpredictable. (MPEP 2164.03.) 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 laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.
In the instant case, before the effective filing date of the present invention, the state of the art with regard to burning fat in the body using plant/extracts was at an early stage of development and obtaining therapeutically effective outcomes by administering compositions such as the composition currently claimed was highly unpredictable.
In reviewing the state of the art with respect to natural products in burning fat, Vermaak (IDS filed 08/15/2023) teaches using plants/extracts to treat obesity.
Thus, at the time the instant application was filed the skilled artisan would recognize that even treating obesity and burning fat using plant and their extracts were known, however their method of administration and safety were would be highly unpredictable.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: Although the relative level of skill in the art is high, one of ordinary skill would not have been able to develop a method of burning fat using the broad scope of the claimed compositions without undue experimentation. The instant application describes one method of administering the claimed composition, nutritional supplement, and seeks to claim all method of administering the compositions. The guidance provided in the specification amounts to no more than one method of administering of a specific composition. However, given the highly unpredictable state of the art evidenced above the skilled artisan clearly would not be able to extend these teachings and develop the broad scope of compositions useful for burning fat covered by the claims without extensive trial and error experimentation.
The law is clear that the first paragraph of 35 USC § 112 requires more that the disclosure of a theoretical possibility. “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. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that ‘a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’) Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, 1005. See also Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297 (Fed. Cir. 2005) (In response to Rasmusson’s argument that the enablement requirement of section 112 does not mandate a showing of utility or, if it does, it mandates only a showing that it is “not implausible” that the invention will work for its intended purpose, the Court states, “As we have explained, we have required a greater measure of proof, and for good reason. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.”)
In view of the broad scope of the claims, the nascent and unpredictable state of the art and the failure of the application to teach one of skill in the art how to make and use the full scope of the claimed invention as asserted in the disclosure in clear, concise and exact terms, it must be concluded that one would not be enabled to make and use the invention as broadly as claimed.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 13-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the claim recites method comprising the following 5 elements: 1) inducing thermogenesis in brown adipocytes of the subject; 2) increasing an amount of cyclic adenosine monophosphate (cAMP) released by the brown adipocytes of the subject; 3) inhibiting adipogenesis in the brown adipocytes of the subject; 4) elevating uncoupling protein 1 (UCP1) levels in the brown adipocytes of the subject; and 5) reducing hunger cravings by the subject. Later the claim recites: “….the acts of 1) inducing thermogenesis,….2) increasing the amount of cAMP,….3) inhibiting adipogenesis in the brown adipocytes, and 5) reducing hunger cravings comprise: administering …. a composition….”. It is noted that element 4) of “….elevating uncoupling protein 1 (UCP1) levels” is not included in the elements addressed by the composition. Is the claimed composition has not effect on element 4?
Further, claim 13 recites the composition comprising both dihydrocapsiate and red pepper fruit extract, however in paragraph [0010] of the original disclosure, applicants disclosed that: “….composition may include, consist essentially of or even consist of dihydrocapsiate (a capsinoid) or a source thereof (e.g., CH-19 Sweet pepper (Capsicum annuum) fruit extract….”. Therefore, the claimed dihydrocapsiate, capsinoid and red pepper fruit extract are the same, and will be examined as equivalents.
Regarding claims 14-16, the claim 14 recite “dihydrocapsiate being sweet pepper fruit extract”, claim 15 recites “red pepper fruit extract being 2% capsaicinoids”, and claim 16 recites “dihydrocapsiate and/or the red pepper fruit extract”. The claims are confusing and overlapping in scope and do not set forth the metes and bounds of the claims. Applicants disclosed in paragraph [0010] of the current disclosure that dihydrocapsiate is a capsinoid, and Sweet pepper (Capsicum annuum) fruit extract is the source of dihydrocapsiate which is a capsinoid. Therefore, the claimed dihydrocapsiate, capsinoid and red pepper fruit extract are the same, and will be examined as equivalents.
For all the above 112/b rejection, boundaries of coverage is not imposed by the disclosure. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02.
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.
Claims 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of the article to Vermaak (Natural products in anti-obesity therapy), Cains (US 2015/0157672), Yamka et al. (US 2010/0048723), Ito et al. (US 2008/0213413), the article to Gupta et al. (Appetite suppressing phyto nutrients: Potential for combating obesity), the article to Astell et al. (A review on botanical species and chemical compounds with appetite suppressing properties for body weight control), Stankov (US 6,447,818), the article iHerb, and Oben (US 2009/0226553). All references are cited/provided by IDS filed 08/15/2023, except for Gupta references that is currently cited on PTO 892 and copy is provided.
Applicant Claims
Claim 13 is directed to a method for burning fat in a body of a subject, comprising:
inducing thermogenesis in brown adipocytes of the subject;
increasing an amount of cyclic adenosine monophosphate (cAMP) released by the brown adipocytes of the subject;
inhibiting adipogenesis in the brown adipocytes of the subject;
elevating uncoupling protein 1 (UCP1) levels in the brown adipocytes of the subject; and
reducing hunger cravings by the subject,
the acts of inducing thermogenesis in the brown adipocytes, increasing the amount of cAMP released by the brown adipocytes of the subject, inhibiting adipogenesis in the brown adipocytes, and reducing hunger cravings comprise:
administering to the subject a composition consisting of:
dihydrocapsiate;
African mango seed extract;
citrus peel extract;
Coleus forskohlii root extract; and
red pepper fruit extract
in proportions and in an amount effective for inducing thermogenesis in the adipocytes, increasing the amount of cAMP) released by the cells, inhibiting adipogenesis in the adipocytes, and reducing hunger cravings.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Vermaak teaches natural products that are suitable as obesity therapy that are safe and successful for anti-obesity treatment. The natural products have different mechanisms of actions in anti-obesity and weight loss preparations. The natural products are plants that have any of mechanism of actions without side effects. Example of the mechanisms contributing to weight loss and treatment of obesity are: reduction of food intake; activation of 3',5'-cyclic adenosine monophospate (cAMP) that promotes the breakdown of stored fat; increasing and regulating the thermogenic response to food; inhibition of cholesterol synthesis and lipo-genesis, and increasing expression of uncoupling proteins UCP1 that increases thermogenesis. Examples of plants that reduces weight and treat obesity by the above mechanisms include Capsicum annuum (red pepper) and Citrus anurantium that both induce thermogenesis and reduces food intake. Capsicum further upregulates UCP1 in brown adipose tissues. Another plant is Coleus forskohlii that activates cAMP and reduces food intake. The reference teaches mango that increases lipolysis. Capsicum includes red and sweet peppers. The active ingredient in capsicum are capsaicin and dihydrocapsiate. The active ingredient in Citrus anurantium extract is synephrine in amount 4-6%. (See the entire document, and in particular: abstract; pages: 1493, 1495-1497; paragraphs: 3.7, 3.11, 3.12, 3.19, 3.29; Table 1).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Vermaak teaches treating obesity and weight reduction using capsicum annuum (rede pepper), citrus anurantium, coleus forskohlii, and mango, the reference however does not explicitly teach a composition containing all the plants/extracts as claimed by claim 13.
While Vermaak teaches mango, the reference does not explicitly teaches African mango claimed by claim 13.
Cairns teaches method for reducing appetite and effecting weight loss by administering weight loss agent comprising capsicum (chili pepper) known as capsinoid and comprises capsaicinoids; Citrus aurantium, Coleus forskohlii, and Irvingia gabonensis (African mango). The weight loss agent administered in the form of nutritional supplement. (See entire document, and in particular abstract, and ¶¶ 0006, 0032, 0041, 0052, 0065, 0067, 0076, 0092, 0093, 0098, 0099, 0124, 0125, 0128, 0165-0167, example 5, tables 1 and 7).
Yamka teaches method for treating obesity comprising administering a food composition comprising capsicum from chili peppers. Capsicum comprises capsaicinoid and, capsaicin, and metabolites thereof, e.g. dihydrocapsaicin (see entire document and in particular: abstract; ¶¶ 0006-0010, 0020, 0022, 0026, 0030; claims).
Ito teaches food composition useful as anti-obesity supplement, the composition comprising capsinoid compound, and in particular dihydrocapsiate. Capsinoid isolated from capsicum plant body or seed. Capsicum as used by the reference means any pepper includes sweet pepper or any other species (see the entire document; and in particular the abstract; ¶¶ 0006, 0013, 0014; examples; claims).
Gupta teaches appetite suppressing phyto nutrients used to combat obesity. Examples of these nutrients are those obtained from capsicum, e.g. sweet red pepper, Citrus aurantium, and Coleus forskohlii. The nutrients can be included in dietary supplement. The active ingredient in Citrus aurantium is synephrine. (See the entire document, and in particular: abstract; page 4, right column; page 5, left column; page 7, right column).
Astell teaches botanicals for appetite suppression and body weight and obesity control. The botanicals include Citrus aurantium that comprises synephrine as an active agent, and Coleus forskohlii. Citrus aurantium further comprises flavonoids in the peel. The reference suggests dietary supplement. (see the entire document, and in particular: abstract; page 215, left column; page 216).
Stankov teaches nutritional supplement to stimulate weight loss, stimulate thermogenesis, control sensation of hunger and treat obesity. The supplement comprises Citrus aurantium extract that comprises 4% synephrine. The composition further comprises source of flavonoids (Oterin). (See entire document, and in particular: abstract; col.2, lines 15-30, 50-62; col.4, lines 35-67; col.5, lines 1, 25-41; col.6, lines 1-10; col.7, lines 1-30; claims).
The article iHerb teaches extract from African mango (Irvingia gabonensis) induced weight loss (see the entire document).
Oben teaches mango seed extract reduced body weight and total amount of stored fat and treats obesity and reduced the amount of LDL cholesterol. It is given as supplement. (See entire document, and in particular abstract; paragraphs: 0008-0010, 0012-0014; 0018-0023, 0032, 0044; and claims).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to reduce fat in the body using extracts from capsicum, Citrus aurantium, Coleus forskohlii, and mango to reduce weight as taught by Vermaak, and include the extracts in a nutritional supplement as taught by Cairns, Yamka, Ito, Gupta, Astell, and Stankov, further replaces mango with African mango as taught by Cairns, the article iHerb and Oben. One would have been motivated to do so because the cited references teach these plants and their extracts can be included in a nutritional supplement that reduces appetite thus effecting weight loss. One would reasonably expect to successfully reduce appetite and body weight by administering composition comprising capsicum, Citrus aurantium, Coleus forskohlii, and African mango.
Regarding the claimed functions of burning fat as claimed by claim 13, they are taught by at least Vermaak. In any event such functions are inseparable from the claimed plants/extracts.
Regarding dihydrocapsiate claimed by claim 13, it is a natural ingredient of capsicum, and it is taught by both Yamka and Ito.
Regarding African mango claimed by claim 13, and functions achieved as claimed by claims 17-18, it is taught by Cairn, and the article by IHerb, and further Oben that teaches reduction of LDL cholesterol.
Regarding Citrus peel extract claimed by claim 13, and its functions as claimed by claims 20 and 21, it is taught by Vermaak, Cairns, Gupta, Astell and Stankov, all teach citrus extract that implies extract from peel as well, and the references teach appetite suppression.
Regarding Coleus forskohlii extract claimed by claim 13, and its function as claimed by claim 22, it is taught by it is taught by Vermaak, Cairns, Gupta, Astell and Stankov.
Regarding red pepper fruit extract, as claimed by claim 13, this is at least taught by Vermaak, Cairns, Yamka, Ito, and Gupta.
Regarding the effective amounts of the claimed ingredients to induce the claimed functions as claimed by claims 13 and 16, this is implied by the cites references, weight reduction being achieved.
Regarding claim 14 and 15 reciting the amounts of dihydrocapsiate and capsaicinoids, respectively, the cited references implied use of effective amounts to achieve the claimed functions.
Regarding claim 19 that the composition comprises 5% synephrine and 80% flavonoids, Vermaak, Cairns, Gupta, and Astell, all teach citrus fruit that comprises 4% synephrine and flavonoid. The claimed amounts can be determined by one having ordinary skill in the art based on the desired amount of weight loss and fat burning.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
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