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 .
Election/Restriction
In the reply filed on May 18, 2026, applicant elected group I, claim(s) 1-17 and 23-25 and elected vitamin B species of thiamin which reads on claim(s) 1-17 without traverse. Claim(s) 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-17 and 23-25 are examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on May 28, 2025 are being considered by the examiner. The signed IDS form is attached with the instant office action.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably
within the range of 50 to 150 words in length. The abstract of the disclosure is roughly 26 words. A corrected abstract of the disclosure within the preferred ranges disclosed is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
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.
Claim(s) 13 and 23-25 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.
Claim 13 is indefinite because it is unclear what “NE” means; the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim 23 is indefinite because it is unclear what is meant by “bulk” within “bulk package”; in addition, it is unclear what sizes are considered encompassed by the term “bulk” the specification does not list a thorough meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-17 and 23-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising arugula extract, grape seed extract or grape skin extract and mango leaf extract of claim(s) 1-17 and 23-25 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims 1-17 and 23-25 are drawn to a composition that comprises arugula extract, grape seed extract or grape skin extract and mango leaf extract. In addition, claim(s) 9-10, 14 and 24 further recite the combination of arugula extract, grape seed extract or grape skin extract, mango leaf extract and caffeine. Arugula (e.g. Eruca sativa), grape seed extract or grape skin extract (e.g. derived from Vitis vinifera), mango leaf extract (e.g. Mangifera indica) and caffeine are all naturally occurring. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature- based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP §2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties”.
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products. There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. In addition, the closest naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication that mixing the following ingredients together such as arugula (e.g. Eruca sativa), grape seed extract or grape skin extract (e.g. derived from Vitis vinifera), mango leaf extract (e.g. Mangifera indica) and caffeine as commensurate in scope with the stated claims changes the structure, function, or other properties of the components in any marked way in comparison with the closest naturally occurring counterpart. Thus, the claims are drawn directly to a product of nature. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use as a dietary supplement. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. In this case, the additional element is the mixing of the claimed ingredients and the packaging of the dietary supplement composition. Mixing arugula (e.g. Eruca sativa), grape seed extract or grape skin extract (e.g. derived from Vitis vinifera), mango leaf extract (e.g. Mangifera indica) and caffeine and packaging a dietary supplement composition does not amount to significantly more than a combination of judicial exception because mixing compounds and packaging a composition is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter. In addition, applicant's intended use of a dietary supplement is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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, 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 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gokaraju (WO 2017203540 A1) in view of Crozier (WO 2014201360 A1) and Sun (WO 2022083748 A1).
Gokaraju teaches a composition that comprises Mangifera indica leaf extract (page 13). Gokaraju teaches that the composition the composition of the present invention may further contain optionally one or more of the non-limiting components such as vitamins selected from B vitamins, including thiamin (page 20). Gokaraju teaches novel dietary herbal supplements selected from the extracts and fractions derived from Mangifera indica as natural energy enhancer for enhancing physical performance, muscle mass, muscle strength, energy levels (page 2). Gokaraju teaches [that the] compositions can further be combined optionally with one or more pharmaceutically or dietetically acceptable excipients, carriers and diluents, which include but not limited to glucose ([e.g. a sweetener]) (page 23). Gokaraju teaches [that] the extracts or fractions or composition(s) of the present invention may be formulated in dry form, liquid form, food product, dietary supplement or any suitable form such as tablet, a capsule or a soft chew (page 22). Gokaraju teaches [that] the concentration of Mangifera indica derived ingredients in the composition individually or jointly varies from 0.01 % to 99.99% (page 21).
Gokaraju does not teach that the composition further comprises arugula extract and grape seed extract, grape skin extract, or a combination thereof (as stated within claim 1 of the present invention). Gokaraju does not teach that the composition comprises about 20% to about 50% by weight of said arugula extract (as stated within claim 2 of the present invention). Gokaraju does not teach that the composition comprises said arugula extract in an amount sufficient to produce about 90 mg to about 1240 mg nitrate (as stated within claim 3 of the present invention). Gokaraju does not teach that the composition comprises said arugula extract in an amount of about 2 g to about 15 g (as stated within claim 4 of the present invention). Gokaraju does not specifically teach that the composition comprises about 2% to about 5% by weight of said grape seed extract, grape skin extract, or combination thereof (as stated within claim 5 of the present invention). Gokaraju does not teach that the composition comprises said grape seed extract, grape skin extract, or combination thereof in an amount of about 100 mg to about 500 mg (as stated within claim 6 of the present invention). Gokaraju does not teach that the composition comprises said mango leaf extract in an amount of about 140 mg to about 19,350 mg (as stated within claim 8 of the present invention). Gokaraju does not teach that the composition comprises caffeine (as stated within claim 9 of the present invention). Gokaraju does not teach that the composition comprises said caffeine in an amount of about 18 mg to about 540 mg (as stated within claim 10 of the present invention). Gokaraju does not teach that the composition comprises thiamin within the claimed percentage by weight (as stated within claim 12 of the present invention). Gokaraju does not teach that the composition comprises thiamin in the stated milligrams (mg) (as stated within claim 13 of the present invention).
Gokaraju does not teach that the composition comprises majority of the claimed ingredients (except the Mangifera indica leaf (e.g. mango leaf) extract and one or more B vitamins) (as stated within claim 14 of the present invention). Gokaraju does not teach that the composition is contained within a bulk package, the bulk package containing a measuring scoop and the powdered dietary supplement composition, the measuring scoop being sized to scoop an amount of the powdered dietary supplement composition suitable for blending with a liquid to form a beverage, wherein the amount of the powdered dietary supplement composition is 15 g to 40 g and comprises: (a) arugula extract in an amount of about 20 wt% to about 50 wt%; (b) grape seed extract, grape skin extract, or a combination thereof, in an amount of about 2 wt% to about 5 wt%; and (c) mango leaf extract in an amount of about 2 wt% to about 5 wt% (as stated within claim 23 of the present invention). Gokaraju does not teach that the composition further comprises caffeine in an amount of about 1 wt% to about 5 wt% (as stated within claim 24 of the present invention).
Crozier teaches a composition for improving exercise performance (abstract). Crozier teaches that the composition has a plant-derived nitrate selected from arugula extract (claim(s) 4 and 8). Crozier teaches 100-200 mg of a plant-derived nitrate ([e.g. arugula extract]) (paragraph 0012). Crozier teaches [that] additional combinations can be made with food supplements or vitamins or herbal products, in particular but not limited to caffeine (paragraph 0016).
Sun teaches a pharmaceutical composition comprising grape seed extract (page 6). Sun teaches [that the] pharmaceutical composition is also used for: alleviating body dysfunction (including but not limited to: enhancing exercise ability and enhancing endurance) (page 7).
The composition as taught by Gokaraju can be modified to further include ingredients such as arugula extract and caffeine as taught by Crozier, and grape seed extract as taught by Sun in order to create a dietary supplemental composition. In addition, one of ordinary skill in the art would understand that arugula extract as taught by Crozier is known in the art to contain high levels of nitrate. Thus, one would reasonably expect that the aforementioned references (e.g. Gokaraju, Crozier and Sun) that teaches the claimed ingredients are sufficient to be combined into a dietary supplemental composition that intrinsically, would result in being packaged in the form of a solid, tablet, capsule or liquid in order to eventually be used by a consumer.
Regarding claim(s) 2, 4-6, 8, 10, 12-13 and 23-24, the combined aforementioned references do not specifically teach adding the ingredients together in the amounts claimed by the applicant and do not specifically teach a powdered dietary supplement in the amounts claimed by the applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
In addition, these references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in a composition to assist with strenuous activity (e.g. working out or enhancing performance). It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from them having been used individually in the prior art. Based on the disclosure by these references that these substances are used in compositions, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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