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 of Group II, claims 12-21 in the reply filed on January 09, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-11 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 09, 2026.
Claims 12-21 are examined on the merits.
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) 12-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising an Alpinia galanga extract, coffee fruit extract (e.g. Coffea arabica) and phosphatidylserine of claims 12-21 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 recite extracts from Alpinia galanga and coffee fruit are naturally occurring plants and phosphatidylserine which is a naturally occurring compound. 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, the closest naturally occurring counterpart for phosphatidylserine is the compound itself. In regards to the Alpinia galanga extract and coffee fruit extract, 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 Alpinia galanga and coffee fruit extracts with phosphatidylserine as commensurate in scope with the stated claim changes the structure, function, or other properties of the extracts and the phosphatidylserine 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 extracts 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. 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 the intended use of 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.” In this case, the additional element in the claims is the combination of the ingredients. 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. Mixing specific components within the extract of coffee fruit as taught by Gratson (U.S. Pub. No. US 2021/0236521 A1), such as phosphatidylserine as taught by Gratson (U.S. Pub. No. US 2021/0236521 A1) and a Alpinia galanga extract as taught by Chaudhary (U.S. Pub. No. US 2021/0205400 A1) does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
Moreover, applicant’s intended use as 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.
Claim(s) 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gratson (U.S. Pub. No. US 2021/0236521 A1) in view of Chaudhary (U.S. Pub. No. US 2021/0205400 A1).
Gratson teaches a dietary supplement composition for improving cognitive function which comprises phosphatidylserine and coffee fruit extract (abstract). Gratson teaches that phosphatidylserine is in an amount of about 75 mg to about 400 mg (claim 2). Gratson teaches that coffee fruit extract is in an amount of about 80 mg to 300 mg (claim 3). Gratson teaches teaches the dietary supplement composition further comprises one or more vitamins (claim 20). Gratson teaches wherein the vitamins comprise at least one of vitamin B6 and vitamin B12 (claim 21). Gratson teaches the dietary supplement composition comprising folate (claim 26). Gratson teaches the dietary supplement composition wherein the supplement is in a form selected from the group consisting of a solution, a capsule, a tablet, a gummy, a chewable, a melt in the mouth, a liquid or a caplet (claim 30).
Gratson does not teach the above-mentioned dietary supplement composition that includes the Alpinia galanga extract.
Chaudhary teaches preparing an extract of Alpinia galanga for improving cognitive function (paragraph 0002). Chaudhary teaches 100-900 mg of a water extract of Alpinia galanga (claim 3). Chaudhary teaches an effective amount of an extract of Alpinia galanga that is free of methyl eugenol (claim 2). Chaudhary teaches a water-soluble extract of Alpinia galanga (abstract).
The dietary supplement composition as taught by Gratson can be modified to include the Alpinia galanga extract, as taught by Chaudhary in order to obtain a dietary supplement composition containing the following components: phosphatidylserine, coffee fruit extract, and Alpinia galanga extract. The two references combined show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients within a composition that can be used to improve cognitive function.
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 compositions that can improve cognitive function. 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 to improve cognitive function, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to improve cognitive function. 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
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655