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 .
DETAILED ACTION
The Amendments filed on 7/8/2026 has been received and entered.
Claims 63-67 and 74-82 are pending. Claims 63-67 and 74-76 are examined on the merits. Claims 77-82 are withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant’s election of Group I (Claims 63-76), the species whey protein in the reply filed on 11/20/2025 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Claims 77-82 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 7/8/2026 and 1/26/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. The 1/26/2024 IDS was considered in the Non-Final office action mailed on February 9, 2026. The July 8, 2026 IDS is currently being considered.
Response to Amendment
Claim Rejections - 35 USC § 101
Claims 63-67 and 74-76 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 63-67 and 74-76 are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims chromium picolinate, amino acid source and a pharmaceutically acceptable vehicle. Chromium picolinate is found in meats, grain products, fruits, vegetables, nuts, spices, brewer’s yeast, beer, and wine (see Brown 2017, Discover the Natural Sources of Chromium Picolinate: Foods You Need to Know - EasyHealthyFoods). Amino acid is found in nature as milk. Pharmaceutically acceptable vehicle is a carrier, which can be sugar, a substance found in nature. 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, in claims 63-67 and 73-74, the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
In this case, claim 76, the form of a powder does not make the chromium picolinate, amino acid, and pharmaceutically acceptable carrier have markedly different characteristic. Powder form is found in nature when the milk and fruit or vegetables dried and became ground by gravity or animals.
In the instant case, claims 63 and 74-75 have no amounts for chromium picolinate, the claimed composition does not necessarily have any markedly different characteristics when the amounts of the components are too low to impart any characteristics. However, when specific amounts being claimed, those amounts might or might not impart markedly different characteristics. The ingredients are known for treating body weight (see rejection below); thus, there is no markedly different characteristic from its natural counterparts.
A change in the ratio or amount of extract does not transform the claims into an exemption of the ‘judicial exception' because amounts/ratios/percentages do not set forth a ‘markedly different' structure as compared to the naturally-occurring product (see; e.g., Diamond v. Chakrabarty, 447 U.S. 303 (1980)). Therefore, all of the ingredients recited in the claims are natural products; thus, the claims involve the use of judicial exceptions.
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.
The composition of the chromium picolinate, amino acid, and a pharmaceutically acceptable vehicle together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then 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.” The mixing of chromium picolinate, amino acid and a pharmaceutically acceptable vehicle are well understood, routine, and conventional method of making a product for supplementing nutrition (see below). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 63-67 and 74-76 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gao (CN 1557301 A).
Gao teaches a supplementary nutrient composition comprising free amino acids 500-1500 mg lysine, 500-1500 mg arginine, 500-1500 mg glutamine, 400-1000 mg glycine, 400-1000 mg leucine, 400-1000 mg isoleucine, 400-1000 mg valine, and 50-1000 microgram chromium picolinate (Claim 1) with pharmaceutically acceptable carrier (Claim 7) for oral administration as a powder (page 5, paragraph 10). The essential amino acids are from about 1-30 g. Since the same amounts are taught, the same percentages of Claim 65 would be taught.
Response to Arguments
Applicant argues that chromium picolinate is not a natural product.
In response to Applicant’s argument, Brown teaches sources of chromium picolinate are from whole grains, meat and poultry, fruits and vegetables, nut and seed, dairy products, herbs and spices, and brewer’s yeast (2017, Discover the Natural Sources of Chromium Picolinate: Foods You Need to Know - EasyHealthyFoods). Even if chromium picolinate is not a natural product, Claims 63 and 74-76 do not contain amount for chromium picolinate. If the claimed composition is a combination of two nature-based components, which combination is not found together in nature, each of which imparts a different characteristic to the overall composition, then the claimed composition having those two characteristics are compared to each of the nature-based components separately, then because in that comparison the composition has a different set of characteristics compared to the individual components, then the claimed composition is markedly different from either of the nature-based components. In the instant case, claim 63 has no amounts, so even if the combinations of the ingredients (at particular amounts) had markedly different characteristics when in combination, because there are no claimed amounts, the claimed composition does not necessarily have any markedly different characteristics when the amounts of the components are too low to impart any characteristics. However, when specific amounts being claimed, those amounts might or might not impart markedly different characteristics. The ingredients are known for treating health; thus, there is no markedly different characteristic from its natural counterparts.
A change in the ratio or amount of extract does not transform the claims into an exemption of the ‘judicial exception’ because amounts/ratios/percentages do not set forth a ‘markedly different’ structure as compared to the naturally-occurring product (see; e.g., Diamond v. Chakrabarty, 447 U.S. 303 (1980)). Therefore, all of the ingredients recited in the claims are natural products; thus, the claims involve the use of judicial exceptions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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