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
Claims 63-82 are pending. Claims 63-76 are examined on the merits. Claims 77-82 are withdrawn.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Claims 77-82 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim.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 statement (IDS) submitted on 1/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 63-76 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, 68-70 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. Amino acid source of whey protein 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, 68-70, 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, whey protein, 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 this case, Claims 71-73, hydrolyzed amino acid source, is not an additional element that renders the claim markedly different from the natural amino acid source found in nature because water is found in nature, which is found in milk.
In the instant case, claims 64-67, 74-75 has 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 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 source 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 source and a pharmaceutically acceptable vehicle are well understood, routine, and conventional method of making a product for supplementing nutrition such as a juice or powder supplement (see https://ods.od.nih.gov/factsheets/Chromium-HealthProfessional/#:~:text=Many%20whole%20grains%2C%20fruits%2C%20and,and%20seeds%3B%20and%20soy%20products.). 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, 68-73, and 76 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mao et al. (US 20100009014 A1).
Mao et al. teaches a composition comprising essentially of chromium picolinate (Claim 1), whey protein (Claim 4) at a ratio ranging from 1:001 to 1:10 (Claim 2). The composition of the present invention can be formed by mixing the powder of lactoferrin with the powder of trivalent chromium compound. Moreover, water can also be added into the mixture of lactoferrin and the trivalent chromium compound to form a mixed solution. The mixed solution can be heated properly so that the mixing can be done adequately. The heating temperature ranges around 37.degree. C. to 95.degree. C., and preferably ranges from 50.degree. C. to 80.degree. C. The well-mixed solution can be then spray-dried to form the composition containing trivalent chromium lactoferrin of the present invention [0019]. Water is a pharmaceutically acceptable carrier and can hydrolyze the amino acid source; thus, limitation of Claims 71-73 are met. Spray-dried form will be a powder; thus, Claim 76 limitation is met.
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.
Claim(s) 63-76 are rejected under 35 U.S.C. 103 as being unpatentable over Mao et al. (US 20100009014 A1).
Mao et al. teaches a composition comprising essentially of chromium picolinate (Claim 1), whey protein (Claim 4) at a ratio ranging from 1:001 to 1:10 (Claim 2). The composition of the present invention can be formed by mixing the powder of lactoferrin with the powder of trivalent chromium compound. Moreover, water can also be added into the mixture of lactoferrin and the trivalent chromium compound to form a mixed solution. The mixed solution can be heated properly so that the mixing can be done adequately. The heating temperature ranges around 37.degree. C. to 95.degree. C., and preferably ranges from 50.degree. C. to 80.degree. C. The well-mixed solution can be then spray-dried to form the composition containing trivalent chromium lactoferrin of the present invention [0019]. Water is a pharmaceutically acceptable carrier and can hydrolyze the amino acid source; thus, limitation of Claims 71-73 are met. Spray-dried form will be a powder; thus, Claim 76 limitation is met.
However, the amounts of Claims 64-67, 74-75 are not taught.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising amounts of Claims 64-67, 74-75 of the active agent combination for the following reasons. The reference does teach the composition for treating body weight. Mao et al. teaches a composition comprising essentially of chromium picolinate (Claim 1), whey protein (Claim 4) at a ratio ranging from 1:001 to 1:10 (Claim 2). Thus, it would have been obvious to make a concentrated composition containing both flavonoids and tocotrienols for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
No claim is allowed.
Contact Information
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 on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 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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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655