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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 23, 2025 has been entered.
Claims 1-18 are pending. Claims 1-6 are examined on the merits. Claims 7-18 are withdrawn.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.
Election/Restrictions
Claims 7-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on Feb. 28, 2024.
Applicant's election with traverse of Group I (Claims 1-6), the species taurine in the reply filed on Feb. 28, 2024 is acknowledged. The traversal is on the ground(s) that there is no burden to search all the species and groups. This is not found persuasive because a search of one group is not coextensive with the search of the other groups. Thus, it would be burdensome to search the entire claims.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/8/22 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner on April 9, 2024.
Response to Amendment
Claim Rejections - 35 USC § 101
Claims 1-6 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) 1-5 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 recite a supplement with caffeine from coffee, green tea, and guaran seed. Taurine is from meat or fish. 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 supplement of caffeine and taurine do not have markedly different characteristics. The claimed mixture is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the instantly claimed mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. The inherent or innate characteristics of the naturally occurring counterpart cannot show a markedly difference. The differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference. There is no difference in function, structure or other properties. Here, the extracts are from natural products. Applicant needs to demonstrate that the mixture as a whole would result in markedly different characteristics from its natural activities. When specific amounts being claimed, those amounts might or might not impart markedly different characteristics. The ingredients are known for treating health supplement; 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. In this case, the formulation as a health supplement does not add additional elements to the composition because the plant extracts in a supplement would be a naturally found pharmaceutically acceptable form that, in combination in the composition, is not a specific practical application (see US 20040001817 A1).
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.” In this case, Applicant does not indicate there are other characteristics that are different than those found in nature for the specific ingredients, caffeine and taurine. The mixture of ingredients even with one molecule of the different plant products would not affect the chemical characteristics of the composition to have markedly different characteristics. Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant argues that the extract contains not only caffeine.
In response to Applicant’s argument, the claims are written as “caffeine from an extract containing caffeine from coffee beans… and … from an extract containing caffeine from green tea.” The broadest reasonable interpretation of the claim language would be caffeine. As long as caffeine is taught in the prior art teaching a formulation containing the amounts of caffeine, then the claims are taught by the prior art.
Applicant argues that the composition of caffeine is not naturally occurring.
In response to Applicant’s argument, the claims are drawn toward caffeine composition. In order for the composition to show markedly difference, the characteristic(s) must be changed as compared to nature. The inherent or innate characteristics of the naturally occurring counterpart cannot show a markedly difference. The differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference. There is no difference in function, structure or other properties. Here, the claimed composition is simply caffeine, without requiring any other components. The chemical structure and property of caffeine is the same in nature and the claimed composition because it is the same chemical. Caffeine is naturally found in coffee or tea. The source of caffeine does not render the caffeine different in chemical activity. The closest naturally occurring counterpart would be caffeine, which is found in nature. The pH of about 3.4 is acid pH, which is the pH found in tea or coffee; thus, there is no markedly different characteristics.
The declaration under 37 CFR 1.132 filed by Ashoo Jain on January 24, 2025 is insufficient to overcome the rejection as set forth in the last Office action because the declaration is drawn toward Application 16/053963, which is not for this case. The Application 16/053963 are drawn toward methods of formulating a caffeine supplement using caffeine extracts, which is not the same as the instant caffeine composition. It refer(s) only to the system described in the above referenced application and not to the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716. The claims are not directed to patent eligible subject matter based on 35 U.S.C. 101 judicial exception analysis stated above.
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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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655