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 1/12/2026 has been received and entered.
Claims 1-2 are pending and examined on the merits. Claims 3-9 are canceled.
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Any rejection not reiterated below are hereby withdrawn.
Response to Amendment
Claim Objections
Claim 3-9 are objected to because of the following informalities: Applicant is referred to 37 CFR 1.121 (c) (4) (i).
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of "canceled" or "not entered."
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1-2 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 is 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 herbs, which are plants. 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 claim 1, the parts of the plants 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. Artemisinin are found in plants. Artemisinin-base compounds, is not an additional element that renders the claim markedly different from the natural artemisinin-base compounds found in other antimalarial plants. 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.
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 homogenized composition of the different plants and vegetables 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 homogenized herbs are well understood, routine, and conventional method of making a product for supplementing nutrition such as a fruit juice or powder (see Liu, 2013, J American Society for Nutrition Adv Nutr, 4: 3845-3925). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
Claim(s) 1- 2 are rejected under 35 U.S.C. 103 as being anticipated by Omara (2020, Evidence-Based Complementary and Alternative Medicine, Volume 2020, Article ID 4538602, 31 pages).
Omara teaches the composition artemisinin-base combination for malaria treatment (page 1, right column, paragraph 1) with antimalarial plants Justicia betonica aerial parts decoction (page 3, line 2), which can derived from powders (page 14, left column, paragraph 1, middle) or its shoot extracted with methanol, water (Table 3). Antimalarial plants used in Kenya are majorly shrubs (33.2%), trees (30.1%), and herbs (29.7%) (Figure 2), and the commonly used plant parts are leaves (27.7%) and roots (19.4%) followed by bark (10.8%), root bark (10.5%), and stem bark (6.9%) (Figure 3). Antimalarial remedies in Kenya are prepared by different methods. These include decoctions (70.5%), infusions (5.4%), ointments and steaming (1.3%), and roasting (0.3%) (page 12, paragraph 2). Preparation of antimalarial remedies from dry parts of one plant or several plants and ashes by using grinding stones was reported (page 12, left column, Malarial formulations is taken thrice a day for 5 days (page 14, left column, paragraph 1, last line). Conventional treatment is to gather comprehensive ethnobotanical information on various antimalarial plants and their use in Kenyan communities to identify which plants require further evaluation for their efficacy and safety in malaria management (page 2, left column, paragraph 2).
However, Omara does not teach combination with artemisinin-base compunds, 0.1-1.0 g of dried herbs, herbs combined equally.
These reference show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions that treat malaria. 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 their having been used individually in the prior art. In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by these references that these substances are used in compositions to treat malaria, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat malaria. 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 In re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; In re Crockett 126 USPQ 186.
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 0.1-1.0 g of dried herbs, herbs combined equally of the active agent combination for the following reasons. The reference does teach the composition for treating malaria. Omara teaches the composition artemisinin-base combination for malaria treatment (page 1, right column, paragraph 1) with antimalarial plants Justicia betonica aerial parts decoction (page 3, line 2). Thus, it would have been obvious to make a concentrated composition containing Justicia betonica and artemisinin-base compounds for use as a supplement to treat malaria. 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.
Response to Arguments
Applicant did not present arguments. Thus, the rejection remain of record for Claims 1-2.
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.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655