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 1/26/2026 has been received and entered.
Claims 1, 3, and 5-7 are pending and examined on the merits.
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Any rejection not reiterated below are hereby withdrawn.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 without traverse of the species interleukin-1 beta in the reply filed on 7/2/25 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/21/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claim Rejections - 35 USC § 101
Claims 1, 3, and 5-7 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) 1-7 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 Syneilesis palmata leaf extracted in water then lyophilized as an active ingredient. Powder form is found in nature because dried leaves in puddles of water then steeped on by animals or humans will form a powder after the water evaporated from the sunlight. The heating at 60 degree C for 3 hours speeded up the extraction process. The composition is still the same ingredient from the extract. 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, Claims 5-7 formulates a Syneilesis palmata extract in a food composition would have the same immunity-enhancing abilities as claimed. 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, 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.” In this case, formulations of an extract in a food composition 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 § 102/103
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 -
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 3, and 5-7 are rejected under 35 U.S.C. 102(b) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Hwang et al. (KR 20160038144 A). This is a new rejection.
Hwang et al. teaches a composition containing syneilesis palmata as the active ingredient ([0001], Description of Embodiments, paragraph 1). The solvent for the production of the extract includes water ([0001], Description of Embodiments, paragraph 3). The herb used includes the upper part (stem, leaf) ([0001], Description of Embodiments, paragraph 4). The herb effective ingredients can be used for medicine for health promotion and or prevention of aging or health food (page 3, paragraph 1). Formulations for administration include lyophilized preparations (page 3, paragraph 7). The effective amount daily dose is 0.1-100 mg/kg, preferably 30-80 mg/kg, 50-60 mg/kg (page 2, paragraph 8). Therefore, a concentration of 50 microgram/mL can be formulated from 0.1-100 mg/kg. Hot water extract showed 7%, 37%, 25%, and 22% DPPH radical scavenging ability at 0.1 mg/mL (experimental Example 1). The same food composition can be used in companion animals and have the biological effects of Claim 3 because they are used for the same purpose. Therefore, the limitations of claims 1, 3, and 5-7 are met.
The claims are drawn to an immunity-enhancing composition comprising lyophilized water extract of Syneilesisi palmata leaves as the active ingredient therein comprising amount ranges of naturally occurring water extract of Syneilesisi palmata leaves therein, within a product-by-process claim.
The cited reference teaches a composition (including in lyophilized form) consisting of (or consisting essentially of) an aqueous extract of Syneilesisi palmata leaves as the active ingredient therein which appears to be identical to (and thus anticipate) the presently claimed Syneilesisi palmata leaf extract composition (including inherently comprising the instantly claimed levels of Syneilesisi palmata leaves water extract, as well as the naturally-occurring quercetin derivatives of claim 1, therein) since both were prepared using similar hot aqueous extraction (including the same essential temperature heating range) and concentration steps, and both demonstrate the same/similar activity with respect to radical scavenging ability at 0.1 mg/mL (experimental Example 1). Consequently, the instantly claimed Syneilesisi palmata leaf extract composition appears to be anticipated by the cited reference.
In the alternative, even if the claimed Syneilesisi palmata leaf composition is not identical to the referenced Syneilesisi palmata leaf extract composition with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced Syneilesisi palmata leaf composition is likely to inherently possess the same characteristics of the claimed Syneilesisi palmata leaf composition particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed Syneilesisi palmata leaf composition would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Further, if not anticipated, the result-effective adjustment of particular conventional working conditions (e.g., forming a tablet or other commonly employed oral pharmaceutical form comprising a result-effective amount of the red leaf extract beneficially taught by Abeles therein) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether the levels of Syneilesisi palmata leaf within Applicant’s Syneilesisi palmata leaf differ and, if so, to what extent, from the levels within the red leaf extract disclosed by the cited reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Please also note that “the patentability of a product does not depend upon its method of production. If the product in [a] product-by-process claim is the same as or obvious from a product of the prior art, [then] the claim is unpatentable even though the prior [art] product was made by a different process.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289, 292 (Fed. Cir. 1983).
Response to Arguments
Applicant argues that there is markedly different characteristics because a lyophilized powder is not natural.
In response to Applicant’s argument, powder form is found in nature because dried leaves in puddles of water then steeped on by animals or humans will form a powder after the water evaporated from the sunlight. Thus, there is no markedly different characteristics.
Applicant argues that the heating of the herbal extract makes the composition markedly different.
In response to Applicant’s argument, the heating at 60 degree C for 3 hours speeded up the extraction process. The composition is still the same ingredient from the extract. There is no markedly different characteristics. The hand of man is no longer the limitation for patentability.
Applicant argues that the amount of 50 microgram/mL is not a concentration that is found in nature.
In response to Applicant’s argument, the concentration does not render the composition markedly different in characteristic. The chemical composition is still the same ingredient as those found in nature. The amount does not make the composition markedly different in characteristic because the chemical is still the same.
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.
Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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