DETAILED ACTION
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 .
Claim Summary
Claims 1-4 are pending
Claims 1-3 are currently amended
Claim 4 has been added as a new claim
Summary of rejections in the CTNF on 1/9/26.
Claim objection of claim 1 – maintained
Applicant did not address the issue nor did they respond to this claim objection.
35 USC 112b rejections are withdrawn due to applicant’s claim amendments.
101 rejection is maintained
Response to Arguments
Applicants’ arguments filed 6/9/26 have been fully considered but they are not persuasive.
Applicant’s arguments have been considered but are not persuasive. The rejection of claims 1-3 under 35 U.S.C. § 101 is maintained.
Applicant argues that supplemental testing data demonstrates that the claimed mixture as a whole exhibits a property “markedly different” from the properties of the individual natural components. Specifically, applicant points to alleged changes in immune cell counts, HBV-DNA viral load, HBsAg values, and liver function markers in several individual testers after taking the claimed composition.
However, the response does not provide sufficient objective evidence to establish that the claimed composition has markedly different characteristics from its naturally occurring components. The submitted information appears to consist primarily of attorney argument and summary characterization of alleged testing results, without a supporting declaration or affidavit, without complete underlying test data, and without sufficient explanation of the test conditions. While rebuttal evidence may be presented in different forms during prosecution, arguments by applicant cannot take the place of factually supported objective evidence. See MPEP 2145; In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
Additionally, the submitted information does not establish that the alleged differences in results are statistically and practically significant. See MPEP 716.02(b); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. PAT. App. & Inter. 1992). The supplemental data appears to involve only a small number of individual testers and does not identify a statistically meaningful test population, control group, placebo group, baseline variability, confidence intervals, statistical analysis, or other parameters necessary to determine whether the alleged changes are attributable to the claimed composition rather than to other causes.
The response also does not establish adequate control parameters. For example, applicant does not sufficiently identify whether the testers were taking other medications or supplements, whether their diets or lifestyles changed, whether they received concurrent medical treatment, whether the testing was blinded or controlled, or whether the observed changes fall within expected biological variability. Accordingly, the record does not establish that the alleged changes were caused by the claimed composition.
Further, applicant has not shown that the evidence is commensurate in scope with the claims. Claim 1 broadly recites a composition comprising eight natural plant-based ingredients over broad percentage ranges and includes water-extracted powder, concentrated liquid, paste, and other forms. Applicant has not identified the exact formulation tested, the actual weight percentages of each ingredient, the preparation method, dosage, frequency of administration, treatment duration for each subject, or whether the tested composition corresponds to the full scope of claim 1. As such, the evidence does not establish that the full breadth of the claimed composition exhibits the alleged markedly different property.
Most importantly, applicant has not shown that the claimed combination of natural products produces a new or markedly different characteristic relative to the individual natural components. The submitted data does not compare the claimed eight-ingredient combination against the individual ingredients, subcombinations, or conventional herbal aggregates. Thus, the data does not show whether the alleged immune or liver-related effects result from the claimed mixture as a whole, from one or more individual ingredients, from a subset of ingredients, or from other non-composition-related factors.
The rejection previously identified evidence that at least some of the alleged properties are known properties of individual ingredients or related herbal components, including immune-enhancing, liver-related, antiviral, mitochondrial/ROS-related, and cholesterol-related effects. Applicant’s response does not persuasively rebut this finding. Instead, applicant provides outcome observations from a small number of testers, but does not establish that the claimed combination produces a property different in kind from the natural properties of the individual components, or that the combination produces synergistic or otherwise markedly different characteristics.
Accordingly, the record does not establish that the claimed nature-based product has markedly different characteristics from its natural counterparts. Nor does the claim recite additional elements integrating the nature-based product into a practical application or amounting to significantly more than the judicial exception. The claim remains directed to a mixture of natural plant materials/extracts in routine forms and broad relative amounts.
The mere observation that certain individuals experienced changes in immune or liver-related biomarkers after consuming an unidentified or insufficiently characterized herbal composition does not establish that the claimed composition has markedly different characteristics from the natural products themselves. The claimed subject matter remains a mixture of natural plant materials/extracts, and the record does not demonstrate that the combination produces a new structure, new function, synergistic effect, or other markedly different characteristic sufficient to render the claimed nature-based product patent eligible under 35 U.S.C. § 101.
Therefore, the rejection of claims 1-4 under 35 U.S.C. § 101 is maintained.
Claim Objections
Claim 1 is objected to because of the following informalities: There are two component (iv) in claim 1. Please fix and renumber the components. Appropriate correction is required.
The numbering needs corrected ad (iv) is repeated twice.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more. The claim(s) recite(s) a collection of known wild plants used in combination. This judicial exception is not integrated into a practical application because the composition is just an extraction or concentration of known plant material. . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no specific non-natural chemical modification of constituents, no unconventional processing beyond extraction and concentration, and no evidence of a new structure arising from the mixture are recited.
101 Analysis
Step 1: Statutory category determination
The claim is to a composition of matter. It falls within a statutory category under 35 U.S.C. § 101.
Step 2A, Prong 1: Identify judicial exception(s)
The claim recites a mixture of natural products (plant materials/extracts) known in nature. The “nature-based product” analysis applies. See MPEP 2106.04 (c). In this case, we will compare the combination as claimed to the individual natural components.
See MPEP 2106.04(c)(II)(A)
When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").
Markedly different analysis.
As claimed, each ingredient is a known natural plant material used in TCM (Traditional Chinese Medicine); the claim encompasses routine extract forms (“water extracted powder,” “concentrated liquid,” “paste”) and broad percentage ranges.
The claim does not recite any structural modification to the plant constituents (e.g., chemical derivatization, synthetic conjugates), nor does it recite a non-natural structure of the mixture (e.g., co-precipitated complexes, nanoparticles with defined architecture) that yields properties not possessed by the natural counterparts.
The specification presents outcome data (changes in immune cell counts, HBV DNA, lipid values) but does not provide evidence that the mixture as a whole exhibits a property “markedly different” from the properties of the individual components or their conventional aggregates (e.g., demonstrated synergism beyond additive effects with proper controls, or a new function not present in any individual herb).
In paragraph 0023/0027 of applicant’s specification there is an allegation of the following outcomes:
Promotion of immune system
This is a known property of at least one individual component, see Wang et al. (US 2022/0273687 A1) in paragraph 0002 discloses that “pharmacological studies have shown that the Hedyotis diffusa Willd. has antibacterial, immunity-enhancing, anti-tumor and anti-aging effects.”
Enhanced energy
This is a known property of at least one individual component, see Cohen et al. (US 2010/0069480A1) at abstract and paragraph 0022 disclosing connection between scutellaria barbata and mitochondrial change as ROS generation.
Detoxifying advantage (liver)
This is a known property of at least one individual component, see Dao et al., (US 2016/0143970 A1) in paragraph 0040 discloses that “Scutellaria barbata (Skullcap): Scutellaria barbata, a traditional Chinese medicine for liver, lung and rectal tumors, has been shown to inhibit mutagenesis, DNA binding and metabolism of aflatoxin B1 (AFB1) and cytochrome P450-linked aminopyrine N-demethylase (Wong B. Y. et al., (1993) Eur. J. Cancer Prev. 2(4):351-6; Wong B. Y. et al., (1992) Mutat. Res. 279(3):209-16). Scutellaria barbata is also capable of enhancing macrophage function in vitro and inhibiting tumor growth in vivo (Wong B. Y. et al., (1996) Cancer Biother. Radiopharm. 11(1):51-6).”
HBV (hepatitis)/HIV improvement
This is a known property of at least one individual component, see WU (US 2002/0076446 A1) disclosing in claim 1 that “ A herbal pharmaceutical composition for treating patients with liver disease and/or HIV comprising: an entire plant of Herba Hedyotidis diffusae (diffuse hedyotis); a dried rhizome of Rhizoma Bistortae (bistort rhizome); a dried rhizome of Rhizoma Polygoni Cuspidati (giant knotweed rhizome); and a dried ripe fruit of Fructus Schisandrae (Chinese magnoliavine fruit).” HPV is also taught in paragraph 0019 to be associated with Herba Hedyotidis diffusae.
Cholesterol Improvement
This is a known property of at least one individual component, see Seo (US 2010/0285156 A1) at paragraph 0039 that discloses that Lysimachiae extract is known to reduce cholesterol.
On this record, the claim “recites” a product of nature without establishing markedly different characteristics.
Step 2A, Prong 2: Analyze integration into a practical application; discuss any claimed technological improvement; address whether extra-solution activity or field-of-use limitations are present.
The claim is a pure composition claim, not a method. Aside from the listing and relative amounts of natural ingredients and routine extract forms, there are no additional elements tying the nature-based mixture to a particular machine, transformation, or a specific manufacturing process that imparts new structural/functional characteristics to the composition.
No asserted improvement to a technology or technical field (e.g., a new extraction process that alters constituent chemistry, a delivery system improving bioavailability via defined microstructure) is recited. The field-of-use (enhancing the immune system) is an intended result, not a technological application.
Therefore, the claim does not integrate the exception into a practical application.
Step 2B: Assess whether additional elements are significantly more; discuss WURC (Well-understood, routine, and conventional) with evidentiary considerations.
Additional elements beyond the natural ingredients are limited to:
Relative percentage ranges of each herb.
Conventional extract forms (“water extracted powder,” “concentrated liquid,” “paste”).
Selecting proportions of known herbal ingredients and forming routine extracts are well-understood, routine, conventional activities in herbal formulation. The specification frames the invention in conventional nutritional supplement terms and does not disclose non-conventional processing steps or structures that would supply an “inventive concept.”
There is no recitation of non-routine formulation technology (e.g., defined microencapsulation parameters imparting a new dissolution profile, covalent modification producing non-natural conjugates, or fermentation yielding non-naturally occurring metabolites). Thus, even if Step 2B were reached, the additional elements would be WURC and do not amount to “significantly more.” See Berkheimer (WURC requires factual support; here, the art and the spec indicate conventional extraction and blending).
Conclusion
Ineligible under § 101. The claim recites a nature-based product (a mixture of known natural herbs) without markedly different characteristics from the natural counterparts and without integration into a practical application or an inventive concept. This determination is made in part do to the alleged benefits being associated with these TCM herbs for many years.
Conclusion
THIS ACTION IS MADE FINAL. 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 AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
