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 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, in step (vii) applicant claims “etc”. It is unclear as to the metes and bounds of this claim. Generally, “etc” is used to denote similar variants. This is a relative term, and applicant has provided no direction on how to interpret “etc”.
Dependent claims are included.
Regarding claim 1, in step (vii) there is an including step and it is unclear if that including step limits only step (vii) or is intended to be additional components for the entire composition. For example, is it extracted prunellau vulgaris or the mixture of the entire composition that is extracted. As these are two different compositions it is unclear what is being linked to including.
Dependent claims are included.
Claims 2-3, are also rejected due to the inclusion of “can be” in line 2 of both claims. Does the claim require the actual claimed percentages in claims 2 and 3 or is this like a preference. Because it is unclear if it is a requirement, the claims are indefinite.
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 1-3 are rejected under 35 U.S.C. 101 because yhe 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
A review of the prior art shows no prior art formulations using all 8 claimed extracts at their specific formulations. It is noted that the claimed extracts are generally in the laundry lists of many traditional Chinese medicinal formulations. See for example, Yng-Wong (WO 01/22934 A2). The claimed extracts are in the laundry lists starting at page 14 and ending in page 44. However, the office has determined that there is not motivation to pick and choose these 8 extracts.
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.
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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