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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Response to Amendment
Applicant's amendment and argument filed 12/22/2025, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-19 are pending of which claims 3-4, 6, 8-19 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 04/04/2025.
Claims 1-2, 5 and 7 are being examined on the merits.
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.
This rejection for claims 1-2 and 5 are maintained due to the arguments filed on 12/22/2025 and current claim 7 is rejected as explained below
Claims 1-2, 5 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a composition comprising fungal compounds and grape seed extracts, a birch bark extract, Andrographis paniculate or an extract thereof, Capsicum annum or an extract thereof, capsaicin, chromium picolinate, a mineral, vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, and any combination thereof. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products listed above the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterparts.
The claim recites the naturally occurring components found within plants. Fungal and plant extracts are made by partitioning the starting material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant/fungus versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant and fungal extracts are purified by removing unwanted plant/fungal material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant/fungus in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the fungi and plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way. The same is true of the vitamins claimed because those vitamins are natural judicial exceptions being claimed without any significant markedly characteristics and are merely being claimed as they would be found existing in nature. Claiming the fungal components in a synergistic ratio without showing that these components actually exert synergy for any activity does not allow those judicial exceptions the synergy that is actually being claimed.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the composition is only comprising the nature-based products and the only other additional elements to consider are the varying amounts (ratios) of those components. Claiming the fungal components in a synergistic ratio does not integrate the recited judicial exceptions into any practical application.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
The formulations which include chewable dosage forms, sprays, and even aerosols when so broadly claimed do not overcome natural forms of those judicial exceptions because these fungi and fungal components can indeed exist naturally as a liquid or solid which would be these broadly claimed limitations.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring plant extracts is well-understood, routine practice in the art and has been conducted for centuries. Admixing plant and fungal extracts for creating nutritional compositions is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US 20060062859 A1, US 20060088574 A1, US 20060121006 A1, US 20130337116 A1 and US 20190117778 A1.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive. The applicant argues that since the composition is human engineered it cannot occur in nature. The applicant argues that a formulated dosage composition that integrates its components into a practical therapeutic from such as emulsions, tablets, pills, pellets, capsules, suppositories, aerosols, sprays, chewable dosage forms or gelatin dosage forms overcomes the 101 rejections. The applicant is merely claiming multiple judicial exceptions into a composition and although they are put together by a human, they are not different from their nature-based counterparts. The formulations which include chewable dosage forms, sprays, and even aerosols when so broadly claimed do not overcome natural forms of those judicial exceptions because these fungi and fungal components can indeed exist naturally as a liquid or solid which would be these broadly claimed limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Li Qingjie et. al. (CN107441126B) and Manjinder Kaur et. al. (Anticancer and Cancer Chemopreventive Potential of Grape Seed Extract and Other Grape-Based Products, The Journal of Nutrition, July 29, 2009, 1806S-1812S). This is a new rejection based on the amendments filed on 12/22/2025.
Qingjie teaches of a macro-fungus composition capable of improving NK cell tumor killing activity (see abstract) and teaches wherein the composition comprises of 90g of Hericium erinaceus and 10g of Cordyceps sinensis fermentation powder (see claim 1). Here, Qingjie clearly teaches both fungal components and within the instantly claimed synergistic ratio.
Qingjie teaches creating tablets, capsules, granules, pills, syrup and soft extract oral preparations (see page 4, para. 5).
Qingjie does not specifically teach the composition to comprise of grape seed extract.
Kaur teaches grape seed extract targets signaling cascades for its anticancer and/or chemopreventive efficacy (see page 1807S, right column, first para.). Kaur teaches grape seed extract is well established as having chemopreventive and anticancer effects against skin, colorectal, prostate and breast cancers through multiple mechanisms of action (see page 1808S, right column and table 1).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to combine grape seed extract in with the composition taught by Qingjie because Qingjie teaches of a fungal composition for increasing NK cells tumor fighting activities and Kaur teaches that grape seed extract is known to having anticancer properties through various mechanisms of action. Thus, combining these into a single composition is prima facie obvious for creating a composition with increased anticancer properties.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Qingjie et. al. (CN107441126B) and Manjinder Kaur et. al. (Anticancer and Cancer Chemopreventive Potential of Grape Seed Extract and Other Grape-Based Products, The Journal of Nutrition, July 29, 2009, 1806S-1812S) as applied to claims 1, 5 and 7 above, and further in view of Song Chi Hyun et. al. (KR2007-0001502A). This is a new rejection based on the amendments filed on 12/22/2025.
Qingjie and Kaur’s combined teachings make obvious the instant invention, however are silent on the composition comprising an additional third fungal component as claimed.
Qingjie also teaches wherein the fungal component can be from the Pleurotaceae genus (see page 4, para. 5), however is silent on the species.
Hyun teaches “Endo-biopolymers produced from submerged mycelium culture of Pleurotus eryngii are provided to inhibit proliferation of tumor cancer cells, increase activity of natural killer (NK) cells in the spleen and activity of glutathione S-transferase in the liver. The endo-biopolymers produced from submerged mycelium culture of Pleurotus eryngii, having antitumor activity are provided, wherein the endo-biopolymers are composed of 77.5% of carbohydrates and 21.6% of proteins, and contain glucose and mannoses as major sugars, and glycine and aspartic acid as major amino acids. An anti-tumor agent contains the endo-biopolymers as effective ingredient” (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to combine an extract of Pleurotus eryngii in with the composition taught by Qingjie for increasing NK cells targeting tumors because Hyun teaches that Pleurotus eryngii has the same activity and it is prima facie obvious to combine known equivalents into a single composition with the expectation of increasing the activity.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 5 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655