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 .
Election/Restrictions
Applicant's election with traverse of Group I and the species Ganoderma lucidum, strain CBS 147379, in the reply filed on 11/10/2025 is acknowledged. The traversal is on the ground(s) that the applicant believes there to be unity of invention and argues the differences between the art recited in the election/restriction by Stamets to be different than the inventions recited in the instant application. The subtle differences between the instant application and the relied upon art do not yet need to be argued as there has not yet been a rejection made. The Office relied upon the Stamets to show that the special technical feature was previously described in the art and therefore unity of invention has been broken. The special technical feature is the active compounds from strains of Ganoderma lucidum, not necessarily the method of obtaining them. The applicant argues that the Office should examine each separate invention because the inventions are related and there is unity of invention, however the applicant does not consider that the guidelines clearly illustrate that if the common technical feature among the product and process is known in the art, unity is lacking.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-14, 16-19 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/10/2025.
Claims 1-8, 15 and 20 are being examined on the merits.
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.
Regarding claims 1 and 3, the phrase "essentially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The term makes the metes and bounds of the claims confusing because it cannot be understood if this further limits the claim to specific amounts of liquid or if the culture can be something different than liquid for claim 3 or limits the amount of agitation or lack thereof in claim 1.
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.
Claim 1-8, 15 and 20 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. 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 fungal 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 biologically active components from strains of Ganoderma lucidum the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within fungi. Fungal extracts are made by partitioning the starting fungal 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 versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the fungal material. Fungal extracts are purified by removing unwanted 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 fungi 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 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.
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 Ganoderma lucidum composition is only comprising the nature-based products and the only other additional elements to consider are the varying amounts (ratios) of the fungal components and the culture conditions.
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.
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)). In the instant case there are no other additional elements to consider besides the components that exist within the fungal species and these are the judicial exceptions.
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.
Claim Rejections - 35 USC § 102
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou Yingkui (CN107384809A).
Regarding claim 1, Yinhkui discloses a Ganoderma Lucidum liquid fermentation culture (see pages 8-10, embodiments 1-4) and discloses the liquid fermentation product to be able to treat micro-biological infections such as virus (see page 8, para. 4). Regarding the limitation “culturing said fungi in essentially liquid culture medium in a culture tank or a bioreactor in conditions essentially excluding agitation”, the limitation is to a composition and not a method. The composition itself appears to be identical to the prior arts as the antiviral properties have already been reported. Determination of patentability is based on the resultant product itself, including the implied structure therein.
Regarding claim 5, Yinhkui discloses active compounds such as molecular protein (LZ-8) accounts for 16.2~16.6% and GL-B more than 16%, (see page 3 last para.).
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 1-3, 5-8, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Paul Stamets (From IDS, WO2016161138A1).
Regarding claims 1 and 3, Stamets teaches antiviral compositions from mushroom mycelium (see abstract) and teaches the mushroom to be Ganoderma lucidum (see claim 39 and 0015).
Stamets teaches “Remarkably, and unexpectedly, the author's discovery that the alcohol soluble extracts of Ganoderma lucidum (Ganoderma lucidum var. resinaceum) mycelium showed anti-flu activity is novel in that it is in direct contradiction to past results that alcohol extracts from fruitbody extracts had no activity” (see 0015).
“The medicinal mushroom mycelium is grown utilizing liquid culture techniques. Whereas growing on rice might have 30-40% conversion of rice to mycelium, liquid vat culture may have essentially complete conversion with >3x more mycelium per unit mass. Hence the liquid vat culture of mycelium and its extracellular metabolites will be easier to utilize in the development of this invention as the process of using vat culture eliminates the need to remove non-metabolized substrate ingredients. Any means, methods or process steps known to the art for inoculating or cultivating a pure mycelial culture on a liquid substrate, extracting a mycelial culture, filtering an extract or partially or fully removing a solvent may be utilized” (see example 9, 00123). “Continued heating and stirring concentrates this substance with noticeably sweeter properties” (see 00124).
Regarding claim 2, pertaining the wherein the biologically active compounds is obtainable from the isolated strain CBS147379, this limitation does not appear to distinguish the instant invention over the prior art, because the active components from Ganoderma lucidum already have been shown to have virucidal activity. There has been nothing done to the strain to distinguish it over the prior art besides giving the strain a deposit number and thus the Ganoderma lucidum of the prior art and the instantly claimed strain appear identical.
Regarding claim 5, Stamets teaches active ingredients can be in ranges 1: 1 to 99: 1 by weight percentage (see 0031-0033).
Regarding claims 6-8, Stamets teaches that “any means, methods or process steps known to the art for inoculating or cultivating a pure mycelial culture on grains, nuts or woods, for extracting a mycelial culture” (see 00124) and these are lignocellulosic materials which would comprise of and produce hemicellulose as recognized by the applicant wherein they state: “In embodiment, hemicellulose is produced from lignocellulosic biomass” (see Summary of the invention, page 3).
Regarding claim 15, Stamets teaches formulations which are to be applied to the skin (see 00173-0174).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to select Ganoderma lucidum as the mushroom species for the invention taught by Stamets because Stamets teaches that this species is specifically useful for antiviral compositions. It would have also been obvious to grow the G. lucidum in a liquid culture medium in a culture tank in conditions essentially without agitation because Stamets teaches growing in a vat and teaches that continued heating and stirring concentrates this substance with noticeably sweeter properties, thus one could slowly heat and stir the culture within the tank without agitating the medium to concentrate the active components. Additionally, the composition itself appears to be identical to the prior arts as the antiviral properties have already been reported. Determination of patentability is based on the resultant product itself, including the implied structure therein.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Paul Stamets (WO2016161138A1) as applied to claims 1-3, 5-8, 15 and 20 above, and further in view of Qinchang Zhu et. al. (Inhibition of neuraminidase by Ganoderma triterpenoids and implications for neuraminidase inhibitor design, Scientific Reports, 5, Article number: 13194 (2015)).
Stamets teaches the instant inventio however is silent on the composition comprising Ganoderic acid.
Zhu teaches “Neuraminidase (NA) inhibitors are the dominant antiviral drugs for treating influenza in the clinic. Increasing prevalence of drug resistance makes the discovery of new NA inhibitors a high priority. Thirty-one triterpenoids from the medicinal mushroom Ganoderma lingzhi were analyzed in an in vitro NA inhibition assay, leading to the discovery of ganoderic acid T-Q and TR as two inhibitors of H5N1 and H1N1 NAs. Structure-activity relationship studies revealed that the corresponding triterpenoid structure is a potential scaffold for the design of NA inhibitors. Using these triterpenoids as probes we found, through further in silico docking and interaction analysis, that interactions with the amino-acid residues Arg292 and/or Glu119 of NA are critical for the inhibition of H5N1 and H1N1. These findings should prove valuable for the design and development of NA inhibitors” (see abstract).
Ganoderma lingzhi (previously known as Ganoderma lucidum), an oriental fungus, has been used to promote health and treat various diseases in East Asian countries, especially China, Japan and Korea, for thousands of years.The lanostane-type triterpenoids are the major bioactive constituents of G. lingzhi and are reported to have numerous physiological activities including anti-cancer, immunomodulatory, anti-hypertensive, anti-androgenic, anti-diabetic and antiviral properties (see Introduction, 4th para.).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to include ganoderic acid in the invention taught by Stamets for having antiviral activity because ganoderic acid is known to act as neuraminidase inhibitors for H5N1 and H1N1 strains.
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