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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/11/2026 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Response to Amendment
Applicant's amendment and argument filed 03/30/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-5 and 7-22 are pending of which claims 9-14, 16-19 and 21-22 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 without traverse in the reply filed on 11/10/2025.
Claims 1-5, 7-8, 15 and 20 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.
Claim 1-5, 7-8, 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 and hemicellulose 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. The claims also recite hemicellulose which are components of cell walls of plants. The same analysis is done for plant extracts which would be the same analysis just described above except for plant components.
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)).
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 components for creating antiviral compositions is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US5840308A, US4869903A, US20030026859A1, US20030170326A1 and US 770303B1.
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.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive. The applicant argues that the hemicellulose enhances the antiviral activity of the composition and stabilizes the composition. The claims are broadly directed to fungal components and hemicellulose. The activity would not be expected in merely any amount of the combined components and therefore outside the tested amounts in figures 11A-11F and 12A and 12B would still exist only a combination of judicial exceptions claimed together in a composition. Additionally, it is not quite clear how the hemicellulose enhances the antiviral activity of the Ganoderma lucidum components. The applicant has tested for cells treated with the Ganoderma lucidum components with and without hemicellulose and figure 11 A and 11 B show wherein the absorbance is slightly increased when hemicellulose is added however there appears to be no control for the hemicellulose alone and what effect this exerts on the cells and/or the ability for the cells to be infected. What is the increase in absorbance readout indicating for the assay? For instance, was there a component such as tetrazolium salts commonly applied during MTT assays added to the medium which can be enzymatically converted to allow for colorimetric readout through viability or metabolic activity? Is this an MTT assay or something different? What is absorbance being measured for?
It is suggested to more clearly describe what assay is being performed and describe in more detail the results. The specifications describe the steps taken in the assay (see page 20) however does not particularly describe why they used absorbance as a readout. More clearly understanding these results would help to move along prosecution.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 7-8, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Paul Stamets (From IDS, WO2016161138A1) and Hwang Ji Hwan et. al. (KR20040067175A).
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 claim 15, Stamets teaches formulations which are to be applied to the skin (see 00173-0174).
Stamets does not specifically teach wherein the composition comprises hemicellulose.
Hwan teaches of method for preparing immune enhancing polysaccharides (see abstract).
Hwan teaches of growing Basidomycetes, specifically Ganoderma lucidum, with hemicellulose in conditions that does not allow for the fungus to break down the hemicellulose and instead uses other carbon sources for energy (see abstract). Hwan teaches that “arabinoxysilane is a hemicellulose with arabinose on its main chain composed of xylose, and is known to be contained in many grains. In particular, this arabinoxysilane has been widely known to be effective in boosting immunity, such as activating natural killer cells” (see page 2, 3rd para.). The arabinoxysilane appear to be a typo of arabinoxylan, a common hemicellulose found in many grains.
Regarding claims 7-8, arabinoxylan is known to be found in wood and lignocellulosic biomass.
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. It would have also been obvious to add hemicellulose such as arabinoxysilane because as Hwan teaches it is commonly known to boost immunity and activate natural killer cells. Combining hemicellulose with the composition taught by Statements for having antiviral activity would have been obvious in order to increase immunity and activate NK cells as discussed by Hwan.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Paul Stamets (WO2016161138A1) and Hwang Ji Hwan et. al. (KR20040067175A) as applied to claims 1-3, 5, 7-8, 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 and Hwan teach the instant invention however are 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 and Hwan for having antiviral activity because ganoderic acid is known to act as neuraminidase inhibitors for H5N1 and H1N1 strains.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive. The applicant argues that Stamets does not specifically teach the growing conditions, particularly wherein there is no agitation and wherein the liquid in the culture medium in a culture tank or bioreactor is in stationary conditions. The examination is to a composition and not necessarily to the process of creating the composition. The specific cultivation methods are not being examined and do not appear to create a markedly different product than the prior art, especially considering the difference being agitation or any movement during culturing in a bioreactor. The applicant argues that a person having skill in the art would not be motivated to not agitate the liquid medium during culturing because Stamets teaches that agitation enhances antiviral metabolite production. Even if one were to grow the cultures without agitation it would still be expected to end up with a product having antiviral metabolites, perhaps just not as many or as concentrated as opposed to the agitated conditions. Additionally, the extract is described in the instant claims in product-by-process form, determination of patentability is based on the resultant product itself, including the implied structure therein, but patentability is not limited to the recited method of production steps (see MPEP 2113).
The applicant argues that the prior art does not describe an antiviral Ganoderma lucidum composition which also comprises hemicellulose. The Office relies upon Hwan to show why it would have been obvious to include hemicellulose in the composition taught by Stamets.
The applicant argues that Stamets does not teach that lignocellulosic growth substrates, whether grains, nuts, woods or otherwise enhance the antiviral activity of compositions obtained by G. lucidum. Hwan teaches that hemicellulose enhances immunity by activating NK cells and this would be an obvious reason to include hemicellulose in the G. lucidum composition which is known to have anti-viral activity.
Conclusion
Currently no claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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