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 .
Response to Amendment
Applicant's amendment and argument filed 07/23/2026, 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 Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-21 are pending of which claims 3-4, 6, 8-19 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 without traverse in the reply filed on 04/04/2025.
Claims 1-2, 5, 7 and 20-21 are being examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a nutraceutical composition, does not reasonably provide enablement for one that is comprising of the instant components being in a “synergistic ratio ranging from about 10:1 to about 1:10” as required of claim 1, or “wherein the synergistic ratio provides efficacy for supporting immune function, maintaining cognitive function, maintaining adaptogenic support, maintaining antioxidant activity, or any combination thereof that is greater than the sum of the efficacy of the first fungal compound and the second fungal compound administered independently” as required of claim 20. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claims recite a composition which comprises of a combination of fungal compounds from different species of fungi. The claims require some synergistic activity however does not give evidence as to what the activity would be. Claim 20, recites some activity: “wherein the synergistic ratio provides efficacy for supporting immune function, maintaining cognitive function, maintaining adaptogenic support, maintaining antioxidant activity, or any combination thereof that is greater than the sum of the efficacy of the first fungal compound and the second fungal compound administered independently”; however does not give support for how this activity is to be achieved and therefore the claims are not enabled.
The state of the prior art: Synergy is a highly unpredictable phenomenon which is dependent on relative proportions of constituent components but fungal extracts contain numerous bioactive phytochemicals, there is unpredictability in determining active ingredients thereof, and there is unpredictability regarding the pharmaceutical capabilities of natural product extracts.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The art is unpredictable because synergy is unpredictable unless already described in the prior art and then that would make the claims obvious to combine the fungal components to arrive at a synergistic combination. Synergy cannot be predicted if it is unknown.
The breadth of the claims: The scope of the claims requires that synergy be found within a ratio of combined fungal components from about 10:1 to about a 1:10 ratio. This makes the claims somewhat narrow in scope however the applicant does not show any synergy for this ratio claimed and therefore the claims are not enabled for synergy.
The amount of direction or guidance presented: The specifications, drawings or claims do not describe how one could make a composition as claimed and have some sort of synergy even with the described effects being claimed in claim 20. The invention must describe how to create the invention as claimed to arrive at some synergistic activity, which it does not. Merely combining the claimed ingredients together and claiming that there is synergy is not the same as creating a composition with synergy.
The presence or absence of working examples: The applicant has provided no working examples which point to the synergy that they are claiming.
The quantity of experimentation necessary: There may not necessarily need excessive amounts of experimentation necessary to determine that the claimed composition does not have synergy, however the applicant must show how to make the claimed composition in order for any person having skill in the art to be able to do the same. The applicant has not shown any evidence or support for these limitations and they make the scope of the invention unenabled.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for preventing cadmium-induced toxicity in a brain and/or liver of a patient.
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 1-2, 5, 7 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Li Qingjie et. al. (CN107441126B), 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) and Thorsteinn Loftsson and Marcus E. Brewster (Cyclodextrins as Functional Excipients: Methods to Enhance Complexation Efficiency, Journal of Pharmaceutical Sciences, Vol. 101, NO. 9, September 2012). This is a new rejection based on the amendments filed on 07/23/2026.
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 or to comprise of one of the auxiliary agents being claimed.
Kaur teaches grape seed extract targets signaling cascades for its anticancer and/or chemo-preventive efficacy (see page 1807S, right column, first para.). Kaur teaches grape seed extract is well established as having chemo-preventive and anticancer effects against skin, colorectal, prostate and breast cancers through multiple mechanisms of action (see page 1808S, right column and table 1).
Loftsson teaches of cyclodextrins as functional excipients (see abstract).
Loftsson teaches Cyclodextrins have gained currency as useful solubilizing excipients with an ever-increasing list of beneficial properties and functionalities (see abstract).
Frequently, an increase in the drug–cyclodextrin complex molar ratio will lead to an increase in drug bioavailability (see page 3020, right side). The continuing exploitation of these materials is evidenced by not only new products using these materials for traditional reasons, that is solubility or bioavailability modification (see Conclusions).
Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to combine cyclodextrin and 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. Additionally, Loftsson teaches that cyclodextrins are excipients which can increase bioavailability of the active pharmaceuticals and can increase their solubility. Thus, combining these into a single composition is prima facie obvious for creating a composition with increased anticancer properties and solubility and bioavailability.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Qingjie et. al. (CN107441126B), Manjinder Kaur et. al. (Anticancer and Cancer Chemo-preventive Potential of Grape Seed Extract and Other Grape-Based Products, The Journal of Nutrition, July 29, 2009, 1806S-1812S) and Thorsteinn Loftsson and Marcus E. Brewster (Cyclodextrins as Functional Excipients: Methods to Enhance Complexation Efficiency, Journal of Pharmaceutical Sciences, Vol. 101, NO. 9, September 2012) as applied to claims 1, 5, 7 and 20-21 above, and further in view of Song Chi Hyun et. al. (KR2007-0001502A). This is a new rejection based on the amendments filed on 17/23/2026.
Qingjie, Kaur and Loftsson’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 filed 07/23/2026 have been fully considered but they are not persuasive. The applicant argues that the previously relied upon art does not teach any of the newly amended limitation pertaining to the auxiliary agents or their specific effects. The Office relies upon new art by Loftsson to show why it would have been obvious to add cyclodextrins as an excipient which can help enhance solubility and bioavailability of pharmaceutical agents.
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
