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 07/07/2026, 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 Any previous rejection or objection not mentioned herein is withdrawn.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 1-15 and 23-27 and 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 therefore, subject to the conditions and requirements of this title.
Claims 1-15 and 23-27 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 whole mycelium of Cordyceps militaris 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 product which is mycelium of Cordyceps militaris the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim merely recites a whole mycelium of Cordyceps militaris. The closest natural counterpart is the same whole mycelium of Cordyceps militaris found growing in nature, in a lab or anywhere it can be found growing. There is no distinction between what the applicant claims and the natural counterpart because the two are identical. An applicant cannot claim a judicial exception or living organism. The properties that are claimed are the properties of the mycelium of Cordyceps and are naturally apart of the living organism. 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 applicant is merely claiming the judicial exception and nothing more.
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.
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)).
The additional elements considered are any formulations that may bring about any distinction from that of the judicial exceptions and in the instant case, claiming the phenotype or claiming how it may grow on a substrate does not warrant any significantly more than the judicial exceptions themselves. Additionally, claiming the formulations as powder and presumably to be in a capsule, or as a drink mix for a cold or hot beverage do not prescribe any structural differences to the judicial exceptions because mycelium when dehydrated and crushed can be found in a powder form. Powder encapsulated by a capsule is merely claiming the judicial exception to be in powder form and placed inside of a structure (capsule). These limitations do not help overcome the rejection.
Response to Arguments
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive. The applicant argues that since the whole mycelium is a product of human intervention it is not a product of nature. Humans can intervene with nature and the product claimed from human intervention can indeed still be a product of nature because they still contain components that are judicial exceptions. Although humans can cross two patent strains of mycelium this does not necessarily make the nature-based product from that crossing any different than what exists or happens in nature. The mycelium is still compared to the same species found naturally existing and that would be the Cordyceps militaris species.
The applicant claims the whole mycelium possesses markedly different characteristics from its natural counterpart. The applicant claims the specific strain M2-105-04 (PTA-127612) does not have any entomopathogen such as an insect-host material. This is not a markedly characteristic as Cordyceps militaris species would at some point not have an insect-host on the mycelium. The applicant claims that since the whole mycelium has a cordycepin content of approximately 0.4 to 1.1 mg/gm, a beta-glucan content spanning 20% to 49%, a 10-to-15-day colonization time on hulled oats, fruiting initiation at or near 18 days and fruiting-maturation at or near 55 days after inoculation, and a plurality of fruiting bodies on top of the substrate and along the perimeter of the bioreactor bag that these would be markedly different than what naturally exists. These are not markedly different characteristics of Cordyceps militaris species as different strains would be expected to have varying fruiting initiation times, colonization times, content of cordycepin and beta-glucan content, etc. Selection of preferable traits by crossing parent strains to end up with an offspring with those traits is genetic selection and these acquired traits are still traits that stem from the genes of the natural Cordyceps. The mere fact that a human can intervene to make this happen is no different than this process naturally taking place. Gene selection happens with or without human interaction. Claiming the natural product from that crossing is no more than claiming the natural judicial exception. The applicant is merely selecting for naturally occurring characteristics that would already exist and there has been no genetic manipulation to alter the Cordyceps in any markedly different way.
It is advised to claim the mycelium product in some formulation that does not exist in nature.
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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