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 without traverse of Group I in the reply filed on 02/27/2026 is acknowledged.
Claims 16-22 were previously canceled by the applicant on 02/27/2026.
Claims 1-15 and 23-27 are being examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
The specification is objected to under 35 U.S.C. 112, first paragraph, as failing to provide an adequate written description, enablement and best mode for practicing the claimed invention. The specification is objected to because the Cordyceps militaris designated as strain M2- 105-04 as deposited with the ATCC Patent Depository under the Budapest Treaty (10801 University Blvd, Manassas, VA 20110), on July 28, 2023, with the unofficial ATCC Patent Deposit Designation No. PTA-127612 and the official deposit date of July 28, 2023 and the official patent deposit number of PTA-127612, is used in the claims as a composition. Since the mycelium of Cordyceps militaris are essential to the claimed invention it must be obtainable by a repeated method set forth in the specification or otherwise be readily available to the public. If the organism. is not so obtainable or available, the requirement of 35 U.S.C. 112 may be satisfied by a deposit of the cells.
That the applicants have apparently incorporated specific references into the specification does not eliminate the issue of public availability and permanence as the vectors cited in the references and the references per se do not include public availability of the starting materials inasmuch as the biological materials mentioned in a publication may be proprietary and no publicly available. The specification does not disclose a repeatable process to obtain the cells nor is it apparent that the culture is readily available to the public. It is noted that the applicants have deposited the mycelium but there is no indication in the specification as to public availability. If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strains have been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and a receipt showing that the appropriate biological material was received and entered into the depository, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. 1.801-1.809 applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number indicating that:
a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
d) a test of the viability of the biological material at the time the deposit was made and that such test result indicated that said biological material was viable (see 37 C.F.R. 1.807); and;
e) the deposit will be replaced if it should ever become inviable.
The Office notes that a deposit of the mycelium of Cordyceps militaris designated as strain M2- 105-04 as deposited with the ATCC Patent Depository under the Budapest Treaty (10801 University Blvd, Manassas, VA 20110), on July 28, 2023, with the unofficial ATCC Patent Deposit Designation No. PTA-127612 and the official deposit date of July 28, 2023 and the official patent deposit number of PTA-127612, and during the pendency of this application, access to the invention will be afforded to the Commissioner upon request where all restrictions upon availability to the public will be irrevocably removed upon granting of the patent and that the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer where the deposit will be replaced if it should ever become inviable. Therefore, no 35 U.S.C. 112 paragraph 1 rejection has been entered even though it is apparent that the claimed plasmid is essential to the claimed invention and the deposit is essential and necessary for an adequate written description, enablement, and best mode for the claimed invention.
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.
Claims 2-12 and 23-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 2 recites “characterized by” which makes the claim limitations that follow appear suggestive in nature and not an affirmative requirement. The claim language is indefinite. Additionally the claim recites “abundance” which is relative language and the amount is not defined in the specifications making the limitation confusing. The claim also requires the whole mycelium of Cordyceps militaris to have a phenotype of some determined amount of growth (abundance) on a substrate and bioreactor bag however this is confusing as the examination is to a composition and not a method of growing and there is no substrate or bioreactor bag that is required of the composition.
Claims 5 and 23-27 are rejected for the same purpose as there is no required “hulled oats”, “organic grain substrate”, “rice”, “rye”, “wheat”, “wheat bran”, “brewer’s yeast” and “calcium carbonate” for the composition being claimed. These limitations would make more sense if the term “characterized” was removed and by reciting “when grown on” instead of merely stating “on top of” a substrate.
Claim 14, recites “the whole mycelium of claim 13 is a capsule form” and it is unclear if the intent is to make the whole powdered mycelium into a capsule or requiring the powder to be in a capsule.
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.
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.
Conclusion
Currently no claims are allowed.
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 BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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