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
Claims 33, 42, 43, 52, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/14/26.
Applicant’s election without traverse of Claims 32, 34-41, 44-51, and 54 in the reply filed on 9/14/26 is acknowledged.
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 32 and 34 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter, the claimed invention is directed a natural phenomenon to without significantly more. The claims recites a non-living biomass of Hericium erinaceus. This judicial exception is not integrated into a practical application because the claim is drawn to a natural phenomenon. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to fungi that are no longer alive but have at least its mycelium, fruiting bodies, or grains (upon which it was growing) and is configured as a consumable. This limitation of it being configured as a consumable does not render it different from what can be found in nature since in nature lion’s mane that has been harvested is technically no longer alive although it is in raw form.
In the overall determination for subject matter eligibility, three questions must beanswered:
1. Is the claimed invention directed to one of the four statutory patent-eligiblesubject matter categories: process, machine, manufacture, or composition ofmatter? Yes, because it is a composition.
2A. Is the claim directed to a law of nature, a natural phenomenon, or an abstractidea (judicially recognized exceptions)? Yes, because the products are found in nature.
2B. Does the claim recite additional elements that amount to significantly morethan the judicial exception? As to claims 32 and 34 the claims do not recite more than a judicial exception. The claim as a whole is drawn to a harvested fungi. The claims do not recite additional elements or functions that amount to significantly more than the judicial exception, the claims are not eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 32 and 34 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ specific strains of Hericium erinaceus M2-102-10 and X. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
Since the microorganism is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism(s) is/are not so obtainable or available, the requirements of 35 USC 112 may be satisfied by deposit(s) of the microorganism(s). The specification does not disclose a repeatable process to obtain the microorganism(s) and it is not clear from the specification or record that the microorganism(s) is/are readily available to the public.
This rejection may be overcome by establishing that the each microorganism identified is readily available to the public and will continue to be so for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer, or by an acceptable deposit as set forth herein.
If the depository is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his/her signature and registration number, stating that the specific strain has 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, 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 CFR 1.801-1.809, applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney over his/her registration number, showing that,
(a) during the pendency of the 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 the 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 effective life of the patent, whichever is longer; and,
(d) the deposit will be replaced if it should ever become inviable.
The specification must also state the date of deposit(s), the number(s) granted the deposit(s) by the depository and the name and address of the depository.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will
be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
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 32, 50, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nadal et al. (US 2022/0232854).
Regarding Claims 32, 50, and 51: Nadal discloses a myceliated protein composition comprising fungi grown on grain substrate where the substrate contains oats, the formation of mycelia [0020-0021; 0082; 0083]. Nadal discloses biomass formation [0043]. Nadal discloses the formation of beta-glucan [0061]. Nadal discloses that the biomass is inactivated (non-viable) [0073]. Nadal discloses Hericium erinaceus [0141].
Further, despite Applicants’ recitation of Hericium erinaceus M2-102-10 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Nadal as also being a good source of protein and is a consumable product. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shift to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of Nadal; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with food preserving properties and utilize such strains within the known methods of Nadal.
Claims 32, 34, 36, 45, 47, 50, 51, and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner-Salvini (US 2020/0352206).
Regarding Claims 32, 34, 50: Wagner-Salvini discloses a composition comprising Hericium erinaceus [0063; 0119-0125; 0185; 0186]. Wagner-Salvini discloses drying harvested mycelium-fungi [0040]. Wagner-Salvini discloses mycelial powder [0048]. Wagner discloses using whole mushrooms, mycelium, mycelium extracts (fruiting bodies) [0095; 0106; 0144].
Further, despite Applicants’ recitation of Hericium erinaceus M2-102-10 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Wagner-Salvini as also being a good source of protein and is a consumable product. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shift to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of Wagner-Salvini; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with food preserving properties and utilize such strains within the known methods of Wagner-Salvini.
Regarding Claim 36: Wagner-Salvini discloses as discussed above in claim 32. Wagner-Salvini discloses the composition in a powdered form [0047; 0106].
Regarding Claim 45: Wagner-Salvini discloses as discussed above in claim 34. Wagner-Salvini discloses oats [0137; 0139].
Regarding Claim 47: Wagner-Salvini discloses as discussed above in claim 34. Wagner-Salvini discloses the composition in a powdered form [0047; 0106].
Regarding Claims 51: Wagner-Salvini discloses as discussed above in claim 32. Wagner-Salvini discloses drying harvested mycelium-fungi [0040]. Wagner-Salvini discloses mycelial powder [0048] which is indicative of being free of viable cells since the powdered mycelia are dead.
Regarding Claim 54: Wagner-Salvini discloses as discussed above in claim 34. Wagner-Salvini discloses harvesting the mycelium and fruiting body before dehydration [0096; 0099; 0122-0125; 0136].
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.
Claim 44 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner-Salvini (US 2020/0352206) as applied to claims 32.
Regarding Claim 44: Wagner-Salvini discloses as discussed above in claim 32.
Wagner-Salvini discloses the medicinal and therapeutic properties of Hericium sp. [0015]. Wagner-Salvini discloses other mushroom as having bitter features that make them less suitable for use in food whereas Hericium sp. would therefore be considered suitable.
“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 35, 37-41, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner-Salvini (US 2020/0352206) as applied to claims 32 and 34 in view of Chen (US 2019/0249211).
Regarding Claims 35 and 46: Wagner-Salvini discloses as discussed above in claims 32 and 34 respectively. Wagner-Salvini discloses drying [0145].
Wagner-Salvini does not explicitly disclose wherein the biomass is in a dehydrated form having a moisture content of less than 5 percent by weight.
Chen discloses H. erinaceus [0023]. Chen discloses H. erinaceus and drying spray drying mushroom beta-glucan powder to a water content below 5% [0048]. Chen discloses health benefits from mushroom mycelium and beta-glucan [0002; 0006].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Wagner-Salvini to contain a moisture content of less than 5% as in Chen since Wagner-Salvini discloses the biomass in dried form and since dehydrating to a moisture content as in Chen would help maintain the stability of the powder form.
Regarding Claims 37-41: Wagner-Salvini discloses as discussed above in claim 32. Wagner-Salvini does not disclose wherein the composition has a beta-glucan content of at least 20 percent by dry weight (claim 37); wherein the beta-glucan content is from 20 percent to 40 percent by dry weight (claim 38); wherein the beta-glucan content is from 25 percent to 35 percent by dry weight (claim 39); wherein the beta-glucan content is from 25 percent to 30 percent by dry weight (claim 40); wherein the beta-glucan content is from 20 percent to 25 percent by dry weight (claim 41).
Chen discloses β-glucan from mushrooms and specifically H. erinaceus [0023]. Chen discloses that culturing mushrooms can increase β-glucan [0031]. Chen discloses a mushroom β-glucan powder containing 20-85% or 20-40% β-glucan [0052; 0053]. Chen discloses spray drying mushroom beta-glucan powder to a water content below 5% [0048].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Wagner-Salvini to contain 20-85% or 20-40% β-glucan as in Chen since Wagner-Salvini also discloses H. erinaceus and it therefore would have been expected to contain 20-85% or 20-40% β-glucan.
“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 44, 48, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner-Salvini (US 2020/0352206) as applied to claims 32 and 47 above and in further view of Kelly et al (KR 20150131293) Machine Translation.
Regarding Claim 44: Wagner-Salvini discloses as discussed above in claim 32.
Wagner-Salvini discloses the medicinal and therapeutic properties of Hericium sp. [0015]. Wagner-Salvini discloses other mushroom as having bitter features that make them less suitable for use in food whereas Hericium sp. would therefore be considered suitable.
Kelly discloses myceliation of green coffee bean can result in a decrease of compounds that is responsible for bitter taste of coffee and caffeine content, thus coffee brewed from roasted, myceliated coffee beans can eventually offer a smooth drink of coffee with low caffeine content. [pg. 5]. Kelly discloses H. erinaceus [pg. 10, “Mold Component”]. Kelly discloses the formation of fruiting bodies and mycelium [pg. 18; pg. 21].
Regarding Claim 48: Wagner-Salvini discloses as discussed above in claim 47.
Wagner-Salvini does not disclose wherein the hot beverage precursor is configured for reconstitution with a liquid to form a hot beverage.
Kelly discloses mycelliated coffee powder [Ex. 10; pg.2, Background]. Kelly discloses myceliation of green coffee bean can result in a decrease of compounds that is responsible for bitter taste of coffee and caffeine content, thus coffee brewed from roasted, myceliated coffee beans can eventually offer a smooth drink of coffee with low caffeine content. [pg. 5]. Kelly discloses H. erinaceus [pg. 10, “Mold Component”]. Kelly discloses the formation of fruiting bodies and mycelium [pg. 18; pg. 21].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Wagner-Salvini to include the myceliated coffee in powder form in order to for a hot beverage including coffee as in Kelly in order to provide a coffee having a reduced bitter taste and lower caffeine content.
Regarding Claim 49: Wagner-Salvini discloses as discussed above in claim 48.
Wagner-Salvini does not disclose wherein the hot beverage is selected from mushroom coffee or mushroom hot chocolate.
Kelly discloses forming a hot myceliated coffee or chocolate beverage [Ex. 2; Ex. 3; Ex. 11]. Kelly discloses myceliation of green coffee bean can result in a decrease of compounds that is responsible for the bitter taste of coffee and caffeine content, thus coffee brewed from roasted, myceliated coffee beans can eventually offer a smooth drink of coffee with low caffeine content. [pg. 5]. Kelly discloses H. erinaceus [pg. 10, “Mold Component”]. Kelly discloses the formation of fruiting bodies and mycelium [pg. 18; pg. 21].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Wagner-Salvini to include the myceliated coffee in powder form in order to for a hot beverage including coffee as in Kelly in order to provide a coffee having a reduced bitter taste and lower caffeine content and to provide hot coffee or chocolate with increased nutritional content.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen (US 2009/0098620) discloses a production method effectively increases the amount and yield of mushroom beta-glucan, and widely applied in the fields of food, biotechnology, cultivation and medical development. The cultivating medium contains the nutrition of three natural grains, including brown rice, adlay and oat, to provide a complete physiological environment for the mushrooms to grow well [abstract]. Chen discloses the nutrition of three natural grains provided in the present invention helps mushrooms grow well [0031].
Kelly et al (US 2014/0065131) Kelly discloses mycelium, fruiting bodies derived mushrooms specifically from H. erinaceus [0060; 0071; 0078, 0079; 0087]. Kelly discloses including agricultural substrates including grains/cereals and specifically oats, with the mushroom [0072; 0084]. Kelly discloses the myceliation of green and producing from it coffee brewed from roasted, myceliated coffee beans can eventually offers a smooth drink of coffee with low caffeine content. [0085]. Kelly discloses the product in drink mix form, and powder form [0088]. Kelly discloses green coffee beans, green cocoa beans as agricultural substrate [claim 20].
Miller et al. (WO 2015/164596) Miller discloses an enhanced mycelial biomass [abstract]. Miller discloses co-fermentation with a grain [abstract; 005; 016]. Miller discloses Hericium erinaceus and discloses that it has a wider tolerance for growth media [004; 008; 016]. Miller discloses beta-glucan [006]. Miller discloses formation of fungal fruiting bodies [0016].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
