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 .
This action is in response to amendments received on May 28th, 2026.
The applicant has cancelled claim 2.
Claims 1 and 3 are pending and were examined on the merits.
Any objections or rejections not reiterated below are hereby withdrawn.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed May 28th, 2026, with respect to the objection to the instant specification regarding the spelling of the term "Sparassis" have been fully considered and are persuasive. The objections to the instant specification have been withdrawn. The applicant has amended the instant specification to recite the term “Sparassis” with correct spelling.
Applicant’s arguments, filed May 28th, 2026, with respect to the rejection of claims 1 and 3 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 1 and 3 under 35 U.S.C. 112(b) has been withdrawn. The applicant has amended claims 1 and 3 to recite the broadly known genus name “Sparassis” in place of the term “Sparassia” which deviated from the broadly accepted spelling of the term.
The rejection of claim 2 under 35 U.S.C. 112(b) has been withdrawn, this claim having been cancelled by the applicant.
Applicant’s arguments, filed May 28th, 2026, with respect to the rejections of claims 1 and 3 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. The applicant has amended independent instant claim 1 to recite administering a Sparassis crispa extract obtained by extracting Sparassis crispa in water, wherein the Sparassis crispa extract increases gamma-aminobutyric acid (GABA) content of a subject. Although Jo discloses GABA in Sparassis crispa, it would not be obvious to one of skill in the art from the prior art or general knowledge of one of skill in the art that GABA would partition into the residue fraction resulting from a water extraction of Sparassis crispa along with the glucan(s) (Tada et al.) which are reasonably useful for reducing light sleep (Raghavan et al.). Furthermore, it is within the knowledge of one of skill in the art to interpret an extract of a biological material as a distinct material from the residue of the extract. Instant claim 3 depends from and therefore incorporates the limitations of independent claim 1. However, upon further consideration, a new ground of rejection is made in view of prior art cited in the previous office action.
The rejection of claim 2 under 35 U.S.C. 103 has been withdrawn, this claim having been cancelled by the applicant.
Pending Objections and Rejections
Specification
The disclosure is objected to because of the following informalities: the applicant has recited "Thermo" (paragraphs [0070] and [0072]), when the applicant may have intended to recite the vendor name "Thermo Fisher" or "Thermo Fisher Scientific"; the full name of the vendor should be used for clarity.
The disclosure is objected to because of the following informalities: it is not clear what the abbreviated term "BSS" refers to (paragraph [0084]), clarification could be provided by reciting the unabbreviated form of the term.
Appropriate correction is suggested.
The use of the terms DMEM (see serial number 98618988), BUCHI, and Rotavapor, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Although the examiner has attempted to find all trademarks and trade names in the instant specification, the applicant’s assistance is requested in properly reciting any trademarks and trade names that they may become aware of, even if they are not explicitly identified by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the term "mins" should be changed to "minutes" for formality. Appropriate correction is suggested.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Jo and Shin (J. Mushrooms 2017, 15 (1), 38-44) in further view of Hepsomali et al. (Front. Neurosci. 2020, 14, 923).
Claim 1 recites a method for reducing light sleep and/or dreaming in a subject in need thereof, comprising: administering to the subject an effective dose of the Sparassis crispa extract, wherein the Sparassis crispa extract is obtained by extracting Sparassis crispa in water at 90°C ± 5°C for 60 mins, wherein the Sparassis crispa extract increases gamma-aminobutyric acid (GABA) content of the subject. Claim 3 recites the method according to claim 1, wherein the Sparassis crispa extract contributes to nerve relaxation of the subject.
Jo and Shin recite “the enhancement of growth and GABA production in the mycelium of
medicinal and edible mushroom S. latifolia was investigated”(Abstract), where GABA is γ-
aminobutyric acid (Abstract) and S. latifolia is “Sparassis latifolia (formerly S. crispa)”(Abstract) and therefore equivalent to Sparassis crispa. They summarize their results: “Addition of glutamic acid and ornithine positively affected the growth of S. latifolia mycelia, and glutamic acid positively affected GABA production; no degradation of GABA was observed with addition of glutamic acid” (Abstract). Therefore, a subject could orally ingest material from Sparassis latifolia (Sparassis crispa) mycelia grown in a medium comprising glutamic acid, with the reasonable expectation of increasing the GABA content of that subject (instant claim 1). One of skill in the art would have been motivated to use water as an extraction solvent because it is more readily available, from municipal sources, compared to organic solvents; further supporting this motivation, water lacks the flammability hazard of organic solvents and the toxicity of certain organic solvents such as methanol. The molecular structure of GABA comprises a polar carboxylic acid group and a polar primary amino group that would reasonably enable its dissolution in polar solvents such as water (instant claim 1). Therefore, one of skill in the art would have a reasonable expectation of success at using a Sparassis crispa water extract to increase the gamma-aminobutyric acid (GABA) content of a subject (instant claim 1). One of skill in the art would have been motivated to develop the method to increase the gamma-aminobutyric acid (GABA) content of the subject (instant claim 1), because the method would reasonably contribute to nerve relaxation and therefore contribute stress relief and at least a temporary effect of deepening sleep (Hepsomali et al., page 9 of 13 right column under subheading “Stress”, page 10 of 13 left column and right column (lines 1-35); instant claims 1 and 3).
Although the cited prior art references do not explicitly recite a water temperature during extraction of 90°C ± 5°C, or an extraction time of 60 mins, these parameters are obvious to one of skill in the art over routine optimization. One of skill in the art could manipulate the temperature of the water used for extraction using a hot plate and a thermometer, and could measure the time of the extraction using a timer. Extraction could be terminated by removing the Sparassis crispa material from the water. One of skill in the art could measure the concentrations of GABA in different extracts prepared using different temperatures and times using liquid-chromatography and mass spectrometry. By thee means, one of skill in the art could optimize the extraction temperature and time for the extraction of GABA from Sparassis crispa. Therefore, the extraction temperature and time recited in instant claim 1 are obvious to one of skill in the art over routine optimization.
Jo and Shin, and Hepsomali et al., are relied upon for the reasons discussed above. If not
expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing a method comprising administering a Sparassis crispa extract that increases the GABA content of a subject, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the method comprising administering a Sparassis crispa extract), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Jo and Shin in view of Hepsomali et al., the invention as a whole, drawn to a method comprising administering a Sparassis crispa extract as described in Claims 1 and 3, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
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 Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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