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 Invention I (claims 1-3) in the reply filed on February 10th, 2026 is acknowledged.
Claims 4-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to (a) nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 10th, 2026. The requirement is deemed proper and is therefore made FINAL.
Claims 1-3 were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on January 11th, 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is December 14, 2023.
Information Disclosure Statement
The information disclosure statement filed November 22nd, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a copy of Non-Patent Literature Document 1 is not included in the instant application, and the included copy of Non-Patent Literature Document 3 has illegibility in Figure 2 and in URLs as a result of insufficient resolution. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
A legible copy of Non-Patent Literature Document 3; Raghavan et al. Brain Behav. 2022, 12, e2750; has been retrieved, included, and cited on the PTO-892.
Drawings
The drawings were received on January 11th, 2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities: although there is precedent for the equivalence of the terms "Sparassis" and "Sparassia" in the art (CN 105661486 A, invention contents, paragraph 7), the term "Sparassia" is not broadly used in the art and should be replaced with "Sparassis" to avoid confusion.
Appropriate correction is suggested.
The use of the terms Excel, ATCC, DMEM, Gibco, Thermo [Fisher Scientific], Thermo Fisher Scientific, Eagle, BSS, SuperScript, Invitrogen, ABI, StepOnePlus, KAPA, KAPA Biosystems, and SYBR, 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, the 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.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The term "Sparassis" (instant claim 1) is interpreted as equivalent to the term "Sparassia", per precedent in the art (CN 105661486 A, invention contents, paragraph 7). The claims are not read as limiting the growth conditions of the “Sparassia crispa” organism, such as the nutrients available to the organism. The term “light sleep” (instant claim 1) is read as encompassing both the first stage of non-REM sleep, and situations in which the brain is abnormally alert in other stages of sleep (non-REM stages 2 and 3, and REM sleep). Therefore, light sleep is read as encompassing sleep that is of poor quality because of anxiety and/or physical pain. The “subject in need thereof’ is understood as a subject in need of sleep improvement because of excessive light sleep and/or dreaming (instant claim 1).
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 1-3 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “Sparassia” in claims 1-3 is used by the claim to mean “Sparassis,” while the accepted meaning is not broadly known in the art, because the term "Sparassia" is not broadly known in the art. The term is indefinite because the specification does not clearly define the term. If the applicant intends to recite an organism from the genus Sparassis, then the applicant should do so using the broadly accepted term “Sparassis”.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Raghavan et al. (Brain Behav. 2022, 12, e2750) and further in view of Tada et al. (Carbohydrate Research 2007, 342, 2611–2618).
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 Sparassia crispa extract, wherein the Sparassia crispa extract is obtained by extracting Sparassia crispa by water”.
Raghavan et al. indicates a pressure to solve a problem in the treatment of sleep disorders, reciting “melatonin has been found to be effective mostly in the short-term treatment of sleep disorders, with clinical studies demonstrating that the positive effects decrease during follow-up (6−12months)” (Introduction, paragraph 2). Raghavan et al. further recites “patients with ASD showed improved sleep quality and improved levels of serum melatonin following nutritional supplementation with a beta-1,3/1,6-glucan (Nichi Glucan) derived from the AFO-202 strain of black yeast Aureobasidium pullulans” (Conclusion), specifically there was a significant increase in serum melatonin among patients treated with the beta-1,3/1,6-glucan composition (subheadings 2.1 and 3.2.2). Raghavan et al. recites the significance of melatonin for sleep quality in individuals with autism: “Melatonin has been shown to exert a positive effect on sleep in individuals with autism by relieving anxiety, improving sensory processing, possessing anti-nociceptive effects, and mitigating gastrointestinal (GIT) dysfunction or gut dysbiosis” (Introduction, paragraph 2). Given the positive effects of melatonin of record above, and the melatonin levels of patients treated with a beta-1,3/1,6-glucan composition, it would have been obvious to one of skill in the art to try using a beta-1,3/1,6-glucan composition to reduce light sleep, as an alternative to melatonin supplementation, with a reasonable expectation of success (Raghavan et al., Discussion paragraph 4, Conclusion; instant claim 1). Although Raghavan et al. does not recite obtaining a beta-1,3/1,6-glucan composition from a water extraction of Sparassis crispa, Tada et al. recites a composition “SCG” obtained through a water extraction of Sparassis crispa (subheading 3.2; instant claim 1), where the purified β-glucan SCG obtained from the fruiting bodies of S. crispa contains a “β-(1→3)- and β-(1→6)-glucans unit” (page 2615, left column). Therefore, a water extract of Sparassis crispa is an alternative to an Aureobasidium pullulans derived composition as a source of a beta-1,3/1,6-glucan. Considering the effect of a beta-1,3/1,6-glucan on serum melatonin of record above, and the biological activity of melatonin of record above; it would be obvious to one of skill in the art to try reducing light sleep in a subject in need thereof using a water extract of Sparassis crispa, with a reasonable expectation of success (instant claim 1).
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Raghavan et al. (Brain Behav. 2022, 12, e2750) and further in view of Tada et al. (Carbohydrate Research 2007, 342, 2611–2618) as applied to claim 1 above, and further in view of Jo and Shin (J. Mushrooms 2017, 15 (1), 38-44) and Hepsomali et al. (Front. Neurosci. 2020, 14, 923).
Claim 2 recites “the method according to claim 1, wherein the Sparassia crispa extract increases gamma-aminobutyric acid (GABA) content of the subject”. Claim 3 recites “The method according to claim 1, wherein the Sparassia crispa extract contributes to nerve relaxation of the subject”. Claim 3 recites “the method according to claim 1, wherein the Sparassia crispa extract contributes to nerve relaxation of the subject”.
The claims and teachings of the cited references are as of record.
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 2). 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. 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 2). 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 2), because the method would reasonably contribute to nerve relaxation and therefore stress relief (Hepsomali et al., page 10 of 13, left column; instant claims 2 and 3).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655