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 .
DETAILED ACTION
Claims 14, 18, 22-29, 37-40, and 42-45 are pending. Claims 14, 16, 22-24, 27-29, 37-40, and 42-44 are examined on the merits. Claims 25-26 and 45 are withdrawn.
Election/Restrictions
Applicant’s election of the species viral invention, Orthomyoxyoviridae, IL-4, in the reply filed on 12/31/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 25-26 and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/31/2025.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 1/21/2026, 3/7/2025, 11/25/2024, 11/4/2024, 9/19/2024, 9/6/2024, 9/4/2024, 6/3/2024, 5/6/2024, 2/19/2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 24 and 44 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.
In Claims 24 and 44, the parentheses after the different viral infection are indefinite because one does not know whether the terms within the parentheses are included in the claimed terms or are they examples of what the viruses include or are they part of their other names. Please correct.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 14, 22, 27, 28, 29, and 37-39 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Borodina et al. (CA 3151154 A1).
Borodina et al. teaches a method of treating a subject with a pharmaceutical composition administered to a subject in need thereof in an amount of norpsilocin (Claim 112) ranging in 1 ng to 1 mg (Claim 113). Probiotics produce norpsilocin which (page 135, lines 5-13) have been useful in treating obesity, diabetes, inflammation, cancer, allergies, and many other ailments (page 134, lines 19-23). Inflammation treatment would inherently involve cytokine storm, IL-4 activation, neuroregeneration, and neurite outgrowth, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. The methods of claims 22, 27, 28, 29, 37, 38, and 39 will necessarily occur, because the same composition is administered and will necessarily possess the characteristics claimed.
Claim Rejections - 35 USC § 103
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.
Claim(s) 14, 18, 22-24, 27-29, 37-40, and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Borodina et al. (CA 3151154 A1) further in view of Stamets (US 20050276815 A1).
Borodina et al. teaches a method of treating a subject with a pharmaceutical composition administered to a subject in need thereof in an amount of norpsilocin (Claim 112) ranging in 1 ng to 1 mg (Claim 113). Probiotics produce norpsilocin which (page 24, paragraph 1) have been useful in treating obesity, diabetes, inflammation, cancer, allergies, and many other ailments (page 139, lines 19-22). Inflammation treatment would inherently involve cytokine storm, IL-4 activation, neuroregeneration, and neurite outgrowth, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. The methods of claims 22, 27, 28, 29, 37, 38, and 39 will necessarily occur, because the same composition is administered and will necessarily possess the characteristics claimed.
However, Borodina et al. does not teach about 1 ng-2000 mg Hericium erinaceus mushroom extract, influenza.
Stamets teaches a method of preventing, treating, ameliorating, mitigating, alleviating or reducing infection from an Orthopox virus comprising administering a therapeutically effective amount of a medicinal mushroom derivative treating influenza infection [0072] with Hericium erinaceus extract [0035]. Typical therapeutic amounts of mycelium on rice (individual fungal species and/or combinations of species) are preferably 0.1-20 gm./day, more preferably 0.25-10 gm./day, and most preferably 0.5-5 gm./day. Typical therapeutic amounts of extracts (individual fungal species and/or combinations of species) preferably deliver 0.1-20 mg. extracted materials per kg. of body weight, more preferably 0.25-10 mg./kg. and most preferably 0.5-5 mg./kg [0039].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine Hericium erinaceus mushroom extract with norpsilocin because Stamets teaches a method of preventing, treating, ameliorating, mitigating, alleviating or reducing infection from an Orthopox virus comprising administering a therapeutically effective amount of a medicinal mushroom derivative treating influenza infection [0072] with Hericium erinaceus extract [0035]. Borodina et al. teaches a method of treating a subject with a pharmaceutical composition administered to a subject in need thereof in an amount of norpsilocin (Claim 112) ranging in 1 ng to 1 mg (Claim 113). One would have been motivated to make a treatment with norpsilocin and Hericium erinaceus mushroom extract for the expected benefit of treating inflammation or infection from influenza. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14, 18, 22-24, 27-29, 37-40, and 42-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28, 29, 35, 36, 39, 63 of copending Application No. 17/221411 (US 20210308201 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because norpsilocin is not explicitly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17/221411 teaches:
28. A method for treating, prophylaxis of, or ameliorating symptoms of an infectious disease or any type of pain, or enhancing a viral therapy comprising: administering to a subject in need thereof an effective amount of a composition comprising: an aqueous or solid fraction of a mycelium, a fermented substrate thereof, or a combination thereof; one or more buffering agents; ethanol; and water.
29. The method claim 28, wherein the mycelium comprises one or more of Agaricus brasiliensis f. blazei, Cordyceps militaris, Flammulina velutipes, Fomes fomentarius, Fomitopsis officinalis, Ganoderma applanatum, Ganoderma lucidum s.l., Ganoderma oregonense s.l., Grifola frondosa, Hericium erinaceus, Inonotus obliquus, Lentinula edodes, Phellinus linteus, Piptoporus betulinus, Pleurotus ostreatus, Schizophyllum commune, or Trametes versicolor.
35. The method of claim 28, wherein the infectious disease comprises one or more symptoms comprising shortness of breath, wheezing, coughing, yellow mucus, green mucus, blood-tinged mucus, chest pain, breathlessness, rapid breathing, hypoxia, inflammation of the lung tissue, rapid heart rate, or increased blood pressure, or decreased blood pressure.
36. The method of claim 28, wherein the infectious disease is a bacterial infection or a viral infection.
39. The method of claim 36, wherein the viral infection comprises one or more of Paramyxoviridae (respiratory syncytial virus (RSV), parainfluenza virus (PIV), metapneumovirus (MPV), enteroviruses), Picornaviridae (Rhinovirus, RV), Coronaviridae (CoV), Adenoviridae (Adenovirus), Parvoviridae (HBoV), Orthomyxoviridae (influenza A, B, C, D, Isavirus, Thogotovirus, Quaranjavirus), or Herpesviridae (human herpes viruses, Varicella zoster virus, Epstein-Barr virus, cytomegalovirus).
63. The method of claim 28, wherein the pain comprises one or more types of neuropathic pain, somatic pain, visceral pain, and other types of pain.
However, norpsilocin is not taught.
Norpsilocin is part of the isolates of a mycelium (17/221411 [0075]). Therefore, the extract of mycelium in Claim 29 would include norpsilocin and Hericium erinaceus extract or isolates.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655