DETAILED ACTION
Notice of 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 .
Status of Application
Claims 1-17 are pending and subject to examination on the merits.
Priority
The instant application is a 371 of PCT/JP2021/019023 filed 19 May 2021 which claims benefit of foreign priority documents JP2020-087899 and JP2020-167343 filed 20 May 2020 and 01 October 2020, respectively, are acknowledged. Said documents have been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07 July 2025 and 09 December 2022 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Rejections - 35 USC § 112(b)
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.
Claims 7 and 9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims are deemed indefinite because the recitation of the term “novel coronavirus”. Given viruses are evolving and mutating everyday, it is unclear what constitutes a “novel” coronavirus virus/infection or a novel COVID-19 virus/infection.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a composition of matter.
Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring compound, including glutathione trisulfide (GSSSG).
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claims are generically drawn to “a drug” comprising an active ingredient which has an active sulfur compound, such as in dependent claims, glutathione trisulfide (GSSSG). However, glutathione trisulfide is a naturally occurring compound found in the human body/mammalian tissues – See Kunikata et al. (Scientific Reports, 2017 – cited herein) and Ichinose et al. (US 2023/0181676 – cited herein) at paragraph 0015. There is nothing in the claims which differentiates this naturally occurring active sulfur compound comprising GSSSG in terms of structure and/or function. Thus, there is ultimately nothing in the claims which integrates the judicial exception into a practical application. Even for the claims which recite various intended use of the active sulfur compound, such as GSSSG, as an antiviral drug, preventative/ therapeutic drug against COVID, an immune control agent, an anti-inflammatory drug or a preventative/therapeutic drug against viral pneumonia (claims 1, 9-12), this does nothing to distinguish what is being claimed from that which is naturally produced in the human body.
Step 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more in terms of structure and/or function and the claims read on naturally active sulfur compounds such as GSSSG. Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ichinose et al. (US 2023/0181676 – cited herein, with an effectively filed date of 12 May 2020).
With regard to the intended use of the claimed drugs having an active sulfur compound, such as GSSSG: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also M.P.E.P. § 2112(I).
Regarding claims 1-17, Ichinose et al. teach a therapeutic composition comprising glutathione trisulfide (GSSSG) as the active ingredient – See claims 1-9 and paragraphs 0004, 0025-0031.
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fujimoto et al. (WO 2018/117186 – cited herein, wherein US 2020/0079818, cited on the IDS 07/04/2024, is utilized as an official English translation. All references to various teachings will utilize the paragraph numbering the PG-Pub).
With regard to the intended use of the claimed drugs having an active sulfur compound, such as GSSSG: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also M.P.E.P. § 2112(I).
Regarding claims 1-17, Fujimoto et al. teach crystalline and aqueous solutions e.g. GSSSG in water, which is considered to be a pharmaceutically acceptable composition are taught in Examples 1 and 2, especially paragraphs 0125-0126.
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fujimoto et al. (WO 2018/117186 – cited herein, wherein US 2020/0079818, cited on the IDS 07/04/2024, is utilized as an official English translation. All references to various teachings will utilize the paragraph numbering the PG-Pub).
With regard to the intended use of the claimed drugs having an active sulfur compound, such as GSSSG: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also M.P.E.P. § 2112(I).
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nakazawa et al. (US 2018/0296504 – cited on IDS 12/09/2022).
With regard to the intended use of the claimed drugs having an active sulfur compound, such as GSSSG: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also M.P.E.P. § 2112(I).
Regarding claims 1-17, Nakazawa et al. teach a pharmaceutical drug comprising an active sulfur compound comprising glutathione trisulfide (GSSSG) – See Figures 7-11, paragraphs 0043, 0083-0087.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 27 June 2025