Wk- head 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 . Claims included in prosecution are claims 1, 3-7, 10-11, 13, and 15-16.
Previous Rejections
Applicants' arguments, filed 12/22/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 52-59 are objected to because of the following informalities: Claims 52-59 are withdrawn as recognized by the previous Office Action and Applicant’s response but appear to be inadvertently marked as “(Previously Presented)”, “(Original)”, and/or “(Currently Amended)”. Appropriate correction is required.
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.
1. Claims 6-7 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.
Claim 6 recites the limitation "infectivity of the coronavirus" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 6 depends, does not recite a “coronavirus”.
Claim 7 recites the limitation "intracellular replication of the coronavirus" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 7 depends, does not recite a “coronavirus”.
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.
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.
1. Claims 1, 3-7, 10-11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Crum (US 2017/0281713, Oct. 5, 2017) (hereinafter Crum) in view of Spearow et al. (Review: Improving Therapeutics for COVID-19 with Glutathione-boosting Treatments that Improve Immune Responses and Reduce the Severity of Viral Infections, May 15, 2020) (hereinafter Spearow).
Crum teaches the use of compositions comprising a glutathione precursor and a selenium source in the therapy of subjects suffering from viral diseases (Abstract). The individual components of the compositions include the three amino acids which serve as precursors of glutathione, i.e., glycine, L-cysteine (as L-cystine) and a glutamate source (which can, in turn, be provided in the form of glutamic acid or glutamine) plus a selenium containing amino acid such as selenomethionine or selenocysteine serving as a cofactor (satisfies composition of claim 1-5) (¶ [0031]). The glutathione precursor includes, individual components, e.g., L-glutamic acid, L-cystine and L-Methionine, and glycine (¶ [0035]). Preferably, the selenium is provided with L-methionine ( e.g., selenomethionine) (¶ [0047]). The aforementioned compositions may include suitable additives and further pharmaceutical ingredients such as coenzyme Q10 (CoQ10) (satisfies claim 10-11) (¶ [0057]). The methods of the invention find utility in the control or treatment of a variety of viruses and viral diseases, such as SARS (¶ [0084]).
Crum differs from the instant claims insofar as not explicitly disclosing wherein the compositions are used to treat SARS-CoV-2.
However, Spearow discloses that glutathione-boosting treatments have been shown to enhance immune responses and reduce the severity of influenza, coronavirus, HIV and other viral infections. Such viral infections markedly increase the production of Reactive Oxygen Species (ROS) and deplete cysteine and critical antioxidants, including reduced glutathione (GSH). These viruses use depletion of GSH to create an oxidized environment needed for viral replication/assembly and evading the host immune system. High levels of reduced glutathione in antigen presenting cells is critical for mounting an adaptive immune response to viral infections and for avoiding inflammatory cytokine responses. Demographic groups with highest susceptibility to SARS-CoV-2 infection have lower levels of glutathione, lower amino acid substrate and/or critical enzyme needed to synthesize glutathione. Spearow reviews the potential for glutathione-boosting supplements to reduce risks of severe COVID-19 induced cytokine storms and disease in susceptible populations (Abstract). Some studies support that the inability to maintain glutathione levels in the face of SARS-CoV-2 generated reactive oxygen species as an important risk factor for severe Covid-19 infection. As such, boosting glutathione levels should reduce the severity of Covid-19 (Pg. 10). Nutraceuticals such as selenium have been proposed to boost immune responses and reduce inflammatory responses to viral infections such as Covid-19. Regions in China with a selenium deficiency showed higher mortality rates from Covid-19 compared to regions with adequate selenium rates which actually showed higher cure rates from the infection (Pg. 11-12).
According, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have utilized the composition of Crum in methods of treating Covid-19 motivated by the desire to utilize a composition which boosts glutathione and selenium levels which have been shown to reduce the severity of Covid-19 and increase the cure rates from the infection as taught by Spearow.
Regarding claims 1, 6-7, and 16 reciting “increasing intracellular glutathione”, “reducing infectivity”, and “reducing intracellular replication”, as discussed above, the composition of Crum contains substantially the same components as the composition of the instant claims. Further, Crum discloses that the composition is useful in methods of controlling or treating viruses and viral diseases. As such, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Crum would “increase intracellular glutathione”, “reduce infectivity”, and “reduce intracellular replication” in the manner recited by the instant claims.
Therefore, the combined teachings of Crum in view of Spearow render obvious claim 1, 3-7, 10-11, and 16.
2. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Crum (US 2017/0281713, Oct. 5, 2017) (hereinafter Crum) in view of Spearow et al. (Review: Improving Therapeutics for COVID-19 with Glutathione-boosting Treatments that Improve Immune Responses and Reduce the Severity of Viral Infections, May 15, 2020) (hereinafter Spearow) and further in view of Hutchinson (Antiviral Research, Vol. 5, Iss. 4, Pg. 193-205, Aug. 1985) (hereinafter Hutchinson).
The combined teachings of Crum and Spearow are discussed above.
Crum and Spearow differ from the instant claim insofar as not disclosing wherein the composition contains metal chelators.
However, Hutchinson discloses that metal-chelating compounds have antiviral properties (Abstract).
Accordingly, it would have been obvious for one of ordinary skill in the art to have modified Crum’s composition to include metal-chelating compounds to treat viral diseases motivated by the desire to utilize their antiviral properties as taught by Hutchinson.
Therefore, the combined teachings of Crum, Spearow, and Hutchinson render obvious claim 13.
3. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Crum (US 2017/0281713, Oct. 5, 2017) (hereinafter Crum) in view of Spearow et al. (Review: Improving Therapeutics for COVID-19 with Glutathione-boosting Treatments that Improve Immune Responses and Reduce the Severity of Viral Infections, May 15, 2020) (hereinafter Spearow) and further in view of Kung et al. (US 2005/0004063, Jan. 6, 2005) (hereinafter Kung).
The combined teachings of Crum and Spearow are discussed above. Crum further discloses that the compositions may be provided in dosage unit form and may contain excipients (satisfies dosage form and excipient of claim 15) (¶ [0048]).
Crum and Spearow differ from the instant claim insofar as not disclosing wherein the composition contains additional antivirals such as acyclovir.
However, Kung teaches therapeutic agents useful for the treatment of Severe Acute Respiratory Syndrome (SARS) in humans (Abstract). Suitable antivirals for use include acyclovir, amantadine, delavirdine, didanosine, ganciclovir, lamivudine, nelfinavir, nevirapine, oseltamivir, penciclovir, pleconaril, ribavirin, rimantadine, ritonavir, saquinavir, stavudine, zalcitabine, zidovudine, and interferons (¶ [0037]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have modified Crum’s composition/methods of treating viruses to include antivirals such as acyclovir, amantadine, delavirdine, didanosine, ganciclovir, lamivudine, nelfinavir, nevirapine, oseltamivir, penciclovir, pleconaril, ribavirin, rimantadine, ritonavir, saquinavir, stavudine, zalcitabine, zidovudine, and interferons motivated by the desire to utilize their antiviral properties as taught by Kung.
Therefore, the combined teachings of Crum, Spearow, and Kung render obvious claim 15.
Response to Argument
Applicant’s arguments with respect to claims 1, 3-7, 10-11, 13, and 15-16 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. As discussed in the current rejections, Crum discloses a composition comprising glycine, L-cystine, a glutamate source, and a selenium for use in a method to treat viruses but does not expressly disclose wherein the viruses include SARS-CoV-2. However, Spearow’s teaching in reference to glutathione and selenium boosting compositions and their effects on Covid-19 is applied to meet the requirements of the new limitation “SARS-CoV-2 infection”.
Conclusion
Claims 1, 3-7, 10-11, 13, and 15-16 are rejected.
Claims 52-59 are withdrawn.
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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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, Sahana S. Kaup can be reached at 571-272-6897. 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.
/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612