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 office action is in response to the amendment received on September 10th, 2026.
The applicant has cancelled claims 8, 10, and 12-20; and added new claims 21-24.
Any objections or rejections not reiterated below are hereby withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 10th, 2026 has been entered.
Response to Amendment
The declaration under 37 CFR 1.132 filed September 10th, 2026 is insufficient to overcome the rejection of newly presented claims 21-24 as stated in the new rejection under 35 U.S.C. 103 below.
Withdrawal of Objections and Rejections
The rejection of claims 8, 10, and 12-20 under 35 U.S.C. 103 is withdrawn, these claims having been cancelled by the applicant.
Pending objections and Rejections
Claim Objections
Claim 21 is objected to because of the following informalities: the terms "Sarracenia flava" and "Sarracenia purpurea" should be italicized. Appropriate correction is suggested.
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 21-24 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. It is unclear whether the terms “coronavirus disease 2019” (claim 21) and “coronavirus” (claim 22) refer to a genus of coronaviruses, or a species or specific strain of coronavirus. It is also unclear how coronavirus can still be present in the subject if the composition is administered (claim 22, step b).
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention. The response filed September 10th, 2026, has introduced NEW MATTER into the claims. Newly added claim 21 recites a method comprising administering a composition comprising an herbal preparation of Sarracenia flava, Sarracenia purpurea, or a mixed hybrid thereof; magnesium, glutathione, or both; and valacyclovir. The response pointed out Example 4 of the specification to support the claim amendments. However, Example 4 does not disclose the administration of magnesium, glutathione, or both with, or incorporated into, the SarraV composition. Example 4 does not disclose the species of pitcher plant(s) used in the SarraV composition administered to a subject, where SarraV is defined as Sarravis® Core with valacyclovir (paragraph [00142]), and Sarravis® Core is defined broadly as “a composition comprising pitcher plant extracts with one or more cofactors” (paragraph [0062]). Example 4 does not disclose the PCR of mRNA testing steps recited in claim 22. Example 4 does not disclose the chemical components recited in claim 23, or the protease inhibitor recited in claim 24. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). Instant claims 21-24 now recite limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly added claims 21-24, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claims 21-24 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Langland et al. (WO 2014081976 A1), abbreviated "Langland"; in further view of Fehr and Perlman (Methods Mol Biol. 2015, 1282, 1-23); Baker (International Journal of Clinical Case Reports and Reviews 2022, 10 (2), DOI: 10.31579/2690-4861/199; Far et al. (Journal of Biomolecular Structure and Dynamics 2023, 41 (10), 4253-4271), published online April 21st, 2022, abbreviated "Far"; Buck (Acyclovir for Neonatal and Pediatric Viral Infections. Pediatric Pharmacology 2002, 8 (6)); and Guloyan et al. (Antioxidants (Basel) 2020, 9 (10), 914), abbreviated "Guloyan".
Claim 21 recites “A method of treating coronavirus disease 2019 (COVID-19) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition comprising: a. 0.1%-99% wt. of an herbal preparation of Sarracenia flava, Sarracenia purpurea, or mixed hybrids thereof; b. 0.0 1%-95% wt. of magnesium, glutathione, or both; and c. 0.0 1%-95% wt. of valacyclovir”.
Langland recites “In various embodiments, the present disclosure includes methods comprising administering one or more botanical extracts and/or pharmaceutical formulation thereof, to a patient in need of treatment, for example, a patient infected with a virus, or to inhibit virus replication or infection of a cell in a patient, or to treat a disease or condition associated with such virus replication or infection of a cell. Although not wishing to be bound to any theories of action, botanical extracts of the present disclosure are believed to block viral replication. For example, Sarracenia spp. is believed to block viral RNA synthesis. Melissa spp. is believed to block viral attachment to the cell” (page 9, lines 6-13; instant claim 21). Coronaviruses are known in the art as RNA viruses, as taught by Fehr and Perlman “Coronaviruses (CoVs), enveloped positive-sense RNA viruses, are characterized by club-like spikes that project from their surface, an unusually large RNA genome, and a unique replication strategy” (Abstract). Therefore, a person of skill in the art would have had a reasonable expectation of success at administering Sarracenia as taught by Langland, with the effect of treating a patient infected with a coronavirus.
Baker recites “This observational study aimed to investigate utilizing acyclovir as the primary antiviral treatment against SARS-CoV-2 infection and its role in minimizing disease burden of COVID-19 among individuals with asymptomatic to critical illness” (page 2 of 7, left column, lines 6-9 from the top). Baker further recites “This cohort of established patients were at very high risk for progression to severe disease related to SARS-CoV-2 as 58% were of age greater than 60 and 72% had one or more comorbid illnesses” (Discussion, paragraph 1). Baker further recites “97% of our patients achieved full recovery as defined by resolution of acute symptoms, resolution of acute radiologic findings and improvement in inflammatory markers” (Discussion, paragraph 2). Baker further recites “Acyclovir with adjunct treatment allowed for successful recovery and prevented progression to severe disease or need for hospitalization” (Discussion, Paragraph 4). Baker recites “Acyclovir, as the primary antiviral agent, is effective, safe, and inexpensive in decreasing initial and potential long-term impacts from SARS-CoV-2 virus infection in humans. It has proved to be beneficial in preventing hospitalization for high-risk individuals with mild to critical illness” (Abstract, Conclusion section). Far recites the results of a molecular dynamics study clarifying a possible mechanism of acyclovir in COVID-19 treatment: “The current study demonstrates that three FDA-approved drugs, namely, metronidazole, acyclovir and tetrahydrobiopterin, are potential repurposable treatment options for overexpressed serum cytokines found in COVID-19 patients”. It would have been obvious to one of skill in the art to substitute acyclovir with valacyclovir, because valacyclovir is known to be converted into acyclovir in vivo, as recited by Buck “Valacyclovir is a prodrug which is converted to acyclovir in the GI tract and liver”. Therefore, a person of skill in the art could substitute acyclovir with valacyclovir, with the predictable effect of increasing acyclovir concentration in the serum of the subject, and the therapeutic effects of acyclovir against COVID-19 (instant claim 21).
Guloyan recites “GSH deficiency has been associated with a more severe clinical manifestation of coronavirus. One article with a small number of cases shows decreased plasma GSH is associated with more severe presentation of disease. Levels of GSH and ROS were measured in 4 patients with laboratory confirmed COVID-19. In the patients with higher baseline levels of GSH, there was an observed decrease in ROS, and these patients had a shorter course of illness. Decreased GSH was associated with increased ROS and more severe symptoms” (heading 14, paragraph 3; instant claim 21). Guloyan suggests “supplying a bioavailable formulation of GSH in the form of reduced liposomal GSH as an adjunct in COVID-19 treatment” (heading 14, paragraph 8; instant claim 21).
A person of skill in the art would have been motivated to combine the above references to formulate a composition to administer to a patient for treating COVID-19, as the teachings of each of these references are either directly relevant to treating COVID-19 in a subject, or relevant to establishing general knowledge in the art regarding the biology of coronaviruses, inhibition of viral RNA synthesis, or in vivo prodrug processing relevant to treating COVID-19 (instant claim 21).
Although the cited references do not recite the weight percent parameters recited in claim 21, these parameters are obvious to a person of skill in the art over routine optimization. A person of skill in the art could control the weight percent of each ingredient by using a laboratory scale to weigh each ingredient before combining them. A person of skill in the art could administer different compositions, varying by the weight percents of ingredients, to subjects who have tested positive for SARS-CoV-2 infection using a polymerase chain reaction (PCR) test. A person of skill in the art could perform PCR tests on the subjects at regular intervals to monitor the effect of administering each composition on the SARS-CoV-2 infection. A person of skill in the art could compare the outcome of each subject to select a composition effective at treating SARS-CoV-2 infection.
Langland, Fehr and Perlman, Baker, Far, Buck, and Guloyan 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 the ingredients of a composition administered to a patient, 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 composition administered in the claimed method), 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 Langland in view of Fehr and Perlman, Baker, Far, Buck, and Guloyan, the invention as a whole, drawn to a method comprising administering a therapeutic composition to a subject as described in Claim 21, 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).
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Langland (WO 2014081976 A1); in further view of Fehr and Perlman (Methods Mol Biol. 2015, 1282, 1-23); Baker (International Journal of Clinical Case Reports and Reviews 2022, 10 (2), DOI: 10.31579/2690-4861/199; Far (Journal of Biomolecular Structure and Dynamics 2023, 41 (10), 4253-4271); Buck (Acyclovir for Neonatal and Pediatric Viral Infections. Pediatric Pharmacology 2002, 8 (6)); and Guloyan (Antioxidants (Basel) 2020, 9 (10), 914) as applied to claim 21 above, and further in view of Zhong et al. (CN 111686095 A), abbreviated "Zhong".
Claim 23 recites “The method of claim 21, wherein the composition further comprises zinc, chromium, selenium, B-vitamins, keratin, cannabidiol, tetrahydrocannabinol, or a combination thereof”.
Claim 21 and the teachings of cited references are of record above.
Zhong recites anti-SARS-CoV-2 activity of cannabidiol: “research shows that cannabidiol can obviously reduce the cell virus nucleic acid loading of SARS-CoV-2 infection, has the function of inhibiting SARS-CoV-2 replication. In some experiments, the EC50 of cannabidiol to SARS-CoV-2 in Vero E6 cells was 0.62 μM CC50 was 4.10 μM and SI was 6.61, which was shown to be very advantageous for treating diseases or infections caused by SARS-CoV-2” (machine translation, Contents of the Invention, paragraph 1; instant claim 23). Zong implies that SARS-CoV-2 is the virus of the disease COVID-19 “In the present invention, the term ‘2019 novel coronavirus (2019 -nCoV)’ is formally classified as severe acute respiratory syndrome coronavirus 2 (acute respiratory syndrome avirus (sic) 2. SARS-CoV-2). In this context, the term ‘2019 novel coronavirus (2019 -nCoV’) is used herein the formal name of the disease is COVID-19” (machine translation, page 7 of 11, lines 12-15 from the bottom). A person of skill in the art would have been motivated to combine cannabidiol with the composition administered in the process recited in claim 21, for the purpose of treating COVID-19, and would have had a reasonable expectation of success from the teachings of Zhong regarding the anti-SARS-CoV-2 activity of cannabidiol (instant claim 23).
Claims 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Langland (WO 2014081976 A1); in further view of Fehr and Perlman (Methods Mol Biol. 2015, 1282, 1-23); Baker (International Journal of Clinical Case Reports and Reviews 2022, 10 (2), DOI: 10.31579/2690-4861/199; Far (Journal of Biomolecular Structure and Dynamics 2023, 41 (10), 4253-4271); Buck (Acyclovir for Neonatal and Pediatric Viral Infections. Pediatric Pharmacology 2002, 8 (6)); and Guloyan (Antioxidants (Basel) 2020, 9 (10), 914) as applied to claim 21 above, and further in view of Wang et al. (CN 111481547 A), abbreviated "Wang".
Claim 24 recites “The method of claim 21, wherein the composition further comprises a protease inhibitor”.
Claim 21 and the teachings of cited references are of record above.
Wang recites: “Novel coronavirus pneumonia (Corona Virus Disease 2019, COVID-19) refers to pneumonia caused by new coronavirus (SARS-CoV-2) infection, mainly through respiratory foam propagation and contact propagation, people are generally easy to feel, It has high infectivity” (Description, Background, paragraph 1). Wang suggests pirfenidone as a PLpro protease inhibitor for treating a coronavirus “using GA-FEP method to calculate to obtain absolute combination free energy of pirfenidone and PLpro is -10.283kcal/mol, indicating that the pirfenidone and new coronavirus target PLpro protease has strong binding strength, can inhibit PLpro protease activity, so as to inhibit the transcription and replication of virus, indicating that pirfenidone has potential therapeutic effect on pneumonia caused by new coronavirus” (Example 1; instant claim 24). Wang also teaches experimental results supporting pirfenidone as a PLpro protease inhibitor: “pirfenidone can be strongly combined with new coronavirus PLpro, and has inhibiting coronavirus PLpro protease activity, indicating that the pirfenidone has the function of preventing and treating pneumonia caused by new coronavirus; it can be prepared as anti-pneumonia medicine for application” (Example 2, (3) Experimental Results, b. Inhibition of Activity Test of Piperidone PLpro Protease; instant claim 24). A person of skill in the art would have been motivated to combine the protease inhibitor pirfenidone with the composition administered in the process recited in claim 21, for the purpose of treating COVID-19, and would have had a reasonable expectation of success from the teachings of Wang regarding the PLpro-inhibiting activity of pirfenidone (instant claim 24).
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
German, E. R.; et al. Treatment of Long-Haul COVID Patients With Off-Label Acyclovir. Cureus 2023, 15 (4), e37926. DOI: 10.7759/cureus.37926
German et al. recites treating four patients in 2021 with acyclovir, showing a decrease in IgM and IgG antibodies in at least three of the patients (Patients A-C), where these antibodies are used to assess COVID-19 viral load (see the Case Presentation section).
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
