DETAILED ACTION
Applicants’ arguments, filed 17 June 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Office Action is NON-FINAL
This office action includes a newly set forth provisional non-statutory double patenting rejection over the claims of US application serial number 18/026,568. This newly applied rejection does not appear to be necessitated by amendment. As this office action includes a newly applied rejection that was not necessitated by amendment or by filing an IDS, this office action has been made NON-FINAL.
Claim Rejections - 35 USC § 103 – Obviousness
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) 31-32 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heister et al. (Pharmacological Research Perspectives, 2020;e00653, pages 1-8, published 15 September 2020) in view of Carroll (US 2014/0275137 A1).
Heister et al. (hereafter referred to as Heister) is drawn to the use of tetrandrine as a therapeutic agent for COVID-19, as of Heister, page 1, title and abstract. Heister suggests oral dosing as of page 4, right column, first two paragraphs.
For the purposes of this rejection, the examiner understands that Heister fails to teach the required pharmaceutically acceptable excipient.
Carroll is drawn to a drug formulation of d-tetrandrine or a pharmaceutically acceptable salt thereof, as of Carroll, title and abstract. Carroll teaches capsule formulations as of paragraph 0110 and paragraphs 0014-0028; these capsules appear to be for oral administration.
Carroll does not teach an antiviral method.
It would have been prima facie obvious for one of ordinary skill in the art to have used the dosage form of Carroll to have administered the tetrandrine of Heister. Heister teaches the use of tetrandrine as a therapeutic agent for COVID-19. While Heister is silent as to the pharmaceutical formulation used to administer the tetrandrine, Carroll teaches a pharmaceutical formulation that can be used to administer tetrandrine. As such, the skilled artisan would have been motivated to have administered the tetrandrine of Heister in the formulation taught by Carroll in order to have predictably provided the tetrandrine to a patient suffering from a viral infection to have predictably achieved an antiviral method with a reasonable expectation of success.
As to claim 31, the claim recites an antiviral method of treating a patient. Because Heister teaches that tetrandrine is a potential therapeutic agent for COVID-19, the skilled artisan would have been motivated to have administered the tetrandrine of Heister to a patient suffering from COVID-19 with a reasonable expectation that said tetrandrine would have successfully treated COVID-19 in said patient.
As to claim 31, the claim requires a pharmaceutically acceptable excipient. The materials taught by Carroll, paragraphs 0015-0028 appear to be pharmaceutically acceptable excipients.
As to claim 31, the claim requires a dose of from 0.1 mg to 100 mg. Heister teaches a dose of 60-100 mg three times a day to treat a different disease, as of Heister, page 4, left column, second full paragraph. Heister provides other teachings and suggestions regarding the dose of tetrandrine elsewhere in page 4, left column. Generally, differences in concentration (wherein the examiner understands dose to be a form of concentration) between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been presented. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a method of administering tetrandrine to treat SARS-CoV-2 (i.e. COVID-19) has been taught by the prior art. As such, it would have been inventive for the skilled artisan to have discovered optimum or workable ranges of tetrandrine via routine experimentation.
As to claim 32, the capsule taught by Carroll, at least paragraph 0014 would appear to read on the required unit dose.
As to claim 38, Heister teaches the following regarding oral administration, as of page 4, right column, relevant text reproduced below with text highlighted by the examiner.
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Additionally, the capsule of Carroll would appear to be intended for oral administration.
As to claim 39, the composition of Carroll would appear to read on the required capsule.
Note Regarding Reference Date: The instant application claims benefit to multiple provisional applications, the earliest of which were filed on 17 September 2020. Heister appears to have been published on 15 September 2020; see the last page of the reference in which the examiner has provided the abstract of Heister. Relevant text from that page is reproduced below.
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As such, Heister was published less than a year earlier than the earliest effective filing date of the instant application. Therefore, Heister is prior art under AIA 35 U.S.C. 102(a)(1). There does not appear to be common inventors/authors or a common assignee between Heister and the instant application; as such, there appears to be no evidence that the exceptions under AIA 35 U.S.C. 102(b)(1)(A or B) are applicable.
Response to Arguments Regarding Obviousness Rejection
Applicant has presented arguments regarding the previously applied rejection, as of applicant’s response on 17 June 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
Applicant took the following position regarding the previously applied rejection over Heister in view of Carroll, as of applicant’s response, page 7, relevant text reproduced below.
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These arguments are not persuasive for at least the following reasons:
First, the examiner notes that Heister teaches that tetrandrine is a potential therapeutic for COVID-19, as of Heister, page 1, title. COVID-19 is the disease caused by SARS-CoV-2; as such, the skilled artisan would have understood that a compound taught to be effective against COVID-19 would have been effective against SARS-CoV-2. The teaching of Heister that tetrandrine is a potential therapeutic for COVID-19 would have been sufficient to establish that (A) the skilled artisan would have been motivated to have used tetrandrine as a therapeutic for COVID-19, and (b) there would have been a reasonable expectation that tetrandrine could have successfully treated COVD-19. See MPEP 2143, Exemplary Rationale E, regarding the “obvious to try” rationale – it would have been prima facie obvious for the skilled artisan to have tried administering tetrandrine to have treated COVID-19.
The examiner notes that primary purpose of the Heister reference appears to be to review articles published prior to Heister and does not appear to present the results of new experiments. Nevertheless, this does render Heister to be non-enabling art. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. See MPEP 2121(I). The mere fact that Heister summarizes prior research rather than conducting new experiments is insufficient to meet applicant’s burden of rebutting the presumption of operability in Heister.
Applicant then presents arguments on the grounds that Heister fails to teach an effective dose of tetrandrine. This is not persuasive. As an initial matter, Heister provides teachings related to the tetrandrine dose on the left column of page 4 of Heister. The examiner admits that the doses taught here are not necessarily for treatment of SARS-CoV-2; and, in some cases, are higher than the 100 mg maximum recited by claim 31. Nevertheless, generally, differences in concentration (wherein the examiner understands dose to be a form of concentration) between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been presented. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
In this case, the general conditions of a method of administering tetrandrine to treat SARS-CoV-2 (i.e. COVID-19) has been taught by the prior art. As such, it would have been inventive for the skilled artisan to have discovered optimum or workable ranges of tetrandrine via routine experimentation.
As such, the examiner takes the position that there is a prima facie case of obviousness in view of the guidance in MPEP 2144.05 regarding optimization of ranges.
Applicant also presented arguments regarding previously applied rejections other than that based on the combination of Heister in view of Carroll, as of applicant’s response on 17 June 2026. The arguments regarding other previously applied rejections other than that over Heister in view of Carroll relate to rejections that have been withdrawn by the examiner. As such, these arguments are understood to be moot and have not been substantively addressed by the examiner in this response.
Non-Statutory 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 31-32 and 38-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 66-68 and 70 of copending Application No. 18/026,568 in view of Mudatsir et al. (Scientia Pharmaceutica, Vol. 88(36), 2020, pages 1-8, published 17 August 2020).
The instant claims are drawn to a method for treating SARS-CoV-2 with tetrandrine at a particular dose.
The copending claims are drawn to a method of treating a viral disease with a combination of tetrandrine, cepharanthine, and a particular immune modulator, as of copending claim 66. Copending claim 68 teaches treating a SARS-CoV disease.
The copending claims (a) fail to specifically recite SARS-CoV-2 (rather than a generic SARS-CoV disease), (b) do not teach the required elements of instant claim 39, (c) do not teach the required dose, and (d) recite elements in addition to the tetrandrine, which are not explicitly recited by the instant claims.
Mudatsir et al. (hereafter referred to as Mudatsir) teaches SARS-CoV-2 as the disease causing agent which causes the COVID-19 pandemic, as of Mudatsir, page 1, title and abstract. Mudatsir teaches tablets, capsules, and an oral solution as drug delivery forms for oral administration of an active agent, as of Mudatsir, page 2, second to last paragraph.
Mudatsir differs from the claimed invention because the active agent in Mudatsir differs from that in the claimed invention.
It would have been prima facie obvious for one of ordinary skill in the art to have administered the formulation of the copending claims to have treated SARS-CoV-2. The formulation of the copending claims is recited for administration for treating a SARS-CoV coronavirus; however, SARS-CoV-2 is not specifically recited by the copending claims. Nevertheless, Mudatsir teaches that SARS-CoV-2 was known to have existed at the time of publication and was the cause of a pandemic. As such, the skilled artisan would have been motivated to have administered the method of the copending claims to a patient suffering from the SARS-CoV-2 virus for predictable treatment of COVID-19 with a reasonable expectation of success.
Additionally, the copending claims recite oral administration in copending claim 70, but do not specifically suggest particular oral dosage forms. However, Mudatsir teaches that tablets, capsules, and an oral solution as drug delivery forms for oral administration of an active agent to treat COVID-19, as of Mudatsir, page 2, second to last paragraph. As such, the skilled artisan would have been motivated to have formulated the compounds of the copending claims into a tablet, capsule, or oral solution for predictable oral administration with a reasonable expectation of success.
As to issue (a) listed above, SARS-CoV-2 is taught by Mudatsir, as explained above.
As to issue (b) listed above, tablets and capsules have been taught by Mudatsir, as explained above.
As to issue (c) listed above, Mudatsir is silent as to the dose. Nevertheless, where the general conditions of a claim are disclosed in the prior art (or in this case, copending claims), it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a method of administering tetrandrine to treat SARS-CoV-2 (i.e. COVID-19) has been recited by the copending claims. As such, it would have been inventive for the skilled artisan to have discovered optimum or workable ranges of tetrandrine via routine experimentation.
As to issue (d), that the copending claims recited additional ingredients not recited by the instant claims is not sufficient to overcome the applied provisional non-statutory double patenting rejection. This is because the instant claims recite the transitional phrase “comprising”, which does not exclude additional unrecited elements or method steps. See MPEP 2111.03(I) regarding appropriate claim interpretation of the term “comprising.” As such, that the copending claims recite additional elements not recited by the instant claims does not result in the subject matter of the copending claims being outside the scope of that of the instant claims.
The examiner clarifies that Mudatsir was published on 17 August 2020. This is earlier than the earliest effective filing date of the instant application, which appears to be 17 September 2020. As such, Mudatsir is understood to be prior art under AIA 35 U.S.C. 102(a)(1).
As of the date of preparation of this office action, the copending application has been allowed, but has not yet issued as a patent. In view of this fact pattern, this is a provisional nonstatutory double patenting rejection because the copending claims have not been patented.
This is a newly applied rejection that does not appear to have been necessitated by amendment. As such, this office action has been made NON-FINAL.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana 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.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights