Detailed Action
The present office action is in response to the response filed on 23 Mar 2026.
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 .
Status
Claims 211-214, 219-222, 230, 255-256, 259, 267, and 269 of the pending application have been examined on the merits. Claims 1, 8-10, 13-18, 23, 27, 29, 32, 38, 40, and 44 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 23 Sep 2023. Acknowledgement is made of the cancellation of claims 2-7, 11-12, 19-22, 24-26, 28, 30-31, 33-37, 39, 41-43, 45-210, 215-218, 223-229, 231-254, 257-258, 260-266, and 268.
Priority
Applicants identify the instant application, Serial #: 18/205,745, filed 05 Jun 2023, as claiming priority from Provisional Application #s: 63/461,218, filed 21 Apr 2023, and 63/349,531, filed 06 Jun 2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 07 Jul 2023, 29 Sep 2023, 22 Feb 2024, 09 Jan 2025, 31 Oct 2025, and 23 Mar 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election without traverse of Group II, claims 211-214, 219-222, 230, 255-256, 259, 267, and 269, in the reply filed on 23 Mar 2026 is acknowledged. Prior art was returned after a search for the elected invention.
Claims 1, 8-10, 13-18, 23, 27, 29, 32, 38, 40, and 44 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 Mar 2026.
Specification Objections
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Examiner has identified browser executable code in at least paragraph [0584] of the specification. Applicant cooperation is respectfully requested in finding any other instances of browser-executable code in the instant disclosure.
Claim Rejections - 35 USC § 112(a)
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 211-212, 219, 220, 222, 230, 255-256, 259, 267, and 269 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(s), at the time the application was filed, had possession of the claimed invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize the applicant was in possession of the claimed invention as a whole at the time of filing include:
Actual reduction to practice;
Disclosure of drawings or structural chemical formulas;
Sufficient relevant identifying characteristics such as:
Complete structure,
Partial structure,
Physical and/or chemical properties, or
Functional characteristics when coupled with a known or disclosed correlation between function and structure;
Method of making the claimed invention;
Level of skill and knowledge in the art;
Predictability in the art.
While all these factors are considered, a sufficient number for a prima facie case are discussed below.
Regarding claims 211-212 and 219-220, here, the claims are drawn to "prodrug." Applicant provides the following definition of prodrug, “the term ‘prodrug,’ as used herein, refers to a biologically inactive derivative of a drug that, upon administration to the patient, can be converted to a parent drug according to some chemical or enzymatic pathway.” The definition, however, does not provide sufficient guidance as to prodrugs. The artisan understands that prodrug forms are generally determined a posteriori, and it is only through trial and error that prodrugs are identified. The artisan understands the concept of prodrugs, however the artisan does not per se understand what specifically describes a prodrug form. Han (AAPS Pharmsci, 2000, vol. 2, article 6), cited here for evidence, teaches there is no strict universal definition for a prodrug itself but that, in general, the prodrug is an inactivated form of the drug that activates in vivo to the active form (pg. 1, column 2). While some prodrugs are simply esters or salts, other prodrug forms are not chemically or structurally related to their active form, one example being glucose as the prodrug form of hydrogen peroxide (Table 1, pg. 5), as is hypoxanthine, thus posing a problem as to understanding what is the exact prodrug form of a compound, as hydrogen peroxide has two prodrug forms in the limited set of compounds exemplified in Han.
According to Ettamayer et al. (J Med Chem, 2004, 47:2393-2404), cited here for evidence, prodrugs are often accidental discoveries (pg. 2393, column 2). Furthermore, Testa et al. (Biochem Pharm, 2004, 68:2097-2106), cited here for evidence, teaches:
[A] number of challenges await medicinal chemists and biochemists carrying out prodrug research, such as the additional work involved in synthesis, physiochemical profiling, pharmacokinetic profiling and toxicological assessment. Two of these challenges are introduced here, namely biological variability and toxicity potential. The challenge of biological variety results principally but not only from the huge number and evolutionary diversity of enzymes involved in xenobiotic metabolism. Inter- and intra-species differences in the nature of these enzymes, as well as many other differences such as the nature and level of transporters, may render prodrug optimization difficult to predict and achieve. (pg. 2098, column 2)
Methods of making compounds, in general, are known to the artisan. However, the methods of making any specific prodrug are complex and poorly understood, requiring an undue amount of experimentation to determine if a compound is actually a prodrug, and the instant specification fails to provide guidance to overcome the complexity and difficulties known to the artisan, as discussed above.
Thus, the artisan would have increased difficulty in determining how to convert the claimed compound into a prodrug.
Regarding claims 222, 230, 255-256, 259, 267, and 269, these claims are similarly rejected as these claims refer back to claims 211, but do not remedy the rationale underpinning the basis for rejecting claim 211.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections – Improper Markush Grouping
Claim 212 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “Compound 1, or the prodrug of Compound 1, or a pharmaceutically acceptable salt” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: a pharmaceutically acceptable salt does not share the same structure as Compound 1 or a prodrug of Compound 1 and the person having skill in the art would not recognize these Markush group members to have a common use. Applicant may amend the pharmaceutically acceptable salt to be a “pharmaceutically acceptable salt thereof” to overcome this rejection.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
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.
Claim(s) 211-214, 219-222, 230, 255, 256, 259, 267, and 269 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Tempestilli et al. (J Antimicrob Chemother, 2020, 75:2977-2980), hereinafter Tempestilli, further in view of Hammond et al. (N Engl J Med, 2022, 186:1397-1408; provided in IDS 07/07/23; first published 16 Feb 2022), hereinafter Hammond, and Cao et al. (Sci Transl Med, 2022, 10.1126/scitranslmed.abm7621; provided in IDS 07/07/23; first published 17 May 2022), hereinafter Cao, in light of Yan et al. (ACS Med Chem Lett, 2020, 11:1361-1366; provided in IDS 07/07/23; cited for evidentiary purposes), hereinafter Yan.
The instant claims are drawn to a method of treating a viral infection in a human by administering Compound 1 (below) or a prodrug or deuterated form of Compound 1, and nirmatrelvir, ritonavir, or a combination of nirmatrelvir and ritonavir (claims 211-214, 219-220, and 230).
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The claims further narrow the prodrug to the following compound (claim 221):
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The claims further narrow the patient population to non-pregnant humans (claim 222), the administration of nirmatrelvir and ritonavir to be oral (claim 255), the timing of nirmatrelvir and ritonavir administration to be twice daily (claim 256), and that nirmatrelvir and ritonavir are administered within 5 days of symptom onset (claim 259). The type of virus is further narrowed to SARS-CoV-2 (claims 267 and 269).
Regarding claims 211-214, 219-220, 222, 230, 255-256, 259, 267, and 269, Tempestilli teaches the evaluation of the nucleoside analog GS-441524 and its prodrug remdesivir for the treatment of SARS-CoV-2-infected patients and further records the administration of both compounds to two critically ill COVID-19 patients (pg. 2977, Background and Objectives). Tempestilli teaches these patients were a 66-year-old female and 67-year-old male. Yan, cited for evidence, teaches the structure of GS-441524 and remdesivir (pg. 1362, Fig. 1):
GS-441524
Remdesivir
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GS-441524 has the same structure as the instant Compound 1. However, Tempestilli does not teach the administration of nirmatrelvir, ritonavir, or the combination of nirmatrelvir and ritonavir to treat SARS-CoV-2-infected patients.
Hammond teaches the treatment of symptomatic, unvaccinated, nonhospitalized adults with either 300 mg or nirmatrelvir plus 100 mg of ritonavir or placebo every 12 hours for 5 days and that the treatment with the combination resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo without evident safety concerns (pg. 1397). Hammond teaches that eligible participants were required to be at least 18 years old and to have confirmed Sars-CoV-2 infection and symptom onset no more than 5 days before randomization. Hammond teaches that the exclusion criteria for the study included pregnancy or breastfeeding (Supplementary Appendix, pg. 9).
Based on the teachings of Tempestilli and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of GS-441524 with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS-CoV-2 with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Based on the teachings of Tempestilli and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of remdesivir with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS-CoV-2 with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claim 221, Cao teaches a prodrug of GS-441524, ATV006, possesses potent anti-SARS-CoV-2 activity (pg. 1, Abstract). Cao further teaches ATV006 improved oral absorption compared to GS-441524 and potently inhibited the replication of SARS-CoV-2 (pg. 4, column 2 to pg. 5, column 1). Cao teaches that ATV006 is structurally simpler and easier to synthesize compared to remdesivir which may reduce cost and accelerate mass production (pg. 5, column 2).
Based on the teachings of Tempestilli, Hammond, and Cao, in the composition of GS-441524, nirmatrelvir, and ritonavir for the treatment of SARS-CoV-2 (see above), taught by Tempestilli and Hammond, the artisan would replace GS-441524 with ATV006, taught by Cao, and have a reasonable expectation of success in treating SARS-CoV-2. The artisan would be motivated to make this exchange because ATV006 improves oral absorption compared to GS-441524.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 211-212, 219-222, 267, and 269 are rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1, 3-5, 41, and 42-44 of U.S. Patent No. 11,660,307. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 teaches a method of treating SARS-CoV-2 in a human by administering a compound of Formula (III):
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Where R6 is CN; R8 is NH2; and R9 is H. Reference claim 3 further limits the R2 and R3 variables to OH and reference claim 5 (dependent on reference claims 3-4) limits the R7 variable to -(C=O)R11 where R11 is CH(CH3)2 which matches Compound 1 of the instant claims. Reference claim 42 further teaches administering an additional therapeutic agent and reference claim 43 includes ritonavir as an additional therapeutic agent. By teaching treating humans, the reference necessarily includes treating humans who are not pregnant. Therefore, the instant claims are not patentably distinct from the reference.
Claims 211-212, 219-222, 230, 255-256, 259, 267, and 269 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 16-18 and 20 of U.S. Patent No. 11,814,406 in view of Hammond.
The reference patent teaches a method of treating a coronavirus infection in a human by administering a crystalline form of the following compound in an oral form (claims 16-17):
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Reference claim 18 further teaches administering at least one additional therapeutic or prophylactic agent. Reference claim 20 teaches the viral infection to be SARS-CoV-2. By teaching the treatment of humans, the reference necessarily includes treating humans who are not pregnant. However, the reference patent does not teach administering nirmatrelvir, ritonavir, or a combination of nirmatrelvir and ritonavir to the patient.
Hammond teaches the treatment of symptomatic, unvaccinated, nonhospitalized adults with either 300 mg or nirmatrelvir plus 100 mg of ritonavir or placebo every 12 hours for 5 days and that the treatment with the combination resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo without evident safety concerns (pg. 1397). Hammond teaches that eligible participants were required to be at least 18 years old and to have confirmed Sars-CoV-2 infection and symptom onset no more than 5 days before randomization. Hammond teaches that the exclusion criteria for the study included pregnancy or breastfeeding (Supplementary Appendix, pg. 9).
Based on the teachings of the reference patent and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of the crystalline form of the reference compound with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS-CoV-2 with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 211-212, 219-222, 230, 255-256, 259, 267, and 269 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 54-56 of U.S. Patent No. 11,926,645 in view of Hammond.
The reference patent teaches a method of treating a coronavirus infection in a human by administering a crystalline form of the following compound (claims 54-55):
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Reference claim 56 teaches the viral infection to be SARS-CoV-2. By teaching the treatment of humans, the reference necessarily includes treating humans who are not pregnant. However, the reference patent does not teach administering nirmatrelvir, ritonavir, or a combination of nirmatrelvir and ritonavir to the patient.
Hammond teaches the treatment of symptomatic, unvaccinated, nonhospitalized adults with either 300 mg or nirmatrelvir plus 100 mg of ritonavir or placebo every 12 hours for 5 days and that the treatment with the combination resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo without evident safety concerns (pg. 1397). Hammond teaches that eligible participants were required to be at least 18 years old and to have confirmed Sars-CoV-2 infection and symptom onset no more than 5 days before randomization. Hammond teaches that the exclusion criteria for the study included pregnancy or breastfeeding (Supplementary Appendix, pg. 9).
Based on the teachings of the reference patent and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of the crystalline form of the reference compound with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS-CoV-2 with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 211-212, 219-222, 230, 255-256, 259, 267, and 269 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 12,297,226 in view of Hammond.
The reference patent teaches a method of treating a coronavirus infection in a human by administering a crystalline form of the following compound (claims 11-12):
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Reference claim 13 teaches the viral infection to be SARS-CoV-2. By teaching the treatment of humans, the reference necessarily includes treating humans who are not pregnant. However, the reference patent does not teach administering nirmatrelvir, ritonavir, or a combination of nirmatrelvir and ritonavir to the patient.
Hammond teaches the treatment of symptomatic, unvaccinated, nonhospitalized adults with either 300 mg or nirmatrelvir plus 100 mg of ritonavir or placebo every 12 hours for 5 days and that the treatment with the combination resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo without evident safety concerns (pg. 1397). Hammond teaches that eligible participants were required to be at least 18 years old and to have confirmed Sars-CoV-2 infection and symptom onset no more than 5 days before randomization. Hammond teaches that the exclusion criteria for the study included pregnancy or breastfeeding (Supplementary Appendix, pg. 9).
Based on the teachings of the reference patent and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of the crystalline form of the reference compound with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS-CoV-2 with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 211-212, 219-222, 230, 255-256, 259, and 267 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 43 of U.S. Patent No. 11,382,926 in view of Hammond.
The reference patent teaches a method of treating a Coronaviridae infection in a human by administering a compound of Formula III (claim 1):
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Where R6 is CN; R8 is NH2; and R9 is H. Reference claim 4 further limits the R2 and R3 variables to OH and reference claim 6 (dependent on reference claims 4-5) limits the R7 variable to -(C=O)R11 where R11 is CH(CH3)2 which matches Compound 1 of the instant claims. Reference claim 43 teaches the viral infection to be SARS. By teaching the treatment of humans, the reference necessarily includes treating humans who are not pregnant. However, the reference patent does not teach administering nirmatrelvir, ritonavir, or a combination of nirmatrelvir and ritonavir to the patient.
Hammond teaches the treatment of symptomatic, unvaccinated, nonhospitalized adults with either 300 mg or nirmatrelvir plus 100 mg of ritonavir or placebo every 12 hours for 5 days and that the treatment with the combination resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo without evident safety concerns (pg. 1397). Hammond teaches that eligible participants were required to be at least 18 years old and to have confirmed Sars-CoV-2 infection and symptom onset no more than 5 days before randomization. Hammond teaches that the exclusion criteria for the study included pregnancy or breastfeeding (Supplementary Appendix, pg. 9).
Based on the teachings of the reference patent and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of the crystalline form of the reference compound with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS Coronaviridae infection with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 211-212, 219-222, 230, 255-256, 259, 267, and 269 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1 and 114-115 of copending Application No. 18/243,812 in view of Hammond.
The reference application teaches a method of treating a coronavirus infection in a human by administering Compound 16 (claim 1):
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Reference claims 114-115 teach the viral infection to be SARS-CoV-2. By teaching the treatment of humans, the reference necessarily includes treating humans who are not pregnant. However, the reference patent does not teach administering nirmatrelvir, ritonavir, or a combination of nirmatrelvir and ritonavir to the patient.
Hammond teaches the treatment of symptomatic, unvaccinated, nonhospitalized adults with either 300 mg or nirmatrelvir plus 100 mg of ritonavir or placebo every 12 hours for 5 days and that the treatment with the combination resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo without evident safety concerns (pg. 1397). Hammond teaches that eligible participants were required to be at least 18 years old and to have confirmed Sars-CoV-2 infection and symptom onset no more than 5 days before randomization. Hammond teaches that the exclusion criteria for the study included pregnancy or breastfeeding (Supplementary Appendix, pg. 9).
Based on the teachings of the reference patent and Hammond, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of the crystalline form of the reference compound with the composition of nirmatrelvir and ritonavir administered every 12 hours (2 times a day) within 5 days of symptom onset to create a third composition for the treatment of SARS-CoV-2 with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2024/0317754 is considered pertinent for teaching prodrugs of GS-441524.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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, Andrew Kosar can be reached at (571) 272-0913. 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.
/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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