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 .
DETAILED ACTION
Claims 1-50 are pending in the instant application and are examined on the merits herein.
Priority
The application claims benefit to provisional application US 63/469153 filed on 5/26/2023.
Information Disclosure Statement
The information disclosure statements (IDS) dated 9/18/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 19 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-9, 12-26 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta et al. (US 2016/0220595A1, PTO-892).
Liotta et al. discloses a method of treating a viral infection by orally administering a pharmaceutical composition comprising a compound of formula 2023 and at least one additional active agent selected from among several compounds, including telaprevir, boceprevir and ribavirin, where the viral infection may be caused any of genotypes 1-6 of the hepatitis C virus (HCV). (Claims 32-36; ¶0024, 1132-1134, 1223, 1158)
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Liotta exemplifies that compound 2023 is an effective HCV polymerase inhibitor for numerous HCV strains, including GT1b/2b NS5B. (¶1246, Example 161)
Liotta also discloses that:
The patient being treated can be infected with HCV genotype I, such as genotype Ia or Ib or the patient can be infected with HCV genotype 2 or 3. (¶1158);
Depending on the condition to be prevented or treated and the route of administration, such an effective amount will usually be between 0.01 to 1000 mg per kilogram body weight of the patient per day, more often between 0.1 and 500 mg, such as between 1 and 250 mg, for example about 5, 10,20, 50, 100, 150, 200 or 250 mg, per kilogram body weight of the patient per day. (¶1122);
The envisioned compounds can be administered in doses from 100-250 mg, either once daily or with multiple doses to provide a total daily dose. (¶1152-1154);
The duration of administration can be up to 12 weeks. (¶1158);
HCV leads to inflammation of the liver, and chronic infection leads to cirrhosis. Most people with hepatitis C infection have the chronic form. (¶1133);
During infection the host immune response results in viral clearance. (¶1144)
Liotta does not exemplify or claim a method for treating an HCV infection by administering a composition, to a subject in need thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of treating a viral infection, in general, by administering the disclosed nucleosides phosphoramidate prodrugs, to a subject in need thereof, could be specifically applied to treat an HCV infection, in a subject in need thereof, by administering compound 2023, thereby arriving at the instant invention. One would have been motivated to modify Liotta in this manner because Liotta exemplifies in vitro data showing compound 2023 to be an effective HCV polymerase inhibitor. Thus, one would reasonably expect that compound 2023 would be an effective therapeutic agent when administered to a subject having an HCV infection. It has been decided that:1) when there is a reasonable correlation between in vitro or in vivo animal testing and a claimed method invention, a rigorous correlation between said testing and the claimed method is not necessary and 2) that there is no insurmountable difficulty in moving to the next level in the screening chain (i.e. in vitro testing – in vivo animal testing – in vivo human testing) once successful testing has been demonstrated at the previous link in the chain. Cross v. Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747-48 (Fed. Cir. 1985) and (MPEP § 2107.03 and § 2164.02)
With respect to the claimed limitations regarding viral clearance, this effect is considered an obvious result of the method of Liotta. Liotta discloses that host immune response results in viral clearance. Since the therapeutic intervention of administering a nucleoside phosphoramidate assists the hosts’ immune system in combating the viral infection, one of ordinary skill would expect that the combination of the therapeutic intervention and the hosts’ natural immune response would result in viral clearance.
With respect to the claimed limitations regarding liver cirrhosis, specifically the subject not having cirrhosis, this limitation is considered obvious over Liotta. Because Liotta discloses that HCV leads to inflammation of the liver, and chronic infection leads to cirrhosis, where most people have the chronic form, it is obvious that some subset of the subject population having HCV does not have the chronic form and therefore do not have cirrhosis.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 10, 11, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta et al. (US 2016/0220595A1, PTO-892), in view of Sommadossi et al. (WO 2019/200005A1, IDS).
The disclosure of Liotta is referenced as discussed above. Liotta does not teach a subject having compensated or decompensated cirrhosis.
Sommadossi et al. discloses administering nucleoside phosphoramidates to a subject having HCV, as well as compensated or decompensated cirrhosis. (Claims 1-3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that since Liotta discloses that subjects having chronic HCV also have cirrhosis, that some subset of the cirrhotic subjects have either compensated or decompensated cirrhosis, as per the disclosure of Sommadossi.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 34-41 and 44-50 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta et al. (US 2016/0220595A1, PTO-892), in view of Sophia et al. (Antivir. Chem. Chemo., 2011, PTO-892).
The disclosure of Liotta is referenced as discussed above. Liotta does not teach that the nucleoside analogs are metabolized in the liver to yield one or more of the compounds as in claim 34.
Sophia et al. discloses that nucleoside phosphoramidates are metabolized by liver enzymes to yield the following compound types: (pp. 26-27; Figure 4)
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Sophia further teaches that a nucleoside monophosphate is further modified by kinases to yield diphosphate and triphosphate versions of said nucleoside. (Figure 3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the nucleosides phosphoramidate prodrugs of Liotta would be subject to the same liver-based metabolic processes as any other nucleoside phosphoramidate, yielding metabolites having a one or more of the structures as per formulae II thru VI, thereby arriving at the instant invention. One would expect such metabolic process to occur for the nucleoside phosphoramidates of Liotta due to the teaching of Sophia that such metabolic processes are known to occur in the liver for nucleoside phosphoramidates.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta et al. (US 2016/0220595A1, PTO-892), in view of Sophia et al. (Antivir. Chem. Chemo., 2011, IDS), further in view of Sommadossi et al. (WO 2019/200005A1, IDS)
The disclosure of Liotta/Sophia is referenced as discussed above. The combined prior art does not teach a subject having compensated or decompensated cirrhosis.
Sommadossi et al. discloses administering nucleoside phosphoramidates to a subject having HCV, as well as compensated or decompensated cirrhosis. (Claims 1-3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that since Liotta discloses that subjects having chronic HCV also have cirrhosis, that some subset of the cirrhotic subjects have either compensated or decompensated cirrhosis, as per the disclosure of Sommadossi.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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