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 .
Claim Status
Applicant’s amendment, filed 09 September 2025, has been received and entered. As a result of that amendment:
Claims 1, 14, 30 and 33 have been amended and claims 19-28 and 34-38 have been cancelled. Therefore, claims 1-18 and 29-33 are now pending and currently under examination.
Priority
This application is a national stage 371 application of PCT/US2020/055714 filed on October 15, 2020. There are three previously filed provisional applications: 63/070,047 filed on August 25, 2020; 63/014,774 filed on April 24, 2020; and 62/915,933 filed on October 16, 2019. Applicant claims priority for all claims based on the provisional application 62/915,933 filed on October 16, 2019.
Instant claims 1-18 and 29-33 are disclosed in the provisional application, 62/915,933 filed on October 16, 2019, and thus, the claims are afforded that October 16, 2019 priority date.
Withdrawn Claim Objections
By Applicant amending claims 1, 30, and 33, Examiner’s objection to these claims is hereby withdrawn.
Withdrawn Claim Rejections
By Applicant amending claim 14, the rejection under 35 U.S.C. 112(b) is hereby withdrawn.
By Applicant amending claim 1, the rejection of claims 5 and 6 under 35 U.S.C. 112(d) is hereby withdrawn.
By Applicant amending claim 1, the 35 U.S.C. 102(a)(1) rejection of claims 1-4, 7-13, 17, and 18 is hereby withdrawn. Since the rejection of independent claim 1 is withdrawn, the subsequent rejection of claims 5, 6, 14-16, and 30-32 under 35 U.S.C. 103 are also withdrawn.
In view of Applicant cancelling claim 36, the 35 U.S.C. 103 rejection (as obvious over Koh (2018) and Wedemeyer (2018)) is moot and hereby withdrawn.
In view of applicant cancelling claim 37 and 38, the 35 U.S.C. 103 rejection (as obvious over Koh (2018) and Bagomolov (2018)) is moot and hereby withdrawn.
By Applicant amending claim 1, the nonstatutory double patenting rejections over U.S. Patent Nos. 10,828,283, 10,076,512, 11,311,519, and 11,793,793 and provisional nonstatutory double patenting rejections over U.S. Application Nos. 17/268,657, 18/467,858 (now U.S. Patent No. 12,290,509), and 19/028,365 are hereby withdrawn.
New Claim Rejections
The following rejections are necessitated by amendment:
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 was amended to require the treatment of lonafarnib, ritonavir, and lambda interferon (IFN-λ) for 48 weeks (“…and wherein the interferon lambda, the lonafarnib, and the ritonavir have been administered for at least 48 weeks.”). Claim 4, which depends from claim 1, recites: “[t]he method of claim 1, wherein the interferon lambda, the lonafarnib, and the ritonavir are administered for at least 12 weeks, at least 24 weeks, at least 36 weeks, at least 48 weeks, at least 54 weeks, or from 12 weeks to 96 weeks.” Since claim 1 now requires administration for 48 weeks, claim 4 fails to limit the subject matter of claim 1.
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.
Claims 1-13, 16-18, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Koh (cited in prior Office Action: Treatment of chronic hepatitis with lonafarnib, ritonavir and lambda interferon. Identifier No. NCT03600714. Record History Version 8: 18 September 2018) in further view of Martins (A Study of Lonafarnib With or Without Ritonavir in Patients With HDV (LOWR-5). NIH Identifier No. NCT02968641. Record History Version 1: 16 November 2016) and Apelian (cited in prior Office Action: A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (LIMT). NIH Identifier No. NCT02765802. Record History Version 6: 27 July 2018).
Koh discloses an experimental study “Treatment of Chronic Delta Hepatitis with Lonafarnib, Ritonavir, and Lambda Interferon” to investigate whether the combination of lonafarnib, ritonavir, and lambda interferon (IFN-λ) is safe and effective to treat chronic hepatitis D infection (‘Objectives,’ page 11).
Regarding the limitations of instant claim 1, Koh discloses over 24 weeks of treatment, the lonafarnib and ritonavir will be taken by mouth daily while the IFN-λ will be subcutaneously injected weekly (‘Brief Summary,’ p. 12). The primary therapeutic endpoint will be a decline of HDV RNA viral titer of 2 logs at the end of therapy (‘Detailed Description,’ p. 12).
Regarding the limitations of instant claims 2 and 3, Koh discloses the IFN-λ is pegylated IFN-1λa (‘Detailed Description,’ p. 12).
Regarding the limitations of instant claim 4, Koh discloses the IFN-1λa, lonafarnib, and ritonavir combination is administered for a treatment period of 24 weeks (‘Detailed Description,’ p. 12).
Furthermore, Koh discloses numerous outcome measures of the study:
Regarding instant claim 7, Koh discloses an outcome measure marked by the decline of HDV RNA viral titer of > 2 logs from baseline at the end of therapy which shows the ability to tolerate the drugs at the prescribed dose for the full course of therapy (‘Primary Outcome Measures No. 1,’ p. 14).
Regarding instant claim 8, Koh discloses an outcome measure marked by a sustained undetectable HDV RNA in serum at weeks 12 and 24 of a post-treatment follow-up (‘Secondary Outcome Measures No. 7,’ p. 15).
Regarding instant claim 9, Koh discloses an outcome measure marked by a reduction in histologic inflammatory scores (modified HAI) by at least two points at the end of treatment with no progression in histologic fibrosis (‘Secondary Outcome Measures No. 4,’ p. 15).
Regarding instant claims 10, 11, and 12, Koh discloses an outcome measure marked by a normalization of serum ALT levels (ALT < 20 or AST < 20 U/L in females and ALT < 31 or AST < 31 U/L in males) at the end of therapy, at week 12 of post-therapy follow-up and at week 24 of post-therapy follow-up or reduction in serum ALT by > 50% (‘Secondary Outcome Measures No. 6,’ p. 15).
Regarding instant claim 13, Koh discloses an outcome measure marked by a reduction in hepatic venous pressure gradient (HVPG) measurements by > 25% of baseline OR normalization of HVPG (<5 mm Hg) at the end of therapy (‘Secondary Outcome Measures No. 5,’ p. 15).
Regarding instant claims 17 and 18, Koh discloses an outcome measure marked by a loss of HBsAg from the serum at the end of therapy, at week 12 of post-therapy follow-up and at week 24 of post-therapy follow-up (‘Secondary Outcome Measures No. 3,’ p. 15).
Furthermore, regarding instant claim 29, Koh proposes to institute/continue nucleoside or nucleotide analog therapy to prevent the possibility of HBV reactivation or flare for the duration of the clinical trial (‘Detailed Description,’ p. 12).
While Koh discloses a method of treating HDV that comprises administering to subjects lonafarnib and ritonavir by mouth daily and IFN-λ by subcutaneous injection weekly, Koh does not disclose this method of treatment over a 48-week period as now required by instant claim 1.
Martins discloses a phase 2b, open-label, randomized study of the safety, tolerability, and pharmacodynamic activity of lonafarnib with or without ritonavir in patients chronically infected with HDV (‘Detailed Description,’ p. 4-5). Martins discloses various interventions: 1) patients taking lonafarnib 25 mg BID, ritonavir 100 mg BID, and an HBV nucleos(t)ide analog for 48 weeks; or 2) patients taking lonafarnib 50 mg BID, ritonavir 100 mg BID, and an HBV nucleos(t)ide analog for 48 weeks; or 3) patients taking lonafarnib 100 mg BID and an HBV nucleos(t)ide analog for 48 weeks (‘Arms and Interventions,’ p. 6). Martins further discloses outcome measures including:
Regarding instant claim 16, Martins teaches improvement in liver histology by at least 2 points in the HAI with improvement or no worsening of the fibrosis score at the end of treatment compared to baseline (‘Secondary Outcome Measures No. 2,’ p. 7).
Sustained virologic response measured by HDV RNA below the lower limit of quantification (LLOQ) 12 weeks after the end of treatment (‘Secondary Outcome Measures No. 3,’ p. 7).
Sustained virologic response measured by HDV RNA below the LLOQ 24 weeks after the end of treatment (‘Secondary Outcome Measures No. 4,’ p. 7).
Therefore, Martins teaches a method of treating HDV with lonafarnib and ritonavir and further shows this treatment combination is safe and effective for administration over the course of 48 weeks.
Apelian discloses a study to evaluate the safety and tolerability of an HDV infection treatment with 2 different dose levels of IFN-λ over a 48-week treatment period (‘Brief Summary,’ p. 6). Regarding instant claims 5 and 6, Apelian divided participants in two arms that received either 180 mcg or 120 mcg of IFN-λ administered once weekly by subcutaneous injection for a total of 48 weeks and evaluated the safety and tolerability of IFN-λ treatment and the effect of treatment on HDV levels (‘Brief Summary,’ p. 6). Finally, Apelian et al. suggest that IFN-λ treatment could be associated with fewer adverse effects compared to IFN-α because of IFN-λ’s more limited receptor distribution (‘Brief Summary,’ p. 6).
Therefore, Apelian teaches a method of treating HDV with IFN-λ and further shows this treatment is safe and effective for administration over the course of 48 weeks.
Koh discloses a 24-week treatment protocol for HDV whereby lonafarnib and ritonavir are taken by mouth daily, IFN-λ is subcutaneously injected weekly, and a nucleos(t)ide analog is administered over the duration of the 24-week treatment. Regarding the limitations now contained within instant claim 1, Koh fails to disclose a treatment duration lasting 48 weeks. However, armed with the protocol disclosed by Koh, one of ordinary skill in the art, before the effective filing date of the claimed invention, could combine elements of other treatment protocols disclosed by prior art to arrive at the currently claimed invention. Specifically, Martins discloses a 48-week HDV treatment protocol with lonafarnib and ritonavir, indicating this treatment combination is safe and effective for administration over the course of 48 weeks. In addition, Apelian discloses a 48-week HDV treatment protocol with IFN-λ, indicating this treatment is safe and effective for administration over the course of 48 weeks. One of ordinary skill could easily extend the treatment protocol taught by Koh to 48 weeks with predictable results (treating HDV) because both Martins and Apelian taught such using, in combination, the same treatment drugs.
Claims 14, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Koh (previously cited), Martins (previously cited), Apelian (previously cited) and in further view of Wu (previously cited in prior Office Action: “Longitudinal monitoring of liver fibrosis status by transient elastography in chronic hepatitis B patients during long-term entecavir treatment,” published: 25 April 2018) and Puigvehí (previously cited in prior Office Action: “The oncogenic role of hepatitis delta virus in hepatocellular carcinoma,” published: 16 May 2019).
The teachings of Koh, Martins, and Apelian are previously discussed. While a combination of Koh, Martins, and Apelian teach the method of instant claim 1, none of the references explicitly teach that what is claimed in instant claims 14, 31, and 32.
Regarding instant claim 14, Wu teaches liver stiffness measurement by transient elastography (TE) is a useful tool for monitoring the change in liver fibrosis after antiviral therapy (p. 434, column 1). To monitor liver stiffness in response to treatment with entecavir, Wu took FibroScan® measurements every 26 weeks (p. 434, column 2). Wu suggests that a decline of 45% in liver stiffness from baseline to week 78 is a significant determinant of fibrosis regression in chronic hepatitis B patients after antiviral treatment with entecavir (p. 441, columns 1 and 2).
Regarding instant claims 31 and 32, Wu teaches chronic HBV infections lead to serious health conditions including liver cirrhosis (p. 443, “Introduction”). Wu also teaches that changes in liver stiffness at week 26 of therapy could predict 2-year clinical outcomes in HBV-related compensated cirrhosis (p. 441, “Discussion”). However, Wu does not specifically teach liver cirrhosis and HDV.
Puigvehí teaches that HDV needs HBV to replicate and propagate (p. 120, “Summary”). Furthermore, Puigvehí teaches chronic HDV promotes inflammatory cell infiltration and progressive fibrosis, leading to cirrhosis and other forms of chronic hepatitis (p. 123, column 2). Liver histology from HDV-infected patients is usually no different than observed in other forms of viral hepatitis (p. 123, column 2).
Regarding instant claim 14, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Wu and Puigvehí to establish a preferred range or at least within the broader range taught to determine successful antiviral treatment on liver fibrosis in the invention set forth by Koh, Martins, and Apelian. Since Puigvehí teaches the liver histology profile from HDV-infected patients is usually no different than what is observed in other forms of viral hepatitis, the value taught by Wu meets or overlaps with the range that is instantly claimed, thereby rendering the claimed range obvious (see MPEP § 2144.05). Therefore, claim 14 is obvious over Koh, Martins, and Apelian in further view of Wu and Puigvehí.
Regarding instant claims 31 and 32, Wu teaches the correlation between HBV, liver cirrhosis, and a method to predict successful antiviral treatment by measuring liver stiffness. Puigvehí teaches HDV/HBV coinfection usually occurs and accelerates progression to cirrhosis (p. 127, column 1). It would have been prima facie obvious, before the effective filing date of the claimed invention, to use the teachings of the combined references to teach the method of instant claim 1 will simultaneously include subjects with liver cirrhosis due to the high probability of co-infection with HBV and rapid progression to cirrhosis. Furthermore, the combined references establish a threshold of liver stiffness following treatment to predict a successful outcome. Therefore, claims 31 and 32 are obvious over Koh, Martins, and Apelian in further view of Wu and Puigvehí.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Koh (previously cited), Martins (previously cited), and Apelian (previously cited) in further view of Heller (previously cited in prior Office Action: “Long term therapy of chronic delta hepatitis with peginterferon alfa,” published: 11 May 2014).
The teachings of Koh, Martins, and Apelian are previously discussed. While a combination of Koh, Martins, and Apelian teach the method of instant claim 1, none of the references explicitly teach that what is claimed in instant claim 15.
Heller teaches treatment of chronic HDV infection using IFN-α (p. 1, abstract). In this study, Heller discloses a study involving peginterferon treatment for up to 260 weeks (“Methods,” p. 2) and that inclusion criteria included patients with at least 1 for hepatic fibrosis (Ishak) (p. 3, “Patients”). Heller further discloses that the endpoint of the study was defined as a decrease in HAI score of equal to or greater than 3 and patients without a 1-point improvement in the Ishak modification HAI fibrosis score were considered non-responders (p. 3, “Definition of Endpoints and Response”; p. 4, “Study Design and Dosing of PegInterferon”).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Heller to establish a preferred range or at least within the broader range taught to determine therapy response to HDV treatment as required by instant claim 15. Heller discloses a study where inclusion criteria is limited to patients with an Ishak fibrosis score of at least 1. Heller also discloses that after 48 weeks of treatment with peginterferon, those patients without a 1-point improvement in Ishak fibrosis score were considered non-responders. Conceivably, a patient with a score of F2 would meet the inclusion criteria set forth by Heller and after 48 weeks of treatment, must have responded with a decrease in score to F1 (or below) to be considered responsive to the treatment. The values taught by Heller meet or overlap with the range that is instantly claimed, thereby rendering the claimed range obvious (see MPEP § 2144.05). Therefore, claim 15 is obvious over Koh, Martins, and Apelian in view of Heller.
Claims 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Koh (previously cited), Martins (previously cited), and Apelian (previously cited) in further view of Heller et al. (previously cited in prior Office Action: Treatment of chronic delta hepatitis with lonafarnib and ritonavir. Identifier No. NCT02511431. Record History Version Current: 25 September 2018. http://clinicaltrials.gov/study/NCT02511431?term=NCT02511431&rank=1&tab=history).
The teachings of Koh, Martins, and Apelian are previously discussed. While a combination of Koh, Martins, and Apelian teach the method of instant claim 1, none of the references explicitly teach that what is claimed in instant claims 30 and 33.
Heller discloses a study to evaluate lonafarnib in combination with ritonavir in patients chronically infected with HDV. The lonafarnib is administered at a daily dose of 50-100 mg and the ritonavir is administered at a daily dose of 100 mg (‘Participant Flow,’ p. 16). Regarding instant claim 30, Heller discloses the subject is also treated with a nucleoside/nucleotide analog to prevent the possibility of an HBV reactivation/flare and that analog is either entecavir or tenofovir (‘Detailed Description,’ p. 8).
Regarding instant claim 33, a combination of the references teaches the dosing schedule as follows:
Apelian discloses IFN-λ at two treatment doses – 120 mcg and 180 mcg – administered subcutaneously once per week. [“…the interferon lambda is administered at 50 mg BID”]
Martins discloses lonafarnib and ritonavir administered twice daily at doses of 25 and 50 mg (lonafarnib) and 100 mg (ritonavir). [“…the lonafarnib is administered at 50 mg BID”]
Heller discloses lonafarnib and ritonavir are suitable for administration once daily at various doses. In light of Martins disclosing a safe and tolerable daily dose of ritonavir at 200 mg, one of ordinary skill could easily manipulate the dosing schedule taught by Martin as 100 mg ritonavir twice daily to 200 mg once daily. [“the ritonavir is administered at 200 mg QD”]
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the dosing of ritonavir and the nucleoside/nucleotide analogs disclosed by Heller in the treatment protocol outlined by Koh, Martins, and Apelian to arrive at the claimed invention. One would have been motivated to do so because the combination of the references outlines a method to treat HDV. Regarding the nucleos(t)ide analog, none of the references name a specific nucleos(t)ide analog. Heller teaches success in using entecavir or tenofovir in combination with HDV treatment and further postulates the nucleos(t)ide analogs entecavir or tenofovir will prevent HBV reactivation/flare in subjects undergoing this treatment. Regarding the dosing schedule of ritonavir, Martins teaches success with dosing at 100 mg twice daily (200 mg total daily) and Heller teaches success with ritonavir dosing only once daily. Therefore, this is considered combining prior art elements according to known methods to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
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.
US Patent No. 10,076,512
Claims 1-13, 16-18, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-11, 13, and 21 of U.S. Patent No. 10,076,512 B2 (reference ‘512) in further view of Koh (previously cited), Martins (previously cited), and Apelian (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘512 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘512 do not encompass each limitation in instant claims 1-13, 16-18, and 29, these limitations are made obvious by what is disclosed in Koh, Martins, and Apelian as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘512 to arrive at the methods claimed in the instant invention. The instant invention and ‘512 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘512 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘512 with known elements in the prior art to arrive at the currently claimed invention.
Claims 14, 31, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-11, 13, and 21 of U.S. Patent No. 10,076,512 B2 (reference ‘512) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), Wu (previously cited), and Puigvehí (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘512 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘512 do not encompass each limitation in instant claims 14, 31, and 32, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, Wu, and Puigvehí as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘512 to arrive at the methods claimed in the instant invention. The instant invention and ‘512 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘512 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘283 with known elements in the prior art to arrive at the currently claimed invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-11, 13, and 21 of U.S. Patent No. 10,076,512 B2 (reference ‘512) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘512 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘512 do not encompass each limitation in instant claim 15, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘512 to arrive at the methods claimed in the instant invention. The instant invention and ‘512 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘512 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘512 with known elements in the prior art to arrive at the currently claimed invention.
Claims 30 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-11, 13, and 21 of U.S. Patent No. 10,076,512 B2 (reference ‘512) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited; NCT02511431). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘512 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘512 do not encompass each limitation in instant claims 30 and 33, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller (NCT02511431) as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘512 to arrive at the methods claimed in the instant invention. The instant invention and ‘512 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘512 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘512 with known elements in the prior art to arrive at the currently claimed invention.
US Patent No. 10,828,283
Claims 1-13, 16-18, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of U.S. Patent No. 10,828,283 B2 (reference ‘283) in further view of Koh (previously cited), Martins (previously cited), and Apelian (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘283 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘283 do not encompass each limitation in instant claims 1-13, 16-18, and 29, these limitations are made obvious by what is disclosed in Koh, Martins, and Apelian as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘283 to arrive at the methods claimed in the instant invention. The instant invention and ‘283 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘283 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘283 with known elements in the prior art to arrive at the currently claimed invention.
Claims 14, 31, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of U.S. Patent No. 10,828,283 B2 (reference ‘283) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), Wu (previously cited), and Puigvehí (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘283 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘283 do not encompass each limitation in instant claims 14, 31, and 32, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, Wu, and Puigvehí as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘283 to arrive at the methods claimed in the instant invention. The instant invention and ‘283 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘283 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘283 with known elements in the prior art to arrive at the currently claimed invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of U.S. Patent No. 10,828,283 B2 (reference ‘283) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘283 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘283 do not encompass each limitation in instant claim 15, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘283 to arrive at the methods claimed in the instant invention. The instant invention and ‘283 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘283 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘283 with known elements in the prior art to arrive at the currently claimed invention.
Claims 30 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of U.S. Patent No. 10,828,283 B2 (reference ‘283) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited; NCT02511431). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘283 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ once per week at a dose of 120-180 mcg, and lonafarnib and ritonavir daily.
While the claims of ‘283 do not encompass each limitation in instant claims 30 and 33, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller (NCT02511431) as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘283 to arrive at the methods claimed in the instant invention. The instant invention and ‘283 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘283 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘283 with known elements in the prior art to arrive at the currently claimed invention.
US Patent No. 11,311,519
Claims 1-13, 16-18, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8, and 10-13 of U.S. Patent No. 11,311,519 B2 (reference ‘519) in further view of Koh (previously cited), Martins (previously cited), and Apelian (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘519 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘519 do not encompass each limitation in instant claims 1-13, 16-18, and 29, these limitations are made obvious by what is disclosed in Koh, Martins, and Apelian as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘519 to arrive at the methods claimed in the instant invention. The instant invention and ‘519 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘519 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘519 with known elements in the prior art to arrive at the currently claimed invention.
Claims 14, 31, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8, and 10-13 of U.S. Patent No. 11,311,519 B2 (reference ‘519) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), Wu (previously cited), and Puigvehí (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘519 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘519 do not encompass each limitation in instant claims 14, 31, and 32, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, Wu, and Puigvehí as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘519 to arrive at the methods claimed in the instant invention. The instant invention and ‘519 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘519 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘519 with known elements in the prior art to arrive at the currently claimed invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8, and 10-13 of U.S. Patent No. 11,311,519 B2 (reference ‘519) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘519 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘519 do not encompass each limitation in instant claim 15, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘519 to arrive at the methods claimed in the instant invention. The instant invention and ‘519 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘519 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘519 with known elements in the prior art to arrive at the currently claimed invention.
Claims 30 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8, and 10-13 of U.S. Patent No. 11,311,519 B2 (reference ‘519) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited; NCT02511431). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘519 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘519 do not encompass each limitation in instant claims 30 and 33, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller (NCT02511431) as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘519 to arrive at the methods claimed in the instant invention. The instant invention and ‘519 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘519 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘519 with known elements in the prior art to arrive at the currently claimed invention.
US Patent No. 11,793,793
Claims 1-13, 16-18, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 14, 25, and 34 of U.S. Patent No. 11,793,793 B2 (reference ‘793) in further view of Koh (previously cited), Martins (previously cited), and Apelian (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘793 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘519 do not encompass each limitation in instant claims 1-13, 16-18, and 29, these limitations are made obvious by what is disclosed in Koh, Martins, and Apelian as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘793 to arrive at the methods claimed in the instant invention. The instant invention and ‘793 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘793 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘793 with known elements in the prior art to arrive at the currently claimed invention.
Claims 14, 31, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 14, 25, and 34 of U.S. Patent No. 11,793,793 B2 (reference ‘793) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), Wu (previously cited), and Puigvehí (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘793 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘793 do not encompass each limitation in instant claims 14, 31, and 32, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, Wu, and Puigvehí as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘793 to arrive at the methods claimed in the instant invention. The instant invention and ‘793 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘793 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘793 with known elements in the prior art to arrive at the currently claimed invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 14, 25, and 34 of U.S. Patent No. 11,793,793 B2 (reference ‘793) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘793 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘793 do not encompass each limitation in instant claim 15, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘793 to arrive at the methods claimed in the instant invention. The instant invention and ‘793 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘793 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘793 with known elements in the prior art to arrive at the currently claimed invention.
Claims 30 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 14, 25, and 34 of U.S. Patent No. 11,793,793 B2 (reference ‘793) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), and Heller (previously cited; NCT02511431). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘793 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘793 do not encompass each limitation in instant claims 30 and 33, these limitations are made obvious by what is disclosed in Koh, Martins, Apelian, and Heller (NCT02511431) as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘793 to arrive at the methods claimed in the instant invention. The instant invention and ‘793 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘793 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘793 with known elements in the prior art to arrive at the currently claimed invention.
US Patent No. 12,290,509 (formerly 18/467,858)
Claims 1-13, 16-18, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 12,290,509 B2 (reference ‘509) in further view of Koh (previously cited), Martins (previously cited), and Apelian (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘509 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of ‘509 do not encompass each limitation in instant claims 1-13, 16-18, and 29, these limitations are made obvious by what is disclosed in Koh, Martins, and Apelian as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in ‘509 to arrive at the methods claimed in the instant invention. The instant invention and ‘509 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between ‘509 and the instant claims was previously disclosed by the prior art in the realm of HDV treatment and one of ordinary skill would predict success in substituting or modifying what is claimed in ‘509 with known elements in the prior art to arrive at the currently claimed invention.
Claims 14, 31, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 12,290,509 B2 (reference ‘509) in further view of Koh (previously cited), Martins (previously cited), Apelian (previously cited), Wu (previously cited), and Puigvehí (previously cited). Although the claims at issue are not identical, they are