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 .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 10/08/2025.
Claims 82-127 are pending.
Claims 119-127 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/08/2025.
Claims 82-118 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
Amount of pegylated interferon lambda-la administered per week in each treatment period
Applicant elects as follows:
(a) 180 micrograms per week administered during the first treatment period
(b) 120 micrograms per week administered during the second treatment period
(c) 80 micrograms to 120 micrograms per week administered during the third treatment period.
Characteristics of the subject
Applicant elects the subject who has compensated liver disease.
Liver function parameter
Applicant elects alanine aminotransferase (ALT).
Duration of treatment periods
Applicant elects as follows:
(a) the first treatment period ends when the subject has an alanine aminotransferase (ALT) level > 15 to 20 times the upper limit of normal (ULN); (b) the second treatment periods begins when the subject has an ALT level less than 10 times the ULN.
Treatment end result
Applicant elects durable virologic response comprising a clinically meaningful viral load decline as the treatment end result.
Nucleotide analog or nucleotide analog
Applicant elects nucleoside analog and, particularly, nucleoside analog entecavir.
Method of assessing liver fibrosis
Applicant elects magnetic resonance elastography as a method of assessing liver fibrosis.
Upon further search and examination the species election over nucleotide analog or nucleotide analog is broadened to include lamivudine, adefovir, telbivudine, or tenofovir. The species election over method of assessing liver fibrosis to include biopsy with histological analysis, or transient ultrasound elastography. As well as species election over liver function parameters include one or more of serum albumin, bilirubin, aspartate aminotransferase (AST), prothrombin.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2024, 05/11/2023, 07/12/2022,04/06/2022, 05/18/2021, 04/14/2021 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claim 99 is objected to because of the following informalities:
Claim 99 recites “lamuvidine,” which does not exist. It is assumed this is a typographical error and for the purposes of examination, it is also assumed this is the nucleoside analog lamivudine.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim (s) 82-86,93-101,110-118 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Martins discloses methods of treating a hepatitis delta virus (HDV) infection in a human patient (abstract). The method comprising administering to the patient a therapeutically effective amount of interferon lambda for at least four weeks (abstract). Martins teaches the pegylated interferon lambda-1a is subcutaneously administered at a dose of 180 micrograms per week (see entire document, for instance [0006], claim 8). Martins teaches the pegylated interferon lambda-1a is administered as a subcutaneous injection at a dose of 120 micrograms per week (see entire document, for instance [0006], claim 6). Martins discloses interferon lambda administered at a dose of 80 micrograms (mcg) QW ([0059]). Martins teaches treatment with interferon lambda therapy results in a sustained reduction of HDV viral load (see entire document, for instance [0050], claim 18).
Martins teaches the terms “course of treatment” and “course of therapy” are used interchangeably therein, and refer to the medical interventions made after a patient is diagnosed, e.g., as being infected with HDV and in need of medical intervention ([0025]). Medical interventions include, without limitation, the administration of drugs for a period of time, typically, for HDV infected patients, at least one and typically several or many months or even years ([0025]).
Martins discloses duration of treatment and treatment endpoints ([0047]). Martins teaches patients may receive interferon lambda therapy for a predetermined time, an indefinite time, or until an endpoint is reached ([0047]). Martins teaches for at least 12 weeks duration of treatment ([0047]). Martins teaches the interferon lambda (pegylated interferon lambda-1a) is administered to the patient in a course of therapy extending at least 8 weeks, at least 12 weeks, or at least 24 weeks ([0008]). Martins discloses the interferon lambda therapy comprises administering interferon lambda at a dose of 180 micrograms per week for a first treatment period followed by administering interferon lambda at a dose of 120 micrograms per week for a second treatment period ([0058]). Martins discloses the first treatment period and the second treatment period are different lengths of time ([0058]). Martins teaches dose escalation further comprises administering one or more additional doses of interferon lambda for one or more additional treatment periods ([0057]).
Martins discloses the patient's HDV titer rises from baseline prior to dropping below baseline during the course of treatment ([0053]). Martins teaches the patient's HDV level rises to more than 150% of baseline, or more than 200% of baseline ([0053]). The rise in the titer occurs within 2 weeks after initiation of therapy ([0053]). Martins discloses the patient's elevated HDV titer drops to below baseline within 3 weeks, of initiation of therapy ([0053]).
Martins discloses the patient to be treated has compensated liver disease (see entire document, for instance [0007], claims 2-3). Martins teaches the course of treatment results in improved liver function in the patient parameters (see entire document, for instance [0015], claim 19). Martins discloses the improved liver function is an improvement in one or more serum markers (see entire document, for instance [0015], claim 20). The improved liver function is an improvement in one or more serum markers (e.g., one, two, three, four, five, six or more markers), such as serum albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin, alfa2-macroglobulin, apolipoproteinA1, haptoglobin, gamma-glutamyl transpeptidase (GGT) (see entire document, for instance [0054], claim 20)
Martins disclose the improved liver function is an improvement in liver fibrosis ([0015]). Martins discloses the methods described herein exhibits an improvement in liver fibrosis (e.g., as assessed by biopsy with histological analysis, transient ultrasound elastography (e.g., FibroScan), or magnetic resonance elastography) ([0054]). Martins teaches at least 40%, at least 50% or more in one or more liver function parameters (e.g., an improvement in serum marker(s) or an improvement in liver fibrosis) ([0054]).
Martins discloses prior to the onset of treatment, the patient has a serum alanine aminotransferase (ALT) level that is above the upper limit of normal (ULN), and the course of treatment results in an improvement in serum ALT level in the patient to a level that is within the ULN (see entire document, for instance claim 17). Martins disclose patients receiving interferon lambda therapy (e.g., pegylated interferon lambda therapy) are also treated with the antiviral nucleotide or nucleoside analog (e.g., an anti-HBV nucleotide or nucleoside analog) ([0036]). In Example 1. Protocol Synopsis for Treating HDV Patients with Pegylated Interferon Lambda discloses telbivudine (Tyzeka or Sebivo). Martins disclose Child-Turcotte-Pugh score of 5-6 (class A) ([0045]). Martins teaches a baseline viral load 104 HDV RNA copies per mL or at least 104 IU/mL serum or plasma ([0043]). Martins teaches treatment results in an HDV viral load that is below the level of detection (see entire document, for instance claim 14).
Martins discloses treatment with interferon lambda therapy results in a reduction of HDV viral load in the patient of at least 2.0 log HDV RNA copies/mL serum ([0049]).
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.
Claim(s) 82-118 are rejected under 35 U.S.C. 103 as being unpatentable over Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Martins discloses methods of treating a hepatitis delta virus (HDV) infection in a human patient (abstract). The method comprising administering to the patient a therapeutically effective amount of interferon lambda for at least four weeks (abstract). Martins teaches the pegylated interferon lambda-1a is subcutaneously administered at a dose of 180 micrograms per week (see entire document, for instance [0006], claim 8). Martins teaches the pegylated interferon lambda-1a is administered as a subcutaneous injection at a dose of 120 micrograms per week (see entire document, for instance [0006], claim 6). Martins discloses interferon lambda administered at a dose of 80 micrograms (mcg) QW ([0059]). Martins teaches treatment with interferon lambda therapy results in a sustained reduction of HDV viral load (see entire document, for instance [0050], claim 18).
Martins teaches the terms “course of treatment” and “course of therapy” are used interchangeably therein, and refer to the medical interventions made after a patient is diagnosed, e.g., as being infected with HDV and in need of medical intervention ([0025]). Medical interventions include, without limitation, the administration of drugs for a period of time, typically, for HDV infected patients, at least one and typically several or many months or even years ([0025]).
Martins discloses duration of treatment and treatment endpoints ([0047]). Martins teaches patients may receive interferon lambda therapy for a predetermined time, an indefinite time, or until an endpoint is reached ([0047]). Martins teaches for at least 12 weeks duration of treatment ([0047]). Martins teaches the interferon lambda (pegylated interferon lambda-1a) is administered to the patient in a course of therapy extending at least 8 weeks, at least 12 weeks, or at least 24 weeks ([0008]). Martins discloses the interferon lambda therapy comprises administering interferon lambda at a dose of 180 micrograms per week for a first treatment period followed by administering interferon lambda at a dose of 120 micrograms per week for a second treatment period ([0058]). Martins discloses the first treatment period and the second treatment period are different lengths of time ([0058]). Martins teaches dose escalation further comprises administering one or more additional doses of interferon lambda for one or more additional treatment periods ([0057]).
Martins discloses the patient's HDV titer rises from baseline prior to dropping below baseline during the course of treatment ([0053]). Martins teaches the patient's HDV level rises to more than 150% of baseline, or more than 200% of baseline ([0053]). The rise in the titer occurs within 2 weeks after initiation of therapy ([0053]). Martins discloses the patient's elevated HDV titer drops to below baseline within 3 weeks, of initiation of therapy ([0053]).
Martins discloses the patient to be treated has compensated liver disease (see entire document, for instance [0007], claims 2-3). Martins teaches the course of treatment results in improved liver function in the patient parameters (see entire document, for instance [0015], claim 19). Martins discloses the improved liver function is an improvement in one or more serum markers (see entire document, for instance [0015], claim 20). The improved liver function is an improvement in one or more serum markers (e.g., one, two, three, four, five, six or more markers), such as serum albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin, alfa2-macroglobulin, apolipoproteinA1, haptoglobin, gamma-glutamyl transpeptidase (GGT) (see entire document, for instance [0054], claim 20)
Martins disclose the improved liver function is an improvement in liver fibrosis ([0015]). Martins discloses the methods described herein exhibits an improvement in liver fibrosis (e.g., as assessed by biopsy with histological analysis, transient ultrasound elastography (e.g., FibroScan), or magnetic resonance elastography) ([0054]). Martins teaches at least 40%, at least 50% or more in one or more liver function parameters (e.g., an improvement in serum marker(s) or an improvement in liver fibrosis) ([0054]).
Martins discloses prior to the onset of treatment, the patient has a serum alanine aminotransferase (ALT) level that is above the upper limit of normal (ULN), and the course of treatment results in an improvement in serum ALT level in the patient to a level that is within the ULN (see entire document, for instance claim 17). Martins disclose patients receiving interferon lambda therapy (e.g., pegylated interferon lambda therapy) are also treated with the antiviral nucleotide or nucleoside analog (e.g., an anti-HBV nucleotide or nucleoside analog) ([0036]). In Example 1. Protocol Synopsis for Treating HDV Patients with Pegylated Interferon Lambda discloses telbivudine (Tyzeka or Sebivo). Martins disclose Child-Turcotte-Pugh score of 5-6 (class A) ([0045]). Martins teaches a baseline viral load 104 HDV RNA copies per mL or at least 104 IU/mL serum or plasma ([0043]). Martins teaches treatment results in an HDV viral load that is below the level of detection (see entire document, for instance claim 14).
Martins discloses treatment with interferon lambda therapy results in a reduction of HDV viral load in the patient of at least 2.0 log HDV RNA copies/mL serum ([0049]).
Regarding instant claim (s) 87-90, Martins teaches the improved liver function is an improvement in one or more serum markers selected from the group consisting of serum albumin, bilirubin, alanine aminotransferase (ALT) (see entire document, for instance [0015], claim 20). Thus it’s in the purview of a skilled artisan to measure the reduction in serum markers an advantage which would flow naturally from following the suggestion of the prior art.
Regarding instant claim (s) 91-92, Martins teaches dose reduction is prescribed if the patient exhibits unacceptable side effects ([0058]). Table 1 disclose safety endpoints include: Treatment-emergent adverse event, adverse event leading to early discontinuation of study treatment, and adverse event leading to dose reduction. Thus it is in the purview of a skilled artisan to ends treatment when the subject experiences an adverse event, an advantage which would flow naturally from following the suggestion of the prior art.
Claim 103-104 recites that treatment results in durable virologic response (DVR). Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., pg. [ 10], lines [ 0050]). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining composition is disclosed in the prior art, the recited limitation of claim 103-104, will also be considered to be met.
Regarding instant claim (s) 105-106, Martins teaches patients treated according to the methods described herein exhibit a reduction in HBsAg levels or an improvement in clearance of HBsAg antigen ([0056]). Thus it is in the purview of a skilled artisan to measure the reduction in HBsAg, an advantage which would flow naturally from following the suggestion of the prior art.
Regarding instant claim (s) 107-109, Martins teaches the patient exhibits an improvement in serum ALT levels to a level that is within the upper limit of normal (([0054]). Thus it is in the purview of a skilled artisan to measure the reduction in serum ALT levels, an advantage which would flow naturally from following the suggestion of the prior art.
Claims 82,90, 95-99, 105-106,116 are rejected under 35 U.S.C. 103 as being unpatentable over Koh (Treatment of chronic hepatitis with lonafarnib, ritonavir and lambda interferon. Identifier No. NCT03600714. Record History Version 8: 18 September 2018) and Cory et al (US 20170042862 A1).
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). 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). Koh discloses the IFN-λ is pegylated IFN-1λa (‘Detailed Description,’ p. 12). 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:
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).
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).
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).
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).
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, 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).
Cory discloses methods of reducing hepatitis delta virus (HDV) viral loads (see entire document, abstract). Cory teaches ritonavir administered at a therapeutically effective dose and further in combination with an interferon (pegylated interferon alpha) administered at a therapeutically effective dose ([0005]). Cory discloses treatment results in a reduction of viral load to less than 103 IU/mL serum ([0006]). Cory teaches treatment results in a viral load of less than 102 HDV RNA copies per mL serum ([0023]). Cory discloses HDV viral load may be reduced by at least 2 log, by at least 3 log, or reduced to an undetectable level ([0035]). Cory teaches pegylated interferon lambda, and which may be administered at a dose of 120 mcg QW or 180 mcg QW ([0039]). Cory discloses the liver function parameter is selected from the group consisting of serum albumin, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and prothrombin activity ([0154]). Cory discloses treatment results in improved liver function in the patient (claim 66). Cory teaches improved liver biopsy (e.g., as assessed by histological staining, immunohistochemical staining, and/or fibrosis grading) ([0174]).
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 to administer to the subject 120 micrograms to 200 micrograms per week of pegylated interferon lambda-la. There would be a reasonable expectation of success since Koh and Cory are both drawn to compositions for reducing hepatitis delta virus.
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 82-84, 98-99, and 107 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,8,11-13, and 17-18 of U.S. Patent No. US 10076512 B2 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and US 10076512 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 US 10076512 do not encompass each limitation in instant claims 82-84, 98-99, and 107, these limitations are made obvious by what is disclosed in Martins as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in US 10076512 to arrive at the methods claimed in the instant invention. The instant invention and US 10076512 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between US 10076512 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 US 10076512 with known elements in the prior art to arrive at the currently claimed invention.
Claims 82-84,97-99 and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,4-7,10-15, and 18-20 of U.S. Patent No. US 10828283 B2 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and US 10828283 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 US 10076512 do not encompass each limitation in instant claims 82-84,97 and 101, these limitations are made obvious by what is disclosed in Martins as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in US 10828283 to arrive at the methods claimed in the instant invention. The instant invention and US 10828283 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between US 10828283 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 US 10828283 with known elements in the prior art to arrive at the currently claimed invention.
Claims 82,93, 96-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,10-15,18, and 21 of U.S. Patent No. US 11311519 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and US 11311519 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib, and ritonavir.
While the claims of US 11311519 do not encompass each limitation in instant claims 82,93, 96-97, these limitations are made obvious by what is disclosed in Martins as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in US 11311519 to arrive at the methods claimed in the instant invention. The instant invention and US 11311519 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between US11311519 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 US11311519 with known elements in the prior art to arrive at the currently claimed invention.
Claim 82,95,97-99, 101, and 115-116 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,11-12,14-17,20,21,23-25,31, and 34-35 of U.S. Patent No. US 11793793 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and US 11793793 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib and ritonavir daily.
While the claims of US 11793793 do not encompass each limitation in instant claims 82,95,97-99, 101, and 115-116, these limitations are made obvious by what is disclosed in Martins as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in US 11793793 to arrive at the methods claimed in the instant invention. The instant invention and US 11793793 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between US 11793793 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 US 11793793 with known elements in the prior art to arrive at the currently claimed invention.
Claims 82 and 98-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4,8-12,15,16, of U.S. Patent No. US 12290509 B2 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and US 12290509 claims are directed to a method for treating a patient infected with HDV by administering IFN-λ, lonafarnib and ritonavir daily.
While the claims of US 12290509 do not encompass each limitation in instant claims 82 and 98-99, these limitations are made obvious by what is disclosed in Martins as discussed above. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to use the claims in US 12290509 to arrive at the methods claimed in the instant invention. The instant invention and US 12290509 recite identical elements (IFN-λ, ritonavir, and lonafarnib) to treat HDV. Any discrepancies between US 12290509 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 US 12290509 with known elements in the prior art to arrive at the currently claimed invention.
Claims 82-84, 86, 95-96, 98-100, 105, 107, and 115-117 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14,17-18,29-33 of copending Application No. 17/754,587 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating a human patient having an HDV infection, the method comprising administering to the patient a therapeutically effective dose of INF-λ.
The claims of both reference patent application 17/754,587 and the instant application are drawn to treating an HDV infection using INF-λ. The treatment length, treatment protocol, and outcome measures of both 17/754,587 and the instant application contain overlapping ranges. Although the reference application teaches a similar method to the instant claims, the reference application teach the daily administration of lonafarnib and ritonavir in conjunction with INF-λ. The teachings of Martins is set forth above.
It would have been obvious to use the claims in 17/754,587 to arrive at the methods claimed in the instant invention. The instant invention and 17/754,587 recite similar methods to treat an HDV infection. Moreover, although 17/754,587 indicate co-administration of lonafarnib/ritonavir administration in the reference claims, it would have been obvious to one of ordinary skill in the art at the time of the claimed invention to improve upon the invention claimed in 17/754,587 and utilize a combination of the three compounds to treat HDV Martins taught these compounds were an effective alternative to treat both an HDV infection and liver damage caused by such. Therefore, the instant claims are prima facie obvious over the 17/754,587 and in further view of Martins.
This is a provisional nonstatutory double patenting rejection.
Claims 82-84, 86, 95-96, 98-100, 105, 107, and 115-117 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,19-20,22,32,37,40-41,57-63, and 65-67 of copending Application No. 19/028,365 in view of Martins (WO 2017143253 A1; as submitted on IDS of 04/14/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating a human patient having an HDV infection, the method comprising administering to the patient a therapeutically effective dose of INF-λ.
The claims of both reference patent application 19/028,365 and the instant application are drawn to treating an HDV infection using INF-λ. The treatment length, treatment protocol, and outcome measures of both 19/028,365 and the instant application contain overlapping ranges. Although the reference application teaches a similar method to the instant claims, the reference application teach the daily administration of lonafarnib and ritonavir in conjunction with INF-λ. The teachings of Martins is set forth above.
It would have been obvious to use the claims in 19/028,365 to arrive at the methods claimed in the instant invention. The instant invention and 19/028,365 recite similar methods to treat an HDV infection. Moreover, although 19/028,365 indicate co-administration of lonafarnib/ritonavir administration in the reference claims, it would have been obvious to one of ordinary skill in the art at the time of the claimed invention to improve upon the invention claimed in 19/028,365 and utilize a combination of the three compounds to treat HDV Martins taught these compounds were an effective alternative to treat both an HDV infection and liver damage caused by such. Therefore, the instant claims are prima facie obvious over the 19/028,365 and in further view of Martins.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611