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
The present application is being examined under the pre-AIA first to invent provisions. Claims 1-30 are pending in the current application.
Election/Restrictions
Applicant elected without traverse 2.4 mg once weekly from List 1 and liver fibrosis from List 2 in the reply filed December 16, 2025.
The restriction is deemed proper and is made FINAL in this office action. Claims 1-18, 21, 24, 27, 30 are withdrawn as being drawn to a non-elected species. Claims 19-20, 22-23, 25-26, 28-29 are examined on the merits of this office action.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19-20, 22-23, 25-26, 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over NCT02970942 (NCT02970942, published version 4/24/2019) in view of Kabisch (WO2019072941).
Please note that the term “about” is construed to be plus or minus 10% based on the specification definition (see paragraph 0050). Accordingly about 2.4 mg per week is construed as encompassing 2.16-2.64 mg per week. Furthermore, the weekly administration amount can be divided over many doses over the course of the week unless specifically stated that it is administered once.
NCT02970942 (“investigation of efficacy and safety of three dose levels of subcutaneous semaglutide Once daily versus placebo in subjects with NASH) teaches a method of treating NASH comprising administering subcutaneous semaglutide to subjects diagnosed with NASH (see Study overview, page 1) over 72 weeks (see Primary outcome Measure, page 17).
NCT02970942 teaches that the study enrolls subjects having liver fibrosis stages 1, 2 and 3, administers semaglutide once daily at does including 0.1, 0.2 and 0.4 mg/day, of which 0.4 mg/day corresponding to a cumulative weekly dose of approximately 2.8 mg at the high end and 0.1 corresponds to 0.7/week and 0.2 corresponds to 1.4 weekly (see page 16, Intervention/Treatment). NCT02970942 teaches treating NASH, administering semaglutide subcutaneously, treating liver fibrosis states 1-3 with the objective of achieving resolution of NASH without worsening fibrosis (see page 17, “what is the study measuring, primary outcomes). NCT02970942 is silent to a weekly dose of 2.4 mg.
Kabisch teaches dosing regimens for semaglutide including: once weekly administration of semaglutide; weekly doses including 2.4 mg; weekly doses ranging 2.2-2.7 mg and 2.4-3.2 mg; subcutaneous administration; interchangeable daily and weekly dosing regimens (see description, page 1, see administration, page 3).
It would have been obvious to a person of ordinary skill in the art to apply the once-weekly 2.4 mg semaglutide dosing regimen taught by Kabisch to the NASH treatment method disclosed in NCT02970942. A person of ordinary skill in the art would have been motivated to make this modification in order to reduce dosing frequency; improve patient compliance; utilize a clinically established semaglutide dosing regimen; and optimize treatment convenience while treating the same disease with the same therapeutic agent. Such modification represents routine dose selection and optimization of a known dosing regimen for a known drug used to treat the same condition and would have been expected to achieve the same therapeutic effect. A person of ordinary skill in the art would have had a reasonable expectation of success. Dose amount and dosing frequency are result effective variables and it would have been obvious to optimize (see MPEP 2144.05).
Regarding claims 20 and 23, NCT02970942 discloses administering semaglutide to subjects having NASH and fibrosis stages 1, 2 and 3 (see Eligibility Criteria page 14). Thus, treating subjects having fibrosis stage 2 using the method of claim 19 would have been obvious to a person of ordinary skill in the art.
Regarding claim 22, as stated above, NCT02970942 teaches administering semaglutide subcutaneously to treat NASH. Kabisch teaches once weekly administration of semaglutide. It would have been obvious to modify the daily dosing regimen of NCT02970942 to a once weekly dosing regimen as taught by Kabisch in order to reduce dosing frequence and improve compliance. Such modification represents routine optimization of dosing frequency, which is a recognized result effective variable in the pharmaceutical field.
Regarding claim 25, Kabisch teaches administering semaglutide in an amount of 2.4 mg per week, including in once-weekly dosing regimens. Selecting this dose amount for the NASH treatment method taught by NCT02970942 constitutes routine dose selection from a finite set of disclosed weekly doses. A person of ordinary skill in the art would have had a reasonable expectation of success. Dose amount and dosing frequency are result effective variables and it would have been obvious to optimize (see MPEP 2144.05).
Claim 26 depends from claim 25 and further recites that the subject has liver fibrosis stage 2. NCT02970942 teaches treating subjects having fibrosis stage 2. Applying the 2.4 mg dose of claim 25 to this disclosed patient population would have been obvious in view of Kabisch.
Claim 28 depends on claim 19 and recites that the semaglutide is administered in an amount of 2.4 mg once weekly. Kabisch teaches once weekly administration of 2.4 mg semaglutide, and NCT02970942 teaches administering semaglutide to treat NASH. Combining these teachings would have been obvious as a matter of routine dose and frequence selection for a known therapeutic agent used to treat the same disease. Furthermore, dose amount and dosing frequency are result effective variables and it would have been obvious to optimize (see MPEP 2144.05).
Claim 29 depends from claim 28 and further recites that the subject has liver fibrosis stage 2. NCT02970942 teaches treating subjects having fibrosis stage 2. Applying the 2.4 mg dose once weekly of claim 28 to this disclosed patient population would have been obvious in view of Kabisch. Furthermore, dose amount and dosing frequency are result effective variables and it would have been obvious to optimize (see MPEP 2144.05).
Regarding the limitation of “wherein the administering results in resolution of NASH and no worsening of liver fibrosis” in instant claim 19, NCT02970942 in view of Kabisch teach the same method of the instant claims including administering the same drug, same amount to the same patient population and thus, these desired result oriented effects with be inherently achieved as a result of practicing the method of NCT02970942 in view of Kabisch.
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 19-20, 22-23, 25-26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US Patent No. 11478533 (reference application) in view of NCT02970942 (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A method of treating non-alcoholic steatohepatitis (NASH), comprising administering semaglutide subcutaneously in an amount of about 2.4 mg per week to a subject diagnosed with NASH, wherein the administering results in resolution of NASH and no worsening of liver fibrosis” (Claim 19). The instant application further claims liver fibrosis stage 2 (claim 20); administered once weekly, and administered 2.4 mg once weekly (claim 28).
US Patent No. 11478533claims “A method of treating non-alcoholic steatohepatitis (NASH), comprising administrating semaglutide subcutaneously in an amount of about 2.4 mg per week to a subject diagnosed with NASH, wherein the administering results in an improvement in lobular inflammation” (see claim 1). US Patent No. 11478533 further claims “wherein the semaglutide is administered once weekly” (claim 14); wherein the method provides no worsening of liver fibrosis in the subject (claim 15). US Patent No. 11478533 is silent to treating NASH with stage 2 fibrosis.
However, NCT02970942 teaches that the study enrolls subjects having liver fibrosis stages 1, 2 and 3, administers semaglutide once daily at does including 0.1, 0.2 and 0.4 mg/day, of which 0.4 mg/day corresponding to a cumulative weekly dose of approximately 2.8 mg at the high end and 0.1 corresponds to 0.7/week and 0.2 corresponds to 1.4 weekly (see page 16, Intervention/Treatment). NCT02970942 teaches treating NASH, administering semaglutide subcutaneously, treating liver fibrosis states 1-3 with the objective of achieving resolution of NASH without worsening fibrosis (see page 17, “what is the study measuring, primary outcomes).
It would have been obvious before the effecting filing date of the claimed invention to treat stages 1, 2 and 3. One of ordinary skill in the art would have been motivated to do so given Co-pending 15931093 claims teaches treating NASH and preventing worsening of fibrosis and lobular inflammation both of which would be beneficial in any stage fibrosis.
Claims 19-20, 22-23, 25-26, 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of US Patent No. 11318191 (reference application) in view of NCT02970942 (cited above) and Kabisch (see reference above). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A method of treating non-alcoholic steatohepatitis (NASH), comprising administering semaglutide subcutaneously in an amount of about 2.4 mg per week to a subject diagnosed with NASH, wherein the administering results in resolution of NASH and no worsening of liver fibrosis” (Claim 19). The instant application further claims liver fibrosis stage 2 (claim 20); administered once weekly, and administered 2.4 mg once weekly (claim 28).
US Patent No. 11318191 B2 claims A liquid pharmaceutical composition consisting of semaglutide (see claim 23). The intended use of the liquid formulation is parenteral and in particular subcutaneous administration (see claim 24 and “administration and kits”).
US Patent No. 11318191 B2 further claims “A method of treating diabetes, obesity, Alzheimer's disease, nonalcoholic steatohepatitis (NASH) and/or cardiovascular diseases comprising administering to a subject in need thereof a therapeutically effective amount of the liquid pharmaceutical composition according to claim 23”. US Patent No. 11318191 B2 is silent to treating stage 2 fibrosis with NASH and 2.4 mg/week dose.
However, NCT02970942 teaches that the study enrolls subjects having liver fibrosis stages 1, 2 and 3, administers semaglutide once daily at does including 0.1, 0.2 and 0.4 mg/day, of which 0.4 mg/day corresponding to a cumulative weekly dose of approximately 2.8 mg at the high end and 0.1 corresponds to 0.7/week and 0.2 corresponds to 1.4 weekly (see page 16, Intervention/Treatment). NCT02970942 teaches treating NASH, administering semaglutide subcutaneously, treating liver fibrosis states 1-3 with the objective of achieving resolution of NASH without worsening fibrosis (see page 17, “what is the study measuring, primary outcomes).
Kabisch teaches dosing regimens for semaglutide including: once weekly administration of semaglutide; weekly doses including 2.4 mg; weekly doses ranging 2.2-2.7 mg and 2.4-3.2 mg; subcutaneous administration; interchangeable daily and weekly dosing regimens (see description, page 1, see administration, page 3).
It would have been obvious before the effecting filing date of the claimed invention to try and treat stages 1, 2 and 3 of Nash as taught by NCT02970942 One of ordinary skill in the art would have been motivated to do so given US Patent No. 191 claims treating NASH an NCT02970942 teaches treating NASH and stages 1-3 of NASH with the same drug and thus, treating NASH with semaglutide would be beneficial in any stage fibrosis as taught by NCT02970942 and obvious to try.
Furthermore, it would have been obvious to a person of ordinary skill in the art to apply the once-weekly 2.4 mg semaglutide dosing regimen taught by Kabisch to the NASH treatment method disclosed in US Patent No. ‘819. A person of ordinary skill in the art would have been motivated to make this modification in order to reduce dosing frequency; improve patient compliance; utilize a clinically established semaglutide dosing regimen; and optimize treatment convenience while treating the same disease with the same therapeutic agent. Such modification represents routine dose selection and optimization of a known dosing regimen for a known drug used to treat the same condition and would have been expected to achieve the same therapeutic effect. A person of ordinary skill in the art would have had a reasonable expectation of success. Dose amount and dosing frequency are result effective variables and it would have been obvious to optimize (see MPEP 2144.05).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 19-20, 22-23, 25-26, 28-29 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 24, 26, 28, 30, 32, 31, 32, 34-36, 38-39 of copending Application No. 19/022171 (reference application).
Claim 19 is identical in scope to co-pending claim 24, as both claims recite a method of treating non-alcoholic steatohepatitis by administering semaglutide subcutaneously in an amount of about 2.4 mg per week, resulting in resolution of NASH and no worsening of liver fibrosis.
Claim 20 is identical in scope to co-pending claim 26, as both claims further limit the method to subjects having liver fibrosis stage 2.
Claim 22 is identical in scope to co-pending claim 28, as both claims further limit the method to once-weekly administration.
Claim 23 is identical in scope to co-pending claim 30, as both claims further limit the once-weekly administration to subjects having liver fibrosis stage 2.
Claim 25 is identical in scope to co-pending claim 32, as both claims further limit the method to administration of semaglutide in an amount of 2.4 mg.
Claim 26 is identical in scope to co-pending claim 34, as both claims further limit the 2.4 mg administration to subjects having liver fibrosis stage 2.
Claim 28 is identical in scope to co-pending claim 36, as both claims further limit the method to administration of semaglutide in an amount of 2.4 mg once weekly.
Claim 29 is identical in scope to co-pending claim 38, as both claims further limit the 2.4 mg once-weekly administration to subjects having liver fibrosis stage 2.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claims are allowed.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654