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 .
Priority
Instant application 18/258,620 filed on 06/21/2023 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 51-52, 54-60, 62, 64-67, 70, 72, 74, 75, 79-83 and 116
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/16/2025, 06/24/2025, 07/25/2024, 09/14/2023, 06/21/2023 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election, with traverse, of Group I in the reply filed on 12/16/2025 is acknowledged.
The traversal is on the ground(s) that it would not impose a serious burden on the Office to simultaneously search subject matter of Groups I and II. Regarding species election, Applicant submitted that search all the species together would not impose a serious burden on the Office.
These arguments have been considered but are not found persuasive as such arguments do not apply when restriction is required under 35 USC 121 and 372, as in the instantly filed application. Thus, when the Office considers international applications as an International Searching Authority, as an International Preliminary Examining Authority, and during the national stage as a Designated or Elected Office under 35 U.S.C. 371, only PCT Rule 13.1 and 13.2 will be followed when considering unity of invention of claims of different categories without regard to the practice in national applications filed under 35 U.S.C. 111. Thus, it is maintained that the technical feature linking the inventions of Groups I-II does not constitute a special technical feature as defined by PCT Rule 13.2 and does not define a contribution over the prior art for the reasons of record.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claim 116 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/16/2025.
Regarding species election, Applicant’s election, with traverse, of compound A
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in combination with GLP-1 receptor agonist, semaglutide, in the reply filed on 12/16/2025 is acknowledged.
Claims 55 and 58-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/16/2025.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Claim Objections
Claim 52 is objected to because of the following informalities:
Claim 52 recites the first compound is of Formula (I). However, the structure is labeled (II).
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It should be noted that claim 51 recite Formula (II):
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The compound recited in claim 52 should be labeled (I).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 51, 52, 54, 56, 57, 62, 64, 65-70, 72, 74, 75, 79-81 and 83 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by STEINEGER (WO-2019111048-A1) (published 13 June 2019).
STEINEGER discloses a method of treating non-alcoholic steatohepatitis and/or alcoholic steatohepatitis using the same compounds as recited in instant claims:
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STEINEGER discloses compounds of Formula (I):
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Further, STEINEGER discloses the instant elected compound A:
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Further, STEINEGER discloses:
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Furthermore, STEINEGER discloses GLP-1 as an additional agent:
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STEINEGER teaches the elected species, semaglutide, as the additional agent (see page 24, lines 15-18):
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Regarding instant claim 62, STEINEGER teaches (see page 13, lines 24-26):
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Regarding instant claim 65, STEINEGER teaches and claims:
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Regarding instant claim 66, STEINEGER teaches and claims the compound is administered once daily:
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Regarding claim 70, STEINEGER teaches and claims:
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Regarding claim 72, STEINEGER teaches and claims the method reduces hepatic inflammation (see claim 45).
Regarding claim 74, STEINEGER teaches and claims:
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Regarding claim 75, STEINEGER teaches and claims the pharmaceutical composition is formulated for oral administration (see claim 48).
Regarding claim 79, STEINEGER teaches and claims:
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Regarding claim 80, STEINEGER teaches and claims:
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Regarding claim 81, STEINEGER teaches and claims:
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Regarding claim 83, STEINEGER teaches and claims:
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Since the teachings of STEINEGER meet all the limitations of instant claims 51, 52, 54, 56, 57, 62, 64, 65-70, 72, 74, 75, 79-81 and 83, those claims are anticipated.
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 51, 52, 54, 56, 57, 62, 64, 65-70, 72, 74, 75, 79-81 and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12440466-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of U.S. Patent No. 12440466-B2 recite a method of inhibiting the progression of hepatitis fibrosis wherein the method treats non-alcoholic steatohepatitis:
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Further, the claims of U.S. Patent No. 12440466-B2 recite that GLP-1 receptor agonist, FXR agonist, and/or ACC inhibitor may be selected as the additional agent (see claim 14).
Therefore, the instant claims and the claims of the issued patent are overlapping in scope.
Claims 51, 52, 54, 56, 57, 62, 64, 65-70, 72, 74, 75, 79-81 and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11925614-B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims a directed to a method of treating NASH and/or ASH wherein the method treats the development of hepatic fibrosis or reduces existing hepatitis fibrosis (see instant claim 72).
The claims of U.S. Patent No. 11925614-B2 are directed to a method of reducing fibrosis using the same compounds (including the instant elected species, Compound A, see claim 12) in combination with one or more additional agent chosen from GLP-1 receptor agonist, ACC inhibitor and FXR agonist (see claim 27).
The claims are overlapping in scope because treating of a disease will also treat its symptoms, such fibrosis. It should be noted that treating fibrosis is claimed in both the pending application and in the issued patent.
Claims 51, 52, 54, 56, 57, 62, 64, 65-70, 72, 74, 75, 79-81 and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11234948-B2 in view of Kalogirou (Kalogirou M, Sinakos E. Treating nonalcoholic steatohepatitis with antidiabetic drugs: Will GLP-1 agonists end the struggle? World J Hepatol. 2018 Nov 27;10(11)) and in view of Mascolini (AASLD The Liver Meeting Digital Experience, November 13-16-2020).
The claims of U.S. Patent No. 11234948-B2 recite a method for treating non-alcoholic steatohepatitis using the same compounds as recited in instant claims (including the instant elected species, Compound A):
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It should be noted that the instant claims are also directed to a method of treating NASH and/or ASH comprising administering to the subject a pharmaceutically effective amount of the same compound (compound of formula (II)). However, the instant claims require at least one additional active agent chosen from GLP-1 receptor agonist, ACC inhibitor and FXR agonist.
The claims of U.S. Patent No. 11234948-B2 do not recite administration of additional active agent.
Kalogirou teaches GLP-1 agonists in the treatment of NASH (see abstract).
Further, Kalogirou teaches the instant elected GLP-1 agonists, semaglutide (see page 792, last paragraph):
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In addition, regarding the instant elected GLP-1 receptor agonist, Mascolini teaches semaglutide is effective in treatments of nonalcoholic steatohepatitis (NASH):
“Semaglutide, a glucagon-like peptide-1 agonist (GLP-1RA) licensed for treatment of type 2 diabetes, resolved nonalcoholic steatohepatitis (NASH) without worsening fibrosis significantly more often than placebo at all 3 subcutaneous doses used in a 320-person 72-week trial [1]. The medication did not significantly improve fibrosis compared with placebo, but it did improve weight, lipids, and the diabetes metric HbA1c.”(first paragraph).
Applying KSR prong (A) - Combining prior art elements according to known methods to obtain predictable results - 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 combine the compound recited in claims of U.S. Patent No. 11234948-B2 (including Compound A) with GLP-1 receptor agonists (including the elected species semaglutide) disclosed by Kalogirou and Mascolini.
MPEP 2144.06 states that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”.
In the instant case, it would have been prima facie obvious to use the combination comprising the compound recited in claims of U.S. Patent No. 11234948-B2 and GLP-1 receptor agonists, disclosed by Kalogirou and Mascolini, for the same purpose: treating non-alcoholic steatohepatitis, with a reasonable expectation of success. A skilled artisan would expect additive effect because prior art teaches that both compounds are effective in treatments of nonalcoholic steatohepatitis (NASH).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621