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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2019/064548 filed 12/04/2019, which claims the benefit of the priority of US Provisional application 62/775,799 filed 12/05/2018 and 62/821,303 filed 03/20/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1, 54-59, and 86-89 are pending. Claims 2-53, and 60-85 are canceled. Claims 1, and 54-59 are amended. claims 86-89 are new.
Claims 1, 54-59, and 86-89 are being examined on the merits in this office action.
Claim Objections - Withdrawn
The objection of claim 1 is withdrawn in view of the claim amendment.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claims 1, and 54-59 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the claim amendments.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the claim amendments.
The rejection of claim 17 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of the canceled claim.
The rejection of claims 1, and 54-59 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36, 37-45, 65-75, 101 of copending Application No. 18/008,425 in view of Cable et al. (US2017/0112864A1 – hereinafter “Cable”) and Hansen et al. (Drug Discovery Today, Vol. 22, 11: 2017, 1707-1718) is withdrawn in view of the arguments.
Claim Rejections - 35 USC § 103 – Maintained and Updated
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.
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, 54-59, and 86-89 are rejected under 35 U.S.C. 103 as being unpatentable over Cable et al. (US2017/0112864A1 – hereinafter “Cable”) in view of Hansen et al. (Drug Discovery Today, Vol. 22, 11: 2017, 1707-1718).
This rejection has been updated include new claims 86-89.
Cable teaches a method of preventing, treating, or ameliorating a fatty liver disease in an animal, comprising administering to said animal a therapeutically effective amount of a thyromimetic compound or a pharmaceutically acceptable salt thereof (claims 1-2; [0053]), wherein said fatty liver disease is selected from the group consisting of steatosis, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis (claim 3; [0053), wherein said thyromimetic compound is administered in the form of a pharmaceutical composition (claim 17; [0258-0259]), wherein said pharmaceutical composition is in the form of a controlled release composition, transdermal patch, tablet, hard capsule, or soft capsule (claim 18), wherein said thyromimetic compound is administered orally (claim 19; [0829]). Cable teaches that the compound includes the compound
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(claim 32 and [0781]). Cable further teaches that the compounds present may be administered in combination with pharmaceutical agents such as GLP-1 analogs [0815-0817]. Further, Cable teaches that the compounds of the invention can be combined with anti-obesity agents such as a glucagon-like peptide-1 receptor agonist [0813].
Cable does not explicitly teach that the GLP-1 analog is semaglutide.
Hansen teaches several treatment for non-alcoholic fatty liver disease (NAFLD) (Abstract) and further suggests combination therapies (Page 1708, right col., line 10-15) and teaches that it is advantageous that drug therapies in NASH also induce weight loss, because successful weight management (≥5–10% weight loss) per se improves liver histology in NASH (Page 1708, right col., 2nd paragraph). Hansen teaches several drugs that are in use for liver disease therapy and include Glucagon-like peptide-1 analogues, such as semaglutide and TRb receptor agonists such as VK2809 (See Table 1, on Page 1712).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Cable and administer the instant thyromimetic compound in combination with GLP-1 analogues such as those taught by Hansen such as semaglutide since Hansen teaches that semaglutide has been used for the treatment of liver diseases such as NASH (See Table 1, on Page 1712). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using semaglutide in combination with the instant compound since Hansen suggests combination treatments for liver disease and discloses compounds such as VK2809 and semaglutide that have been successful in the treatment of liver diseases such as NASH. The disclosures render obvious claims 1 and 54.
Regarding claim 55, Cable teaches wherein said thyromimetic compound is administered in the form of a pharmaceutical composition (claim 17), wherein said pharmaceutical composition is in the form of a controlled release composition, transdermal patch, tablet, hard capsule, or soft capsule (claim 18), wherein said thyromimetic compound is administered orally (claim 19).
Regarding claims 56, and 86, Cable teaches that the instant compound is administered in combination with other therapeutic agents and that the dosage of the second drug may be reduced [0789-0791]. Examiner notes that the disclosure reads on either sequential or simultaneous administration rendering obvious claim 56.
Regarding claims 57-59, ad 87-89, Cable teaches pharmaceutical compositions comprising a first compound useful in the present invention and a second compound useful for decreasing the fat content of the liver, useful for the prevention, treatment, or amelioration of a fatty liver disease such as steatosis, NASH, or NAFLD, or useful for the prevention, treatment, or amelioration of a disease or disorder that is related to or results in fatty liver disease [0259] and that in NASH, fat accumulation is associated with varying degrees of inflammation (hepatitis) which may lead to scarring (fibrosis) of the liver [0205]. Further, Hansen teaches that the agents promote extracellular degradation (Page 1708, right col., last paragraph, line 6-7). Examiner further notes that regarding the limitations of claims 57-59, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that the compound shown in the Office Action is not compound 2 but is a stereoisomer thereof of compound 2. Applicant argues that the compound shown in the Office Action and Compound 2 are among a list of 50 compounds in paragraph [0781] and repeated in Claim 32 of Cable, which are each among a set of 3 lists totaling about 181 compounds. Applicant argues that Cable's broad "can be combined" language is an unbounded, generic suggestion of possible co-administration with various classes of compounds, without any particularized guidance toward semaglutide as the GLP-1 agent. Applicant argues that Hansen lacks the claimed teaching (Page 7-8 of Arguments).
Applicant argues unexpected results and claims that Example 6 in the application as filed shows that the semaglutide/compound 2 combination reduced plasma total cholesterol in treated animals relative to vehicle more than either Compound 2 or semaglutide alone. Paragraph [0305] and FIG. 26. The semaglutide/compound 2 combination was also effective in reducing liver triglycerides (FIG. 27), liver hydroxyproline (FIG. 28), total liver lipids (FIG. 29), and liver fibrosis (FIG. 30) (Page 9 of Arguments).
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that Applicant argument that the compound of Cable is different from compound 2 is unpersuasive. Examiner notes that independent claim 1 and 54 recite that the compound is
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.
Cable teaches that the compound is
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also called Cis-13-1.
Examiner notes that the two compounds are identical. Further, Examiner notes that Cable reduced to practice the instant compound and teaches that the compound cis-13-1 decreased hepatic triglyceride content [0048, 0944], decreased hepatic steatosis [0049, 0948], decreased hepatic steatosis [0050, 0952]. Examiner notes from the many compounds that Cable discloses, Cable teaches that the instant displayed superior results. Further, Examiner notes that Cable suggests using the compounds in combination with other pharmaceutical agents used to lower the fat content of liver or pharmaceutical agents that are used to treat or prevent disorders that are related to or result in an increase in the fat content of liver [0783]. GLP-1 analogs such as liraglutide and semaglutide are known to lower the fat content of the liver (Newsome et al.). Examiner further notes that Hansen teaches several treatment options for liver diseases such as NAFLD and NASH). Hansen, like the Cable reference, suggests combination therapy for treating liver diseases. Hansen discloses use of the compound VK2809 (which is 100% the instant compound) and further discloses other agents for treatment of liver diseases such as GLP-1 analogs specifically semaglutide. Examiner notes that both references suggest combination treatment for treating liver disease. Bothe references disclose the instant compound and the GLP-1 analogs such as semaglutide. Examiner notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Examiner notes that co-administration of the instant compound and semaglutide is already suggested or taught by the cited reference. The Argument that the combination treatment displayed unexpected results than the treatment of the compound alone is unpersuasive. Such a combination was already known in the art; thus it is expected that the combination of the compound and semaglutide would result to superior results than the treatment with the compound only. Further, it is already known as taught by Cable that the instant compound reduces cholesterol levels [0009, 0017], decreased hepatic triglyceride content [0048, 0944], decreased hepatic steatosis [0049, 0948], decreased hepatic steatosis [0050, 0952]. Examiner notes these are all the results disclosed in the instant application and are thus expected results in the recited method. Examiner is not convinced that the instant method displayed unexpected results. Examiner insists that when the teachings of the cited references are combined, the instant claims are obvious.
Double Patenting – Maintained and Updated
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.
This rejection has been updated include new claims 86-89.
Claims 1, 54-59, and 86-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-10, 12-13, 18-21 of U.S. Patent No. US11707472B2 in view of Cable et al. (US2017/0112864A1 – hereinafter “Cable”) and Hansen et al. (Drug Discovery Today, Vol. 22, 11: 2017, 1707-1718).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method of preventing, treating, or ameliorating one or more fatty liver diseases in a subject in need thereof comprising administering to said subject in need thereof at least one TR-β agonist in combination with one or more second pharmaceutical agents (claim 1).
The claims of the patent recite a method of treating fibrosis, said method resulting in the reduction in the amount of extracellular matrix proteins present in one or more tissues in a subject in need thereof, comprising administering to said subject in need thereof at least one compound
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(claim 1), wherein said subject has one or more conditions including fatty liver disease (claim 2).
The difference between the instant claims and the claims of the patent is that the claims of the patent do not recite administering the compound in combination with one or more second pharmaceutical agent such as GLP-1 agonist such as semaglutide.
However, administering the compound of the patent in combination with a second pharmaceutical agent is known in the art as taught by Cable and Hansen.
Cable teaches a method of preventing, treating, or ameliorating a fatty liver disease in an animal, comprising administering to said animal a therapeutically effective amount of a thyromimetic compound or a pharmaceutically acceptable salt thereof (claims 1-2), wherein said fatty liver disease is selected from the group consisting of steatosis, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis (claim 3), wherein said thyromimetic compound is administered in the form of a pharmaceutical composition (claim 17), wherein said pharmaceutical composition is in the form of a controlled release composition, transdermal patch, tablet, hard capsule, or soft capsule (claim 18), wherein said thyromimetic compound is administered orally (claim 19). Cable teaches that the compound includes the compound
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(claim 32 and [0781]). Cable further teaches that the compounds present may be administered in combination with pharmaceutical agents such as GLP-1 analogs [0815-0817].
Further, Hansen teaches several treatment for non-alcoholic steatohepatitis (NASH) (Abstract) and further suggests combination therapies (Page 1708, right col., line 10-15). Hansen teaches several drugs that are in use for NASH therapy and include Glucagon-like peptide-1 analogues, such as semaglutide and TRb receptor agonists such as VK2809 (See Table 1, on Page 1712).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the patent with the teachings of Cable and Hansen and administer the instant thyromimetic compound in combination with GLP-1 analogues such as those taught by Cable and Hansen such as semaglutide since Cable teaches combination therapy of the instant compound with GLP-1 and Hansen teaches that semaglutide has been used for the treatment of NASH (See Table 1, on Page 1712). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the teachings of the patent and administer the compound in combination with a second pharmaceutical agent as taught by Cable and Hansen since Cable to teaches the method was for treating fatty liver disease (claims 1-2). The claims 1 and 54 of the instant application are obvious over the claims of the patent.
Regarding claim 17, the claims of the patent recite the method of treating liver disease comprising administering the compound
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(claim 1). The difference between the instant claims and the claims of the patent is that the claims of the patent do not recite administering the compound in combination with one or more second pharmaceutical agent such as GLP-1 agonist such as semaglutide. However, this is known in the art since Cable and Hansen teach combination treatment with the instant compounds and agents such as GLP-1 agonists. It would have been obvious to modify the claims the patent to include agents such as GLP-1 agonists.
Regarding claim 28, the claims of the patent recite treating conditions including non-alcoholic steatohepatitis (NASH), alcoholic fatty liver disease (claim 2).
Regarding claim 55, the claims of the patent recite wherein said composition is formulated for oral, intravenous, intraarterial, intestinal, rectal, vaginal, nasal, pulmonary, topical, intradermal, transdermal, transbuccal, translingual, sublingual, or opthalmic administration, or any combination thereof (claim 3).
Regarding claims 56 and 86, Cable teaches that the instant compound is administered in combination with other therapeutic agents and that the dosage of the second drug may be reduced [0789-0791]. Examiner notes that the disclosure reads on either sequential or simultaneous administration and it would have been obvious to modify the claims the patent to include agents such as GLP-1 agonists for sequential or simultaneous administration.
Regarding claim 57 and 87, the claims of the patent recite the method for fibrosis comprising administering the compound (claims 1-3). Further, Cable and Hansen teach combination treatment with the instant compounds and agents such as GLP-1 agonists like semaglutide. It would have been obvious to modify the claims the patent to include agents such as GLP-1 agonists to treat fibrosis.
Regarding claim 58 and 88, the claims of the patent recite a method of reduction in the amount of extracellular matrix proteins present in one or more tissues in a subject, comprising administering one or more compounds (claim 8). Further, Cable and Hansen teach combination treatment with the instant compounds and agents such as GLP-1 agonists like semaglutide. It would have been obvious to modify the claims the patent to include agents such as GLP-1 agonists for reduction in the amount of extracellular matrix proteins.
Regarding claim 59 and 89, the claims of the patent recite wherein said administration of said compound results in a reduction in the amount of Type I, Type Ia, or Type III collagen present in one or more tissues of said subject (claims 20-21). Further, Cable and Hansen teach combination treatment with the instant compounds and agents such as GLP-1 agonists like semaglutide. It would have been obvious to modify the claims the patent to include agents such as GLP-1 agonists for reduction in the amount of collagen.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims of the patent are for monotherapy and do not require co-administration.
Examiner notes that the claims of the patent are administering the same compound to treat the same instant condition and that one of ordinary skill in the art, in view of Cable and Hansen would be motivated to co-administer the compound with semaglutide for improved treatment. The arguments are unpersuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/
Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654