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 . 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.
Priority
The instant application is a 371 of PCT/EP2022/055224 filed on 03/02/2022 and claims foreign priority to PCTEP2021055348 filed on 03/03/2021. The certified copy of the foreign priority application filed on 09/01/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/30/2026 and 05/28/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 06/08/2026 is acknowledged. Claims 8-9, 14, and 17-18 are amended. Claims 11-13 are cancelled
Accordingly, claims 1-10 and 14-18 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(a) scope of enablement rejection for claims 14 and 17-18 are withdrawn because Applicant has amended these claims to a method for the treatment of a disease in the recited list, which is enabled by the disclosure.
The 35 USC 112(a) written description rejection for claims 14 and 17-18 are withdrawn for the following reason. After reconsideration, Applicant has provided sufficient support of using their claimed compounds to treat the various recited diseases and conditions in claims 14 and 17-19 because Applicant has identified and provided evidence of a common characteristic among each of the recited genus disease/condition, in which galectin-3 is up-regulated in several species of these recited diseases and conditions. Furthermore, Applicant has demonstrated that their claimed compounds inhibit galectin-3 (Table 10 pages 94-96 in the specification). Therefore, the ordinary skilled artisan would be able to recognize that the inventor was in possession of the necessary common attributes or feature possessed by the members of the genus in view of the species disclosed, which are the recited diseases and conditions in which gal-3 is up-regulated and the use of their gal-3 inhibiting compounds.
The nonstatutory double patenting rejection over US’672 and co-pending app ’332 for claims 8-9 are withdrawn after reconsideration for reasons as discussed in the reasons for allowance section below.
The following grounds of rejection are maintained.
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 1-7, 10, and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,319,672.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of US’672 recites the following compound structure:
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The Ar1 includes various aryl structures such as
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recited in claim 6 of US’672. Furthermore, claim 1 of US’672 recites that R1 represents hydroxy or methoxy, A can be 1,2,3-triazole-1,4-diyl, and R2 can be several structures that overlap with the R2 structures recited in the instant claims.
Claim 13 of US’672 recites a method for the treatment of an indication selected from fibrosis of organs; liver diseases and disorders; cardiovascular diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; acute kidney injury and chronic kidney disease; interstitial lung diseases and disorders; and transplant rejection; comprising administering to a subject in a need thereof an effective amount of a compound according to claim 1 of US’672. Claim 12 of US’672 recites a pharmaceutical composition comprising the recited compound and a pharmaceutically acceptable carrier.
US’672 recites the same base compound structure for the treatment of the same diseases or conditions. Furthermore, US’672 recites overlapping Ar1, R1, A, and R2 substituents such that an ordinary skilled artisan could have selected substituents from within the claims of US’672 to arrive at the compounds recited in the instant claims.
Claims 1-7, 10, and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-36 of copending Application No. 19/193,332 (‘332).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of ‘332 recites the following compound structure:
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The Ar1 includes various aryl structures such as
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recited in claim 19 of ‘332. Furthermore, claim 16 of ‘332 recites that R1 represents -O-CH2-CO-R1x wherein R1x represents hydroxy, A can be 1,2,3-triazole-1,4-diyl, and R2 can be several structures that overlap with the R2 structures recited in the instant claims.
Claim 27 of ‘332 recites a method for the treatment of an indication selected from fibrosis of organs; liver diseases and disorders; cardiovascular diseases and disorders; cell proliferative diseases and cancers; inflammatory and autoimmune diseases and disorders; gastrointestinal tract diseases and disorders; pancreatic diseases and disorders; abnormal angiogenesis-associated diseases and disorders; brain-associated diseases and disorders; neuropathic pain and peripheral neuropathy; ocular diseases and disorders; acute kidney injury and chronic kidney disease; interstitial lung diseases and disorders; and transplant rejection; comprising administering to a subject in a need thereof an effective amount of a compound according to claim 16 of ‘332. Claim 26 of ‘332 recites a pharmaceutical composition comprising a recited compound and a pharmaceutically acceptable carrier.
‘332 recites the same base compound structure for the treatment of the same diseases or conditions. Furthermore, ‘332 recites overlapping Ar1, R1, A, and R2 substituents such that an ordinary skilled artisan could have selected substituents from within the claims of ‘332 to arrive at the compounds recited in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on 06/08/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states in regards to the nonstatutory double patenting rejections over US’672 and co-pending app ‘332 that the assertion that the substituents in US’672 and ‘332 contain overlapping substituents is not sufficient to establish a prima facie vase of obviousness. Applicant states that it is necessary to identify some reason that would have led a chemist modify a compound in a particular manner to establish obviousness. Applicant states that simply asserting that an ordinary skilled could have selected substituents from within the claims of US’672 or co-pending ‘332 to arrive at the instant compounds without providing any explanation for why an ordinary skilled artisan would make the specific choices required is not sufficient to establish obviousness.
Applicant’s arguments described above were not found persuasive because an explicit motivation is not required in order establish a prima facie case of obviousness. Furthermore, MPEP 2141 II C states that “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton … Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ”.
MPEP 2143 I provides seven exemplary rationales that may be used to support a conclusion of obviousness, KSR (A)-(G), only one of which requires that there be some teaching, suggestion, or motivation in the prior art. In this case, the nonstatutory double patenting rejections discussed above relies on the selection of substituents from within the recited groups in the reference applications, which is KSR(E). As described above, US’672 and co-pending ‘332 recite the same base compound structure of the instant compound Formula (l) and recites all of the same instant substituent structures (A, R1, R2, RP2-4) that can be selected. The reference applications recite many of the same substituents such as the same aryl structure such as
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as seen in the instant claims, the same hydroxy substituent for the instant R1 position, the same 1,2,3-triazole-1,4-diyl substituent for the instant A position, and the same instant R2 structures such as C3-6-cycloalkyl wherein said C3-6-cycloalkyl independently is unsubstituted.
Therefore, the ordinary skilled artisan would have reasonably expected that any combination of substituents from US’672 or ‘332 can be selected and used to make their respective compounds, and since many of these substituents are the same as described above, the ordinary skilled artisan would have been able to choose from a finite list of overlapping substituents from US’672 and co-pending ‘332 to arrive at a compound in the instant claims.
Allowable Subject Matter
Claims 8-9 are allowable.
The following is an examiner' s statement of reasons for allowance:
The instant claims are drawn to a list of several different compounds.
The following references are considered to be the closest prior art:
Rao et al. (WO2019067702A1 in IDS filed 01/17/2024)
Rao discloses a compound of Formula I (page 2) shown below:
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Furthermore, Rao teaches several specific compounds (pages 7-10) such as:
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Rao teaches that their compounds can inhibit Gal-3 (page 2 lines 8-10).
Even though Rao teaches a similar base structure as the recited compounds in instant claims 8-9, Rao does not teach any of the recited substituents at the R2 position of these instant compounds. Furthermore, Rao does not teach the same stereocenter at the A-R2 position of these instant compounds.
The prior art does not teach or suggest the A-R2 position substituents as well as the same stereocenter for gal-3 inhibiting compounds with similar structures. Therefore, the ordinary skilled artisan would not have been able to arrive at the compounds of instant claims 8-9 through routine experimentation and would have relied on hindsight in order to modify the compounds of Rao to arrive at the compounds in instant claims 8-9.
Conclusion
Claims 1-7, 10, and 14-18 are rejected.
Claims 8-9 are allowable.
THIS ACTION IS MADE FINAL. 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 DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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