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
The present application, filed June 8, 2022, is a continuation of 16/611609, filed November 17, 2019, now issued as U.S. patent 11,576,924, which is a national stage application of PCT/US2018/032349, filed May 11, 2018, which claims the benefit of U.S. provisional application 62/505544, filed May 12, 2017.
Status of the Application
Applicant’s communication, received February 26, 2026, wherein claims 1 and 10 are amended, claims 2-7 are canceled, and new claims 21-22 are added, is acknowledged.
Claims 1 and 8-21 are pending in this application.
Claim 13-20 were withdrawn as being directed to a non-elected invention with the Office action mailed September 9, 2025.
Claims 1, 8-12, and 21-22 are examined on the merits herein.
Withdrawn Objections
Applicant’s amendment, received February 26, 2026, with respect to the objections to claims 1-3, 5-7, and 10 for minor informalities, has been fully considered and found to be persuasive to remove the objections because claims 2-3 and 5-7 are canceled and claims 1 and 10 are amended to remove the minor informalities. Therefore the objections are withdrawn.
Withdrawn Rejections
Applicant’s amendment, received February 26, 2026, with respect to the rejection of claims 1-12 under 35 U.S.C. § 112(a) for lacking enablement of solvates of the claimed compounds, has been fully considered and found to be persuasive to remove the rejection because claims 2-7 are canceled and independent claims 1 and 10 are amended to remove solvates from the scope of the claims. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection of claims 1-6, 8-9, and 11-12 under 35 U.S.C. § 112(b) as indefinite over the additional methyl group presented in the structure of claim 1, has been fully considered and found to be persuasive to remove the rejection because claims 2-6 are canceled and because the structure of claim 1 is amended to remove this additional methyl group. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejections of claims 1-6 and 8-12 under 35 U.S.C. § 112(b) as indefinite over the term hydrophobic hydrocarbon derivatives and the limitations “including heterocyclic substitutions of 3 or more atoms” and “including heterocyclic substitutions of molecular weight of about 50-200 D”, have been fully considered and found to be persuasive to remove the rejections because claims 2-6 are canceled and because claims 1 and 10 are amended to remove the indefinite terms. Therefore the rejections are withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection of claims 1-6 and 10-12 under 35 U.S.C. § 112(b) as indefinite over uncertainty regarding hydrocarbon definitions as applying to variable group Y or variable groups R1, R2, and R3, has been fully considered and found to be persuasive to remove the rejection because claims 2-6 are canceled and because claims 1 and 10 are amended to clarify that the definition of hydrocarbon applies to Y, R1, R2, and R3 in claim 1 and Y, Z, R1, R2, and R3 in claim 10. Therefore the rejections are withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejections of claims 4 and 5 under 35 U.S.C. § 112(b) as indefinite over the definition of A-M and the phrase “such as”, has been fully considered and found to be persuasive to remove the rejection because claims 4 and 5 are canceled. Therefore the rejections are withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection of claim 10 under 35 U.S.C. § 112(b) as indefinite as indefinite over the additional methyl group presented in the structure of claim 10, has been fully considered and found to be persuasive to remove the rejection because the structure of claim 10 is amended to remove this additional methyl group. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejections of claims 1 and 10 under 35 U.S.C. § 112(b) as indefinite as indefinite over the required substitutions for M and Z with groups R2 and R3, has been fully considered and found to be persuasive to remove the rejection of claim 1 because claim 1 is amended to recite that the A-M spacer is linked to R2, R3 or R2 and R3. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejections of claims 5 and 8-9 under 35 U.S.C. § 112(b) as indefinite over the term “the A-M spacer”, has been fully considered and found to be persuasive to remove the rejection because claim 5 is canceled and independent claim 1 is amended to recite A-M as a spacer. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection of claims 2-3 and 6-7 under 35 U.S.C. § 112(d) for failing to include all the limitations of the claim upon which they depend, has been fully considered and found to be persuasive to remove the rejection because claims 2-3 and 6-7 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1, 4, 8, and 11 under 35 U.S.C. § 102 as anticipated by Giguere, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which Giguere does not teach, and because claim 4 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1-4 and 8 under 35 U.S.C. § 102 as anticipated by Murphy, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which Murphy does not teach, and because claims 2-4 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1-4 and 8 under 35 U.S.C. § 102 as anticipated by the compound with CAS RN 1160299-32-0, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which the compound with CAS RN 1160299-32-0 does not teach, and because claims 2-4 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1-4, 8, and 11 under 35 U.S.C. § 102 as anticipated by Courtney, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which Courtney does not teach, and because claims 2-4 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1-4 and 9 under 35 U.S.C. § 102 as anticipated by Steyermark, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which Steyermark does not teach, and because claims 2-4 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1-6 under 35 U.S.C. § 103 as unpatentable over the compound with CAS RN 1160299-32-0 in view of Aylward, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which the combination of CAS RN 1160299-32-0 and Aylward does not teach, and because claims 2-6 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1-6 under 35 U.S.C. § 103 as unpatentable over the compound with CAS RN 1160299-32-0 in view of Aylward, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which the combination of CAS RN 1160299-32-0 and Aylward does not teach, and because claims 2-6 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 26, 2026, with respect to the rejection to claims 1 and 12 under 35 U.S.C. § 103 as unpatentable Courtney, has been fully considered and found to be persuasive to remove the rejection because independent claim 1 is amended to include the proviso that Y-R1 is not -OH, which Courtney does not teach. Therefore the rejection is withdrawn.
The following are new claim objections in response to Applicant’s amendments received February 26. 2026.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities:
Claims 1 and 10 recite several functional groups that should be revised to promote clarity in the claims:
-sulfonamide -N(H)-S(=O2)- should be revised to recite -N(H)-S(=O)2-.
-methylether -C(-H2)-O-, should be revised to recite -C(H)2-O- or -CH2-O-.
-methylester -C(=O)-O- typically refers to an ester with a methyl group substituent, which is not indicated by the claim. Based on the chemical structure, this limitation would be more clear reciting “ester -C(=O)-O-” instead of “methylester.”
-carbosulfon -C(-H2)-S(=O)(=O)- should be revised to recite -C(-H)2-S(=O)(=O)- or -C(-H)2-S(=O)2-.
Claims 1 and 10 recite “an aryl group, and a heterocycle and derivatives” in the third line from the end of each claim. Please amend these claims to recite “an aryl group,
In addition, the chemical structure in claim 10 is of sufficiently low resolution that some variable groups are difficult to interpret. Please replace the structure in claim 10 with a higher resolution structure.
Appropriate correction is required.
Claim Interpretation
Claim 1 is interpreted as if the stereochemistry shown in the compound of Formula 1 is required by the claim. This interpretation includes the requirement that the carbon linked to A-M is the β anomer (or is cis to the CH2-OH group adjacent to the variable group W).
Prior art structures which do not include the required stereochemistry are interpreted herein to not satisfy the requirements of claim 1.
This interpretation is also applied to the compound of Formula 2 recited in claim 10.
The following rejection is maintained from the previous office action, updated herein to include new claims that depend from claim 10.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 claims the structure Formula 2 as shown. This structure has Z substituted with both R2 and R3 groups.
However, as one example, Z in formula 2 of claim 10 includes both O and S as options for Z, and valency would require that O and S form two bonds, one with X and one with R2 and/or R3.
For the purposes of expedited prosecution, claim 10 is interpreted as permitting X-Z as linked to R2, R3, or R2 and R3, consistent with the amendments to claim 1 regarding substitution of A-M with R2, R3, or R2 and R3.
Because claims 21 and 22 depend from claim 10 and fail to cure this deficiency, claims 21 and 22 are also indefinite.
The following is a modified grounds of rejection, necessitated by Applicant’s amendment received February 26, 2026.
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, 8-9, and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 4 of U.S. Patent No. 11,576,924 (reference patent, herein referred to as ‘924). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘924 anticipate the claimed invention.
The present application and ‘924 are each assigned to Galectin Sciences, LLC.
Claim 1 of ‘924 claims a compound or a pharmaceutically acceptable salt or solvate thereof having the structures shown.
One compound recited in claim 1 of ‘924 is the compound shown below (column 79, lines 20-25), which satisfies all limitations of present claims 1 and 8. This compound has W as O, A-M as -N(-Ra)-C(=O), Ra as CH3, B as OH, Y as a heteroaryl group, and R1 as a phenyl substituted with at least one halogen.
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Another compound in claim 1 of ‘924 is the compound shown below (column 84, lines 30-35), which satisfies the limitations of present claims 1 and 9, wherein W is O, A-M is -N(-Ra)-C(=O), Ra is CH3, B is OH, Y is a heteroaryl group, and R1 is a phenyl substituted with at least one halogen. R2/R3 in this instance is C3-[1,2,3]-triazol-1-yl-substituted D galactose further substituted with the phenyl group attached to galactose via amide bond, and thus in this compound, spacer A-M asymmetrically links two substituted galactoside derivatives as required by claim 9. Thus this compound satisfies the limitations of claims 1 and 9.
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Claim 3 of ‘924 claims a composition comprising a therapeutically effective amount of the compound of claim 1 and a pharmaceutically acceptable adjuvant, excipient, formulation carrier or combinations thereof, which satisfies the limitations of present claim 11.
Claim 4 of ‘924 claims a composition comprising a therapeutically effective amount of the compound claim 1 and a therapeutically effective amount of an anti-inflammatory drug, vitamin, pharmaceutical drug, nutraceutical drug, supplement, or combinations thereof, which satisfies the limitations of present claim 12.
Response to Applicant’s arguments: With respect to the nonstatutory double patenting rejection of claims 1, 8-9, and 11-12 over claims 1, 3, and 4 of U.S. Patent No. 11,576,924, Applicant has deferred substantive rebuttal until the identified claims of the above-identified application have been allowed.
Accordingly, the above nonstatutory double patenting rejection is maintained.
Allowable Subject Matter
Claims 10 and 21-22 are currently rejected under 35 U.S.C. § 112(b). However, the examiner notes that claim 10 is free of prior art, and if the indefiniteness of claim 10 were resolved to include that X-Z may be linked to R2, R3, or R2 and R3, then claims 10 and 21-22 would be allowable.
The closest prior art to the compounds of claim 10 is considered Henderson (Publication no. CA 2794066 A1; cited in the IDS received June 8, 2022. Henderson teaches the thiodigalactoside compound shown below (p. 3, line 6), with the 3 and 3’ positions substituted with heteroaryl groups. However, this compound does not have A-M or X-Z as required by claim 10, and does not have the general structure required by claim 10 in which the A-M substitution joins the galactosides. Furthermore, Henderson does not teach or suggest modification to this compound to the prepare a compound of claim 10.
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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 BENJAMIN BRANDSEN whose telephone number is (703)756-4780. The examiner can normally be reached Monday - Friday from 9:00 am to 5:00 pm.
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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693
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