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 .
Claim Status
The claim set and Applicant’s remarks filed May 14, 2026 has been entered.
Claims 1-15 are canceled.
Thus, claims 16-28 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on May 14, 2026:
(I) The objection of claims 16-17, 26 and 28 is withdrawn in view of Applicant’s amendment to these claims.
(II) The rejection of claims 16-28 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment to claims 16 and 28.
Response to Arguments
(I) The rejection of claims 16-28 under 35 U.S.C. 103;
(II) The rejection of claims 16-17, 19-23, 24-25 and 27-28 on the ground of nonstatutory double patenting; and
(III) The provisional rejection of claims 16-17, 19-22, 24-25 and 27-28 on the ground of nonstatutory double patenting; are all maintained.
Applicant argues:
(A) Dahlqvist does not teaches that pyrazoles are superior or preferred replacements for triazoles in galaectin-3 selective inhibitors, to the contrary, Dahlqvist teaches that changing the heterocycle significantly alters galectin selectivity behavior, which would caution a skilled person that replacing a triazole with a pyrazole could reduce selectivity, which undermines the motivation to make the proposed substitution in Jalagam’s inhibitors of galectin-3, see Applicant’s remarks, pg. 24, lines 8-12.
With respect to Applicant’s argument (A), Dahlqvist exemplifies C1-galactopyranosyl heteroaryls as promising scaffolds for galectin inhibition, see pg. 7047, abstract.
Dahlqvist further exemplifies synthesizing said C1-galactopyranosyl heteroaryls where the C-1 position comprises either a triazole or a pyrazole, see pg. 7048, Scheme 1.
Dahlqvist examines the dissociation constants of said exemplified compounds comprising either a triazole (see compounds 1a-c) or a pyrazole (see compounds 4a-c) to binding either galectin-1 and galactin-3, see pg. 7049, Table 1.
Additionally, Dahlqivst teaches the pyrazole compounds (4a-c) exhibit lower dissociation constants for galactin-3 then the triazole compounds (1a-c), see pg. 7049, Table 1; and thus, Dahlqvist teaches the modification of a triazole to a pyrazole strengthens the binding of the galectin inhibitor to galectin-3 when the triazole is replaced with a pyrazole.
Finally, with particular note to Applicant's argument that changing the heterocycle significantly alters galectin selectivity, and accordingly undermines the motivation to make the proposed substitution in Jalagam's inhibitors of galectin-3, the Examiner notes the pyrazole compounds (4a-c) of Dahlqvist show a preference for galactin-3 over galectin-1.
(B) Dahlqvist does not teach or suggest the claimed substitution, nor provides sufficient motivation or reasonable expectation of success to arrive at the claimed invention, see Applicant’s remarks, pg. 22, paragraph 1.
(C) Dahlqvist’s compounds within scheme 1 are triazole and pyrazole structures which are attached directly to the anomeric carbon (C1) of the galactopyranose ring, see Applicant’s remarks, pg. 24, paragraph #2, second paragraph; while Applicant’s present claims require a pyrazole directly attached to the galactopyranose ring at a different carbon position (A1), i.e. the carbon opposite the ring oxygen, see pg. 25, first paragraph.
(D) The Office Action’s proposed substitution relies on an incorrect structural mapping between the two references as Dahlqvist does not teach or suggest replacing the heterocycle at the claimed A1 position, nor does it provide motivation to modify Jalagam’s compounds in the manner required by the claims, see Applicant’s remarks, pg. 25, second paragraph.
(E) There is no reasonable expectation of success for the claimed substitution, as Dahlqvist’s binding data are generated in a different chemical context and do not establish predictable structure-activity equivalence across unrelated scaffolds; there is no teaching the pyrazole substitution preserves or improves galactin-3 inhibition within Jalagam’s specific compounds; and at most Dahlqvist shows that chaining heterocycles can significantly alter binding behavior which reinforces the unpredictability of such modifications, see Applicant’s remarks, pp. 25-26, paragraph #3.
(F) In carbohydrate-based galectin ligands, attachment position, and molecular geometry substantially influence galectin binding and affinity, and neither Jalagam nor Dahlqvist alone or in combination teach or suggest that the presently claimed specific structural arrangement would have been routine or predictable, see Applicant’s remarks, pg. 26, paragraph #4, first-third paragraph.
With respect to Applicant’s arguments (B)-(F), the Examiner reiterates their arguments above and further notes Dahlqvist is not relied upon for teaching a pyrazole which is directly attached to the galactopyranose ring at the claimed A1 position of formula (1) as recited within instant claim 16.
As the Examiner particularly notes Jalagam teaches the compound of formula (I) as recited in claim 16 with the exception of the pyrazole being directly connected to the galactopyranose ring as depicted in A1 of formula (I) as recited in claim 16.
Accordingly, the Examiner further notes Jalagam teaches their compounds inhibit galaectin-3 and is therefore why one of ordinary skill in the art would have used Dahlqvist to modify the compounds of Jalagam; as Dahlqvist already teaches substituting a triazole for a pyrazole on the galactopyransoyl ring as exemplified by the C1 position of Dahlqvist, and when substituted the pyrazole lowers the dissociation constant (e.g. strengthens the binding affinity) when compared to the triazole when said compounds bind to galectin-3 as discussed in Table 1 of Dahlqvist.
Furthermore, the Examiner notes Jalagam teaches Ar1 of Formula (I) can be either a pyrazolyl or a triazolyl, see pg. 4, lines 20-30; which the Examiner notes Ar1 of Formula (I) of Jalagam corresponds to the anomeric carbon (C1) of the galactopyranose ring of the compounds taught by Dahlqvist.
Therefore, the prior art references teach substituting a triazole for a pyrazole connected via the galactopyranose ring as a known consideration and modification; and thus, the Examiner reasonably considers the substitution of the triazole at the C-3 position of the galactopyranose ring present on the compounds of Jalagam for a pyrazole as taught and exemplified at the C-1 position of the galactopyranose ring of the compounds of Dahlqvist above is obvious to one of ordinary skill in the art by ring hopping the pyrazole taught on the galactopyranose ring at the C-1 carbon of the compounds of Dahlqvist to the C-3 carbon of the galactopyranose ring of the compounds of Jalagam absence secondary considerations in view of the reasons discussed above as Jalagam’s compounds are drawn to inhibit galacetin-3 as discussed in the maintained 103 rejection below.
Thus, Applicant’s arguments (A)-(F) have been fully considered but are not found persuasive.
Claim Rejections - 35 USC § 103
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.
Claims 16-28 remain rejected under 35 U.S.C. 103 as being unpatentable over Jalagam et al. (Published 04 April 2019, WO-2019067702-A1, IDS filed 06/23/2023) in view of Dahlqvist et al. (Published 18 April 2019, ACS Omega, Vol. 4, Issue 4, pp. 7047-7053, PTO-892 mailed 11/14/2025).
Regarding claims 16-20, 22-25 and 27-28, Jalagam teaches compounds of formula (I) which inhibit galectin-3 (Gal-3) and includes pharmaceutically acceptable salts, compositions comprising such compounds and methods of using and making such compounds and compositions, see pg. 2, lines 5-10.
Jalagam teaches a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier (e.g. the pharmaceutical composition, required in claim 27), see pg. 13, lines 19-22.
Jalagam teaches treating liver fibrosis comprising administering a compound of formula (I) to a patient (e.g. the method, required in claim 28), see pg. 14, lines 20-25; in a therapeutically effective amount, pg. 453, claim #14 – pg. 454, paragraph 1.
Jalagam teaches a compound of formula (I) depicted as the general formula,
PNG
media_image1.png
221
229
media_image1.png
Greyscale
, see pg. 2, lines 10-15, where R1 is Ar2, see pg. 2, lines 15-20, wherein Ar2 is selected from and including phenyl (e.g. C1 is phenyl, required in claims 16-18) and pyridinyl (e.g. C1 is pyridinyl, required in claims 16-17 and 19-20), and is substituted with 0-5 substituents selected from and including halo, see pg. 4, lines 30-31.
Jalagam teaches Ar1 is selected from and including a triazolyl (e.g. B1 is triazolyl, required in claims 22-23) and is substituted with 0-3 substituents selected from and including haloalkyl, see pg. 4, lines 20-25.
Jalagam teaches R2 is selected from and including hydroxy (e.g. R1 is OH, required in claims 24-25), see pg. 2, lines 15-20.
Jalagam exemplifies a compound of formula I selected from the group consisting of and including the following structure,
PNG
media_image2.png
175
374
media_image2.png
Greyscale
, see pg. 7, line 24, first recite compound.
Although, Jalagam does not teach (a) the pyrazole ring directly connected to the galactopyranose ring as depicted in A1 of formula (I) of claims 16 and 21; and (b) exemplifies the compound recited in claim 26.
However, in the same filed of endeavor of galectin-3 inhibitors, Dahlqvist teaches the synthesis, evaluation of galectin affinities, and computational modeling of galectin inhibitors based on four different C1-heterocycles including triazoles and pyrazoles and led to the discovery that the C1-heterocycle structure and substitutions significantly influence the selectivity and affinity for galectins, see pg. 7048, left column, paragraph 1.
Dahlqvist exemplifies synthesis of C1-Heteroaryl galactosides 1-4, where compound 1 contains a triazole directly connected to the galactopyranose ring and compound 4 contains a pyrazole directly connected to the galatopyranose ring, see pg. 7048, scheme 1, compound 4.
Dahlqvist teaches dissociation constants (Kd in µM) of the triazole (compound 1) and the pyrazole (compound 4) when binding to galectin-3, wherein the pyrazole of compound 4 has consistently lower dissociation constants for binding galectin-3 when compared to the dissociation constants of the triazole of compound 1 for binding galectin-3, see pg. 7049, Table 1.
Dahlqvist teaches the triazoles 1a-1c turned out to be selective for galectin-1, however, the pyrazoles 4a-4c had almost no selectivity between galectin-1 and galectin-3, with noteworthy affinities toward any galectin, see pg. 7048, right column, last paragraph of the column – pg. 7049, left column, first paragraph.
The Examiner respectfully notes when the triazole ring of the exemplary compound of Jalagam depicted above is substituted for a pyrazole ring as taught by Dahlqvist above, the result of these combined teachings of Jalagam and Dahlqvist correspond to the compound of 1-{5-{3-[4-(4-Chloro-3,5-difluorophenyl)-1H-1,2-pyrazol-1-yl]-3-deoxy-p-D-galactopyranosyl}-3-methyl-1H-1,2,4-triazol-1-yl}-5-chloro-2-(trifluoromethyl)benzene, which is recited in claim 26, pg. 14, lines 1-2.
It would have been prima facie obvious to one of ordinary skill in the art before the invention’s effective filling date to have modified the triazole within formula (I) of Jalagam depicted above for a pyrazole as taught by Dahlqvist above as a simple substitution of a nitrogen atom (e.g. -N=) on the triazole ring of formula (I) of Jalagam for a carbon atom (e.g. -CH=) on the pyrazole ring of compound 4 of Dahlqvist as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have had a particular motivation to make the substitution discussed above as Dahlqvist teaches the pyrazoles 4a-4c had almost no selectivity between galectin-1 and galectin-3, with noteworthy affinities toward any galectin, and where pyrazoles of compound 4 specifically demonstrated lower dissociation constants (Kd) for galectin-3 when compared to the triazoles of compound 1; and thus the lower dissociation constants taught by Dahlqvist above demonstrate galectin-3 has a stronger binding affinity for the pyrazoles of compound 4 than the triazoles of compound 1 of Dahlqvist as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success to make this substitution as both Jalagam and Dahlqvist teach the synthesis of galactopyranose compounds as galacetin-3 inhibitors as discussed above.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included limitations (a)-(b) into the compounds of formula (I) of Jalagam above by using the teachings of Dahlqvist as a simple substitution of one known element for another as within the scope of the artisan by combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to include limitations (a)-(b) into the compounds of formula (I) of Jalagam above, as Jalagam is specifically drawn to compounds which inhibit galectin-3 (Gal-3) as discussed above, and wherein Dahlqvist demonstrates galectin-3 has a stronger binding affinity for the pyrazoles of compound 4 than the triazoles of compound 1 based on Kd binding affinity data screened against galectin-3 as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated limitations (a)-(b) into the compounds of formula (I) of Jalagam above, as Dahlqvist exemplifies synthesis of C1-Heteroaryl galactosides 1-4, wherein compound 4 contains a pyrazole directly connected to the galatopyranose ring as discussed above; and Jalagam teaches making compounds of formula (I) as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
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.
(I) Claims 16-17, 19-23, 24-25 and 27-28 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 10-11 of U.S. Patent No. 12,441,755 (Applicant: Galecto Biotech AB, PTO-892 mailed 11/14/2025) in view of Dahlqvist et al. (Published 18 April 2019, ACS Omega, Vol. 4, Issue 4, pp. 7047-7053, PTO-892 mailed 11/14/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a D-galactopyranose compound of formula (I).
Reference claim 1 recites a D-galactopyranose compound of formula (I) depicted as,
PNG
media_image3.png
427
458
media_image3.png
Greyscale
, wherein Het1 is a five or six membered heteroaromatic ring selected from the group consisting of and including
PNG
media_image4.png
159
152
media_image4.png
Greyscale
, wherein R20 to R23 are each independently selected from and including H and halogen; R1 is selected from the group consisting of and including H and OH.
Reference claim 4 recites B1 is selected from the group consisting of and including a triazolyl, optionally substituted with a group selected from and including a C1-C6 alkyl with one or more halogen.
Reference claim 10 corresponds to instant claim 27.
Reference claim 11 corresponds to instant claim 28.
Although, ‘755 does not recite the pyrazole ring directly connected to the galactopyranose ring as depicted in A1 of formula (I) of instant claims 16 and 21.
However, in the same field of endeavor of compounds that bind to galectin-1 and/or galectin-3, Dahlqvist teaches the synthesis, evaluation of galectin affinities, and computational modeling of galectin inhibitors based on four different C1-heterocycles including triazoles and pyrazoles which led to the discovery that the C1-heterocycle structure and substitutions significantly influence the selectivity and affinity for galectins, see pg. 7048, left column, paragraph 1.
Dahlqvist exemplifies synthesis of C1-Heteroaryl galactosides 1-4, where compound 1 contains a triazole directly connected to the galactopyranose ring and compound 4 contains a pyrazole directly connected to the galatopyranose ring, see pg. 7048, scheme 1, compound 4.
Dahlqvist teaches dissociation constants (Kd in µM) of the triazole (compound 1) and the pyrazole (compound 4) when binding to galectin-3, wherein the pyrazole for compound 4 has consistently lower dissociation constants for binding galectin-3 when compared to the dissociation constants of the triazole of compound 1 for binding galectin-3, see pg. 7049, Table 1.
Dahlqvist teaches the triazoles 1a-1c turned out to be selective for galectin-1, however, the pyrazoles 4a-4c had almost no selectivity between galectin-1 and galectin-3, with noteworthy affinities toward any galectin, see pg. 7048, right column, last paragraph of the column – pg. 7049, left column, first paragraph.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention’s effective filling date to have modified the triazole within formula (I) of ‘755 depicted above for a pyrazole as taught by Dahlqvist above as a simple substitution of a nitrogen atom (e.g. -N=) on the triazole ring of formula (I) of ‘755 for a carbon atom (e.g. -CH=) on the pyrazole ring of compound 4 of Dahlqvist as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have had a particular motivation to make the substitution discussed above as Dahlqvist teaches the pyrazoles 4a-4c had almost no selectivity between galectin-1 and galectin-3, with noteworthy affinities toward any galectin, and where pyrazoles of compound 4 specifically demonstrated lower dissociation constants (Kd) for binding galectin-3 when compared to the triazoles of compound 1; and therefore the lower dissociation constants taught by Dahlqvist above demonstrate galectin-3 has a stronger binding affinity for the pyrazoles of compound 4 than the triazoles of compound 1 of Dahlqvist as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success to make this substitution as both ‘755 recites and Dahlqvist teaches galactopyranose compounds that bind galectin-1 and/or galacetin-3 as discussed above.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the substitution discussed above into the compounds of formula (I) of ‘755 by using the teachings of Dahlqvist as a simple substitution of one known element for another as within the scope of the artisan by combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to include the substitution discussed above into the compounds of formula (I) of ‘755 above, as ‘755 is specifically drawn to compounds which bind to galectin-1 and/or galectin-3 as discussed above, and wherein Dahlqvist demonstrates galectin-3 has a stronger binding affinity for the pyrazoles of compound 4 than the triazoles of compound 1 based on Kd binding affinity data screened against galectin-3 as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the substitution discussed above into the compounds of formula (I) of ‘755 above, as Dahlqvist exemplifies synthesis of C1-Heteroaryl galactosides 1-4, wherein compound 4 contains a pyrazole directly connected to the galatopyranose ring as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of ‘755 and the teachings of the prior art.
(II) Claims 16-17, 19-22, 24-25 and 27-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 27-28 of copending Application No. 18/257,382 (Applicant: Galecto Biotech AB, amended claim set filed 01/24/2024) in view of Dahlqvist et al. (Published 18 April 2019, ACS Omega, Vol. 4, Issue 4, pp. 7047-7053, PTO-892 mailed 11/14/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a D-galactopyranose compound of formula (I).
Reference claim 1 recites a D-galactopyranose compound of formula (I) depicted as,
PNG
media_image5.png
364
562
media_image5.png
Greyscale
, wherein Het1 is a five or six membered heteroaromatic ring selected from the group consisting of and including
PNG
media_image6.png
170
134
media_image6.png
Greyscale
, wherein R20 to R23 are independently selected from and including H and halogen; R1 is selected from the group consisting of and including OH; and B1 is a pyrazol.
Reference claim 27 corresponds to instant claim 27.
Reference claim 28 corresponds to instant claim 28.
Although, ‘382 does not recite the pyrazole ring directly connected to the galactopyranose ring as depicted in A1 of formula (I) of instant claims 16 and 21.
However, in the same field of endeavor of compounds that bind to galectin-1 and/or galectin-3, Dahlqvist teaches as discussed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention’s effective filling date to have modified the triazole within formula (I) of ‘382 depicted above for a pyrazole as taught by Dahlqvist above as a simple substitution of a nitrogen atom (e.g. -N=) on the triazole ring of formula (I) of ‘382 for a carbon atom (e.g. -CH=) on the pyrazole ring of compound 4 of Dahlqvist as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have had a particular motivation to make the substitution discussed above as Dahlqvist teaches the pyrazoles 4a-4c had almost no selectivity between galectin-1 and galectin-3, with noteworthy affinities toward any galectin, and where pyrazoles of compound 4 specifically demonstrated lower dissociation constants (Kd) for binding galectin-3 when compared to the triazoles of compound 1; and therefore the lower dissociation constants taught by Dahlqvist above demonstrate galectin-3 has a stronger binding affinity for the pyrazoles of compound 4 than the triazoles of compound 1 of Dahlqvist as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success to make this substitution as both ‘382 recites and Dahlqvist teaches galactopyranose compounds that bind galectin-1 and/or galacetin-3 as discussed above.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the substitution discussed above into the compounds of formula (I) of ‘382 by using the teachings of Dahlqvist as a simple substitution of one known element for another as within the scope of the artisan by combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to include the substitution discussed above into the compounds of formula (I) of ‘382 above, as ‘382 is specifically drawn to compounds which bind to galectin-1 and/or galectin-3 as discussed above, and wherein Dahlqvist demonstrates galectin-3 has a stronger binding affinity for the pyrazoles of compound 4 than the triazoles of compound 1 based on Kd binding affinity data screened against galectin-3 as discussed above.
One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the substitution discussed above into the compounds of formula (I) of ‘382 above, as Dahlqvist exemplifies synthesis of C1-Heteroaryl galactosides 1-4, wherein compound 4 contains a pyrazole directly connected to the galatopyranose ring as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of ‘382 and the teachings of the prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed in this action.
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 JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights