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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 06/23/2023 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The preliminary amendment filed June 23, 2023 has been entered. Claims 1-15 are canceled. Claims 16-28 are new. Thus, claims 16-28 are examined on the merits herein.
Claim Objections
Claims 16-17, 26 and 28 are objected to because of the following informalities:
Claim 16, lines 10-11, recite “wherein R2 and R3 are independently selected from” which the Examiner notes improperly refers to multiple positions of -CONR2R3 within line 10. Thus, to promote clarity the Examiner suggests inserting the word “each” immediately before the word “independently” as discussed above.
The Examiner encourages the Applicant to review the entire claim set to see if there are additional instances where multiple positions are improperly referred to as exemplified above.
Claim 17, line 1, recites “the compound of a claim 16” which states a superfluous “a” before the phrase “claim 16”. Thus, to promote clarity the Examiner suggests deleting “a” as discussed above.
Claim 26, pg. 17, last line of the claim, recites “or solvat thereof”, which the Examiner reasonably interprets “solvat” is a misspelling of “solvate”. Thus, to promote clarity the Examiner suggests replacing “solvat” with “solvate” as discussed above.
The Examiner encourages the Applicant to review the entire claim set to see if there are additional instances of misspellings as exemplified above.
Claim 28, pg. 19, line 6 is missing the transitional word “and” before the phrase “peripheral nephropathy”. Thus, to promote clarity the Examiner suggests inserting the word “and” as discussed above.
Appropriate correction is required.
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 16-28 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.
(I) Claim 16 is drawn to a galactopyranose of formula (I) where A1 depicts a pyrazole ring. However, the claim recites in line 7 “the asterix * indicates the nitrogen atom of the triazole ring that is covalently attached to the galactopyranose”.
The Examiner respectfully notes A1 is a pyrazole ring (a 5-membered ring containing 2 nitrogen atoms and 3 carbon atoms) as depicted in line 6 of the claim, but is not a triazole ring (a 5-membered ring containing 3 nitrogen atoms and 2 carbon atoms) as recited in line 7 of the claim.
Thus, it is unclear and indefinite as to whether or not Applicant seeks to claim A1 is a pyrazole ring as depicted in line 6 of claim 16 or a triazole ring as recited within claim 16, line 7.
Claims 17-28 are included in this rejection as they depend from the galactopyranose recited in claim 16.
In the interest of compact prosecution the Examiner will interpret A1 is a pyrazole ring as depicted in line 6 of claim 16.
(II) Regarding claim 28, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 28, lines 7-8, recite “chronic autoimmune diseases in all organs (e.g. lung, liver, kidney, heart skin, muscle, gut)”; and
Claim 28, pg. 18, line 13, recites “e.g. neovascularization related to cancer”. The Examiner reasonably interprets the “e.g.” recited above is “for example”.
Claim 28, pg. 18, line 21, recites “including Hermansky-Pudlak syndrome”. The Examiner reasonable interprets the word “including” to mean “for example”.
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 are 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).
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,
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, 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,
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, 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 are 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) in view of Dahlqvist et al. (Published 18 April 2019, ACS Omega, Vol. 4, Issue 4, pp. 7047-7053, PTO-892). 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,
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, wherein Het1 is a five or six membered heteroaromatic ring selected from the group consisting of and including
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, 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 are 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). 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,
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, wherein Het1 is a five or six membered heteroaromatic ring selected from the group consisting of and including
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, 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.
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.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691