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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a compound that is (3,5-dibromo-4-hydroxyphenyl)(6-hydroxy-2-(1-hydroxyethyl)benzofuran-3-yl-4,5,7-d3)methanone having the structure:
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, and a pharmaceutical composition comprising the compound is maintained.
Claims 5, 8-14, 16, and 33-36 remain withdrawn and claims 2-4 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Please note claims 2-4 and 7 are directed to a compound species non-elected.
Action Summary
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on June 17, 2025, wherein claim 2 is amended; claims 1, 3-5, 7-14, 16, 33-36 and 38 are unchanged; and claims 6, 15, 17-32, 37, and 39-63 are canceled.
Claims 1-4, 7 and 38 rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (WO 2018/017368 A1) are maintained, but revisited and modified in light of the claim amendment.
Claims 1-4, 7 and 38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 11,236,058 B2 (referred to herein as ‘058 patent), in view of Yan et al. (WO 2018/017368 A1) are maintained, but revisited and modified in light of the claim amendment.
Claims 1-4, 7 and 38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/757,212 (reference application; referred to herein as ‘212 application), in view of Yan et al. (WO 2018/017368 A1) are withdrawn in view of the abandonment of the ‘212 application.
The rejection of claims 2-4 and 7 set forth in the previous Non-Final Office Action mailed on November 18, 2024 are withdrawn, because the claims are directed to a compound species non-elected.
Status of Claims
Claims 1-5, 7-14, 16, 33-36, and 38 are pending.
Claims 5, 8-14, 16, and 33-36 remain withdrawn. Claims 2-4 and 7 are withdrawn.
Claims 1 and 38 are under examination in accordance to the elected invention and species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 17, 2025 was filed after the mailing date of the Non-Final Office Action on December 18, 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Please note that foreign references without an English translation but that have an English
translation of the abstract will only have the abstract considered by the Examiner.
Priority
The instant application 17/610,673 filed on November 11, 2021 is a 371 of PCT/US2020/032725 filed on May 13, 2020, which claims priority to, and the benefits of U.S. Provisional Application No.
62/847,519 filed on May 14, 2019.
Declarations
The declaration under 37 CFR 1.132 filed on June 17, 2025 is insufficient to overcome the rejection of record as set forth in the last Office action and the reasons are addressed in the response to arguments set forth below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1 and 38 remain rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (WO 2018/017368 A1; cited under “Foreign Patent Documents”, cited no. 008 in the IDS filed on February 15, 2022).
Yan et al. is available as prior art under 35 U.S.C § 102(a)(1) as its publication date of January 25, 2018 and under 35 USC § 102(a)(2) as its effectively filing date of July 18, 2016.
Yan et al. teaches a compound of formula 27: 2,6-dibromo-4-[2-(1-hydroxyethyl) ( 4,5,6,7-2H4)-1-benzofuran-3-carbonyl]phenol, having the structure shown as follows:
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(see e.g., p. 10, Formula 27; [0035]). Yan et al. further teaches a formulation including a therapeutic effective amount of the compound is useful for treating a condition associated with hyperuricemia or gout (see e.g., [0035]). Yan et al. further teaches the compound represented by Formula I
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, wherein X can be, inter alia, -OH; R1, R2, R3, R4 and R5 can each independently be, inter alia, H, deuterium, and hydroxyl (see e.g., [0024]-[0025]). Yan et al. further teaches a composition comprising a pharmaceutically acceptable carrier and a compound of formula I or a pharmaceutically acceptable salt thereof (see e.g., [00108]), and the composition is useful for the treatment of a condition associated with hyperuricemia or gout (see e.g., [0037]).
The difference between the compound of formula 27 of Yan et al. and the elected compound species lies on the R2 substituent of Yan et al. (equivalent to R3 of Formula [I] instantly claimed) circled as follows:
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.
Even though Yan et al. does not teach the elected compound species, it would have been prima facie obvious for one of ordinary skill in the art at the time the application was filed to select a compound of formula 27 of Yan et al., and then modify the said compound by substituting the deuterium atom with a hydroxyl (-OH) group at the position of R2 of Formula I. One would have been motivated to do so, because Yan et al. clearly teaches a list of suitable R2, including deuterium and hydroxyl, that can arrive a compound, and a composition comprising the compound useful for treating a condition associated with hyperuricemia or gout. One would have reasonably expected that the modified compound of formula 27 would have exerted the same or substantially similar biological activity as the compound of formula 27, thus, incorporate the said compound into the pharmaceutical composition with a pharmaceutically acceptable carrier would be similarly useful.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on June 17, 2025 with respect to the rejection of claims 1-4, 7 and 38 rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (WO 2018/017368 A1) have been fully considered but they are not persuasive.
All rejections pertaining to claims 2-4 and 7 are withdrawn and moot, because these claims are withdrawn as they are directed to a compound species non-elected.
In Summary, applicant argues one of ordinary skill in the art would not have a reasonable expectation of success to arrive at the claimed invention, because none of the exemplified compounds taught by Yan et al. contain a hydroxyl group at the R2 position of Formula 1 taught by said prior art; and hydroxyl group is not taught in the preferred embodiments. Applicant further argues the claimed compound (referred to therein as compound 1) exhibits unexpected results by directing attention to the additional experimental data supported by the declaration under 37 CFR 1.132 filed on June 17, 2025. Specifically, in view of the declaration, applicant argues that after administering the compound of Formula 27 of Yan et al. (referred to therein as parent compound) at a dose of 25 mg, 50 mg, and 75 mg once daily for 10 days, the claimed compound gradually increased to peak concentration and slowly decline with a long half-life of 16-22 hours; has a Cmin/Cmax ratio between 0.48-0.55 that helps avoid a sharp turnover; and reduce serum urate acid over 24 hours as a single dose.
In response, applicant’s argument is not found persuasive for the reasons set forth below:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, the examiner recognized that “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)”. It may well be true that Yan et al. does not specifically exemplify a compound species with a hydroxyl group at the R2 position of Formula 1. However, Yan et al. clearly teaches a compound of Formula 27 having the structure of:
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is a compound of Formula 1 (see e.g., p. 10, Formula 27; [0035]); and further teaches the compound of Formula 1:
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, wherein -R2 is selected from a group consisting of, inter alia, -deuterium and -hydroxyl in a broader disclosure (see e.g., claim 1). In other words, the teachings of Yan et al. reasonably suggested that deuterium and hydroxyl are interchangeable at R2 position of Formula 1; and therefore, one would have a reasonable expectation of success to arrive at the claimed invention by modifying the compound of Formula 27 in view of the nonpreferred embodiments. According to MPEP 2123, “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)”.
In response to applicant's argument that the claimed compound exhibits unexpected results supported by the declaration under 37 CFR 1.132 filed on June 17, 2025, the experimental data/working example disclosed in the declaration does not appear to be a true comparison between the claimed invention (compound 1) with the closest prior art (compound of Formula 27 of Yan et al., equivalent to parent compound). In the declaration under 37 CFR 1.132 filed on June 17, 2025, applicant noted that the claimed invention (compound 1) is an active metabolite of the compound of Formula 27 of Yan et al. The examiner noted that in the working example provided therein (see declaration), applicant only administered the compound of Formula 27 of Yan et al. to healthy subjects and noted that the PK/PD profile of the claimed invention is better than the closest prior art. However, in the working example, there is no direct or indirect comparison of the claimed invention with the closest prior art. In other words, the experimental data does not compare the half-life of the claimed invention with the compound of Formula 27 of Yan et al. and/or compare the serum urate acid (sUA) lowering effect of the claimed invention with the compound of Formula 27 of Yan et al. In addition, even though the line graphs in Figure 2 of said declaration labeled the lines with “compd 1 effect” or “parent compd effect”, the title of said figure noted that only the compound of Formula 27 of Yan et al. is being administered to healthy subject; therefore, it is not clear what “compd 1 effect” is referring to if compound 1 is not being administered.
Therefore, the rejection is maintained for the same reasons of record and for the reasons set forth herein, but revisited and modified in light of the amendment.
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 and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 11,236,058 B2 (referred to herein as ‘058 patent), in view of Yan et al. (WO 2018/017368 A1; cited under “Foreign Patent Documents”, cited no. 008 in the IDS filed on February 15, 2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘058 patent is drawn to a compound of Formula (I) that renders obvious the elected compound species.
In the present case, the claims of ‘058 patent teaches a compound of Formula 1, or a pharmaceutically acceptable thereof, wherein:
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X is -OH (see claim 2); -R5 is -H (see claim 3); -R1, -R2, -R3, and -R4 are each independently selected from a group consisting of -H, -deuterium, -F, -Cl, -C1-C6-alkyl, and -hydroxyl; and wherein at least one of -R1, -R2, -R3, -R4 and -R5 is deuterium (see claim 1). The claims of ‘058 patent is further drawn to a pharmaceutical composition comprising: a pharmaceutically acceptable carrier and a compound of claim 1, or a pharmaceutically acceptable salt thereof (see claim 6). The claims of ‘058 patent is further drawn to a method of treating hyperuricemia or gout in a mammal, comprising administering to the mammal a therapeutically effective amount of a compound of claim 1, or a pharmaceutically acceptable salt thereof (see claim 7).
The claims of ‘057 patent does not teach the elected compound species
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Yan et al. teaches a compound of formula 27: 2,6-dibromo-4-[2-(1-hydroxyethyl)( 4,5,6,7-2H4)-1-benzofuran-3-carbonyl]phenol, having the structure shown as follows:
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(see e.g., p. 10, Formula 27; [0035]). Yan et al. further teaches a formulation including a therapeutic effective amount of the compound is useful for treating a condition associated with hyperuricemia or gout (see e.g., [0035]). Yan et al. further teaches the compound represented by Formula I
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, wherein X can be, inter alia, -OH; R1, R2, R3, R4 and R5 can each independently be, inter alia, H, deuterium, and hydroxyl (see e.g., [0024]-[0025]). Yan et al. further teaches a composition comprising a pharmaceutically acceptable carrier and a compound of formula I or a pharmaceutically acceptable salt thereof (see e.g., [00108]), and the composition is useful for the treatment of a condition associated with hyperuricemia or gout (see e.g., [0037]).
Even though the claims of ‘058 patent does not teach the elected compound species, the claims of ‘058 patent teaches a compound of Formula 1, wherein X is -OH and -R5 is -H. It would have been prima facie obvious for one of ordinary skill in the art at the time the application was filed to arrive the elected compound species by particularly selecting deuterium atom at the R1, R2, R3, and R4 position, and then replacing one of the deuterium atoms with the hydroxyl at the R2 position, because Yan et al. clearly gives a suggestion to select deuterium at the position of the elected compound species, and a hydroxyl group at the R2 position of the Formula I. One would have been motivated to do so in order to arrive a compound useful for treating a condition associated with hyperuricemia or gout, as taught by Yan et al. One would have reasonably expected that the compound of ‘058 patent and Yan et al. would have exerted the same or substantially similar biological activity as the compound of formula 27 of Yan et al., thus, incorporate the said compound into the composition with a pharmaceutically acceptable carrier would be similarly useful.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on June 17, 2025 with respect to the rejection of claims 1-4, 7 and 38 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 11,236,058 B2 (referred to herein as ‘058 patent), in view of Yan et al. (WO 2018/017368 A1)
have been fully considered but they are not persuasive.
All rejections pertaining to claims 2-4 and 7 are withdrawn and moot, because these claims are withdrawn as they are directed to a compound species non-elected.
In response, since Applicant presents the same arguments with respect to Yan et al. in the rejections under 35 U.S.C. § 103 set forth above, the argument is not persuasive for the same reasons set forth above and applied as before. Therefore, the rejection is maintained for same reasons of record and for the reasons set forth herein, but revisited and modified in light of the claim amendment.
Conclusion
No claims are allowed.
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 Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628