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) dated September 16, 2025 was in compliance with 37 CFR 1.97 and 1.98. Accordingly, the IDS was considered and a signed copy of the 1449 form is attached.
STATUS OF CLAIMS
Claims 1, 8-10, 14-15 and 18-22 are currently pending in the instant application according to the Claim Amendment submitted on September 17, 2025.
RESPONSE TO REMARKS AND AMENDMENTS
Applicant’s remarks and amendments filed September 17, 2025 have been entered and are considered herein.
Applicant’s amendment to import the limitations of claims 2, 12, 13 and 16 into claim 1 was sufficient to overcome the rejection under 35 USC 102. Claims 2 and 12 were not included in the novelty rejection, so their incorporation into claim 1 is sufficient to overcome the finding of anticipation.
With respect to the rejection under 35 USC 103, Applicants traverse the rejection on several grounds as it pertains to the claims as amended. The traversals were considered but were not found persuasive to overcome the rejection. Applicants first argue that in order to arrive at the claimed invention, the person of ordinary skill in the art would have to make five selections from within the disclosure of the prior art reference. However, the examiner maintains that the references contain the requisite level of disclosure to select each required option as recited by the claimed method. As cited in MPEP 2141.02(VI), In re Fulton (73 USPQ2d 1141) states the following passage at 1146: “The prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed in the ′198 application. Indeed, in the case cited by appellants, In re Gurley, we held that the invention claimed in the patent application was unpatentable based primarily on a prior art reference that disclosed two alternatives, one of which was the claimed alternative. Accordingly, mere disclosure of alternative designs does not teach away”.
The compounds disclosed for use in the ‘368 publication represent a finite number of predictable solutions, where the compound of Formula 27 (identical to the compound of the instant claims) is explicitly taught as being useful for the purpose described therein. The disclosure of alternative embodiments would not dissuade or take away from the motivation to select the compound for therapeutic use as described in the ‘368 publication.
Similarly, the dosage is described in its most preferable range as being from 0.1 to 50 mg/kg/day and the dosing regiment is described as ranging from 1-4 times per day, for example (‘368 paragraph [0050]). As described in the rejection, selecting and optimizing from within an art-disclosed range, especially one indicated as being preferred, is not considered inventive. MPEP 2144.05(I) provides that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention).
With respect to the claimed oral formulation, oral formulations of the prior art compounds are singularly disclosed at paragraph [00101].
With respect to the selection of chronic kidney disease for treatment, the rationale for the selection was provided in the original rejection based on the combined teachings with the ‘539 publication, where chronic kidney disease is explicitly taught as a condition associated with hyperuricemia or gout.
Finally, with respect to the data described in Example 4, Table 3, and reference in Applicant’s remarks, it is noted that the data provides evidence that the compound in the claimed dosage is expected to be useful for the claimed purpose, but no data providing that the compound or dosage amount would be considered unexpectedly useful when compared to another disclosed compound or a dosage falling outside the claimed range, for example. The data seems to suggest that the compound would perform the therapeutic function expected, namely treating a condition associated with hyperuricemia and gout (CKD) with a known compound in a dosage selected from the art-disclosed range.
Accordingly, the claims are maintained to be obvious over the teachings of the ‘368 and ‘539 publications, as set forth herein.
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.
Claim(s) 1, 8-10, 14-15 and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/017368 (“the ‘368 publication”) in view of WO 2020/070539 (“the ‘539 publication”).
Determining the scope and contents of the prior art
The ‘368 publication discloses a method for treating a condition associated with hyperuricemia comprising administering a compound of the formula
PNG
media_image1.png
125
132
media_image1.png
Greyscale
, and in particular as it pertains to the instantly claimed method, the administration of the compound 27 (paragraph [0035]), which is identical to the compound recited in the instant claims. As it pertains to the instantly claimed method, the prior art teaches the embodiment of treating hypertension as the condition associated with hyperuricemia to be treated (paragraph [0046]). As disclosed by the prior art, the recitation of administration of a compound therein refers to the act of providing the compound to a subject in need of treatment (paragraph [0090]). The prior art teaches oral dosage forms as recited in instant claim 13 (paragraph [0048]). Claims 14-15 pertain to whether or not food is consumed with the administration. As the prior art is silent in this respect, it is taken as a teaching of the method under either circumstance. the prior art teaches that the dose is normally administered, for examples 1-4 times a day of 2-4 times a day (either recitation anticipated instant claims 16 and 17, respectively). With respect to claims 18-20, the ‘368 publication teaches administration with one or more xanthine oxidase inhibitors such as allopurinol, oxypurinol, febuxostat, topiroxostat, inositols and a compound of Formula 1 (paragraph [0058]).
Ascertaining the differences between the prior art and the claims at issue
The difference between the instant invention and the prior art is that the prior art does not teach a specific example where chronic kidney disease is treated by administering an oral formulation with the particular dosage details listed in the claim.
With regard to claims 21-22, the ‘368 publication does not exemplify administration with a further active ingredient having SGLT2 activity.
Resolving the level of ordinary skill in the pertinent art
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
The ‘539 publication discloses that both chronic kidney disease and heart failure are diseases known to be associated with hyperuricemia. Accordingly, it would not have been considered inventive for the skilled artisan to follow the explicit suggestion of the prior art to treat diseases known in the art to be associated with hyperuricemia when the primary reference discloses such diseases to be treatable by the compounds described therein. Doing so would have been obvious because a person of ordinary skill in the art would recognize that both conditions are known to each be treatable by Compound 27.
With respect to the dosages in claims 8-12, the art describes that typically 20-75 mg/day, 50-250 mg/day or 100-200 mg/day should be administered, each of which overlaps with the ranges recited by the instantly claimed methods. MPEP 2144.05(I) provides that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). Thus, the prior art ranges render the dosages of the instant claims obvious.
Accordingly, based on the teachings of the MPEP and KSR above, by employing the rationale in (B), (D), (E) or (G) above, it would have been obvious for one of ordinary skill in the art to treat chronic kidney disease or heart failure in view of the combined teachings of the ‘368 publication and the ‘539 publication. The ‘368 publication discloses the use of the instant compound for treating diseases associated with hyperuricemia, and the ‘549 publication teaches that such diseases associated with hyperuricemia are inclusive of chronic kidney disease and heart failure. Therefore, when selecting a patient population to treat other conditions known to be associated with hyperuricemia, as disclosed by the primary reference, it would have been obvious to conduct the treatment method on a patient having chronic kidney disease or heart failure to be treated. There would have been a reasonable expectation of success in treating these diseases since the same Compound was already known in the art for the treatment of diseases associated with hyperuricemia, and the art also recognized the comorbidity of the diseases to be treated. The instantly claimed invention would have therefore been obvious to a person of ordinary skill before the filing of the instantly claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALICIA L OTTON whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
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, Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALICIA L OTTON/Primary Examiner, Art Unit 1699