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 .
DETAILED ACTION
Status of the Claims
Claims 1-3, 5-12, 14-19 and 21-25 currently pending. Claims 22-25 are withdrawn. Claims 9-12, 14-19 and 21 are rejected. Claims 1-3 and 5-8 are allowed.
Response to Amendment/Arguments
The amendment filed 02/02/2026 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
35 USC § 112 Rejections
The rejection of claims 2, 10 and 18 under 35 USC 112 has been overcome by the amendments to said claims. The rejection has been withdrawn.
35 USC § 103 Rejection
The rejection of claims 1-3, 5 and 7-8 under 35 USC 103 for being obvious over the prior art has been overcome by the amendments to said claims. The rejection has been withdrawn. The separate rejection of claim 6, which depends from claim 1, has also been withdrawn.
Applicant’s arguments with respect to the rejection of claims 9-12, 14-19 and 21 under 35 USC 103 for being obvious over Hoffman et al. in US 3,415,834 in view of Hainer et al. in “Diagnosis, Treatment, and Prevention of Gout”, American Family Physician, Vol. 90, No. 12, December 15, 2024, pp. 831-836 have been fully considered but are not persuasive.
Regarding claims 9-12 and 14-16, Applicant argues that the references do not teach urate-lowering therapies using niflumic acid,
PNG
media_image1.png
100
190
media_image1.png
Greyscale
, particularly with respect to treatment of gout. As stated in the Office Action dated 11/04/2025 on page 7, Hoffman et al. teach a finite number of only 11 compounds closely related to the structure of niflumic acid. While niflumic acid was not tested for the treatment of gout or otherwise used to reduce serum uric acid levels in a subject, Example 1 (2-(2,3-xylylamino)nicotinic acid) was tested for this purpose. Since Hoffman advises that all 11 compounds “have analgesic and anti-inflammatory effects and may be used in the treatment of, for example, gout” (see col. 1, lines 66-68), it would be obvious to try using niflumic acid in the presently claimed method for reducing serum uric acid levels. Given the teachings of Hainer et al. that NSAIDs and allopurinol can prevent chronic gout (page 834, Table 4) and treat acute gout flares (page 835, left column, first full paragraph), a person having ordinary skill would have been motivated to use niflumic acid with allopurinol as presently claimed.
Regarding claims 17-19 and 21, drawn to a method of inhibiting xanthine oxidase activity in a cell using a composition comprising a disclosed compound, Applicant argues a person having ordinary skill in the art would not be motivated to do so. However, Hainer et al. teach allopurinol as a xanthine oxidase inhibitor and advises that NSAIDs should be used in conjunction with an NSAID during an acute gout flare. See for instance page 835, left column, first full paragraph:
PNG
media_image2.png
311
358
media_image2.png
Greyscale
. Since a person of ordinary skill would already have the disclosure from Hoffman et al. which teaches the use of Example VIII (i.e. niflumic acid) for the treatment of gout, they would be motivated to combine allopurinol with the NSAID niflumic acid for said treatment.
Scope of the Elected Invention
In accordance with the MPEP 803.02, examination of the Markush-type subject matter of claims 1-3 and 5-8 has been extended, as necessitated by amendment, to the scope of claim 1, which was not found allowable over the prior art.
Examination of claims 9-12, 14-19 and 21 was not extended since the claims remain obvious in view of the prior art cited in the Office Action dated 11/04/2025.
Claims 22-25 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Updated 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 9-12, 14-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffmann et al. in US 3,415,834, in view of Hainer et al., “Diagnosis, Treatment, and Prevention of Gout”, American Family Physician, Volume 90, No. 12, December 15, 2014, pp. 831-836, as cited in the IDS dated 05/14/2024.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Hoffmann et al. teach anti-inflammatory compounds of the formula
PNG
media_image3.png
123
226
media_image3.png
Greyscale
that may be used in the treatment of gout. See abstract; column 1, line 31; and column 1, lines 67-69. Example VIII is 2-(m-trifluoromethyl-anilino)nicotinic acid (see column 4, lines 46-49) which has the structure of niflumic acid:
PNG
media_image4.png
76
155
media_image4.png
Greyscale
. Hoffmann et al. teach a method of administering Example 1 to mice “intraperitoneally with 0.25 mL of an aqueous alcohol solution of phenyl-benzoquinone” at various dosages, see col. 5, lines 33-42. Hoffmann et al. also teach methods of administering an oral formulation of compound Example I, also called 2-(2,3-xylyamino)nicotinic acid, to subjects with gout. See column 6, lines 1-44.
Hainer et al. teach various considerations for the treatment and prevention of gout, including the use of nonsteroidal anti-inflammatory drugs (NSAIDs) as a first-line therapeutic for treatment of the disease (see page 833, right column, second paragraph and also Table 3 on the same page), and use of the xanthine oxidase inhibitor allopurinol for the prevention of chronic gout, due to its ability to lower serum uric acid levels. See page 834, Table 4 and also page 835, left column, last paragraph. Given the nonsteroid structure of niflumic acid, and its anti-inflammatory effects as taught by Hoffmann et al, it is an example of an NSAID.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Hoffmann et al. do not explicitly teach administering a composition comprising the non-elected species niflumic acid,
PNG
media_image4.png
76
155
media_image4.png
Greyscale
, to a subject for the treatment of gout or any other disease or condition associated with elevated serum uric acid levels.
Neither Hoffmann et al. nor Hainer et al. explicitly teach administering a composition comprising the non-elected species niflumic acid,
PNG
media_image4.png
76
155
media_image4.png
Greyscale
, to a subject for the treatment of gout or any other disease or condition associated with elevated serum uric acid levels.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
It would have been obvious to a person having ordinary skill in the art to use the known species niflumic acid,
PNG
media_image4.png
76
155
media_image4.png
Greyscale
, taught by Hoffmann et al. as a treatment for gout given Hoffmann’s teaching that related compound 2-(2,3-xylyamino)nicotinic acid is able to treat gout in a subject. Hoffmann et al. teach that the 11 disclosed examples “have analgesic and anti-inflammatory effects and may be used in the treatment of, for example gout…”. A skilled artisan would be motivated to make this substitution because Hoffmann et al. teach a finite list of 11 examples of nicotinic acids for the treatment of gout and related diseases with raised uric acid levels (see columns 2-5, Example I - XI), so it would have been obvious to try treating a subject using niflumic acid. This substitution would have been expected to yield the predictable results wherein niflumic acid would be used to treat gout in a subject, which is associated with elevated serum uric acid levels.
A skilled artisan would be motivated to combine niflumic acid and allopurinol in a composition for the treatment and prevention of gout because Hainer et al. teach that NSAIDS should not be used alone for long periods of time due to the build-up of urate acid crystals. They also encourage the concurrent use of a urate-lowering medication and an NSAID. See page 835, left column:
PNG
media_image5.png
336
382
media_image5.png
Greyscale
.
Therefore, claims 9-10, 12, 14-15 and 17-18 are obvious over the prior art.
Regarding dependent claim 11, drawn to a method further comprising selecting a subject having a disease or condition associated with elevated serum uric acid levels, the prior art demonstrates treating subjects with gout. Selecting a subject with gout is an expected and obvious part of treating subjects having gout. Therefore, claim 11 is obvious over the prior art.
Regarding dependent claims 16 and 21, drawn to a method wherein the pharmaceutical composition is substantially free from tetrazoles, triazoles, or solubility enhances for monosodium urate, the method described by Hoffmann et al. recite administering formulations wherein the cited substances are not included. Therefore, claims 16 and 21 are obvious over the prior art.
Regarding dependent claim 19, drawn to a method wherein the contacting is performed in vivo or in vitro, the methods described by Hoffmann et al. (see col. 6) were performed in living humans. Therefore, claim 19 is obvious over the prior art.
Conclusion
Claims 1-3 and 5-8 are allowed. Claims 9-12, 14-19 and 21 are rejected. Claims 22-25 remain withdrawn.
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 extension fee 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 date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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, Amy L. Clark can be reached on (571) 272-1310. 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.
/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
Prosecution Insights