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 .
Response to Amendment
The amendments received 08/27/2026 have been entered. Claims 1, 3-4, 6-8, and 10-17 are pending. Any objection or rejection previously set forth in the Office Action mailed 05/28/2026 not maintained herein has been overcome and is withdrawn.
New grounds for rejection are set forth herein, as necessitated by amendment.
Claim Rejections - 35 USC § 112(b)
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.
Claim 16 is 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.
Claim 16 recites the limitation "the unit dose". There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to recite “in a unit dose” rather than “the unit dose”.
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.
Claim(s) 1, 3-4, 6-8, and 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gardam (CN111808098A; 2020; IDS filed 05/14/2024) in view of Chimenti et al. (Expert Opin. Pharmacother., 2015) and Solak et al. (Angiology; 2017). Examiner has attached an English translation of Gardam which is referred to herein. All references were cited in the previous office action mailed 05/28/2026.
Gardam discloses a method of treating inflammatory diseases in a mammal, such as a human, comprising administering Compound I (English translation, p. 12; original document, p. 7). Gardam discloses that Compound I is a PDE4 inhibitor (English Translation, p. 3-4).
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Compound I is identical in structure to Formula (Ia) as in the instant claims. Gardam additionally teaches that the inflammatory diseases to be treated include diabetes mellitus and psoriasis (English translation, p. 12). Gardam discloses that the compound can be administered in combination with other therapeutic agents to obtain a desired therapeutic effect (English translation, p. 11). Gardam discloses that the compound can be administered orally as tablets or capsules; at doses from 1 to 100 mg, 1 to 50 mg, 10 to 50 mg, 30 to 50 mg, 1 to 20 mg, 5 to 15 mg, 10 to 20 mg, or 20 to 30 mg; and at a period of once per day, twice per day, etc. according to the condition and subject to be treated (English translation, p. 10).
Gardam does not explicitly teach administering compound I for the treatment of psoriasis or the particularly claimed doses, schedules, or modes of administration. Gardam does not teach combining compound I with a uric acid-reducing agent. Gardam does not teach fasting serum uric acid levels in the individual on different days are higher than 420 umol/L. These limitations are obvious over Chimenti et al. and Solak et al.
Chimenti et al. teaches that apremilast, a PDE4 inhibitor (p. 2086, col. 1), has been approved for treatment of adult patients with psoriasis (Table 4; p. 2090) and has been investigated in multiple clinical trials demonstrating good tolerability and safety (p. 2089).
Solak et al. teaches that patients with psoriasis have elevated serum uric acid levels compared to the general population (Abstract).
It would have been prima facie obvious for one of ordinary skill in the art to substitute apremilast with Compound I for the treatment of psoriasis, a disorder associated with elevated serum uric acid levels. One would have been motivated to do so, with reasonable expectation of success, as Compound I and apremilast are taught to be equivalent in function as PDE4 inhibitors, wherein Compound I is additionally suggested by Gardam for use in treating psoriasis. One would therefore be apprised that substitution of agents that have equivalent functions would yield expected results.
It would have been prima facie obvious for one of ordinary skill in the art to combine Compound I with apremilast. One would have been motivated to do so, with reasonable expectation of success, as both agents are equivalent in function and have been indicated in their use for treatment of psoriasis. One would therefore be apprised that their use in combination would yield an additive effect.
It would have been prima facie obvious for one of ordinary skill in the art to arrive at the instantly claimed doses, modes of administration, and schedules by routine optimization. One would have been motivated to do so, with reasonable expectation of success, as Gardam discloses ranges which substantially overlap with those of the claimed invention. Therefore, absent unexpected results, the claimed ranges would be obtainable through experimentation within the purview of one of ordinary skill in the art. Additionally, one of ordinary skill in the art would be knowledgeable regarding the elevation of serum uric acid levels in patients with psoriasis and would expect fluctuations above normal ranges (see instant claim 14).
Claim(s) 1, 3-4, 6-8, and 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gardam (CN111808098A; 2020; IDS filed 05/14/2024) in view of Kley et al. (WO2006094933A1; 2006). All references were cited in the previous office action mailed 05/28/2026.
Gardam discloses a method of treating inflammatory diseases in a mammal, such as a human, comprising administering Compound I (English translation, p. 12; original document, p. 7). Gardam discloses that Compound I is a PDE4 inhibitor (English Translation, p. 3-4).
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Compound I is identical in structure to Formula (Ia) as in the instant claims. Gardam additionally teaches that the inflammatory diseases to be treated include diabetes mellitus and psoriasis (English translation, p. 12). Gardam discloses that the compound can be administered in combination with other therapeutic agents to obtain a desired therapeutic effect (English translation, p. 11). Gardam discloses that the compound can be administered orally as tablets or capsules; at doses from 1 to 100 mg, 1 to 50 mg, 10 to 50 mg, 30 to 50 mg, 1 to 20 mg, 5 to 15 mg, 10 to 20 mg, or 20 to 30 mg; and at a period of once per day, twice per day, etc. according to the condition and subject to be treated (English translation, p. 10).
Gardam does not explicitly teach administering compound I for the treatment of diabetes mellitus or the particularly claimed doses, schedules, or modes of administration. Gardam does not teach combining compound I with a uric acid-reducing agent. Gardam does not teach fasting serum uric acid levels in the individual on different days are higher than 420 umol/L. These limitations are obvious over Kley.
Kley teaches a method of treating diabetes mellitus and related disorders comprising administering to a patient in need thereof PDE4 inhibitor roflumilast (p. 1, p. 7-8). Kley additionally teaches that diabetes mellitus is characterized by elevated uric acid levels in the blood and hyperuricemia comorbidity (p. 6).
It would have been prima facie obvious for one of ordinary skill in the art to substitute the roflumilast of Kley with Compound I for the treatment of diabetes mellitus, a disorder associated with elevated serum uric acid levels. One would have been motivated to do so, with reasonable expectation of success, as Compound I and roflumilast are taught to be equivalent in function as PDE4 inhibitors, wherein Compound I is additionally suggested by Gardam for use in treating diabetes mellitus. One would therefore be apprised that substitution of agents that have equivalent functions would yield expected results.
It would have been prima facie obvious for one of ordinary skill in the art to combine Compound I with roflumilast. One would have been motivated to do so, with reasonable expectation of success, as both agents are equivalent in function and have been indicated in their use for treatment of psoriasis. One would therefore be apprised that their use in combination would yield an additive effect.
It would have been prima facie obvious for one of ordinary skill in the art to arrive at the instantly claimed doses, modes of administration, and schedules by routine optimization. One would have been motivated to do so, with reasonable expectation of success, as Gardam discloses ranges which substantially overlap with those of the claimed invention. Therefore, absent unexpected results, the claimed ranges would be obtainable through experimentation within the purview of one of ordinary skill in the art. Additionally, one of ordinary skill in the art would be knowledgeable regarding the elevation of serum uric acid levels in patients with psoriasis and would expect fluctuations above normal ranges (see instant claim 14).
Response to Arguments
Applicant's arguments filed 08/27/2026 have been fully considered but they are not persuasive.
Regarding the outstanding rejections under 35 U.S.C. 103, Applicant argues that one of ordinary skill in the art would not have had an expectation of success in using the compound of Gardam to treat psoriasis or diabetes, as serum uric acid levels did not modulate inflammation in psoriasis (Solak et al.) or diabetes (Kley et al.). This is not persuasive. The instant claims are drawn to a method of “reducing uric acid level, preventing an increased uric acid level, or treating, or alleviating a disease, disorder, or condition associated with an increased uric acid level in an individual” (claim 1, emphasis added). The method of treating or alleviating a disease, disorder, or condition associated with an increased uric acid level does not require any modulation of uric acid levels or expectation that modulation of uric acid levels would achieve some degree of therapeutic effect. Moreover, the term “associated” does not clearly convey that the individual to which the compound of Formula (I) must have increased uric acid levels at the time of treatment. Examiner’s citations of Solak et al. and Kley et al., as in the above rejections, establish that both psoriasis and diabetes (respectively) are associated with increased uric acid levels as required by claim 1. For these reasons the rejections are maintained.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 09/14/2026
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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