DETAILED ACTION
The preliminary amendment submitted on September 14, 2023 has been entered. Claims 1-12 are pending in the application. Claims 2, 8, and 10 are rejected for the reasons set forth below. Claims 1, 3-7, 9, and 11-12 are objected to for the reasons discussed below.
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 .
Allowable Subject Matter
The examiner agrees, in principle, with the conclusion of the Written Opinion (mailed August 9, 2021) and the International Search Report (mailed August 19, 2021, see the English translation submitted by applicant on September 14, 2023) in PCT/CN2021/098759, of which the present application is a national-phase application under 35 U.S.C. 371, that the claims include allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter. These three references are the closest prior art:
US 2014/0309200 A1 by Kompella et al.
Larsen et al., Int. J. Pharm. 1987:37(1-2);87-95.
US 2005/0267189 A1 by Gao et al.
Kompella et al. discloses prodrugs of celecoxib that were known in the prior art. See Table 2 at para. 0050. While many of the compounds in Kompella et al. are structurally similar to the compound of Formula I of the instant claims, this reference does not specifically teach the --COCH₂CH₂NH₂ group of Formula I, nor is there any motivation in the prior art to use this particular group. Larsen et al. is cited as being representative of the state of the art concerning prodrugs for sulfonamides, such as the sulfonamide found in celecoxib. See Fig. 1 of Larsen at p. 88. Again, Larsen et al. does not specifically recognize that --COCH₂CH₂NH₂ group as a known prodrug of sulfonamides. Finally, Gao et al. discloses that celecoxib, although not the claimed prodrug, was known to be useful for the prevention or treatment of conjunctivitis, i.e., ocular inflammation within the meaning of claim 11. See Gao et al. at para. 0002-04 and 0061.
Drawings
The drawings are objected to because the text is not legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandon-ment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the draw-ings will not be held in abeyance.
Claim Objections
Claims 1, 3-7, 9, and 11-12 are objected to because of the following informalities. Claim 1 lacks an article before the term “Compound.” The chemical structures in claims 1 and 3 are not clear and legible. In claim 3, the steps should be positively recited, e.g., “reacting” instead of “are reacted” or “is reacted.” In claim 9, the second recitation of “a” is redundant in the first line of the claim (“a pharmaceutical”). Claim 10 either has the incorrect article or should be the singular “eyedrop.” Claims 4-7, 9, and 11-12 are objected to only inasmuch as they depend from claims 1 and 3 or otherwise include limitations thereof. Appropriate correction is required.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufac-ture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 8 is rejected under 35 U.S.C. 101 because is it drawn to non-statutory subject matter. “Use” claims that do not purport to claim a process, machine, manufacture, or compo-sition of matter fail to comply with 35 U.S.C. 101. See MPEP 2173.05(q) (“use” claims). Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility. The examiner suggests that claim 8 be cancelled.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 8 is rejected under 35 U.S.C. 112(a) for lack of enablement. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
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.
Claims 2 and 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inven-tor regards as the invention.
Claim 2 is indefinite because it uses an improper Markush grouping. “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group ‘consisting of’ (rather than ‘comprising’ or ‘including’) the alternative members.” See MPEP 2173.05(h) (alternative limitations). See MPEP 2117 (Markush claims) for guidance about suitable language for Markush claims. The examiner suggests that in claim 2 “include” be changed to “is selected from the group consisting of.”
Claim 10 contains the trademark TWEEN. See, e.g., the TWEEN Registration Certificate (Ser. No. 76/451,302), a copy of which is included with this action. Where a trademark is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain because a trademark cannot be used properly to identify any particular material or product. A trademark is used to identify a source of goods, and not the goods themselves. Thus, a trademark does not identify or describe the goods associated with the trademark . See MPEP 2173.05(u) (trademarks or trade names in a claim).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 7:00 am - 6:00 pm (Eastern Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervi-sor, 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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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
December 2, 2025 (revised December 16, 2025)