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 .
According to paper filed on May 19, 2026, the applicants have canceled claims 13-14 and 16 and furthermore, have amended claims 6-9, 12 and 15.
Claims 5-10, 12 and 15 are pending in the application.
Response to Arguments
Applicant's arguments filed May 19, 2026 have been fully considered but they are not persuasive regarding enablement rejection for preparing hydrates and solvates as well as for treating fbrotic diseases. The applicants have amended claims to overcome indefiniteness rejections. Regarding preparing solvates and hydrates, the applicants present several exhibits. However, the examiner does not agree with applicant’s arguments on pages 11-12 that the specification is enabling for preparing every known or unknown solvate and hydrate of instant compounds. The applicants admit in their response that preparing solvates involves dissolving a compound in a desired solvent at specific temperature. In exhibit B, applicants present preparing a single solvate of fluconazole with ethyl acetate as solvent while in exhibit D, more than 100 solvates are prepared for sulfathiazole. However, in the instant specification, the number of solvates or hydrates prepared as well as specific solvents used as well as specific temperatures used for preparing each one of these solvates or hydrates are not defined. Therefore, the instant specification is not enabling for preparing any solvates or hydrates. In regard to enablement rejection of instant claim 12, the applicants did not provide specific NPL documents showing well established utility of transglutaminase inhibitors for treating any fibrotic disease in the art. The applicants did provide one NPL document showing well established utility of transglutaminase inhibitors for treating celiac disease.
Conclusion
The enablement rejection of claims 5-8, 10 and12 for preparing solvates and hydrates under 35 U.S.C. 112, 1st paragraph is maintained.
The enablement rejection of claim 12 for treating fibrotic disease under 35 U.S.C. 112, 1st paragraph is maintained.
Allowable Subject Matter
Claims 9 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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, Clinton A Brooks can be reached at 571-270-7682. 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.
/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
Prosecution Insights