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 .
This is a Final Office Action.
Claims 1, 5 and 8-21 are pending and claims 1, 5 and 11-13 are under examination. Claims 8-10 and 14 are withdrawn based on the species election and the lack of unity requirement.
Election/Restrictions
Applicant’s election without traverse (MPEP § 818.01(a) of Group (I) in the reply filed on August 29, 2025 is acknowledged. Group (I), drawn to the compounds of formula (I) and compositions thereof, embraced by claims 1-13 was elected by Applicant.
Applicant further elected the following species on November 12, 2025:
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and indicated claims 1-7 and 11-14 read on said species. However, claims 8 and 9 do not embrace the elected species and claim 14 is found in Group (II) of the lack of unity.
The elected species was not found during the search, and thus, the search was expanded.
Claim Objections
The objection to claim 1 because of the “or O” in the definition of X and X3, is withdrawn based on the amendments.
The objection to claim 7 because a period is missing at the end of the claim, is withdrawn based on the amendments.
Claim 11 is objected to because of the following informalities: there is a period before the end of the claim. The definition of X4 as S or O is the only proper definition that fall within the scope of claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1-7 and 11-13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for pharmaceutically acceptable salts, does not reasonably provide enablement for prodrugs, is withdrawn based on the amendments.
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.
Claims 1, 5, 11 and 13 are 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 pre-AIA the applicant regards as the invention.
The definitions for the variables R4, R4’ and R5 are no longer valid based on the amendments. Thus, all claims dependent from claim 1, which do not remedy the deficiency, are also rejected.
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. There are many species that fall outside of the scope of the currently amended claim 1, e.g. all the species on the second row on page 5 of 11, among others. Please review the claim and remove all species outside of the presently amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-6, 11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ghosh et al. (WO 2015175994, cited on the IDS), is withdrawn based on the amendments.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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, Jeffrey Murray can be reached on 571-272-9023. 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.
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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