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 .
Information Disclosure Statement
The lined-through refence is simply an entire standard reference text. (Note 37 CFR 1.98(b)(5): “Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication [emphasis added], date, and place of publication.”)
Claim Rejections - 35 USC § 112
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 63 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.
In the definition of variable RY, it is unclear how this moiety may be -NRY1-. RY is a terminal moiety yet -NRY1- is coordinatively unsaturated (i.e. is not a terminal moiety).
Clarification is in order.
Claims 66 and 68 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
There is insufficient antecedent basis for the last diagramed structure in the claims. That is, there appears to be no antecedent basis for the -C(CH3)3 substituent on the phenyl ring in this structure. (As taught by claim 63, the claim from which claims 66 and 68 immediately depend, Q may be selected from C1-C6 alkyl substituted with C6-C10 aryl which may be substituted with halogen and -OCF3.)
Claim 74 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.
There is insufficient antecedent basis for the limitation “…a pharmaceutically acceptable salt…” in the claim.
Claims 64, 65, 67, 69-73 and 75-82 are also 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.
The claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 64, 65, 67, 69-73 and 75-82 are also, therefore, indefinite.
Allowable Subject Matter
The subject matter of claims 63-82 would be allowable once the 112 rejections outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter:
The key to the instant invention is the Markush group of compounds of S4-4 and S4-3. As in the parent application, the closest prior art appears to be WO 2013/038386 A1 which teaches heterocyclic compounds for the treatment of inter alia cystic fibrosis (abstract; page 1, line 21ff). The prior art compounds are structurally dissimilar to those of the instant invention. That being the case, the prior art does not teach, show, suggest or make obvious the instant method of converting compound S4-3 to S4-4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/24/2026
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