DETAILED ACTION
This action is in response to Applicant’s submission dated November 13, 2022, in which Applicant amended the specification and claims 1, 3-6, 8-10, 13, 18-20, 22, and 24-26; as well as cancelled claims 7, 11-12, 14-17, 21, and 23.
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 .
Closest Prior Art
The closest prior art is Registry No. 1069911-16-5, which was entered into STN on 02 Nov. 2008 with the following structure:
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178
304
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. While this species possesses an aryl that falls within the definition of ring “A”, it is attached to the carbon instead of the correct nitrogen atom of the pyrazolo ring. Therefore, the claims are free of prior art.
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.
Claims 1-6, 8-10, 18-20, 22, and 24-26 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 applicant regards as the invention.
In claim 1, although only one R4 is mentioned , compounds Glx-308 and Glx-341 have two substituents on the benzene ring. Similarly, it is unclear whether Glx-402 falls within claim 1 because R2 is not defined as oxo. Correction is required.
Further, the definitions of moieties A, R, R1-R2, and R6 as “or a combination thereof” is broad and unclear. Correction is required.
Also, in view of the exemplified compounds, substituent R1 should be restricted only to the carbon ring atom on the 5-position of the pyrazole ring. Correction is required.
As disclosed by the present application, the inhibition of Gli-activity, particularly Gli1, is expected to have therapeutic utility in the treatment of a neurological disorder or cancer. It is unclear; however, which additional medical conditions are covered by “a disease or disorder associated wit an abnormal expression of Gli in a subject” of claim 18, “afflicted with a disease or a disorder comprising an abnormal expression of Gli” or “abnormal expressing of Gli” of claim 20. Correction is required.
Claims 1 and 2 refer to “Formula VIIIa”; however, the structure of this formula in each of the claims is different: Formula VIIIa in claim 2 is simply a subgenus of Formula VIIIa in claim 1. Correction is required.
Since the structural formulae in claims 4, 8, and 9 include the moiety R3, this group should be clearly defined in these claims, or alternatively, the dependency of these three claims which depend on claim 1 should be amended. Correction is required.
The redundant groups in the definition of moiety “A” in claim 1 (e.g. cycloalkyl and heterocyclyl) should be removed. Correction is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932