DETAILED ACTION
This action is in response to Applicant’s submission dated March 11, 2026, in which Applicant elected the invention of Group I.
Election/Restriction
Examiner hereby withdraws the restriction requirement.
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 references contained in the IDS dated March 11, 2026 and August 14, 2024 are made of record.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Determining the scope and contents of the prior art.
Claims 1 and 22-36 are rejected under 35 U.S.C. § 103 as being unpatentable over WO 2017/004674, which discloses the free base form of the present application (see p. 18 first compound). The exemplified salt is hydrochloride (see p. 75). Numerous other salts are however contemplated by the reference, including phosphoric and tartaric salts (see for example claim 45 or paragraph 0103). The free base is not disclosed as a crystal or crystalline solid.
Ascertaining the difference between the prior art and the claims at issue.
The difference between the claimed invention and the reference is the choice of salt and the further crystallization thereof and of the freebase. The present invention is directed to new salt and solid forms of the present compound, addressing the need for improved properties. The ordinary person skilled in the art seeking to prepare such salts and forms would consider it obvious to arrive at the present claims when reading the reference. Screening for salts is a common and routine practice in the field. There appears to be no barrier in applying alternative salt forms, which the reference suggests, that could be regarded as inventive. The present salts are merely obvious alternatives to one of ordinary skill in the art. Their selection provides no new or surprising result that the person of ordinary skill in the art would not expect from reading the reference or considering the general knowledge in the field.
The present invention is directed to new salt and solid forms of the present compound, addressing the need for improved properties. The person of ordinary skill in the art seeking to prepare such salts and forms would consider it obvious to arrive at the present claims when reading the reference. Screening for salts is a common and routine practice in the art. There appears to be no barrier in applying alternative salt forms, which have been suggested in the reference, which could be regarded as more than routine experimentation in this art. The present salts are merely obvious alternatives to the person of ordinary skill in the art. Their selection provides no new or surprising result that the person of ordinary skill in the art would not expect from reading the reference or considering the general knowledge in the field of medicinal chemistry.
The present invention also includes new solid forms. While the reference does not mention crystalline forms, the person of ordinary skill in the art is aware that searching for, and discovering new solid forms can lead to improved properties. Such exploration is common in the field and the person of ordinary skill in the art would consider it an obvious step to take when trying to prepare new forms with improved properties. Carrying out an obvious process to find new forms cannot be impart patentability to an invention.
The claims of the reference also disclose the same methods and uses as presently claimed in claim 36 (see, for example claim 78 of the reference).
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here. The scope of salts is a very finite list and Applicant was not left to pick and choose from a generic disclosure which compound(s) should be tested against the claimed salts in addition to the crystal of 1-methyl-1,4,5,10-tetrahydropyrazolo[3,4-b][1,5]benzodiazepine. The instant salt forms of the present claims thus is reasonably expected to share the same properties as that taught in the reference given the express equivalency teaching recited.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
In the absence of any substantiated unexpected property of the claimed salts and the crystal of 1-methyl-1,4,5,10-tetrahydropyrazolo[3,4-b][1,5]benzodiazepine, which is relevant in comparison, then non-obviousness cannot be acknowledged for the claimed salts and subject matter referring thereto.
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
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