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
Information disclosure statements were filed 02/22/2024 and 05/07/2024.
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.
Claims 1-10 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.
Claim 1, parts 1) and 2) are indefinite in reciting a “certain temperature” without particularly setting it out. Further claims 6 and 9 set out different temperature ranges for this term. Clarification is requested.
Claim 1, part 2), sets out “adjusting pH” without pointing out how it and to what pH it is adjusted.
Claim 1, parts 1) – 3), set out “organic solvent A” without particularly pointing it out. Clarification is requested.
Taken together, applicant has set out a method of making, without defining conditions such as pH, temperature, and the organic solvent used in the process. Applicant is requested to clarify the claimed method steps.
Conclusion
No claims are allowed.
CN 106727358 A is cited as a patent of interest in disclosing a method of forming aripiprazole microspheres . It is noted that step 2) of claim 1 is missing from this reference. Specifically, the reference does not add a solution of PVA to the aripiprazole and organic solvent.
CN 108498456 B to Livzon Pharmaceuticals sets out the same method as instantly claimed. However, this application claims priority to the same foreign priority document as the instant application.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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