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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claims 81 and 101-109 are pending in the application.
This action is in response to applicants' amendment dated March 12, 2026.
Response to Amendment
Applicant's arguments filed March 12, 2026 have been fully considered with the following effect:
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 7) in the last office action, the applicant’s amendments and remarks have been fully considered but they are not persuasive. The applicants stated that “ansolvate” does not appear in ipsis verbis in the as-filed application. The applicants further stated that “ansolvate” is an art-reconized term that refers to a crystalline form that does not contain repeating solvent molecules (e.g., water) within its crystalline lattice, that is to say, an ansolvate is a crystalline form that is desolvated. However, the ansolvate form is also known of the anhydrous form which is the solvent-free state of a compound, typically obtained by removing all solvent molecules (e.g., water) from a hydrate or solvate. Desolvated solvate is the product formed when solvent molecules are removed from a solvate (hydrate or organic solvent inclusion compound). Further desolvation does not necessary remove all of the solvate and thus desolvation would not necessarily yield an ansolvate where there is no solvent in the product. Zhang states that a crystalline form may contain a single entity (the active pharmaceutical ingredient (API) molecule) or multiple entities, including the API and other adducts, crystals containing only the API molecule are usually called anhydrate or ansolvate. The additional adduct to the API in the crystal could be a solvent, a neutral guest, or a counter-ion and the crystal form would be defined as a solvate, a cocrystal, or a salt, respectively. Zhang further states that a solvate is not a polymorph of an anhydrate, as they have different chemical compositions, while an amorphous form is not a polymorph neither as it is not crystalline.
Claim 81 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention, for reasons of record and stated above.
In view of the amendment dated March 12, 2026, the following new grounds of rejection apply:
Election/Restrictions
Claims 101-109 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected by original presentation in the final rejection mailed November 24, 2025, there being no allowable generic or linking claim. Election is being treated as a final election without traverse.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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