CLAIMS 1-3, 5-12 AND 21-28 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s amendment/remarks filed July 02, 2026 and Information Disclosure Statements filed July 02, 2026 and September 02, 2026 have been received and entered into the application. As reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner. Also, the application papers have been amended as directed by Applicant.
Claim Rejection - 35 USC § 112
Claim 12 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 for the reasons of record as applied to claims 13-20 in the previous Office action, which reasons are here incorporated by reference (the Examiner failed to include present claim 12 in the previous rejection).
Insofar as no arguments touching the merits of this rejection have been presented by Applicant, the rejection is deemed proper.
Claim Rejection - 35 USC § 103, (Withdrawn)
The rejection of the claims under 35 U.S.C. 103 as being unpatentable over Sinha, (U.S. 2024/0474594, (effective 09/29/21), in view of Reynolds et al., and Jordan et al., (US 6,448,323, cited by the Examiner) has been overcome by at least the amendment to claim 1.
In particular, by adding the limitation that hydroxypropyl methylcellulose is present, in any amount/proportion, the dosage form of the claim is now an obvious, i.e., possible, composition and because for inherency the result must be necessarily so, i.e., the dosage form of the claim must be the same as the prior art, it cannot be said that the dissolution and pharmacokinetic parameters of the claim are inherent to the dosage form of claim 1. Also, there is no teaching or suggestion in the art that dosage form of claim 1 containing hydroxypropyl methylcellulose would have the claimed dissolution and/or pharmacokinetic parameters.
Accordingly, this rejection is properly withdrawn.
Double Patenting
Provisional
Claims 1-3, 5-12 and 21-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, (unless otherwise specified), of copending Application Nos. (reference applications): 19/094,703; 19/422,011; 19/413,834; 19/242,858; 19/404, 931; 19/241,304; 19/230,051; 19/236,933; 19/235,535; 19/250,029; 19/324,046; 19/234,212; 19/329,476, (claims 1-19); 19/245,208; 19/303,300; 19/315,441; 19/230,007, (claims 1-21); 19/409,546; 19/414,251 or 19/397,854, each of record, for the reasons of record as set forth in the previous Office action as applied to claims 1-20, which reasons are here incorporated by reference.
Although claim 1 has been amended as pointed to by Applicant, the limitations added have already been considered and addressed by the Examiner in the previous Office action.
Accordingly, the claims are deemed properly rejected.
Non-Provisional
Claims 1-3, 5-12 and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,268,688, (cited by Applicant), already of record, for the reasons of record as set forth in the previous Office action as applied to claims 1-20, which reasons are here incorporated by reference.
Although claim 1 has been amended as pointed to by Applicant, the limitations added have already been considered and addressed by the Examiner in the previous Office action.
Accordingly, the claims are deemed properly rejected and none are currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629
September 29, 2026
