Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ayer et al. CA 2389568A1, in view of Zeldis CA 2563810 A1.
Ayer teaches an osmotic dosage form comprising a drug core, an inner, fluid-permeable membrane surrounding the drug core, and an outer, semipermeable membrane having exit means formed or formable therein surrounding the inner membrane. The drug core forms a solution with imbibed fluid through the membranes and dissolves the inner membrane over time, thereby furthering the maintenance of controlled, sustained delivery of drug from the dosage form. See Abstract and pages 6-7. Drug includes vasodilator is found in page 3, line 25. Dosage form comprising drug core mixing with at least one lubricant, e.g., sodium lauryl sulfate is found in pages 4-5. The dosage form further includes osmagent such as sugar including sucrose, lactose, and glucose. See page 5, second paragraph. Osmopolymer comprising low molecular weight polymers is found in page 6, first paragraph. Semipermeable polymer on the outer membrane is found in page 8. Plasticizer such as polyethylene glycol in the coating membrane is found in page 9. Method for providing the osmotic dosage form comprising mixing the drug with the pharmaceutically acceptable excipients such as lubricant is found in pages 11-12.
Ayer does not expressly teach drug including treprostinil.
Zeldis teaches a method for treating, preventing and managing pulmonary hypertension comprising the administration of an immunomodulatory compound, or a pharmaceutically acceptable salt, solvate (e.g., hydrate), stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active agent including treprostinil (page 30). Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed. See Abstract and pages 6-7. Active agents such as vasodilator including Treprostinil is found in pages 5, 7 and 28. Single unit dosage forms of the invention are suitable for oral. See page 31, lines 25-29. Oral dosage such as tablet is found in page 34-35. Excipients including lubricant such as sodium lauryl sulfate is found in page 36. Osmotic system is found in page 37, lines 15 through page 38, lines 1-11.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Ayer to include vasodilator such as treprostinil in the osmotic delivery system in view of the teaching of Zeldis with the expectation to obtain a drug delivery device useful for the delivery of treprostinil. This is because Zeldis teaches treprostinil is a well known vasodilator, and because Ayer teaches the desirability to include a vasodilator in an osmotic device. Therefore, one of ordinary skill in the art would have been motivated to prepare an osmotic dosage form comprising treprostinil with the expectation to provide a controlled release of treprostinil safe and effective for the treatment of pulmonary hypertension. This is because it is well known in pharmaceutical art that osmotic delivery system is particularly beneficial for chronic diseases that require repeated dosing.
Response to Arguments
Applicant’s arguments filed 07/09/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Correspondence
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615