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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 6-18, 20 and 43-53) in the reply filed on 07/03/2025 is acknowledged.
Claims 21, 22, 29-35, 39 and 40 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/03/2025.
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.
Claims 1, 6-18, 20 and 43-53 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. US 20170224476, in view Gillis US 20010041870 A1.
You teaches a method for delivering an agent by implanting into a sinus cavity an implantable delivery device. See Abstract and Claims. Device includes expandable device is found in paragraph 0042. Device further include a coating that comprises an additional coating material and a therapeutic agent, for example, selected from the therapeutic agents described elsewhere herein, among other possibilities. The additional conformal coating may range, for example, from between 1 μm to 25 μm in thickness (e.g., ranging from 1 to 2 to 5 to 20 to 25 μm in thickness), among other possibilities. In certain embodiments, the additional coating material may be a biodegradable polymer such as poly(lactide-co-ε-caprolactone) or a mixture of poly(lactide-co-ε-caprolactone) and an additional polymer such as a homopolymer or copolymer of lactide, for instance, poly(lactide-co-glycolide) (also referred to herein as poly(lactic acid-co-glycolic acid)). Where included, the additional polymer may be present, as a weight percent of the additional conformal coating, in amounts ranging, for example, from 5 to 50%. The poly(lactide-co-ε-caprolactone) may have, for example, a molar percentage of lactide ranging from 50 to 95% and a molar percentage of caprolactone ranging from 50 to 5%, among other possibilities. Where present, the poly(lactide-co-glycolide) may have, for example, a molar percentage of lactide ranging from 50 to 99.9% and a molar percentage of glycolide ranging from 50 to 0.1%, among other possibilities. See paragraph 0037. Therapeutic agents include mometasone furoate, glucocorticoids, steroid, antibodies, proteins and peptide are found in paragraphs 0484-0486 and 0495.
You is only deficient in the teaching of an osmotic device that comprises a coating with an orifice and a lumen that comprises osmogene.
Gillis teaches an implantable device comprises a proximal end, a distal end, and a guide body defining a lumen, and can optionally comprise a stable positioning element for stably positioning a drug delivery device within the guide. The device can be provided in connection with a drug delivery device. In use, the device is implanted within a subject so as to provide a conduit through which a drug delivery device can be retrievably introduced to facilitate delivery of drug to a treatment site within a subject at a site distal to an accessible implantation site. The drug delivery device is then positioned within the guide lumen to provide for delivery of drug from the drug delivery to the desired treatment site. See Abstract and Claims. Drug delivery device including an osmotic pump with an orifice is found in paragraphs 0124-0137. Treatment site includes intranasal. See page 0072. Polymer coating membrane is found in paragraphs 0091-0092 and 0139.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in You to include an osmotic pump intranasal device in view of the teaching in Gillis. This is because Gillis teaches using an osmotic pump to control the release rate of active agent is known and useful in pharmaceutical art.
Correspondence
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615