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 .
Detailed Action
Restriction/Election
Applicant's election with traverse of group III, claims 16-18 and 24-38 in the reply filed on 02/03/26 is acknowledged. The traversal is on the ground(s) that there exists lack of unity amongst the inventions. This is not found persuasive because the elected group does not comprise a device and thus lacks unity. Additionally, the prior art of record makes obvious the claimed invention thereby not contributing to the prior art. The requirement is still deemed proper and is therefore made FINAL.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/03/26.
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 16-18 and 24-38 are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishnan et al. (WO 2021/113775A1, presented in IDS) in view of Touitou et al. (EP 0139127A1, presented in IDS).
Radhakrishnan et al. discloses compositions for intranasal, sublingual, and subcutaneous administration of bumetanide for the treatment of subjects suffering from edema refractory to oral diuretics. The reference discloses aqueous solutions comprising between 5 to 10 mg/mL of bumetanide having a pH between 5 and 9 and further comprising a surfactant such as a polysorbate. The composition can comprise a buffering agent (see claims 1-66, table 7).
Radhakrishnan et al. fails to disclose a bumetanide liquid composition comprising non-ionic surfactant polyoxyethylene 20 sorbitan monooleate.
Touitou et al. discloses a transdermal drug delivery device comprising a therapeutically effective amount of a drug and from 20 to essentially 100% by weight of a hydrophilic polymer said hydrophilic polymer being a synthetic water soluble polymer of acrylic acid cross-linked with allyl sucrose containing 56-68% carboxylic groups. The hydrophilic solvent is water and the non-ionic surfactant is polyoxyethylene 20 sorbitan monooleate (claims 1-18).
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to have utilized non-ionic surfactant polyoxyethylene 20 sorbitan monooleate in place of polysorbate of Radhakrishnan et al. One of ordinary skill would have been motivated to do so because simple substitution of one non-ionic surfactant with another would have provided predictable results of obtaining an aqueous liquid composition comprising bumetanide for intranasal administration. Given the generic amounts of the drug and the surfactant, it would have been obvious to one of
ordinary skill to have manipulated the amounts for obtaining optimum therapeutic effects with optimum viscosity.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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