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 .
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.
Claim(s) 28, and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ignatious et al. (U.S. Patent Application Publication 2006/0083784). Regarding Claim 28, Ignatious et al., hereafter “Ignatious,” shows a solution electrospun fiber (Abstract; 0002, 0024) comprising an ingredient in an amorphous form (0078); and a polymer (0106); wherein the solution electrospun fiber is a product of electrospinning a polymer solution (0123-0126, 0138). Ignatious discloses that the composition can have varying concentrations of polymer and solvent in the solution (0096, 0125-0126). It would have been obvious to one of ordinary skill in the art to use any appropriate amount of polymer and solvent, such as that which is claimed, in order to control the viscosity of the resulting solution which is then electrospun to create the resulting fiber, and because where the general conditions of a claim are disclosed by the prior art, it is not inventive to discover the optimum or workable range by routine experimentation (MPEP 2144.05 (II)(A)).
Regarding Claims 30-31, Ignatious shows the fiber of claim 28 above, including one wherein the polymer comprises amorphous poly(2-alkyl-2-oxazoline) (0107), meeting applicant’s claim.
Regarding Claim 32, Ingatious shows the fiber of claim 28 above, including one wherein the ingredient and the polymer provide a mixture consisting of the ingredient and the polymer in the solvent (0138), including having an appropriate glass transition temperature (0106: glass transition temperature should be above storage temperature, and it would be reasonable that the storage temperature would be below 77F/25C). Since Ignatious shows all of the claimed ingredients, the claimed property of glass transition temperature is held to be implied by Ignatious’ disclosure.
Regarding Claim 33, Ignatious shows claim 28 above, including a composition which comprises an additive (0133).
Allowable Subject Matter
Claims 16, 18-20, 22-27, and 34 are allowed.
Claim 29 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: Applicant’s arguments, specifically asserting the unobviousness of the claimed amount of active pharmaceutical ingredient present, are considered persuasive.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Regarding Claims 28 and 30-33, applicant's arguments filed 21 July 2026 have been fully considered but they are not persuasive.
Applicant contends that Ignatious does not clearly suggest the instant invention because he does not show the claimed concentration percentages. This is not persuasive because the concentrations were held to be obvious in view of his disclosure that concentrations can be variable (see above). It is set forth that a concentration of an ingredient in a mixture which comprises other ingredients would reasonably be lower than a concentration of an ingredient in a mixture with less other ingredients. Claim 28 does not require the same concentration of active pharmaceutical ingredient as independent claim 16 does, and therefore arguments as to the novelty of the specific concentration of claim 16 are not commensurate in scope with claim 28.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA HUSON whose telephone number is (571)272-1198. The examiner can normally be reached M-F 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at 571-272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MONICA ANNE HUSON
Primary Examiner
Art Unit 1742
/MONICA A HUSON/Primary Examiner, Art Unit 1742
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