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 .
Claims 1-30 are pending in the instant application. Claims 1-7 and 20-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 8-19 are rejected.
Information Disclosure Statements
The information disclosure statements filed on October 6, 2023, March 11, 2024 and April 2, 2026 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 8-19, in the response filed on April 9, 2026 is acknowledged. The restriction requirement is still deemed proper and is hereby made final.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0000881 A1.
US 2022/0000881 A1 discloses an intranasal pharmaceutical composition comprising a therapeutically effective amount of scopolamine or a pharmaceutically acceptable salt thereof, wherein the intranasal pharmaceutical composition is used in the treatment of exposure to chlorine gas. It is disclosed that “for intranasal administration, the composition preferably includes one or more gelling agents… Such gels can be either a true gel or a viscous liquid.” The reference also discloses that “the composition is an intranasal formulation in a dose of between 0.2 mg and 2 mg scopolamine, such as a dose of 0.2 mg or 0.4 mg scopolamine.” See [0006] and [0031].
US 2022/0000881 A1 does not specifically disclose that the administration of the gel composition to a human subject results in a Cmax of free scopolamine measured with a 90% confidence level which is 80% to 125% of a least squares geometric mean of less than about 160 pg/mL or the more specific least squares geometric means of dependent claims 9-19. The reference also not disclose that the intranasal pharmaceutical composition can be used for the prevention of, or rescue from, one or more of nausea and emesis related to motion.
However, it is well known in the art that scopolamine can be used in the prevention of, or rescue from, one or more of nausea and emesis related to motion (see 0002] of the instant specification). Also, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Since US 2022/0000881 A1 teaches an intranasal scopolamine composition containing the same ingredients, in the same amount, as what is recited in the claims (i.e., see instant claim 1), the Cmax of free scopolamine would, therefore, would be similar to what is claimed. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the intranasal pharmaceutical composition of the instant claims in view of US 2022/0000881 A1 with a reasonable expectation of success. The motivation would have been to find an optimal intranasal pharmaceutical composition which can be used for additional pharmaceutical purposes besides treatment of exposure to chlorine gas, such as prevention of, or rescue from, one or more of nausea and emesis related to motion.
Thus, a prima facie case of obviousness has been established.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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