DETAILED ACTION
Claims 1-12 are currently pending and are examined on the merits herein.
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 .
Application Priority
This application filed 09/26/2024 is a 371 of PCT/JP2023/012751 filed on 03/29/2023 which claims foreign priority to JAPAN 2022-056765 filed on 03/29/2023.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 3/28/2025 and 3/25/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The following rejections are made:
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sigma Aldrich 5.05821(date of February 2014) in view of Gad PHARMACEUTICAL MANUFACTURING HANDBOOK 2008 p. 166).
Sigma Aldrich catalog teaches Otenzepad (AF-DX 116) storage conditions include OK to freeze and protect from light.
While Sigma Aldrich teaches to protect AF-DX 116 from light, the reference fails to teach the container as claimed.
Gad teaches carefully selected packaging material may help protect drug products. For example, a blister or pouch and use of secondary packing may be used to protect pack photosensitive material, especially when a dark polymeric film with a covering lid made of aluminum is used for blister packing. Blister packaging using multilayer HDPE material and selection of an adequate sealing technique may help prevent moisture in the blister system.
It would have been obvious to one of ordinary skill in the art at the time of filing to use a modified container. The motivation to modify the container is because Sigma Aldrich teaches and protect from light and Gad teaches carefully selected packaging material may help protect drug products. For example, a blister or pouch and use of secondary packing may be used to protect pack photosensitive material, especially when a dark polymeric film with a covering lid made of aluminum is used for blister packing. Blister packaging using multilayer HDPE material and selection of an adequate sealing technique may help prevent moisture in the blister system. A skilled artisan would have reasonable expectation of successfully achieving stability.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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