DETAILED ACTION
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. However, the Figures do not appear to depict a film material having two or more layers for packaging the container. Therefore, this feature must be shown or canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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.
1. Claims 1 and 4-6 are rejected under 35 U.S.C. 103 as unpatentable over Tsukada et al. (WO2017057126A1) in view of Tanaka (JP2009050194A) and Hiroi (US 20230136856A1).
Regarding Claim 1, Tsukada teaches the following:
A culture vessel with a plurality of culture spaces capable of containing one cell aggregate and a culture medium (a cell accommodation part which accommodates cell and a liquid culture medium to perform cell culture) (page 8, para 2)
The material of the culture vessel is resin (page 28, para 2)
At least the inner surface bottom portion of each well portion is treated to reduce cell adhesion, such as a hydrophilization treatment including coating a layer of a water-soluble resin and forming a coating layer using a hydrophilic resin (a coating layer made of a water-soluble resin having a hydrophilic functional group at a side chain is formed on an inner surface of the cell accommodation part)(page 24-25).
Water-soluble resin solution was prepared by dissolving a polyvinyl alcohol having an azide group in its side chain… in a light-shielding polypropylene container colored with brown pigment in a 25 vol% ethanol aqueous solution. The water-soluble resin solution was added to 50 μL per well of a plasma-treated 24-well multi-well plate with a cylindrical body, and after standing for 1 minute, the plate was turned over and the excess solution was discarded. Next, after primary drying at 40°C for 60 minutes, the water-soluble resin was cured (process of cross-linking) by irradiating it with 250 nm UV light from a UV lamp at 1.0 mW/cm¹ for 30 seconds (cross-linking is formed in the water-soluble resin itself and between the water-soluble resin and the inner surface of the cell accommodation part)
Tsukada further teaches the multiwell plate irradiated with gamma rays at an absorbed dose of 10 kGy (page 50).
In view of the above, Tsukada anticipates the limitation regarding subjecting the container to a radiation sterilization treatment with an absorbed radiation dose of 20-45 kGy because this is a process limitation and the patentability of a product does not depend on its method of production and the final product of Tsukada is a sterilized container. See MPEP 2113.
In the alternative, Tanaka teaches a culture container having wells for forming an culturing cell aggregates (para 16). Tanaka further teaches the absorbed radiation dose is preferably 1 kGy to 50 kGy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the device of Tsukada with the absorbed radiation dose of 20-45 kGy. One would have been motivated to make this modification as Tanaka teaches it to be an acceptable range to impart sterilization properties while fully maintaining the characteristics of the container (para 37).
Tsukada, however, still differs from Applicant’s claimed invention because Tsukada does not disclose two or more layers of a film material having gas permeability.
Hiroi discloses a sterile container for cell culture that is packaged using two or more layers of a film material having an elevated gas permeability. See Figs. 1 and 2 and paragraphs [0007], [0039] and [0040] (“the primary packaging of the resin molding which is subject to be radiation-irradiated, preferably the resin molding for treatment of sterilization to be conducted, the oxygen permeable packaging material is used”). Examples 1-6 describe embodiments in which a packaging comprising two or more layers of film material is constructed using a polyethylene material characterized by a high oxygen permeability.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enclose the Tsukada sterile container in a package comprising two or more layers of a film material having a gas permeability of at least 1.0 L/m2 day atm. Hiroi indicates that packaging is critical for maintaining sterility and for regulating gas diffusion. Hiroi indicates that this is important for preserving cell stability over a long period of time (“Since the primary packaging usually remains to be maintained, when the intensity of radiation irradiation is strong enough to sterilize, and the primary packaging has porous materials (e.g., nonwoven fabric) having a physicochemical strength such degree that oxygen permeates without direct contamination of bacteria and microorganisms, the resin molding within the primary packaging shall be secured (retained) in a sterile state. This sterilization condition is maintained for at least 1 year as long as the primary packaging is not opened or the seal is well maintained”).
Regarding Claim 4, Tsukada in view of Tanaka and Hiroi teach all of the limitations of Claim 1 (see above). Tsukada further teaches water-soluble resin solution was prepared by dissolving a polyvinyl alcohol having an azide group in its side chain… having an alkyl group having carbonyl and amine… in a light-shielding polypropylene container colored with brown pigment in a 25 vol% ethanol aqueous solution. The water-soluble resin solution was added to 50 μL per well of a plasma-treated 24-well multi-well plate with a cylindrical body, and after standing for 1 minute, the plate was turned over and the excess solution was discarded. Next, after primary drying at 40°C for 60 minutes, the water-soluble resin was cured (process of cross-linking) by irradiating it with 250 nm UV light from a UV lamp at 1.0 mW/cm¹ for 30 seconds (the water-soluble resin forming the coating layer has a side chain including an aromatic azide group and a side chain including a carbonyl group, a carbonyl group is formed in the inner surface of the cell accommodation part, and cross-linking is formed between the aromatic azide group of the water-soluble resin and the carbonyl group of the water-soluble resin and between the aromatic azide group of the water-soluble resin and the carbonyl group in the inner surface of the cell accommodation part).
Regarding Claim 5, Tsukada in view of Tanaka and Hiroi teach all of the limitations of Claim 1 (see above). Tsukada further teaches the water soluble resin preferred is represented by formula (Ib)(below).
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Regarding Claim 6, Tsukada in view of Tanaka and Hiroi teach all of the limitations of Claim 1 (see above). Tsukada further teaches the culture vessel (sterile container for cell culture) comprises a multi-well plate body including a plurality of wells (cell accommodation part)(page 29).
Response to Arguments
In response to Applicant’s amendment filed 15 September 2026, the previous rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the combination of Tsukada with Tanaka and Hiroi.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
