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 .
Status of Application/Election/Restrictions
Applicant’s election without traverse of Group 1 (Claims 1-8) on 8/3/2026 is acknowledged. Claims 1-10 are pending. Claims 9-10 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-8 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application JP 2023-082736 filed on 5/19/2023 under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged. Accordingly, the effective priority date of the instant application is granted as 5/19/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/5/2024 and 7/7/2026 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Singh et al. US 2024/0124819, published 4/18/2024, priority date 2/8/2021 (hereinafter Singh).
Claim 1: Singh describes a cell culture membrane comprising a porous membrane having a plurality of pores which are opened on at least one surface and penetrate the membrane creating through-holes (Singh, para 10-12, 72). Singh describes a solid coating material that is applied over the membrane to alter the properties of the cell culture membrane structure including hydrophobicity, cell proliferation, attachment and mobility, thereby providing control over how a cell interacts with the membrane (Singh, para 10, 31, 51). Singh provides embodiments wherein the coating material blocks specific cells from passing through the pores (Singh, para 57).
Claim 5: Singh describes the use of a gelatin derivative as the coating material (Singh, para 22).
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 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (supra) in view of Oku et al. US 2022/0228108, published 4/21/2022 (hereinafter Oku).
A description of Singh can be found above with respect to claims 1 and 5. Singh does not expressly describe a resin porous membrane comprising polyurethane or coating material comprising dried glycoprotein or polysaccharide gel.
Claim 2: Singh describes the composition of the porous membrane as comprising polypropylene, polycarbonate and numerous other plastic polymers but does not expressly describe polyurethane (Singh, para 21). Singh describes the through-holes having a variety of shapes and cross-sectional shapes including circular, which reads on a cone shape and is further illustrated below (Singh, para 55 and Fig 7 shown below).
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Claims 1-2: Oku describes a similar cell culturing membrane having a porous body and expressly states that the membrane is made from polyurethane (Oku, para 47). Oku states that polyurethane has particularly good deformability properties (Oku, para 49). Oku describes controlling the filling rates of the through-holes, from 60% to 100%, which reads on suppressing cell passage through the through-holes (Oku, para 82).
Claims 3-4 and 6: Oku describes an extracellular matrix coating present in the inside of the hole of the porous membrane, comprising fibronectin, collagen and laminin in addition to other glycoprotein products (Oku, 75). Oku further describes applications of these as a gel or as freeze-dried products (Oku, para 79).
Claims 7-8: Oku describes the use of commercially available products like Matrigel and Geltrex, which contain polysaccharides and are in a gel state (Oku, para 75).
It would have been prima facie obvious to one of ordinary skill in the art to use resin porous membrane materials like polyurethane and solid coating materials like collagen or Matrigel as described by Oku for constructing the cell culture membrane described by Singh. One skilled in the art could readily substitute these materials into the methods for producing the cell culturing membrane described by Singh. Both Singh and Oku address porous resin membranes with through-holes which are used as cell-culture scaffolds where the choice of membrane resin and coating material is expressly stated to be selected based on the cells to be grown and the mechanical and adhesive properties of the membrane, showing that these are result-effective variables to be optimized for a known purpose, see MPEP § 2144.05. Thus, one would have been motivated to make this substitution since the selection of polyurethane provides for enhanced deformability and elastic properties of the resin porous membrane and the selection of a dried glycoprotein or polysaccharide gel would provide for specific cell-adhesion properties to control cell passage through the through-holes (Oku, para 47, 82). One would have a reasonable expectation of success since the methods of Singh allow for various resin porous membrane and coating materials to be used to form a functioning cell-culture membrane structure and no unexpected results are needed to bridge the combination. Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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