DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10 September 2025 has been entered.
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.
Claims 1, 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Aratani (US 20190309257) in view of Nakazawa (US 20080138900).
With respect to claim 1, Aratani discloses a cell culture sheet comprising a plurality of recesses (7:120) having an inner face defined by a structural layer (Figure 7:110) having an inner circumferential face and a bottom face defined by a base layer (Figure 7:130). Aratani discloses in paragraphs [0067]-[0071] that the inner circumferential face has a non-cell-adhesive surface. Paragraphs [0073] and [0074] teach that the bottom face has a cell-adhesive surface (Figure 7:B) comprising collagen, fibronectin and laminin. Paragraphs [0065] and [0071] additionally state that the bottom face includes a polyimide resin composition (“The constituent material of the base material is not particularly limited…Examples of the constituent material include organic materials and inorganic materials described below. One of these constituent materials may be used alone or two or more of these constituent materials may be used in combination” and “Examples of the organic materials include…polyimide”). Paragraph [0174] states that the cell-adhesive surface is substantially 100% of the area of the bottom face of the recess (“seeding the cell adhesive material over the entire surface”). Aratani further teaches in paragraph [0193] that each having an opening of 1,000 microns or less in diameter. Paragraph [0095] and Figure 14 teach that the recesses may be formed in a shape tapered to the bottom face. Paragraphs [0008], [0033], [0062] and [0090] further indicate that the cell culture sheet is a laminate comprising a layer having the non-cell adhesive surface 110 and a layer having the cell-adhesive surface 130, wherein the layer 110 having the non-cell adhesive surface has through-holes (see Figs. 7-9B) (“the member for containing cells of the present disclosure is produced by laminating a structural layer, which is obtained by forming a plurality of holes in a layer formed of a cell non-adhesive material, over a plane of a base material having at least the plane”).
Aratani discloses in paragraphs [0067]-[0071] that the inner circumferential face has a non-cell-adhesive surface made from a variety of different materials, however Aratani does not expressly disclose materials from the claimed group.
Nakazawa discloses a cell culture sheet comprising a plurality of recesses (Figure 2:12). Each recess has an inner circumferential face (Figure 3:22) and a bottom face, wherein the inner circumferential face has a non-cell-adhesive surface and the bottom face has a cell-adhesive surface (Figure 3:30). This is taught in paragraphs [0022]-[0037]. Nakazawa states in paragraph [0045] that polyethylene glycol, MPC, poly-HEMA and SPC or the like are typically used to create non-cell-adhesive surfaces.
Before the effective filing date of the claim invention, it would have been obvious to use polyethylene glycol, MPC, poly-HEMA and SPC or the like when fabricating the inner circumferential face of Aratani. Aratani teaches that “cell non-adhesive material is not particularly limited and may be appropriately selected depending on the intended purpose”. Nakazawa states that polyethylene glycol, MPC, poly-HEMA and SPC materials are well known in the art and especially suitable for creating biological assays and are characterized as having poor cellular adhesiveness.
With respect to claim 3, Aratani and Nakazawa disclose the combination as described above. Aratani further teaches that an adhesive layer configured as a masking tape is disposed between the two layers of the laminated structure. See paragraph [0090] (“Examples of the laminated structure include a structure with a masking tape laminated. In this case, the masking tape is not particularly limited and may be appropriately selected depending on the intended purpose. A masking tape having a thin tackifier layer and a weak tackifying force is preferable. When a masking tape has a thin tackifier layer and a weak tackifying force, there is an advantage that when the laminated masking tape is machined with a laser to open holes, the wall surfaces of the holes are less likely to be sticky with the tackifier layer. The material of the masking tape is not particularly limited and may be appropriately selected depending on the intended purpose. Examples of the material of the masking tape include polyethylene”)
With respect to claim 7, Aratani and Nakazawa disclose the combination as described above. Nakazawa teaches in paragraphs [0031] and [0059] that each recess may be approximately 400 microns in diameter, thereby enabling 10 to 1,000 recesses to be formed on a surface of the sheet per cm2. Aratani additionally describes in paragraph [0193] dimensions that enable the formation of a plurality of recesses at 10 to 1,000 per cm2.
Response to Arguments
Applicant's arguments filed 11 August 2025 have been fully considered but they are not persuasive.
Applicant argues that Aratani fails to describe obtaining spheroids wherein the size of the spheroids is highly homogeneous. However, the claims do not require highly homogeneous spheroids or spheroids of any nature at all. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., homogenous spheroids) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues that Aratani requires an ink jet method that is incompatible with the claimed multilayer laminate. This is unpersuasive because Aratani uses the ink jet method to deposit cell adhesive material B and cells A (and coating liquid C) into the multiplayer laminate defined by the layer 110 having a non-cell-adhesive surface and the layer 130 having a cell-adhesive surface. See paragraphs [0172]-[0191]. The ink jet method is not used for building the multilayer laminate itself (rather, the two layers are laminated using a masking tape – see paragraph [0090]), and it is therefore unclear why Applicant asserts that Aratani teaches away from the claimed invention. Indeed, for the reasons expressed in the rejection above, it is believed that Aratani reads directly on the vast majority of the claim limitations (which is the opposite of “teaching away”)and only fails to expressly disclose the necessary materials for creating the non-cell-adhesive surface.
Applicant references the Declaration filed 16 July 2024 showing unexpected results (i.e., highly homogeneously sized spheroids). For the reasons expressed in the rejection above, the Aratani reference shows a structure that is nearly identical to the claimed invention. Accordingly, it is not understood how unexpected results could be obtained using the claimed invention, which is essentially the same in structure as the Aratani device. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Therefore, an effective affidavit must show how a device modeled after the disclosure of Aratani is incapable of producing highly homogeneously sized spheroids. The Declaration filed 16 July 2024 instead compares the claimed invention to a device that does not have a plurality of recesses each having a diameter of less than 1,000 microns or an inner circumferential layer having non-adhesive surface coupled to a base layer having a cell-adhesive surface, which is very different than the device disclosed by Aratani.
Conclusion
This is a non-final rejection.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799