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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 11-15) in the reply filed on 11/20/2024 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2024.
Newly submitted claims 26 and 28-29 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: they are dependent upon claim 16 which was withdrawn from consideration as being a non-elected invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 26 and 28-29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to JP 2019-125709 filed 7/5/2019.
Information Disclosure Statement
The IDS filed 3/29/2022, 9/07/2023 and 5/31/2024 have been considered by the Examiner.
Status of Claims
Claims 11-15 and 22-23 are under examination.
Claims 16-20 and 25-26, and 28-29 are withdrawn.
Claim 1-10, 21, 24, and 27 are cancelled.
Claim Rejections - 35 USC § 102
Rejection of claims 11-13 and 15 under 35 U.S.C. 102(a)(1) as being anticipated by Hase (US 2010/0190246 Al) has been withdrawn in view of the applicant’s amendments and arguments filed 06/16/2026
Claim Rejections - 35 USC § 103
Rejection to claims 11-15 under 35 U.S.C. 103 as being unpatentable over Kusunoki (IEEJ Transactions on Electronics, Information and Systems,2009) and in further view of and Ikeya (WO 2014/112633) have been withdrawn in view of applicant’s arguments and amendments filed 06/20/2025.
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.
New rejections necessitated by arguments and amendments :
Claims 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hase (US 2010/0190246 Al) in view of Gomi et al. (US 2018/0201892 Al).
Regarding claim 11, Hase teaches a method for obtaining biological tissue (cover page 1, abstract) where the cells are cultured on a surface of a cell adhesion molecule using a cell culture scaffold (page 4 paragraph 0060). Hase teaches the inner bottom surface of the culture vessel is a surface which can be converted into a non-cell-adhesive surface, such as a stimuli-responsive polymer, a detachment operation is carried out in the environment in which a surface can be converted into a non-cell-adhesive surface (page 6, paragraph 0076). Hase teaches detachment may be carried out via a known method, while maintaining tissue configuration. Hase teaches gelatin is first introduced onto the tissue surface formed on a non-cell-adhesive substrate for gelation, gelatin gel is held by a holding substrate, such as a PET film, and tissue is then detached and collected from the noncell-adhesive substrate with gelatin gel (page 6, paragraph 0076). Hase teaches improvement in the interaction between a coating material and a cell culture support is necessary, or adjustment of the hydrophilic/hydrophobic balance of a cell support is necessary (page 5, paragraph 0062). Hase teaches materials physically or chemically crosslinked to each other or bound to substrates, which include dextran and heparin (cell adhesion molecules) (page 3, paragraph 0055). Hase teaches the method to facilitate detachment of a cell sheet, a technique of providing a layer of a temperature-responsive polymer compound on a cell adhesion surface to accelerate cell detachment (page 1, paragraph 0003). Hase teaches the substrate material can be plastics including fluorine resin (page 3, paragraph 0051). Hase teaches a temperature-responsive polymer that can be preferably used in the present invention, which exhibits hydrophobic properties at a temperature at which cells are cultured and exhibits hydrophilic properties at a temperature at which the cultured cell sheet is collected (page 4, paragraph 0060).
Hase et al. do not teach the cell adhesion molecule is selected from the group consisting of extracellular matrices, a molecule prepared by fragmenting cell adhesion sites of the extracellular matrix, a cationic polymer, polyethylenimine, and poly(allylamine hydrochloride).
Gomi et al. teach an invention provides a culture container provided with a base having a concave portion; and a water-repellent layer formed on an outer edge region of the bottom of the concave portion and the inner circumferential surface of the concave portion. One of the surfaces of the water-repellent layer is exposed to the space in the concave portion (cover page, abstract). Gomi et al. teach an extracellular matrix layer serving as a scaffold of adhering cells is formed in the central region of the bottom surface of the concave portion (page 4, paragraph 0055).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Hase et al. for a method for obtaining biological tissue with the teachings of Gomi et al. for an extracellular matrix layer for cell culture. Gomi et al. provide motivation teaching it is advantageous when an extracellular matrix layer serving as a scaffold of adhering cells is formed in the central region of the bottom surface of the concave portion (page 4, paragraph 0055). One of skill in the art would have had a reasonable expectation of success at combining Hase et al. and Gomi et al. because both teach methods of culturing cells in a concave pattern.
Regarding claim 12, Gomi et al. teach an extracellular matrix layer serving as a scaffold of adhering cells is formed in the central region of the bottom surface of the concave portion (page 4, paragraph 0055).
Regarding claim 13, Hase teaches various patterns including a concave-convex pattern which comprises a plurality of island-like convex portions and sealike concave portions continuously formed around such convex portions (page 3, paragraph 0045). Hase teaches a vessel for culture was prepared using a concave-convex template coated with resist (page 8, paragraph 0090).
Regarding claim 15, Hase teaches the cells migrate toward the bottom surface and accumulate with the aid of centrifugal or magnetic force, and cells adhere to each other to form tissue, thereby the cells are adherent (page 2, paragraph 0041).
Claims 14 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hase (US 2010/0190246 Al) in view of Gomi et al. (US 2018/0201892 Al) as applied to claim 11 above, and further in view of Ikeya (WO2014/112633).
Regarding claim 14, Hase and Gomi teach the method for producing the cell culture product in regard to claim 11 above, but does not teach the cell adhesion molecule formed in the shape of a dot with a diameter of 100 to 1000 μm.
Ikeya teaches a molecule formed in a dot shape feature having a diameter of 100-1000um. Ikeya teaches the spheroid growth pattern utilizing a cell adhesive material layer that is arranged in a circular shape with a diameter of 50-500um(paragraph 0040). Ikeya achieves this growth pattern indicating the use of a cell adhesive material such as fibronectin or collagen in a desired pattern on a layer of a material in which cells do not adhere(paragraph 0037).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Hase and Gomi for a method for producing the cell culture product with the teachings of Ikeya et al. for a dot shape feature having a diameter of 100-1000 μm. Ikeya provide motivation by teaching that there is no particular restriction on the shape of the microdroplets. Ikeya further teach cell arrays form spheroids of different animal cells, desirable for various applications (paragraph 0040). Ikeya et al. further teach cell arrays have various applications and can relate to a method for producing a substrate for cell sequence culture (paragraph 0001). One of skill in the art would have had a reasonable expectation of success at combining Hase, Gomi, and Ikeya because they teach 3-dimensional culture methods for cells. Ikeya further teaches polylysine is interchangeable for gelatin which is used in Hase(paragraph 0037).
Regarding claim 22, Hase teaches the cell adhesion molecules can be dextran and heparin (page 3, paragraph 0055).
Regarding claim 23, Ikeya teaches the cell adhesive substances can include polylysine (paragraph 0037).
Response to Arguments
Applicant’s arguments, see pages 7-12, filed 06/20/2025, with respect to the rejections of claims 11-15 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Hase (US 2010/0190246 Al)
Applicant’s arguments, see pages 7-10, filed 06/16/2026, have been fully considered and are persuasive. The rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Hase and Gomi.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.L.M./Examiner, Art Unit 1638
/ANNA SKIBINSKY/Primary Examiner, Art Unit 1635
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