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 the Claims
Claims 1-14 are pending (claim set as filed on 09/29/2023).
Election/Restrictions
Applicant’s election without traverse of Group I, method claims, in the reply filed on 01/15/2026 is acknowledged.
Product claims 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, only method claims 1-8 are presented for examination.
Priority
This application is a CIP of PCT/JP2022/015780 filed on 03/30/2022, which has a foreign application to JP 2021-059860 filed on 03/31/2021.
Drawings
The drawings filed on 09/29/2023 have been accepted.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 09/29/2023 and 04/11/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Rejections - 35 USC §102, Anticipation
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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshida (US 2021/0054406 A1 - cited in the IDS filed on 09/29/2023).
Yoshida’s general disclosure relates to a method for producing cells having the desired substance introduced therein (see ¶ [0001], [0007]).
Regarding claim 1, Yoshida teaches “A method for producing cells having the desired substance introduced therein, the production method comprising the step of forming an aggregate of cells under conditions that permit transfection of the cells with the substance in a non-cell-adhesive container (step 1)” (see ¶ [0009] & Examples 1-2: Production of Cardiomyocytes from iPSCs-1). Yoshida teaches the cells are cardiomyocytes (see ¶ [0017], [0132]).
Regarding claims 2-3 pertaining to the container, Yoshida teaches “the non-cell adhesive container that can be used is a container with its surface not artificially treated (e.g., by coating with extracellular matrix or the like) for the purpose of improving adhesiveness to cells. … The term ‘non-cell-adhesive’ means that adherent cells do not adhere or rarely adhere to the container (e.g., less than 20%, preferably less than 10%, more preferably less than 1 % cells based on the total number of cells inoculated to the container adhere to the container) … The container can be a microplate, a petri dish (dish), a cell culture flask (a stirring flask, a shaker flask, etc.), a cell culture bag, a roller bottle, a bioreactor or a culture tank, etc. and is appropriately selected according to a production scale (e.g., 1 mL to 2000 L). In the present invention, particularly, a large-capacity (e.g., 100 mL to 2000 L) container may be suitably used” (see ¶ [0085]-[0087]).
Regarding claims 4-5 pertaining to the stirring, Yoshida teaches wherein the step C is performed under static culture of the cells (see ¶ [0037]). Yoshida further teaches “After the static culture, stirring culture may be performed in order to maintain the formed aggregate. The static culture period is not particularly limited, and can be, for example, on the order of 12 to 48 hours and is preferably on the order of 24 hours. The culture conditions are not particularly limited and can involve culture at approximately 37°C in the presence of 5% CO2. The stirring rate and time are appropriately set according to a cell density and the size of the culture container. Typically, the cells are left standing for 4 to 6 hours and then stirred at 25 rpm for 12 hours or longer. Excessive stirring or shaking places physical stress on the cells and also inhibits the maintenance of the aggregate. Thus, it is desirable to control the stirring rate so as to be able to uniformize medium components and the internal oxygen concentration of the medium and so as not to inhibit the maintenance of the aggregate” (see ¶ [0111]-[0112]).
Regarding claim 6 pertaining to the stem cell, Yoshida teaches pluripotency means the ability to be able to differentiate into tissues and cells having various different shapes and functions and to be able to differentiate into cells of any lineage of the 3 germ layers (see ¶ [0056]). Examples of the stem cells include pluripotent stem cells (see ¶ [0058]-[0063]).
Regarding claim 7 pertaining to the cell strainer, Yoshida teaches “the cell solution thus pipetted was passed through a cell strainer (Sterile Cell Strainer 40 μm, Thermo Fisher Scientific Inc.) to recover single cells” (see ¶ [0167], [0184], [0188]).
Regarding claim 8 pertaining to the cell concentration, Yoshida teaches “the number of microcarriers for use in cell culture is not particularly limited and is, for example, one microcarrier per ten cells. The amount of the microcarrier used in cell culture is not particularly limited and is, for example, 0.1 g of the microcarrier per 1x106 to 5x107 cells, preferably 0.1 g of the microcarrier per 2x107 to 3x107 cells” (see ¶ [0096]-[0097], [0156], [0168], [0174]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 6, 8, and 11 (claim set as filed on 01/13/2023) of co-pending Application no. 18/016,266.
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a method for producing cardiomyocyte spheroids.
Regarding claims 1-2, co-pending ‘266 teaches “a method for producing cardiomyocyte spheroids, comprising an aggregation step of allowing dissociated cardiomyocytes having a history of stabilization culture to flow under suspension conditions to aggregate the cells” ((see co-pending ‘266’s claims 1 and 6) and “wherein the flow is performed at a rotation speed of 20 rpm or more and less than 200 rpm” (see co-pending ‘266’s claim 8).
Regarding claim 6, co-pending ‘266 teaches wherein the cardiomyocytes are derived from a pluripotent stem cell (see co-pending ‘266’s claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653