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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed at the EPO on 09/06/2022. It is noted, however, that applicant has not filed a certified copy of the EP22178172.7 application as required by 37 CFR 1.55.
It should be noted that an electronic retrieval of the document was attempted on 02/06/2024 and 11/07/2024, but did not result in the document being placed within the file wrapper of the instant application. It is requested that applicant file a copy of the certified Foreign Priority document in response to the Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because the Abstract has Fig. 1B listed in the last line and this should be removed in order to conform to current U.S. practice. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 (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 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, 6, 7 and 17 are rejected under 35 U.S.C. 102a1 as being anticipated by Lee et al. (US 2022/0073852 A1 – hereafter ‘852).
‘852 discloses a porous microwell (Abstract ) that includes the following limitations of claim 1:
“A cell culture membrane structure”: ‘852 discloses a membrane (membrane 20; Fig. 2; [0059]) that serves as a cell culture surface.
“a membrane made of a membrane material”: ‘852 discloses that the membrane is made of a material such as polyurethane, PVDF, collagen, gelatin and chitosan ([0059]) where these materials are being interpreted as the membrane material of the instant application.
“the membrane includes a first surface being partially deformed by one or more membrane structure cavities protruding from the first surface”: ‘852 discloses that the membrane has a first surface that is deformed/formed in the shape of a microwell (Fig. 4; microwell 21; [0061]) where the microwell is being interpreted as the membrane structure cavities of the instant application.
“one or more pores formed therein”: ‘852 discloses that the membrane has more than one pore formed in the membrane ([0068]). This includes the microwell (microwell 21; Fig. 4) and the connection portion (portion 22; Fig. 4).
“wherein the membrane material is selected based on at least one type of cells to be cultured on the membrane.”: This limitation appears to be a method for manufacturing the membrane and does not appear to be drawn to a structural limitation that would define the membrane over the prior art. Furthermore, ‘852 discloses multiple biocompatible membranes that can be used for cell culture. Finally, Applicant is reminded that process steps in an apparatus are not accorded patentable weight. “The patentability of a product does not depend on its method of production”. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)." Furthermore, the processing steps do not structurally define the instant application over the prior art since the claimed processing steps do not impart a distinctive structural characteristic to the final product.
For claim 6, ‘852 discloses a body (body 10; Fig. 4; [0050]; [0051]) that is inserted into the opening/well of the plate. This body has sidewalls that extend from the membrane (membrane 20; Fig. 4) to the opening in the well.
For claim 7, ‘852 discloses a plate (plate 30; Fig. 4) that surrounds the wells, i.e. the housing ([0050]) that receives the body (body 10; Fig. 4, i.e. the insert) into a well where the insert and membrane attached to the bottom of the well are immersed into a culture medium.
‘852 discloses the following limitations for claim 17:
“A method for producing a cell culture membrane structure”: ‘852 discloses a method for preparing a membrane ([0021]).
“providing a membrane made of a membrane material”: ‘852 discloses the step of forming a membrane ([0021]) from polymer fibers.
“deforming the membrane comprising one or more through pores formed therein”: ‘852 further discloses that the membrane is deformed in a downward direction for form microwells ([0021]) with pores formed in the membrane. This forming step is done by an embossing process on the membrane in order to form the wells.
“thereby obtaining one or more membrane structure cavities protruding from a first surface of the membrane”: The microwells of ‘852 are being interpreted as the membrane structure cavities of the instant application and would extend from a first surface of the membrane (Fig. 4).
“wherein the membrane material is selected based on at least one type of cells to be cultured on the membrane”: Since ‘852 is used to culture cell spheroids, the membrane material would be selected for a cell type ([0063]).
Therefore, ‘852 meets the limitations of claims 1, 6, 7 and 17.
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 (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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0073852 A1 – hereafter ‘852) in view of Kasendra et al. (US 2020/0224136 A1 – hereafter ‘136).
For claims 4 and 5, ‘852 discloses a surface for cell attachment, but does not disclose the step of coating the surface with a cell attachment molecule.
‘136 discloses a microfluidic system that contains intestinal epithelial cells co-cultured with intestinal endothelial cells (Abstract) that for claims 4 and 5 includes coating a membrane with a cell adhesion surface on both sides of the membrane ([0666]). These adhesion promoting substances can be ECM proteins such as fibronectin, laminin and fibrin. Furthermore, a cell adhesion coating can be applied to the second surface in order to allow a second type of cell to be attached to the membrane ([0066]). This coating would allow the pores to remain open.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the coating of ‘136 within ‘852 in order to promote cell adhesion to the membrane. The suggestion for doing so at the time would have been in order to allow two different types of cells adhere to the membrane ([0666]).
For claim 18, ‘852 discloses a surface for cell attachment, but does not disclose the step of coating the surface with a cell attachment molecule.
‘136 discloses a microfluidic system that contains intestinal epithelial cells co-cultured with intestinal endothelial cells (Abstract) that for claim 18 includes coating a membrane with a cell adhesion surface on both sides of the membrane ([0666]). These adhesion promoting substances can be ECM proteins such as fibronectin, laminin and fibrin. Furthermore, a cell adhesion coating can be applied to the second surface in order to allow a second type of cell to be attached to the membrane ([0066]). This coating would allow the pores to remain open.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the step of using the coating of ‘136 within ‘852 in order to promote cell adhesion to the membrane. The suggestion for doing so at the time would have been in order to allow two different types of cells adhere to the membrane ([0666]).
‘852 discloses the following limitations for claim 19:
“A method for producing a cell culture membrane structure”: ‘852 discloses a method for preparing a membrane ([0021]).
“providing a membrane made of a membrane material”: ‘852 discloses the step of forming a membrane ([0021]) from polymer fibers.
“deforming the membrane comprising one or more through pores formed therein”: ‘852 further discloses that the membrane is deformed in a downward direction for form microwells ([0021]) with pores formed in the membrane. This forming step is done by an embossing process on the membrane in order to form the wells.
“thereby obtaining one or more membrane structure cavities protruding from a first surface of the membrane”: The microwells of ‘852 are being interpreted as the membrane structure cavities of the instant application and would extend from a first surface of the membrane (Fig. 4).
“wherein the membrane material is selected based on at least one type of cells to be cultured on the membrane”: Since ‘852 is used to culture cell spheroids, the membrane material would be selected for a cell type ([0063]).
For claim 19, ‘852 discloses a surface for cell attachment, but does not disclose the step of coating the surface with a cell attachment molecule.
‘136 discloses a microfluidic system that contains intestinal epithelial cells co-cultured with intestinal endothelial cells (Abstract) that for claim 19 includes coating a membrane with a cell adhesion surface on both sides of the membrane ([0666]). These adhesion promoting substances can be ECM proteins such as fibronectin, laminin and fibrin. Furthermore, a cell adhesion coating can be applied to the second surface in order to allow a second type of cell to be attached to the membrane ([0066]). This coating would allow the pores to remain open.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the step of using the coating of ‘136 within ‘852 in order to promote cell adhesion to the membrane. The suggestion for doing so at the time would have been in order to allow two different types of cells adhere to the membrane ([0666]).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0073852 A1 – hereafter ‘852) in view of Fang et al. (WO 2016/069930 A1 – hereafter ‘930).
For claims 2 and 3, ‘852 differs regarding the dimensions of the microwells.
‘930 discloses a system for culturing 3D aggregates or spheroids ([0003]; [0004]) that for claims 2 and 3 includes where the wells (wells 115; Fig. 1; Fig. 7) have a diameter of 500 mm or greater ([0044]) where this dimension includes both the opening and the interior of the well. This allows for the well to control the size of the spheroid.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the dimensions of the microwell suggested by ‘930 within ‘852 in order to culture the 3D cell aggregates. The suggestion for doing so at the time would have been in order to control the size of the spheroid such that the cells in the interior are maintained in a healthy state ([0044]).
Allowable Subject Matter
Claims 8-16 and 20-23 are allowed.
The following is an examiner’s statement of reasons for allowance: For claim 8, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a cell culture apparatus that includes one or more modules where the modules include the following features: at least two culture medium reservoirs each having a top part and a bottom part, the top part having an inlet for a culture medium and the bottom part having an outlet for the culture medium; a first chamber configured to be arranged between the at least two culture medium reservoirs such that the first chamber and the at least two culture medium reservoirs are aligned with each other in a first direction, and a cell culture membrane structure configured to be arranged between the first chamber and a second chamber such that the first chamber and the second chamber are in flow communication with each other via the through pores, the cell culture membrane comprising: a membrane made of a membrane material, the membrane comprising: a first surface being partially deformed by one or more membrane structure cavities protruding from the first surface, and one or more through pores formed therein; wherein the membrane material is selected based on at least one type of cells to be cultured on the membrane; or a cell culture membrane structure, wherein the cell culture membrane structure further comprises an insert wall attached to the cell culture membrane structure, an inner insert cavity, and an insert opening; wherein the inner insert cavity is surrounded by the insert opening, the membrane, and the insert wall; the insert wall extending from the membrane to the insert opening; and the inner insert cavity is located between the insert opening and the membrane, (600) as defined in claim 6configured to be arranged between the at least two culture medium reservoirs such that the cell culture membrane structure and the at least two culture medium reservoirs are aligned with each other in a first direction, the membrane of the cell culture membrane structure being arranged between the inner insert cavity and a second chamber such that the inner insert cavity and the second chamber are in flow communication with each other via the through pores; wherein the second chamber being either arranged under and aligned with the first chamber, or arranged under and aligned with the cell culture membrane structure, in a second direction, the second direction having an angle being more than 0 degrees but 90 degrees or less in respect to the first direction, the second chamber having a bottom part having at least two lateral holes; and at least two flow, each of the at least two flow channels being configured to pass a fluid or cell culture media therethrough, and each of the at least two flow channels connecting the outlet of the bottom part of one of the at least two culture medium reservoirs to one of the at least two lateral holes of the bottom part of the second chamber.
Claims 9-16 and 20-23 would be allowable for the same reasons as claim 8.
The closest prior art is Lee et al. (US 2022/0073852 A1) that discloses an insert for a well plate where a membrane is attached to the insert with microwells formed from the membrane. However, Lee does not teach or fairly suggest the invention of claim 8.
The next closest prior art is Kasendra et al. (US 2020/0224136 A1 ) is a cell culture device that includes a coating on both sides of a membrane for cell adhesion, but Kasendra does not teach or fairly suggest the microcavities of the instant application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Issenberg et al. (US 2022/0340848 A1) discloses a cell culture device with a deformable membrane.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799