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 .
Preliminary Remarks
The amendment filed on 01/30/2026 has been entered. Claims 8-9, and 11-12 have been amended, claims 10 and 13-14 are canceled, and claims 16-17 are newly added claims.
Claim Rejections - 35 USC § 112
The 35 U.S.C. 112(d) rejection of claim 14 is withdrawn since applicant has canceled the rejected claim previously cited in the Office Action mailed on 11/07/2025.
The 35 U.S.C. 112(b) rejection of claims 8-15, in particular, claims and 10, is withdrawn, since applicant has amended the claims to overcome the rejection of said claims.
Claim Interpretation
The 112(f) claim interpretation(s) of claims 9-11, noted in the previously mailed Action, is withdrawn, since applicant has amended the claims to overcome the claim interpretation of said claims.
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 8-9, 11, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over JP2018183062A-Takagi et al. (hereinafter Takagi, all citations are made to the English machine translation), and in further view of another embodiment of Takagi and US 2014/0178992 A1-Nakashima et al. (hereinafter Nakashima).
Regarding claim 8, Takagi teaches a cell culture membrane (cell culture instrument 10, para. [0017], line 1, Figs. 2-1). Further, Takagi teaches a first surface (layer 22, para. [0066], line 3, Fig. 2) and a second layer (layer 24, para. [0020], line 1, Fig. 2) comprising: a membrane body (isolating portion 20, para. [0023], line 1, Fig. 2 that is formed of a thermosetting (a resin other than an elastomer may be used to constitute layer 24, para. [0026], line 3-4). Further, Takagi teaches a bottom surface 16 (para. [0076], line 1, Fig. 2) of the device. However, Takagi does not explicitly teach a plurality of through pores formed on the membrane wherein in the through pores, a first average pore diameter in the first surface is smaller than a second average pore diameter in the second surface, a pore density of the through pores is equal to or less than 2.0 x 105 pores / cm2, the first surface is used to seed and culture first cells and the second surface is used to seed and culture second cells that are different from the first cells.
Another embodiment of Takagi teaches the cell culture membrane 45 can be a porous membrane (para. [0046], line 7) and Takagi teaches when the cell culture membrane 45 is a porous membrane, each of the pores of the cell culture membrane 45 may be opened only on one surface of the cell culture membrane 45. Alternatively, at least a part of the pores of the cell culture membrane 45 may be through holes penetrating the cell culture membrane 45 in the thickness direction of the membrane (para. [0046], lines 7-10) and a film made of a thermosetting resin film (para. [0046], line 1). Also, Takagi teaches the average pore diameter of the pores on the surface of the porous polyurethane film can be, for example, 0.1 to 100 μm. The average pore size is a value obtained by observing the surface of the cell culture membrane 45 with a laser microscope (para. [0047], lines 1-3); membrane 45 can also be used for double-side culture in which cells are cultured on both sides of the cell culture membrane 45 (para. [0053], lines 6-7). Furthermore, Takagi teaches it is possible to analyze the interaction between different cells by culturing different kinds of cells on each surface of the cell culture membrane 45 (para. [0053], lines 10-12), which reads on the instant claim limitation of a plurality of through pores formed on the membrane wherein in the through pores, a first average pore diameter in the first surface is smaller than a second average pore diameter in the second surface, the first surface is used to seed and culture first cells and the second surface is used to seed and culture second cells that are different from the first cells.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of the first embodiment of Takagi and further include a plurality of through pores formed on the membrane wherein in the through pores, a first average pore diameter in the first surface is smaller than a second average pore diameter in the second surface, a pore density of the through pores is equal to or less than 2.0 x 105 pores / cm2, the first surface is used to seed and culture first cells and the second surface is used to seed and culture second cells that are different from the first cells as taught by another embodiment of Takagi. Moreover, another embodiment of Takagi teaches medium can be supplied to either side of membrane 45 for analyzing different cell types (para. [0053], lines 7-11).
Also, for claim 8, Nakashima teaches an invention relating to a membrane separation culture device and to a membrane separation culture kit which may be used to separate the stem cells and dental pulp stem cells of an organism of any species, and a method for separating stem cells using the same (para. [0001], lines 1-5) and Nakashima teaches the separation membrane 12 has a pore density of 2.5x103 to 2.5x107 pores/cm2, and preferably 1x105 to 4x106 pores/cm2, which reads on the instant claim limitation of pore density of the through pores is equal to or less than 2.0 x 105 pores / cm2.
Also, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the membrane of Takagi and further include a pore density of the through pores is equal to or less than 2.0 x 105 pores/cm2 as taught by Nakashima. Further, Nakashima teaches pore density previously taught by Nakashima allow for cells to permeate through the pores and the higher the porosity rate, the better the results can be obtained (para. [0108], lines 5-6 and 8-10).
Additionally, for claim 8, Takagi teaches the invention discussed above. Further, Takagi teaches cell culture, also discussed above. However, the first embodiment of Takagi does not explicitly teach wherein the first average pore diameter is equal to or greater than 3 µm and equal or less than 5µm.
A different embodiment of Takagi teaches the average pore diameter of the pores on the surface of the porous polyurethane film can be, for example, 0.1 to 100 μm (para. [0047],lines 1-2), which reads on the instant claim limitation of wherein the first average pore diameter is equal to or greater than 3 µm and equal or less than 5µm.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of the first embodiment of Takagi and further include wherein the first average pore diameter is equal to or greater than 3 µm and equal or less than 5µm as taught by a different embodiment of Takagi. Further, a different embodiment of Takagi teaches setting the value of the average pore size within the above range facilitates compatibility of flexibility and strength in the cell culture membrane 45 (para. 0047], lines 6-7).
Regarding claim 9, Takagi teaches the invention discussed above in claim 8. Further, Takagi teaches a cell culture membrane, also discussed above. However, embodiment of Takagi discussed above does not explicitly teach a cell culture method comprising preparing the cell culture membrane and seeding and culturing the first cells on the first surface and the second surface of the cell culture membrane prepared.
A different embodiment of Takagi teaches porous membrane made of polyurethane manufactured by the method disclosed in Japanese Unexamined Patent Publication No. 2015-107096 was used (para. [0067], lines 3-5) and Takagi teaches cells are seeded on the surface where the pores are opened on cell culture membrane 45 (para. [0053) and Takagi teaches for double-side culture in which cells are cultured on both sides of the cell culture membrane 45 (para. [0053], lines 5-7), which reads on the instant claim limitation of a cell culture method comprising preparing the cell culture membrane and seeding and culturing the first cells on the first surface and the second surface of the cell culture membrane prepared.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of the first embodiment of Takagi and further include a cell culture method comprising preparing the cell culture membrane and seeding and culturing the first cells on the first surface and the second surface of the cell culture membrane prepared as taught by another embodiment of Takagi. Further, Takagi teaches the double-side culture of cell culture membrane 45 allows for the analyzation of the interaction between different cells by culturing different kinds of cell s on each surface of the cell culture membrane (para. [0053], lines 10-12).
Regarding claim 11, Takagi teaches the invention discussed above in claim 9. Further, Takagi teaches cell culture, also discussed above. However, does not explicitly teach wherein seeding and culturing the first cells on the first surface and the second cells on the second surface of the cell culture membrane prepared includes: seeding and culturing the cells on the first surface; and seeding and culturing, after the seeding and culturing the first cells on the first surface, the second cells on the cells on the second surface.
A different embodiment of Takagi teaches cells are seeded on the surface where the pores are opened on cell culture membrane 45 (para. [0053) and Takagi teaches for double-side culture in which cells are cultured on both sides of the cell culture membrane 45 (para. [0053], lines 5-7), which reads on the instant claim limitation of seeding and culturing the cells on the first surface; and seeding and culturing, after the seeding and culturing the first cells on the first surface, the second cells on the cells on the second surface.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of the first embodiment of Takagi and further include seeding and culturing the cells on the first surface; and seeding and culturing, after the seeding and culturing the first cells on the first surface, the second cells on the cells on the second surface as taught by another embodiment of Takagi. Further, Takagi teaches the double-side culture of cell culture membrane 45 allows for the analyzation of the interaction between different cells by culturing different kinds of cell s on each surface of the cell culture membrane (para. [0053], lines 10-12).
Regarding claim 15, Takagi teaches the invention discussed above in claim 9. However, Takagi does not explicitly teach wherein the pore density is equal to or less than 1.5 x 105 pores/cm2.
Nakashima teaches an invention relating to a membrane separation culture device and to a membrane separation culture kit which may be used to separate the stem cells and dental pulp stem cells of an organism of any species, and a method for separating stem cells using the same (para. [0001], lines 1-5) and Nakashima teaches the separation membrane 12 has a pore density of 2.5x103 to 2.5x107 pores/cm2, and preferably 1x105 to 4x106 pores/cm2, which reads on the instant claim limitation of wherein the pore density is equal to or less than 1.5 x 105 pores / cm2.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the membrane of Takagi and further include pore density is equal to or less than 1.5 x 105 pores / cm2 as taught by Nakashima. Further, Nakashima teaches pore density previously taught by Nakashima allow for cells to permeate through the pores and the higher the porosity rate, the better the results can be obtained (para. [0108], lines 5-6 and 8-10).
Regarding claim 17, Takagi teaches the invention discussed above in claim 8. However, Takagi does not explicitly teach wherein the pore density is equal to or less than 1.5 x 105 pores/cm2.
Nakashima teaches an invention relating to a membrane separation culture device and to a membrane separation culture kit which may be used to separate the stem cells and dental pulp stem cells of an organism of any species, and a method for separating stem cells using the same (para. [0001], lines 1-5) and Nakashima teaches the separation membrane 12 has a pore density of 2.5x103 to 2.5x107 pores/cm2, and preferably 1x105 to 4x106 pores/cm2, which reads on the instant claim limitation of wherein the pore density is equal to or less than 1.5 x 105 pores / cm2.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the membrane of Takagi and further include pore density is equal to or less than 1.5 x 105 pores / cm2 as taught by Nakashima. Further, Nakashima teaches pore density previously taught by Nakashima allow for cells to permeate through the pores and the higher the porosity rate, the better the results can be obtained (para. [0108], lines 5-6 and 8-10).
Claims 12 and 16 are is rejected under 35 U.S.C. 103 as being unpatentable over JP2018183062A-Takagi et al. (hereinafter Takagi, all citations are made to the English machine translation), in view of a different embodiment of Takagi and Nakashima as applied to claim 9 above, and further in view of US 10,655,098 B2-Ingber et al. (hereinafter Ingber, has earlier filing date as of the provisional application).
Regarding claim 12, modified Takagi teaches the invention discussed above in claim 9. Further, modified Takagi teaches first cells seeded and second cells seeded. Also, modified Takagi teaches culturing different kinds of cells. However, modified Takagi does not explicitly teach wherein first cells seeded and cultured on the first surface are intestinal epithelial cells, and second cells seeded and cultured on the second surface are vascular endothelial cells.
Ingber teaches an invention relating to systems and methods for culturing and/or maintaining intestinal cells, tissues and/or organoids in vitro. The cells, tissues and/or organoids cultured according to the methods and systems described herein can mimic or reproduce natural intestinal epithelial structures and behavior as well as support co-culture of intestinal microflora (col. 1, lines 23-25) and Ingber teaches the culturing of intestinal epithelial cells (col. 2, lines 28-29) and Ingber teaches microvascular endothelial cells (col. 34, lines 51-53), which reads on the instant claim limitation of wherein first cells seeded and cultured on the first surface are intestinal epithelial cells, and second cells seeded and cultured on the second surface are vascular endothelial cells.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Takagi and further include wherein first cells seeded and cultured on the first surface are intestinal epithelial cells, and second cells seeded and cultured on the second surface are vascular endothelial cells as taught by Ingber teaches the device can provide an organ-level functionality to display how proximity of different cell types can contribute to make synergies in the absorption and transport of nutrients and drug compounds (col. 37, lines 41-44) and Ingber teaches the device allows for physiological relevance will be valuable in developing reliable drug screening process in mid-stage of drug development and reproducible pharm acokinetics as well (col. 37,lines 38-41).
Regarding claim 16, modified Takagi teaches the invention discussed above in claim 8. Further, Takagi teaches culturing different kinds of cells. However, modified Takagi does not explicitly teach wherein the first cells are intestinal epithelial cells, and the second cells are vascular endothelial cells.
Ingber teaches an invention relating to systems and methods for culturing and/or maintaining intestinal cells, tissues and/or organoids in vitro. The cells, tissues and/or organoids cultured according to the methods and systems described herein can mimic or reproduce natural intestinal epithelial structures and behavior as well as support co-culture of intestinal microflora (col. 1, lines 23-25) and Ingber teaches the culturing of intestinal epithelial cells (col. 2, lines 28-29) and Ingber teaches microvascular endothelial cells (col. 34, lines 51-53), which reads on the instant claim limitation of wherein the first cells are intestinal epithelial cells, and the second cells are vascular endothelial cells.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Takagi and further include wherein the first cells are intestinal epithelial cells, and the second cells are vascular endothelial cells as taught by Ingber teaches the device can provide an organ-level functionality to display how proximity of different cell types can contribute to make synergies in the absorption and transport of nutrients and drug compounds (col. 37, lines 41-44) and Ingber teaches the device allows for physiological relevance will be valuable in developing reliable drug screening process in mid-stage of drug development and reproducible pharm acokinetics as well (col. 37,lines 38-41).
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive. On the top of page 6 of applicant’s remarks, applicant discusses the status of the claims. On the middle and bottom of page 6 of applicant’s remarks, applicant acknowledges the submitted IDS(s), and the foreign priority, cited in the Office Action mailed on 09/25/2025. Further, on the top of page 7, applicant discusses the rejection of claim 14 (112d rejection), and notes its moot as claim 14 has been canceled. On the middle of page 6, applicant acknowledges the claim interpretations of claim 9-11, cited by the examiner in the previously mailed Action. On the bottom of page 7 and the top of page 8, applicant discusses the 112(b) rejection of claims 8-15, regarding the term “type.” The examiner addressed the withdrawal of the 112(b) rejection; the claim interpretation and the 112(d) rejection of claim 14, above in the beginning of the Office Action.
On the middle of page 8 of applicant’s remarks, applicant notes prior art relied upon for the U.S.C. 103 rejection of claims 8-11 and 13-15. It is noted, that claims 10 and 13-14, have been canceled. However, applicant has incorporated the limitations of claim 14 into independent claim 8 of the instant application. Further, on the middle and bottom of page 9, and the top of page 10, of applicant’s remarks, applicant cites a segment of page 9 of the previously mailed Action and cites paragraph [0046] of Takagi. Further, applicant asserts “Takagi fails to disclose, or even suggest, ‘a plurality of through pores that are formed in the membrane body and penetrate from the first surface to the second surface, wherein in the through pores, a first average pore diameter in the first surface is smaller than a second average pore diameter in the second surface,’ as recited in independent claim 8.” Applicant argument continues on the top, middle, and bottom of page 11 and the top of page 12 of applicant’s remarks.
In response, the latter argument is moot as applicant’s argument appears to discuss the Takagi reference and does not take into account the Nakashima reference relied upon to address the claim limitations of dependent claim 14, which was incorporated into independent claim 8 of the instant application. Moreover, the claim limitations of claim 14 has been addressed by the additional reference, Nakashima, discussed above in the rejection.
On the middle and bottom of page 12 and the top of page 13 of applicant’s remarks, applicant discusses the Nakashima reference as it pertains to canceled claim 14. Applicant asserts “however, Nakashima discloses a separation membrane. The pore diameter and density disclosed in Nakashima are selected to efficiently cause stem cells to permeate the membrane. (See paragraphs 0017, 0050, and 0108 of Nakashima.) As such, Nakashima is not directed to suppressing cell invasion and is instead specifically directed to facilitating permeation of certain cells through the membrane. Accordingly, because Takagi discloses a cell culture membrane while Nakashima discloses a separation membrane, a person of ordinary skill in the art would not have looked to Nakashima to determine an appropriate pore density for the cell culture membrane of Takagi. Therefore, no prima facie case of obviousness is made.”
In response, the latter argument is not found persuasive because In response to applicant's argument that the Nakashima is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, as discussed above in the rejection, both Takagi and Nakashima both relate to inventions pertaining to membranes and in particular, both references relate to cell culture, which is also relevant to the instant application, which also pertains to cell culture, and the use of membranes as well. The use of membranes is not uncommon in the field of cell culture. Furthermore, membranes comprising various pore diameters and densities, also well known in the art.
Lastly, on the middle of page 13 of applicant’s remarks, applicant discusses claims 9, 11, 12, and 15 depend from clam 8 and are allowable for at least the reasons given above for claim 1. However, claim 1 of the instant application was withdrawn from examination, because it was one of many non-elected claims. That is, claims 1-7 were withdrawn from consideration.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799