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 .
1. Claims 15 – 18, 21 – 30, and 33 – 38 remain pending. Claims 15 – 18, 21 – 30, and 37 – 38 are under consideration.
Priority
2. This application claims the benefit of the filing date of JP2019-032200, which was filed on February 25, 2019.
3. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Withdrawn Claim Objections
4. The objection to claim 23 is withdrawn in view of Applicant’s amendment to the claim.
5. The objection to claim 24 is withdrawn in view of Applicant’s amendment to the claim
Withdrawn Claim Rejections
6. The rejection of claim 19 under 35 U.S.C. 103 is rendered moot in view of Applicant’s cancellation of the claim.
7. The rejection of claim 20 under 35 U.S.C. 103 is rendered moot in view of Applicant’s cancellation of the claim.
8. The rejection of claims 16, 18, 22, 24, and 26 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to claim 16.
9. The rejection of claims 15, 17, 21, 23, 25, 27, 29, and 37 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 15.
10. The rejection of claims 16, 18, 22, 24, 26, 28, 30, and 38 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 16.
11. The rejection of claims 16, 18, 20, 22, 24, and 26 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 16.
Objections/Rejections Necessitated by Amendment
Claim Objections
12. Claim 23 is objected to because of the following informalities: in the last line, “a cell-adhesive” should read “the cell-adhesive” to clarify that the cell-adhesive surface of claim 23 is the same cell-adhesive surface containing a fluorine-containing polyimide resin of claim 15. Appropriate correction is required.
13. Claim 24 is objected to because of the following informalities: in the last line, “a cell-adhesive” should read “the cell-adhesive” to clarify that the cell-adhesive surface of claim 24 is the same cell-adhesive surface containing a fluorine-containing polyimide resin of claim 16. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
14. Claims 21 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
15. Regarding claim 21, it is unclear if the claim 21 means claim 15 further comprises culturing on a flat cell-adhesive surface or if the cell-adhesive surface of claim 15 is flat. For the purpose of applying prior art, claim 21 is interpreted as the cell-adhesive surface of claim 15 is flat.
16. Regarding claim 22, it is unclear if the claim 22 means claim 16 further comprises culturing on a flat cell-adhesive surface or if the cell-adhesive surface of claim 16 is flat. For the purpose of applying prior art, claim 21 is interpreted as the cell-adhesive surface of claim 16 is flat.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
17. Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 fails to further limit claim 15 because claim 15 requires the cell-adhesive surface comprise a fluorine-containing polyimide resin and Applicant’s specification discloses synthetic resins including fluorine resins and polyimide resins are cell-adhesive substances (page 10, lines 9 – 12; page 11, lines 1 – 6). Therefore, claim 17 broadens claim 15 to any “cell-adhesive substance”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
18. Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 fails to further limit claim 15 because claim 15 requires the cell-adhesive surface comprise a fluorine-containing polyimide resin and Applicant’s specification discloses synthetic resins including fluorine resins and polyimide resins are cell-adhesive substances (page 10, lines 9 – 12; page 11, lines 1 – 6). Therefore, claim 17 broadens claim 15 to any “cell-adhesive substance”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
19. For the purpose of applying prior art, “substantially 100%” of claims 15 and 16 is interpreted as greater than 99% based on Applicant’s specification at page 38, lines 11 – 14.
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.
20. Claim(s) 15, 17, 21, 23, 25, 27, 29, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori (Mori, Ryuhei, et. al. Journal of bioscience and bioengineering 106.3 (2008): 237-242; previously cited), hereinafter Mori in view of Makino (WO2015163043A1; Filed 03/17/2015, Published 10/29/2015), hereinafter Makino which is cited on the IDS filed 08/25/2021. US11447743B2 is used as the translation of Makino.
Regarding claim 15, Mori teaches a method of culturing cells on a cell-adhesive surface of a cell culture sheet wherein the cell culture sheet has a plurality of recesses each having an opening of 300 µm in diameter, wherein each recess has an inner circumferential face and a bottom face, wherein the inner circumferential face has a non-cell adhesive surface of polyethylene glycol and the bottom face has a cell-adhesive surface of collagen (Abstract; Figure 1A; page 237, right col. last para.; page 238, left col. para. 1 and right col. para. 2; Figure 2D-F; page 239, left col. para. 4; Figure 3D-F). Mori does not teach “culturing undifferentiated cells” or “wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin”.
Regarding claim 17, Mori teaches the cell-adhesive substance is collagen (page 238, left col. para. 1; Figure 1A).
Regarding claim 21, Mori teaches in Figure 1A the cell-adhesive surface is flat.
Regarding claim 23, Mori teaches the culturing is performed on a cell culture sheet having a plurality of recesses each having an opening of 300 µm in diameter wherein each recess has an inner circumferential face and a bottom face wherein the inner circumferential face has a non-cell adhesive surface and wherein the bottom face has a cell-adhesive surface (Figure 1A; page 238, left col. para. 1).
Regarding claim 25, Mori teaches the culturing is not performed with feeder cells (page 238, right col. para. 2).
Mori does not teach “culturing undifferentiated cells” or “wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin” of claim 15 or the cells are undifferentiated stem cells or progenitor cells of claim 27 or the cells are pluripotent stem cells of claim 29 or the cells are iPS cells of claim 37. However, Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture (Abstract; page 241, right col. last para.). Mori teaches the spheroid chip was designed to form organoids of less than approximately 200 µm in diameter (page 237, right col. last para.). Mori teaches the spheroids at 14 days culturing had diameters of approximately 200 µm (page 239, right col. para. 3 – 4; Figure 4; page 241, left col. last para.). Mori teaches the cell-adhesion area can be designed by using artificial materials instead of collagen (page 241, right col. last para.). Mori teaches the culture chip technology may have wide applications for the culture of organoids by using various cells (page 241, right col. last para.).
Regarding “wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin” of claim 15, Makino teaches a cell culture substrate that is a fluorine-containing polyimide (“fluorine-containing polyimide resin”) on which cells are cultured and form spheroids (col. 3, lines 8 – 24; col. 4, lines 30 – 34 and 43 – 57; col. 117, lines 5 – 38 and 55 – 62). Makino teaches in Figure 2 – 6, the fluorine-containing polyimide covers the entire surface for cell culture (“wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess”) (col. 15, lines 17 – 46). Makino teaches in Figure 5 that the fluorine-polyimide surface has a plurality of recesses, each with an inner circumferential face and a bottom face composed of fluorine-containing polyimide and the diameter of the opening is 50 to 500 µm (col. 93, lines 40 – 67). Makino teaches a comparison of culturing rat hepatocytes in a 24-well plate coated with collagen versus a 24-well plate of fluorine-containing polyimide (6FDA/TPEQ) (col. 125, lines 1 – 15). Makino teaches on the collagen coated plate, cells grew as monolayers and cell aggregates was not substantially observed (col. 125, lines 23 – 27). Makino teaches on the 6FDA/TPEQ plate, cell aggregates of adequate sizes were formed while they adhered to the substrate and were evenly distributed all of the wells, and that cell aggregates were prevented from being further aggregated with each other and could maintain adequate sizes, and the cells were prevented from being removed together with the medium at the time of medium exchange (col. 125, lines 37 – 46; Figure 19E). Makino teaches cells to be cultured by the method include iPS cells, embryonic stem cells (ESCs), and mesenchymal stem cells (MSCs) (col. 98, lines 34 – 49). Makino teaches in the field of regenerative medicine aimed at restoration of functions of organs, it is necessary that cells constituting organs be cultured in a manner such that cells can form a three-dimensional network (col. 1, lines 29 – 38).
Regarding “undifferentiated cells” of claim 15 and “undifferentiated stem cells or progenitor cells” of claim 27 and “pluripotent stem cells” of claim 29 and “iPS cells” of claim 37, Makino teaches cells to be cultured by the method include iPS cells, embryonic stem cells (ESCs), and mesenchymal stem cells (MSCs) (col. 98, lines 34 – 49). Makino teaches in the field of regenerative medicine aimed at restoration of functions of organs, it is necessary that cells constituting organs be cultured in a manner such that cells can form a three-dimensional network (col. 1, lines 29 – 38).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Mori regarding a method of culturing cells to form spheroids in a cylindrical vessel where the inner walls have a non cell-adhesive surface and a portion of the bottom surface has a cell-adhesive substance with the teachings of Makino regarding culturing cells that include iPS cells on a surface of a fluorine-containing polyimide resin to form spheroids to arrive at the claimed method for producing undifferentiated cell spheroids, the method comprising the step of culturing undifferentiated cells on a cell-adhesive surface of a cell culture sheet, wherein the culturing is performed on a cell culture sheet having a plurality of recesses each having an opening of 2,000 μm or less in diameter, wherein each recess has an inner circumferential face and a bottom face, wherein the inner circumferential face has a noncell adhesive surface, and wherein the bottom face has a cell-adhesive surface, wherein the noncell adhesive surface comprises at least one substance selected from the group consisting of polyethylene glycol and its derivatives, compounds including 2-methacryloyloxyethyl and its derivatives and hydroxyethyl methacrylate and its derivatives or polymers thereof, segmented polyurethane and its derivatives, albumin, agarose and cellulose, wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin. One would have been motivated to combine the teachings of Mori and Makino in a method of producing organoids as Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture and Makino teaches in the field of regenerative medicine aimed at restoration of functions of organs, it is necessary that cells constituting organs be cultured in a manner such that cells can form a three-dimensional network. One would have a reasonable expectation of success in combining the teachings as Mori teaches the spheroid chip was designed to form organoids and Makino teaches on the collagen coated plate, cells grew as monolayers and cell aggregates was not substantially observed compared to the 6FDA/TPEQ plate, where cell aggregates of adequate sizes were formed while they adhered to the substrate and were evenly distributed all of the wells and Makino teaches the method can be used to culture iPS cells, ESCs, and MSCs.
21. Claim(s) 16, 18, 22, 24, 26, 28, 30, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori (Mori, Ryuhei, et. al. Journal of bioscience and bioengineering 106.3 (2008): 237-242; previously cited), hereinafter Mori in view of Makino (WO2015163043A1; Filed 03/17/2015, Published 10/29/2015), hereinafter Makino which is cited on the IDS filed 08/25/2021. US11447743B2 is used as the translation of Makino.
Regarding claim 16, Mori teaches a method of culturing hepatocytes on a cell-adhesive surface of a cell culture sheet wherein the cell culture sheet has a plurality of recesses each having an opening of 300 µm in diameter, wherein each recess has an inner circumferential face and a bottom face, wherein the inner circumferential face has a non-cell adhesive surface of polyethylene glycol and the bottom face has a cell-adhesive surface of collagen (Abstract; Figure 1A; page 237, right col. last para.; page 238, left col. para. 1 and right col. para. 2; Figure 2D-F; page 239, left col. para. 4; Figure 3D-F). Mori does not teach “wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin”.
Regarding claim 18, Mori teaches the cell-adhesive substance is collagen (page 238, left col. para. 1; Figure 1A).
Regarding claim 22, Mori teaches in Figure 1A the cell-adhesive surface is flat.
Regarding claim 24, Mori teaches the culturing is performed on a cell culture sheet having a plurality of recesses each having an opening of 300 µm in diameter wherein each recess has an inner circumferential face and a bottom face wherein the inner circumferential face has a non-cell adhesive surface and wherein the bottom face has a cell-adhesive surface (Figure 1A; page 238, left col. para. 1).
Regarding claim 26, Mori teaches the culturing is not performed with feeder cells (page 238, right col. para. 2).
Mori does not teach “ “wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin” of claim 16 or the cells are undifferentiated stem cells or progenitor cells of claim 28 or the cells are pluripotent stem cells of claim 30 or the cells are iPS cells of claim 38. However, Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture (Abstract; page 241, right col. last para.). Mori teaches the spheroid chip was designed to form organoids of less than approximately 200 µm in diameter (page 237, right col. last para.). Mori teaches the spheroids at 14 days culturing had diameters of approximately 200 µm (page 239, right col. para. 3 – 4; Figure 4; page 241, left col. last para.). Mori teaches the cell-adhesion area can be designed by using artificial materials instead of collagen (page 241, right col. last para.). Mori teaches the culture chip technology may have wide applications for the culture of organoids by using various cells (page 241, right col. last para.).
Regarding “wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin” of claim 15, Makino teaches a cell culture substrate that is a fluorine-containing polyimide (“fluorine-containing polyimide resin”) on which cells are cultured and form spheroids (col. 3, lines 8 – 24; col. 4, lines 30 – 34 and 43 – 57; col. 117, lines 5 – 38 and 55 – 62). Makino teaches in Figure 2 – 6, the fluorine-containing polyimide covers the entire surface for cell culture (“wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess”) (col. 15, lines 17 – 46). Makino teaches in Figure 5 that the fluorine-polyimide surface has a plurality of recesses, each with an inner circumferential face and a bottom face composed of fluorine-containing polyimide and the diameter of the opening is 50 to 500 µm (col. 93, lines 40 – 67). Makino teaches a comparison of culturing rat hepatocytes in a 24-well plate coated with collagen versus a 24-well plate of fluorine-containing polyimide (6FDA/TPEQ) (col. 125, lines 1 – 15). Makino teaches on the collagen coated plate, cells grew as monolayers and cell aggregates was not substantially observed (col. 125, lines 23 – 27). Makino teaches on the 6FDA/TPEQ plate, cell aggregates of adequate sizes were formed while they adhered to the substrate and were evenly distributed all of the wells, and that cell aggregates were prevented from being further aggregated with each other and could maintain adequate sizes, and the cells were prevented from being removed together with the medium at the time of medium exchange (col. 125, lines 37 – 46; Figure 19E).
Regarding “undifferentiated stem cells or progenitor cells” of claim 28 and “pluripotent stem cells” of claim 30 and “iPS cells” of claim 38, Makino teaches cells to be cultured by the method include iPS cells, embryonic stem cells (ESCs), and mesenchymal stem cells (MSCs) (col. 98, lines 34 – 49). Makino teaches in the field of regenerative medicine aimed at restoration of functions of organs, it is necessary that cells constituting organs be cultured in a manner such that cells can form a three-dimensional network (col. 1, lines 29 – 38).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Mori regarding a method of culturing cells to form spheroids in a cylindrical vessel where the inner walls have a non cell-adhesive surface and a portion of the bottom surface has a cell-adhesive substance with the teachings of Makino regarding culturing cells on a surface of a fluorine-containing polyimide resin to form spheroids to arrive at the claimed method for producing undifferentiated cell spheroids, the method comprising the step of culturing undifferentiated cells on a cell-adhesive surface of a cell culture sheet, wherein the culturing is performed on a cell culture sheet having a plurality of recesses each having an opening of 2,000 μm or less in diameter, wherein each recess has an inner circumferential face and a bottom face, wherein the inner circumferential face has a noncell adhesive surface, and wherein the bottom face has a cell-adhesive surface, wherein the noncell adhesive surface comprises at least one substance selected from the group consisting of polyethylene glycol and its derivatives, compounds including 2-methacryloyloxyethyl and its derivatives and hydroxyethyl methacrylate and its derivatives or polymers thereof, segmented polyurethane and its derivatives, albumin, agarose and cellulose, wherein the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess, and wherein a resin constituting the cell-adhesive surface is a fluorine-containing polyimide resin.. One would have been motivated to combine the teachings of Mori and Makino in a method of producing organoids as Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture and Makino teaches in the field of regenerative medicine aimed at restoration of functions of organs, it is necessary that cells constituting organs be cultured in a manner such that cells can form a three-dimensional network. One would have a reasonable expectation of success in combining the teachings as Mori teaches the spheroid chip was designed to form organoids and Makino teaches on the collagen coated plate, cells grew as monolayers and cell aggregates was not substantially observed compared to the 6FDA/TPEQ plate, where cell aggregates of adequate sizes were formed while they adhered to the substrate and were evenly distributed all of the wells and Makino teaches the method can be used to form hepatocyte spheroids.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
22. Claims 15 – 30 and 37 – 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 13 of U.S. Patent No. 11447743 in view of Mori (Mori, Ryuhei, et. al. Journal of bioscience and bioengineering 106.3 (2008): 237-242; previously cited), hereinafter Mori.
Claim 1 of Makino of ‘743 recites a cell culture substrate having at least one type of fluorine-containing polyimide.
Claim 4 of Makino ‘743 recites a cell culture vessel at least a part of which is composed of the cell culture substrate according to claim 1.
Claim 5 of Makino ‘743 recites a cell culture vessel comprising, in at least in part, a substrate that is provided in a manner such that one surface of the substrate constitutes the bottom of a container portion for containing a cell and medium and the other surface is exposed to the outside of the vessel, wherein the substrate is the cell culture substrate according to claim 1 and at least a part of the one surface is composed of the resin composition.
Claim 12 of Makino ‘743 recites the cell culture substrate according to claim 1, wherein the substrate comprises a cylindrical or conical cavity.
Claim 13 of Makino ‘743 recites The cell culture substrate according to claim 12, wherein the cylindrical or conical cavity has a diameter of 50 to 500 μm and a depth of 50 to 500 μm.
Claims 1, 4, and 5 lack a non-cell adhesive surface and culturing cells. Mori teaches a chip comprising microwells modified with PEG to create a non-adhesive area and also containing a cell-adhesive area and a method for culturing cells to produce spheroids where the spheroids did not attach to the PEG surface (Abstract; Figure 1; page 238, left col. para. 1; page 239, left col. para. 4; page 240, left col. para. 1). Mori teaches cells inoculated on the chip were trapped in each microwell and accumulated on the cell-adhesive surface within 1 day of culture and formed smooth-surfaced and highly circular spheroids within 2 – 3 days (page 239, left col. para. 4). Mori teaches a cell-adhesion area can be designed by using artificial materials (page 241, right col. last para.). Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture (Abstract; page 241, right col. last para.). It would have been obvious prior to the effective filing date of the invention as claimed to have modified the cell culture vessel of claim 4 or 5 of Makino to include a non-cell adhesive inner circumferential face to force the cells to form spheroids on the cell-adhesive surface. One would have been motivated to make this modification to produce organoids because Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture. One would have a reasonable expectation of success in making this modification because Mori teaches providing both a cell-adhesive surface and a non-cell adhesive surface caused the cells to accumulate on the cell-adhesive surface and smooth-surfaced and highly circular spheroids formed within 2 – 3 days of culture and Mori teaches a cell-adhesion area can be designed by using artificial materials.
Applicant’s Arguments/ Response to Arguments
23. Applicant Argues: Applicant asserts that from Mori, the skilled person cannot arrive at the cell culture sheet wherein “the proportion of the cell-adhesive surface of the bottom face of the recess is substantially 100% of the area of the bottom face of the recess” of amended claims 15 an 16.
Response to Arguments: The prior rejection of the claims using the teachings of Amit has been withdrawn in view of Applicant’s amendment to claim 15 and 16 to require the cell adhesive substance comprise a fluorine-containing polyimide resin. In the new rejection, Makino teaches a cell culture plate where 100% of the bottom surface comprises a fluorine-containing polyimide resin.
Applicant Argues: Applicant asserts that it is not possible to predict at all whether undifferentiated cell spheroids can be obtained by culturing undifferentiated cells using the method of described in Mori.
Response to Arguments: This is not found persuasive because Makino teaches iPS cells can be cultured in the cell culture plate where 100% of the bottom surface comprises a fluorine-containing polyimide resin and Makino teaches successfully forming spheroids by culturing hepatocytes or fibroblasts (col. 117) on this surface. Therefore, one of ordinary skill in the art would have a reasonable expectation that undifferentiated cell spheroids would be obtained by culturing iPS cells on a cell-adhesive surface comprising a fluorine-containing polyimide.
Applicant Argues: Applicant asserts the method enables the efficient production of undifferentiated cell spheroids and integrin-expressing cell spheroids at a high level.
Response to Arguments: This is not found persuasive because one of ordinary skill in the art would expect efficient production of undifferentiated cell spheroids and integrin-expressing cell spheroids because Makino teaches the formation of multiple cell spheroids by culturing cells on the fluorine-containing polyimide surface (Figure 19E) and one of ordinary skill in the art knows that hepatocytes produce integrins.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/Z.M.B./Examiner, Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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