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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/04/2025 has been entered.
Claim Status
1. The amendment filed 07/21/2025 has been entered. Claims 15 – 30 and 33 – 38 remain pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I (claims 15 – 30) in the reply filed on 08/26/2024 is acknowledged. Upon reconsideration, claims 31 – 32 have been rejoined.
3. Claims 33 – 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2024.
4. Claims 15 – 30 and 37 – 38 are under consideration.
Priority
5. This application claims the benefit of the filing date of JP2019-032200, which was filed on February 25, 2019.
6. 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Withdrawn Claim Rejections
7. The rejection of claims 15, 17, 19, 21, 23, 25, 27, and 29 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to claim 15.
8. The rejection of claims 16, 18, 20, 22, 24, 26, 28, and 30 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to claim 16.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 The rejection of claims 15 and 37 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to claim 15.
10. The rejection of claims 16 and 38 under 35 U.S.C. 102(a)(1) is withdrawn in view of Applicant’s amendment to claim 16.
11. Applicant’s filing of a terminal disclaimer on 07/21/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 17258940 has been reviewed and is accepted. The terminal disclaimer has been recorded. Accordingly, the rejection of claims 15, 23, 16, and 24 on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 17258940(reference application) is withdrawn.
New Claim Objections
12. Claim 23 is objected to because of the following informalities: in line 2, “on a cell culture sheet” should read “on the cell culture sheet”. Appropriate correction is required.
13. Claim 24 is objected to because of the following informalities: in line 2, “on a cell culture sheet” should read “on the cell culture sheet”. Appropriate correction is required.
Rejections Necessitated by Amendment
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.
14. Claim(s) 16, 18, 22, 24, and 26 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mori (Mori, Ryuhei, et. al. Journal of bioscience and bioengineering 106.3 (2008): 237-242.), hereinafter Mori.
Claim 16 is drawn to method for producing integrin-expressing cell spheroids, the method comprising the step of culturing 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 non-cell adhesive surface, and wherein the bottom face has a cell-adhesive surface, wherein the non-cell 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.
Regarding claim 16, 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 (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).
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 um 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).
Therefore, Mori anticipates claims 16, 18, 22, 24, and 26.
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.
15. 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.), hereinafter Mori in view of Amit (Amit, Michal, et al. Stem Cell Reviews and Reports 6.2 (2010): 248-259.), hereinafter Amit.
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 um 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 (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”.
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” 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.).
Regarding “culturing undifferentiated cells” of claim 15, the cells are undifferentiated stem cells or progenitor cells of claim 27 or the cells are pluripotent stem cells of claim 29 and the cells are iPS cells of claim 37, Amit teaches suspension culturing of undifferentiated human embryonic stem cells (hESCs) to form spheroids (claims 15, 27, and 29) and iPSCs (claim 37) in medium supplemented with IL6RIL6 chimera and bFGF for maintaining pluripotency (Abstract; page 257, left col. para. 3 and right col. para. 1 – 3; page 249, right col. para. 1; page 257, left col. para. 2). Amit teaches hESC created spheroids and were cultured successfully and split mechanically every 5 – 7 days all while maintaining their morphology, allowing to expand the suspension culture (page 249, right col. para. 1; Figure 1). Amit teaches the culturing method maintained the hESC and iPSCs in an undifferentiated state and maintained their pluripotency (page 250, left col. para. 2 and right col.; Figure 2; page 251, right col. last para.; page 252; page 253, left col. para. 1 – 2; page 254, right col.; page 256, right col. para. 3). Amit teaches hESC expansion over 14 days resulted in spheroid diameter increasing to 500 µm along with 30% apoptosis with most of the apoptotic and necrotic cells located in the center of the sphere (page 253, left col. para. 3 – 4; Figure 4). Amit teaches suspension cultures of hESC hold significant advantages over conventional ones in regard to obtaining large amounts of cells for cell and tissue transplantation (page 249, right col. para. 1). Amit teaches future clinical uses of hESC will require a reproducible, defined and xeno-free culture system (page 256, right col. para. 5).
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 with the teachings of Amit regarding a method of culturing undifferentiated cells to form spheroids to arrive at the claimed 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 polyethylene. One would have been motivated to combine the teachings of Mori and Amit in a method of expansion of pluripotent cells as Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture and Amit teaches future clinical uses of hESC will require a reproducible, defined and xeno-free culture system and Amit teaches hESC expansion over 14 days resulted in spheroid diameter increasing to 500 µm along with 30% apoptosis with most of the apoptotic and necrotic cells located in the center of the sphere. One would have a reasonable expectation of success in combining the teachings as Mori teaches the spheroid chip was designed to form organoids of less than approximately 200 µm in diameter and Amit teaches spheroid culture of cells allowed for expansion and maintenance of pluripotency and in an undifferentiated state.
16. 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.), hereinafter Mori in view of Amit (Amit, Michal, et al. Stem Cell Reviews and Reports 6.2 (2010): 248-259.), hereinafter Amit.
Mori anticipates claim 16 as set forth above. Mori does not teach 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.).
Regarding the cells are undifferentiated stem cells or progenitor cells of claim 28 or the cells are pluripotent stem cells of claim 30 and the cells are iPS cells of claim 38, Amit teaches suspension culturing of undifferentiated human embryonic stem cells (hESCs) to form spheroids (claims 28 and 30) and iPSCs (claim 38) in medium supplemented with IL6RIL6 chimera and bFGF for maintaining pluripotency (Abstract; page 257, left col. para. 3 and right col. para. 1 – 3; page 249, right col. para. 1; page 257, left col. para. 2). Amit teaches hESC created spheroids and were cultured successfully and split mechanically every 5 – 7 days all while maintaining their morphology, allowing to expand the suspension culture (page 249, right col. para. 1; Figure 1). Amit teaches the culturing method maintained the hESC and iPSCs in an undifferentiated state and maintained their pluripotency (page 250, left col. para. 2 and right col.; Figure 2; page 251, right col. last para.; page 252; page 253, left col. para. 1 – 2; page 254, right col.; page 256, right col. para. 3). Amit teaches hESC expansion over 14 days resulted in spheroid diameter increasing to 500 µm along with 30% apoptosis with most of the apoptotic and necrotic cells located in the center of the sphere (page 253, left col. para. 3 – 4; Figure 4). Amit teaches suspension cultures of hESC hold significant advantages over conventional ones in regard to obtaining large amounts of cells for cell and tissue transplantation (page 249, right col. para. 1). Amit teaches future clinical uses of hESC will require a reproducible, defined and xeno-free culture system (page 256, right col. para. 5).
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 with the teachings of Amit regarding a method of culturing undifferentiated cells to form spheroids to arrive at the claimed method where the cells are undifferentiated stem cells or progenitor cells. One would have been motivated to combine the teachings of Mori and Amit in a method of expansion of pluripotent cells as Mori teaches the chip culturing technology has potential for use in various applications that involve organoid culture and Amit teaches future clinical uses of hESC will require a reproducible, defined and xeno-free culture system and Amit teaches hESC expansion over 14 days resulted in spheroid diameter increasing to 500 µm along with 30% apoptosis with most of the apoptotic and necrotic cells located in the center of the sphere. One would have a reasonable expectation of success in combining the teachings as Mori teaches the spheroid chip was designed to form organoids of less than approximately 200 µm in diameter and Amit teaches spheroid culture of cells allowed for expansion and maintenance of pluripotency and in an undifferentiated state.
17. Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over over Mori (Mori, Ryuhei, et. al. Journal of bioscience and bioengineering 106.3 (2008): 237-242.), hereinafter Mori in view of Amit (Amit, Michal, et al. Stem Cell Reviews and Reports 6.2 (2010): 248-259.), hereinafter Amit as applied to claims 15, 17, 21, 23, 25, 27, 29, and 37 above, and further in view of Matsumoto (Matsumoto, Norihiro, et al. Journal of Photopolymer Science and Technology 21.1 (2008): 137-141.), hereinafter Matsumoto.
Mori in view of Amit make obvious the limitations of claim 15 as set forth above. Mori does not teach the cell-adhesive surface comprises a polyimide resin. 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.).
Matsumoto teaches a polyimide surface for cell adhesion and the cells attached to the surface are three-dimensional cell spheroids (Abstract; page 138, right col. para. 2; page 139, right col. para. 3). Matsumoto teaches the cells rapidly moved on the surface suggesting that the rapid movement led to the emergence of spheroids (page 139, right col. para. 4). Matsumoto teaches the spheroids formed had diameters less than 200 µm indicating that the cells in the spheroid are alive (page 140, left col. para. 1). Matsumoto teaches the method of forming the polyimide surface is a simple process and can easily prepare large surface areas, suggesting the method may become a novel cell culture method (page 140, right col.). Matsumoto teaches controlling cell morphologies is of interest with regard to tissue cultures because the morphologies are closely related to cell functions (page 137, left col. para. 1). Matsumoto teaches cell spheroids have been used in research areas of tissue engineering or cell chips because they appear to mimic not only the morphology but also the physiological functions of cells in living tissues and organs unlike two-dimensional cell culture (page 137, left col. para. 1). Matsumoto teaches the spheroid is well-known to sustain viability for extended culture periods and maintain high levels of cell functions when compared with those of cells as monolayers (page 137, left col. para. 1).
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 with the teachings of Amit regarding a method of culturing undifferentiated cells to form spheroids with the teachings of Matsumoto regarding culturing on a polyimide surface to form spheroids to arrive at the claimed method where the cell-adhesive surface comprises a polyimide resin. One would have been motivated to combine the teachings of Mori, Amit, and Matsumoto in a method of expansion of pluripotent cells that are viable as Amit teaches future clinical uses of hESC will require a reproducible, defined and xeno-free culture system and Amit teaches hESC expansion over 14 days resulted in spheroid diameter increasing to 500 µm along with 30% apoptosis with most of the apoptotic and necrotic cells located in the center of the sphere and Matsumoto teaches cell spheroids have been used in research areas of tissue engineering or cell chips because they appear to mimic not only the morphology but also the physiological functions of cells in living tissues and organs unlike two-dimensional cell culture. One would have a reasonable expectation of success in combining the teachings as Amit teaches spheroid culture of cells allowed for expansion and maintenance of pluripotency and in an undifferentiated state and Matsumoto teaches the spheroids formed had diameters less than 200 µm indicating that the cells in the spheroid are alive.
18. Claim(s) 16, 18, 20, 22, 24, and 26 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.), hereinafter Mori in view of Amit (Amit, Michal, et al. Stem Cell Reviews and Reports 6.2 (2010): 248-259.), hereinafter Amit.
Mori anticipates claim 16 as set forth above. Mori does not teach the cell-adhesive surface comprises a polyimide resin of claim 20. However, 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 it may be possible to control the diameters of rat hepatocyte-derived organoids by manipulating the density of inoculated cells (page 241, left col. para. 3).
Matsumoto teaches a polyimide surface for cell adhesion and the cells attached to the surface are three-dimensional cell spheroids (Abstract; page 138, right col. para. 2; page 139, right col. para. 3). Matsumoto teaches the cells rapidly moved on the surface suggesting that the rapid movement led to the emergence of spheroids (page 139, right col. para. 4). Matsumoto teaches the spheroids formed had diameters less than 200 µm indicating that the cells in the spheroid are alive (page 140, left col. para. 1). Matsumoto teaches the method of forming the polyimide surface is a simple process and can easily prepare large surface areas, suggesting the method may become a novel cell culture method (page 140, right col.). Matsumoto teaches controlling cell morphologies is of interest with regard to tissue cultures because the morphologies are closely related to cell functions (page 137, left col. para. 1). Matsumoto teaches cell spheroids have been used in research areas of tissue engineering or cell chips because they appear to mimic not only the morphology but also the physiological functions of cells in living tissues and organs unlike two-dimensional cell culture (page 137, left col. para. 1). Matsumoto teaches the spheroid is well-known to sustain viability for extended culture periods and maintain high levels of cell functions when compared with those of cells as monolayers (page 137, left col. para. 1).
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 with the teachings of Matsumoto regarding culturing on a polyimide surface to form spheroids to arrive at the claimed method where the cell-adhesive surface comprises a polyimide resin. One would have been motivated to combine the teachings of Mori and Matsumoto in a method of expansion of liver cells that are viable for tissue engineering as Matsumoto teaches cell spheroids have been used in research areas of tissue engineering or cell chips because they appear to mimic not only the morphology but also the physiological functions of cells in living tissues and organs unlike two-dimensional cell culture. One would have a reasonable expectation of success in combining the teachings as Matsumoto teaches the spheroids formed had diameters less than 200 µm indicating that the cells in the spheroid are alive.
Applicant’s Arguments/ Response to Arguments
19. Applicant Argues: On page 6 – 7 and page 8, para. 1, Applicant argues that Horikawa does not teach the amended claims.
Response to Arguments: The prior rejection of the claims using the teachings of Horikawa has been withdrawn in view of Applicant’s amendment to claim 15 and 16 to require the non-cell adhesive substance require one of the recited substances. A new rejection is set forth above where Mori teaches a method of culturing cells to form spheroids on a spheroid chip that meets the limitations of claims 15 and 16 (Figure 1A). Mori teaches in Figure 1A the diameter of the recesses is 300 µm, which meets the limitation of “an opening of 2,000 um or less in diameter” of claims 15 and 16. Mori teaches in Figure 1A that the bottom face has a cell-adhesive surface and an inner circumferential face coated with PEG (page 238, left col. para. 1).
Conclusion
No claims allowed.
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/Z.M.B./Examiner, Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632