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 .
Response to Amendment
The amendment filed 12/26/25 has been entered. Claims 19 have been amended. Claims 20-38 are in the previously presented/original form. Claims 1-18 and 39 are cancelled. Claim 40 is newly presented. Thus, claims 19-38 and 40 remain pending in the application. There were no objections or 112 rejections previously set forth in the Non-Final Office Action mailed 08/14/25. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claim 40 is objected to because of the following informalities:
Claim 40 line 1 reads “wherein clamp section” and should likely read “wherein the clamp section” for grammatical reasons and to provide antecedent basis for clamp section
Appropriate correction is required.
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.
Claims 19-22, 27-28, 30-31, 33, 35, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto et al. (U.S. PGPUB No. 2009/0156931), hereinafter Nemoto, in view of Uber, III et al. (U.S. PGPUB No. 2017/0165427), hereinafter Uber, Tachibana (U.S. PGPUB No. 2005/0029277), and Desch et al. (U.S. PGPUB No. 2015/0157791), hereinafter Desch.
Regarding claim 19, Nemoto discloses a syringe pump (110, see FIG. 2) to which a prefilled (see [0071]: syringe 200 can be pre-filled) syringe (200) is mounted (see [0076]: syringe 200 mounted to pump 110) comprising:
the prefilled syringe (200) comprising:
a liquid medicine (see [0008]: chemical liquid injector may inject physiological saline and/or contrast medium);
a barrel (210) including a body section that is cylindrical (tubular body of 210--see FIG. 2 and [0069]: syringe comprises cylinder member 210 which includes a tubular cylinder body) and that contains the liquid medicine (see medicine type in [0008] and in [0071]: syringe may be pre-filled with liquid), and a nozzle section (212)(see FIG. 6) that is provided on a distal end side (towards 212 "forward" as shown in axis of Fig. 2) of the body section (tubular body of 210) and configured to discharge the liquid medicine (see [0102]: syringe 200 and 110 combine to perform an injection operation--an injection must discharge the liquid medicine by definition);
a plunger (220) configured to slide toward a distal end side (see [0183]: plunger driver 116 moves in forward/ distal direction and [0079]: driver 116 moves plunger 220 of syringe. Thus, prefilled syringe plunger also moves toward distal end side.) of the body section (tubular body 210) to discharge liquid medicine (see [0105]: controls injection rate to discharge liquid medicine) from the nozzle section (212) of the barrel (210); and
an RFID tag (230)(see FIG. 6) that has a fixed location with respect to an outer circumferential surface (see [0074]: RFID tag 230 is placed on outer circumference of 210 using adhesive--adhesive implies position is "fixed") of the body section (tubular body of 210) of the prefilled syringe (200) and has an antenna (233, see FIG. 7) for communication (see [0147]: antenna 233 of RFID tag 230 enables favorable wireless communication) and a memory (see [0072]: RFID tag has various types of data recorded thereon, therefore must have a memory i.e. see [0074]: chip body 231 contains various information), the antenna (233) being structured from an antenna wire that is wound in a rectangle (see FIG. 7—antenna wire 233 follows shape of RFID tag 230, generally in shape of rectangle: 2 sets of parallel sides on a 4-sided figure);
the syringe pump (110) comprising:
a syringe plunger (116-- see [0078]: plunger driver 116 in rearward section of concave area 114, behind holding mechanism 120, see FIG. 2) driving section configured to drive (see [0105]: 116 drives piston at controlled rate) the plunger (220) of the prefilled syringe (200) in a distal direction toward the distal end of the body section (see [0183]: plunger driver 116 moves in forward direction, see axis on Fig. 2 where "forward" corresponds to a distal direction);
a main body (100)(see FIG. 3 &11 and [0082]: injector 100 includes reader 130) provided with a reader (130)(see FIG.11) and a control unit (150) configured to control the syringe plunger driving section (see [0103]: injection controller 158 of control means 150 controls operation of plunger driver 116 based on data), the reader (130) configured to read a data set (see [0090]: reader and RFID tag communicate wirelessly, and [0095]: data is accumulated and stored via control means 150, and [0096]: control means 150 stores data recorded wirelessly from RFID tag) stored in the memory of the RFID tag (230) of the prefilled syringe (200);
a supporting section (114) configured to support the outer circumferential surface (see outer circumferential surface of the tubular body section of barrel 210) of the body section (tubular body of 210) of the prefilled syringe (200) in a direction perpendicular (in upward direction against gravity according to axis in Fig. 2) to an axis (body of barrel 210 extends in forward/rearward according to axis shown in Fig. 2) of the body section (tubular body of 210);
a clamp section (120) configured to clamp (see [0080]: clamp section 120 formed of pair of holding members, left and right) the body section (tubular body of 210. Clamp section has ‘holding members’ forming a slot to enclose flange of syringe. Further, the holding members of the clamp section include a circumferential edge that is in contact with the syringe body on the outside of flange. Therefore, the clamp section is ‘configured to clamp’ the body section because the clamp section exerts a force on the syringe body section by the contact with the body section as seen in ‘Modified FIG. 2’ below. The edge is traced in black)
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of the prefilled syringe (200) within (see [0080]: clamp section 120 for holding syringe in place within, see [0078], [0081]: the concave portion of 114) the supporting section (114);
wherein the main body (100) of the syringe pump (110) has a first region (surface portion along axial axis of 114 and rearward of structure 120) facing (see [0080]: clamp section 120 formed of pair of holding members, left and right, these portions "face" inwardly/ perpendicular/ leftward/ rightward according to axis in Fig. 1B/ relative to concave surface of 114 extending in axial direction, see Fig. 2) the clamp section (120) and a second region (surface portion along axial axis of 114 and forward of structure 120, see FIG. 2) that is adjacent (see Fig. 2) to the first region (surface portion along axial axis of 114 and rearward of structure 120) and is located on a side opposite (forward direction is opposite to rearward direction as indicated on axis of Fig. 2) to the syringe plunger driving section (116) in an axial direction (forward/rearward is axial direction) of the body section (tubular body of 210);
the reader (130) includes (see [0169]: reader includes reader antennas 132) a reader antenna (132) configured to communicate (see [0147]: direction of RFID tag antenna 233 coincides with reader antenna 132 to enable favorable wireless communication) with the antenna (233) of the RFID tag (230) and that is structured from a reader antenna wire (see [0083]: 132 formed of a single wire, and see Fig. 10A);
at least a part of the reader antenna (132) is located in the second region (surface portion along axial axis of 114 and forward of structure 120, see FIG. 2);
when the prefilled syringe (200) is mounted (see [0076]: syringe 200 mounted onto syringe pump 110) on the supporting section (114) of the syringe pump (110), the RFID tag (230) is located proximal (in rearward direction as indicated in Fig. 2) to a distal end of the plunger (116) of the prefilled syringe (200, see [0183]: plunger driver 116 moves in forward direction, [0079]: driver 116 moves plunger 220 of syringe to, see [0105]: controls injection rate to discharge liquid medicine from nozzle. Therefore, there must exist a time when the RFID tag is located proximal to the distal end of the plunger because plunger moves forward/distally to discharge medicine during injection procedure.) in the axial direction (forward/backward as indicated by axis in Fig. 2) and the RFID tag (230) faces (see fig. 6 for correct orientation of RFID tag of syringe in mounted position and Fig. 10B showing RFID tag 230 aligned with antenna 132 that is located on second region) the second region (surface portion along axial axis of 114 and forward of structure 120, see FIG. 2), and which ensures that the RFID tag (230) does not interfere with a visibility of the liquid medicine (see ‘Modified Fig.2’: “a” visibility of the liquid medicine will always be viewable in front of where the RFID tag is mounted. Thus, the positioning of the RFID in the mounted position ‘does not interfere with “a” visibility’ of the medicine) in the body section (tubular body of 210) of the barrel (210), and wherein the clamp section (120) and the RFID tag (230) do not overlap one another (see FIG. 2: when the device is assembled along the dashed line as shown, the RFID tag will be located in front of clamp section 120 that mates with flange 213, see [0080] for mating. Thus, the RFID tag 230 does not overlap the clamp section 120 when the syringe is mounted); and
wherein
wherein the clamp section (120, see FIG. 2) is supported by a base (113), and a distance (see ‘Modified FIG. 2’ below)
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between the clamp section (120) and the supporting section (114) provided on the front surface (see ‘Modified FIG. 2’ above) of the main body (113) of the syringe pump (110);
the supporting section (114) includes a concaved surface (see concaved surface of 114 in Fig. 2 for receiving syringe and [0077]: concave portion 114) having a semicircular cross section (see semi-circular cross-section of 114 looking in ‘Rearward’ direction as shown in Fig. 2) configured to receive an outer circumferential surface (circumferential surface of 210, see [0077]: surface receives surface of 210) of the body section (tubular body of barrel 210) of the prefilled syringe (200), and the supporting section (114) is configured to receive a plurality of types of body sections having different outer diameters (configure to is functional language. Therefore, because the section 114 is capable of receiving a body section, it is also configured to receive body sections of different diameters. Further, see FIG. 19 and [0172-0176]: a cylinder adapter placed into supporting section 114 is provided to accommodate different sized diameter syringes); and
the reader (130, see [0082]: reader 130 formed of antenna 132 and circuit 131 and [0083]: antenna 132 formed of portions 132R and 132L) is arranged adjacent (see Fig. 9 antenna portions 132R, 132L adjacent surface 114 and [0083]) to the concaved surface (see Fig. 2 and [0077]) of the supporting section (114).
Nemoto is silent to: “a cap configured to seal a distal end opening provided on a distal end section of the nozzle section;”, “a gasket configured to slide on an inner circumferential surface of the body section of the prefilled syringe, the gasket” configured to slide toward the distal end side of the body section to discharge the liquid medicine from the nozzle section of the barrel; a plunger “configured to be attachable to the gasket,” and when the prefilled syringe is mounted on the syringe pump, the RFID tag is located proximal to a distal end of the “gasket” of the prefilled syringe in the axial direction, and “the distal end of the gasket being visually recognized at all times”, wherein the clamp section is supported by a base “and is configured to be movable in a longitudinal direction of the base, the longitudinal direction of the base being perpendicular to the axis of the body section of the barrel of the prefilled syringe and in a horizontal direction relative to the main body of the syringe pump,” and wherein the distance between the clamp section and the supporting section “can be changed by moving the clamp section in the longitudinal direction of the base”.
However, Uber teaches a syringe pump (10, see FIG. 1) with a prefilled syringe (12) comprising a gasket (26) configured to slide on an inner circumferential surface of a body section (18, see FIG. 2 and [0037]: 26 forms a liquid tight seal against sidewall of barrel) of the prefilled syringe (12), the gasket (26) configured to slide toward the distal end (see [0046]: gasket 26 moved in distal direction expels fluid) side of the body section (18, see FIG. 2) to discharge the liquid medicine from the nozzle section (22, see FIG. 2); a plunger configured to be attachable to the gasket (see [0034]: pump has ‘piston elements’ for connecting to gasket 26 and [0046]: a ‘linear actuator’==plunger of pump engages==attachable to gasket 26 to withdraw or expel fluid. Therefore, plunger is ‘configured to be’ attachable to the gasket), and when the prefilled syringe (12) is mounted on the syringe pump (see FIG. 1), an RFID tag (34) is located proximal (leftward in FIG. 1) to a distal end (rightward in FIG. 1) of the gasket (26) of the prefilled syringe (12) in the axial direction (left/right), the distal end of the gasket being visually recognized at all times (see FIG. 1: the distal end of the gasket is visually recognized because RFID tag/ other structural elements of pump do not impede view of gasket through the transparent barrel 18—see [0052]--of the syringe 12).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger disclosed in Nemoto to include the gasket as taught by Uber for the purpose of forming a liquid tight seal within the prefilled syringe when the plunger is moved (see [0037]), thus achieving “a gasket configured to slide on an inner circumferential surface of the body section of the prefilled syringe, the gasket” configured to slide toward the distal end side of the body section to discharge the liquid medicine from the nozzle section of the barrel; a plunger “configured to be attachable to the gasket.”
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the RFID tag at a proximal end of the syringe barrel disclosed in Nemoto to be located proximal to a distal end of the gasket such as taught by Uber for the purpose of ensuring that the RFID tag can be read when the prefilled syringe is mated with the syringe pump (see [0035], [0039], and [0046]), thus achieving when the prefilled syringe is mounted on the syringe pump, the RFID tag is located proximal to a distal end of the “gasket” of the prefilled syringe in the axial direction and “the distal end of the gasket being visually recognized at all times”.
Nemoto in view of Uber remain silent to “a cap configured to seal a distal end opening provided on a distal end section of the nozzle section”, wherein the clamp section is supported by a base “and is configured to be movable in a longitudinal direction of the base, the longitudinal direction of the base being perpendicular to the axis of the body section of the barrel of the prefilled syringe and in a horizontal direction relative to the main body of the syringe pump,” and wherein the distance between the clamp section and the supporting section “can be changed by moving the clamp section in the longitudinal direction of the base”.
However, Tachibana teaches a syringe pump (1, see FIG. 1) with a prefilled syringe (2, see FIG. 5A and [0061]: syringe 2 is prefilled syringe) comprising a cap (32, see FIG. 5A) configured to seal a distal end opening provided on a distal end section of the nozzle section (see [0061]: cap 32 maintains sterility of delivery outlet==distal end opening of distal end section of nozzle).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the nozzle section disclosed in Nemoto with the cap configured to seal a distal end opening as taught by Tachibana for the purpose of maintaining sterility of the prefilled syringe (see [0061]), thus achieving “a cap configured to seal a distal end opening provided on a distal end section of the nozzle section.”
Nemoto in view of Uber and Tachibana remain silent to wherein the clamp section is supported by a base “and is configured to be movable in a longitudinal direction of the base, the longitudinal direction of the base being perpendicular to the axis of the body section of the barrel of the prefilled syringe and in a horizontal direction relative to the main body of the syringe pump,” and wherein the distance between the clamp section and the supporting section “can be changed by moving the clamp section in the longitudinal direction of the base”.
However, Desch teaches a syringe pump (500, see FIG. 28) with a prefilled syringe (504) and a clamp section (518) supported by a base (see rod extending from main body 502 in ‘Modified FIG. 29’ below)
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and is configured to be movable in a longitudinal direction (see [0514]: 518 is pulled from a resting position, such as in direction shown by arrow in ‘Modified FIG. 29’ above) of the base (see ‘Modified FIG. 29’ above and [0514]) the longitudinal direction of the base (rod of clamp, see ‘Modified FIG. 29’ above) being perpendicular to (as seen in ‘Modified FIG. 29 above or see FIG. 32) the axis of the body section of the barrel of the prefilled syringe (see ‘Modified FIG. 29’ above) and in a horizontal direction (longitudinal axis of base extends horizontally or left/right from main body) relative to the main body (502) of the syringe pump (500), and wherein a distance (see ‘Modified FIG. 31’ below)
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between the clamp section (518) and a supporting section (506, see [0514]: syringe seat 506) can be changed by moving the clamp section (518) in the longitudinal direction of the base (see [0514] & [0519]: 518 is pulled). Desch further teaches the supporting section (506) of the syringe side-mounted to the housing by a mount (508, see FIG. 29 and [0502]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamp section disclosed in Nemoto to further include a movable base portion/ rod fitted with a retractable projection as taught by Desch for the purpose of allowing the clamping mechanism to adjust for fitting various syringe sizes (see [0509]), thus achieving wherein the clamp section is supported by a base “and is configured to be movable in a direction of the base,” and wherein the distance between the clamp section and the supporting section “can be changed by moving the clamp section in the direction of the base”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supporting section in a vertically mounted position disclosed in Nemoto to be horizontally mounted onto the syringe pump by a side mount as taught by Desch for the purpose of forming a splash guard between the syringe and the pump (see [0502]) that prevents unwanted material entering the rest of the device (see [0504]), thus achieving wherein the clamp section is supported by a base and is configured to be movable in a “longitudinal” direction of the base, “the longitudinal direction of the base being perpendicular to the axis of the body section of the barrel of the prefilled syringe and in a horizontal direction relative to the main body of the syringe pump,” and wherein the distance between the clamp section and the supporting section can be changed by moving the clamp section in the “longitudinal” direction of the base.
Further, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the vertically-orientation of the supporting section disclosed in Nemoto with the horizontal/ side orientation of the supporting section as taught by Desch. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a vertical orientation for mounting a syringe to a housing) for another known element (a vertical orientation for mounting a syringe to a housing) in the art to obtain the predictable result of mounting a syringe to a pump by known orientations in the art (see MPEP § 2143.I.B).
Regarding claim 20, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein a centerline (see ‘Modified Fig. 10A’ below)
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of the reader antenna (132) perpendicular (upward/downward) to the axial direction (see ‘Modified Fig. 10A’ above) of the body section (tubular body of 210) of the barrel (210) is located in the second region (see Fig. 2, antenna 132 located in second region, forward of 120--therefore centerline MUST also be in second region) in a front view (looking in rightward direction toward Fig. 2) of the supporting section (114).
Regarding claim 21, the modified system of Nemoto teaches the syringe pump according to claim 20, and Nemoto further discloses wherein at least a part of the reader antenna (132, see Fig. 10B) overlaps with the antenna (233) of the RFID tag (230) in the front view (looking “rightward” as shown in axis of Fig. 10B) of the supporting section (114).
Regarding claim 22, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein, when the clamp section (120, see Fig. 2) is configured to clamp (see [0080]: clamp section 120 for holding syringe in place within, see [0078], [0081]: the concave portion of 114) the prefilled syringe (200) between the supporting section (114) and the clamp section (120), and wherein a region (front surface within dotted lines of flange 213) clamped (see Fig. 1B) by the clamp section (120) in the outer circumferential surface (see circumferential surface of syringe body that would contact circumferential ‘edge’ as labeled in ‘Modified FIG. 2’ above) of the body section (210) is different from a region where the RFID tag (230) is attached (230 affixed on top face of circumferential surface of barrel 210).
Regarding claim 27, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein the RFID tag (230, see FIG. 2) is not located distal (‘forward’ as indicated by axis in Fig. 2) to the distal end of the plunger (220) in the axial direction (‘forward’/ ‘rearward’ as indicated by axis) of the body section of the prefilled syringe (200) during the discharge of the liquid medicine (there must be a point during discharge when the distal end of the plunger is located distal to the RFID tag-- see [0183]: plunger driver 116 moves in forward/ distal direction and [0079]: driver 116 moves plunger 220 of syringe. Thus, prefilled syringe plunger also moves toward distal end side.) from the nozzle section (212) of the barrel (210) of the prefilled syringe (200), but is silent to the RFID location relative to the distal end of the “gasket”.
However, Uber teaches a syringe pump (10, see FIG. 1) with a prefilled syringe (12) comprising a gasket (26), wherein an RFID tag (34) is not located distal to the distal end (see FIG. 1: RFID tag 34 located proximal/ leftward of gasket 26) of the gasket (26) in the axial direction (left/right) of a body section of the prefilled syringe (12).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the RFID tag at a proximal end of the syringe barrel disclosed in Nemoto to be located proximal to a distal end of the gasket such as taught by Uber for the purpose of ensuring that the RFID tag can be read when the prefilled syringe is mated with the syringe pump (see [0035], [0039], [0046]), thus achieving the RFID location relative to the distal end of the “gasket”.
Regarding claim 28, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein the liquid medicine (see medicine type in [0008] and in [0071]: syringe may be pre-filled with liquid) is contained in the barrel (210, see FIG. 2 and [0072]: liquid contained in syringe barrel) of the prefilled syringe (200) between the nozzle section (212) of the barrel (210) of the prefilled syringe (200) and the distal end of the plunger (220) when the prefilled syringe (200) is mounted on the supporting section (114) of the syringe pump (110), but is silent to “a cap on” the nozzle section and the liquid medicine between the nozzle section and the distal end of “the gasket”
However, Uber teaches a syringe pump (10, see FIG. 1) with a prefilled syringe (12) comprising a gasket (26), with a liquid medicine between a nozzle section and the distal end of the gasket (26).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the liquid medicine between a nozzle section and distal end of a plunger disclosed in Nemoto to be between a nozzle section and a distal end of a gasket as taught by Uber for the purpose of ensuring a liquid tight seal when the plunger is moved (see [0037]), so that medicine does not leak out of the syringe, thus achieving the liquid medicine between the nozzle section and the distal end of “the gasket.”
Nemoto in view of Uber remain silent to “a cap on” the nozzle section.
However, Tachibana teaches a syringe pump (1, see FIG. 1) with a prefilled syringe (2, see FIG. 5A and [0061]: syringe 2 is prefilled syringe) comprising a cap (32, see FIG. 5A) on a nozzle section (see [0061]: cap 32 maintains sterility of delivery outlet==distal end opening of distal end section of nozzle).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the nozzle section disclosed in Nemoto to include a cap as taught by Tachibana for the purpose of maintaining sterility of the prefilled syringe (see [0061]), thus achieving “a cap on” the nozzle section.
Regarding claim 30, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein the clamp section (120) and the RFID tag (230) do not overlap one another (see FIG. 2: when the device is assembled along the dashed line as shown, the RFID tag will be located in front of clamp section 120 that mates with flange 213, see [0080] for mating. Thus, the RFID tag 230 does not overlap the clamp section 120 when the syringe is mounted, which prevents the RFID tag (230) from being damaged (clamp section 120 does not touch/overlap RFID tag and therefore could not damage the tag) by the clamp section (120).
Regarding claim 31, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein a portion (see circumferential portion of syringe body that aligns with clamping ‘edge’ as shown in ‘Modified FIG. 2’ above) clamped by the clamp section (120) of the syringe pump (110) in an outer circumferential surface (see circumferential portion of syringe body that aligns with clamping ‘edge’ as shown in ‘Modified FIG. 2’ above) of the prefilled syringe (200) is located proximal (proximal direction toward plunger back 222 in FIG. 2) to a portion (see surface area of barrel 210 where RFID tag 230 is attached) where the RFID tag (230) is attached (see [0071]: 230 placed on 210).
Regarding claim 33, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein the reader (130, see FIG. 11) of the syringe pump (110) includes a reader antenna configured to receive a data set stored in a memory of the RFID tag (230, see [0090]: reader and RFID tag communicate wirelessly, and [0095]: data is accumulated and stored via control means 150, and [0096]: control means 150 stores data recorded wirelessly from RFID tag. Thus the reader antenna is configured to receive a data set stored in the memory of the RFID tag), the reader antenna (130) being structured from an antenna wire (see [0083]: 132 formed of a single wire, see FIG. 10A).
Regarding claim 35, the modified system of Nemoto teaches the syringe pump according to claim 22, and Nemoto further discloses wherein the reader (130, see Fig. 2) of the syringe pump includes a reader antenna (132) configured to receive a data set stored (see [0108]: reader 130 receives recorded data from RFID tag 230) in a memory of the RFID tag (230, see [0072]: RFID tag has various types of data recorded thereon, therefore must have a memory i.e. see [0074]: chip body 231 contains various information), the reader antenna (132) being structured from an antenna wire (see [0083]: 132 formed of a single wire, and see Fig. 10A) and wherein a part of the reader antenna (132, see Fig. 2) is displaced (see antenna 132 located distally from the first region and separated by the clamp section 120) from the first region (surface portion along axial axis of 114 and rearward of structure 120) that faces the clamp section (120) of the clamp region (front surface within dotted lines of flange 213, shown in Fig. 1B) in a front view (such as looking “Rightward” as labeled in Fig. 2: 132 is shown displaced from the first region) of the supporting section (114).
Regarding claim 40, the modified system of Nemoto teaches the syringe pump according to claim 19, but Nemoto is silent to “wherein clamp section is configured to be movable in a circumferential direction around a central axis of the base.”
However, Desch teaches a syringe pump (500, see FIG. 29) with a prefilled syringe (504, see FIG.31) and a clamp section (518) supported by a base (see ‘Modified FIG. 29’ above), wherein clamp section (518) is configured to be movable in a circumferential direction around a central axis of the base (see rotation of clamp from position in FIG. 31 to position in FIG. 32 and see [0519-0520]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamp section disclosed in Nemoto to further include a movable base portion/ rod fitted with a rotatable projection as taught by Desch for the purpose of allowing the clamping mechanism to raise and rotate to adjust for fitting various syringe sizes (see [0509]) and to allow the syringe to be locked into position (see [0519]), thus achieving “wherein clamp section is configured to be movable in a circumferential direction around a central axis of the base.”
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto in view of Uber, Tachibana, and Desch as applied to claim 19 above, and further in view of Nemoto et al. (U.S. PGPUB No. 2009/0149744), hereinafter Nemoto2.
Regarding claim 23, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses wherein the barrel (210) has a flange (213) that protrudes from a proximal end (in direction of “rearward” as labeled in Fig. 2) section of the body section (tubular body of 210 terminates proximally at flange 213); the clamp section (120) is configured to come into contact within a vicinity (see ‘Modified Fig. 1B’ above: front surfaces of flange 213-- shown in dotted lines—are in contact with clamp section 120) of the flange (213) of the body section (tubular body of 210), and to clamp (see [0080]: clamp section 120 for holding syringe in place within, see [0078], [0081]: the concave portion of 114) the prefilled syringe (210) with the supporting section (114), and a distance between a proximal end of the RFID tag (230) and a distal end of the flange (213) of the barrel (210) in an axial direction of the body section (see ‘Modified fig. 6’ below)
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Nemoto is silent to the distance “is 15 mm to 40 mm”
However, Nemoto2 teaches a syringe pump (see Fig. 1(a)) with a prefilled syringe (200) an axial distance between an RFID tag (230) and an RFID antenna (240), wherein the axial distance is 15mm (see [0066]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the axial distance between the RFID tag and the barrel flange disclosed in Nemoto to be a distance of 15mm as taught by Nemoto2 for the purpose of providing a distance that is an integral multiple of the communication wavelength to achieve desired amplification from the RFID tag (see [0066]), which in Nemoto is formed on the RFID tag itself, thus achieving the distance “is 15 mm to 40 mm”
Claims 24-26 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto in view of Uber , Tachibana, and Desch as applied to claim 19 above, and further in view of Shaw et al. (U.S. PGPUB No. 2019/0298929), hereinafter Shaw, and Appelbaum (U.S. PGPUB No. 2020/0261655).
Regarding claim 24, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses the prefilled syringe (200, see FIG. 2) is mounted on the supporting section (114) of the syringe pump (110) and an RFID tag (230) is located on the prefilled syringe barrel (210), but is silent to “wherein the prefilled syringe includes a plurality of scales, the RFID tag being located between at least two scales of the plurality of scales, and when the prefilled syringe is mounted on the supporting section of the syringe pump, at least one scale of the at least two scales is exposed and configured to be visually recognized be a user.”
However, Shaw teaches a syringe (20, see FIG.1) with a barrel (22) including a plurality (see [0013]: two oppositely facing scales/ other indicia) of scales (27), at least one scale of the at least two scales is exposed and configured to be visually recognized be a user (see [0013]: volumetric scale/ other indicia easily readable due to outwardly facing surface areas where scales are provided).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel disclosed in Nemoto with the two opposingly facing volumetric scales as taught by Shaw for the purpose of making the volumetric scale easily readable, thereby reducing the likelihood of dosing errors (see [0013]), thus achieving “wherein the prefilled syringe includes a plurality of scales, and when the prefilled syringe is mounted on the supporting section of the syringe pump, at least one scale of the at least two scales is exposed and configured to be visually recognized be a user”.
Nemoto in view of Shaw is silent to “the RFID tag being located between at least two scales of the plurality of scales”.
However, Appelbaum teaches a syringe (740, see Figure 7) with a barrel including a volume scale (742, see [0120]: 742 graduations indicating volume) and an RFID tag (see [0066]: system includes patient specific data and [0073]: patient identifier may be RFID tag) adjacent (see ‘Modified FIG. 7’ below) the volume scale (742).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel with the two opposingly faced volumetric scales taught by Nemoto in view of Shaw2 to include the RFID tag adjacent to the volumetric scales as taught by Applebaum for the purpose of receive medicament information relating to the dosing regimen based on the patient data (see [0018-0021], [0027]), thus achieving “the RFID tag being located between at least two scales of the plurality of scales”.
Regarding claim 25, the modified system of Nemoto teaches the syringe pump according to claim 24, but Nemoto is silent to “wherein the at least two scales of the plurality of scales are symmetrical with respect to a central axis of the body section of the barrel of the prefilled syringe.”
However, Shaw teaches a syringe (20, see FIG.1) with a barrel (22) including at least two (see [0013]: two oppositely facing scales/ other indicia) scales (27) that are symmetrical (see [0013]: oppositely facing) with respect to a central axis (longitudinal axis extending through barrel 22) of the body section of the barrel (22) of the syringe (20).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel disclosed in Nemoto with the two opposingly facing volumetric scales as taught by Shaw for the purpose of making the volumetric scale easily readable, thereby reducing the likelihood of dosing errors (see [0013]), thus achieving “wherein the at least two scales of the plurality of scales are symmetrical with respect to a central axis of the body section of the barrel of the prefilled syringe.”
Regarding claim 26, the modified system of Nemoto teaches the syringe pump according to claim 25, but Nemoto is silent to “wherein the at least two scales of the plurality of scales are configured to indicate an amount of liquid medicine contained in the barrel of the prefilled syringe.”
However, Shaw teaches a syringe (20, see FIG.1) with a barrel (22) including at least two (see [0013]: two oppositely facing scales/ other indicia) scales (27) configured to indicate an amount of liquid medicine (see [0013]: oppositely facing scales are volumetric scales) contained in the barrel (22) of the syringe (20).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel disclosed in Nemoto with the two opposingly facing volumetric scales as taught by Shaw for the purpose of making the volumetric scale easily readable, thereby reducing the likelihood of dosing errors (see [0013]), thus achieving “wherein the at least two scales of the plurality of scales are configured to indicate an amount of liquid medicine contained in the barrel of the prefilled syringe.”
Regarding claim 32, the modified system of Nemoto teaches the syringe pump according to claim 24, but Nemoto is silent to “wherein the prefilled syringe includes an information area arranged between the at least two scales of the plurality of scales and distal of the RFID tag.”
However, Shaw teaches a syringe (20, see FIG. 1) with a barrel (22), wherein the syringe includes at least two (see [0013]: two oppositely facing scales/ other indicia) scales of a plurality of scales (see [0013]: more than 1 scale).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel disclosed in Nemoto with the two opposingly facing volumetric scales as taught by Shaw for the purpose of making the volumetric scale easily readable, thereby reducing the likelihood of dosing errors (see [0013]), thus achieving “wherein the prefilled syringe includes at least two scales of the plurality of scales”
Modified Nemoto in view of Shaw remain silent to “an information area arranged between” the at least two scales of the plurality of scales “and distal of the RFID tag”.
However, Appelbaum teaches a syringe (740, see Figure 7) with a barrel including a volume scale (742, see [0120]: 742 graduations indicating volume) and an RFID tag (see [0066]: system includes patient specific data and [0073]: patient identifier may be RFID tag), with an information area (see “0.5 mg” and “+4mL saline” in Figure 7 indicating recommended dosing of medicine and dilution information, see [0079]) arranged beside the scale (742) and distal (toward tip shown in Figure 7) of an RFID tag (see [0073] and RFID tagin ‘Modified FIG. 7’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify one of the plurality of scales taught by Modified Nemoto in view of Shaw to include an information area beside the scale and distal of the RFID tag as taught by Appelbaum for the purpose of providing critical information related to the medicament contained therein (see [0079]) and guiding administration of the medicament dosing without impeding the readability of the RFID tag, which also contains information related to medicament dosing (see [0015], [0026-0028]), thus achieving “an information area arranged between” the at least two scales of the plurality of scales “and distal of the RFID tag” (the placement of the information section beside one of the scales would subsequently dispose the information section ‘between’ the scales).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto in view of Uber, Tachibana, and Desch as applied to claim 19 above, and further in view of Palmer et al. (U.S. PGPUB No. 2013/0090594), hereinafter Palmer.
Regarding claim 29, the modified system of Nemoto teaches the syringe pump according to claim 19, wherein the antenna (233, see FIG. 7) of the RFID tag (230) and the reader antenna (132, see FIG. 10A) of the of the syringe pump (110) are configured to have a communicable distance (see [0090]: reader and RFID tag communicate wirelessly), but is silent to the distance being “of 35 mm or less.”
However, Palmer teaches a dispensing device for inpatient use (see [0253]) with high frequency RFID communication such that the RFID communicable distance between the RFID tag and antenna is between 0 and 3 inches—or 0 to 76.2 mm—to make unauthorized data access very difficult (see [0253]). Palmer further teaches that modifying the alignment and location of the RFID tag antenna relative to the reader antenna and/or changing the wavelength (frequency) of the communication device will change the communicable distance of an RFID tag (see [0252-0253]). Therefore, a person of ordinary skill in the art would consider the communicable distance of an RFID tag to be a result effect variable that is optimized through routine experimentation of modifying the alignment and location of the RFID tag relative to the RFID reader or modifying the RFID communicating frequency to obtain a communicable distance being “of 35mm or less.”
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the communicable distance of the RFID tag disclosed in Nemoto by modifying the alignment and location of the RFID tag relative to the RFID reader or by modifying the RFID communicating frequency as taught by Palmer to obtain a communicable distance being “of 35mm or less” as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, a person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the identified (Palmer teaches an example communicable distance of 0 to 76.2mm), predictable (see Palmer [0252-0253]: alignment and frequency affect communicable distance) solutions with a reasonable expectation of success for obtaining a communicable distance of the RFID tag being “of 35mm or less”, thus achieving the distance being “of 35 mm or less.”
Claim 34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto in view of Uber, Tachibana, and Desch as applied to claim 19 above, and further in view of Nemoto et al. (U.S. PGPUB No. 2008/0125713), hereinafter Nemoto3.
Regarding claim 34, the modified system of Nemoto teaches the syringe pump according to claim 33, but Nemoto is silent to “wherein an outer perimeter of the reader antenna is wound in a rectangle.”
However, Nemoto3 teaches a syringe pump to which a prefilled syringe is mounted, the syringe pump comprising a reader antenna (131, see Fig. 4) for reading an RFID tag (see [0117]: reader antenna 131 for communicating with RFID tag), wherein an outer perimeter of the reader antenna (131) is wound in a rectangle (see [0118]: reader antenna 131 formed of an elongated sheet==rectangle. Therefore AT LEAST the outer perimeter must be in the shape of a rectangle in order to form a sheet. See also Fig. 4 and Fig.1: cross sections in both directions are rectangular—therefore the sheet is rectangular).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reader antenna disclosed in Nemoto to be wound in a rectangular shape as taught by Nemoto3 for the purpose of having the rectangular shape of the RFID antenna align longitudinally with the rectangular shape of the reader antenna such that wireless communication is properly achieved (see [0146-0149]: when the longitudinal directions are not aligned, wireless communication does not work), thus achieving “wherein an outer perimeter of the reader antenna is wound in a rectangle”.
Regarding claim 36, the modified system of Nemoto teaches the syringe pump according to claim 33, and Nemoto further discloses wherein at least a part of the reader antenna (132, see Fig. 2) is located in the second region (surface portion along axial axis 114 and forward of structure 120), and an axial length of the reader antenna and an axial length of the RFID tag (see ‘Modified FIG. 10B’ below)
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Modified Nemoto is silent to “an axial length of the reader antenna is greater than an axial length of the RFID tag”
However, Nemoto3 teaches a syringe pump to which a prefilled syringe is mounted, the syringe pump comprising a reader antenna (131, see Fig. 4) for reading an RFID tag (see [0117-0118]: reader antenna 131 for communicating with RFID tag), an axial length of the reader antenna (see ‘Modified FIG. 1’ below) is greater than an axial length of the RFID tag (see ‘Modified FIG. 1’ below).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the axial length of the reader antenna disclosed in Nemoto to be longer than the axial length of the RFID tag as taught by Nemoto3 for the purpose of ensuring that the antennas are aligned longitudinally in a parallel direction for achieving wireless communication (see [0146]), thus achieving “an axial length of the reader antenna is greater than an axial length of the RFID tag.”
Further, a person of ordinary skill in the art could have combined the elements (an axial length of a reader antenna and an RFID tag disclosed in Nemoto with an axial length of a reader antenna greater than an axial length of an RFID tag taught by Nemoto3) as claimed by known methods (forming a reader antenna by wound wire as disclosed in both Nemoto and Nemoto3) with no change to the respective functions (the reader antenna and RFID tag antenna are attuned for communication at a certain frequency, for example see [0090] of Nemoto. Thus the geometrical configuration/ the axial length of the reader antenna has little effect on wireless communication). Further, the combination would yield nothing more than predictable results (a wireless communication between a reader antenna and an RFID tag where the reader antenna has an axial length greater than that of the RFID tag. ) to one of ordinary skill in the art.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto in view of Uber ,Tachibana, and Desch as applied to claim 19 above, and further in view of Chung (U.S. Patent No. 7,501,954).
Regarding claim 37, the modified system of Nemoto teaches the syringe pump according to claim 33, and Nemoto further discloses wherein an axial length of the RFID tag is 50mm (see [0090] RFID tag uses a specific product, MM tag, with the dimensions disclosed), but Modified Nemoto is silent to the axial length being “8 mm to 25 mm.”
However, Chung teaches an RFID tag with an axial length being 8mm to 25mm (see Fig. 10a and col. 4 lines 9-14: 10a is 1.5cm by 1.5 cm making both dimensions equivalent to 15mm within the claimed range).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the RFID tag comprising the dimensions of the specific product line disclosed in Nemoto with an RFID tag having an axial length of 8 to 25mm as taught by Chung for the purpose of optimizing the RFID tag for use in identifying a small article, such as a medication container (i.e. a syringe) (see col. 4 lines 9-14), thus achieving the axial length being “8 mm to 25 mm.”
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto in view of Uber, Tachibana, and Desch as applied to claim 19 above, and further in view of Hasegawa (U.S. PGPUB No. 2011/0184383) and British Standards Institution (see NPL previously provided on 03/12/25: BS ISO 11040-4-2015).
Regarding claim 38, the modified system of Nemoto teaches the syringe pump according to claim 19, and Nemoto further discloses a circumferential length (see length disposed around circumference of 210 in Fig. 2) of an outer circumferential surface (see surface forming cylindrical body 210 and outer circumference described in at least [0070]) of the body section (tubular body of 210) of the prefilled syringe (200) and a maximum circumferential length (see ‘Modified Fig. 7’ below) of the antenna (233) of the RFID tag (230) along the outer circumferential direction of the body (see ‘Modified FIG. 7’ below),
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and the maximum circumferential length (see ‘Modified Fig. 7’ above) of the antenna (233) of the RFID tag (230) is 9 mm to 25 mm (see [0090]: RFID tag 230 has dimension of 18mm by 50mm, the circumferential length being the shorter as depicted in fig. 7 and thus is the 18mm. Because the antenna 233 is formed on the tag 230, 232 MUST have a dimension less than or equal to that of the tag at 18mm and therefore the MAXIMUM circumferential length of the antenna 232 would be 18mm, which falls within the claimed range. )
Modified Nemoto is silent to the circumferential length of the syringe “is 2 times to 7 times” a maximum circumferential length of the antenna of the RFID tag along the outer circumferential direction of the body
However, Hasegawa teaches a syringe pump (11, see FIG.1) to which a syringe (12a) is mounted (see FIG. 2), wherein the syringe is a 20mL syringe (see [0048]: syringe can be any of a plurality of different sized standard syringes such as 10mL).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prefilled syringe in Nemoto to be a 20mL syringe as taught by Hasegawa for the purpose of using a syringe of a readily available size (see [0048]).
Next, British Standards Institution teaches that the outer diameter of a 20mL syringe MUST be 22.05mm ± 0.2mm (see Figure 1 and Table 1 on pages 5-6, equivalent to between 21.85mm and 22.25mm in diameter), resulting in a circumferential length of the syringe body of between 68.6mm and 69.9 mm (Circumference=π*diameter).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the 20mL syringe body taught by Modified Nemoto in view of Hasegawa has a diameter between 21.85 and 22.25mm as taught by British Standards Institution for the purpose of adhering to mandatory industry standards (parameters provided in the British Standards Institution reference align with U.S. standards for syringe barrels, i.e.: ISO 11040-4: 2015(E)), thus achieving the circumferential length of the syringe “is 2 times to 7 times” a maximum circumferential length of the antenna of the RFID tag along the outer circumferential direction of the body (the circumferential length of the syringe is between 68.6 and 69.9mm based on the diameter of Modified Nemoto in view of Hasegawa and British Standards Institution—see above. Further, the max circumferential length of the antenna of the RFID tag is 18mm—see above. 18mm *2 =36mm and 18mm *7 is 126mm. Thus, the circumferential length of the syringe-- between 68.6 and 69.9mm-- is 2 times to 7 times-- between 36 and 126mm--the max circumferential length of the antenna because 68.6 to 69.9 is between 36 and 126 and thus within the claimed range.)
Response to Arguments
Applicant’s arguments with respect to claim 19 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
A new reference, Desch, has been used to teach the newly amended limitation in combination with the previously cited references, rendering the argument against Tachibana for the amended feature moot.
Applicant's arguments filed 12/26/25 have been fully considered but they are not persuasive. On page 14, Applicant submits that the “front-surface of the main body” is of the supporting section 114 in Nemoto and thus is not the main body of the pump. The examiner disagrees. The front surface of main body 113 comprises the U-shaped cutout forming the supporting section 114 (see modified figures and rejection of claim 19 above) and therefore the examiner maintains that the front-surface as identified is of “the main body”.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783