DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 03 March 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claims 1-15, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto et al. (US Pat. No. 8728097 B1), “Sugimoto” in view of Gross et al. (US Pat. No. 10195030 B2), “Gross”.
Regarding claim 1, Sugimoto teaches a system for use with tissue of a heart (Figs. 1A-B), the system comprising: a helical member (Fig. 4A, helical fastener 94); and a guide assembly (Fig. 4A), having a distal part that is transluminally advanceable to the heart while in a delivery state (Fig. 4B, delivery sheath 90 (including region nearest distal tip 106) is advanced through the vascular system to the surgical site within the heart (col. 3, lines 7-12)), a guide rail (Fig. 4A, guide-wire 62), and a driver, configured to, while the guide rail is in the guide arrangement, anchor the helical member along an intracardial surface of tissue adjacent the guide frame, guided by the guide rail (Fig. 4A, coil delivery device 126 comprises torque coil 130, hub 122, and adapter cup 146, among other parts that together embed the helical fastener 94 into tissue (col. 4-6, lines 65-28)), but fails to teach a guide frame, intracardially expandable toward an expanded state, and multiple fasteners, configured to hold the guide rail in a guide arrangement around at least part of the guide frame.
Gross teaches a cardiac implant comprising a guide frame (Fig. 12B, leaflet-restraining frame 244), intracardially expandable toward an expanded state (Fig. 12B, frame 244 is transluminally advanced in a constrained state and then automatically expands into a working state when deployed (col. 28, lines 11-16)), and multiple fasteners (Fig. 12B, anchors 46), configured to hold the guide rail in a guide arrangement around at least part of the guide frame (Fig. 12B, anchors 46 hold support structure 242 to annulus 16 of native valve 10 (col. 27, par. 6)). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Regarding claim 2, Sugimoto fails to teach the limitations of claim 2. Gross teaches a cardiac implant wherein the guide frame is self-expanding (Fig. 12B, frame 244 is transluminally advanced in a constrained state and then automatically expands into a working state when deployed (col. 28, lines 11-16)). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Regarding claim 3, Sugimoto teaches wherein the system is configured to facilitate the guide assembly withdrawing the guide rail and the guide frame from the heart while the helical member remains in the heart (Figs. 3A-E, guide-wire 62 is retracted from surgical site leaving helical fastener 94 in position within tissue 118 (col. 4, lines 61-64)) but fails to teach a guide frame.
Gross teaches a cardiac implant comprising a guide frame (Fig. 12B, frame 244). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Regarding claim 4, Sugimoto teaches wherein the driver is configured to anchor the helical member along the intracardial surface of the tissue by advancing the helical member over and along the guide rail (Fig. 4A, coil delivery device 126 comprises torque coil 130, hub 122, and adapter cup 146, among other parts that together embed the helical fastener 94 into tissue along guide-wire 62 (col. 4-6, lines 65-28)).
Regarding claim 5, Sugimoto teaches the guide arrangement and guide rail (Fig. 4A, guide-wire 62), but fails to teach wherein the guide rail is held, by the fasteners, in an arc around at least part of the guide frame.
Gross teaches a cardiac implant wherein the guide rail is held, by the fasteners, in an arc around at least part of the guide frame (Fig. 12B, anchors 46 hold support structure 242 (col. 28, lines 49-54) and frame 244 to annulus 16 of native valve 10 (col. 27, par. 6)). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Regarding claim 6, Sugimoto teaches wherein the guide rail is radiopaque (Fig. 4A, guide-wire 62 comprises a fluoroscopic marker that allows for in vivo localization (col. 3, lines 13-15)).
Regarding claim 7, Sugimoto teaches the guide rail (Fig. 4A, guide-wire 62) but fails to teach wherein each of the fasteners is openable within the heart, to decouple the guide frame from the guide rail.
Gross teaches a cardiac implant wherein each of the fasteners (Fig. 12B, anchors 46) is openable within the heart, to decouple the guide frame from the guide rail (Fig. 12B, guide members 246 provide guidance for frame 244 and are coupled directly to anchors 46 and then subsequently guide members 246 are decoupled from anchors 46 and removed from the patient to facilitate frame 244 deployment (col. 27-28, par. 6-3)). Gross discloses that the anchors assist in more evenly distributing loads over the implant and tissue to which it is coupled (col. 28, lines 54-61). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the fasteners and guide frame taught by Gross with the guide rail taught by Sugimoto in order to better distribute forces across the implant to avoid device malfunction.
Regarding claim 8, Sugimoto teaches wherein the driver is configured to anchor the helical member along the intracardial surface of the tissue via rotation of the helical member (Fig. 4A, coil delivery device 126 comprises torque coil 130, hub 122, and adapter cup 146, among other parts that together embed the helical fastener 94 into tissue by twisting (col. 4-6, lines 65-28)).
Regarding claim 9, Sugimoto teaches wherein the helical member has an axial length of 5-12 cm (Fig. 4A, first pitch of helical fastener 94 is 5.08 mm long and second pitch of helical fastener 94 ranges from 1.27 mm to 2.54 mm (i.e., total length of helical fastener 94 ranges from 0.635 cm to 0.762 cm) (col. 3, lines 41-45)). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). MPEP § 2144.05-I.
Regarding claim 10, Sugimoto teaches wherein the helical member has a sharpened tip (Fig. 4A, helical fastener 94 comprises distal tip 106 which is a sharpened point or knife-like (col. 3-4, lines 65-1)).
Regarding claim 11, Sugimoto teaches further comprising a sheath (Fig. 4A, delivery sheath 90), the distal part of the guide assembly being transluminally advanceable to the heart while in the delivery state within the sheath (Fig. 4B, delivery sheath 90 (including region nearest distal tip 106) is advanced through the vascular system to the surgical site within the heart (col. 3, lines 7-12)).
Regarding claim 12, Sugimoto teaches the delivery state (Fig. 4A) and the sheath (Fig. 4A, delivery sheath 90), but fails to teach wherein: in the delivery state, the guide frame is constrained within the sheath, and the guide frame is configured to automatically self-expand within the heart upon becoming deployed out of the sheath.
Gross teaches a cardiac implant wherein: in the delivery state, the guide frame is constrained, and the guide frame is configured to automatically self-expand within the heart upon becoming deployed (Fig. 12B, frame 244 is transluminally advanced in a constrained state and then automatically expands into a working state when deployed (col. 28, lines 11-16)). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Regarding claim 13, Sugimoto teaches wherein the system comprises an annuloplasty implant, the helical member being a component of the annuloplasty implant (Fig. 6B, helical fastener 94 is implanted into the posterior annulus 70 of mitral valve 50 (i.e., acts as an annuloplasty implant)).
Regarding claim 14, Sugimoto teaches wherein: the tissue is tissue of an annulus of a valve of the heart (Fig. 6B, helical fastener 94 is implanted within the posterior annulus 70 tissue of the mitral valve 50), the annulus circumscribing an orifice of the valve (Fig. 6B, mitral valve 50), the intracardial surface of the tissue is an atrial-facing surface of tissue of the annulus (Fig. 1B, mitral valve 50 wherein helical fastener 94 is implanted faces left atrium 82), and the driver is configured to anchor the helical member along the atrial-facing surface of the tissue of the annulus (Fig. 4A, coil delivery device 126 comprises torque coil 130, hub 122, and adapter cup 146, among other parts that together embed the helical fastener 94 into mitral valve 50 (col. 4-6, lines 65-28)), but fails to teach the guide assembly is configured to position the guide frame through the orifice such that the guide frame is adjacent the annulus.
Gross teaches a cardiac implant wherein the guide assembly is configured to position the guide frame through the orifice such that the guide frame is adjacent the annulus (Figs. 5C-E, tubular member 102 is implanted through annulus 16 by catheter 64). Gross discloses that the tubular member traverses the valve at multiple points in order to inhibit the movement of at least one valve leaflet (col. 1, lines 33-38). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame taught by Gross with the system taught by Sugimoto in order to treat valve prolapse in the heart.
Regarding claim 15, Sugimoto teaches wherein the helical member defines multiple turns that circumscribe a central channel of the helical member (Fig. 4A, helical fastener 94 is formed on a spring winder by winding the material around a mandrel (col. 3, lines 55-57) (i.e., winding forms central channel)), and the helical member is anchorable along the intracardial surface of the tissue while the guide rail extends within the central channel (Fig. 3B, helical fastener 94 is threaded along tissue 118 by positioning guide-wire 62 along tissue 118 (col. 4, lines 23-26)).
Regarding claim 23, Sugimoto teaches wherein the helical member defines a series of turns (Fig. 4A, helical fastener 94 is formed on a spring winder by winding the material around a mandrel (col. 3, lines 55-57) (i.e., winding forms turns)), and wherein the driver is configured to anchor the helical member along the intracardial surface of the tissue by screwing the helical member along the intracardial surface of the tissue such that a part each turn becomes embedded in the tissue and another part of each turn becomes disposed outside of the tissue (Fig. 4A, coil delivery device 126 comprises torque coil 130, hub 122, and adapter cup 146, among other parts that together embed the helical fastener 94 into mitral valve 50 (col. 4-6, lines 65-28)).
Regarding claim 25, Sugimoto teaches a system for use with tissue of a heart (Figs. 1A-B), the system comprising: an implant (Fig. 4A, helical fastener 94); and a guide assembly (Fig. 4A), having a distal part that is transluminally advanceable to the heart while in a delivery state (Fig. 4B, delivery sheath 90 (including region nearest distal tip 106) is advanced through the vascular system to the surgical site within the heart (col. 3, lines 7-12)), a guide rail (Fig. guide-wire 62), and a driver, configured to, while the guide rail is in the guide arrangement, secure the implant along an intracardial surface of tissue adjacent the guide frame, guided by the guide rail (Fig. 4A, coil delivery device 126 comprises torque coil 130, hub 122, and adapter cup 146, among other parts that together embed the helical fastener 94 into tissue (col. 4-6, lines 65-28)), but fails to teach a guide frame, intracardially expandable toward an expanded state and multiple fasteners, configured to hold the guide rail in a guide arrangement around at least part of the guide frame.
Gross teaches a cardiac implant comprising a guide frame (Fig. 12B, leaflet-restraining frame 244), intracardially expandable toward an expanded state (Fig. 12B, frame 244 is transluminally advanced in a constrained state and then automatically expands into a working state when deployed (col. 28, lines 11-16)), and multiple fasteners (Fig. 12B, anchors 46), configured to hold the guide rail in a guide arrangement around at least part of the guide frame (Fig. 12B, anchors 46 hold support structure 242 to annulus 16 of native valve 10 (col. 27, par. 6)). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Regarding claim 26, Sugimoto teaches wherein the system is configured to facilitate the guide assembly withdrawing the guide rail from the heart while the implant remains in the heart (Figs. 3A-E, guide-wire 62 is retracted from surgical site leaving helical fastener 94 in position within tissue 118 (col. 4, lines 61-64)), but fails to teach the guide frame.
Gross teaches a cardiac implant comprising a guide frame (Fig. 12B, leaflet-restraining frame 244). Gross discloses that the frame is resilient, comprising a shape-memory material (col. 28, lines 16-17). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Sugimoto with the guide frame and fasteners taught by Gross in order to provide a more adaptable implant.
Claims 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto et al. (US Pat. No. 8728097 B1), “Sugimoto” in view of Gross et al. (US Pat. No. 10195030 B2), “Gross”, and further in view of Gross et al. (US Pat. No. 9192472 B2), “Gross 472”.
Regarding claim 16, Sugimoto teaches the guide rail (Fig. 4A, guide-wire 62), but fails to teach wherein the guide rail is configured to limit a depth of penetration of the helical member into the tissue.
Gross 472 teaches an annuloplasty device wherein the guide rail is configured to limit a depth of penetration of the helical member into the tissue (Fig. 4, head portion 380 prevents continued distal motion of anchor 360 (col. 26-27, par. 6-1) beyond a predetermined depth (col. 17, lines 36-46)). Gross 472 discloses that if a gap is created between the annulus tissue and annuloplasty structure, the continued rotation of the anchor pulls the tissue closer to the structure, rather than pierce deeper, and therefore eliminating the gap (col. 27, lines 7-13). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the guide rail taught by Sugimoto with the ability to limit anchor penetration as taught by Gross 472 in order to limit excessive damage to patient tissue and ensure best fit of the implant.
Regarding claim 17, Sugimoto teaches the helical member (Fig. 4, helical fastener 94) comprising a central channel (Fig. 4A, helical fastener 94 is formed on a spring winder by winding the material around a mandrel (col. 3, lines 55-57) (i.e., winding forms central channel)), but fails to teach further comprising a contraction member extending coaxially through the central channel, and a tensioning tool that is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member by applying tension to the contraction member.
Gross teaches a cardiac implant comprising a contraction member extending coaxially through the central channel (Fig. 1A, adjusting mechanism 48 and contracting wire 49 which extends through tubular member 42), and a tensioning tool that is configured to contract the tissue along which the helical member is anchored by axially contracting the helical member by applying tension to the contraction member (Figs. 1A and 2E-F, adjusting mechanism 48 comprises a spool wherein tool 72 rotates the adjusting mechanism thereby contracting wire 49 and tubular member 42 by wrapping the wire 49 onto the spool 48 (col. 17, par. 2-5)). Gross discloses that the longitudinal member may be anchored with more slack than is desired for its final state and is subsequently contracted (col. 17, lines 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the helical member taught by Sugimoto with the contraction member and tensioning tool taught by Gross in order to ensure the best fit of the device upon implantation.
Regarding claim 18, Sugimoto teaches the guide rail (Fig. 4A, guide-wire 62) and central channel (Fig. 4A, helical fastener 94 is formed on a spring winder by winding the material around a mandrel (col. 3, lines 55-57) (i.e., winding forms central channel)), but fails to teach wherein the contraction member extends coaxially through the central channel alongside the guide rail.
Gross teaches a cardiac implant wherein the contraction member extends coaxially through the central channel alongside the guide rail (Figs. 1A and 12B, adjusting mechanism 48 and contracting wire 49 which extends through tubular member 42 (i.e., through support structure 242) (col. 17, par. 2-5)). Gross discloses that the longitudinal member may be anchored with more slack than is desired for its final state and is subsequently contracted (col. 17, lines 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the guide rail and central channel taught by Sugimoto with the contraction member and tensioning tool taught by Gross in order to ensure the best fit of the device upon implantation.
Regarding claim 19, Sugimoto teaches the central channel (Fig. 4A, helical fastener 94 is formed on a spring winder by winding the material around a mandrel (col. 3, lines 55-57) (i.e., winding forms central channel)) defined by the guide rail (Fig. 4A, guide-wire 62), but fails to teach wherein the contraction member extends coaxially through the central channel.
Gross teaches a cardiac implant wherein the contraction member extends coaxially through the central channel (Figs. 1A and 12B, adjusting mechanism 48 and contracting wire 49 which extends through tubular member 42 (i.e., through support structure 242) (col. 17, par. 2-5)). Gross discloses that the longitudinal member may be anchored with more slack than is desired for its final state and is subsequently contracted (col. 17, lines 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the guide rail and central channel taught by Sugimoto with the contraction member and tensioning tool taught by Gross in order to ensure the best fit of the device upon implantation.
Regarding claim 20, Sugimoto teaches wherein, the guide rail is configured such that, while the helical member remains anchored along the tissue, the guide rail is withdrawable from the helical member by sliding the guide rail proximally out of the central channel (Figs. 3A-E, guide-wire 62 is retracted from surgical site leaving helical fastener 94 in position within tissue 118 (col. 4, lines 61-64)), but fails to teach leaving the contraction member exposed within the central channel.
Gross teaches a cardiac implant leaving the contraction member exposed within the central channel (Figs. 1A and 12B, adjusting mechanism 48 and contracting wire 49 which extends through tubular member 42 (i.e., through support structure 242) (col. 17, par. 2-5)). Gross discloses that the longitudinal member may be anchored with more slack than is desired for its final state and is subsequently contracted (col. 17, lines 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the guide rail and central channel taught by Sugimoto with the contraction member and tensioning tool taught by Gross in order to ensure the best fit of the device upon implantation.
Regarding claim 21, Sugimoto teaches the central channel (Fig. 4A, helical fastener 94 is formed on a spring winder by winding the material around a mandrel (col. 3, lines 55-57) (i.e., winding forms central channel)), but fails to teach further comprising a stopper coupled to a distal end of the contraction member, such that tension applied to the contraction member longitudinally contracts the helical member by the stopper inhibiting sliding of the contraction member through the central channel.
Gross teaches a cardiac implant further comprising a stopper coupled to a distal end of the contraction member (Fig. 12B, adjusting mechanism includes a locking element (col. 17, lines 9-11)), such that tension applied to the contraction member longitudinally contracts the helical member by the stopper inhibiting sliding of the contraction member through the central channel (Figs. 1A and 12B, adjusting mechanism 48 tensions contracting wire 49 to shorten tubular member 42 and the adjusting mechanism 48 is subsequently locked to limit further adjustment (col. 17, par. 4)). Gross discloses that the longitudinal member may be anchored with more slack than is desired for its final state and is subsequently contracted (col. 17, lines 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the central channel taught by Sugimoto with the contraction member and tensioning tool taught by Gross in order to ensure the best fit of the device upon implantation.
Regarding claim 22, Sugimoto teaches the helical member (Fig. 4A, helical fastener 94), but fails to teach wherein the stopper is a first stopper, and wherein the system further comprises a second stopper, configured to lock the tension in the contraction member by being couplable to the contraction member proximally from the helical member.
Gross teaches a cardiac implant wherein the stopper is a first stopper (Fig. 12B, adjusting mechanism 48 includes a locking element (col. 17, lines 9-11)), and wherein the system further comprises a second stopper (Fig. 20, implants 360a-b both comprise adjusting mechanism 48 which include locking elements), configured to lock the tension in the contraction member by being couplable to the contraction member proximally from the helical member (Fig. 20, adjusting mechanism is disposed at proximal end of implants 360 adjusting mechanism 48 tensions contracting wire 49 to shorten tubular member 42 and the adjusting mechanism 48 is subsequently locked to limit further adjustment (col. 17, par. 4) (col. 33, par. 6)). Gross discloses that the longitudinal member may be anchored with more slack than is desired for its final state and is subsequently contracted (col. 17, lines 3-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the helical member taught by Sugimoto with the contraction member and tensioning tool taught by Gross in order to ensure the best fit of the device upon implantation.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto et al. (US Pat. No. 8728097 B1), “Sugimoto” in view of Gross et al. (US Pat. No. 10195030 B2), “Gross”, and further in view of Rafiee et al. (US 2007/244555 A1), “Rafiee”.
Regarding claim 24, Sugimoto teaches the helical member (Fig. 4A, helical fastener 94) but fails to teach it has a constant pitch.
Rafiee teaches an annuloplasty device comprising a constant pitch (Fig. 2A, helical anchor 245 comprises 14 coils per inch [0042]). Rafiee discloses that the number of coils per inch on the helical anchor can vary based on the desired degree of flexibility and resilience [0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the helical member taught by Sugimoto with the constant pitch taught by Rafiee in order to improve the device’s resilience.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0049875 A1 and US 2012/0053680 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799