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 .
Claim Status
Applicant’s Remarks and Amendments filed 16 January 2026 have been entered. Claim 16 is cancelled. Claims 51-57 are new. Claims 1-2, 4, 7-10, 13-15, 20-, 22-23, and 51-57 are pending.
Response to Arguments
Applicant’s arguments with respect to the drawings have been considered but are not persuasive. Though applicant stated amended drawings Figs. 3A and 3B were submitted on page 3 of the remarks, they are not found, thus the objections are maintained.
Applicant’s arguments with respect to claims 1-2, 4, 7-10, 13-15, 20-, 22-23, and 51-57 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “plurality of side-holes”, “first side-hole”, and “second side-hole” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2, 4, 7-9, 13-15, 51-52, and 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (EP 2803340 A1), “Zhu” in view of Bogusky (US 2015/0374956 A1), “Bogusky”.
Regarding claim 1, Zhu teaches an endovascular device comprising a tube (Fig. 1, guide catheter 8) comprising a) a side-hole segment (Fig. 1B) comprising at least one side-hole (Fig. 1B, outlets d, e, f); b) a first segment comprising a primary opening (Fig. 2, proximal end of guide catheter 8 (left of inlets a, b, c) comprises a guide channel opening [0031]); and c) a second segment comprising an end (Fig. 2A, tapered head 20), wherein said at least one side-hole comprises a first side-hole located most proximal to a proximal end of said tube (Fig. 2A, outlet d), said first side-hole having a proximal side (Fig. 2A, side of outlet d closest to proximal end of guide catheter 8) and a distal side (Fig. 2A, side of outlet d nearest tapered head 20); said side-hole segment (Fig. 1B) extends from the proximal side of said first side-hole to the distal side of said second side-hole (Figs. 2-2A, region from outlet d to outlet f); said side-hole segment (Fig. 1B) and said first segment (Fig. 2, proximal end of guide catheter 8) form a working lumen (Fig. 7, guide catheter 8 forms lumen comprising guide wires 5, 6, 7); wherein said second segment (Figs. 2-2A, region from outlet f to tapered head 20) forms a support segment (Fig. 1-2A, guide catheter 8 comprises lumen for control guide wire 2), but fails to teach wherein the endovascular device further comprises at least one wire within a wall of an intravascular portion of the endovascular device, wherein the at least one wire extends in a spiral configuration such that the at least one wire is wound about a longitudinal axis of the endovascular device to thereby rotate the endovascular device about the longitudinal axis via a force applied to the at least one wire.
Bogusky teaches a steerable catheter system wherein the endovascular device further comprises at least one wire within a wall of an intravascular portion of the endovascular device (Fig. 7A, pullwires 108 housed within lumen 110 [0093]), wherein the at least one wire extends in a spiral configuration such that the at least one wire is wound about a longitudinal axis of the endovascular device (Figs. 7 and 8-9, pullwires 108 extend proximally from distal articulating section 114 into lumens 150, and further stiffening tube 130, and fit along channels 146 which spiral around the adapter body 140 [0101]) to thereby rotate the endovascular device about the longitudinal axis via a force applied to the at least one wire (Figs. 7 and 8-9, pullwires 108 are tensioned to cause bending moments of articulating section 114 while the proximal shaft section 120 will twist during tensioning of pullwires 108 [0111]). Bogusky discloses that the design of the current invention requires only one stiffening tube for the four pullwires which provides a significant reduction in production costs and a consistent low bending stiffness irrespective of the articulation loads applied to the pullwire [0111]. 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 lumen taught by Zhu with the pullwires and lumens taught by Bogesky in order to reduce production costs of the device.
Regarding claim 2, Zhu teaches wherein the plurality of side-holes are either along a same length of said tube, at different circumferential locations, or staggered at different lengths along said tube (Fig. 1B, outlets d, e, f are placed at different locations along and around guide catheter 8).
Regarding claim 4, Zhu teaches wherein the plurality of side-holes are staggered at different lengths along either a same circumferential location of said tube or at various circumferential locations of said tube (Fig. 1B, outlets d, e, f are placed at different locations along and around guide catheter 8) wherein some of the plurality of side-holes are staggered at different lengths along said tube and some of the plurality of side-holes are along a same length of said tube (Figs. 1A-B, inlets a, b, c align with outlets d, e, f to feed guide wires 5, 6, 7 through (Fig. 7)).
Regarding claim 7, Zhu teaches wherein the plurality of side-holes are along partially overlapping lengths of said tube, along varying circumferential locations (Fig. 2A, outlets d, e, f partially overlap and are placed along difference circumferential locations).
Regarding claim 8, Zhu teaches wherein each of the plurality of side-holes does not have a side-hole directly across from it (Fig. 1B, outlets d, e, f do not comprise another hole circumferentially placed on the other side of guide catheter 8).
Regarding claim 9, Zhu teaches wherein the support segment is configured to facilitate placement of one or more additional endovascular devices (Fig. 8, branched stent 9), wherein the one or more additional endovascular devices comprise a catheter, a wire, a therapeutic balloon, an embolic device, a therapeutic stent or a combination thereof (Fig. 1, stent delivery system comprises guide catheter 8, guide wires 2, 5, 6, 7, and branched stent 9 (Fig. 8)).
Regarding claim 13, Zhu teaches wherein said working lumen is a conduit through which the one or more additional endovascular devices are advanced into a blood vessel (Fig. 8, guide catheter 8 comprises lumens for the delivery of stent branches 10, 11, 12).
Regarding claim 14, Zhu teaches wherein the tube contains a bend between the first and the second segments to assist in anchoring the endovascular device (Fig. 7, guide catheter 8 bends when in blood vessel between proximal end and tapered head 20).
Regarding claim 15, Zhu teaches wherein the endovascular device comprises an actively adjustable angled extension (Fig. 8, stent branches 10, 11, 12 are deployed using guidewires 5, 6, 7) extending from one of said plurality of side-holes (Fig. 1B, outlets d, e, f) serving to facilitate steering of said one or more additional endovascular devices into a blood vessel (Fig. 8, stent branches 10, 11, 12).
Regarding claim 51, Zhu teaches an endovascular device comprising: a tube (Fig. 1, guide catheter 8), wherein the tube comprises: a) a side-hole segment (Figs. 1A-B) with at least one side-hole (Fig. 1A-B, inlets a, b, c and outlets d, e, f), wherein the at least one side-hole includes a proximal end (Fig. 1A, proximal end of guide catheter 8 includes inlets a, b, c) and a distal end (Fig. 1B, distal end of guide catheter 8 includes outlets d, e, f); b) a first segment having a primary end hole at a proximal end thereof (Fig. 2, proximal end of guide catheter 8 (left of inlets a, b, c) comprises a guide channel opening [0031]); and c) a second segment having a distal end hole at a distal end thereof (Fig. 2A, distal end of guide catheter 8 comprises tapered head 20 that is axially split to provide outlets for the guidewires [0031]), wherein said first segment extends from the primary end hole to the proximal end of the at least one side-hole (Figs. 1-1A), and the second segment extends from the distal end of the at least one side-hole to the distal end hole (Fig. 2A), but fails to teach at least one wire within a wall of the tube, wherein the at least one wire extends in a spiral configuration such that the at least one wire is wound about a longitudinal axis of the tube to thereby rotate at least one segment of the endovascular device about the longitudinal axis via a force applied to the at least one wire, and positioned relative the at least one wire such that when a force is applied to the at least one wire, a position is rotated.
Bogusky teaches a steerable catheter system comprising at least one wire within a wall of the tube (Fig. 7A, pullwires 108 housed within lumen 110 [0093]), wherein the at least one wire extends in a spiral configuration such that the at least one wire is wound about a longitudinal axis of the tube (Figs. 7 and 8-9, pullwires 108 extend proximally from distal articulating section 114 into lumens 150, and further stiffening tube 130, and fit along channels 146 which spiral around the adapter body 140 [0101]) to thereby rotate at least one segment of the endovascular device about the longitudinal axis via a force applied to the at least one wire (Figs. 7 and 8-9, pullwires 108 are tensioned to cause bending moments of articulating section 114 while the proximal shaft section 120 will twist during tensioning of pullwires 108 [0111]), and positioned relative the at least one wire such that when a force is applied to the at least one wire, a position is rotated (Figs. 7 and 8-9, pullwires 108 cause proximal shaft section 120 to twist when tensioned [0111]). Bogusky discloses that the design of the current invention requires only one stiffening tube for the four pullwires which provides a significant reduction in production costs and a consistent low bending stiffness irrespective of the articulation loads applied to the pullwire [0111]. 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 lumen taught by Zhu with the pullwires and lumens taught by Bogesky in order to reduce production costs of the device.
Regarding claim 52, Zhu teaches further comprising: a handle positioned on a proximal segment of the first segment (Fig. 1, manipulating handle 1 is proximal to guide catheter 8).
Regarding claim 54, Zhu teaches wherein the handle includes at least one lever coupled to the at least one wire and capable of applying the force to the at least one wire upon movement of the lever (Fig. 1, manipulating handle 1 comprises control switch 3 which actuates guide wires of device).
Regarding claim 55, Zhu teaches wherein the at least one side-hole includes a plurality of side-holes (Figs. 1A-B, inlets a, b, c and outlets d, e, f).
Regarding claim 56, Zhu teaches wherein the plurality of side-holes includes the first side-hole (Fig. 1A, inlet a) and a second side-hole located most distal to a distal end of said tube (Fig. 1A, inlet c), said second side-hole having a proximal side (Fig. 1A, inlet c) and a distal side (Fig. 1B, outlet f), wherein said first segment extends from said primary opening to the proximal side of said first side-hole (Figs. 1-1A), wherein said second segment extends from the distal side of said second side-hole (Fig. 2A), wherein said side-hole segment extends from the proximal side of said first side-hole to the distal side of said second side-hole (Fig. 1B).
Regarding claim 57, Zhu teaches wherein said second segment tapers externally to an end hole (Fig. 2A, distal end of guide catheter 8 comprises tapered head 20 that is axially split to provide outlets for the guidewires [0031]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (EP 2803340 A1), “Zhu” in view of Bogusky (US 2015/0374956 A1), “Bogusky” and further in view of Fischell et al. (US 20140121641 A1), “Fishcell”.
Regarding claim 10, Zhu teaches wherein said endovascular device further comprises an angled extension at one of said plurality of side-holes (Fig. 8, stent branches 10, 11, 12) but fails to teach wherein said angled extension extends at an angle ranging from 10 degrees to 180 degrees.
Fischell teaches an intravascular catheter wherein the angle of said angled extension extends at an angle ranging from 10 degrees to 180 degrees (Fig. 21B, guide tubes 515 and needles 519 are positioned at 120 degrees with respect to each other [0281]). Fischell teaches that the positioning of these tubes is to provide uniform injection of fluid into the targeted area [0281]. 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 extensions and side-holes taught by Zhu to reflect the angles taught by Fischell in order to provide a uniform and accurate delivery of the endovascular device.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (EP 2803340 A1), “Zhu” in view of Chan et al. (US 20090105643 A1), “Chan” and Bogusky (US 2015/0374956 A1), “Bogusky” and further in view of Sheps et al. (US 20140309661 A1), “Sheps”.
Regarding claim 20, Zhu teaches said endovascular device (Fig. 1, stent delivery device), but fails to teach wherein said endovascular device further comprises at least one balloon disposed thereon, and said intravascular portion includes at least one additional lumen within the wall that serves solely to inflate and deflate said at least one balloon, the wall having a distal end and a proximal end, wherein the at least one wire spirals along said intravascular portion, wherein a distal end of the at least one wire is affixed towards the distal end of the wall and wherein a proximal end of the at least one wire is affixed at or near the primary opening to a mechanism for applying the force to the at least one wire, thereby rotating said intravascular portion of said device.
Chan teaches an occlusion balloon catheter comprising at least one balloon disposed thereon (Fig. 1, balloon 40), and said intravascular portion (Fig. 2, catheter 10) includes at least one additional lumen within the wall that serves solely to inflate and deflate said at least one balloon (Fig. 2, inflation lumen 58), the wall having a distal end (Fig. 1, distal end 18) and a proximal end (Fig. 1, proximal region 14). Chan discloses that the balloon has the same general diameter as the distal end of the shaft which allows the catheter to be maneuvered easily into smaller vessels [0023]. 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 endovascular device taught by Zhu with the balloon catheter taught by Chan in order to easily maneuver the device within complex vasculature. However, Zhu in view of Chan fails to teach wherein the at least one wire spirals along said intravascular portion, wherein a distal end of the at least one wire is affixed towards the distal end of the wall and wherein a proximal end of the at least one wire is affixed at or near the primary opening to a mechanism for applying the force to the at least one wire, thereby rotating said intravascular portion of said device.
Bogusky teaches a steerable catheter system wherein the at least one wire spirals along said intravascular portion device (Figs. 7 and 8-9, pullwires 108 extend proximally from distal articulating section 114 into lumens 150, and further stiffening tube 130, and fit along channels 146 which spiral around the adapter body 140 [0101]), wherein a distal end of the at least one wire is affixed towards the distal end of the wall (Fig. 7, distal ends of pullwires 108 are attached directly to a section of the catheter body 102 where it is steered, articulated, or bent [0095]) and wherein a proximal end of the at least one wire is affixed at or near the primary opening to a mechanism for applying the force to the at least one wire (Fig. 7, pullwires 108 terminate in the proximal adapter 101, particularly spools 103, which allows for actuation [0094]), thereby rotating said intravascular portion of said device (Figs. 7 and 8-9, pullwires 108 are tensioned to cause bending moments of articulating section 114 while the proximal shaft section 120 will twist during tensioning of pullwires 108 [0111]). Bogusky discloses that the design of the current invention requires only one stiffening tube for the four pullwires which provides a significant reduction in production costs and a consistent low bending stiffness irrespective of the articulation loads applied to the pullwire [0111]. 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 lumen taught by Zhu and the balloon catheter taught by Chan with the pullwires and lumens taught by Bogesky in order to reduce production costs of the device.
Regarding claim 22, Zhu in view of Chan and Bogusky fails to teach the limitations of claim 22. Sheps teaches an implant-delivery tool wherein said mechanism for applying force to said at least one wire is a wheel (Fig. 2, steering wires 31a, 31b are coupled to steering knob 214). Sheps discloses that the steerable system maintains its configuration without affecting the bending or steering of the distal end of the guide catheter [0208]. 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 endovascular device taught by Zhu, the ballon catheter taught by Chan, and the wires taught by Sheps in order to allow for more controlled steering of the device when within the vasculature of a patient.
Regarding claim 23, Zhu teaches wherein said mechanism for applying force to said at least one wire is a lever (Fig. 1, manipulating handle 1 and control switch 3 (i.e., lever) are controlled in such a way that the guide wire and control guide wire are guided into the vessel cavity [0019]).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (EP 2803340 A1), “Zhu” in view of Bogusky (US 2015/0374956 A1), “Bogusky” and further in view of Sheps et al. (US 20140309661 A1), “Sheps”
Regarding claim 53, Zhu the handle (Fig. 1, manipulating handle 1), but Zhu in view of Bogusky fails to teach at least one wheel coupled to the at least one wire and capable of applying the force to the at least one wire upon rotation of the wheel.
Sheps teaches an implant-delivery tool having at least one wheel coupled to the at least one wire and capable of applying the force to the at least one wire upon rotation of the wheel (Fig. 2, steering knob 214 is coupled to steering wires 31a and 31b and rotation of knob 214 adjusts the degree of tension in wires 31a and 31b [0205]). Sheps discloses that the steerable system maintains its configuration without affecting the bending or steering of the distal end of the guide catheter [0208]. 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 endovascular device taught by Zhu and the knob taught by Sheps in order to allow for more controlled steering of the device when within the vasculature of a patient.
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 GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
Prosecution Insights