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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-25 and 29-32) in the reply filed on 2/12/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted before the mailing date of the instant action are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-8, 12-18, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Chou (US 2020/0289136) in view of Corindus Inc (EP 2821094; hereafter Corindus).
In regard to claim 1, Chou discloses a robotic procedure system for treating neurovasculature of a patient, the system comprising: a guide sheath (400) comprising: a sheath body (402) having at least one lumen (see par. [0092]) extending between a proximal end region (403) and a distal end region defining a distal opening (408) from the at least one lumen; and a hub (434) coupled to the proximal end region of the sheath body; a catheter system comprising: a support catheter (200) comprising a distal luminal portion having a first outer diameter sized to be positioned within the at least one lumen of the guide sheath, the distal luminal portion (222) coupled at a proximal end region to a proximal control element (230) adjacent a proximal opening from a single lumen of the distal luminal portion; and a navigation catheter (300) having a guidewire lumen, a distal tip region (346) that tapers from an outer diameter sized to fill the single lumen of the support catheter to a distal-most end defining an opening from the guidewire lumen (Fig. 2A; see par. [0184]), and a proximal extension (366).
Chou fails to disclose a robotic drive system configured to drive the catheter system within a patient's vessel, the robotic drive system comprising: a cassette having at least a first set of rollers and at least a second set of rollers, the first set of rollers is configured to engage the proximal control element of the support catheter and the second set of rollers is configured to engage the proximal extension of the navigation catheter, the second set of rollers positioned proximal of the first set of rollers; and a controller operatively coupled to the cassette, the controller configured to control the first set and second set of rollers so as to determine a magnitude of linear translation of the support catheter and a magnitude of linear translation of the navigation catheter.
In a similar art, Corindus discloses a robotic drive system (see Fig. 6) configured to drive a catheter system within a patient's vessel, the robotic drive system comprising: a cassette (24) having at least a first set of rollers (48) and at least a second set of rollers (52) (see par. [0025]-[0026] and [0134]), the first set of rollers is configured to engage a proximal control element of a elongate medical device and the second set of rollers is configured to engage the proximal extension of an elongate medical device (see par. [0021]), the second set of rollers positioned proximal of the first set of rollers (see Fig. 6); and a controller (see par. [0012]) operatively coupled to the cassette, the controller configured to control the first set and second set of rollers so as to determine a magnitude of linear translation of the elongate medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Chou with the support and navigation system of Corindus in order to provide a known means for inserting and translating elongate medical devices into the body to reach a treatment area.
In regard to claim 2, the combination teaches further comprising a guidewire (25) and a third set of rollers (158) located proximal to the second set of rollers that is configured to engage the guidewire (see Fig. 6), a spacing of the third set of rollers designed to allow a full range of motion of the navigation catheter through the second set of rollers (see par. [0139]).
In regard to claim 3, Chou discloses wherein the proximal control element of the support catheter is a ribbon, a hypotube, or a solid round wire (see par. [0115]).
In regard to claim 4, Chou discloses wherein the proximal extension of the navigation catheter is a polymer-coated rigid component (see par. [0178]).
In regard to claim 5, Corindus teaches, wherein at least one of the first and second set of rollers is configured to accommodate different outer diameters (elongate medical devices 50, 54 can be different diameters; see par. [0021]).
In regard to claim 6, Corindus teaches wherein rollers of the first set of rollers are spaced closer together than rollers of the second set of rollers (see Fig. 6).
In regard to claim 7, Corindus teaches wherein the first set of rollers is proximal to and off-set from an axis of a working lumen of the guide sheath (see Fig. 6).
In regard to claim 8, Chou discloses further comprising an aspiration system operatively coupled to the controller (see par. [0087]).
In regard to claim 12, Corindus teaches wherein the guide sheath is coupled to the robotic drive system by securing the hub to the cassette via at least one connector and/or cavity within the cassette (see par. [0039]).
In regard to claim 13, Corindus teaches wherein the at least one connector is configured to rotate the guide sheath around a longitudinal axis of the sheath body (see par. [0034]).
In regard to claim 14, Corindus teaches wherein at least one of the first set and the second set of rollers is configured change the magnitude of linear translation, an angle, or both (functional limitation- the speed of the rollers will control magnitude of linear translation).
In regard to claim 15, Corindus teaches wherein the first set of rollers and the second set of rollers are configured to be driven in unison (functional limitation- the rollers can be driven at the same time).
In regard to claim 16, Corindus teaches wherein the first set of rollers and the second set of rollers are driven in unison due to a mechanical linkage between the first set of rollers and the second set of rollers to advance together the support catheter and the navigation catheter (the mechanical linkage is considered to be any intervening structure between the roller sets while both sets are being driven- applicant is encouraged to recite more specific structure).
In regard to claim 17, Chou discloses further comprising one or more markers on the support catheter (see par. [0149]).
In regard to claim 18, Chou discloses further comprising one or more markers on the navigation catheter (see par. [0188]).
In regard to claim 29, Chou discloses wherein the proximal control element (230) has a second outer diameter that is smaller than the first outer diameter (see Fig. 2a).
In regard to claim 30, Corindus teaches wherein the first set of rollers is configured to automatically accommodate the first outer diameter and the second outer diameter of the support catheter to engage the proximal control element and the distal luminal portion of the support catheter as the support catheter is axially moved (functional limitation- the system is configured to accept different medical devices).
In regard to claim 31, Corindus teaches wherein at least one of the first set of rollers and the second set of rollers is arranged to advance the support catheter and the navigation catheter together through the patient's vessel (functional limitation).
In regard to claim 32, Chou discloses wherein the support catheter (200) is mechanically clipped (see par. [0207]) to the navigation catheter (300) and at least one of the first set of rollers and the second set of rollers is driven to advance the support catheter and the navigation catheter together through the patient's vessel.
Claim(s) 9-11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chou and Corindus in further view of Janardhan et al. (US 2019/0133744; hereafter Janardhan).
In regard to claims 9-11, the combination fails to teach wherein the aspiration system is configured to apply static or cyclic aspiration (functional limitation), wherein the cyclic aspiration is applied using a spring-operated pressure relief valve or a solenoid valve, wherein the aspiration system is actuated manually or by software running on the controller, and further comprising one or more flow sensors and one or more pressure transducers.
In a similar art, Janardhan teaches a mobile pump with an external control panel for generating crescendo suction patterns for aspiration. In some embodiments, suction tubing 12340 is connected to a disposable canister 12330 and a peristaltic motor pump 12310 and exhaust unit. The suction tubing 12340 may include an on/off switch or valve. In some embodiments, the suction tubing 12340 may be configured to extend from the disposable canister 12330 to a hub or port at the proximal end of a guide catheter, a distal access microcatheter, or the second microcatheter 12300. In some embodiments, the peristaltic motor pump 12310 is controlled by power electronics to generate the crescendo suction patterns 11800, 11805, 11810, 11815, 11820 with a desired intensity and/or duration of negative suction pressure. The power electronics may comprise an customized integrated circuit board or an integrated chip, and the crescendo suction patterns 11800, 11805, 11810, 11815, 11820 can be stored in the power electronics. The peristaltic motor pump 12310 includes a switch or external control panel 12320 for the operator configured to allow the operator to choose from any of the crescendo suction patterns 11800, 11805, 11810, 11815, 11820 during a thrombus aspiration procedure, thereby providing customizability based on clot burden.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the features of Janardhan in order to cyclic aspiration for clot fragmentation.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chou and Corindus and in further view of Bergman et al. (US 10,779,775; hereafter Bergman).
In regard to claims 19-20, the combination fails teach wherein the controller is programmed to detect the one or more markers on the support catheter and the one or more markers on the navigation catheter to assess extension of the support catheter relative to the navigation catheter and wherein the controller is programmed to detect the one or more markers on the support catheter and the one or more markers on the navigation catheter to assess total distance of advancement.
In a similar art, Bergman discloses an automated rapid advancement of a guide wire (50) through a guide catheter (40) using x-ray markers (44, 46, 48). The procedure involves providing a guide wire with a marker at or adjacent its tip (52), providing a guide catheter with a marker at or adjacent its distal terminus, rapidly advancing the guide wire through the guide catheter from its proximal end to its distal end under the control of an automated apparatus, and terminating the automated rapid advancement when the guide wire tip marker becomes adjacent to the guide catheter distal end marker. Fluoroscopic images may be taken of the of the guide wire as it rapidly advances through the guide catheter and image processing software used to determine when to terminate the rapid advancement. This software may use either the position or the velocity of the guide wire to make this determination (see at least the Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the features of Bergman in order to provide an automated means for advancing the elongate medical devices.
Claim(s) 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Chou and Corindus in further view of Hansen Medical Inc (WO 2007/098494; hereafter Hansen)
In regard to claims 22-25, the combination fails to teach further comprising an oscillation input configured to cause the support catheter to follow a pattern of one or more retractions and one or more advancements, wherein the oscillation input is programmable by a user, wherein the oscillation input initiates a pattern of a short retraction of the support catheter withdrawing a distal opening of the distal luminal portion from a first position relative to an occlusion to a second position relative to the occlusion and an advancement of the support catheter advancing the distal opening from the second position towards the first position, and wherein the pattern begins after a period of static aspiration through the support catheter.
In a similar art, Hansen discloses a working instrument 30 is shown being secured to the robotic instrument driver 400. The working instrument 30 may comprise any number of types of instruments, including but not limited to guidewires, probes, laser fibers, injection devices, surgical tools, and catheters, such as electrophysiology catheters, ablation catheters, and the like. The working instrument 30, or "working catheter" in this instance, may be custom designed for use with the robotic instrument system 2 or, alternatively, the working instrument 30 or working catheter may comprise an off-the- shelf catheter such as those used by physicians in conventional, manually-navigated procedures. The working instrument 30 is loaded into the robotic instrument system 2 by passing the distal end 34 through a seal 40. The mechanical ditherer 50 is a mechanical subsystem that moves in a reciprocating or oscillating motion in the direction of arrow B, and may be coupled to other structures, such as a working instrument, to induce oscillatory, reciprocating, or "dithering" motion in such other structures. The mechanical ditherer 50 is driven by a motor (not shown in FIG. 1A) which may be located on-board the robotic instrument driver 400 or, in other embodiments, off-board the robotic instrument driver 400 as a separate dithering actuation subsystem. In the depicted variation, the mechanical ditherer 50 dithers or causes reciprocating axial movement of the working instrument 30 relative to the guide instrument 4 and sheath instrument 6. For example, FIG. 1A illustrates the distal end 34 of the working instrument 30 dithering back and forth in the direction of arrow "C". The length or stroke of the dithering may be adjusted depending on the nature of the procedure but generally is less than a few millimeters. In some embodiments, the stroke of the dithering may be less than about 1 .5 mm. The mechanical ditherer 50 comprises at least one force sensor (not shown in FIG. 1A) that is used to detect the force or load that is being applied to the proximal portion of the working instrument 30. The force sensors are able to determine the insertion and withdrawal forces applied to the working instrument 30 via the mechanical ditherer 50. Over one or more dithering cycles, these force profiles or waveforms can be used to accurately estimate contact forces at the distal end 34 of the working instrument 30. For example, FIG. 1 A shows the distal end 34 in close proximity to an anatomical surface 70 which may comprise, for instance, cardiac tissue. Of course, contact forces may also come from other objects in the vicinity of the distal end 34 such as, for instance, medical instruments or the like. See page 10, line 14- page 11, line 20.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the features of Hansen in order to provide an improved advancement technique for advancing catheters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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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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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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