DETAILED ACTION
This Office Action is in response to the amendment filed 25 November 2025.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 25 November 2025, Applicant argues Stahler’025 fails to teach a cassette which is (1) coupled to the base and to the actuator and (2) includes a transmission element configured to transmit movement to the guidewire. This argument is persuasive.
In the last rejection, the cassette was identified as the mounting plate in Figure 8c. This is coupled to the base 15 and to the actuator (ie the internal mechanical elements which slide the mounting plate). However, there is no disclosure that the mounting plate includes an element which engages with the control knobs 107 of the instrument 102; rather the actuator directly connects to the control knobs 107. Therefore, the rejection is withdrawn.
However, upon further search and consideration, a new rejection under Saeed’108 in view of Stahler et al. (US Patent Publication 2008/0262513). Stahler’513 discloses more details regarding how the instrument 3 is actuated through the mounting plate. See the updated rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, there is an inconsistency in the language of the preamble and that of body of the claim thus making their scope unclear.
The preamble recites “a microcatheter guidewire unit for use in a hollow organ” while the body of the claim was amended to positively recite a first and second robot-assisted drive system. As such it is unclear whether Applicant intends the claims to be drawn to the combination or the subcombination. Applicant is hereby required to indicate which, the combination (microcatheter guidewire unit and robot-assisted drive systems) or subcombination (microcatheter guidewire unit) the claims are intended to be drawn and make the language consistent with this intent.
Any claim not directly addressed is rejected based on its dependency from a base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-13, 16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Saeed et al. (US Patent 2004/0073108) in view of Stahler et al. (US Patent Publication 2008/0262513).
Claim 1: Saeed’108 teaches a microcatheter guidewire unit for use in a hollow organ, the microcatheter guidewire unit comprising:
a catheter body (11) with a distal end (towards element 17) and a proximal end (towards element 25); and
at least two guidewires (14, 15) with guidewire tips (Figure 1 shows the guidewires have tips), wherein a first guidewire of the at least two guidewire, a tip of the first guidewire, or the first guidewire and the tip of the first guidewire have a higher rigidity than a second guidewire of the at least two guidewires, a tip of the second guidewire, or the second guidewire and the tip of the second guidewire (paragraph [0017] discloses the guidewires are the same type but have different widths – e.g. paragraph [0017] states guidewire 14 can be 0.025" METRO™ Wire Guide (Wilson-Cook Medical) while guidewire 15 can be a 0.035" METRO™ Wire Guidewhich would result in the two guidewires having different rigidities),
wherein the first guidewire and the second guidewire are passed through the catheter body and are arranged such that the tip of the first guidewire and the tip of the second guidewire are advanceable or retractable independently of one another along corresponding longitudinal axes (Figure 1 shows the guidewires extend separately from the proximal end of the catheter such that they could be controlled separately; paragraph [0019] describes using the device which involves independent movement of the guidewires 14, 15);
wherein the first guidewire and the second guidewire are configured to be controlled by at least one control unit to move at a speed and a stroke corresponding to respective rigidities of the first guidewire and the second guidewire (the free ends of the guidewires extend from the proximal end of the catheter, as shown in Figure 1, therefore, they are configured to be controlled by a control unit).
Saeed’108 does not teach the first and second guidewires are coupled to a respective first and second robot-assisted drive system.
Stahler’513 teaches a catheter body (63) and a pair of instruments (“catheter assembly” 3; paragraph [0090] discloses multiple catheter assemblies such that each catheter assembly is controlled by its own instrument driver 15) which can be advanced and retracted via a control unit (5; paragraph [0082]) and a first and second robot-assisted drive system (15) (paragraph [0090] discloses each tool can have its own drive system 15).
The drive system (15) includes:
a base (outer shell 15a of element 15, as shown in Figure 5k or 5l) including an actuator (“motor”; paragraph [0092]); and
a cassette (“carriage” 67 or 69) coupled to the base (15) and to the actuator (paragraph [0092], [0096], [0097]), the cassette including a transmission element (15d or 15f) to transmit movement to the instrument (paragraphs [0096], [0097]; the instrument is mounted to the cassette).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Saeed’108 by providing each guidewire with its own drive system, as taught by Stahler’513, in order to allow the surgical system to be controlled remotely (paragraph [0081]) and/or automatically (paragraph [0083]).
Claim 2: Saeed’108 discloses the catheter body (11) comprises at least two channels or lumens (16, 17) and each guidewire (14, 15) is arranged individually in a respective one of the two lumens (Figure 3).
Claim 3, 4: Saeed’108 fails to teach the rigidities of the first guidewire and the second guidewire, the tip of the first guidewire and the tip of the second guidewire, or the first guidewire and the second guidewire and the tip of the first guidewire and the tip of the second guidewire, respectively, differ by a factor of at least 1.5 (claim 3) or 2 (claim 4).
However, the rigidity of the guidewires in Saeed’108 is considered a results effective variable. In Saeed’108, the guidewire 14 is chosen based on its rigidity such that it has a desired flexibility in order to reach a particular branch artery via deflection (paragraph [0016]). In light of this, it would be obvious to choose a guidewire 14 with a different rigidity (e.g. less rigidity) in order to allow the guidewire to more (or less) readily deflect in order to reach a branch vessel extending from the main vessel at a different angle (e.g. a greater angle) than what is shown in Figure 4. If the rigidity of guidewire 14 is changed, the rigidities between the two guidewires 14, 15 will change by a factor.
Based on these teachings, It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the rigidity of guidewire 14, for the purpose of reaching a desired branch vessel, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Claim 6: Saeed’108 teaches a robotic catheter system comprising:
a microcatheter guidewire unit (Figure 1) for use in a hollow organ, the microcatheter guidewire unit comprising:
a catheter body (11) with a distal end (towards element 17) and a proximal end (towards element 25); and
at least two guidewires (14, 15) with guidewire tips (Figure 1 shows the guidewires have tips), wherein a first guidewire of the at least two guidewire, a tip of the first guidewire, or the first guidewire and the tip of the first guidewire have a higher rigidity than a second guidewire of the at least two guidewires, a tip of the second guidewire, or the second guidewire and the tip of the second guidewire (paragraph [0017] discloses the diameters are the same type but have different widths which would result in the two guidewires having different rigidities); and
wherein the first guidewire and the second guidewire are passed through the catheter body and are arranged such that the tip of the first guidewire and the tip of the second guidewire are advanceable or retractable independently of one another along corresponding longitudinal axes (Figure 1 shows the guidewires extend separately from the proximal end of the catheter such that they could be controlled separately; paragraph [0019] describes using the device which involves independent movement of the guidewires 14, 15);
Saeed’108 does not teach the catheter system includes a control unit or a robot-assisted drive system.
Stahler’513 teaches a catheter body (63) and a pair of instruments (“catheter assembly” 3; paragraph [0090] discloses multiple catheter assemblies such that each catheter assembly is controlled by its own instrument driver 15) which can be advanced and retracted via a control unit (5; paragraph [0082]) and a first and second robot-assisted drive system (15) with a drive and a drive mechanism (Figures 5k, 5l; paragraph [0090] discloses each tool can have its own drive system 15).
The first robot assisted drive system (15) is detachably coupled to the instrument (Figure 5c shows the drive system 15 detached from instrument 3; Figure 5a shows the drive system attached to instrument 3).
The robot-assisted drive system is configured to automatically or semi-automatically advance or retract the instrument (3) in an axial direction independently of other instruments (paragraph [0088], [0090], [0091], [0093]).
The drive system (15) includes:
a base (outer shell 15a of element 15, as shown in Figure 5k or 5l) including an actuator (“motor”; paragraph [0092]); and
a cassette (“carriage” 67 or 69) coupled to the base (15) and to the actuator (paragraph [0092], [0096], [0097]), the cassette including a transmission element (15d or 15f) to transmit movement to the instrument (paragraphs [0096], [0097]].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Saeed’108 by providing each guidewire with its own drive system, as taught by Stahler’513, in order to allow the surgical system to be controlled remotely (paragraph [0081]) and/or automatically (paragraph [0083]).
In the resulting device of Saeed’108 in view of Stahler’513, the first and second guidewires of Saeed’108 will be configured to be controlled by the at least one control unit to move at a speed and stroke corresponding to the respective rigidities of the first and second guidewires (in both Saeed’108 and Stahler’513, each instrument is individually controllable, including according to their stiffness/purpose as discussed in paragraph [0019] of Saeed and paragraph [0090], [0091] of Stahler).
Claim 7: Stahler’513 teaches the first robot assisted drive system (15) is detachably coupled to the first instrument (3) at the proximal end (Figure 4h, 5a, 5c).
Claim 8: Stahler’513 teaches the catheter body (63) is detachably coupleable to the first robot-assisted drive system (15) (via 7; Figure 4g and paragraph [0090]);
the first robot assisted drive system (15) is configured such that, when actuated automatically or semi-automatically, the catheter body is advanceable and retractable in an axial direction (paragraph [0090]).
Claim 9: Stahler’513 teaches the second robot assisted drive system (15) comprises at least one drive (motor; paragraph [0092], [0090]) and at least one drive mechanism (15d or 15f) or the first robot-assisted drive system (15) has two drives (motor; paragraph [0092]) and two drive mechanisms (15d or 15f; Figures 5k, 5l and paragraph [0092] disclose one drive and one drive mechanism for each of platforms 67 and 69).
Claim 10: Stahler’513 teaches the drive mechanism (15d or 15f) of the first drive system (15) is coupled to a first instrument (3, as described in the rejection to claim 6 above) and the drive mechanism of the second drive system (15) is coupled to a second instrument (3) ((paragraph [0090] discuses providing multiple drive systems for use with a second instrument – see rejection to claim 6).
Further, Stahler’513 teaches the system is configured to advance the first and second instruments to a target location (such as an occlusion) and to cause a plurality of short-stroke alternating advance and retraction movements to be executed in rapid succession so that a force is exerted on a location (Stahler’513’s system is configured to individually advance and retract the instruments 3 and 3 – including to an occlusion and in rapid succession, as described in paragraph [0090] and [0092]).
Claim 11: In Stahler’513, the first drive system (15) is coupled to the first instrument (3) and is configured to drive the first instrument so that the first instrument executes a plurality of short-stroke alternate advance and retraction movements in succession so that a force is exertable by the advance movements on an object in the hollow organ (paragraph [0092] disclose advancing and retraction of the instruments).
Claims 12, 16: Saeed’108 in view of Stahler’513 teach the limitations of claim 12, as discussed in the rejection to claim 6 above.
Further regarding claims 12 and 16, Stahler’’025 teaches a medical imaging device, such as an x-ray device (paragraph [0295]), to visualize the surgical procedure and progress of the instruments (paragraph [0295]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Saeed’025 with an imaging device, as taught by Stahler’513, in order to visualize the surgical procedure and progress of the instruments.
Claim 13: Saeed’108 in view of Stahler’513 teach the limitations of claim 13, as discussed in the rejection to claim 10 above.
Stahler’513 further discloses a sensor for detecting an occlusion in a hollow organ (paragraph [0295] teaches sensors for detecting “fluid flow” or “force”).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Saeed’513 with a sensor, as taught by Stahler’513, in order to ensure the treatment is effective during the procedure in order to avoid needing to repeat the surgical intervention.
Claims 18, 19, 20: Stahler’513 teaches the transmission element (15f) is configured to move through a coupling between the cassette (carriage 67 or 69) and the base (15), the transmission element (15f) comprising a roller (“rolling element nut”, paragraph [0097]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Saeed’108 in view of Stahler’513, as applied to claim 1, further in view of Gray et al. (US Patent Publication 2013/0304030).
Claim 5: Saeed’108, as modified, teaches the limitations of claim 5 except for a third guidewire.
Like Saeed’108, Gray’030 teaches a catheter system with a plurality of guidewires for accessing a bifurcation (see paragraphs [0011], [0012] and claim 37 of Gray’030). Gray’030 teaches providing a set of three guidewires in order to accommodate variety of different patient anatomies (paragraph [0014], [0050]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by modified Saeed’108 with a third guidewire, as taught by Gray’030, in order to accommodate a variety of different patient anatomies.
Claim 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Saeed’108 in view of Stahler’513, as applied to claims 13, 6 and 12 respectively, further in view of Covington et al. (US Patent Publication 2017/0312481)
Claim 14: Stahler’513 does not teach the sensor is a torque sensor.
Covington’481 teaches a device similar to Stahler’513 (see Figure 1 of Covington’481 is substantially the same as Figure 1 of Stahler’513). Covington’481 teaches providing the robotic drive system with a torque sensor to measure the torque required to insert the catheter or guidewire (paragraph [0011]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Saeed’108 in view of Stahler’513, with a torque sensor on the robotic drive system, as taught by Covington’481, in order to measure the torque needed to insert an instrument.
Claim 15: Stahler’513 teaches the medical system is configured to execute a pre-trained machine-learning algorithm that determines a size of a respective next stroke based on imaging information or a behavior of the first guidewire with previous strokes (paragraph [0086] teaches the master computer 49 may execute software and process instructions to the instrument driver computer 55 to activate the appropriate medical response from the associated motors and mechanical components; this same hardware could be used to run a trained machine-learning algorithm, as recited in the claims).
Conclusion
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 17 February 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771