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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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.
Claims 1 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al. (U.S. Patent Application Publication No. 20010004700; hereinafter “Honeycutt”) in view of McGuckin, Jr. et al. (U.S. Patent Application Publication No. 20170273698; hereinafter “McGuckin”).
Regarding claim 1, Honeycutt discloses a rotational atherectomy device (10; Fig. 8) comprising:
an elongate flexible shaft (24);
an abrasive element (23; para. [0051]) connected to a distal end of the elongate flexible shaft (Fig. 7; paras. [0049]-[0051]);
a handle (18) comprising a housing (Fig. 8), the handle comprising:
an electric motor (90) operatively connected to the elongate flexible shaft to rotate the elongate flexible shaft (Fig. 8; para. [0086]);
a power source (122) electrically connected to the electric motor for supplying power thereto (Fig. 8; para. [0114]);
a controller (134) that controls operation of the electric motor using the power source (Fig. 8; para. [0113]); and
a sensor that provides a signal indicative of an operating condition of the electric motor (paras. [0113], [0122]);
wherein the controller is configured to:
monitor a motor supply current of the electric motor (para. [0113]); and
monitor a speed of the electric motor using the signal from the sensor (para. [0113]).
Honeycutt further discloses the controller being configured to make automatic adjustments to motor speed (para. [0114]).
The device of Honeycutt is not explicitly disclosed with the controller being configured to reduce a speed of the electric motor while attempting to maintain motor supply current or stop the electric motor when motor supply current is above a first or second threshold, respectively.
McGuckin, a reference in the atherectomy device field of endeavor, teaches configuring a controller so that
if the motor supply current is above a first predetermined threshold (e.g., during function in slow-speed mode; para. [0150]), reduce a speed of the electric motor while attempting to maintain motor supply current of the electric motor (para. [0154]); then
if the motor supply current is above a second predetermined threshold higher than the first predetermined threshold (e.g., during fast-speed mode; para. [0150]), stop the electric motor (para. [0154]).
McGuckin teaches that such a configuration allows for maintaining a constant, desired rotational speed for navigation within or treatment of a patient’s vasculature during a procedure (paras. [0150], [01353]-[0154]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller to operate the motor in multiple modes such that the controller is configured to
if the motor supply current is above a first predetermined threshold, reduce a speed of the electric motor while attempting to maintain motor supply current of the electric motor; then
if the motor supply current is above a second predetermined threshold higher than the first predetermined threshold, stop the electric motor
in view of McGuckin, in order to maintain a desired rotational speed of the abrasive element to facilitate navigation within and treatment of a patient’s vasculature.
Regarding claim 6, Honeycutt discloses wherein the power source is between 5V and 24V (para. [0114]).
Regarding claim 7, Honeycutt discloses wherein the power source comprises one or more batteries located in the handle (para. [0114]).
Regarding claim 8, Honeycutt discloses wherein the controller is configured to monitor a motor supply voltage (paras. [0122]-[0123]).
Regarding claim 9, Honeycutt discloses wherein the controller is configured to detect presence of a guide wire using input from another sensor (e.g., controller (134) is structured to be capable of detecting the presence of a guidewire using an input from another sensor because the circuitry of the controller is designed to receive inputs from sensors and make a determination; Fig. 10; paras. [0119]-[0124]; see also claim 1 and claim 60).
Regarding claim 10, Honeycutt discloses wherein the handle comprises a user input device (124), the controller receiving an input from the user input device to control operation of the electric motor (Figs. 9A-9C; paras. [0105]-[0108])).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt in view of McGuckin, as applied to claim 1 above, and further in view of Rivers et al. (U.S. Patent Application Publication No. 20110213391; hereinafter “Rivers”).
Regarding claim 2, the modified device discloses the invention substantially as claimed, including the device further comprising an irrigation pump (Honeycutt para. [0092]), except for the pump being electrically connected to the power source of the handle.
Rivers, a reference in the atherectomy device field of endeavor, teaches configuring a control unit so that an irrigation pump is electrically connected to the power source that is located in the handle (paras. [0043]-[0047]) to facilitate controlling the pump rate of fluid from the pump.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the irrigation pump to be electrically connected to the power source that is located in the handle, in view of Rivers, in order to provide control over the rate of fluid flow from the pump during use.
Regarding claim 3, Rivers discloses wherein the controller controls operation of the irrigation pump (par. [0045]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt in view of McGuckin and Rivers, as applied to claim 3 above, and further in view of Nash et al. (U.S. Patent Application Publication No. 20050240146; hereinafter “Nash”).
Regarding claim 4, the modified device discloses the invention substantially as claimed, except for the controller monitoring a speed of the irrigation pump and shutting down the irrigation pump.
Nash, a reference in the atherectomy device field of endeavor, teaches configuring a controller to monitors a speed of the irrigation pump and shuts down the irrigation pump if the irrigation pump is operating at below a predetermined speed (para. [0081]) as a safety feature when the device malfunctions (para. [0081]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller to monitor a speed of the irrigation pump and shut down the irrigation pump if the irrigation pump is operating at below a predetermined speed, in view of Nash, in order to prevent the device from harming a patient if the pump malfunctions.
Regarding claim 5, Honeycutt discloses wherein the controller comprises a single printed circuit board (133) that controls operation of both the irrigation pump and the electric motor (Fig. 8; para. [0112]).
Claims 11 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt in view of Rousso et al. (U.S. Patent Application Publication No. 20240299062; hereinafter “Rousso”).
Regarding claim 11, Honeycutt discloses a rotational atherectomy device (10; Fig. 8) comprising:
an elongate flexible shaft (24);
an abrasive element (23; para. [0051]) connected to a distal end of the elongate flexible shaft (Fig. 7; paras. [0049]-[0051]);
a handle (18) comprising a housing (Fig. 8), the handle comprising:
an electric motor (90) operatively connected to the elongate flexible shaft to rotate the elongate flexible shaft (Fig. 8; para. [0086]);
a power source (122) electrically connected to the electric motor for supplying power thereto (Fig. 8; para. [0114]);
a controller (134) that controls operation of the electric motor using the power source (Fig. 8; para. [0113]); and
a sensor that provides a signal indicative of an operating condition of the electric motor (paras. [0113], [0122]);
wherein the controller is configured to:
monitor a motor supply current of the electric motor (para. [0113]); and
monitor a speed of the electric motor using the signal from the sensor (para. [0113]).
Honeycutt further discloses the controller being configured to make automatic adjustments to motor speed (para. [0114]).
The device of Honeycutt is not explicitly disclosed with the controller being configured to reduce a speed of the electric motor and the motor and upon a preselected period of time after reducing the speed, increasing the speed of the electric motor.
Rousso, a reference in the plaque cutting/dissecting device field of endeavor, teaches configuring a controller such that
if the motor supply current is above a predetermined threshold, reduce a speed of the electric motor and the motor supply current (para. [0882],[0884]);
upon a preselected period of time after reducing the speed of the electric motor and the motor supply current, increase speed of the electric motor and the motor supply current (para. [0886]; Figs. 47a-47b).
Rousso teaches such a configuration allows for maintaining performance and durability of the operation of a motor (para. [0877]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller to
if the motor supply current is above a predetermined threshold, reduce a speed of the electric motor and the motor supply current;
upon a preselected period of time after reducing the speed of the electric motor and the motor supply current, increase speed of the electric motor and the motor supply current
in view of Rousso, in order to maintain proper performance of the motor during operation.
Regarding claim 16, Honeycutt discloses wherein the power source is between 5V and 24V (para. [0114]).
Regarding claim 17, Honeycutt discloses wherein the power source comprises one or more batteries located in the handle (para. [0114]).
Regarding claim 18, Honeycutt discloses wherein the controller is configured to monitor a motor supply voltage (paras. [0122]-[0123]).
Regarding claim 19, Honeycutt discloses wherein the controller is configured to detect presence of a guide wire using input from another sensor (e.g., controller (134) is structured to be capable of detecting the presence of a guidewire using an input from another sensor because the circuitry of the controller is designed to receive inputs from sensors and make a determination; Fig. 10; paras. [0119]-[0124]; see also claim 1 and claim 60).
Regarding claim 20, Honeycutt discloses wherein the handle comprises a user input device (124), the controller receiving an input from the user input device to control operation of the electric motor (Figs. 9A-9C; paras. [0105]-[0108])).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt in view of Rousso, as applied to claim 11 above, and further in view of Rivers.
Regarding claim 12, the modified device discloses the invention substantially as claimed, including the device further comprising an irrigation pump (Honeycutt para. [0092]), except for the pump being electrically connected to the power source of the handle.
Rivers, a reference in the atherectomy device field of endeavor, teaches configuring a control unit so that an irrigation pump is electrically connected to the power source that is located in the handle (paras. [0043]-[0047]) to facilitate controlling the pump rate of fluid from the pump.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the irrigation pump to be electrically connected to the power source that is located in the handle, in view of Rivers, in order to provide control over the rate of fluid flow from the pump during use.
Regarding claim 13, Rivers discloses wherein the controller controls operation of the irrigation pump (par. [0045]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt in view of Rousso and Rivers, as applied to claim 13 above, and further in view of Nash.
Regarding claim 14, the modified device discloses the invention substantially as claimed, except for the controller monitoring a speed of the irrigation pump and shutting down the irrigation pump.
Nash, a reference in the atherectomy device field of endeavor, teaches configuring a controller to monitors a speed of the irrigation pump and shuts down the irrigation pump if the irrigation pump is operating at below a predetermined speed (para. [0081]) as a safety feature when the device malfunctions (para. [0081]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller to monitor a speed of the irrigation pump and shut down the irrigation pump if the irrigation pump is operating at below a predetermined speed, in view of Nash, in order to prevent the device from harming a patient if the pump malfunctions.
Regarding claim 15, Honeycutt discloses wherein the controller comprises a single printed circuit board (133) that controls operation of both the irrigation pump and the electric motor (Fig. 8; para. [0112]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Carlson et al. (U.S. Patent Application Publication No. 20190175211) disclosing a rotational medical device controlling a motor using sensors and parameter limits (Figs. 4-7);
Saterbak et al. (U.S. Patent Application Publication No. 2021/0251653) disclosing an atherectomy device controlling a motor using a speed signal and a current signal (Fig. 5);
Ellering et al. (U.S. Patent Application Publication No. 20220265310) disclosing an atherectomy device controlling a motor using sensors and parameter limits (Fig. 4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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