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 .
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 11-18 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.
Claims 11-18 include several limitations such as “the motor state estimation block” (claim 11), “the main controller” (claim 12), “the motor controller” (claim 13), etc. There is insufficient antecedent basis for these limitations in the claims.
Claims 10-18 are listed under independent claim 9, however the preambles state they are dependent on claim 1. For examination purposes, the limitation will be seen as depending from claim 9, which would overcome the numerous lack of antecedent basis issues in the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie (US 4679557 A) in view of Hull (US 2088654 A), Culp et al. (US 6017354 A), and Creighton et al. (US 20150230810 A1).
Regarding claim 1, Opie discloses an atherectomy system (10), comprising:
a drive mechanism (12+18) adapted to rotatably actuate an atherectomy burr (20) (Figure 1; Col 2, line 58-68);
a controller (30) adapted to regulate operation of the drive mechanism (Col 3, Line 1-11);
the controller adapted to calculate an estimated motor torque (Col 3, line 12-31);
the controller adapted to calculate an estimated drag torque (Col 3, line 22-31); and
wherein the controller is adapted to stop or reverse the drive mechanism when an estimated load torque Tload exceeds a torque threshold (Col 7, Line 16-20).
Opie fails to explicitly disclose the controller adapted to calculate an estimated motor torque Tmotor in accordance with: Tmotor = KT*i, where KT is a torque constant for a drive motor and i is a drive motor current; the controller adapted to calculate an estimated drag torque Tdrag in accordance with Tdrag = Cp* θ, where Cp is a coefficient of friction value and θ is an angular velocity value; wherein the controller is adapted to stop or reverse the drive mechanism when an estimated load torque Tload exceeds a torque threshold, where: Tload = Tmotor - Tdrag - I* α, where I is a system inertia value and α is an angular acceleration value. Opie does teach accounting for acceleration, mechanical energy storage, and friction when determining torque trip threshold (Col 7, line 4-10).
Hull teaches that the motor torque can be expressed as a function of friction and acceleration (col. 1, line 43 to col. 2, line 24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Opie to determine load torque as taught by Hull, in order to employ a well-known equation for expressing the relationship between motor torque, friction, and acceleration. Examiner notes that the load torque is a form of friction. As explained in Opie, it is necessary to separate out drag caused by rotation of the device within the guide sheath from drag caused by interaction with tissue (see col. 3, II. 32-38).
Further, Culp teaches that motor torque can be determined as a function of motor current (col. 18, II. 31-43).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Opie in view of Hull with the method of determining motor torque taught by Culp, in order to solve for an unknown on the right side of Hull's equation, and physics equations would generally be known by one of ordinary skill in the art.
Lastly, Creighton discloses drag force as a function of angular velocity (Paragraph 0219).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Opie in view of Hull and Culp with the method of determining motor drag taught by Creighton, in order to solve for an unknown on the right side of Hull's equation, and physics equations would generally be known by one of ordinary skill in the art.
Regarding claim 2, the combination is fully capable of operating such that wherein when operating at constant velocity, Tmotor is substantially equal to Tdrag, and Tload is calculated by the controller in accordance with: Tload = -I*a.
Regarding claim 3, Opie further discloses wherein the drive mechanism comprises: a drive motor (12) (Col 2, line 58-59); a drive cable (18) coupled between the drive motor and the atherectomy burr (Figure 1; Col 2, line 59-61); and wherein the drive motor has a power rating of at least about 60 watts (Col 6, line 24-27).
Regarding claim 4, the combination is fully capable of performing such that the drive mechanism is adapted to accelerate the atherectomy burr to full speed in less than 2 seconds ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
Regarding claim 7, the combination teaches the atherectomy system of claim 1, and Hull further teaches wherein the controller is adapted to determine an angular position of the atherectomy system by monitoring a motor position signal (Hull; col. 1, line 55-col. 2, line 24).
Regarding claim 8, Hull further teaches wherein the controller is adapted to:
determine an angular velocity of the atherectomy system by determining a first derivative with respect to time of the angular position (Hull; col. 1, line 55 to col. 2, line 24); and
determine an angular acceleration of the atherectomy system by determining a second derivative with respect to time of the angular position (Hull; col. 1, line 55 to col. 2, line 24).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie, Hull, Culp, and Creighton and further in view of Jay (US 20040143415 A1).
Regarding claim 5, modified Opie teaches the atherectomy system of claim 1, but fails to explicitly disclose wherein the coefficient of friction value Cp is calculated by the controller based on at least one of: an amount of commanded current, system speed, and total run time of the system.
However, Jay teaches it is known for a computer (26) to calculate the coefficient of friction given velocity and acceleration, essentially system speed (Paragraph 0038; 0044).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie as modified by Hull, Culp, and Creighton with the teachings of Jay by incorporating wherein the coefficient of friction value Cp is calculated by the controller based on system speed in order to incorporate the values the system already has found and such a calculation is well known in the art.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie, Hull, Culp, and Creighton and further in view of Philipp et al. (US 20070085496 A1).
Regarding claim 6, Opie, Hull, Culp, and Creighton teach the atherectomy system of claim 1, but fail to explicitly disclose wherein the controller includes a lookup table that provides particular values for the coefficient of friction Cp for each of a number of rotational speed ranges.
However, Philipp is directed to a surgical tool and teaches employing a look-up table to store coefficients (Paragraph 0260; 0330; 0343).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie, Hull, Culp, and Creighton with the teachings of Philipp by incorporating a lookup table that provides particular values for the coefficient of friction in order to store and easily look up calculated values (Philipp Paragraph 0260).
Claim(s) 9-10, 13-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Mark et al. (US 20100152615 A1) and Philipp et al.
Regarding claim 9, Opie discloses an atherectomy system (10), comprising:
a drive mechanism (12+18) including a drive motor (12) adapted to rotatably actuate an atherectomy burr (20) (Figure 1; Col 2, line 58-68);
a controller (30) adapted to regulate operation of the drive mechanism (Col 3, Line 1-11);
wherein the controller is adapted to stop or reverse the drive mechanism when an estimated load at the atherectomy burr exceeds a threshold value (Col 7, Line 16-20).
Opie fails to explicitly disclose the controller comprising: a motor state estimation block adapted to: receive a motor position signal indicating rotational position of the drive motor; receive current and voltage signals from the drive motor; and output state feedback signals including motor speed; a main controller adapted to: receive the state feedback signals from the motor state estimation block; generate control signals to regulate operation of the drive motor based on the state feedback signals; a motor controller adapted to: receive the control signals from the main controller; control velocity of the drive motor based on the control signals; and provide current feedback to the motor state estimation block; and wherein the controller includes memory storing coefficient values in a lookup table, the coefficient values corresponding to different rotational speed ranges of the drive motor.
However, Mark is directed to a medical cutting device and teaches a motor state estimation block (160) (Paragraph 0090) adapted to: receive a motor position signal indicating rotational position of the drive motor (Paragraph 0095); receive current and voltage signals from the drive motor (Paragraph 0090); and output state feedback signals including motor speed (Paragraph 0090); a main controller (132) (Paragraph 0076-77) adapted to: receive the state feedback signals from the motor state estimation block (Paragraph 0077); generate control signals to regulate operation of the drive motor based on the state feedback signals (Paragraph 0076-77); a motor controller (172) adapted to: receive the control signals from the main controller (Paragraph 0092); control velocity of the drive motor based on the control signals (Paragraph 0092); and provide current feedback to the motor state estimation block (Paragraph 0089; 0096).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Opie such that to include the controller comprising: a motor state estimation block adapted to: receive a motor position signal indicating rotational position of the drive motor; receive current and voltage signals from the drive motor; and output state feedback signals including motor speed; a main controller adapted to: receive the state feedback signals from the motor state estimation block; generate control signals to regulate operation of the drive motor based on the state feedback signals; a motor controller adapted to: receive the control signals from the main controller; control velocity of the drive motor based on the control signals; and provide current feedback to the motor state estimation block, as taught by Mark, as both references and the claimed invention are directed to medical cutting devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie with the teachings of Mark by incorporating the controller comprising: a motor state estimation block adapted to: receive a motor position signal indicating rotational position of the drive motor; receive current and voltage signals from the drive motor; and output state feedback signals including motor speed; a main controller adapted to: receive the state feedback signals from the motor state estimation block; generate control signals to regulate operation of the drive motor based on the state feedback signals; a motor controller adapted to: receive the control signals from the main controller; control velocity of the drive motor based on the control signals; and provide current feedback to the motor state estimation block in order to optimize the control the movement of the motor automatically.
Further, Philipp is directed to a surgical tool and teaches employing a look-up table to store coefficients, which are fully capable of including coefficient values corresponding to different rotational speed ranges of the drive motor (Paragraph 0260; 0330; 0343).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie, with the teachings of Philipp by incorporating a lookup table that provides particular values for a coefficient in order to store and easily look up calculated values (Philipp Paragraph 0260).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 10, Opie further discloses wherein the drive mechanism comprises: a drive motor (12) (Col 2, line 58-59); a drive cable (18) coupled between the drive motor and the atherectomy burr (Figure 1; Col 2, line 59-61).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 13, Mark further teaches wherein the motor controller includes a speed feedback control loop (“closed loop feedback analog circuits”) for maintaining proper speed control of the drive motor (Paragraph 0092).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 14, Opie further discloses wherein the drive motor has a power rating of at least about 60 watts (Col 6, line 24-27).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 15, the combination is fully capable such that wherein the drive mechanism is adapted to accelerate the atherectomy burr to full speed in less than 2 seconds ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 17, the combination of Opie and Philip further teaches wherein the coefficient values stored in the lookup table comprise coefficient of friction values for different rotational speed ranges of the drive motor.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Mark and Philipp as applied to claim 9 above, and further in view of Kim et al. (US 20050212548 A1).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 11, Opie as modified by Mark and Philipp teaches the atherectomy system of claim 9, but fails to explicitly disclose wherein the motor state estimation block is further adapted to: predict drive motor current more rapidly than the drive motor current could be measured; and receive a reference current signal from the main controller for predicting the drive motor current.
However, Kim is directed to a motor control system and teaches determining the presence or absence of a motor lock error in the motor by determining whether the determined difference is equal to or higher than a predetermined reference difference, so that it quickly determines the presence or absence of a motor lock error in the motor without using a sensor and prevents an overcurrent from flowing in the motor, resulting in the prevention of a faulty operation or damage to the motor, essentially, predicting drive motor current more rapidly than the drive motor current could be measured (Abstract; Paragraph 0017) and the resulting combination would include receiving a reference current signal from the main controller for predicting the drive motor current (Paragraph 0020; 0024).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Opie as modified by Mark and Philipp such that wherein the motor state estimation block is further adapted to: predict drive motor current more rapidly than the drive motor current could be measured; and receive a reference current signal from the main controller for predicting the drive motor current, as taught by Kim, as both references and the claimed invention are directed to motor control systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie as modified by Mark and Philipp with the teachings of Kim by incorporating wherein the motor state estimation block is further adapted to: predict drive motor current more rapidly than the drive motor current could be measured; and receive a reference current signal from the main controller for predicting the drive motor current in order to prevent a faulty operation or damage to the motor (Kim Abstract).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Mark and Philipp as applied to claim 9 above, and further in view of Malackowski et al. (US 20060074405 A1).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 12, Opie as modified by Mark and Philipp teaches the atherectomy system of claim 9 but fails to explicitly disclose wherein the main controller comprises a PID controller having: a proportional control portion; an integral control portion; and a derivative control portion.
However, Malackowski is directed to a surgical device and teaches a PID controller (406), which inherently includes a proportional control portion, an integral control portion, and a derivative control portion (Paragraph 0160-162).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Opie as modified by Mark and Philipp such that the main controller is a PID controller, as taught by Malackowski, as both references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie as modified by Mark and Philipp with the teachings of Malackowski by incorporating the main controller being a PID controller, which is well known in the art for dynamically adjusting to input data, and would further serve as a simple substitution, substituting an undisclosed controller for another known type of controller. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson' s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Mark and Philipp as applied to claim 9 above, and further in view of Hull.
As best understood in view of the interpretation presented under 112(b) above, regarding claim 16, Opie as modified by Mark and Philipp teaches the atherectomy system of claim 9, but fails to explicitly disclose wherein the controller is adapted to: determine an angular velocity of the atherectomy system by determining a first derivative with respect to time of the rotational position; and determine an angular acceleration of the atherectomy system by determining a second derivative with respect to time of the rotational position.
However, Hull teaches wherein the controller is adapted to: determine an angular velocity of the atherectomy system by determining a first derivative with respect to time of the rotational position (Hull; col. 1, line 55 to col. 2, line 24).; and determine an angular acceleration of the atherectomy system by determining a second derivative with respect to time of the rotational position (Hull; col. 1, line 55 to col. 2, line 24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Opie to determine angular velocity and acceleration of the system as taught by Hull, in order to employ a well-known equation for expressing the relationship between the values to increase synchronism and sensitivity to prevent system failure (Hull Col 2 line 45-53).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opie in view of Mark and Philipp as applied to claim 9 above, and further in view of Culp et al. (US 6017354 A).
As best understood in view of the interpretation presented under 112(b) above, regarding claim 18, Opie as modified by Mark and Philipp teaches the atherectomy system of claim 9, but fails to explicitly disclose wherein the controller is adapted to continually update a transfer function coefficient to minimize variations in control of the atherectomy system due to individual variations of the controller and changes in component characteristics that occur as a result of thermal changes in the controller.
However, Culp is directed to a surgical system and teaches wherein the controller is adapted to continually update a transfer function coefficient to minimize variations in control of the atherectomy system due to individual variations of the controller and changes in component characteristics that occur as a result of thermal changes in the controller (Col 47 line 40-55; Col 49 line 4-17).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Opie as modified by Mark and Philipp such that wherein the controller is adapted to continually update a transfer function coefficient to minimize variations in control of the atherectomy system due to individual variations of the controller and changes in component characteristics that occur as a result of thermal changes in the controller, as taught by Culp, as both references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Opie as modified by Mark and Philipp with the teachings of Culp by incorporating wherein the controller is adapted to continually update a transfer function coefficient to minimize variations in control of the atherectomy system due to individual variations of the controller and changes in component characteristics that occur as a result of thermal changes in the controller in order to adjust speed and minimize variations in the control of the device by compensating for changes throughout operation (Col 49- line 6-17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
