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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/17/2025 and 11/10/2025.The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No.US12440294. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons: “US12440294 teaches the bolded limitations”.
A robotic medical device system comprising: a controller configured to, control a robotic medical device to maintain a constant overshoot for different step responses of the robotic medical device system independent of variations in a delay associated with control of the robotic medical device, wherein different step responses include different step response settling times for the robotic medical device system. US12440294 discloses performing velocity to maintain the overshoot, i.e., controlling the device to maintain constant overshoot.
Claims 2, 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 18 of U.S. Patent No.US12440294. Claims 17, 18 US12440294 teaches identical limitations.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No.US12440294. claim 1 of US12440294 teaches identical limitations.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 of U.S. Patent No.US12440294. claim 2 of US12440294 teaches identical limitations.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 of U.S. Patent No.US12440294. claim 4 of US12440294 teaches identical limitations.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No.US12440294. claim 1 of US12440294 teaches identical limitations.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 of U.S. Patent No.US12440294. claim 3 of US12440294 teaches identical limitations.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 of U.S. Patent No.US12440294. claim 5 of US12440294 teaches identical limitations.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No.US12440294. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons: “US12440294 teaches the bolded limitations”.
A non-transitory computer readable medium storing computer-executable instructions that, when executed at a controller of a robotic medical device system, causes the robotic medical device system to perform a method comprising: controlling a robotic medical device to maintain a constant overshoot for different step responses of the robotic medical device system independent of variations in a delay associated with control of the robotic medical device, wherein different step responses include different step response settling times for the robotic medical device system. US12440294 discloses performing velocity to maintain the overshoot, i.e., controlling the device to maintain constant overshoot. It would have been obvious to one of ordinary skill in the art to modify the teaching of US12440294 to incorporate a non-transitory medium for storing instruction to be executed yielding predictable results in order to store instructions for controlling a robotic device accurately and reliably store information on a physical tangible device.
Claims 11, 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 18 of U.S. Patent No.US12440294. Claims 17, 18 US12440294 teaches identical limitations.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No.US12440294. claim 1 of US12440294 teaches identical limitations.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 of U.S. Patent No.US12440294. claim 2 of US12440294 teaches identical limitations.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 of U.S. Patent No.US12440294. claim 4 of US12440294 teaches identical limitations.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No.US12440294. claim 1 of US12440294 teaches identical limitations.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 of U.S. Patent No.US12440294. claim 3 of US12440294 teaches identical limitations.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 of U.S. Patent No.US12440294. claim 5 of US12440294 teaches identical limitations.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No.US12440294. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons: “US12440294 teaches the bolded limitations”.
A robotic medical device system comprising: a controller configured to constrain a velocity of a robotic medical device in response to a control delay being greater than or equal to a maximum acceptable delay threshold and less than a disable threshold, the delay associated with control of the robotic medical device, and the velocity being constrained to maintain a constant maximum overtravel distance of the robotic medical device independent of variations in the control delay, wherein the maximum acceptable delay threshold is greater than zero. US12440294 discloses the performing the non-linear scaling of the velocity which is equivalent to constraining the velocity.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 of U.S. Patent No.US12440294. claim 12 of US12440294 teaches identical limitations.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No.US12440294. claim 1 of US12440294 teaches identical limitations.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 of U.S. Patent No.US12440294. claim 11 of US12440294 teaches identical limitations.
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 of U.S. Patent No.US12440294. claim 14 of US12440294 teaches identical limitations.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 of U.S. Patent No.US12440294. claim 19 of US12440294 teaches identical limitations.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 of U.S. Patent No.US12440294. claim 20 of US12440294 teaches identical limitations.
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 1-6, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/222641, from IDS) in view of Peine (US20220134555).
Regarding claim 1, Kottenstette teaches a robotic medical device system comprising:
a robotic medical device ([0008] disclosing a robotic medical device); and
a controller configured to control robotic medical device to maintain a constant overshoot for different step responses of the robotic medical device system independent of variations in a delay associated with control of the robotic medical device ([0010] disclosing determining a delay in a control signal and controlling the velocity of the medical device based on the delay. [0042] disclosing a controller, via communication over a network, to provide control signals to operate the medical devices. [0054] discloses reducing the movement speed “controlling movement” of the device based on the increase in the delay of the network proportionally, an example is given when the delay is half a predetermined amount, the velocity is half of the commanded amount. [0054] discloses that the approach of reducing the velocity proportional to the increase in delay will provide robust positional control of the robot. It is interpreted that reducing the speed based on the delay will maintain a substantially constant overshoot since the distance is changed based on time and speed, thus changing the speed and the time proportionally to maintain a substantial constant distance is ensured. it is also interpreted that the constant overshoot is independent from the variation in delay, since the position will remain substantially the same over any variation in delay using the control method above by reducing the speed proportional to increase in delay to maintain positional accuracy of the device. Different step responses is interpreted as different delay times).
Kottenstette does not teach the different step responses include different step response settling times for the robotic medical device system.
Peine teaches the different step responses include different step response settling times for the robotic medical device system ([0060]-[0070] disclosing the control of the robotic device based on the different resonant frequency which is indicative of a changing down time “settling time” of the signal).
it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teaching of Kottenstette to incorporate the teaching of Peine of the different step responses include different step response settling times for the robotic medical device system in order to further reduce a latency associated with the stabilization of a signal to reach steady state thus further reducing the delay and improving the robotic control.
Regarding claim 2, Kottenstette as modified by Peine teaches the robotic medical device system of claim 1, wherein the robotic medical device is an elongated medical device (Kottenstette [0055] disclosing elongated medical device).
Regarding claim 3, Kottenstette as modified by Peine teaches the robotic medical device system of claim 2, wherein the elongated medical device is a catheter, a guidewire, a balloon catheter, or a microcatheter (Kottenstette [0051] disclosing a catheter).
Regarding claim 4, Kottenstette as modified by Peine teaches the robotic medical device system of claim 1, wherein the controller is configured to control the robotic medical device based on one or more control signals received via a network (Kottenstette [0010] disclosing determining a delay in a control signal and controlling the velocity of the medical device based on the delay. [0042] disclosing a controller, via communication over a network, to provide control signals to operate the medical devices. [0054] discloses reducing the movement speed “controlling movement” of the device based on the increase in the delay of the network proportionally, an example is given when the delay is half a predetermined amount, the velocity is half of the commanded amount).
Regarding claim 5, Kottenstette as modified by Peine teaches the robotic medical device system of claim 4, wherein the delay includes at least one of a command delay or an image feedback delay (Kottenstette [0008] disclosing a delay in transmission of a control signal “command delay”).
Regarding claim 6, Kottenstette as modified by Peine teaches the robotic medical device system of claim 4, wherein the delay is at least partially based on a transmission delay for the network (Kottenstette [0045] disclosing a delay in transmission of the control signals over the network).
Claims 10-15 are rejected for similar reasons as claims 1-6, respectively, see above rejection. Kottenstette teaches a non-transitory medium [0068].
Claims 7, 9, 16, 18 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/222641, from IDS) in view of Peine (US20220134555) and Shelton (US20160256185).
Regarding claim 7, Kottenstette as modified by Peine teaches the robotic medical device system of claim 1, wherein the controller is configured to control a velocity of the robotic medical device to maintain the substantially constant overshoot (Kottenstette [0054] discloses reducing the movement speed “controlling movement” of the device based on the increase in the delay of the network proportionally, an example is given when the delay is half a predetermined amount, the velocity is half of the commanded amount. [0054] discloses that the approach of reducing the velocity proportional to the increase in delay will provide robust positional control of the robot. It is interpreted that reducing the speed based on the delay will maintain a substantially constant overshoot since the distance is changed based on time and speed, thus changing the speed and the time proportionally to maintain a substantial constant distance is ensured. it is also interpreted that the constant overshoot is independent from the variation in delay, since the position will remain substantially the same over any variation in delay using the control method above by reducing the speed proportional to increase in delay to maintain positional accuracy of the device).
Kottenstette does not teach non-linear scaling of the velocity.
Shelton teaches non-linear scaling of a velocity ([0276]-[0278] disclosing the non-linear scaling of velocity).
It would have been obvious to one of ordinary skill in the art to substitute the teaching of Shelton of a non-linear scaling of velocity with the linear velocity scaling of Kottenstette yielding predictable results in order to offer more flexible control over the velocity in a non linear scaling which accounts for non linear changes in signal and expected reached values thus improving the control of the device.
Regarding claim 9, Kottenstette as modified by Peine and Shelton teaches the robotic medical device system of claim 7, wherein the velocity of the robotic medical device includes at least one of a linear or rotational velocity (Kottenstette [0054] disclosing slowing down the retraction and advancement velocity “linear velocity”).
Claims 16, 18 are rejected for similar reasons as claims 7, 9, respectively.
Claims 8, 17 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/222641) in view of Peine (US20220134555) and Shelton (US20160256185) and Shelton IV (US20200405375).
Regarding claim 8, Kottenstette as modified by Peine and Shelton teaches the robotic medical device system of claim 1, wherein the controller is configured to perform the non-linear scaling of the velocity of the robotic medical device to maintain a constant overtravel distance of the robotic medical device (Kottenstette [0054] discloses reducing the movement speed “controlling movement” of the device based on the increase in the delay of the network proportionally, an example is given when the delay is half a predetermined amount, the velocity is half of the commanded amount. [0054] discloses that the approach of reducing the velocity proportional to the increase in delay will provide robust positional control of the robot. It is interpreted that reducing the speed based on the delay will maintain a substantially constant overshoot since the distance is changed based on time and speed, thus changing the speed and the time proportionally to maintain a substantial constant overtravel distance is ensured).
Shelton teaches non-linear scaling of a velocity ([0276]-[0278] disclosing the non-linear scaling of velocity).
It would have been obvious to one of ordinary skill in the art to substitute the teaching of Shelton of a non-linear scaling of velocity with the linear velocity scaling of Kottenstette yielding predictable results in order to offer more flexible control over the velocity in a non linear scaling which accounts for non linear changes in signal and expected reached values thus improving the control of the device.
Kottenstette as modified by Peine and Shelton does not teach a maximum overtravel distance.
Shelton IV teaches a maximum overtravel distance ([0480] disclosing reducing the velocity of the end effector to maintain the distance within a threshold, i.e., maximum overtravel distance).
Kottenstette as modified by Peine and Shelton and Shelton IV are analogous art because they are in the same field of endeavor, medical device control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teaching of Kottenstette to incorporate the teaching of Shelton IV of a maximum overtravel distance in order to accurately control the robot to stop at desired position within distance threshold as taught by Shelton [0480].
Claim 17 is rejected for similar reasons as claim 8, see above rejection.
Claims 19, 20, 24, 25 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/22264) in view of Shelton IV (US20200405375).
Regarding claim 19, Kottenstette teaches a robotic medical device system comprising:
a robotic medical device ([0008] disclosing a robotic medical device); and
a controller configured to constrain a velocity of the robotic medical device in response to a control delay being greater than or equal to a maximum acceptable delay threshold and less than a disable threshold, the control delay being associated with control of the robotic medical device and the velocity being constrained to maintain a constant maximum overtravel distance of the robotic medical device independent of variations in the control delay, ([0010] disclosing determining a delay in a control signal and controlling the velocity of the medical device based on the delay. [0042] disclosing a controller, via communication over a network, to provide control signals to operate the medical devices. [0054] discloses reducing the movement speed “controlling movement” of the device based on the increase in the delay of the network proportionally, an example is given when the delay is half a predetermined amount, the velocity is half of the commanded amount. [0054] discloses that the approach of reducing the velocity proportional to the increase in delay will provide robust positional control of the robot. It is interpreted that reducing the speed based on the delay will maintain a substantially constant overshoot since the distance is changed based on time and speed, thus changing the speed and the time proportionally to maintain a substantial constant distance is ensured. it is also interpreted that the constant overshoot is independent from the variation in delay, since the position will remain substantially the same over any variation in delay using the control method above by reducing the speed proportional to increase in delay to maintain positional accuracy of the device. [0053] disclosing the threshold is a range of values wherein when the delay is between a first threshold and a second threshold, control remotely remains and wherein when the delay is greater than the second value, the control is disabled, i.e., between an acceptable maximum delay threshold and a disable threshold. Also [0054] disclosing when the delay is between zero and a threshold, here zero is considered he maximum acceptable threshold delay and the threshold will be the disable threshold).
Kottenstette does not teach a maximum overtravel distance.
Shelton IV teaches a maximum overtravel distance ([0480] disclosing reducing the velocity of the end effector to maintain the distance within a threshold, i.e., maximum overtravel distance).
Kottenstette and Shelton are analogous art because they are in the same field of endeavor, medical device control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teaching of Kottenstette to incorporate the teaching of Shelton of a maximum overtravel distance in order to accurately control the robot to stop at desired position within distance threshold as taught by Shelton [0480].
While Kottenstette does not explicitly disclose wherein the maximum acceptable delay threshold is greater than zero. Kottenstette in [0053]-[0054] disclosing a plurality of thresholds including ranges of thresholds, it would have been obvious to one of ordinary skill in the art to have modified the threshold to include the range of thresholds as a design choice of ranges yielding predictable results. Nevertheless, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to have provide to Kottenstette with different ranges , since it has been held that where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 20, Kottenstette as modified by Shelton teaches the robotic medical device system of claim 19, wherein the controller is configured to disable operation of the robotic medical device in response to the delay being greater than the disable threshold (Kottenstette [0054] disclosing when the delay is greater than the threshold “disable threshold” to stop the device “disable”).
Regarding claim 24, Kottenstette as modified by Peine teaches the robotic medical device system of claim 19, wherein the robotic medical device is an elongated medical device (Kottenstette [0055] disclosing elongated medical device).
Regarding claim 25, Kottenstette as modified by Peine teaches the robotic medical device system of claim 24, wherein the elongated medical device is a catheter, a guidewire, a balloon catheter, or a microcatheter (Kottenstette [0051] disclosing a catheter).
Claims 21 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/222641) in view of Shelton IV (US20200405375) and Shelton (US20160256185).
Regarding claim 21, Kottenstette as modified by Shelton IV teaches the robotic medical device system of claim 19, wherein the controller is configured to constrain the velocity of the medical device (Kottenstette [0054] discloses reducing the movement speed “controlling movement” of the device based on the increase in the delay of the network proportionally, an example is given when the delay is half a predetermined amount, the velocity is half of the commanded amount. [0054] discloses that the approach of reducing the velocity proportional to the increase in delay will provide robust positional control of the robot. It is interpreted that reducing the speed based on the delay will maintain a substantially constant overshoot since the distance is changed based on time and speed, thus changing the speed and the time proportionally to maintain a substantial constant distance is ensured. it is also interpreted that the constant overshoot is independent from the variation in delay, since the position will remain substantially the same over any variation in delay using the control method above by reducing the speed proportional to increase in delay to maintain positional accuracy of the device).
Kottenstette does not teach non-linear scaling of the velocity.
Shelton teaches non-linear scaling of a velocity ([0276]-[0278] disclosing the non-linear scaling of velocity).
It would have been obvious to one of ordinary skill in the art to substitute the teaching of Shelton of a non-linear scaling of velocity with the linear velocity scaling of Kottenstette yielding predictable results in order to offer more flexible control over the velocity in a non linear scaling which accounts for non linear changes in signal and expected reached values thus improving the control of the device.
Claims 22 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/222641) in view of Shelton IV (US20200405375) and Shelton (US20160256185) and Brandt (US20160256185).
Regarding claim 22, Kottenstette as modified by Shelton IV and Shelton does not teach the robotic medical device system of claim 21, wherein the non-linear scaling of velocity is at least partially based on the constant maximum overtravel distance of the robotic medical device.
Shelton teaches non-linear scaling of a velocity ([0276]-[0278] disclosing the non-linear scaling of velocity).
It would have been obvious to one of ordinary skill in the art to substitute the teaching of Shelton of a non-linear scaling of velocity with the linear velocity scaling of Kottenstette yielding predictable results in order to offer more flexible control over the velocity in a non linear scaling which accounts for non linear changes in signal and expected reached values thus improving the control of the device.
Brandt teaches the scaling of the velocity is at lest partially based on the constant maximum overtravel distance of the robotic medical device ([0089]-[0092] disclosing the reducing of velocity based on the stopping distance of the robotic device).
It would have been obvious to one of ordinary skill in the art to combine the teaching of Brandt of reducing the speed based on the overtravel distance with the non linear velocity control as taught by Kottenstette as modified by Shelton IV yielding predictable results in order to calculate a trajectory such that the velocity control does not cause a distance limit to be exceeded thus avoiding injuries and improving control.
Claims 23 are rejected under 35 U.S.C. 103 as being unpatentable by Kottenstette (WO2019/22264) in view of Shelton IV (US20200405375) and Brandt (US20160256185).
Regarding claim 23, Kottenstette as modified by Shelton IV does not teach the robotic medical device system of claim 19, wherein the constant maximum overtravel distance is a maximum distance traveled by the robotic medical device after receipt of a command to stop movement of the robotic medical device.
Brandt teaches wherein the constant maximum overtravel distance is a maximum distance traveled by the robotic medical device after receipt of a command to stop movement of the robotic medical device ([0077]-[0092] disclosing the reducing of velocity based on the stopping distance of the robotic device, wherein stopping distance is based on the distance travelled when a stop is issued).
It would have been obvious to one of ordinary skill in the art to combine the teaching of Brandt of reducing the speed based on the overtravel distance with the non linear velocity control as taught by Kottenstette as modified by Shelton IV yielding predictable results in order to calculate a trajectory such that the velocity control does not cause a distance limit to be exceeded thus avoiding injuries and improving control.
Conclusion
The prior art made of record and not relied upon is considered pertinent to
applicant's disclosure. The prior art cited in PTO-892 and not mentioned above disclose related devices and methods.
US20190143506 disclosing the control of speed and acceleration to reduce settling times.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMAD O EL SAYAH whose telephone number is (571)270-7734. The examiner can normally be reached on M-Th 6:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ramon Mercado can be reached on (571) 270-5744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMAD O EL SAYAH/Primary Examiner, Art Unit 3658B
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