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 § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0369359 to Blanckaert et al. “Blanckaert” in view of U.S. Publication No. 2010/0121269 to Goldenberg et al. “Goldenberg”.
As for Claims 11 and 14, Blanckaert discloses a robotic system and method to treat a patient (Abstract; Paragraph [0127]) comprising a robotic arm (Abstract; Paragraphs [0010], [0027]; also see 200 in Figs. 5-6 and corresponding descriptions); a probe (e.g. steerable instrument) configured to be coupled to the robotic arm and provide treatment to the patient, the probe sized and shaped to for insertion into the patient (Paragraphs [0010], [0028], [0117] and [0127]), a plurality of sensors disposed in joints of the robotic arm configured to detect a force applied along the axial direction of the probe’s shaft (Paragraph [0249]) and a control unit (e.g. processor) configured to detect a “force event” when the force exceeds a threshold (Paragraph [0249]) wherein the force event results in stopping or reversal of the robotic arm movement (Paragraph [0251]). Examiner notes the measured force in the axial direction would be indicative of compression of the tissue in the patient in its broadest reasonable interpretation.
However, while Blanckaert discloses force sensors in every joint, it is not clear if the force sensor is coupled to the probe between an engagement structure configured to couple the probe to the robotic arm and the distal end of the probe as claimed. In addition, while movement is stopped and reversed, it is not clear if treatment is interrupted too.
Goldenberg teaches from within a similar field of endeavor with respect to robotically steered probe system and methods (Abstract; Paragraph [0002]) where the probe includes a sensor for sensing force axially applied to the distal end of the probe body (Abstract). Goldenberg explains the force reading is indicative of the force applied between the tissue and the distal end (Paragraph [0020]) and measures the magnitude of force (e.g. load) when in contact with tissue structures (Paragraph [0043]). Thus, the measured force is indicative of the tissue compression in its broadest reasonable interpretation. Goldenberg discloses where the probe may include a treatment probe (Paragraph [0009]) and wherein the treatment may be prevented when the force is outside a suitable range (Paragraph [0055]).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Blanckaert to reposition at least one force sensor to be positioned between the distal end of the probe and an engagement structure as described by Goldenberg in order to accurately measure force data imparted on the probe by tissue. Such a modification merely involves a rearrangement of parts. In addition, one skilled in the art would have also been motivated to have interrupted any previously started treatment if and when force readings are outside a suitable range (e.g. above threshold; force event) in order to protect the patient. Such modifications merely involve combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding Claim 13, Goldenberg teaches where the force sensing assembly includes a strain gauge (Paragraph [0080]). Thus, the modified system would provide strain data related to the deflection of the probe between the distal end and the engagement structure in its broadest reasonable interpretation.
Claim(s) 12 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanckaert and Goldenberg as applied to claim 11 above, and further in view of U.S. Publication No. 2014/0081461 to Williamson et al. “Williamson”.
With respect to Claims 12 and 18, Blanckaert and Goldenberg discloses a robotic system and method as described above but fails to specify if the robotic arm can operate in a “zero-gravity mode” or passive as claimed.
Williamson teaches from within a similar field of endeavor with respect to robotic manipulators wherein the robot arm can be operated in a zero force gravity compensation mode to move passively with a user’s guiding (Paragraphs [0029] and [038]).
Accordingly, one skilled in the art would have been motivated to have modified Blanckaert and Goldenberg robotic arm with a zero-gravity, passive mode in order to simplify user movements and allow manual adjustments when necessary. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 18, Williamson’s robotic manipulator arm includes a plurality of joints and sensors to measure parameters of the posture of the manipulator to facilitate the zero gravity mode (Paragraphs [0017], [0027]-[0029]).
Claim(s) 14-17, 24 and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanckaert and Goldenberg as applied to claims 11 and 14 above, and further in view of U.S. Publication No. 2017/0202537 to Ippolito.
As for Claim 14-17, Blanckaert and Goldenberg discloses a robotic system and method as described above including a variety of probes (Paragraph [0127]). However, the art of record does not specify where the probe includes an elongate portion to allow the user to grasp and position the probe into the patient as claimed.
Ippolito teaches from within a similar field of endeavor with respect to robotic probe systems and methods (Fig. 1 and corresponding descriptions). Ippolito’s system includes a plurality of sensors (e.g. load cells) configured to detect forces in a number of directions (Paragraph [0028]) and a processor operatively coupled to the robotic arm and the sensors to move the arm in response to user input and provide haptic feedback according to the sensor data so the user is provided a direct feel of the degree of resistance that the probe encounters in its movement (Paragraphs [0030], [0032]-[0034] and [0042]). Ippolito’s system includes a manual guide device (e.g. elongate portion) for the user to grasp between the sensors and distal end of the probe (7 in Fig. 1 and corresponding descriptions). Moreover, as described above, the haptic feedback according to the sensor data so the user is provided a direct feel of the degree of resistance that the probe encounters in its movement (Paragraphs [0030], [0033]-[0034] and [0042]).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Blanckaert and Goldenberg to equip probes with an elongate portion described by Ippolito in order to allow a medical professional to manually position the probe efficiently and safely when necessary. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 24, Ippolito depicts a supporting structure 3 (e.g. clamp) for carrying the probe and connecting it to the wrist of the robot and a load cell (e.g. sensor) mechanically coupled to the to the clamp to measure loading of the probe/supporting structure relative to the robotic arm (Paragraphs [0026]-[0027]).
As for Claims 27-30, Ippolito’s system allows the user to manually position the robot with a handle and knob having 6 degrees of freedom (Paragraphs [0032], [0037]; Fig. 1 and corresponding descriptions).
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanckaert and Goldenberg as applied to claim 11 above, and further in view of U.S. Publication No. 2019/0380798 to Itkowitz et al. “Itkowitz”.
As for Claim 20, Blanckaert and Goldenberg discloses a robotic system and method as described above but fails to specify utilizing an IMU to detect movement of the probe.
Itkowitz teaches from within a similar field of endeavor with respect to medical device tracking (Abstract) where a control system may determine the motion of the shaft based on sensors including an inertial measurement unit configured to track angular and linear movements (Paragraphs [0064]-[0065]).
Accordingly, one skilled in the art would have been motivated to have equipped Blanckaert and Goldenberg probe or robotic arm with conventional IMU sensors described by Itkowitz in order to enhance the user’s positioning. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding Claim 21, in the modified system, the IMU would be mounted to a predefined position in order to track the angular and linear movements in its broadest reasonable interpretation.
With respect to Claim 22, in the modified system, the processor would receive the data from the IMU in order to determine if further movement is necessary in its broadest reasonable interpretation.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanckaert, Goldenberg and Itkowitz as applied to claim 20 above, and further in view of Ippolito.
As for Claim 23, Blanckaert, Goldenberg and Itkowitz discloses a robotic system and method as described above including a variety of probes (Paragraph [0127]). However, the art of record does not specify where the probe is configured to allow the user to grasp and position the probe as claimed.
Ippolito teaches from within a similar field of endeavor with respect to robotic probe systems and methods (Fig. 1 and corresponding descriptions). Ippolito’s system includes a plurality of sensors (e.g. load cells) configured to detect forces in a number of directions (Paragraph [0028]) and a processor operatively coupled to the robotic arm and the sensors to move the arm in response to user input and provide haptic feedback according to the sensor data so the user is provided a direct feel of the degree of resistance that the probe encounters in its movement (Paragraphs [0030], [0032]-[0034] and [0042]). Ippolito’s system includes a manual guide device (e.g. elongate portion) for the user to grasp between the sensors and distal end of the probe (7 in Fig. 1 and corresponding descriptions). Moreover, as described above, the haptic feedback according to the sensor data so the user is provided a direct feel of the degree of resistance that the probe encounters in its movement (Paragraphs [0030], [0033]-[0034] and [0042]).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Blanckaert, Goldenberg and Itkowitz to equip probes with an elongate portion described by Ippolito in order to allow a medical professional to manually position the probe efficiently and safely when necessary. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-24 and 27-30 have been considered but moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Publication No. 2020/0405417 to Shelton IV et al. is cited herein to provide additional evidence that strain gauge sensors can measure the amplitude or magnitude of strain exerted on an intrabody probe and is indicative of the tissue compression (emphasis added-Paragraph [0227]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/ Primary Examiner, Art Unit 3797