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 1, 3, 5, 7-13, 20-23 and 26-28 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. Claim 1 is rejected because it is unclear what end (e.g. first end or second end) is positioned adjacent the target site in the first “move” step. Claims 20-21 appear to have a similar issue. Claim 8 is rejected because it is unclear if “a first tool position” and “a second tool position” are the same first and second tool positions set forth in Claim 1.
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.
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) 1-3, 5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0151120 to Kostrzewski et al. “Kostrzewski” in view of U.S. Publication No. 2021/0030498 to Peine, U.S. Publication No. 2022/0192769 to Conus et al. “Conus”, U.S. Publication No. 2019/0059973 to Shelton, IV et al. “Shelton” and U.S. Publication No. 2021/0186615 to Shmayahu et al. “Shmayahu” or U.S. Patent No. 8,108,072 to Zhao et al. “Zhao”.
As for Claims 1, 5, 7 and 9, Kostrzewski discloses a robotic surgical system to guide an instrument during surgery (Abstract; Paragraphs [0012] and [0018]) comprising a first robot arm comprising a proximal end and distal end the distal end comprising a rotatable mount flange with a mount flange axis (Fig. 5B, see annotated fig. below). Kostrzewski depicts wherein the instrument has a first end and second end and where the second end is blunt. Kostrzewski teaches wherein the robotic arm can position the instrument with at least 4 degrees of freedom to align an axis at a desired trajectory (Paragraphs [0014] and [0065]). Examiner notes the mount flange in combination with the other robot arm joints allows the system to enable the mount flange to be rotatable in a first position in which the mount flange axis is parallel to the surgical tool axis and the surgical tool is prevented from rotating about an “x-axis” in a YZ plane (see annotated Fig. 5B below) and in a second position where the mount flange is further rotatable in a second position via the robotic arm which the mount flange is perpendicular to the surgical tool axis and allowed to rotate around the x-axis in its broadest reasonable interpretation.
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Fig. 4 depicts where the flange axis is rotated and can be perpendicular to the surgical tool axis when the tool is oriented vertically.
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While Kostrzewski discloses wherein the system can allow multiple surgical tools be swapped, it is not clear if a surgical tool with a blade is used. Kostrzewski also does not disclose an ultrasonic sensor and a processor connected to the ultrasonic sensor used to image the blade and layers of fascia of the patient during a procedure.
Peine teaches from within a similar field of endeavor with respect to surgical robot systems and methods (Abstract) where a surgical instrument may include a probe, grasper, knife, scissors, or the like (Paragraph [0036]). Peine also discloses wherein the system may include multiple robot assemblies (Paragraph [0035]) and wherein the robots may be attached to instruments and/or image capture devices (Paragraph [0036]).
Accordingly, one skilled in the art would have been motivated to have modified the robot system and method described by Kostrzewski to use additional instruments such as a knife (e.g. first end with a blade and second blunt end) as described by Peine in order to perform a variety of surgical procedures as desired.
While Peine does not expressly disclose utilizing both ends of the knife instrument, Conus teaches from within a similar field of endeavor with respect to surgical instruments and robotic arms (Fig. 49 and corresponding descriptions) where each end of a tool may be used for a different treatment (Paragraphs [0069]-[0070]).
Accordingly, one skilled in the art would have been motivated to use both sides of the knife instrument if necessary during a procedure. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
While Peine discloses wherein the imaging device can be any type (Paragraph [0036]), the modified system and method does not specify using an ultrasonic sensor to monitor the procedure through layers of fascia.
Shelton teaches from within a similar field of endeavor with respect to robotic cutting systems and methods where sensors are configured to provide the depth of the tool into tissue (Paragraph [0028], [0069]) and a machine vision system to determine the depth of the blade (Paragraph [0091]) such that the system can provide real time feedback to a user or robotic system during surgery (Paragraph [0076]). Shelton explains that the real-time feedback allows the robot to move and/or cease movement of the tool during surgery when, for example, the tool has reached a particular insertion depth or when the tool has encountered a different type of tissue or when the cut is completed (Paragraph [0076]). Such disclosure would read on the claimed limitations of moving the robot arm to a first pose adjacent a target site (e.g. start of cut) of a patient, move, by actuating the robot arm, the tissue displacement through layers of fascia while continuing to receive real-time sensor data to determine one or more characteristic of the layers of fascia being disposed between the outer layer of the skin and the internal point of the target site wherein the characteristics include an indication that the layers are fully breached in its broadest reasonable interpretation.
As for the ultrasonic sensor, Shmayahu teaches from within a similar field of endeavor with respect to robotic systems and methods for monitoring surgical procedures (Abstract; Paragraph [0005]) where an ultrasound sensor is used to acquire real time intraoperative images used to monitor the advancement of the tool within an area and can provide information used to control operation of the tool (Abstract; Paragraph [0051]). Shmayahu depicts robot 130 with a plurality of arms 132 (Fig. 1) and explains that the coordinate systems of the first and second robotic arms are co-registered (Paragraph [0025]). Examiner notes that co-registered coordinate systems allow the device to infer position of the devices held by the arms through a “reference coordinate system” in its broadest reasonable interpretation. Shmayahu also explains that the intraoperative ultrasound images may provide images used to calculate the amount of material removed (Paragraph [0052]). Examiner notes that in order to collect real-time images of the tool as it moves, the ultrasound probe would also move in its broadest reasonable interpretation. Furthermore, Shmayahu discloses wherein the active tool path may be updated in real time based on the information detected by the images (Paragraph [0087]) and where the system can update the positions of the tool and imaging device an alternating step-by-step movement (Paragraph [0062]).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Kostrzewski, Peine and Conus with an ultrasound imaging means described by Shmayahu to intraoperatively provide real-time visual feedback of the tool as it moves through layers of tissue as described by Shelton. Such a modification would enhance patient safety by providing an additional means to monitor the surgery and requires nothing more than combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Alternatively, Zhao teaches from within a similar field of endeavor with respect to robotic surgical systems and methods (Abstract) where image guided surgery (e.g. real time ultrasound) provided to track a cutting instrument (Column 31, Lines 15-65). Examiner notes that different layers of tissue would be visible in the ultrasound images in its broadest reasonable interpretation. Zhao explains that tool tracking is used to provide automated camera control and guidance to maintain a robotic instrument in view (Column 31, Lines 35-45).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Kostrzewski, Peine and Conus with an ultrasound imaging means described by Zhao to intraoperatively provide real-time visual feedback of the tool as it moves through layers of tissue. Such a modification would enhance patient safety by providing an additional means to monitor the surgery and requires nothing more than combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claims 3 and 8, Examiner notes the modified robotic system is capable of positioning the instrument as claimed via the rotatable flange and other joints in its broadest reasonable interpretation.
With respect to Claims 10-11, Examiner notes that the real-time ultrasound images used for monitoring the surgical tool would be displayed.
As for Claim 12, Shmayhau discloses an ultrasound transducer (Paragraph [0095]). Likewise, Zhao discloses an ultrasound transducer for acquiring intraoperative imaging data (Column 31).
Regarding Claims 13, Shmayhau discloses where the ultrasound transducer may be supported on second robot arm (Paragraph [0005]). Likewise, Zhao discloses an ultrasound transducer for acquiring intraoperative imaging data on robotic arm (Column 31; also Fig. 17 and corresponding descriptions.
Claim(s) 20-23 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peine, Conus, Shelton and Shmayahu or Zhao.
As for Claim 20-23 and 28, Peine discloses a medical robot system and method (Abstract) comprising a processor coupled to a first robot arm and a second robot arm separated from the first arm (Fig. 1A). Peine explains that the robotic arms can hold surgical instrument (e.g. knife) and/or image capture devices (Paragraph [0036]).
However, Peine does not expressly disclose utilizing both ends of the knife instrument and while Peine discloses wherein the imaging device can be any type (Paragraph [0036]), the modified system and method does not specify using an ultrasonic sensor to monitor the procedure through layers of fascia.
Conus teaches from within a similar field of endeavor with respect to surgical instruments and robotic arms (Fig. 49 and corresponding descriptions) where each end of a tool may be used for a different treatment (Paragraphs [0069]-[0070]). The tool is rotated as depicted in Figs. 1-6)
Accordingly, one skilled in the art would have been motivated to use both sides of the knife instrument if necessary during a procedure. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding the ultrasound monitoring, Shelton teaches from within a similar field of endeavor with respect to robotic cutting systems and methods where sensors are configured to provide the depth of the tool into tissue (Paragraph [0028], [0069]) and a machine vision system to determine the depth of the blade (Paragraph [0091]) such that the system can provide real time feedback to a user or robotic system during surgery (Paragraph [0076]). Shelton explains that the real-time feedback allows the robot to move and/or cease movement of the tool during surgery when, for example, the tool has reached a particular insertion depth or when the tool has encountered a different type of tissue or when the cut is completed (Paragraph [0076]). Such disclosure would read on the claimed limitations of moving the robot arm to a first pose adjacent a target site (e.g. start of cut) of a patient, move, by actuating the robot arm, the tissue displacement through layers of fascia while continuing to receive real-time sensor data to determine one or more characteristic of the layers of fascia being disposed between the outer layer of the skin and the internal point of the target site wherein the characteristics include an indication that the layers are fully breached in its broadest reasonable interpretation.
As for the ultrasonic sensor, Shmayahu teaches from within a similar field of endeavor with respect to robotic systems and methods for monitoring surgical procedures (Abstract; Paragraph [0005]) where an ultrasound sensor is used to acquire real time intraoperative images used to monitor the advancement of the tool within an area and can provide information used to control operation of the tool (Abstract; Paragraph [0051]). Shmayahu depicts robot 130 with a plurality of arms 132 (Fig. 1) and explains that the coordinate systems of the first and second robotic arms are co-registered (Paragraph [0025]). Examiner notes that co-registered coordinate systems allow the device to infer position of the devices held by the arms through a “reference coordinate system” in its broadest reasonable interpretation. Shmayahu also explains that the intraoperative ultrasound images may provide images used to calculate the amount of material removed (Paragraph [0052]). Examiner notes that in order to collect real-time images of the tool as it moves, the ultrasound probe would also move in its broadest reasonable interpretation. Furthermore, Shmayahu discloses wherein the active tool path may be updated in real time based on the information detected by the images (Paragraph [0087]) and where the system can update the positions of the tool and imaging device an alternating step-by-step movement (e.g. continually aimed at the tool; Paragraph [0062]).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Peine with an ultrasound imaging means described by Shmayahu to intraoperatively provide real-time visual feedback of the tool as it moves through layers of tissue as described by Shelton. Such a modification would enhance patient safety by providing an additional means to monitor the surgery and requires nothing more than combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Alternatively, Zhao teaches from within a similar field of endeavor with respect to robotic surgical systems and methods (Abstract) where image guided surgery (e.g. real time ultrasound) provided to track a cutting instrument (Column 31, Lines 15-65). Examiner notes that different layers of tissue would be visible in the ultrasound images in its broadest reasonable interpretation. Zhao explains that tool tracking is used to provide automated camera control (e.g. continually aimed at tool) and guidance to maintain a robotic instrument in view (Column 31, Lines 35-45).
Accordingly, one skilled in the art would have been motivated to have modified the robotic system and method described by Peine with an ultrasound imaging means described by Zhao to intraoperatively provide real-time visual feedback of the tool as it moves through layers of tissue taught by Shelton. Such a modification would enhance patient safety by providing an additional means to monitor the surgery and requires nothing more than combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claims 26, Examiner notes that the real-time ultrasound images used for monitoring the surgical tool would be displayed.
Regarding Claim 27, Peine discloses wherein the robotic arms can be coupled with imagers as described above. In addition, Shmayhau discloses where the ultrasound transducer may be supported on second robot arm (Paragraph [0005]). Likewise, Zhao discloses an ultrasound transducer for acquiring intraoperative imaging data on robotic arm (Column 31; also Fig. 17 and corresponding descriptions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5, 7-13, 20-24 and 26-28 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment. New 35 U.S.C. 112(b) rejections also necessitated by amendment.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached on 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797