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 .
Response to Arguments
Applicant’s argument on Page 9 regarding the objections of Claims 1-17 has been fully considered. The objections to Claims 1-17 are withdrawn in view of the amendments.
Applicant’s argument on Page 9 regarding the claim interpretation of Claims 5-6, 8, 11, and 17 under 35 U.S.C. 112(f) has been fully considered. The claim interpretation of Claims 5-6, 8, 11, and 17 under 35 U.S.C. 112(f) is withdrawn in view of the amendments.
Applicant’s argument on Page 10 regarding the rejections of Claims 1-17 under 35 U.S.C. 112(b) has been fully considered. The rejections of Claims 1-17 under 35 U.S.C. 112(b) is withdrawn in view of amendments.
Applicant’s argument on Pages 10-16 regarding the rejection of Claims 1 and 18 under 35 U.S.C. 102(a)(1) as being anticipated by Tognaccini has been fully considered but is not persuasive.
On Page 11, applicant argues that Tognaccini does not disclose or suggest the claimed “plurality of modes” and that “Tognaccini does not even recognize the need to display various working regions of the body let alone provide the ability to receive user input for selecting an operating mode that corresponds to a specific working region of the subject’s anatomy.” However, the claims do not require that the working regions of the body be displayed; moreover, the modes 1801, 1803, 1805 of Tognaccini are interpreted as the plurality of operating modes corresponding to a respective one of said plurality of working regions of the subject’s anatomy because the various operating modes minimize error, collision of the robotic arms, and potential harm to the subject. The modes of Tognaccini vary depending on the actions performed at the time, as in [0080], where it is understood that the actions are centered around specific anatomy of the subject, as the invention of Tognaccini generally relates to a system that performs minimally invasive surgical procedures.
On Pages 11-15 Applicant argues two features that are not disclosed or suggested by Tognaccini: (i) a control panel configured to receive input for selection of a plurality of operating modes displayed on the control panel, each mode corresponding to a specific working region of the subject’s anatomy and (ii) upon selection of an operating mode, and hence working region, the system automatically limits probe movement to a pre-defined range and limits contact of the diagnostic ultrasound probe module within the working region, thereby constraining the probe to operate within the corresponding working region of the subject’s anatomy. However, regarding argument (i), it is understood in the art that a control panel for user input with a display panel is not novel in the art. The displays disclosed in [0044] and [0045] of Tognaccini and various input devices disclosed in [0044] and [0045] teach that the user has control over the operating mode of the system, whose actions are carried out by processor 102, as in [0050]. While the examiner appreciates that the modes may be interpreted as instrument-centric, they may further be interpreted as also being anatomy-centric, as the instruments must be properly navigated to/through/at the surgical site, as in [0071] and [0091]. Regarding argument (ii), the range of motion limitations, which are interpreted as the pre-defined range and limitations of the contact probe, are corresponding to the selected operating mode and thereby the subject’s anatomy because the navigation commands and motion limitations are different depending on the locale of the surgical site. For example, the navigation commands and motion limitations within the subject’s intestines will be different than the navigation commands and motion limitations for the subject’s coronary artery.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 16 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Claim Objections
Claims 6 are objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to […] diagnostic ultrasound probe module […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claims 11 and 16-18 are objected to because of the following informalities: minor error in antecedent basis. The claims should be amended to […] diagnostic [[ultrasonic]] ultrasound probe module […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-5, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tognaccini et al. (US 20090326318).
Regarding Claim 1, Tognaccini teaches a diagnostic imaging system, (Fig. 1, reproduced below, and [0044] “The console 10 includes a 3-D monitor for displaying a 3-D image of a surgical site”), for capturing imaging of a subject’s anatomy, ([0047] “Surgeon views the work site in 3-D on the console monitor 104 as images of the work site are being captured by the articulatable camera 211.”), the subject being positioned on a bed frame, ([0041] “patient 30 who is lying face up on an operating table 50”), comprising:
a) a robot having a manipulator arm, ([0042] “robotic arm assembly 130”), the manipulator arm comprising a plurality of elements, ([0063] “first, second, and third links 322, 324, 326” and [0065] “first, second, and third links 332, 334, 336 […]. […] first, second, and third links 342, 344, 346”), interconnected to each other by a plurality of joints whereby each element is rotatable relative to an adjoining element of the manipulator arm ([0063] “first and second join assemblies (also referred to herein simply as “joints”) 323, 325 […]. The first joint assembly 323 couples the first and second links 322, 324 and the second joint assembly 325 couples the second and third links 324, 326 so that the second link 324 may pivot about the first joint assembly 323 in pitch and yaw” and [0065] “first and second joint assemblies 333, 335 […]. […] first and second joint assemblies 343,345”);
b) a diagnostic ultrasound probe module comprising an ultrasound transducer, ([0071] “image capturing device such as an ultrasound probe,” where it is inherent that an ultrasound probe will have an ultrasound transducer”), the diagnostic ultrasound probe module being coupled to one of the plurality of elements of the manipulator arm by a coupling arrangement, ([0042] “entry guide 200 is held and manipulated by a robotic arm assembly 130,” where the camera 311 may alternately be the ultrasound probe, as in [0071]), to allow movement of the diagnostic ultrasound probe module relative to said one of the plurality of elements of the manipulator arm ([0064] “The wrist assembly 327 also has pitch and yaw angular movement capability so that the camera's tip 311 may be oriented up or down and to the right or left, and combinations thereof.”);
c) a controller, ([0044] “processor (also referred to herein as a “controller”) 102”), coupled to the manipulator arm and the coupling arrangement, (Fig. 1, reproduce below), to employ the manipulator arm to move the diagnostic ultrasound probe module relative to one of a plurality of working regions of the subject's anatomy, (Figs. 3-4 and 20, reproduced below, [0086] “an anatomic structure 360 which is in front of the surgical tools 231, 241,” and [0092] “the joint range of motion limits resemble circles in the present example, ellipses and other joint constrained boundary limits may also be accommodated in a similar manner as described herein for boundary circles.”), based on a selection of one of a plurality of operating modes displayed on a control panel, ([0044] “Other input devices that are provided allow the Surgeon to interact with the medical robotic system 100 include […] a Graphical User Interface (GUI) 170,” [0060] “The selective association of the input devices 108, 109 to other devices in this example may be performed by the Surgeon using the GUI 170,” Figs. 15-18, where the displays illustrate views captured from the camera/probe, the view of the robotic arm holding the articulatable camera/probe, the view of the enabled surgical tools, and Fig. 18 demonstrates how the viewing modes are provided), configured to receive user input, ([0044] “The input devices 108, 109 may include any one or more of a variety of input devices such as joysticks, gloves, trigger-guns, hand-operated controllers, or the like. Other input devices that are provided to allow the Surgeon to interact with the medical robotic system 100 include a foot pedal 105, a conventional voice recognition system 160 and a Graphical User Interface (GUI) 170” and [0050] “The processor 102 performs various functions in the system 100. One important function that it performs is to translate and transfer the mechanical motion of input devices 108, 109 through control signals over bus 110 so that the Surgeon can effectively manipulate devices, such as the tools 231, 241, camera 211, and entry guide 200, that are selectively associated with the input devices 108, 109 at the time.”), each of said plurality of operating modes corresponding to a respective one of said plurality of working regions of the subject's anatomy, ([0086] “an anatomic structure 360 which is in front of the surgical tools 231, 241,” and [0092] “the joint range of motion limits,” where the range of motion limits (circles of Fig. 20) are interpreted as corresponding to the anatomic structure 360 of the patient, thereby corresponding to a plurality of working regions of the subject’s anatomy.), wherein the controller is arranged to control the movement of the plurality of elements and the coupling assembly in each of said plurality of operable modes ([0057] “by placing switches 258, 259 respectively in tool following modes "T2" and "T1", the left and right input devices 108, 109 may be respectively associated with the first and second surgical tools 231, 241, which are telerobotically controlled through their respective controllers 233, 243 (preferably implemented in the processor 102) and manipulators 232, 242 so that the Surgeon may perform a medical procedure on the Patient while the entry guide 200 is locked in place,” [0058] “by placing switches 258, 259 respectively in camera positioning modes "C2" and "C1", the left and right input devices 108, 109 may be associated with the camera 211, which is telerobotically controlled through its controller 213 (preferably implemented in the processor 102) and manipulator 212 so that the Surgeon may position the camera 211 while the surgical tools 231, 241 and entry guide 200 are locked in place by their respective controllers 233, 243, 203,” and [0059] “by placing switches 258, 259 respectively in entry guide positioning modes "G2" and "G1", the left and right input devices 108, 109 may be associated with the entry guide 200, which is telerobotically controlled through its controller 203 (preferably implemented in the processor 102) and manipulator 202 so that the Surgeon may position the entry guide 200 while the surgical tools 231, 241 and camera 211 are locked in place relative to the entry guide 200 by their respective controllers 233, 243, 213.”), such that in each operable mode, motion of the ultrasound probe module relative to the subject's anatomy is limited by limiting movement of one or more of the joints of the manipulator arm in said operating mode to limit motion of the diagnostic ultrasound probe module ([0083] “an undesirable event or condition such as nearing a limit of its range of motion” and [0092] “range of motion limitations for the articulatable instrument 231 that may be displayed in the auxiliary view” and [0093] “indications of range of motion limitations 2011, 2031, 0241, 2051 respectively corresponding to the instruments 211, 231, 241, 251.”), within a pre-defined range and limit contact of the probe module within the working region of the subject’s anatomy that corresponds to the selected operating mode (Fig. 20, reproduced below, [0092] “the instrument's first and third links 332, 336 are maintained in a parallel relationship with each other. […] joint range of motion limits […],” and [0093] “range of motion limitations 2011, 2031, 0241, 2051 respectively corresponding to the instruments 211, 231, 241, 251.” Where the pre-defined range is the generation of the motion limitations for the joints by using the received information and forward kinematics of the one or more articulatable instruments, as in Claim 1 of Tognaccini, which are intended for the anatomical site for surgery.).
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Fig. 1 of Tognaccini
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Fig. 20 of Tognaccini
Regarding Claim 4, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Tognaccini teaches wherein selection of each operating mode, ([0057] “each of the input devices 108, 109 may be selectively associated with one of the devices 211, 231, 241, 200 so that the associated device may be controlled by the input device through its controller and manipulator. For example, by placing switches 258, 259 respectively in tool following modes "T2" and "T1"” and [0060] “The selective association of the input devices 108, 109 to other devices in this example may be performed by the Surgeon using the GUI 170 […]. Alternatively, the association of the input devices 108, 109 may be changed by the Surgeon depressing a button on one of the input devices 108, 109 or depressing the foot pedal 105, or using any other well known mode switching technique.”), corresponds to a respective set of spatial limits on movement of the joints and the diagnostic ultrasonic probe module of the manipulator arm during operation in the selected mode ([0092] “joint range of motion limits” and [0093] “indications of range of motion limitations 2011, 2031, 0241, 2051 respectively corresponding to the instruments 211, 231, 241, 251,” and Fig. 20, reproduced above, where the instruments have limitations that constrain their range of motion.).
Regarding Claim 5, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Tognaccini teaches a user interface on said control panel in communication with the controller, the user interface comprising a display device to display visual representation of the plurality of operating modes, (as taught by Figs. 15-18), the user interface being configured to receive input from the user to effect selection of one of the operating modes ([0044] “a 3-D monitor 104 for displaying a 3-D image of a surgical site to the Surgeon […]. […] Other input devices that are provided to allow the Surgeon to interact with the medical robotic system 100 include […] Graphical User Interface (GUI) 170.” Where a graphical user interface is understood by one of ordinary skill in the art as a way to display a visual representation for a user to interact with a system.).
Regarding Claim 18, Tognaccini teaches a method of visualizing a diagnostic image, (Fig. 9, reproduced below, and [0044] “The console 10 includes a 3-D monitor for displaying a 3-D image of a surgical site”), comprising:
a) positioning a manipulator arm of a robot, ([0042] “robotic arm assembly 130”), at a proximate location relative to a subject positioned on a bed frame, ([0041] “patient 30 who is lying face up on an operating table 50”), the manipulator arm comprising a plurality of elements, ([0063] “first, second, and third links 322, 324, 326” and [0065] “first, second, and third links 332, 334, 336 […]. […] first, second, and third links 342, 344, 346”), interconnected to each other by a plurality of joints whereby each element is rotatable relative to an adjoining element of the manipulator arm, ([0063] “first and second join assemblies (also referred to herein simply as “joints”) 323, 325 […]. The first joint assembly 323 couples the first and second links 322, 324 and the second joint assembly 325 couples the second and third links 324, 326 so that the second link 324 may pivot about the first joint assembly 323 in pitch and yaw” and [0065] “first and second joint assemblies 333, 335 […]. […] first and second joint assemblies 343,345”), and wherein a diagnostic ultrasound probe module comprising an ultrasound transducer, ([0071] “image capturing device such as an ultrasound probe,” where it is inherent that an ultrasound probe will have an ultrasound transducer”), is coupled to one of the elements of the manipulator arm by a coupling arrangement, ([0042] “entry guide 200 is held and manipulated by a robotic arm assembly 130,” where the camera 311 may alternately be the ultrasound probe, as in [0071]), to allow movement of the diagnostic ultrasonic probe module relative to said one of the elements of the manipulator arm ([0064] “The wrist assembly 327 also has pitch and yaw angular movement capability so that the camera’s tip 311 may be oriented up or down and to the right or left, and combinations thereof.”);
b) controlling movement of the manipulator via a controller, ([0044] “processor (also referred to herein as a “controller”) 102”), in communication with the manipulator arm and an operator interface, ([0044] “a 3-D monitor 104 for displaying a 3-D image of a surgical site to the Surgeon […]. […] Other input devices that are provided to allow the Surgeon to interact with the medical robotic system 100 include […] Graphical User Interface (GUI) 170.”), by selecting one out of a plurality of operating modes displayed on the operator interface, , (Figs. 15-18, where the displays illustrate views captured from the camera/probe, the view of the robotic arm holding the articulatable camera/probe, the view of the enabled surgical tools, and Fig. 18 demonstrates how the viewing modes are provided), the operator interface being configured to receive user input, ([0044] “The input devices 108, 109 may include any one or more of a variety of input devices such as joysticks, gloves, trigger-guns, hand-operated controllers, or the like. Other input devices that are provided to allow the Surgeon to interact with the medical robotic system 100 include a foot pedal 105, a conventional voice recognition system 160 and a Graphical User Interface (GUI) 170” and [0050] “The processor 102 performs various functions in the system 100. One important function that it performs is to translate and transfer the mechanical motion of input devices 108, 109 through control signals over bus 110 so that the Surgeon can effectively manipulate devices, such as the tools 231, 241, camera 211, and entry guide 200, that are selectively associated with the input devices 108, 109 at the time.”), each of said plurality of operating modes corresponding to a respective one of a plurality of working regions of the subject's anatomy, ([0086] “an anatomic structure 360 which is in front of the surgical tools 231, 241,” and [0092] “the joint range of motion limits,” where the range of motion limits (circles of Fig. 20) are interpreted as corresponding to the anatomic structure 360 of the patient, thereby corresponding to a plurality of working regions of the subject’s anatomy.), with the coupling arrangement to effect movement of the diagnostic ultrasound probe module relative to the subject's anatomy to limit movement of the diagnostic ultrasonic probe module and the elements of the manipulator arm during operation in said the selected operating mode in a pre-defined range and limit contact of the diagnostic ultrasonic probe module within the working region on the subject's anatomy, ([0057] “by placing switches 258, 259 respectively in tool following modes "T2" and "T1", the left and right input devices 108, 109 may be respectively associated with the first and second surgical tools 231, 241, which are telerobotically controlled through their respective controllers 233, 243 (preferably implemented in the processor 102) and manipulators 232, 242 so that the Surgeon may perform a medical procedure on the Patient while the entry guide 200 is locked in place,” [0058] “by placing switches 258, 259 respectively in camera positioning modes "C2" and "C1", the left and right input devices 108, 109 may be associated with the camera 211, which is telerobotically controlled through its controller 213 (preferably implemented in the processor 102) and manipulator 212 so that the Surgeon may position the camera 211 while the surgical tools 231, 241 and entry guide 200 are locked in place by their respective controllers 233, 243, 203,” and [0059] “by placing switches 258, 259 respectively in entry guide positioning modes "G2" and "G1", the left and right input devices 108, 109 may be associated with the entry guide 200, which is telerobotically controlled through its controller 203 (preferably implemented in the processor 102) and manipulator 202 so that the Surgeon may position the entry guide 200 while the surgical tools 231, 241 and camera 211 are locked in place relative to the entry guide 200 by their respective controllers 233, 243, 213.”), that corresponds to the selected operating mode (Fig. 20, reproduced above, [0092] “the instrument’s first and third links 332, 336 are maintained in a parallel relationship with each other. […] joint range of motion limits […],” and [0093] “range of motion limitations 2011, 2031, 0241, 2051 respectively corresponding to the instruments 211, 231, 241, 251.” Where the pre-defined range is the generation of the motion limitations for the joints by using the received information and forward kinematics of the one or more articulatable instruments, as in Claim 1 of Tognaccini.).
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Fig. 9 of Tognaccini
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 2-3, 6-7, 10, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tognaccini et al. (US 20090326318) in view of Takeuchi (US 20180338745).
Regarding Claim 2, Tognaccini teaches all limitations of Claim 1, as discussed above. However, Tognaccini does not explicitly teach wherein selection of any one of the said plurality of operating modes positions the elements of the manipulator arm into a predetermined starting position corresponding to the selected mode before allowing movement of the one or more of the joints of the manipulator arm in selected mode, by using the controller, within the pre-defined range for the selected mode to limit contact of the diagnostic ultrasound probe module within the working region on the subject’s anatomy that corresponds to the selected operating mode.
In an analogous ultrasound diagnosis field of endeavor, Takeuchi teaches a diagnostic imaging system, ([0017] “ultrasound diagnosis apparatus 1”), wherein selection of any one of the said plurality of operating modes positions the elements of the manipulator arm into a predetermined starting position corresponding to the selected mode before allowing movement of the one or more of the joints of the manipulator arm in selected mode, by using the controller, ([0068] “the processing circuitry 55 obtains a scan protocol corresponding to the diagnosed site (step S102) and moves the robot arm 6 to the initial position (step S103).”), within the pre-defined range for the selected mode to limit contact of the diagnostic ultrasound probe module within the working region on the subject’s anatomy that corresponds to the selected operating mode ([0047] “the robot controlling function 553 reads the scan protocol corresponding to the diagnosed site from the storage 54 and operates the robot arm 6 on the basis of the read scan protocol.” Where it is interpreted that the scan protocol is the pre-defined range.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Tognaccini with Takeuchi because the modification ensures a complete and accurate scanning protocol, and there is minimal chance of human error, as the scan protocol runs based on the selected diagnosed site (selected mode).
Regarding Claim 3, the modified system of Tognaccini teaches all limitations of Claim 2, as discussed above. Furthermore, Takeuchi teaches wherein switching between a first and second operating mode, based on a selection on the control panel, results in the positioning of the elements of the manipulator arm into the predetermined starting position for the first operating mode before effecting further movement and positioning of the elements of the manipulator arm to the predetermined starting position for the second operating mode, ([0047] “the robot controlling function 553 reads the scan protocol corresponding to the diagnosed site from the storage 54 and operates the robot arm 6 on the basis of the read scan protocol” and [0048] “a scan protocol are stored while being kept in correspondence with each of the diagnosed sites. […] the robot controlling function 553 moves the ultrasound probe 2 according to the scan protocol while using the “initial position” as the start position.” Where the first and second operable modes are the different diagnosed sites.), thereby preventing collision between the subject's anatomy and the diagnostic ultrasonic probe module when switching between the first and second operating modes ([0050] “the robot controlling function 553 is able to establish an association about the positional relationship between the positions of the site of the subject and the space in which the ultrasound probe 2 is moved around.” While Takeuchi does not explicitly teach “collision with the subject’s anatomy and ultrasonic probe module,” such is understood by one of ordinary skill in the art that Takeuchi is designed to ensure this would not happen, to uphold safety to both the patient and the device ([0077] “Consequently, the ultrasound diagnosis apparatus 1 according to the first embodiment makes it possible to have the scan performed by the robot more safely.”).).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi for both safety purposes and that of Claim 2, as discussed above.
Regarding Claim 6, Tognaccini teaches all limitations of Claim 5, as discussed above. Furthermore, Takeuchi teaches wherein the display device is configured to present a visual or audible representation of a force being applied by the diagnostic ultrasound probe on the subject's anatomy during use in each operating mode ([0028] “The sensor 62 includes a force sensor configured to detect a force in a three-dimensional direction applied to the ultrasound probe 2” and [0101] “the monitor 11 is configured to output the instruction information for the subject on the basis of control exercised by the processing circuitry 14. For example, the monitor 11 displays the instruction information realized with text, animation, or the like as described above, for the subject. Further, for example, the monitor 11 is configured to output the instruction information realized with audio from a speaker built therein”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi because the device automatically controls the robot arm with an appropriate amount of force so as not to excessively press against the patient, as taught by Takeuchi in [0053].
Regarding Claim 7, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Takeuchi teaches a sensor positioned relative to the one or more elements of the manipulator arm for sensing force applied by manipulator arm on the subject, based on controlling input received by control from a user during operation in a selected operating mode wherein the sensor is coupled with a force feedback module that communicates with the controller and the coupling arrangement to limit or effect movement of the elements of the manipulator arm and at least partially override the controlling input provided by the user when the force sensed by the sensor exceeds a preset threshold value ([0053] “the robot controlling function 553 obtains, from the sensor 62, a counterforce applied to the ultrasound probe 2 from the body surface of the subject and further controls the robot arm 6 so that the obtained counterforce is substantially constant. In other words, the robot controlling function 553 operates the robot arm 6 while monitoring the counterforce applied to the ultrasound probe 2 from the body surface of the subject, so that the ultrasound probe 2 is not excessively pressed against the subject.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi for the same reasons as Claim 6, as discussed above.
Regarding Claim 10, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Tognaccini teaches wherein during operation in any of the operating modes, the spatial position of the diagnostic ultrasound probe module is operable to be temporarily locked to apply and set a constant force on the subject's anatomy during use ([0059] “while the surgical tools 231, 241 and camera 211 are locked in place relative to the entry guide 200 by their respective controllers 233, 243, 213.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi for the same reasons as Claim 6, as discussed above.
Regarding Claim 14, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Takeuchi teaches wherein the manipulator arm is mounted on a robotic trolley, (Fig. 1, reproduced below, and [0022] “the robot arm 6 is attached to the top face of the apparatus main body 5”), or the bed frame, with at least one degree of freedom or at least two degrees of freedom to undertake movement of the manipulator arm towards and away from the subject ([0027] “the degree of freedom of the joints of the robot arm 6 may arbitrarily be set (e.g., to have six or more axes).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi because the greater the number of degrees of freedom, the more adept the robotic arm will be to move about the patient.
Regarding Claim 15, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Takeuchi teaches wherein the manipulator arm comprises at least six degrees of freedom for imparting movement to the diagnostic ultrasound probe module ([0022] “The robot arm 6 includes a holding unit (a probe holder) configured to hold the probe main body of the ultrasound probe 2 and a mechanism unit for moving the ultrasound probe 2 (the probe main body) to a desired position on the body surface of the subject” and [0027] “the degree of freedom of the joints of the robot arm 6 may arbitrarily be set (e.g., to have six or more axes).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi for the same reasons as Claim 14, as discussed above.
Regarding Claim 16, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Takeuchi teaches a camera mounted at or adjacent the diagnostic ultrasound probe module to display location of the diagnostic ultrasonic transducer probe module relative to the subject's anatomy during use ([0079] “the camera 7 is configured to acquire a picture exhibiting a positional relationship between the subject and the robot arm 6 (the ultrasound probe 2)”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi because this provides an advantage in storing information on various common physiques, which may be utilized for future procedures, as taught by Takeuchi in [0080].
Regarding Claim 17, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Takeuchi teaches a proximity sensor to sense distance between the diagnostic ultrasonic probe module and the subject, ([0079] “he camera 7 is configured to acquire a picture exhibiting a positional relationship between the subject and the robot arm 6 (the ultrasound probe 2) and to transmit the acquired picture to the analyzing function 554.”), and wherein the proximity sensor is coupled with a proximity feedback module that communicates with the controller and the coupling arrangement to limit or effect movement of the elements of the manipulator arm and at least partially override the controlling input provided by the user when the distance sensed by the sensor exceeds one or more preset threshold values ([0082] “the analyzing function 554 reads a piece of reference information that has an ultrasound image of the diagnosed site of the current point in time kept in correspondence and further compares the position of the ultrasound probe 2 with respect to the subject kept in correspondence in the read piece of reference information with the position of the ultrasound probe 2 with respect to the subject at the current point in time. Further, when the difference between the read position and the position in the current point in time exceeds a threshold value, the analyzing function 554 determines that an instruction is to be output for the subject. Subsequently, the analyzing function 554 notifies the output controlling function 555 of information about the difference between the read position and the position in the current point in time.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Takeuchi because the modification ensures the procedure is carried out efficiently and accurately and does not veer from the intended trajectory of an operator.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tognaccini et al. (US 20090326318) in view of Krieger et al. (US 20200194117).
Regarding Claim 8, Tognaccini teaches all limitations of Claim 1, as discussed above. However, Tognaccini does not explicitly teach wherein the controller further comprises a feedback controller to allow a user to operate the manipulator arm using haptic feedback.
In an analogous ultrasonic assessment field of endeavor, Krieger teaches a diagnostic imaging system, ([0079] “the trauma assessment system 100 can include a robotic imaging system 102”), wherein the controller further comprises a feedback controller to allow a user to operate the manipulator arm using haptic feedback ([0086] “the computing device 106 can receive positional movements from the haptic device 108, can transmit instructions to the robotic imaging system 102 (e.g., movement parameters for the robot arm 122), and can receive and present information from the mobile platform 110 (e.g., force information, ultrasound or camera images, etc.) to provide visual and/or haptic feedback to a user (e.g., a radiologist). This can allow the user to manipulate the haptic device 108 based on the feedback to control movements of the robot arm 122.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Tognaccini with Krieger because the modification allows for a remote assessment possible, thereby increasing the applicability of the device.
Regarding Claim 9, Tognaccini teaches all limitations of Claim 1, as discussed above. Furthermore, Krieger teaches wherein for each operating mode, the feedback controller is operated with a corresponding set of operational parameters to apply a specific scale factor and direction control to the feedback controller for each operating mode ([0120] “a hybrid control scheme can be used to control the robot arm 122. For example, the hybrid control scheme can use a combination of position and rate guiding modes.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Krieger because the modification allows the device of dynamically adapt to an environment, which increases the efficiency of the procedure.
Claim 11-13 is rejected under 35 U.S.C. 103 as being unpatentable over Tognaccini et al. (US 20090326318) in view of Sebring et al. (CN 109862845), cited with paragraph numbers from its respective US Patent Application Publication containing the same information, US 20210347036).
Regarding Claim 11, Tognaccini teaches all limitations of Claim 1, as discussed above. However, Tognaccini does not explicitly teach an additional body manipulator arm, the body manipulator arm comprising a base that is movably attached to a-the bed frame to allow movement of the additional body manipulator arm along the length of the bed frame, the body manipulator arm further comprising a plurality of movable elements arranged to support and move a lifting member configured to move parts of the subject anatomy to provide space for the diagnostic ultrasonic probe module to be moved closer to a region of the subject's anatomy and contact the region during use.
In an analogous robotic arm field of endeavor, Sebring teaches a diagnostic imaging system, ([0028] “a system 300 for performing robotically-assisted image-guided surgery”), comprising an additional body manipulator arm, ([0028] “Although a single robotic arm 301 is shown in FIGS. 1A-1D, it will be understood that the system 300 may include multiple robotic arms attached to suitable support structure(s).”), the body manipulator arm comprising a base that is movably attached to the bed frame, (Fig. 1A, reproduced below and [0032] “a column 50 which is mounted to a base 20”) to allow movement of the additional body manipulator arm along the length of the bed frame, ([0040] “a robotic arm may be mounted to a mobile cart that may be moved proximate to the surgical area of the patient 200, typically approaching the surgical table 60 from a side of the table 60. The cart may remain fixed in place adjacent to the surgical table 60 while a robotic arm may extend from the cart into the surgical area during a surgical procedure. […] During surgery, the robotic arm may be attached to another support structure, such as a surgical side rail of the patient table 60, and the cart may be moved out of the way.”), the body manipulator further comprising a plurality of movable elements arranged to support and move a lifting member configured to move parts of the subject anatomy to provide space for the ultrasonic probe to be moved closer to a region of the subject's anatomy and contact the region during use ([0091] “Further embodiments include a table mount for a surgical robotic arm. A table mount approach may minimize the size and footprint of the mounting apparatus used to mount a surgical robotic arm while enabling the robotic arm to be located in an advantageous position for performing robotically-assisted surgery. For example, a robotic arm mounted to the surgical table may have a closer physical connection and relationship to the patient” and Fig. 5, reproduced below, which provides another embodiment of which the bed portion 561 may be raised and lowered with respect to the floor and/or to change the tilt angle of the bed portion 561 with respect to the floor, see [0063]. As well as raising and lowering support member 550, see [0065]. This allows for closer contact with the robotic arm 301.).
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Fig. 5 of Sebring
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Tognaccini with Sebring because this allows for an advantageous position in performing a robotically assisted procedure; there will be a closer physical connection and relationship between the robotic arm and the patient, and the robotic arm may better follow or accommodate motion of the patient, as taught by Sebring in [0091].
Regarding Claim 12, the modified system of Tognaccini teaches all limitations of Claim 11, as discussed above. Furthermore, Sebring teaches wherein the plurality of movable elements are interconnected by a plurality of joints and wherein each element of the additional body manipulator arm is rotatable relative to an adjoining element of the additional body manipulator arm ([0028] “The robotic arm 301 may comprise a multi-joint arm that includes a plurality of linkages connected by joints having actuator(s) and optional encoder(s) to enable the linkages to bend, rotate and/or translate relative to one another in response to control signals from a robot control system.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Sebring because the modification allows for application to a variety of procedures, such as minimally-invasive spinal surgical procedure or lumbar spinal procedures.
Regarding Claim 13, the modified system of Tognaccini teaches all limitations of Claim 11, as discussed above. Furthermore, Sebring teaches wherein the base of the additional body manipulator arm is arranged to slide along or across the length of the bed frame to allow the additional body manipulator arm to be positioned in a plurality of supporting locations (Fig. 5, reproduced above, [0065] “the straight portion 550b may extend and retract into a housing in the base portion 540 so that the support member 550 may be raised and lowered in the direction of arrow 504,” and [0069] “he base portion 540 of the mounting apparatus 501 may include one or more bearing elements (e.g., rollers or sliders) that engage with a bearing surface on the base 520 of the imaging system 303 and may enable the mounting apparatus to translate along the length of the base 520 in the direction of arrow 508.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Sebring for the same reasons as Claims 11 and 12, as discussed above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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