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 .
The amendment filed on 11/21/2024, has been received and made of record. In response to the Final Office Action, dated on 09/28/2024. Claims 1-20 are pending in the current application.
Response to Arguments
Applicant’s arguments filed on 11/21/2024 have been fully considered.
In Arguments/Remarks:
Re: Rejection of the Claims Under 35 U.S.C. 102(a)(1)
Applicant’s arguments regarding rejection of the claims under 35 U.S.C. 102(a)(1) have been fully considered, but in view of applicant’s amendments the arguments are rendered moot under new grounds of rejection (see below) necessitated by the applicant’s amendments.
Re: Rejection of the Claims Under 35 U.S.C. 103
Applicant’s arguments regarding rejection of the claims under 35 U.S.C. 103 have been fully considered, but in view of applicant’s amendments the arguments are rendered moot under new grounds of rejection (see below) necessitated by the applicant’s amendments.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Maillet (US 2014/0371577 A1) in view of Stopek (US 2014/0228858 A1).
Regarding claim 1, Maillet teaches a system for controlling a robotic arm comprising: a robotic arm; [(see at least paragraphs 27-28) “To this end, the invention relates to a robotic
medical device for monitoring the respiration of a patient and correcting the trajectory of
a robotic arm, comprising: at least one robotic arm”] a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: control a breathing pattern of a patient; [(see at least paragraphs 53,85) As in 53 “Under such a procedure, the patient is anesthetized. The curarisation affects the muscle function, among which the activity of the diaphragm, up to paralysis. Mechanical ventilation is then implemented, which ensures the ventilation of the patient. Therefore, the device comprises a mechanical ventilator, which the respiration of a patient is subjected to. Thus, the patient fully depends on the machine, which will always insufflate the same volume of air in a precise and indefinitely reproducible timing, subject to a stable pulmonary physiology.” As in 85 “More specifically, said means for correcting the trajectory of the robotic arm comprise a computer module for resetting said anatomical images captured by matching with a previously captured medical imaging. Indeed, the existing robotic systems use a matching or registration of three-dimensional medical imaging, namely proceeding from a scanner or MRI, for "Magnetic Resonance Imaging", and two-dimensional imaging, as fluoroscopy.”] Examiner notes that it is well known within the art that devices such as a computer contain a processing means such as a CPU/processor and memory.
Maillet teaches obtain a sample of the controlled breathing pattern [(see at least paragraph
34) “Therefore, the ventilation of the patient is performed by means of a respirator ensuring
a mechanical ventilation. Under these circumstances, it is then possible to know accurately
and repetitively the breathing parameters of the anaesthetized patient.”] determine a pattern of movement of an anatomical element based on the sample of the controlled breathing pattern [(see at least paragraphs 34-36) “Such a solution relies in the first place on that the operations on the rachis are generally performed under so-called "general" anesthesia. Therefore, the ventilation of the patient is performed by means of a respirator ensuring a mechanical ventilation. Under these circumstances, it is then possible to know accurately and repetitively the breathing parameters of the anaesthetized patient. The means implemented in the invention take these parameters into account and interpret them in order to compensate for the movement of the robotic arm depending on the patient's respiratory movements. In particular, the invention provides as a matter of fact for recording two different positions at two different time instants. These positions are selected among all possible positions during the movement of the patient's body. These are in fact the extreme positions of displacement of the anatomical area, which coincide with the insufflation and expiration generated by the automatic artificial ventilator.”]
Maillet teaches adjust a trajectory of the robotic arm based on a pose of the anatomical element as determined by the pattern of movement. [(see at least paragraphs 26-33, 37-39) As
in 30-33 “means for recording depending on the duration of the time instants during said
mechanical ventilation where said patient is in an original position corresponding to the
position of the patient at the end of expiration of the gases until the next insufflation of gases
and in a high position corresponding to the maximum position at the end of the insufflation;
means for digitally capturing images of an anatomical area of said patient, the triggering of
said means for capturing being synchronized with the instants recorded in said original
position and in said high position; means for calculating at least one three-dimensional
displacement vector of said area between said original and high positions; means for
correcting the trajectory of said robotic arm depending on each calculated three-dimensional
vector.” As in 37 “The invention integrates means permitting to detect the instants at which
the patient is in these positions, using the operating parameters of said respirator. These very
means then permit to control the triggering at these specific moments, without using the internal clock of said respirator as a trigger. In brief, the triggering of capture of images is
performed synchronously thanks to the previously made recording. Thus, the invention
implements a time synchronization different from the simple setting according to the internal
clock of the respirator.” As in 39 “the device according to the invention uses means for
calculating a displacement vector between the two images taken at the two time instants.
This vector is used to correct the trajectory of the robotic arm, through adapted means for
transmitting this correction to said arm.”]
Maillet does not explicitly teach determine a pattern of movement of an anatomical element based on patient data including at least one of age, height and weight of the patient.
However, Stopek teaches determine a pattern of movement of an anatomical element based on patient data including at least one of age, height and weight of the patient. [(see at least paragraph 101) “The breathing model shows relationship between movement of the lung and the patient's breathing pattern. Accurate estimation of a tertiary or terminal bronchus tree while the patient is breathing may not be easily obtained by a generic breathing model because breathing causes the lungs to move cyclically, meaning that the lung movement varies by amplitude and direction during the breathing cycle from 5 mm to 30 mm depending on such breathing characteristics as patient size, age, altitude, health, etc.”]
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Maillet to incorporate the teachings of Stopek of determining a pattern of movement of an anatomical element based on patient data including at least one of age, height and weight of the patient in order to build a dynamic breathing model that can be used to accurately estimate movements of a small bronchial tree during a patient's breathing cycle. [(Stopek 101)]
Regarding claim 5, In view of the above combination of references, Maillet further teaches further comprising: a ventilator configured to control the breathing pattern of the patient. [(see at least paragraph 27-29) “a mechanical ventilator, which the respiration of a
patient is subjected to”]
Regarding claim 10, In view of the above combination of references, Maillet further teaches wherein the sample is a first sample and the pattern of movement is a first pattern of movement, and the memory stores further data for processing by the processor that, when processed, causes the processor to: obtain a second sample of the breathing pattern [(see at least paragraph 34) “Therefore, the ventilation of the patient is performed by means of a respirator ensuring a mechanical ventilation. Under these circumstances, it is then possible to know accurately and repetitively the breathing parameters of the anaesthetized patient.”]
Maillet teaches determine a second pattern of movement of an anatomical element based on
the sample [(see at least paragraph 35) “The means implemented in the invention take these
parameters into account and interpret them in order to compensate for the movement of the
robotic arm depending on the patient's respiratory movements.”]
Maillet teaches adjust the trajectory of the robotic arm based on the second pattern of
movement when the second pattern of movement does not match the first pattern of
movement. [(see at least paragraphs 34-35) “Therefore, the ventilation of the patient is
performed by means of a respirator ensuring a mechanical ventilation. Under these
circumstances, it is then possible to know accurately and repetitively the breathing
parameters of the anaesthetized patient. The means implemented in the invention take these
parameters into account and interpret them in order to compensate for the movement of the
robotic arm depending on the patient's respiratory movements.”]
Regarding claim 11, In view of the above combination of references, Maillet further teaches wherein the trajectory is adjusted in at least one coordinate direction. [(see at least paragraph 39) “Furthermore, the device according to the invention uses means for calculating a displacement vector between the two images taken at the two time instants. This vector is used to correct the trajectory of the robotic arm, through adapted means for transmitting this correction to said arm.”]
Regarding claim 12, In view of the above combination of references, Maillet further teaches wherein the anatomical element comprises one or more vertebrae. [(see at least paragraph 66) “the invention advantageously provides for measuring in space the anatomical position when the patient is in both original and high positions, without trying to accurately measure neither the amplitude nor the deformation vector of the spine, or of a lumbar vertebrae in particular.”]
Claims 2-4, 6-9 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Maillet in view of Stopek and in further view of Joshi (US 2017/0348061 A1).
Regarding claim 2, Modified Maillet has all of the elements of claim 1 as discussed above.
Maillet does not explicitly teach further comprising: a marker disposed on the anatomical
element and a navigation system configured to track the marker, wherein the sample is
obtained from the navigation system tracking a movement of the marker during a time period.
However, Joshi teaches further comprising: a marker disposed on the anatomical element and a
navigation system configured to track the marker, wherein the sample is obtained from the
navigation system tracking a movement of the marker during a time period. [(see at least
paragraph 77) “FIG. 3 illustrates an example embodiment 3600 of surgical robot system 1 that
utilizes a surveillance marker 710 in accordance with one or more aspects of the invention. As
illustrated, the example embodiment 3600 comprises a 4-marker tracker array 3610 attached
to the patient 18 and having a surveillance marker, and a 4-marker tracker array 3620 on the
robot 15. In some embodiments, during usage, it may possible that a tracker array, or tracker
(3610 in FIG. 3), on a patient 18 inadvertently shifts. For example, a conventional clamp
positioned on a patient's 18 spinous process 2310 where the tracker 3610 is attached can be
bumped by the surgeon's arm and move (i.e., bend or translate) to a new position relative to
the spinous process 2310. Alternatively, a tracker 3610 that is mounted to the skin of the
patient 18 can move gradually with the skin, as the skin settles or stretches over time. In this
instance, the accuracy of the robot 15 movement can be lost because the tracker 3610 can
reference bony anatomy from a medical image that no longer is in the same position relative
to the tracker as it had been during the medical image scan. To overcome such problems, some embodiments of the invention provide a surveillance marker 710 as illustrated in FIG. 3.
As shown, in some embodiments, the surveillance marker 710 can be embodied or can
comprise one or more markers 710 rigidly affixed to a patient 18 in a location different than
the location in which a primary tracker array 3610 is affixed; for example, a different spinous
process 2310, on the skin, or on a small post drilled into the ilium.”]
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 teachings of modified Maillet to incorporate the
teachings of Joshi of a marker disposed on the anatomical element and a navigation system
configured to track the marker, wherein the sample is obtained from the navigation system
tracking a movement of the marker during a time period in order to indicate a position of the
patient fixture instrument in a navigational space. [(Joshi abstract)]
Regarding claim 3, Modified Maillet has all of the elements of claim 2 as discussed above.
Maillet does not explicitly teach wherein the marker comprises at least one of an optical
marker, an infrared light emitting diode, an electromagnetic marker, and an inertial
measurement unit tracker.
However, Joshi teaches wherein the marker comprises at least one of an optical marker, an
infrared light emitting diode, an electromagnetic marker, and an inertial measurement unit tracker. [(see at least paragraph 74) “In some embodiments in which the surgical robot
system 1 comprises a conventional infrared optical tracking system, the surgical robot system
1 can comprise conventional optical markers attached to selected locations on the end-
effectuator 30 and/or the surgical instrument 35 that are configured to emit or reflect light. In
some embodiments, the light emitted from and/or reflected by the markers can be read by
cameras (for example with cameras 8200 shown in FIG. 48) and/or optical sensors and the
location of the object can be calculated through triangulation methods (such as stereo-
photogrammetry).”]
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 teachings of modified Maillet to incorporate the
teachings of Joshi of wherein the marker comprises at least one of an optical marker, an
infrared light emitting diode, an electromagnetic marker, and an inertial measurement unit
tracker in order to allow accurate tracking of an anatomical element/robotic arm.
Regarding claim 4, Modified Maillet has all of the elements of claim 2 as discussed above.
Maillet does not explicitly teach wherein determining the pattern of movement of the
anatomical element comprises determining a maximum height and a minimum height of the
movement of the marker and a number of movements of the marker per the time period.
However, Joshi teaches wherein determining the pattern of movement of the anatomical
element comprises determining a maximum height and a minimum height of the movement of
the marker and a number of movements of the marker per the time period. [(see at least
paragraphs 77, 106) “FIG. 3 illustrates an example embodiment 3600 of surgical robot system
1 that utilizes a surveillance marker 710 in accordance with one or more aspects of the
invention. As illustrated, the example embodiment 3600 comprises a 4-marker tracker array
3610 attached to the patient 18 and having a surveillance marker, and a 4-marker tracker
array 3620 on the robot 15. In some embodiments, during usage, it may possible that a
tracker array, or tracker (3610 in FIG. 3), on a patient 18 inadvertently shifts. For example, a
conventional clamp positioned on a patient's 18 spinous process 2310 where the tracker 3610
is attached can be bumped by the surgeon's arm and move (i.e., bend or translate) to a new
position relative to the spinous process 2310. Alternatively, a tracker 3610 that is mounted to
the skin of the patient 18 can move gradually with the skin, as the skin settles or stretches
over time. In this instance, the accuracy of the robot 15 movement can be lost because the
tracker 3610 can reference bony anatomy from a medical image that no longer is in the same
position relative to the tracker as it had been during the medical image scan.” As in 106 “if
more than three markers 4001, 4002, 4003 are utilized for tracking the movement of a rigid
body, the same method can be implemented repeatedly for as many triads of markers as are
present. For example, in a scenario in which four markers, M1, M2, M3, and M4, are attached
to the rigid body, there can be four triads: those formed by {M1, M2, M3}, {M1, M2, M4},
{M1, M3, M4}, and {M2, M3, M4}. In some embodiments, each of these triads can be used
independently in the method described hereinbefore in order to calculate the rigid body motion. In some embodiments, the final values of the translations and rotations can then be
the average of the values determined using the four triads. In some embodiments, in the
alternative or in addition, other methods for achieving a best fit when using more than 3
markers may be used.”]
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 teachings of modified Maillet to incorporate the
teachings of Joshi of determining the pattern of movement of the anatomical element
comprises determining a maximum height and a minimum height of the movement of the
marker and a number of movements of the marker per the time period in order to establish the
position of the anatomy relative to the active markers. [(Joshi 121)]
Regarding claim 6, In view of the above combination of references, Maillet further
teaches wherein the sample is obtained from the ventilator and the sample is based on the
breathing pattern controlled by the ventilator. [(see at least paragraphs 54-60) As in 54-56 “In
this context, the thoracic, abdominal, back movements, depending on the position of the
patient and due to the mechanical ventilation, will always be reproducible and therefore
predictable. For general anesthesia, mechanical ventilation is generally performed in
Controlled Volume, we can also use Controlled Pressure. In an operating mode of
a ventilation in volume mode, the volume is a set value, which is characterized by a constant
flow rate during a constant insufflation time. Generally, the ventilation cycle is adjusted
according to several parameters: the insufflation time or duration Ti adjusted to one third of the cycle, and the expiration time or duration Te adjusted to two thirds of the cycle. The
expiration of gases by the patient corresponds at least to half the expiration time allocated
and is invariable.”]
Regarding claim 7, In view of the above combination of references, Maillet further
teaches wherein the sample is a waveform representing the breathing pattern, and wherein
determining the pattern of movement comprises determining at least one of a crest, a trough,
an amplitude, and a period of the waveform. [(see at least paragraph 62) “the mechanical lung
ventilators generally use flow-rate and pressure sensors, an internal clock for monitoring said
parameters, namely the gas insufflation time Ti, the gas expiration time, the allocated
expiration time Te. Thus, sensors placed in the circuit of the mechanical ventilation system
permit to perform the measuring of said parameters in real time and continuously. It is then
possible, through an appropriate processing, to know when the patient is immobile, when
the movement of the rib cage starts, when the movement reaches its maximum amplitude,
when the rib cage returns to its original position, like all other collateral anatomical parts.
This processing is performed by recording means, depending on the time, on the time
instants during said mechanical ventilation at which said patient is in these precise and well -
defined original and high positions.”]
Regarding claim 8, Modified Maillet has all of the elements of claim 1 as discussed above.
Maillet does not explicitly teach further comprising: a sensor coupled to the robotic arm, the
sensor configured to provide pose information of the robotic arm, wherein the robotic arm is
coupled to the anatomical element, and wherein the sample is obtained from the sensor, the
sample comprising a plurality of poses of the robotic arm for a time period.
However, Joshi teaches further comprising: a sensor coupled to the robotic arm, the sensor
configured to provide pose information of the robotic arm, wherein the robotic arm is coupled
to the anatomical element, and wherein the sample is obtained from the sensor, the sample
comprising a plurality of poses of the robotic arm for a time period. [(see at least paragraphs
65,71) As in 65 “Referring now to FIGS. 1 and 2A, some embodiments include a surgical robot
system 1 is disclosed in a room 10 where a medical procedure is occurring. In some
embodiments, the surgical robot system 1 can comprise a surgical robot 15 and one or more
positioning sensors 12. In this aspect, the surgical robot 15 can comprise a display means 29,
and a housing 27. In some embodiments a display can be attached to the surgical robot 15,
whereas in other embodiments, a display means 29 can be detached from surgical robot 15,
either within surgical room 10 or in a remote location. In some embodiments, the
housing 27 can comprise a robot arm 23, and an end-effectuator 30 coupled to
the robot arm 23 controlled by at least one motor.” As in 71 “Referring to FIG. 1, in some
embodiments, the surgical robot system 1 can comprise a plurality of positioning
sensors 12 configured to receive RF signals from the at least one conventional RF transmitter
(not shown) located within room 10. In some embodiments, the computer (not shown in FIG.
1) is also in communication with surgical robot 15. In some embodiments, the position of surgical instrument 35 can be dynamically updated so that surgical robot 15 is aware of the
location of surgical instrument 35 at all times during the procedure. Consequently, in some
embodiments, the surgical robot 15 can move the surgical instrument 35 to the desired
position quickly, with minimal damage to patient 18, and without any further assistance from
a physician (unless the physician so desires). In some further embodiments, the surgical
robot 15 can be configured to correct the path of surgical instrument 35 if the surgical
instrument 35 strays from the selected, preplanned trajectory.”]
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 teachings of modified Maillet to incorporate the
teachings of Joshi of a sensor coupled to the robotic arm, the sensor configured to provide pose
information of the robotic arm, wherein the robotic arm is coupled to the anatomical element,
and wherein the sample is obtained from the sensor, the sample comprising a plurality of poses
of the robotic arm for a time period in order to correct the path of surgical instrument/robotic
arm if the surgical instrument/robotic arm strays from the selected, preplanned trajectory.
[(Joshi 71)]
Regarding claim 9, In view of the above combination of references, Maillet further
teaches wherein the plurality of poses corresponds to a movement of the anatomical element,
and wherein determining the pattern of movement of the anatomical element comprises
determining a maximum height and a minimum height of the movement and a number of
movements of the robotic arm per the time period. [(see at least paragraphs 61-62) As in 61-62 “First of all, according to a first essential feature, during the operation of the device according
to the invention, a monitoring of the patient's ventilation is performed in order to determine
when the patient is immobile in its original position, when the deformation begins, when it
reaches its maximum in a so-called "high" position and when the respiratory movement ends.
To this end, the mechanical lung ventilators generally use flow-rate and pressure sensors, an
internal clock for monitoring said parameters, namely the gas insufflation time Ti, the gas
expiration time, the allocated expiration time Te. Thus, sensors placed in the circuit of the
mechanical ventilation system permit to perform the measuring of said parameters in real
time and continuously. It is then possible, through an appropriate processing, to know when
the patient is immobile, when the movement of the rib cage starts, when the movement
reaches its maximum amplitude, when the rib cage returns to its original position, like all
other collateral anatomical parts. This processing is performed by recording means,
depending on the time, on the time instants during said mechanical ventilation at which said
patient is in these precise and well-defined original and high positions” As in 84 “ Therefore,
it is possible, based on the three-dimensional movement simulation obtained, to correct and
change, even by anticipation, the trajectory of intervention of the robotic system. Thus, the
device comprises means for correcting the trajectory of said robotic arm depending on each
calculated three-dimensional vector.”]
Regarding claim 13, Maillet teaches a system for controlling a robotic arm comprising: a robotic arm coupled to an anatomical element; [(see at least paragraphs 27-33) “To this end,
the invention relates to a robotic medical device for monitoring the respiration of a patient and correcting the trajectory of a robotic arm, comprising: at least one robotic arm; a
mechanical ventilator, which the respiration of a patient is subjected to; means for recording
depending on the duration of the time instants during said mechanical ventilation where said
patient is in an original position corresponding to the position of the patient at the end of
expiration of the gases until the next insufflation of gases and in a high position
corresponding to the maximum position at the end of the insufflation; means for digitally
capturing images of an anatomical area of said patient, the triggering of said means for
capturing being synchronized with the instants recorded in said original position and in said
high position”]
Maillet teaches a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: obtain a sample of a patient breathing pattern comprising a plurality of poses of the anatomical element for a time period from the sensor [(see at least paragraphs 34-36) “Such a solution relies in the first place on that the
operations on the rachis are generally performed under so-called "general" anesthesia.
Therefore, the ventilation of the patient is performed by means of a respirator ensuring a
mechanical ventilation. Under these circumstances, it is then possible to know accurately and
repetitively the breathing parameters of the anaesthetized patient. The means implemented
in the invention take these parameters into account and interpret them in order to
compensate for the movement of the robotic arm depending on the patient's respiratory
movements. In particular, the invention provides as a matter of fact for recording two
different positions at two different time instants. These positions are selected among all possible positions during the movement of the patient's body. These are in fact the extreme
positions of displacement of the anatomical area, which coincide with the insufflation and
expiration generated by the automatic artificial ventilator.”]
Maillet teaches determine a pattern of movement of the anatomical element based on the sample; [(see at least paragraphs 35-36) “The means implemented in the invention take these parameters into account and interpret them in order to compensate for the movement of the
robotic arm depending on the patient's respiratory movements. In particular, the invention
provides as a matter of fact for recording two different positions at two different time
instants. These positions are selected among all possible positions during the movement of
the patient's body. These are in fact the extreme positions of displacement of the anatomical
area, which coincide with the insufflation and expiration generated by the automatic artificial
ventilator.”]
Maillet teaches to adjust a trajectory of the robotic arm based on a pose of the plurality of poses of the anatomical element as determined by the pattern of movement. [(see at least paragraph29-33, 22) As in 29-33 “a mechanical ventilator, which the respiration of a patient is subjected to; means for recording depending on the duration of the time instants during said
mechanical ventilation where said patient is in an original position corresponding to the
position of the patient at the end of expiration of the gases until the next insufflation of gases
and in a high position corresponding to the maximum position at the end of the insufflation;
means for digitally capturing images of an anatomical area of said patient, the triggering of said means for capturing being synchronized with the instants recorded in said original
position and in said high position; means for calculating at least one three-dimensional
displacement vector of said area between said original and high positions; means for
correcting the trajectory of said robotic arm depending on each calculated three-dimensional
vector.” As in 22 “Therefore, the movements thus detected can permit the correction of
the trajectory of a surgical tool in synchronism with the breathing of the patient, in particular
the trajectory of a robot.”]
Maillet does not explicitly teach a sensor coupled to the robotic arm, the sensor configured to provide pose information of the robotic arm; determine a pattern of movement of the anatomical element based on patient data including at least one of age, height and weight of the patient.
However, Joshi teaches a sensor coupled to the robotic arm, the sensor configured to provide pose information of the robotic arm [(see at least paragraph 65) “Referring now to FIGS. 1 and
2A, some embodiments include a surgical robot system 1 is disclosed in a room 10 where a
medical procedure is occurring. In some embodiments, the surgical robot system 1 can
comprise a surgical robot 15 and one or more positioning sensors 12. In this aspect, the
surgical robot 15 can comprise a display means 29, and a housing 27. In some embodiments a
display can be attached to the surgical robot 15, whereas in other embodiments, a display
means 29 can be detached from surgical robot 15, either within surgical room 10 or in a
remote location. In some embodiments, the housing 27 can comprise a robot arm 23, and an
end-effectuator 30 coupled to the robot arm 23 controlled by at least one motor.”]
Stopek teaches determine a pattern of movement of the anatomical element based on patient data including at least one of age, height and weight of the patient. [(see at least paragraph 101) “The breathing model shows relationship between movement of the lung and the patient's breathing pattern. Accurate estimation of a tertiary or terminal bronchus tree while the patient is breathing may not be easily obtained by a generic breathing model because breathing causes the lungs to move cyclically, meaning that the lung movement varies by amplitude and direction during the breathing cycle from 5 mm to 30 mm depending on such breathing characteristics as patient size, age, altitude, health, etc.”]
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Maillet to incorporate the teachings of Joshi of a sensor coupled to the robotic arm, the sensor configured to provide pose
information of the robotic arm in order to be aware of the location of surgical
instrument/robotic arm at all times during the procedure [(Joshi 71)] and to further incorporate the teachings of Stopek of determining a pattern of movement of the anatomical element based on patient data including at least one of age, height and weight of the patient in order to build a dynamic breathing model that can be used to accurately estimate movements of a small bronchial tree during a patient's breathing cycle. [(Stopek 101)]
Regarding claim 14, Modified Maillet has all of the elements of claim 13 as discussed above.
Maillet does not explicitly teach wherein the plurality of poses corresponds to a movement of
the anatomical element, and wherein determining the pattern of movement of the anatomical
element comprises determining a maximum height and a minimum height of the movement
and a number of movements of the robotic arm per the time period.
However, Joshi teaches wherein the plurality of poses corresponds to a movement of the
anatomical element, and wherein determining the pattern of movement of the anatomical
element comprises determining a maximum height and a minimum height of the movement
and a number of movements of the robotic arm per the time period. [(see at least paragraphs
74,79,159) As in 74 “the surgical robot 15 can also be used with existing conventional
guidance systems. Thus, alternative conventional guidance systems beyond those specifically
disclosed herein are within the scope and spirit of the invention. For instance, a conventional
optical tracking system for tracking the location of the surgical device, or a commercially available infrared optical tracking system, such as Optotrak® (Optotrak® is a registered
trademark of Northern Digital Inc. Northern Digital, Waterloo, Ontario, Canada), can be used
to track the patient 18 movement and the robot's base 25 location and/or intermediate axis
location, and used with the surgical robot system 1. In some embodiments in which the
surgical robot system 1 comprises a conventional infrared optical tracking system, the
surgical robot system 1 can comprise conventional optical markers attached to selected
locations on the end-effectuator 30 and/or the surgical instrument 35 that are configured to
emit or reflect light.” As in 159 “For example, a conventional rotating turntable mechanism
could be incorporated that could swing the fluoro arm into place, while at the same time
swinging the robot arm 23 out of place (since the robot 15 would typically not be in the
surgical field 17 at the same time as the fluoro arm). Furthermore, in some embodiments, the
size of the robot arm 23 could be reduced compared to the stand-alone robot 15 because the
fluoro arm's mass would serve as a counter-balance weight to help stabilize the robot arm
23.”]
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 teachings of modified Maillet to incorporate the
teachings of Joshi of the plurality of poses corresponds to a movement of the anatomical
element, and wherein determining the pattern of movement of the anatomical element
comprises determining a maximum height and a minimum height of the movement and a
number of movements of the robotic arm per the time period in order to establish the position
of the anatomy relative to the active markers. [(Joshi 121)]
Regarding claim 15, In view of the above combination of references, Maillet further
teaches further comprising: a ventilator configured to control the breathing pattern of the
patient. [(see at least paragraph 27-29) “a mechanical ventilator, which the respiration of a
patient is subjected to”]
Regarding claim 16, In view of the above combination of references, Maillet further
teaches wherein the trajectory is adjusted in at least one coordinate direction. [(see at least
paragraph 39) “Furthermore, the device according to the invention uses means for calculating
a displacement vector between the two images taken at the two time instants. This vector is
used to correct the trajectory of the robotic arm, through adapted means for transmitting this
correction to said arm.”]
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Joshi in view of Maillet and in further view of Stopek.
Regarding claim 17, Joshi teaches a system for controlling a robotic arm comprising: a marker disposed on an anatomical element; a navigation system configured to track the marker; [(see at least paragraphs 74,77) As in 74 “the surgical robot 15 can also be used with existing conventional guidance systems. Thus, alternative conventional guidance systems beyond those specifically disclosed herein are within the scope and spirit of the invention. For instance, a conventional optical tracking system for tracking the location of the surgical device, or a commercially available infrared optical tracking system, such as Optotrak® (Optotrak® is a registered trademark of Northern Digital Inc. Northern Digital, Waterloo, Ontario, Canada), can be used to track the patient 18 movement and the robot's base 25 location and/or intermediate axis location, and used with the surgical robot system 1. In some embodiments in which the surgical robot system 1 comprises a conventional infrared optical tracking system, the surgical robot system 1 can comprise conventional optical markers attached to selected locations on the end-effectuator 30 and/or the surgical instrument 35 that are configured to emit or reflect light. In some embodiments, the light emitted from and/or reflected by the markers can be read by cameras (for example with cameras 8200 shown in FIG. 48) and/or optical sensors and the location of the object can be calculated through triangulation methods (such as stereo-photogrammetry).” As in 77 “an example embodiment 3600 of surgical robot system 1 that utilizes a surveillance marker 710 in accordance with one or more aspects of the invention. As illustrated, the example embodiment 3600 comprises a 4-marker tracker array 3610 attached to the patient 18 and having a surveillance marker, and a 4- marker tracker array 3620 on the robot 15.”] a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: track the marker; [(see at least paragraphs 74,67) As
in 74 “For instance, a conventional optical tracking system for tracking the location of the
surgical device, or a commercially available infrared optical tracking system, such as
Optotrak® (Optotrak® is a registered trademark of Northern Digital Inc. Northern Digital,
Waterloo, Ontario, Canada), can be used to track the patient 18 movement and the robot's
base 25 location and/or intermediate axis location, and used with the surgical robot
system 1. In some embodiments in which the surgical robot system 1 comprises a
conventional infrared optical tracking system, the surgical robot system 1 can comprise
conventional optical markers attached to selected locations on the end-effectuator 30 and/or
the surgical instrument 35 that are configured to emit or reflect light. In some embodiments,
the light emitted from and/or reflected by the markers can be read by cameras (for example
with cameras 8200 shown in FIG. 48) and/or optical sensors and the location of the object can
be calculated through triangulation methods (such as stereo-photogrammetry).” As in 67 “the
surgical robot system 1 can comprise a control device (for example a computer 100 having a
processor and a memory coupled to the processor). In some embodiments, the processor of the control device 100 can be configured to perform time of flight calculations as described
herein. In one embodiment, the end-effectuator 30 can be a tubular element (for example a
guide tube 50) that is positioned at a desired location with respect to, for example, a
patient's 18 spine to facilitate the performance of a spinal surgery. In some embodiments, the
guide tube 50 can be aligned with the z axis 70 defined by a corresponding robot motor or,
for example, can be disposed at a selected angle relative to the z-axis 70. In either case, the
processor of the control device (i.e. the computer 100) can be configured to account for the
orientation of the tubular element. In some embodiments, the memory of the control device
(computer 100 for example) can store software for performing the calculations and/or
analyses required to perform many of the surgical method steps set forth herein.”]
Joshi teaches comprising a plurality of poses of the marker for a time period from the navigation system; [(see at least paragraphs 76-78) “In some embodiments, the surgical robot
15 is moveable in a plurality of axes (for instance x-axis 66, y-axis 68, and z-axis 70) in order to
improve the ability to accurately and precisely reach a target location. Some embodiments
include a robot 15 that moves on a Cartesian positioning system; that is, movements in
different axes can occur relatively independently of one another instead of at the end of a
series of joints.” As in 77 “FIG. 3 illustrates an example embodiment 3600 of surgical robot
system 1 that utilizes a surveillance marker 710 in accordance with one or more aspects of
the invention. As illustrated, the example embodiment 3600 comprises a 4- marker tracker
array 3610 attached to the patient 18 and having a surveillance marker, and a 4-marker
tracker array 3620 on the robot 15. In some embodiments, during usage, it may possible that a tracker array, or tracker (3610 in FIG. 3), on a patient 18 inadvertently shifts.” As in 78 “in
response to placement of the surveillance marker 710, execution of a control software
application (e.g., robotic guidance software) can permit an agent (e.g., a surgeon, a nurse, a
diagnostician) to select “set surveillance marker”. At this time, the vector (3D) distances
between the surveillance marker 710, and each of the markers 3611, 3612, 3613, and 3614 on
the primary tracker array 3610 can be acquired and retained in computer 100 memory (such
as a memory of a computing device executing the control software application). In an
embodiment in which a 4-marker tracker array 3610 is utilized (FIG. 3), four distances 3611a,
3612a, 3613a, and 3614a can be acquired and retained, representing the distances between
the surveillance marker 710 and markers 3611, 3612, 3613, and 3614. In such embodiment, at
each frame of real-time data during a procedure, the surgical robot system 1 disclosed herein
can calculate updated distances between each of the markers 3611, 3612, 3613, and 3614 on
the primary tracker array 3610 and the surveillance marker 710. The system 1 can then
compare the updated distances or a metric thereof (for example, the sum of the magnitude
of each distance) to the available values (for example, values retained in the
computer 100 memory). In some embodiments, in view that the surveillance marker 710 and
tracker array 3610 can be on the same rigid body, the updated distances and/or the metric
thereof (such as their sum) can remain substantially fixed unless one or more of the tracker
array 3610 or the surveillance marker 710 shifts. In some embodiments, in response to a shift
of the tracker array 3610 or the surveillance marker 710, or both, a notification can be issued
to alert an agent of a loss in movement accuracy. In some embodiments, if the
surveillance marker 710 offset exceeds a pre-set amount, operation of the surgical robot system 1 can be halted. In some embodiments, in response to a user intentionally shifting the
tracker array 3610 or the surveillance marker 710 to a new position, execution of the control
software application can permit overwriting a set of one or more stored distances with new
values for comparison to subsequent frames.”]
Joshi does not explicitly teach obtain a sample of a patient breathing pattern; determine a pattern of movement of an anatomical element based on the sample and patient data including at least one of age, height and weight of the patient; and adjust a trajectory of the robotic arm based on a pose of the anatomical element as determined by the pattern of movement.
However, Maillet teaches obtain a sample of a patient breathing pattern [(see at least paragraph 61) “according to a first essential feature, during the operation of the device according to the invention, a monitoring of the patient's ventilation is performed in order to determine when the patient is immobile in its original position, when the deformation begins, when it reaches its maximum in a so-called "high" position and when the respiratory movement ends”]
Maillet teaches determine a pattern of movement of an anatomical element based on the sample [(see at least paragraphs 35-36) “The means implemented in the invention take these
parameters into account and interpret them in order to compensate for the movement of the
robotic arm depending on the patient's respiratory movements. In particular, the invention
provides as a matter of fact for recording two different positions at two different time instants. These positions are selected among all possible positions during the movement of
the patient's body. These are in fact the extreme positions of displacement of the anatomical
area, which coincide with the insufflation and expiration generated by the automatic artificial
ventilator.”]
Maillet teaches adjust a trajectory of the robotic arm based on a pose of the anatomical element as determined by the pattern of movement. [(see at least paragraph 29-33, 22) As in
29-33 “a mechanical ventilator, which the respiration of a patient is subjected to; means for
recording depending on the duration of the time instants during said mechanical ventilation
where said patient is in an original position corresponding to the position of the patient at
the end of expiration of the gases until the next insufflation of gases and in a high position
corresponding to the maximum position at the end of the insufflation; means for digitally
capturing images of an anatomical area of said patient, the triggering of said means for
capturing being synchronized with the instants recorded in said original position and in said
high position; means for calculating at least one three-dimensional displacement vector of
said area between said original and high positions; means for correcting the trajectory of said
robotic arm depending on each calculated three-dimensional vector.” As in 22 “Therefore, the
movements thus detected can permit the correction of the trajectory of a surgical tool in
synchronism with the breathing of the patient, in particular the trajectory of a robot.”]
Stopek teaches determine a pattern of movement of an anatomical element based on patient data including at least one of age, height and weight of the patient [(see at least paragraph 101) “The breathing model shows relationship between movement of the lung and the patient's breathing pattern. Accurate estimation of a tertiary or terminal bronchus tree while the patient is breathing may not be easily obtained by a generic breathing model because breathing causes the lungs to move cyclically, meaning that the lung movement varies by amplitude and direction during the breathing cycle from 5 mm to 30 mm depending on such breathing characteristics as patient size, age, altitude, health, etc.”]
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 teachings of Joshi to incorporate the teachings of Maillet of obtaining a sample of a patient breathing pattern, determining a pattern of
movement of an anatomical element based on the sample and adjusting a trajectory of the
robotic arm based on a pose of the anatomical element as determined by the pattern of
movement in order to permit the correction of the trajectory of a surgical tool in synchronism
with the breathing of the patient [(Maillet 22)] and to incorporate the teachings of Stopek of determining a pattern of movement of an anatomical element based on patient data including at least one of age, height and weight of the patient in order to build a dynamic breathing model that can be used to accurately estimate movements of a small bronchial tree during a patient's breathing cycle. [(Stopek 101)]
Regarding claim 18, In view of the above combination of references, Joshi further
teaches wherein the plurality of poses correspondent to a movement of the anatomical
element, and wherein determining the pattern of movement of the anatomical element
comprises determining a maximum height and a minimum height of the movement and a
number of movements of the marker per the time period. [(see at least paragraphs 77, 106)
“FIG. 3 illustrates an example embodiment 3600 of surgical robot system 1 that utilizes a
surveillance marker 710 in accordance with one or more aspects of the invention. As
illustrated, the example embodiment 3600 comprises a 4-marker tracker array 3610 attached
to the patient 18 and having a surveillance marker, and a 4-marker tracker array 3620 on the
robot 15. In some embodiments, during usage, it may possible that a tracker array, or tracker
(3610 in FIG. 3), on a patient 18 inadvertently shifts. For example, a conventional clamp
positioned on a patient's 18 spinous process 2310 where the tracker 3610 is attached can be
bumped by the surgeon's arm and move (i.e., bend or translate) to a new position relative to
the spinous process 2310. Alternatively, a tracker 3610 that is mounted to the skin of the
patient 18 can move gradually with the skin, as the skin settles or stretches over time. In this
instance, the accuracy of the robot 15 movement can be lost because the tracker 3610 can reference bony anatomy from a medical image that no longer is in the same position relative
to the tracker as it had been during the medical image scan.” As in 106 “if more than three
markers 4001, 4002, 4003 are utilized for tracking the movement of a rigid body, the same
method can be implemented repeatedly for as many triads of markers as are present. For
example, in a scenario in which four markers, M1, M2, M3, and M4, are attached to the rigid
body, there can be four triads: those formed by {M1, M2, M3}, {M1, M2, M4}, {M1, M3, M4},
and {M2, M3, M4}. In some embodiments, each of these triads can be used independently in
the method described hereinbefore in order to calculate the rigid body motion. In some
embodiments, the final values of the translations and rotations can then be the average of
the values determined using the four triads. In some embodiments, in the alternative or in
addition, other methods for achieving a best fit when using more than 3 markers may be
used.”]
Regarding claim 19, Modified Joshi has all of the elements of claim 17 as discussed above.
Joshi does not explicitly teach further comprising: a ventilator configured to control the
breathing pattern of the patient.
However, Maillet teaches further comprising: a ventilator configured to control the breathing
pattern of the patient. [(see at least paragraph 27-29) “a mechanical ventilator, which the
respiration of a patient is subjected to”]
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 teachings of modified Joshi to incorporate the
teachings of Maillet of a ventilator configured to control the breathing pattern of the patient in
order to monitor the ventilation frequency of gas/air delivered to the patient.
Regarding claim 20, In view of the above combination of references, Joshi further
teaches wherein the marker comprises at least one of an optical marker, an infrared light
emitting diode, an electromagnetic marker, and an inertial measurement unit tracker. [(see at
least paragraph 74) “In some embodiments in which the surgical robot system 1 comprises a
conventional infrared optical tracking system, the surgical robot system 1 can comprise
conventional optical markers attached to selected locations on the end-effectuator 30 and/or
the surgical instrument 35 that are configured to emit or reflect light. In some embodiments,
the light emitted from and/or reflected by the markers can be read by cameras (for example
with cameras 8200 shown in FIG. 48) and/or optical sensors and the location of the object can
be calculated through triangulation methods (such as stereo-photogrammetry).”]
The Examiner has cited particular paragraphs or columns and line numbers in the references applied to the claims above for the convenience of the Applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the Applicant in preparing responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner. See MPEP 2141.02 [R-07.2015] VI. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed Invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert, denied, 469 U.S. 851 (1984). See also MPEP §2123.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(US 2015/0265368 A1) Chopra - Systems And Methods For Anatomic Motion Compensation
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED YOUSEF ABUELHAWA whose telephone number is (571)272-3219. The examiner can normally be reached Monday-Friday 8:30-5:00 with flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wade Miles can be reached on 571-270-7777. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED YOUSEF ABUELHAWA/Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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