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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/26/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-18, and 20-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 8-13, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and further in view of Elia (US 20220265501).
Regarding claim 1, Solomon discloses a device for stabilizing a patient ([0004] – “a skull clamp device for immobilizing the skull”) comprising:
(a) a head fixation device ([0004] – “a skull clamp device for immobilizing the skull”) comprising a first arm coupled with a first pin holder assembly and a second arm coupled with a second pin holder assembly (Fig. 1 , [0023] – “Each of the lateral arms 20 a, 20 b respectively includes an adjustably attached first and second pin assembly mounting bracket 22 a and 22 b…Each of the pin assembly mounting brackets 22 a, 22 b includes a pair of adjustably attached skull immobilizing pin assemblies”); and
(b) one or more sensors positioned on the head fixation device, wherein the one or more sensors are configured to detect one or more characteristics of the head fixation device ([0027] – “the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”),
Conversely Solomon does not teach wherein the one or more characteristics of the head fixation device includes one or more of a position, displacement, and angular orientation.
However Elia discloses wherein the one or more characteristics of the head fixation device includes one or more of a position, displacement, and angular orientation (Fig. 2D, [0050] – “the sensors 472 can be position sensors configured to measure a spatial position or orientation of the patient engagement assembly 202, the first arm segment 204, the second arm segment 206, and/or the third arm segment 208”, [0051] – “the sensors 472 can be configured to measure one or more metrics (e.g., pressures, forces, torques, displacements, etc.”).
Elia is an analogous art considering it is in the field of a head holding system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the position and orientation sensor of Elia to achieve the same results. One would have motivation to combine because it would provide information that would help “to keep the patient's head and/or neck at the user selected position and/or within a target range associated with the user selected position” (Elia [0010]).
Regarding claim 2, Solomon and Elia disclose all the elements of the claimed invention as cited in claim 1.
Solomon further discloses further comprising a data processing unit connected with the one or more sensors (Fig. 1, computer-controller system 52) such that the data processing unit is configured to receive data from the one or more sensors, wherein the data processing unit is configured to analyze the one or more characteristics of the head fixation device detected by the one or more sensors to provide feedback based on the detected one or more characteristics of the head fixation device ([0029] – “the sensor safety system 62 can be monitored and/or controlled along with all other data transmission remotely by the computer-controller system 52”, [0025] – “The system-controller 52 is also capable of creating a time-line data recording of the pressure exerted by each of the pins 26 and automatically annotating any pressure aberrations in that recorded information”).
Regarding claim 4, Solomon and Elia disclose all the elements of the claimed invention as cited in claim 1.
Solomon further discloses wherein the first pin holder assembly comprises a torque screw assembly (Figs. 4 & 5) including an actuator (Figs. 4 & 5 element 36, [0024] – “manual rotational adjustment and locking element 36”) and a pin configured to contact a head (Figs. 4 & 5 element 66, [0023] – “skull immobilizing pin 26”), wherein the actuator is configured to adjust the pin relative to the head (Fig. 1, [0024] – “The pin assembly holder 34 can be manually adjusted by a manual rotational adjustment and locking element 36”).
Regarding claim 8, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 2.
Solomon further discloses wherein the data processing unit is configured to determine whether the fixation provided by the head fixation device is stable ([0036] – “When the preselected pressure limit is reached, the strain gauges 64 a, 64 b signal the computer-controller system 52, which immediately responds by shutting down the power to the linear drive motor 48 (FIG. 4) or alternatively to the rotational drive motor 134 (FIG. 5) to stop the advance of the respective pin 26 (FIG. 4) or rotatable pin 126 (FIG. 5)”).
Regarding claim 9, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 2.
Solomon further discloses wherein the data processing unit is configured to compare the one or more characteristics of the head fixation device detected by the one or more sensors with a predetermined value to determine whether the fixation provided by the head fixation device is stable ([0029] – “The computer-controller system 52, as discussed above, is the primary means used to preset the clamping pressure of the pins 26”, [0036] – “When the preselected pressure limit is reached, the strain gauges 64 a, 64 b signal the computer-controller system 52, which immediately responds by shutting down the power to the linear drive motor 48 (FIG. 4) or alternatively to the rotational drive motor 134 (FIG. 5) to stop the advance of the respective pin 26 (FIG. 4) or rotatable pin 126 (FIG. 5)”).
Regarding claim 10, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1, 2, and 9.
Solomon further discloses wherein the data processing unit is configured to provide an alarm to indicate when the fixation provided by the head fixation device is not stable ([0012] – “The drive system can also communicate an unsafe status of the pin contact with the patient's skull through an alarm, which can include both visual and audible alarms”, [0029] – “provide an audible alert via a speaker 82 and/or a visual alert such as a light 84 on the computer-controller system 52”).
Regarding Claim 11, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 2.
Solomon does not explicitly teach further comprising a data interface connected with the data processing unit such that the characteristic analyzed by the data processing unit is transmittable to the data interface.
However Solomon teaches (Fig. 1, [0025] – “The system-controller 52 is also capable of creating a time-line data recording of the pressure exerted by each of the pins 26 and automatically annotating any pressure aberrations in that recorded information”, [0029] – “Pressure developed against the skull by each of the pin assemblies 24 can be displayed on the monitor screen 78”, one with ordinary skill in the art would recognize the computer controller 52 would contain a processing element and that the processing element can be separate from the display monitor similar to a desktop computer therefore the analyzed characteristic would be transmittable from the processing element to the data interface [display monitor, antenna 80, speaker 82, control 88, and keypad 54]) which renders the following limitation obvious: further comprising a data interface connected with the data processing unit such that the characteristic analyzed by the data processing unit is transmittable to the data interface.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the separation of the processing element and the display monitor to achieve the same results. One would have motivation to combine because it allow one the ability to more easily replace the processing element or the display in either fails.
Regarding Claim 12, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1, 2, and 11.
Solomon does not explicitly teach wherein the data interface comprises a display for displaying the one or more characteristics of the head fixation device analyzed by the data processing unit.
However Elia discloses wherein the data interface comprises a display for displaying the one or more characteristics of the head fixation device analyzed by the data processing unit ([0034] – “The display 224 may also display a requested or potential change to the position/orientation of the patient's head”, [0054] – “other metrics can be displayed, including rotation, side-bending, or the like”, [0055] – “track and/or display metrics associated with a current position of the patient P relative to a baseline”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the display of the one or more characteristics of Elia to achieve the same results. One would have motivation to combine because it would “enable a surgeon to more easily adjust and stabilize the positioning of a patient's head and neck during cranial and spinal surgery” (Elia [0002]).
Regarding Claim 13, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1, 2, and 11.
Solomon does not explicitly teach wherein the data interface is configured to connect the data processing unit with remote devices.
However Solomon teaches ([0012] – “This important information can also be transmitted by direct wired or by wireless means to a remote monitoring system”, Fig. 1, one with ordinary skill in the art would recognize the computer controller 52 would contain a processing element and that the processing element can be separate from the display monitor similar to a desktop computer therefore the analyzed characteristic would be transmittable from the processing element to the data interface [display monitor, antenna 80, speaker 82, control 88, and keypad 54]) which renders the following limitation obvious: wherein the data interface is configured to connect the data processing unit with remote devices.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the separation of the processing element and the display monitor to achieve the same results. One would have motivation to combine because it allow one the ability to more easily replace the processing element or the display in either fails.
Regarding claim 16, Solomon and Elia disclose all the elements of the claimed invention as cited in claim 1.
Solomon further discloses further comprising a connection assembly connected with a sensor assembly, wherein the connection assembly comprises a data processing unit configured to receive data from the one or more sensors of the sensor assembly (Fig. 1, connection assembly = sensors, signal cables 68, junction box 70, and computer-controller 52, [0028] – “Signals are relayed from the strain gauges 64 a, 64 b through respective signal cables 68 a, 68 b to a central junction box 70 and thence on to the computer-controller system 52”), wherein the connection assembly is configured to analyze the one or more characteristics of the head fixation device detected by the one or more sensors to provide feedback of the detected characteristic ([0029] – “the sensor safety system 62 can be monitored and/or controlled along with all other data transmission remotely by the computer-controller system 52”, [0025] – “The system-controller 52 is also capable of creating a time-line data recording of the pressure exerted by each of the pins 26 and automatically annotating any pressure aberrations in that recorded information”).
Regarding claim 17, Solomon discloses a method of operating a head stabilization system (Fig. 6) comprising a head fixation device ([0004] – “a skull clamp device for immobilizing the skull”) having a first arm coupled with a first pin holder assembly and a second arm coupled with a second pin holder assembly, one or more sensors positioned on the head fixation device (Fig. 1 , [0023] – “Each of the lateral arms 20 a, 20 b respectively includes an adjustably attached first and second pin assembly mounting bracket 22 a and 22 b…Each of the pin assembly mounting brackets 22 a, 22 b includes a pair of adjustably attached skull immobilizing pin assemblies”), and a data processing unit (Fig. 1, computer-controller system 52) connected with the one or more sensors such that the data processing unit is configured to receive data from the one or more sensors ([0029] – “the sensor safety system 62 can be monitored and/or controlled along with all other data transmission remotely by the computer-controller system 52”), the method comprising the steps of:
(a) detecting one or more characteristics of the head fixation device ([0027] – “the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”); and
(b) analyzing the one or more detected characteristics of the head fixation device ([0025] – “The system-controller 52 is also capable of creating a time-line data recording of the pressure exerted by each of the pins 26 and automatically annotating any pressure aberrations in that recorded information”),
Conversely Solomon does not teach wherein the one or more characteristics of the head fixation device includes one or more of a position, displacement, and angular orientation.
However Elia discloses wherein the one or more characteristics of the head fixation device includes one or more of a position, displacement, and angular orientation (Fig. 2D, [0050] – “the sensors 472 can be position sensors configured to measure a spatial position or orientation of the patient engagement assembly 202, the first arm segment 204, the second arm segment 206, and/or the third arm segment 208”, [0051] – “the sensors 472 can be configured to measure one or more metrics (e.g., pressures, forces, torques, displacements, etc.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Solomon to incorporate the position and orientation sensor of Elia to achieve the same results. One would have motivation to combine because it would provide information that would help “to keep the patient's head and/or neck at the user selected position and/or within a target range associated with the user selected position” (Elia [0010]).
Regarding claim 18, Solomon and Elia disclose all the elements of the claimed invention as cited in claim 17.
Solomon further discloses further comprising providing an alarm based on the one or more detected characteristics of the head fixation device (Abstract – “The sensor is also capable of signaling an alarm to warn of any reduction of pressure applied to the pins that might result from pin slippage”).
Regarding claim 20, Solomon and Elia disclose all the elements of the claimed invention as cited in claim 17.
Solomon further discloses further comprising adjusting the head fixation device based on the one or more detected characteristics ([0036] – “The computer-controller system 52 is then used to make the final, fine adjustments of each of the pin assemblies 24…each of the pin assemblies 24 includes at least one sensor or strain gauge 64 a, 64 b that communicates with the computer-controller system 52 to limit the pressure applied by the linear drive motor 48 in FIG. 4 or alternatively the rotational drive motor 134”).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and Elia (US 20220265501) as applied to claim 4 above, and further in view of Dumpe (WO 2021247990).
Regarding claim 5, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 4.
Conversely Solomon does not teach wherein at least one sensor of the one or more sensors is positioned on the actuator and is configured to detect one or more of the position, displacement, and angular orientation of the actuator of the head fixation device.
However Elia discloses wherein at least one sensor of the one or more sensors […] is configured to detect one or more of the position, displacement, and angular orientation of the actuator of the head fixation device (Fig. 2D, [0050] – “the sensors 472 can be position sensors configured to measure a spatial position or orientation of the patient engagement assembly 202, the first arm segment 204, the second arm segment 206, and/or the third arm segment 208”, [0051] – “the sensors 472 can be configured to measure one or more metrics (e.g., pressures, forces, torques, displacements, etc.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the position and orientation sensor of Elia to achieve the same results. One would have motivation to combine because it would provide information that would help “to keep the patient's head and/or neck at the user selected position and/or within a target range associated with the user selected position” (Elia [0010]).
Conversely Solomon and Elia do not teach wherein at least one sensor of the one or more sensors is positioned on the actuator.
However Dumpe discloses wherein at least one sensor of the one or more sensors is positioned on the actuator ([0168] – “a sensor configured to detect the applied torque (or related outputs, such as current draw) of the actuator 706 (which in turn corresponds to the force applied by the blade)”).
Dumpe is an analogous art considering it is in the field of sensing the pressure/force a device is applying to a bone.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the sensor positioned on the actuator of Dumpe to achieve the same results. One would have motivation to combine because it allows provides more of a selection of types of sensors to use to be able to determine the force/pressure.
Regarding claim 6, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 4.
Solomon discloses wherein at least one sensor of the one or more sensors is positioned…[in] the pin in a contacting configuration and is configured to detect one or more […metrics] of the pin of the head fixation device. (Figs. 4 and 5 sensors 64a and 64b, [0027] – “As shown in FIGS. 4 and 5 the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”).
Conversely Solomon does not teach wherein at least one sensor of the one or more sensors is positioned adjacent the pin in a contacting configuration and is configured to detect one or more of the position, displacement, and angular orientation […].
However Elia discloses configured to detect one or more of the position, displacement, and angular orientation (Fig. 2D, [0050] – “the sensors 472 can be position sensors configured to measure a spatial position or orientation of the patient engagement assembly 202, the first arm segment 204, the second arm segment 206, and/or the third arm segment 208”, [0051] – “the sensors 472 can be configured to measure one or more metrics (e.g., pressures, forces, torques, displacements, etc.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the position and orientation sensor of Elia to achieve the same results. One would have motivation to combine because it would provide information that would help “to keep the patient's head and/or neck at the user selected position and/or within a target range associated with the user selected position” (Elia [0010]).
Conversely Solomon and Elia do not teach wherein at least one sensor of the one or more sensors is positioned adjacent the [device] in a contacting configuration.
However Dumpe discloses wherein at least one sensor of the one or more sensors is positioned adjacent the [device] in a contacting configuration ([0168] – “a sensor disposed on the blade 704 that is configured to directly sense the applied force (e.g., a piezoresistive element or a pressure-sensitive film disposed at the distal tip of the blade)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the sensor positioned on the pin in a contacting configuration of Dumpe to achieve the same results. One would have motivation to combine because it would make the sensors easier to replace when a sensor fails.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and Elia (US 20220265501) as applied to claim 1 above, and further in view of Mertens (US 20200093563).
Regarding claim 7, Solomon and Elia discloses all the elements of the claimed invention as cited in claim 1.
Solomon discloses wherein at least one sensor of the one or more sensors is positioned on the pin and is configured to detect one or more […metrics] of the pin of the head fixation device. (Figs. 4 and 5, [0027] – “the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”).
Conversely Solomon does not teach wherein the second pin assembly comprises a rocker arm and a pin coupled with the rocker arm, wherein at least one sensor of the one or more sensors […] is configured to detect one or more of the position, displacement, and angular orientation […] of the head fixation device.
However Elia discloses wherein at least one sensor of the one or more sensors […] is configured to detect one or more of the position, displacement, and angular orientation […] of the head fixation device (Fig. 2D, [0050] – “the sensors 472 can be position sensors configured to measure a spatial position or orientation of the patient engagement assembly 202, the first arm segment 204, the second arm segment 206, and/or the third arm segment 208”, [0051] – “the sensors 472 can be configured to measure one or more metrics (e.g., pressures, forces, torques, displacements, etc.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the position and orientation sensor of Elia to achieve the same results. One would have motivation to combine because it would provide information that would help “to keep the patient's head and/or neck at the user selected position and/or within a target range associated with the user selected position” (Elia [0010]).
Conversely Solomon and Elia do not teach wherein the second pin assembly comprises a rocker arm and a pin coupled with the rocker arm,
However Mertens discloses wherein the second pin assembly comprises a rocker arm and a pin coupled with the rocker arm (Fig. 1 element 202, [0022] – “a pair of pins (206) with rocker arm (202) with pin assembly (200)”),
Mertens is an analogous art considering it is in the field of a head fixation device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate a rocker arm with a pin attached to the rocker arm of Mertens to achieve the same results. One would have motivation to combine because it allow more range of motion for the pins to be placed on the head and therefore provide better stability.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and Elia (US 20220265501) as applied to claim 11 above, and further in view of Charron (US 20190117318).
Regarding Claim 14, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1, 2, and 11.
Solomon discloses displaying the analyzed characteristic with a head of the patient ([0025] – “The system-controller 52 is also capable of creating a time-line data recording of the pressure exerted by each of the pins 26 and automatically annotating any pressure aberrations in that recorded information”).
Conversely Solomon does not teach wherein the data interface is configured to connect the data processing unit with a navigation system configured to display a diagram of the analyzed characteristic with a head of the patient.
However Charron discloses wherein the data interface is configured to connect the data processing unit with a navigation system configured to display a diagram of the analyzed characteristic with a head of the patient ([0064] – “the surgical system encompasses an exemplary surgical navigation system”, [0079] – “providing an image displaying a physical space and confirming tracking system registration alignment and optional corresponding text and/or indicia, an image displaying a motion range of the mobile unit 505 and optional corresponding text and/or indicia, and/or an image displaying a guide head positioning and a patient positioning and optional corresponding text and/or indicia”, one with ordinary skill in the art would recognize that the displayed sensor data od Solomon could be displayed as a diagram as the optional corresponding text and/or indicia).
Charron is an analogous art considering it is in the field of a providing a support structure for the head.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate navigation system of Charron to achieve the same results. One would have motivation to combine because it allow one to see better visualize the sensor data and how it affects the stability of the head.
Regarding Claim 15, Solomon discloses all the elements of the claimed invention as cited in claims 1, 2, and 11.
Solomon discloses displaying the analyzed characteristic with a head of the patient ([0025] – “The system-controller 52 is also capable of creating a time-line data recording of the pressure exerted by each of the pins 26 and automatically annotating any pressure aberrations in that recorded information”).
Conversely Solomon does not teach wherein the data interface is configured to connect the data processing unit with an augmented reality system configured to display an image of the analyzed characteristic with a head of the patient.
However Charron discloses wherein the data interface is configured to connect the data processing unit with an augmented reality system configured to display an image of the analyzed characteristic with a head of the patient ([0072] – “provide an augmented reality (A/R) experience”, [0079] – “providing an image displaying a physical space and confirming tracking system registration alignment and optional corresponding text and/or indicia, an image displaying a motion range of the mobile unit 505 and optional corresponding text and/or indicia, and/or an image displaying a guide head positioning and a patient positioning and optional corresponding text and/or indicia”, one with ordinary skill in the art would recognize that the displayed sensor data od Solomon could be displayed as a diagram as the optional corresponding text and/or indicia).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate navigation system of Charron to achieve the same results. One would have motivation to combine because it allow one to see better visualize the sensor data and how it affects the stability of the head.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and further in view of Narita (US 20220219338).
Regarding claim 21, Solomon discloses a device for stabilizing a patient ([0004] – “a skull clamp device for immobilizing the skull”) comprising:
a head fixation device ([0004] – “a skull clamp device for immobilizing the skull”) comprising a first pin holder assembly having a pin (Fig. 1 , [0023] – “Each of the lateral arms 20 a, 20 b respectively includes an adjustably attached first and second pin assembly mounting bracket 22 a and 22 b…Each of the pin assembly mounting brackets 22 a, 22 b includes a pair of adjustably attached skull immobilizing pin assemblies”); and
one or more sensors positioned on the head fixation device, wherein the one or more sensors are configured to detect a […] force acting on the pin that indicates slipping or slipping potential of the pin ([0027] – “the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”, pressure is a measure of force over area and strain sensor measures deformation caused by force, [0012] – “once the pins are securely in place if there is a loss or reduction of resistance or back pressure on the pin the sensors of the system can trigger an alarm to indicate a possible loosening or slippage of the skull clamp system”),
Conversely Solomon does not explicitly teach the one or more sensors are configured to detect a shear force,
wherein the detected shear force is in a direction transverse to a longitudinal axis of the […holder].
However Narita discloses the one or more sensors are configured to detect a shear force (Abstract – “a detection unit that detects information regarding a shear force of a portion of the surface of the elastic body, the portion being in contact with the object”),
wherein the detected shear force is in a direction transverse to a longitudinal axis of the […holder] (Fig. 4 shows the shear direction transverse to a longitudinal axis of the holder).
Narita is an analogous art considering it is in the field of a grasping device with sensors to monitor slippage.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the shear force sensor of Narita to achieve the same results. One would have motivation to combine because “it is possible to perform an operation of making contact without slipping the object in a specific direction” (Narita [0167]).
Regarding claim 22, Solomon and Narita disclose all the elements of the claimed invention as cited in claim 21.
Solomon discloses further comprising a data processing unit connected with the one or more sensors such that the data processing unit is configured to receive data from the one or more sensors ([0028] – “Signals are relayed from the strain gauges 64 a, 64 b through respective signal cables 68 a, 68 b to a central junction box 70 and thence on to the computer-controller system 52”), wherein the data processing unit is configured to analyze the […] force detected by the one or more sensors to provide feedback based on the detected […] force to indicate whether the fixation provided by the head fixation device is stable ([0029] – “The computer-controller system 52, as discussed above, is the primary means used to preset the clamping pressure of the pins 26…In the event that some anomaly is sensed by the sensor safety system 62, e.g., a sudden decrease in pressure sensed by the strain gauges 64 a and 64 b that could indicate that the pin 26 is suddenly meeting with too little resistance due to an imminent break through or fracture of the skull by the advancing pin 26, the sensor safety system 62 will shut down electrical power to the pin drive motor 48 and simultaneously trigger the alarm system 80”, [0010] – “capable of initiating an alarm if a properly set pin later slips from its position in the bone”).
Conversely Solomon does not explicitly teach the data processing unit is configured to analyze the shear force detected by the one or more sensors to provide feedback based on the detected shear force.
However Narita discloses the data processing unit is configured to analyze the shear force detected by the one or more sensors to provide feedback based on the detected shear force ([0122] – “a sensor capable of measuring the distribution of the shear force, [0198] – “a signal processing block that performs signal processing on an output signal of the sensor”, [0171] “makes it possible to widen dynamic ranges of the gripping force and the shear force, in which a slip can be detected”, as cited above Solomon discloses initiating an alarm if a properly set pin later slips therefore one with ordinary skill in the art would find it obvious to combine Solomon and Narita to teach providing feedback based on the detected shear force).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the shear force sensor of Narita to achieve the same results. One would have motivation to combine because “it is possible to perform an operation of making contact without slipping the object in a specific direction” (Narita [0167]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and Elia (US 20220265501) as applied to claims 1 and 17 above, and further in view of Edlaur (US 20090014011).
Regarding claims 23 and 24, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 17.
Solomon further discloses wherein the one or more characteristics of the head fixation device further includes a […] force acting on a pin of the head fixation device ([0027] – “the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”, pressure is a measure of force over area and strain sensor measures deformation caused by force).
Conversely Solomon does not teach wherein the one or more characteristics of the head fixation device further includes a axial force acting on a pin of the head fixation device in a direction along a longitudinal axis of the pin.
However Edlaur discloses wherein the one or more characteristics of the head fixation device further includes a axial force acting on a pin of the head fixation device in a direction along a longitudinal axis of the pin ([0084] – “arrangement used to measure the forces acting on the pins”, paragraphs [0087]-[0089] show axial force measurements, one with ordinary skill in the art would recognize in view of the pin shown in Fig. 5 that the axial force would be along a longitudinal axis of the pin).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of Solomon to incorporate the axial force sensor of Edlaur to achieve the same results. One would have motivation to combine because it would allow one to be more aware of how deep the pin has gone into the skull.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and Elia (US 20220265501) as applied to claims 1 and 17 above, and further in view of Narita (US 20220219338).
Regarding claims 25 and 26, Solomon and Elia disclose all the elements of the claimed invention as cited in claims 1 and 17.
Solomon further discloses wherein the one or more characteristics of the head fixation device further includes a […] force acting on a pin of the head fixation device ([0027] – “the sensor safety system 62 includes a first and second sensor 64 a, 64 b capable of determining the degree of compression, pressure, or strain placed on the pin 26”, pressure is a measure of force over area and strain sensor measures deformation caused by force).
Conversely Solomon does not teach wherein the one or more characteristics of the […] device further includes a shear force acting on […] the […] device in a direction transverse to a longitudinal axis of the pin.
However Narita discloses wherein the one or more characteristics of the […] device further includes a shear force acting on […] the […] device in a direction transverse to a longitudinal axis of the pin (Abstract – “a detection unit that detects information regarding a shear force of a portion of the surface of the elastic body, the portion being in contact with the object”, Fig. 4 shows the shear direction transverse to a longitudinal axis of the holder).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of Solomon to incorporate the shear force sensor of Narita to achieve the same results. One would have motivation to combine because “it is possible to perform an operation of making contact without slipping the object in a specific direction” (Narita [0167]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Solomon (US 20170042578) and further in view of Edlaur (US 20090014011).
Regarding claim 21, Solomon discloses a device for stabilizing a patient ([0004] – “a skull clamp device for immobilizing the skull”) comprising:
a head fixation device ([0004] – “a skull clamp device for immobilizing the skull”) comprising a first pin holder assembly having a pin (Fig. 1 , [0023] – “Each of the lateral arms 20 a, 20 b respectively includes an adjustably attached first and second pin assembly mounting bracket 22 a and 22 b…Each of the pin assembly mounting brackets 22 a, 22 b includes a pair of adjustably attached skull immobilizing pin assemblies”); and
one or more sensors positioned on the head fixation device, wherein the one or more sensors are configured to detect a […] force acting on the pin […] to indicate a clamping pressure of the pin against a head, wherein the […] force provides […] pin penetration within a skull of a patient (Abstract – “sensor capable of sensing the degree of back pressure on the pin from contact of the pin against the bone of the patient”, pressure is a measure of force over area and strain sensor measures deformation caused by force, [0029] – “preset the clamping pressure of the pins 26…Pressure developed against the skull by each of the pin assemblies 24 can be displayed”, [0023] – “the distal end 66 of the pin 26 terminating in a sharpened tip 30 that is adapted to penetrate the flesh and soft tissue covering the skull and to slightly penetrate the outer layer of bone of the skull”),
Conversely Solomon does not explicitly teach detect an axial force acting on the pin in a direction along a longitudinal axis of the pin […], wherein the detected axial force provides an indication of pin penetration within a skull of a patient.
However Edlaur discloses detect an axial force acting on the pin in a direction along a longitudinal axis of the pin […] ([0084] – “arrangement used to measure the forces acting on the pins”, paragraphs [0087]-[0089] show axial force measurements, one with ordinary skill in the art would recognize in view of the pin shown in Fig. 5 that the axial force would be along a longitudinal axis of the pin), wherein the detected axial force provides an indication of pin penetration within a skull of a patient ([0086]-[0089] – “The following depth data was recorded: Pin 1: penetration depth<1.5 mm (axial force≈360 N), Pin 2: penetration depth≦1.0 mm (axial force≈250 N), Pin 3: penetration depth<1.0 mm (axial force≈180 N)”).
Edlaur is an analogous art considering it is in the field of a device for securing the head of a patient.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Solomon to incorporate the axial force sensor of Edlaur to achieve the same results. One would have motivation to combine because it would allow one to be more aware of how deep the pin has gone into the skull.
Conclusion
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797