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 .
Status of the Application
Claims 1-18 have been examined in this application. This communication is the first action on merits. The Information Disclosure Statement (IDS) filed on 08/22/2024 has been acknowledged by the Office.
Claim Objections
Claim(s) 2, 4, 7 and 9 are objected to because of the following informalities:
In regards to Claim 2 and Claim 7, the claims recite “to determine the adjustment to be in adjusting the head support based on the programmed setting.” The phrase “the adjustment to be in adjusting” is grammatically incorrect and renders the limitation unclear as written.
The Examiner suggests amending the limitation to recite “to determine the adjustment to be made in adjusting the head support based on the programmed setting,” or other appropriate language consistent with the Specification.
In regards to Claim 4, the following is recited: “wherein defining position information includes the steps of,” whereas Claim 1 previously recites “defining initial positioning information.” Thus, “position information” lacks proper antecedent basis and is inconsistent with the terminology previously introduced in Claim 1. The Examiner suggests amending “wherein defining position information includes the steps of” to “wherein defining the initial positioning information includes the steps of,” or other appropriate language consistent with the Specification.
In regards to Claim 9, the following is recited: “when the head moves more than the threshold head movement, determine if movement is controlled movement,” which is grammatically inconsistent with the remaining method steps recited in the claim and fails to include an article before “movement.” The Examiner suggests amending the limitation to recite “when the head moves more than the threshold head movement, determining if the movement is controlled movement,” or other appropriate language consistent with the Specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 8, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al., hereinafter 'Franklin' (WO 2013134623 A1) in view of Ghajar (US 20140081180 A).
In regards to Claim 1, Franklin teaches: A method comprising: defining initial positioning information including information on an initial head position within a head support and a programmed setting for adjustment of the head support (customized head holder/positioning interface 1080 is provided for positioning the patient’s head at a predetermined position and orientation, wherein sensors 400 corresponding to implanted emitters 20 are utilized by a computerized control system to determine the orientation and location of the treated area in the head and control the positioning of the head, noting Para's 0090 - 0094, Figs. 5 and 9); adjusting the head support to the initial head position (customized head holder/positioning interface 1080 positions the patient’s head at a pre-planned location and orientation, noting Para's 0090 - 0094); monitoring head position to generate position data of the head (sensors 400 corresponding to implanted emitters 20 determine the orientation and location of the treated area/head - Para's 0090 - 0094)
Franklin does not explicitly teach: wherein the monitoring occurs during a period of time that a head is within the head support; and adjusting the head support during the period of time based on the current position data and the programmed setting.
Ghajar teaches: monitoring head position to generate current position data of current head position, wherein the monitoring occurs during a period of time that a head is within the head support (motion detection sensors are mounted relative to the head and torso of the subject and detect movement of the subject’s head over time, wherein motion of the head relative to the torso is calculated based on the detected motion - Fig. 21A-21B); and adjusting the head support during the period of time based on the current position data and the programmed setting (damping motion of the subject’s head relative to the torso based on the calculated motion, including damping motion when the calculated motion exceeds a threshold, dynamically damping motion of the subject’s head, and damping utilizing proportional-integral-derivative (PID) control - Fig. 21B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Franklin to include the monitoring and responsive adjustment taught by Ghajar in order to monitor movement of the patient’s head during use and responsively adjust the support provided to the head based on detected movement, thereby maintaining the patient’s head in a desired position and improving stabilization and positioning accuracy.
In regards to Claim 2, Franklin in view of Ghajar teaches: The method of claim 1, Ghajar further teaches, wherein a processor is used to monitor head position (computerized control system receives positioning information from sensors corresponding to implanted emitters to determine the orientation and location of the treated area/head, noting Para 0090-0094; computer 900 includes processing unit 904 - Fig. 8); and to determine the adjustment to be in adjusting the head support based on the programmed setting (Ghajar calculates motion of the head relative to the torso based on information obtained from the motion detection sensors and controls damping of the head based upon the calculated motion, including when calculated motion exceeds a threshold and utilizing PID control - Fig. 21B | Ghajar expressly illustrates the calculation and responsive-control sequence in Fig. 21B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the processor of Franklin to perform the monitoring and responsive control taught by Ghajar in order to automatically determine an appropriate adjustment based upon monitored head movement and a programmed setting, thereby maintaining the desired position of the patient’s head.
In regards to Claim 8, Franklin teaches: A method comprising: providing a processor operably connected to control the position of a head support (computerized control system in communication with customized positioning interface/head holder 1080, noting Para 0090-0094) and operably connected to sensors so that the processor receives information on the position and movement of a head within the head support (sensors 400 corresponding to implanted emitters 20 determine the orientation and location of the treated area/head, Para 0090-0094); defining initial positioning information and a programmed setting using the processor (computerized control system determines and controls a predetermined/pre-planned position and orientation of the patient’s head, Para 0090-0094), wherein the positioning information includes information on an initial head position within the head support (patient’s head is positioned at the predetermined/pre-planned location and orientation using the customized head holder 1080, Para 0090-0094); adjusting the head support to the initial head position wherein the head support provides support to the head (customized head holder 1080 receives and positions the patient’s head at the predetermined position and orientation - Figs. 5 and 9); monitoring head position to generate position data of the head (sensors 400 and implanted emitters 20 determine the position/orientation associated with the patient’s head, noting Para 0090-0094).
Franklin does not explicitly teach: wherein the positioning information includes a threshold for head movement; wherein the head support provides a predetermined amount of support to the head; wherein the monitoring occurs during a period of time that a head is within the head support; and adjusting the head support during the period of time based on the current position data and the programmed setting.
Ghajar teaches: wherein the positioning information includes a threshold for head movement (calculated motion of the subject’s head is compared with a predetermined acceleration/motion threshold); monitoring head position to generate current position data of current head position, wherein the monitoring occurs during a period of time that a head is within the head support (motion detection sensors mounted relative to the subject’s head and torso detect movement over time and the system periodically calculates motion of the head relative to the torso); and adjusting/control of the head support during the period of time based on the current position data and programmed setting (damping motion of the subject’s head relative to the torso, including damping when the calculated motion exceeds a threshold, dynamically damping the motion, and utilizing PID control - Fig. 21B | Ghajar further teaches a head-mounted support arrangement physically secured relative to the user’s head and torso and configured to resist/dampen relative head movement.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Franklin to include the movement threshold and responsive head movement control taught by Ghajar in order to detect movement of the patient’s head away from the desired initial position and responsively control the head support based upon the detected movement, thereby maintaining the patient’s head in the desired position and reducing undesirable movement.
In regards to Claim 12, Franklin teaches: A head supporting system, the system comprising: a head support configured to engage the head (customized patient-specific head holder/positioning interface 1080 - Figs. 5 and 9); an adjustment system connected to the head support to adjust the head support (computerized positioning/control system communicates with and controls the customized positioning interface/head holder to position the patient’s head, noting Para 0090-0094); one or more sensors which detect the head position and which produce a position signal from the detection (sensors 400 detect implanted emitters 20 associated with the patient/head to determine the orientation and location of the treated area/head, noting Para 0090-0094); at least one processor configured to receive the position signals from the sensors (computerized control system receives data from sensors 400 corresponding to emitters 20, noting Para 0090-0094), determine adjustments to be made to the head support (computerized control system determines/controls positioning of the patient’s head at the pre-planned location and orientation, noting Para 0090-0094), and send adjustment signals to the adjustment system so that the head support is adjusted in accordance with the determined adjustments (computerized control system transmits data and control commands to the positioning interface for positioning the patient’s head/treatment area, noting Para 0090-0094).
Franklin does not explicitly teach: wherein the head support has one or more straps to engage the head.
Ghajar teaches: wherein the head support has one or more straps to engage the head (head-mounted relational motion detection apparatus includes support members/straps extending around and engaging the subject’s head - Figs. 2A, 4-5 and 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the customized head support of Franklin to include the strap arrangement taught by Ghajar in order to securely engage the patient’s head with the head support and maintain the head support and associated sensing components in a desired position relative to the patient’s head during use.
In regards to Claim 13, Franklin teaches: The head support system of claim 12, wherein the at least one processor is configured to carry out the following steps: (a) receiving initial positioning information including information on an initial head position within the head support (computerized control system utilizes predetermined/pre-planned positioning information to position the patient’s head/treatment area at a desired location and orientation, noting Para 0090-0094); (b) monitoring head position to generate position data of head position based on the position signals (sensors 400 corresponding with implanted emitters 20 determine the orientation and location of the treated area/head, noting Para 0090-0094); and (c) determining adjustments to be made based on the position signals and a predetermined setting (computerized control system communicates with the customized positioning interface/head holder and provides control commands for positioning the patient’s head/treatment area at the predetermined position and orientation, noting Para 0090-0094).
Franklin does not explicitly teach: wherein the monitoring occurs during a period of time that a head is within the head support; and determining the adjustments to be made during the period of time based on the position signals and a predetermined programmed setting.
Ghajar teaches: monitoring head position to generate current position data based on sensor signals during a period of time that the head is within the head-mounted support (motion detection sensors continuously/periodically provide information regarding movement of the head relative to the torso); and determining responsive control during the period of time based upon the sensor information and predetermined programmed criteria (calculating motion of the head relative to the torso, damping head motion when calculated motion exceeds a threshold, dynamically damping the head motion, and optionally utilizing PID control - Fig. 21B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor-controlled head support system of Franklin to include the ongoing sensor-based monitoring and responsive control taught by Ghajar in order to detect changes in head position occurring after initial positioning and determine responsive adjustments based upon the current position signals and predetermined control parameters, thereby maintaining the patient’s head at the desired position during use.
Allowable Subject Matter
Claim(s) 3-7, 9-11 and 14-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
In regards to Claims 3-7, the prior art of record, either alone or in combination, fails to teach or suggest the limitations of Claim 3 requiring wherein the step of monitoring the head position includes receiving information on current head position and current amount of pressure the head is placing on the head support, and the current position data includes both the information on the current position and the current amount of pressure. Specifically, Franklin teaches sensing and determining position and orientation information associated with the patient’s head using sensors 400 and corresponding implanted emitters 20, but does not teach monitoring an amount of pressure applied by the head to the head support or generating current position data which includes both current head position and the current amount of pressure applied by the head to the head support. Ghajar similarly teaches monitoring motion of the subject’s head using motion detection sensors, including determining translational and rotational movement of the head and calculating motion of the head relative to the torso; however, Ghajar does not teach detecting or monitoring the current amount of pressure that the head is placing on the head support or including such pressure information together with current head position information as the current position data. Therefore, the prior art of record fails to teach or suggest monitoring both the current position of the head and the current amount of pressure the head is placing on the head support and utilizing both the current position and current amount of pressure as the current position data, as required by Claim 3.
In regards to Claims 9-11, the prior art of record, either alone or in combination, fails to teach or suggest the limitations of Claim 9 requiring adjusting the head support to provide less than the predetermined amount of support; determining whether there is a head movement after adjusting the head support to provide less than the predetermined amount of support and whether the head movement is more than the threshold head movement; when the head moves more than the threshold head movement, determining if movement is controlled movement; and when the movement is not controlled movement, adjusting the head support to increase support of the head. Specifically, Ghajar teaches detecting motion of the subject’s head, calculating motion of the head relative to the torso, comparing the calculated motion to a predetermined threshold, and damping motion of the head when the calculated motion exceeds the predetermined threshold, including dynamically damping the motion of the subject’s head. However, Ghajar does not teach first adjusting the head support to provide less than a predetermined amount of support and thereafter monitoring the resulting movement of the head to determine whether the movement exceeds a threshold. Further, Ghajar does not teach determining, after the threshold has been exceeded, whether the detected head movement constitutes controlled movement, nor does Ghajar teach increasing the amount of support provided to the head specifically in response to determining that the movement is not controlled movement. Ghajar’s threshold-based damping of detected motion does not teach the claimed sequence of deliberately reducing support, evaluating the patient’s resulting head movement, determining whether the resulting movement is controlled, and restoring/increasing support when the movement is determined not to be controlled. Ghajar’s feedback process is illustrated in Fig. 21B as calculating relative head motion and damping the motion, including threshold-based and dynamic damping. Franklin similarly fails to teach reducing an amount of head support to evaluate a patient’s ability to control head movement and thereafter increasing the support when the resulting movement is determined to be uncontrolled. Therefore, the prior art of record fails to teach or suggest the claimed adaptive support sequence wherein an amount of support provided to the head is reduced, resulting head movement is evaluated relative to a threshold and for whether the movement is controlled, and support is subsequently increased when the movement is determined not to be controlled, as required by Claim 9.
In regards to Claims 14-18, the prior art of record, either alone or in combination, fails to teach or suggest the limitations of Claim 14 requiring wherein the monitoring the head position includes receiving information on current position of the head support and current amount of pressure the head is placing on the head support, and the current position data includes both the information on the current position and the current amount of pressure. Specifically, Franklin teaches sensors and a computerized control system for determining position and orientation information associated with the patient’s head and controlling the positioning thereof, but does not teach sensing or monitoring the current amount of pressure applied by the patient’s head to the head support or generating current position data which includes both current position information and current pressure information. Ghajar teaches detecting and calculating movement of the subject’s head using motion sensors, including translational and rotational movement and movement of the head relative to the torso, but similarly does not teach sensing the current amount of pressure exerted by the head against the head support. Ghajar describes motion-sensing arrangements including accelerometers, angular velocity sensors, gyroscopes, position sensors, and related motion detection devices, rather than sensing pressure exerted between the head and head support. Therefore, the prior art of record fails to teach or suggest monitoring both the current position and the current amount of pressure the head is placing on the head support and utilizing both the current position information and current pressure information as the current position data, as required by Claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON MATTHEWS whose telephone number is (571)272-8473. The examiner can normally be reached M-F 7:30-4:30 EST.
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MADISON MATTHEWS
Primary Examiner
Art Unit 3673
/MADISON MATTHEWS/Primary Examiner, Art Unit 3673
08/23/2026
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