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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/25/26 has been entered.
Response to Arguments
Claim Objections
Based on applicant’s filed amendments to claim 12, the previously set forth objection has been overcome.
102 Rejection
Applicant’s arguments, see page 12, filed 6/16/26, with respect to the rejection(s) of claim(s) 1-7, 9-15 and 20 under 35 USC §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fadell et al. (2009/0167508).
The examiner disagrees with applicant’s assertion regarding [0009]. Here, Chen discusses two ways to guide a patient during a movement exercise by comparing where they are to where they should be: direction-only feedback and direction-plus-magnitude feedback. The statement of “limiting but limiting the information to just the direction creates a simpler message that may be easier to act on” does not imply one is better than the other nor only one being used.
Applicant further argues that Chen does not teach comparing a response signal to a test signal, however this argument is not persuasive. Under the broadest reasonable interpretation, the claim does not require a direct mathematical or signal-level comparison between the transmitted test signal and the response signal. In Chen, the transmitted visual, audible or haptic instruction reads on the claimed test signal. The image data generated by the camera represents the patient’s resulting movement. By evaluation the detected movement following the instruction to determine whether the positional error has been reduced, Chen teaches assessing whether the patient responded to the test signal.
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) 1-7, 9-15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (2015/0352375A1) in view of Fadell et al. (2009/0167508).
With respect to claim 1, Chen teaches a method for establishing a communication path (through sound, tactile or visual indicators; [0008]) between a subject (i.e. patient; Abstract) and a radiation medical device (10) in real time during operation (as Chen et al discloses monitoring the patient in real-time during the procedure while providing in real-time feedback to the patient regarding their relative position; [0003] and Abstract) of the radiation medical device (10), the method comprising: providing, by a data processing unit (as indirectly taught in Fig. 3 which discloses instructions performed by a taught control system; [0010]), a set of communication methods between the subject (i.e. patient) and the radiation medical device (10), wherein the set of communication methods comprises at least two of an audio communication method (via a loudspeaker 40), a visual communication method (i.e. a display or video glasses; [0025]), or a tactile communication method (via a haptic feedback system; note Chen teaches three communication methods, thereby reading on “at least two”); transmitting, by the data processing unit (as indirectly taught in Fig. 3), at least one test signal (i.e. to either the loudspeaker, display or haptic feedback system) to the subject (patient) via at least one communication method of the set of communication method (as described in [0008]) for testing whether the at least one communication method is suitable for the subject (as Chen teaches in [0009]; The feedback can be just the direction of the vector difference between the patient's current position and the predetermined position, or it can be a combination of the direction and the magnitude. Including the magnitude means that the patient can see how significant the misalignment is, but limiting the information to just the direction creates a simpler message that may be easier to act on; therefore, Chen teaches testing the suitability of a communication method by evaluating whether providing directional feedback or a combination of direction and magnitude; this process tests user responsiveness to different feedback types to determine when a positional goal is achieved); receiving, by the data processing unit (as indirectly taught in Fig. 3), at least one response signal from the subject (as sensed from a camera 34) in response to the at least one test signal (applied to either one of the communication methods taught in [0008]); assessing, by the data processing unit (as indirectly taught in Fig. 3), the at least one response signal (from the camera 34) by comparing it with the at least one test signal (as Fig. 3 details after the test signal was sent, the position of the patient is checked again) for one or more response indicators (i.e. positional error being corrected) indicating whether the subject is responding to the at least one test signal (i.e. the patient has moved to reduce the current position error such that no more test signals need to be sent to the patient for positional correction; Fig. 3), and deriving an assessing result therefrom (at s56, which checks for the error); when the assessing result is positive (i.e. the positional error has been corrected), selecting, by the data processing unit (as indirectly taught in Fig. 3), the at least one communication method (the method effectively achieving communication with the subject such that the position error is eliminated) of the set of communication methods (as disclosed in [0008]) for establishing the communication path (to communicate positional error); when the assessing result is negative (i.e. the position error still remains): transmitting, by the data processing unit (as indirectly taught in Fig. 3), at least one further test signal to the subject (patient) via at least one further communication method of the set of communication methods (as disclosed in [0008]), receiving, by the data processing unit (as indirectly taught in Fig. 3), at least one further response signal from the subject (as sensed via camera 34) in response to the at least one further test signal (as sent via one of the communication method disclosed in [0008]), assessing, by the data processing unit (as indirectly taught in Fig. 3), the at least one further response signal by analyzing the at least one further response signal for one or more response indicators (i.e. as Chen teaches the further response signal is assessed to determine if the positional error has been satisfied) whether the subject (patient) is responding to the test signal (as sent via one of the communication methods disclosed in [0008]), and deriving a further assessing result therefrom (via Fig. 3), and when the further assessing result is positive (i.e. the positional error has been satisfied), selecting the at least one further communication method of the set of communication methods for establishing the communication path (as the communications methods are selected throughout the iterative process disclosed in Fig. 3; thereby reading on the claimed invention), and establishing (as the iterative approach continues using the most effective communication, through either audible, visual or haptic, until the patient is in the correct position) the communication path (i.e. the most effective corrective communication path) between the subject (i.e. patient; Abstract) and the radiation medical device (10) to enable reliable communication during the operation of the radiation medical device (10) for medical imaging the subject (i.e. the patient).
Chen remains silent regarding the transmission of the at least one further test signal to the subject via at least one communication method of the set of communication methods that is different from the at least one communication method.
Fadell et al. teaches based on different determination of feedback from a user, transmitting a signal via at least one communication method of a set of communication methods that is different from the at least one communication method (as Fadel et al. teaches in [0099] control logic that checks a position of a user’s finger at a specific location and then gives specific tactical feedback from a group of tactile feedback based on that location).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the method of Chen to include the conditional control logic of Fadell et al. such that based on signal feedback from the user, different tactile responses are generated different than from the at least one communication method because such a modification aids the user to navigate the use of the device, thereby improving the operability of medical device of Chen.
With respect to claim 15, Chen teaches computer program element (as indirectly taught through the teaches of a control system; [0010]) comprising executable instructions (seen in Fig. 3) stored on anon-transitory computer readable medium (as indirectly taught), which when executed by a processor (i.e. as indirectly taught as part of the disclosed control system) is configured to carry out the rejected method steps of claim 1.
With respect to claim 2, Chen teaches the method wherein two or more communication methods (as disclosed in [0008]) are selected for establishing the communication path (as one or more than one of the communication methods are used in the communication to the patient that there exists positional error that needs to be corrected); and wherein two or more response signals (as sensed by the camera 34) of the of subject (patient) in response to test signals of the two or more communication methods (via the method disclosed in [0008]) are assessed in parallel (i.e. occurring at the same time; thereby reading on “parallel” insofar as how the term is structurally defined within the claim) to assess a plausibility of the two or more response signals of the subject (as based on the response signal, the method disclosed by Chen determines if those test signals from the selected communication methods corrected the positional error).
With respect to claim 3, Chen teaches the method wherein the at least one test signal comprises different signal levels; and wherein the signal level of the test signal is increased from at least one low level to at least one high level to determine a reception threshold of the subject (as based on how much positional error is present, a magnitude of that misalignment is conveyed to the patient, allowing the patient to see how much they are off; [0009]; thereby reading on a signal level being increased from low to high based on the patient’s response signal captured by the camera 34).
With respect to claim 4, Chen teaches the method wherein the at least one signal level of the at least one test signal is increased to a maximum signal level (i.e. larger magnitude than when a positional error is only small) in response to an insufficient response signal (as based on the amount of the positional error, Chen discloses magnitude changes to reflex the magnitude of error, thereby reading on the claimed invention; [0009]).
With respect to claim 5, Chen teaches the method wherein the selecting of the communication methods comprises further a choice of a trigger level of the at least one test signal (i.e. as Chen discloses when a larger positional error is detected, the communication method level is modified to reflect that magnitude); and wherein the trigger level is derived from the reception threshold and the at least one signal levels of the test signal (as Fig. 3 teaches based on the positional error amount derived from the reception of that signal from the user, a magnitude of the signal level is effected).
With respect to claim 6, Chen teaches the method wherein the selecting of the at least one communication method is further based on a reaction time between the at least one test signal and the at least one response signal (as insofar as how “based on a reaction time” is structurally defined, Chen discloses during the real-time processing of the response signal from the patient as collected by the camera 34, the selected communication method disclosed in [0008] is based on when the user has moved enough to correct the positional error).
With respect to claim 7, Chen teaches the method wherein the selecting of the at least one communication methods (disclosed in [0008]) is further based on subject data indicative of a responsiveness of the subject indicative of the responsiveness of the subject (as Chen discloses the communication methods are selected based on the position error detected based on patient positional data collected by the camera 34).
With respect to claim 8, Chen teaches the method wherein, when the assessing result is negative (i.e. the position of the patient after a communication method was applied) and wherein the assessing result indicates an emergency (as Chen teaches if left untreated, treatment is ended; [0036]; if the user is not in the correct position, this could indicated the patient is in distress or if treatment continues while they are in an incorrect position, it could be dangerous to the patient), a control signal is generated (s58), by the data processing unit (as indirectly taught in Fig. 3), to control stopping an operation (s60) of the radiation medical device (10).
With respect to claim 9, Chen as modified teaches all that is claimed in the above rejection of claim 2, but remains silent regarding the method wherein the transmitting of at least one test signal via the two or more communications methods is done coherently with a repeat frequency between 0.2 and 2Hz.
However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller,
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the frequency of the test signal transmission of Chen of the taught visual and audible signals to the patient to be done coherently with a repeat frequency between 0.2 and 2Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working range involves only routine skill in the art. In re Aller, 105 USPQ 233
Further, such a modification would be adventitious to one of ordinary skill in the art as it depicts a sense of urgency to the patient to correct their position, thereby preventing an emergency stop of the radiation device.
With respect to claim 10, Chen teaches the method wherein the radiation medical device (10) is (capable of being) a magnetic resonance tomography device (as there is no active step of providing such a medical device; further, the control system taught in Chen that controls the communication methods disclosed in [0008] is capable of being applied to any medical device requiring patient positional monitoring, as the type of medical device does not further define method over the prior art, insofar as what steps are positively recited).
With respect to claim 11, Chen teaches the method wherein the at least one response signal is derived from a monitoring device comprising a video camera system (34).
With respect to claim 12, Chen teaches a device (control system; [0010]) for establishing a communication path (through sound, tactile or visual indicators; [0008]) between a subject (i.e. a patient) and a radiation medical device (10) in real time during operation (as Chen et al discloses monitoring the patient in real-time during the procedure while providing in real-time feedback to the patient regarding their relative position; [0003] and Abstract) of the radiation medical device (10), the device (Fig. 2) comprising: a processing unit (as indirectly taught in Fig. 3, that depicts instructions performed by a processing unit in a computer environment); and a non-transitory memory storing instructions (seen in Fig. 3) that, when executed by the processing unit (as indirectly taught), cause the processing unit (as indirectly taught) to: provide a set of communication methods (as Chen teaches in [0008] those provide communication methods being visual, audible and tactile/haptic) between the subject (i.e. patient) and the radiation medical device (10), wherein the set of communication methods comprises at least two of an audio communication method, (via a loudspeaker 40), a visual communication method (i.e. a display or video glasses; [0025]), or a tactile communication method (via a haptic feedback system; note Chen teaches three communication methods, thereby reading on “at least two”); transmit at least one test signal (via one of the communication method disclosed in [0008]) to the subject (patient) via at least one communication method of the set of communication methods (disclosed in [0008]) for testing whether the at least one communication method is suitable for the subject (as Chen teaches in [0009]; The feedback can be just the direction of the vector difference between the patient's current position and the predetermined position, or it can be a combination of the direction and the magnitude. Including the magnitude means that the patient can see how significant the misalignment is, but limiting the information to just the direction creates a simpler message that may be easier to act on; therefore, Chen teaches testing the suitability of a communication method by evaluating whether providing directional feedback or a combination of direction and magnitude is more effective for the subject; this process tests user responsiveness to different feedback types to determine the most effective approach for achieving a goal); receive at least one response signal (via a camera 34) from the subject (i.e. patient) in response to the at least one test signal (via one of the communication methods disclosed in [0008]); assess the at least one response signal (via the camera 34) by comparing it (as Fig. 3 details after the test signal was sent, the position of the patient is checked) with the at least one test signal (with the supplied test signal sent to the patient) for one or more response indicators indicating whether the subject is responding to the test signal (as Chen teaches if the patient has moved enough to reduce, the comparison will indicate if another test signal needs to be generated), and to derive an assessing result therefrom (see Fig. 3); when the assessing result is positive (i.e. the communication method for providing a positive reaction with the patient such that they are correcting the positional error), select the at least one communication method of the set of communication methods (as disclosed in [0008]) for establishing the communication path (to the patient); when the assessing result is negative (i.e. when it is determined the user is still out of position), transmit at least one further test signal to the subject (i.e. patient) via at least one further communication method of the set of communication methods (i.e. using another one of the communication method taught in [0008]), receive at least one further response signal (via camera 34) from the subject (i.e. patient) in response to the at least one further test signal (via one of the communication method disclosed in [0008]), assess the at least one further response signal (via the camera) by comparing it with the at least one further test signal for one or more response indicators (i.e. position errors in response to the applied test signal and sensed response signal via the camera 34) indicating whether the subject (i.e. patient) is responding to the at least one further test signal (i.e. moving to correct the positional error), and to derive a further assessing result therefrom (as the steps in Fig. 3 allow the assessing and reassessing to occur until the position error satisfies a threshold), and select, in case the further assessing result is positive (i.e. the patient has moved to correct the positional error), the at least one further communication method of the set of communication methods (i.e. one of the method disclosed in [0008]) for establishing the communication path (as the communications methods are selected throughout the iterative process disclosed in Fig. 3; thereby reading on the claimed invention) and establishing (as the iterative approach continues using the most effective communication, through either audible, visual or haptic, until the patient is in the correct position) the communication path (i.e. the most effective corrective communication path) between the subject (i.e. patient; Abstract) and the radiation medical device (10) to enable reliable communication during the operation of the radiation medical device (10) for medical imaging the subject (i.e. the patient).
Fadell et al. teaches based on different determination of feedback from a user, transmitting a signal via at least one communication method of a set of communication methods that is different from the at least one communication method (as Fadel et al. teaches in [0099] control logic that checks a position of a user’s finger at a specific location and then gives specific tactical feedback from a group of tactile feedback based on that location).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the device of Chen to include the conditional control logic of Fadell et al. such that based on signal feedback from the user, different tactile responses are generated different than from the at least one communication method because such a modification aids the user to navigate the use of the device, thereby improving the operability of medical device of Chen.
With respect to claim 13, Chen teaches a medical imaging system (Fig. 2) comprising the device (i.e. control system; [0010]) according to rejected claim 12 and a medical imaging unit (10).
With respect to claim 14, Chen teaches a medical therapy system (Fig. 2) comprising the device (i.e. control system; [0010]) according to rejected claim 12 and a medical therapy device (i.e. a radiotherapy device; 10).
With respect to claim 19, Chen teaches the non-transitory computer readable medium (as indirectly taught by Fig. 3 for storing the depicted instructions) wherein the selecting of the at least one communication method (i.e. audible, visual or haptic, as taught by Chen) is further based on a reaction time between the at least one test signal and the at least one response signal (as insofar as how “based” is structurally defined, Chen teaches these communication methods are selected throughout a medical procedure occurring in real-time, and if the positional error response signal does not indicate a corrected position, the procedure is stopped; thereby reading on the claimed invention).
With respect to claim 20, Chen teaches the non-transitory computer readable medium (as indirectly taught by Fig. 3 for storing the depicted instructions) wherein the selecting of the at least one communication method (i.e. the loudspeaker, visual or haptic) is further based on subject data indicative of a responsiveness of the subject (i.e. as these communication methods are continuously selected until the positional error of the patient, as detected, is withing defined thresholds).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (2015/0352375A1) in view of Fadell et al. (2009/0167508), as applied to claim 15, further in view of Kaib et al. (2017/0164832).
With respect to claim 16, Chen teaches all that is claimed in the above rejection of claim 15, but remains silent regarding the at least one test signal comprises different signal levels; and wherein the signal level of the at least one test signal is increased from at least one low level to at least one high level to determine a reception threshold of the subject.
Kaib et al. teaches different signal levels (as depicted in Fig. 5); and wherein the signal level of the at least one test signal is increased from at least one low level to at least one high level to determine a reception threshold of the subject (as Fig. 5 depicts an example, the output requests a response from the patient. For example, as shown in FIG. 5, the controller 120 can play a series of sounds at increasing tonal frequencies (e.g., pitch), volumes, and/or durations and request the patient to press a “yes” button displayed on the touch screen 220 or make a movement to indicate when the patient can hear the sound. Based on this test, for example, the controller 120 can automatically determine a patient interaction mode (or set of initial patient interaction features) in which audible alerts and voice commands are provided at the tonal frequencies, volumes, and durations that the patient has indicated that he/she can hear. The controller 120 can add a vibration element to more critical alarms or commands to ensure that a patient with more limited hearing capacities is notified of more critical alarms, such as a treatment alarm issued before providing a treatment shock.)
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the instructions of Chen such that the test signal of Chen comprises different levels that increase from low to high until the subject is responsive, as taught in Kaib et al. because Kaib et al. teaches such a modification improves the patient's level of comfort and understanding during the procedure [0007], thereby improving the overall operation of Chen.
With respect to claim 17, Chen as modified teaches the non-transitory computer readable medium wherein the signal level of the at least one test signal (as modified by Kaib et al.) is increased to a maximum signal level in response to an insufficient response signal (as Kaib et al. teaches the signal level is increased until the patient is responsive).
With respect to claim 18, Chen as modified teaches the non-transitory computer readable medium wherein an alert signal is emitted in response to an insufficient response signal (Kaib et al. [0174], which teaches if the patient is not sufficiently responding, alerts like text or images are supplied to the patient).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fischell et al. (2011/0054334) which teaches a similar method and device for communication with a patient under testing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW G MARINI whose telephone number is (571)272-2676. The examiner can normally be reached Monday-Friday 8am-5pm.
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/MATTHEW G MARINI/ Primary Examiner, Art Unit 2853
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