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 .
Specification
The abstract of the disclosure is objected to because it is not presented on a separate sheet, i.e. the WIPO format of the abstract is object to. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alder et al. (US 2008/0177280) in view of Uber et al. (WO 2016138449).
Adler et al. discloses:
1.
A device for monitoring motion during medical imaging or during radiation therapy, comprising: an input unit; a processing unit; and an output unit;
E.G. via the disclosed medical device and systems for treatment of moving tissue in order to improve radiosurgical treatment of tissues [0008], wherein said system further includes a means to acquire a physiological signal, a model processor 62/a plan processor module 66, and a user interface 64 {[0096]-[0097] & (Fig 5A)}.
wherein the input unit is configured to receive measured from a patient;
E.G. via the disclosed EKG sensor coupled to the patient to provide a signal ([0096]-[0097]).
wherein the processing unit is configured to: determine a readiness potential, RP, based on the received, and provide a control signal via the output unit, if it predicted that the patient motion is likely to happen;
E.G. via the disclosed model processor 62 utilizing the acquired signal to time the acquisition of 3-D volumes, i.e. images, which further communicates with the plan processor module 66 in order to determine dosages in the target tissue [0096].
and wherein the control signal is usable for controlling an apparatus to perform a function to reduce motion artefacts during the medical imaging or to assure radiation dose is delivered according to a planned dose map during the radiation therapy.
E.G. via the disclosed plan 44 that prepares for treatment of the target tissue base off the use of the 3-D volumes which can more accurately identify exposure of radiation in response to physiological cycles so as to generate a desired dosage within the tissue ([0093] & [0117]).
Adler et al. discloses medical device and systems for treatment of moving tissue in order to improve radiosurgical treatment of tissues including a means to acquire a physiological signal measured for a patient, a model processor/a plan processor module, and a user interface, wherein said signal is used to time the acquisition of 3-D volumes, i.e. images, which is further communicated with the plan processor module in order to determine dosages in the target tissue {[0096]-[0097] & (Fig 5A)}. However, Adler fails to disclose that said acquired physiological signal is an electroencephalogram, EEG, signal.
Uber et al. teaches that it is known to use at least one measuring insert, in-scan phantom, for use during an image procedure, wherein said insert makes a measurement related to brain activity, EEG, motion and/or the level of radiation that the patient is subjected to ([0037] & [0070]) and to further be used by a radiation dose estimation system based on the data detected by the phantom, such as motion ([0089]-[0090]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the medical device and systems as taught by Alder et al. with the use of measuring brain activity to determine motion during an imaging process as taught by Uber et al. since such a modification would provide the predictable results pertaining to efficiently determining and improve radiation doses-received by a patient based on imaging procedure (Uber, [0087]-[0088] & [0096]).
2.
The device according to claim 1, wherein the processing unit is configured to apply a pre-trained machine learning algorithm to derive the RP from the EEG signal.
E.G. via the disclosed model processor module 62 receiving the physiological signals and communicating to plan processor module 66 [Adler, 0096].
AND
E.G. via the disclosed correction algorithm (Uber, [0070]-[0071).
3.
The device according to claim 1, wherein the input unit is configured to receive at least one physiological signal different from the EEG signal;
and wherein the processing unit is configured to determine whether patient motion is likely to happen based on the received EEG signal and the at least one physiological signal.
E.G. via the disclosed model processor 62 utilizing the acquired signal, including an EKG signal, to time the acquisition of 3-D volumes, i.e. images, which further communicates with the plan processor module 66 in order to determine dosages in the target tissue [Adler, 0096].
AND
E.G. via the disclosed measuring insert capable of measuring motion, patient heart activity and patient weight during the imaging procedure (Uber, [0037]).
4.
The device according to claim 1, wherein the control signal comprises a signal configured to control an informing device to inform the patient that patient movement is likely to happen such that the patient can proactively react.
E.G. via the disclosed user interface 64 which communicates with a plan processor module 66 (Alder, [0096]-[0097]).
5.
The device according to claim 1, wherein the control signal comprises a signal configured to control a robot and/or an actuator to provide a counter-measure such that a counter force is applied to compensate for the patient motion.
E.G. via the disclosed radiosurgery system 10 {Alder, [0044] & (Fig 1)}.
And
E.G. via the disclosed phantoms designed to experience force and stress from movement (Uber, [0066]).
6.
The device according to claim 1, wherein the actuator is located in one or more of the followings; in a head-fixation holder; in a body-fixation holder; in a head coil; and in a mattress.
E.G. (Uber, [0066] & [0069]).
7.
The device according to claim 1, wherein the control signal comprises a signal configured to control an imaging device to modify the imaging acquisition process in order to account for the patient motion that is likely to happen.
E.G. (Alder [0096]-[0097]).
8.
The device according to claim 1, wherein the control signal comprises a signal configured to control a therapy device to modify the therapy process in order to account the patient motion that is likely to happen;
and wherein the modification of the therapy process comprises one of: ceasing the therapy process and redirecting therapy delivery.
E.G. (Alder, [0093] & [0117]).
9.
The device according to claim 1, wherein the control signal comprises a signal configured to activate a motion detector to detect whether the patient is moving.
E.G. (Uber, [0037]).
10.
A system comprising: a monitoring system configured to measure an electroencephalogram, EEG, signal of a patient;
E.G. via the disclosed medical device and systems for treatment of moving tissue in order to improve radiosurgical treatment of tissues, wherein said system further includes a means to acquire a physiological signal (Alder, [0096]-[0097]).
AND
E.G. via the disclosed at least one measuring insert, in-scan phantom, for use during an image procedure, wherein said insert makes a measurement related to brain activity, EEG, motion and/or the level of radiation that the patient is subjected to (Uber, [0037] & [0070]).
11.
The system according to claim 10, further comprising one or more of: an informing the patient that patient motion is likely to happen, in response to the control signal;
E.G. via the disclosed user interface 64 which communicates with a plan processor module 66 (Alder, [0096]-[0097]).
a robot and/or an actuator to provide a counter-measure such that a counter force is applied to compensate for the patient motion in response to the control signal;
E.G. via the disclosed radiosurgery system 10 {Alder, [0044] & (Fig 1)}.
And
E.G. via the disclosed phantoms designed to experience force and stress from movement (Uber, [0066]).
and a motion detector configured to be activated to detect whether the patient is moving, in response to the control signal.
E.G. (Uber, [0037]).
12.
The system according to the claim 10, wherein the system is a medical imaging system that comprising an imaging device configured to acquire image data of the patient;
and wherein the imaging device is configured to modify a medical imaging acquisition process in order to account for the patient motion that is likely to happen, in response to the control signal.
E.G. (Alder, [0092].
And
E.G. (Uber, [0066])
13.
The system according to the claim 10, wherein the system is radiation therapy system comprising a therapy device configured to deliver ionizing radiation;
and wherein the therapy device is configured to modify a therapy process in order to account for the patient motion that is likely to happen, in response to the control signal.
E.G. (Alder, [0093] & [0117])
14.
A computer-implemented method for monitoring motion during medical imaging or during radiation therapy, comprising: receiving an electroencephalogram, EEG, signal measured from a patient;
E.G. via the disclosed medical device and systems for treatment of moving tissue in order to improve radiosurgical treatment of tissues [0008], wherein said system further includes a means to acquire a physiological signal, a model processor 62/a plan processor module 66, and a user interface 64 {Alder, [0096]-[0097] & (Fig 5A)}.
And
(Uber, [0037] & [0070]).
determining a readiness potential, RP, based on the received EEG signal; determining whether patient motion is likely to happen based on the received EEG signal;
E.G. via the disclosed model processor 62 utilizing the acquired signal to time the acquisition of 3-D volumes, i.e. images, which further communicates with the plan processor module 66 in order to determine dosages in the target tissue [Alder, 0096].
AND
E.G. via the disclosed at least one measuring insert, in-scan phantom, for use during an image procedure, wherein said insert makes a measurement related to brain activity, EEG, motion and/or the level of radiation that the patient is subjected to (Uber, [0037] & [0070]).
providing a control signal via the output unit, if it predicted that the patient motion is likely to happen;
E.G. via the disclosed model processor 62 utilizing the acquired signal to time the acquisition of 3-D volumes, i.e. images, which further communicates with the plan processor module 66 in order to determine dosages in the target tissue [Alder, 0096].
wherein the control signal is usable for controlling an apparatus to perform a function to reduce motion artefacts during the medical imaging or to assure radiation dose is delivered according to a planned dose map during the radiation therapy.
E.G. via the disclosed plan 44 that prepares for treatment of the target tissue base off the use of the 3-D volumes which can more accurately identify exposure of radiation in response to physiological cycles so as to generate a desired dosage within the tissue (Alder, [0093] & [0117]).
15.
A computer program product comprising instructions stored on a non-transitory computer readable medium which, when the program is executed by at least one processing unit, cause the at least one processing unit to carry out the steps of method according to claim 14.
(Alder, [0096]-[0097]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796