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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 7, 2025 has been entered.
The Examiner acknowledges the amendments to claims 1, 7, 38 and 43, and the cancellation of claims 2, 4, 6 and 19-30. Claims 1, 3, 5, 7-18 and 31-43 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed July 7, 2025, with respect to the previous claim objection of claim 38 have been fully considered and are persuasive. The previous claim objection of claim 38 has been withdrawn.
Regarding the previous rejection of the claims under 35 USC 112, while Applicant’s amendments have overcome some of the previous rejections of the claims under 35 USC 112(a) and 112(b), 112(b) issues remain within the claims. With respect to claim 8, it is unclear which claim claim 8 is dependent upon. See 35 USC 112(b) rejections below.
Regarding the previous rejection of the claims under 35 USC 103, Applicant’s arguments, see remarks, filed July 7, 2025, with respect to the rejection(s) of claim(s) 1-3, 5-18 and 31-43 under 35 USC 103 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 Therefore, the rejection has been withdrawn.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 applicant’s arguments and amendments to the claims. See 35 USC 103 rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 is written to be dependent upon claim 2, which is a canceled claim. Therefore, it is unclear as to what claim claim 8 is dependent upon. For examination purposes, it will be interpreted that claim 8 is dependent upon claim 1.
Dependent claims are similarly rejected as their base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 3, 5, 7-18 and 31-43 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites "the patient support device and the at least one sensor located on the patient support device are located between an upper surface of a patient table and a patient supported on the patient table" [emphasis added] at lines 6-7. A patient is required to be physically a part of the system, therefore the scope of claim 1 encompasses a human organism. As such, this claim is rejected under 35 USC 101. The Examiner suggests amending claim 1 to recite “the patient support device and the at least one sensor located on the patient support device are configured to be located between an upper surface of a patient table and a patient supported on the patient table”. Additionally, claim 43 recites “the mouldable vacuum cushion is mouldable to an outline shape of the patient located on the mouldable vacuum cushion to enable the skin-electrode interfaces to be repeatedly positioned in the same position with respect to the patient” [emphasis added] at lines 4-11. As recited in the claim, a patient is required to be physically a part of the system, therefore the scope of claim 43 encompasses a human organism. As such, this claim is rejected under 35 USC 101. The Examiner suggests amending claim 43 to recite “the mouldable vacuum cushion is configured to be mouldable to an outline shape of the patient located on the mouldable vacuum cushion to enable the skin-electrode interfaces to be repeatedly positioned in the same position with respect to the patient”.
Dependent claims are similarly rejected as their base claim.
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.
Claim(s) 1, 3, 5, 8-9, 15-18 & 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2012/0310053, hereinafter referenced as "Henning" in view of US Patent Application Publication 2012/0289759, hereinafter referenced as "Lynch".
With respect to claim 1, Henning teaches a system for monitoring a body motion state of a patient (i.e., a system that measures signals that relate to breathing activity and/or cardiac activity of a patient) (see Henning, par 0012), comprising:
a patient support device, including at least one sensor for measuring biometric data of a patient (i.e., a contact device comprising electrical potential sensors arranged in a 2D matrix, for measuring cardiac activity or breathing activity of a patient) (see Henning, par 0048-0050, figs. 1-2), the at least one sensor located on the patient support device (see Henning, par 0012-0014, 0021, 0048-0050, figs. 1-2), wherein the patient support device and the at least one sensor located on the patient support device are located between an upper surface of a patient table and a patient supported on the patient table (see Henning, figs. 1-2, par 0048-0050);
and a processor (i.e., a computer) (see Henning, par 0024, 0046-0047, 0052), operatively coupled to an active medical device and the at least one sensor of the patient support device (i.e., a computer program loaded into a computer is used to control a medical apparatus such as an imaging medical apparatus or a radiation therapy apparatus based upon signals received from electrical potential sensors) (see Henning, par 0015-0017, 0046-0047, 0052), the processor containing processor-executable instructions configured to perform operations comprising:
generating a control signal to control an operation of the active medical device to perform imaging and/or treatment of an internal anatomy of the patient based on the biometric data measured by the at least one sensor (see Henning, abstract, par 0002, 0011-0012, 0015-0017, 0025, 0046-0047), wherein the biometric data indicates a body motion state of the patient comprising at least one of cardiac activity and respiratory activity of the patient (see Henning, par 0021-0026, 0048-0058, 0067-0069, figs. 1-2).
Henning fails to teach the patient support device comprises a mouldable vacuum cushion comprising a flexible bag of gas-impermeable material.
Lynch teaches an interlocking vacuum cushion made of a flexible urethane or nylon casing containing small spheres made of polystyrene (see Lynch, par 0006, fig. 1). The vacuum cushion is moldable to the body of a patient and gas impermeable due to being made of materials such as nylon reinforced urethane (see Lynch, par 0037). In use, the vacuum cushion is used to position or immobilize a patient for radiation therapy treatments or medical imaging (see Lynch, par 0037, fig. 1).
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 system of Henning such that it comprises a patient support device that comprises a mouldable vacuum cushion comprising a flexible bag because vacuum cushions permit the positioning or immobilization of a patient for radiation therapy treatments or medical imaging (see Lynch, par 0037, fig. 1), which would improve the system of Henning by enabling more accurate biometric data/electrical potential sensor data to be obtained as the patient is positioned/immobilized in the vacuum cushion.
With respect to claim 3, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the active medical device comprises one or more of a magnetic resonance imaging (MRI) device, an X-ray device, a computed tomography (CT) device, an ultrasonography device, a radiotherapy device, a shockwave generator, a positron emission tomography (PET) device, an ElectroCardioGraphic imaging (ECGi) device, and a high-intensity focused ultrasound device (see Henning, par 0016-0017, 0034, 0042-0043, 0047, 0064-0066, figs. 1 & 4).
With respect to claim 5, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the patient support device comprises at least one non-conductive material that does not generate image artifacts during an X-Ray scan and/or an MRI scan (i.e., the electrical potential sensors of the contact device is made from non-magnetic metal for use in a magnetic resonance apparatus) (see Henning, par 0065).
With respect to claim 8, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the at least one sensor of the patient support device comprises at least two skin-electrode interfaces for measuring electronic potentials from the body of the patient (see Henning, par 0018, 0049-0051, fig. 3).
With respect to claim 9, Henning as modified by Lynch teaches the system of claim 8, and Henning further teaches the at least one sensor of the patient support device comprises an electrode array with more than two skin-electrode interfaces for measuring multiple electronic potentials across the body of the patient (see Henning, par 0048, figs. 1 & 2).
With respect to claim 15, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the biometric data comprises time-variable bio-impedance data derived from measured electrical potentials that indicate at least one of cardiac activity and respiration activity of the patient (see Henning, par 0021-0026, 0048-0058, 0067-0069, figs. 1-2).
With respect to claim 16, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the active medical device comprises a diagnostic imaging device, and the control signal generated by the processor is configured to enable or disable a diagnostic imaging procedure by the diagnostic imaging device (i.e., the computer program loaded into the computer is used to control the medical apparatus such as an imaging medical apparatus based upon signals received from electrical potential sensors) (see Henning, par 0015-0017, 0046-0047, 0052).
With respect to claim 17, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the active medical device comprises a radiotherapy device, and the control signal generated by the processor is configured to enable or disable a delivery of a radiation beam from the radiotherapy device (i.e., the computer program loaded into the computer is used to control the medical apparatus such a radiation therapy apparatus based upon signals received from electrical potential sensors) (see Henning, par 0015-0017, 0046-0047, 0052).
With respect to claim 18, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the processor transmits the control signal to the active medical device via at least one of an optical communication channel using optical fibers or a wireless communication channel (see Henning, par 0047).
With respect to claim 43, Henning teaches a system for monitoring a body motion state of a patient (i.e., a system that measures signals that relate to breathing activity and/or cardiac activity of a patient) (see Henning, par 0012), comprising: a patient support device including at least one sensor for measuring biometric data of a patient (i.e., a contact device comprising electrical potential sensors arranged in a 2D matrix, for measuring cardiac activity or breathing activity of a patient) (see Henning, par 0048-0050, figs. 1-2), the at least one sensor located on the patient support device (see Henning, par 0012-0014, 0021, 0048-0050, figs. 1-2), wherein the at least one sensor comprises at least two skin- electrode interfaces for measuring electronic potentials from the body of the patient (see Henning, par 0018, 0049-0051, figs. 1-3), and a processor (i.e., a computer) (see Henning, par 0024, 0046-0047, 0052), operatively coupled to an active medical device and the at least one sensor of the patient support device (i.e., a computer program loaded into a computer is used to control a medical apparatus such as an imaging medical apparatus or a radiation therapy apparatus based upon signals received from electrical potential sensors) (see Henning, par 0015-0017, 0046-0047, 0052), the processor containing processor-executable instructions configured to perform operations comprising: generating a control signal to control an operation of the active medical device to perform imaging and/or treatment of an internal anatomy of the patient based on the biometric data measured by the at least one sensor (see Henning, abstract, par 0002, 0011-0012, 0015-0017, 0025, 0046-0047), wherein the biometric data indicates a body motion state of the patient (see Henning, par 0021-0026, 0048-0058, 0067-0069, figs. 1-2).
Henning fails to teach the patient support device comprises a mouldable vacuum cushion comprising a flexible bag of gas-impermeable material, and further that the mouldable vacuum cushion is mouldable to an outline shape of the patient located on the mouldable vacuum cushion to enable the skin-electrode interfaces to be repeatedly positioned in the same position with respect to the patient.
Lynch teaches an interlocking vacuum cushion made of a flexible urethane or nylon casing containing small spheres made of polystyrene (see Lynch, par 0006, fig. 1). The vacuum cushion is moldable to the body of a patient and gas impermeable due to being made of materials such as nylon reinforced urethane (see Lynch, par 0037). In use, the vacuum cushion is used to position or immobilize a patient for radiation therapy treatments or medical imaging (see Lynch, par 0037, fig. 1).
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 system of Henning such that it comprises a patient support device that comprises a mouldable vacuum cushion comprising a flexible bag, and further that the mouldable vacuum cushion is mouldable to an outline shape of the patient located on the mouldable vacuum cushion to enable the skin-electrode interfaces to be repeatedly positioned in the same position with respect to the patient because vacuum cushions permit the positioning or immobilization of a patient for radiation therapy treatments or medical imaging (see Lynch, par 0037, fig. 1), which would improve the system of Henning by enabling more accurate biometric data/electrical potential sensor data to be obtained as the patient is positioned/immobilized in the vacuum cushion.
Claim(s) 7 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch as applied to claim 1 above, and further in view of US Patent Application Publication 20150282768 --as previously cited--, hereinafter referenced as "Luna".
With respect to claim 7, Henning as modified by Lynch teaches the system of claim 1, but fails to teach the at least one sensor of the patient support device comprises one or more of an accelerometer, a gyroscope, an inclinometer to provide physics motion parameters, and a photoplethysmogram sensor to provide physiological motion parameters as part of the biometric data of the patient.
Luna teaches systems and methods for the physiological signal determination of bioimpedance signals, wherein motion sensors, such as accelerometers and gyroscopic sensors are used to identify motion of a subject so that the motion-related artifacts can be reduced from the signals obtained from electrodes placed on the subject to measure bioimpedance (see Luna, par 0045, 0049).
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 system of Henning as modified by Lynch such that the at least one sensor of the patient support device comprises one or more of an accelerometer, a gyroscope, and inclinometer, and a photoplethysmogram sensor to provide physiological motion parameters as part of the biometric data of the patient, because that would enable the system of Henning as modified by Lynch to determine and therefore remove motion-related signals (i.e., artifacts) in the signals obtained by the electrodes measuring the patient/subject's bioimpedance (see Luna, par 0045, 0049).
With respect to claim 14, Henning as modified by Lynch teaches the system of claim 1, but fails to teach the biometric data comprises bio-impedance data derived from measured electrical potentials, and the processor is configured with processor-executable instructions to perform operations further comprising: analyzing a galvanic skin response of the patient based on the bio-impedance data to determine a stress level of the patient.
Luna teaches determining other information of a subject via sensor data such as stress-related levels, and a pain/stress analyzer that measures the skin conductance of a subject, wherein an increased skin conductance indicates that a user may be under stress or pain (see Luna, par 0050, 0116).
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 system of Henning as modified by Lynch such that the processor is configured with processor-executable instructions to perform analyzing a galvanic skin response of the patient based on the bio-impedance data to determine a stress level of the patient because that would enable the system to determine whether or not a subject is undergoing any stress or pain to determine whether the subject is experiencing an abnormal physiological state (see Luna, par 0016).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning in view of Lynch as applied to claim 8 above, and further in view of US Patent Application Publication 20160074674 previously cited--, hereinafter referenced as "Kohli".
With respect to claim 10, Henning as modified by Lynch teaches the system of claim 8, but fails to teach that each of the at least two skin-electrode interfaces comprises an electrode selected from a wet-contact gel-based Ag/AgC1 electrode, a dry-contact MEMS and metal plate electrode, a thin-film insulated metal plate electrode, a flexible electrode and a stretchable electrode.
Kohli teaches combined respiration and cardiac gating for radiotherapy using electrical impedance technology, wherein bioimpedance is measured non-invasively in real time by applying Ag-AgCl electrodes to a subject to apply a potential difference between the electrodes to measure a resulting electrical current passed between the electrodes (see Kohli, par 0084-0085, figs. 1A-1B).
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 system of Henning as modified by Lynch such that the at least two skin-electrode interfaces comprises an electrode selected from a wet-contact gel-based Ag/AgCI electrode, a dry-contact MEMS and metal plate electrode, a thin-film insulated metal plate electrode, a flexible electrode and a stretchable electrode because it is known in the art that biompedance signals of a patient can be measured non-invasively using Ag-AgCl electrodes (see Kohli, par 0084-0085, figs. 1A-1B).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch as applied to claim 8 above, and further in view of US Patent Application Publication 20130281814 --as previously cited--, hereinafter referenced as "Tilt".
With respect to claim 11, Henning as modified by Lynch teaches the system of claim 8, but fails to teach the at least one sensor comprises a sensor unit coupled to the electrodes of the at least two skin-electrode interfaces by respective interconnections, wherein each of the interconnections is located inside of the patient support device and comprises a flexible and stretchable printed circuit board (PCB), or a flexible and stretchable cable, or a printed conductive signal trace that is located on an interior surface of a cover of the patient support device.
Tilt teaches a sensor array system that includes a plurality of electrodes that are affixed to a substrate layer that comprises a stretchable and conformable material that is configured to allow spaced apart and interconnected portions stretch and conform with the substrate layer when it is attached to a patient (see Tilt, abstract, 0031, 0033-0034, 0036, figs. 1 & 2).
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 system of Henning as modified by Lynch such that the at least one sensor comprises a sensor unit coupled to the electrodes of the at least two skin-electrode interfaces by respective interconnections, wherein each of the interconnections is located inside of the patient support device and comprises a flexible and stretchable printed circuit board (PCB), or a flexible and stretchable cable, or a printed conductive signal trace that is located on an interior surface of a cover of the patient support device because that would enable the maintenance of electrical contact between the electrodes of the sensor array system and a subject/patient (see Tilt, abstract, 0031, 0033- 0034, 0036, 0056, figs. 1, 2 & 18).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch as applied to claim 8 above, and further in view of US Patent 10,727,010 --as previously cited--, hereinafter referenced as "Henke".
With respect to claim 12, Henning as modified by Lynch teaches the system of claim 8, but fails to teach the processor is configured with processor-executable instructions to perform operations further comprising: generating control signals to individually activate and de-activate selected electrodes of the at least two skin-electrode interfaces.
Henke teaches a power switching circuit configured to trigger activation of contact electrodes based on a first logic state signal or deactivation based on a second logic state signal wherein a controller generates the logic state signals to control the power switching circuit (see Henke, Col. 47, lines 32-59).
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 system of Henning as modified by Lynch such that the processor is configured to generate control signals to individually activate and de-activate selected electrodes of the at least two skin-electrode interfaces because that would enable the electrodes to be selectively activated based upon input from the controller/processor (see Henke, Col. 47, lines 32-59).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch as applied to claim 1 above, and further in view of US Patent Application Publication 20160015290 --as previously cited--, hereinafter referenced as "Kim".
With respect to claim 13, Henning as modified by Lynch teaches the system of claim 1, but fails to teach the biometric data comprises bio-impedance data derived from measured electrical potentials, and the processor is configured with processor-executable instructions to perform operations further comprising: determining an estimated body composition of the patient based on the bio-impedance data.
Kim teaches a method and apparatus for measuring bioimpedance wherein the bioimpedance measured by the apparatus is used to estimate a body fat content of the subject/user to provide the user with the body fat estimation (see Kim, par 0049).
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 system of Henning as modified by Lynch such that the process is configured to determine an estimated body composition of the patient based on the bio-impedance date because that would enable the determination of an additional biometric that can be provided to the subject/patient (see Kim, par 0049).
Claim(s) 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch as applied to claim 1 above, and further in view of US Patent Application Publication 2018/0318606 --as previously cited--, hereinafter referenced as "Robinson".
With respect to claim 31, Henning as modified by Lynch teaches the system of claim 1, and Henning further teaches the at least one sensor comprises a sensor array between the patient and the patient table (see Henning, par 0012-0014, 0021, 0048-0050, figs. 1 & 2), wherein the system is configured to: non-invasively measure biometric data of the patient using the sensor array of the patient support device to identify cardiac and respiratory body motion states of the patient (see Henning, par 0002, 0011-0012, 0015-0017, 0021-0026, 0048-0058, 0067-0069, figs. 1-2); and trigger a non-invasive imaging device to obtain images of the patient's heart anatomy based on defined cardiac and respiratory motion states of the patient (i.e., a computer program loaded into a computer is used to control a medical apparatus such as an imaging medical apparatus based upon signals received from electrical potential sensors) (see Henning, par 0015-0017, 0046-0047, 0052).
Henning as modified by Lynch fails to teach the system is configured to generate a co-registered map of electrical activity and anatomy of the heart at the defined cardiac and respiratory body motion states, and determine one or more target treatment regions of the patient's heart anatomy using the co-registered map, wherein the processor generates the control signal to control the active medical device to direct a non-invasive therapy to the one or more target regions at the defined cardiac and respiratory body motion states.
Robinson teaches a non-invasive imaging and treatment system for cardiac arrhythmias wherein a treatment planning system (i.e., TPS) co-registers PET/CT or MRI images to define the arrhythmia target on the primary CT image data (see Robinson, par 0052-0053).
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 system of Henning as modified by Lynch such that it generates a co-registered map of electrical activity and anatomy of the heart at the defined cardiac and respiratory body motion states and uses the co-registered map to determine one or more target treatment regions of the patient's heart anatomy because that would permit the system to define arrhythmia targets in obtained images prior to treatment (see Robinson, par 0052-0053).
With respect to claim 32, Henning as modified by Lynch and Robinson teaches the system of claim 31, and Henning as modified by Lynch and Robinson further teaches the non-invasive therapy comprises one of more of stereotactic radiosurgery, stereotactic body radiotherapy, stereotactic ablative radiotherapy, fractionated radiotherapy, hypofractionated radiotherapy, and high-intensity focused ultrasound (see Robinson, par 0052-0053).
With respect to claim 33, Henning as modified by Lynch and Robinson teaches the system of claim 31, and Henning further teaches the sensor array comprises skin-electrode interfaces configured to measure electrical potentials at a plurality of locations on the patient (see Henning, par 0022-0023, 0048-0051).
With respect to claim 34, Henning as modified by Lynch and Robinson teaches the system of claim 31, and Henning as modified by Lynch and Robinson further teaches the system uses biometric data measured using the sensor array to identify an arrythmia (see Robinson, par 0053).
With respect to claim 35, Henning as modified by Lynch and Robinson teaches the system of claim 34. Henning as modified by Lynch and Robinson teaches the arrythmia is identified using biometric data and a machine learning process (i.e. generating co-registered images to define arrythmia targets for non-invasive treatment using a treatment planning system) (see Robinson, par 0051-0053).
With respect to claim 36, Henning as modified by Lynch and Robinson teaches the system of claim 31, and Henning as modified by Lynch and Robinson further teaches the patient support device including the sensor array is configured to support the patient during the non-invasive therapy (i.e., the contact device containing electrical potential sensors is configured to support a patient during radiation therapy) (see Henning, par 0015-0017, 0046-0050, 0052), and the system is further configured to:
non-invasively measure biometric data of the patient using the sensor array of the patient support device to identify cardiac and respiratory body motion states of the patient during the non-invasive therapy (see Henning, par 0021-0026, 0048-0058, 0067-0069, figs. 1-2), wherein the processor generates the control signal to trigger a non-invasive therapy device to direct the non-invasive therapy to the one or more target regions at the defined cardiac and respiratory body motion states (see Henning, par 0015-0017, 0046-0047, 0052, see Robinson, par 0051-0053), wherein the defined cardiac and respiratory body motion states are the same cardiac and respiratory motion states at which the images of the patient's heart anatomy are obtained by the non-invasive imaging device (see Robinson, par 0051-0053).
Claim(s) 37, 39-40 & 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch as applied to claim 1 above, and further in view of US Patent Application Publication 2020/0179722 --as previously cited--, hereinafter referenced as "Packer".
With respect to claim 37, Henning as modified by Lynch teaches the system of claim 1, wherein the at least one sensor comprises integrated sensors of the patient support device (see Henning, par 0048-0050, figs. 1-2), wherein the system is configured to: receive biometric data from the integrated sensors of the patient support device and medical image data from a medical imaging device (see Henning, par 0010, 0016, 0027, 0030-0031, 0061, 0063-0064) and synchronize the biometric data with the medical image data (see Henning, par 0010, 0016, 0027, 0030-0031, 0061, 0063-0064).
Henning as modified by Lynch fails to teach the system is configured to generate at least one artificial signal that represents a predicted periodically reproducible biological motion state of the body of the patient using the synchronized biometric data and medical imaging data.
Packer teaches a motion sensing algorithm that uses machine learning to input multiple cardiac cycles where an electrocardiogram is used as a reference and changes from one cardiac cycle through the other are used to reject a particular cardiac cycle or to correct the labeled moving part to differentiate it from noise or artifact, which enables input and real-time tracking of a radiation beam source to allow effective energy delivery to the targeted tissue (i.e., the motion sensing algorithm using biometric data representative of cardiac motion and imaging data to generate an electrocardiogram signal that is used to predict whether a particular cardiac signal represents a noise or an artifact) (see Packer, par 0052-0053).
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 system of Henning as modified by Lynch such that it is configured to generate at least one artificial signal that represents a predicted periodically reproducible biological motion state (i.e., a cardiac and/or respiratory motion state) of the body of the patient using the synchronized biometric data and medical imaging data, because that would improve the system of Henning as modified by Lynch by enabling the system to identify noise or artifacts that can be used to effectively control the delivery of the radiation delivery apparatus to the targeted tissue (see Packer, par 0052-0053).
With respect to claim 39, Henning as modified by Lynch and Packer teaches the system of claim 37, and Henning as modified by Lynch and Packer further teaches the artificial signal is generated using a machine learning process (see Packer, par 0052-0053).
With respect to claim 40, Henning as modified by Lynch and Packer teaches the system of claim 39, and Henning as modified by Lynch and Packer further teaches the machine learning process is an empirical learned model that combines features from a set of features with respective learned weights (see Packer, par 0053, 0058).
With respect to claim 42, Henning as modified by Lynch and Packer teaches the system of claim 37, and Henning as modified by Lynch and Packer further teaches the system is further configured to: control an operation of a medical device based on the artificial signal when a confidence level of the predicted periodically reproducible biological motion state is above a threshold level (i.e., a photon beam is controlled based upon a motion sensing algorithm that determines whether a signal is a cardiac cycle signal or a noise/artifact, therefore there is a threshold employed that determines whether the signal is representative of noise or a cardiac cycle motion signal) (see Packer, par 0053).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch and Packer as applied to claim 37 above, and further in view of US Patent Application Publication 2020/0086078--as previously cited--, hereinafter referenced as "Poltorak".
With respect to claim 38, Henning as modified by Lynch and Packer teaches the system of claim 37, but fails to teach the predicted periodically reproducible biological motion state is identified based on a principal component analysis.
Poltorak teaches a system and method of improving sleep that uses principal component analysis to analyze obtained brain waves (see Poltorak, par 0731-0732, 1060, 1067).
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 system of Henning as modified by Lynch and Packer such that it uses principal component analysis to predict periodically reproducible motion state of a subject because that would permit data mining the biometric data representative of a subject's periodically reproducible motion state (i.e., cardiac and/or respiratory motion state) to obtain valuable data that can be used to accurately predict a subject's periodically reproducible motion state (see Poltorak, par 1060, 1067).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henning as modified by Lynch and Packer as applied to claim 39 above, and further in view of US Patent Application Publication 2017/0116387 --as previously cited--, hereinafter referenced as "El-Zehiry".
With respect to claim 41, Henning as modified by Lynch and Packer teaches the system of claim 39, but fails to teach the machine learning process comprises a regression function trained using image-based boosting ridge regression.
El-Zehiry teaches a biopsy-free detection and staging of cancer using a virtual staging score that uses a classifier trained using an image-based boosting ridge regression method (see El-Zehiry, par 0100-0101).
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 system of Henning as modified by Lynch and Packer such that the machine learning process comprises a regression function trained using image-based boosting ridge regression because that would ensure that the image data is accurately representative of a subject's anatomy since image-based boosting ridge regression encapsulates non-linear relationships between image features, image context information, and anatomical object parameters (see El-Zehiry, par 0101).
Conclusion
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791