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 .
Response to Arguments
Applicant's arguments filed 27 October 2025 have been fully considered but they are not persuasive.
With respect to 103 rejections, applicant argues that Kumar does not disclose “instructions” as claimed instead, Kumar appears to merely refer to a collimator shaping a beam in different wats during a treatment (pages 8-9). Moreover, applicant further argues that Kumar does not disclose generation of a second beam gating control signal, based on a detected second physiological motion component, since claimed gating functionality provides motion-responsive control that adapts to detected physiological motion components in real-time, whereas Kumar’s on/off operation is predetermined by treatment plan segments and does not respond dynamically to detected physiological motion (page 9).
However, the examiner respectfully disagrees.
With regards to interpretation of “instructions,” the examiner has found in [0076]-[0077] of instant application’s publication that signal comprising instructions for gating, stop gating, and various configuration of multi-leaf collimator. Thus, controlling the collimator will have instructions to either turn on, off, change collimator configuration which all would result in different time0varyign shapes as claimed.
With regards to “time-varying instruction,” the examiner notes that a physician can give an instruction to change/gate/modify the beam, and send control signal to change the setting of the collimator to result in control signal to either turn on or off the gating.
Accordingly, Kumar clearly discloses delivering time-varying shape of radiation beam ([0033]), including the case, wherein the radiation beam is delivered in successive segments, where each segment corresponds to a certain collimator configuration of beam shape with between segments, collimator is changing while the radiation beam is off. This is clearly reads on the limitation of first shape om a first time period and a second shape in a second time period. Moreover, the examiner notes that the claims does not positively recite first shape is different from second shape. Moreover, the examiner submits that Kumar discloses a control unit implemented in a processor for executing control program comprising the control routines by controlling the modifiable parameters of the radiation source, the collimator and the patient table ([0034]), thus control program would have instruction to carry out the functions set forth above.
With respect to real-time gating control argument, the examiner submits that claim does not recite any “real-time” gating and specification of instant application does not support real-time gating. Thus, Kumar discloses gating control as claimed, and the claim does not limit gating to occur only in real-time as applicant asserts.
With regards to argument that generation of a second beam gating control signal based on a detected second physiological motion component, the examiner submits that the examiner cited “Cmaps” for disclosing independent gating signals due to two different physiological periodic motions ([0032]), and did not cite “Kumar” for the limitation. The examiner cited “Kumar” for “time-varying instructions to collimate the treatment beam to be a first shape in a fist time period and a second shape in a second time period.”
Therefore, rejection is proper and maintained for the reasons set forth above.
Applicant also asserts that four different references were used to reject the independent claims raising serious concerns about hindsight bias (page 10), and argues that only justification of combining four separate references is conclusory statement based on analogous field of endeavor in radiotherapy and cardiac/respiratory gating systems, without providing explanation of why one would combine radiotherapy, a bioimpedance monitoring system for cardiac and respiratory function, cardiac gating for radiation therapy and radiation therapy multi-leaf collimator configuration (page 11).
However, the examiner respectfully disagrees.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
With four references, the examiner crafted rejection based on “Clayton” for disclosing most of the structural limitations of a radiation source, motion detector, a controller for beam shaping control signal based on first and second physiological motion component. The examiner incorporated “Kohli” for teaching a single sensor to detect two physiological components. In addition, the examiner cited “Camps” for cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph) and generating a first beam shaping control signal component and a separate second beam gating control signal component (beam-gating and beam-tracking [0023]). Lastly, Kumar was reference to disclose “time-varying” instructions to have “time-varying instructions to collimate the treatment beam to be a first shape in a fist time period and a second shape in a second time period.” The examiner provided clear teaching and motivation to combine/incorporate each reference, and does not conclude obviousness with hindsight reasoning. The examiner notes that the combination of references are not bodily incorporation or combination of general invention, rather all of the references are clearly in the same field of endeavor in incorporating teachings of monitoring physiological signals, and using the physiological signals to modify/control the collimator and turn on and off to result in “gating” of the beam based on physiological signals.
Therefore, rejection is proper and maintained.
With regards to dependent claims 23-33, 35-44, and 46, the applicant submits same argument for independent claim.
The examiner respectfully disagrees and maintained the rejection for the reasons set forth above for independent claims.
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.
Claims 22-26, 28-31, 34-38, 40-42, and 45-46 rejected under 35 U.S.C. 103 as being unpatentable over “Clayton et al.,” US 2018/0280734 (hereinafter Clayton), “Kohli et al.,” US 2016/0074674 (hereinafter Kohli), and “CAMPS et al.,” US 2022/0386987 (hereinafter CAMPS, provisional 62/935,279 has same disclosure filed on 11/14/2019), and “Kumar et al.,” US 2019/0388708 (hereinafter Kumar).
Regarding to claim 22, Clayton teaches a radiotherapy device comprising:
a radiation source configured to generate a treatment beam for irradiating a subject (energy source, a target for interacting with the particle beam to generate treatment radiation [0050]) ;
a motion detector, the motion detector configurable to detect a motion of the subject, the motion comprising a first physiological motion component and a second physiological motion component (a patient movement monitor include a camera a physiological cycle of the patient, a breathing and cardiac movement [0058]); and
a controller communicatively coupled to the radiation source and the motion detector, wherein the controller is configured to generate a beam shaping control signal based on the first physiological motion component and to generate a beam gating control signal based on the second physiological motion component (processing unit generate one or more control signals to operate the collimator in correspondence with the determined phase, and generate control signals to gate a delivery of the beam based on the determined phases [0058]).
Clayton does not explicitly disclose a motion detector detecting the motion comprising first and second motion components representing first and a different second physiological cycle and a first beam shaping control signal component and a separate second beam gating control signal component as amended.
However, in the analogous field of endeavor in cardiac and respiratory gating of radiotherapy, Kohli teaches using a single sensor or device to monitor both respiratory and cardiac functions, and first physiological motion component representing a first physiological cycle and a second physiological motion component representing a different second physiological cycle, wherein the first and second motion components are received from the motion detector (single sensor detecting both cardiac and respiratory [0078]; bioimpedance monitor generates a bioimpedance signal which is processed by processing circuit to yield a respiration signal 21A and a cardia signal 21B [0081]).
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 target as taught by Clayton to incorporate teaching of Kohli, since single sensor monitoring both cardiac and respiratory motions was well known in the art as taught by Kohli. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing a single sensor for detecting both cardiac and respiratory cyclic signals, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide non-invasive monitoring of two different physiological cyclic motions using a single sensor ([0078]), and there was reasonable expectation of success.
Clayton and Kohli do not further teach a first beam shaping control signal component and a separate second beam gating control signal component, as well as latest amended limitation filed on 08 July 2025, of “wherein the beam gating control signal comprises time-varying instructions to gate the treatment beam during a third time period and not to gate the treatment beam during a fourth time period.”
However, in the analogous field of endeavor in cardiac phase gating system for radiation therapy, Camps teaches that cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph) and generating a first beam shaping control signal component and a separate second beam gating control signal component (beam-gating and beam-tracking [0023]).
Moreover, Camps discloses beam gating controller set an on/off switch to enable or gate the emitting system based on the gating signal ([0067] and [0115]).
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 target as taught by Clayton to incorporate teaching of Camps, since separate gating signals was well known in the art as taught by Camps. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing separate gating control signal for cardiac and respiratory motion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide independent gating signals due to two different physiological periodic motions ([0032]), and there was reasonable expectation of success.
With regards to amended limitation, Clayton, Kohli, and Camps do not explicitly disclose wherein the beam shaping control signal comprises time-varying instructions to collimate the treatment beam to cause the treatment beam to have a first shape in a first time period and to have a second shape in a second time period, and wherein the beam gating control signal comprises time-varying instructions to gate the treatment beam during a third time period and not to gate the treatment beam during a forth time period.
However, in the analogous field of endeavor in radiation therapy system and method, Kumar teaches during delivery of radiation therapy, using a multi-leaf collimator ([0032]), wherein the beam shaping control signal comprises time-varying instructions (time-varying shape [0033]) to collimate the treatment beam to cause the treatment beam to have a first shape in a first time period and to have a second shape in a second time period (time-varying shape of beam delivered treatment is delivered in successive segments, where each segment corresponds to a certain collimator configuration or beam shape [0033], in between two segments, the collimator configuration may be changed from first segment configuration to second segment configuration, during this period, the radiation beam may be turned off [0033]).
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 target as taught by Clayton to incorporate teaching of Kumar, as both Clayton and Kumar are directed to controlling beam shape using multi-lead collimator, and since time-varying beam shape controlled by multi-leaf collimator was well known in the art as taught by Kumar. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing time-varying controlling of beam shape using multi-leaf collimator, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide continuous change of collimator configuration in accordance with the segments ([0033]) and there was reasonable expectation of success.
Regarding to claims 23-26, and 31, Clayton, Kohli, Camps, and Kumar together teach all limitations of claim 22 as discussed above.
Clayton further teaches following limitations:
Of claim 23, wherein the first physiological motion component comprises a first pseudo-periodic component (movement of a chest, a breathing [0058]).
Of claim 24, wherein the first physiological motion component comprises a respiratory motion (movement of a chest, a breathing [0058]).
Of claim 25, wherein the second physiological motion component comprises a second pseudo-periodic component (cardiac movement [0058]).
Of claim 26, wherein the second physiological motion component comprises a cardiac motion (cardiac movement [0058]).
Of claim 31, wherein the motion detector comprises an MR imaging apparatus (imaging device MRI [0058]).
Regarding to claim 28, Clayton, Kohli, and Camps together teach all limitations of claims 22 as discussed above.
Kohli further teaches Of claim 28, wherein the motion detector comprises a detector configured to detect both the first physiological motion component and the second physiological motion component (single sensor detecting both cardiac and respiratory [0078]; bioimpedance monitor generates a bioimpedance signal which is processed by processing circuit to yield a respiration signal 21A and a cardia signal 21B [0081]).
Regarding to claims 29-30, Clayton, Kohli, and Camps together teach all limitations of claim 22 as discussed above.
Of claim 29, wherein: the radiotherapy device comprises a collimator communicatively coupled to the controller; the controller is configured to transmit the beam shaping control signal to the collimator; and the collimator is configured to shape the treatment beam based on the beam shaping control signal (processing unit generate one or more control signals to operate the collimator in correspondence with the determined phase [0058]).
Of claim 30, wherein: the controller is configured to transmit the beam gating control signal to the radiation source; and the radiation source is configured to gate the treatment beam based on the beam (gating control signal generate control signals to gate a delivery of the beam based on the determined phases [0058]).
With regards to first and second control signal components, the examiner submits that Camps discloses first and second control signal components since Camps teaches that cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph).
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 target as taught by Clayton to incorporate teaching of Camps, since separate gating signals was well known in the art as taught by Thomas. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing separate gating control signal for cardiac and respiratory motion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide independent gating signals due to two different physiological periodic motions ([0032]), and there was reasonable expectation of success.
Regarding to claim 34, Clayton teaches a computer-implemented method for generating control signals for a radiotherapy device (processing unit executes treatment plan stored in a non-transitory medium, to operate components of the medical device [0056]), the computer-implemented method comprising:
detecting a motion of a subject, the motion comprising a first physiological motion component and a second physiological motion component (images of a camera determines the phase of breathing and cardiac movement [0058]);
generating a beam shaping control signal based on the first physiological motion component; and generating a beam gating control signal based on the second physiological motion component (generate control signals to operate collimator with determined phases and gate a delivery of the beam on the determined phases [0058]).
Clayton does not explicitly disclose a motion detector detecting the motion comprising first and second motion components representing first and a different second physiological cycle and a first beam shaping control signal component and a separate second beam gating control signal component as amended.
However, in the analogous field of endeavor in cardiac and respiratory gating of radiotherapy, Kohli teaches using a single sensor or device to monitor both respiratory and cardiac functions, and first physiological motion component representing a first physiological cycle and a second physiological motion component representing a different second physiological cycle, wherein the first and second motion components are received from the motion detector (single sensor detecting both cardiac and respiratory [0078]; bioimpedance monitor generates a bioimpedance signal which is processed by processing circuit to yield a respiration signal 21A and a cardia signal 21B [0081]).
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 target as taught by Clayton to incorporate teaching of Kohli, since single sensor monitoring both cardiac and respiratory motions was well known in the art as taught by Kohli. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing a single sensor for detecting both cardiac and respiratory cyclic signals, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide non-invasive monitoring of two different physiological cyclic motions using a single sensor ([0078]), and there was reasonable expectation of success.
Clayton and Kohli do not further teach a first beam shaping control signal component and a separate second beam gating control signal component, as well as latest amended limitation filed on 08 July 2025, of “wherein the beam gating control signal comprises time-varying instructions to gate the treatment beam during a third time period and not to gate the treatment beam during a fourth time period.”
However, in the analogous field of endeavor in cardiac phase gating system for radiation therapy, Camps teaches that cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph) and generating a first beam shaping control signal component and a separate second beam gating control signal component (beam-gating and beam-tracking [0023]).
Moreover, Camps discloses beam gating controller set an on/off switch to enable or gate the emitting system based on the gating signal ([0067] and [0115]).
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 target as taught by Clayton to incorporate teaching of Camps, since separate gating signals was well known in the art as taught by Camps. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing separate gating control signal for cardiac and respiratory motion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide independent gating signals due to two different physiological periodic motions ([0032]), and there was reasonable expectation of success.
With regards to amended limitation, Clayton, Kohli, and Camps do not explicitly disclose wherein the beam shaping control signal comprises time-varying instructions to collimate the treatment beam to cause the treatment beam to have a first shape in a first time period and to have a second shape in a second time period, and wherein the beam gating control signal comprises time-varying instructions to gate the treatment beam during a third time period and not to gate the treatment beam during a forth time period.
However, in the analogous field of endeavor in radiation therapy system and method, Kumar teaches during delivery of radiation therapy, using a multi-leaf collimator ([0032]), wherein the beam shaping control signal comprises time-varying instructions (time-varying shape [0033]) to collimate the treatment beam to cause the treatment beam to have a first shape in a first time period and to have a second shape in a second time period (time-varying shape of beam delivered treatment is delivered in successive segments, where each segment corresponds to a certain collimator configuration or beam shape [0033], in between two segments, the collimator configuration may be changed from first segment configuration to second segment configuration, during this period, the radiation beam may be turned off [0033]).
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 target as taught by Clayton to incorporate teaching of Kumar, as both Clayton and Kumar are directed to controlling beam shape using multi-lead collimator, and since time-varying beam shape controlled by multi-leaf collimator was well known in the art as taught by Kumar. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing time-varying controlling of beam shape using multi-leaf collimator, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide continuous change of collimator configuration in accordance with the segments ([0033]) and there was reasonable expectation of success.
Regarding to claims 35-38, and 42, Clayton, Kohli, Camps, and Kumar together teach all limitations of claim 34 as discussed above.
Clayton further teaches following limitations:
Of claim 35, wherein the first physiological motion component comprises a first pseudo-periodic component (movement of a chest, a breathing [0058]).
Of claim 36 wherein the first physiological motion component comprises a respiratory motion (movement of a chest, a breathing [0058]).
Of claim 37, wherein the second physiological motion component comprises a second pseudo-periodic component (Cardiac movement [0058]).
Of claim 38, wherein the second physiological motion component comprises a cardiac motion (Cardiac movement [0058]).
Of claim 42, wherein the detecting the motion of the subject is performed using an MR imaging apparatus (imaging device MRI in place of camera tracking [0058]).
Regarding to claim 40, Clayton, Kohli, Camps, and Kumar together teach all limitations of claims 34 as discussed above.
Kohli further teaches Of claim 40, wherein the motion detector comprises a detector configured to detect both the first physiological motion component and the second physiological motion component (single sensor detecting both cardiac and respiratory [0078]; bioimpedance monitor generates a bioimpedance signal which is processed by processing circuit to yield a respiration signal 21A and a cardia signal 21B [0081]).
Regarding to claim 41, Clayton, Kohli, Camps, and Kumar together teach all limitations of claim 34 as discussed above.
Clayton further teaches following limitations:
Of claim 41, further comprising: transmitting the beam shaping control signal to a collimator; and transmitting the beam gating control signal to a radiation source (processing unit generate one or more control signals to operate the collimator in correspondence with the determined phase [0058], gating control signal generate control signals to gate a delivery of the beam based on the determined phases [0058]).
Clayton does not further teach first beam shaping control signal component and separate second beam gating control signal component.
However, in the analogous field of endeavor in cardiac phase gating system for radiation therapy, Camps teaches that cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph) and generating a first beam shaping control signal component and a separate second beam gating control signal component (beam-gating and beam-tracking [0023]).
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 target as taught by Clayton to incorporate teaching of Camps, since separate gating signals was well known in the art as taught by Thomas. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing separate gating control signal for cardiac and respiratory motion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide independent gating signals due to two different physiological periodic motions ([0032]), and there was reasonable expectation of success.
Regarding to claim 45, Clayton teaches a non-transitory computer-readable medium comprising computer-executable instructions which, when executed by a processor, cause the processor to perform operations, the operations comprising:
detecting a motion of a subject, the motion comprising a first physiological motion component and a second physiological motion component (images of a camera determines the phase of breathing and cardiac movement [0058]);
generating a beam shaping control signal based on the first physiological motion component; and generating a beam gating control signal based on the second physiological motion component (generate control signals to operate collimator with determined phases and gate a delivery of the beam on the determined phases [0058]).
Clayton does not explicitly disclose a motion detector detecting the motion comprising first and second motion components representing first and a different second physiological cycle and a first beam shaping control signal component and a separate second beam gating control signal component as amended.
However, in the analogous field of endeavor in cardiac and respiratory gating of radiotherapy, Kohli teaches using a single sensor or device to monitor both respiratory and cardiac functions, and first physiological motion component representing a first physiological cycle and a second physiological motion component representing a different second physiological cycle, wherein the first and second motion components are received from the motion detector (single sensor detecting both cardiac and respiratory [0078]; bioimpedance monitor generates a bioimpedance signal which is processed by processing circuit to yield a respiration signal 21A and a cardia signal 21B [0081]).
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 target as taught by Clayton to incorporate teaching of Kohli, since single sensor monitoring both cardiac and respiratory motions was well known in the art as taught by Kohli. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing a single sensor for detecting both cardiac and respiratory cyclic signals, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide non-invasive monitoring of two different physiological cyclic motions using a single sensor ([0078]), and there was reasonable expectation of success.
Clayton and Kohli do not further teach a first beam shaping control signal component and a separate second beam gating control signal component, as well as latest amended limitation filed on 08 July 2025, of “wherein the beam gating control signal comprises time-varying instructions to gate the treatment beam during a third time period and not to gate the treatment beam during a fourth time period.”
However, in the analogous field of endeavor in cardiac phase gating system for radiation therapy, Camps teaches that cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph) and generating a first beam shaping control signal component and a separate second beam gating control signal component (beam-gating and beam-tracking [0023]).
Moreover, Camps discloses beam gating controller set an on/off switch to enable or gate the emitting system based on the gating signal ([0067] and [0115]).
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 target as taught by Clayton to incorporate teaching of Camps, since separate gating signals was well known in the art as taught by Camps. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing separate gating control signal for cardiac and respiratory motion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide independent gating signals due to two different physiological periodic motions ([0032]), and there was reasonable expectation of success.
With regards to amended limitation, Clayton, Kohli, and Camps do not explicitly disclose wherein the beam shaping control signal comprises time-varying instructions to collimate the treatment beam to cause the treatment beam to have a first shape in a first time period and to have a second shape in a second time period, and wherein the beam gating control signal comprises time-varying instructions to gate the treatment beam during a third time period and not to gate the treatment beam during a forth time period.
However, in the analogous field of endeavor in radiation therapy system and method, Kumar teaches during delivery of radiation therapy, using a multi-leaf collimator ([0032]), wherein the beam shaping control signal comprises time-varying instructions (time-varying shape [0033]) to collimate the treatment beam to cause the treatment beam to have a first shape in a first time period and to have a second shape in a second time period (time-varying shape of beam delivered treatment is delivered in successive segments, where each segment corresponds to a certain collimator configuration or beam shape [0033], in between two segments, the collimator configuration may be changed from first segment configuration to second segment configuration, during this period, the radiation beam may be turned off [0033]).
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 target as taught by Clayton to incorporate teaching of Kumar, as both Clayton and Kumar are directed to controlling beam shape using multi-lead collimator, and since time-varying beam shape controlled by multi-leaf collimator was well known in the art as taught by Kumar. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing time-varying controlling of beam shape using multi-leaf collimator, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide continuous change of collimator configuration in accordance with the segments ([0033]) and there was reasonable expectation of success.
Regarding to claim 46, Clayton, Kohli, Camps, and Kumar together teach all limitations of claim 45 as discussed above.
Clayton further teaches the operations further comprising:
transmitting the beam shaping control signal to a collimator (generate control signals to operate collimator with determined phases [0058]); and
transmitting the beam gating control signal to a radiation source (gate a delivery of the beam on the determined; delivery of the beam and energy source synchronized with a physiological cycle [0058]).
Clayton does not further teach first beam shaping control signal component and separate second beam gating control signal component.
However, in the analogous field of endeavor in cardiac phase gating system for radiation therapy, Camps teaches that cardiac motion generates a cardiac gating signal while a separate respiratory gating signal is provided by a separate device ([0031]-[0032] and [0114]-[0115]; 62/935,279 has page 8 second paragraph) and generating a first beam shaping control signal component and a separate second beam gating control signal component (beam-gating and beam-tracking [0023]).
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 target as taught by Clayton to incorporate teaching of Camps, since separate gating signals was well known in the art as taught by Thomas. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, implementing separate gating control signal for cardiac and respiratory motion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide independent gating signals due to two different physiological periodic motions ([0032]), and there was reasonable expectation of success.
Claim(s) 27, 33, 39, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over “Clayton et al.,” US 2018/0280734 (hereinafter Clayton), “Kohli et al.,” US 2016/0074674 (hereinafter Kohli), and “CAMPS et al.,” US 2022/0386987 (hereinafter CAMPS, provisional 62/935,279 has same disclosure filed on 11/14/2019), and “Kumar et al.,” US 2019/0388708 (hereinafter Kumar) as applied to claims 22 and 34 above, and further in view of “Thomas et al.,” US 2021/0370097 (hereinafter Thomas).
Regarding to claims 27, 33, 39, and 44, Clayton, Kohli, Camps and Kumar together teach all limitations of claims 22 and 34 as discussed above.
Clayton does not teach limitations of claims 27, 33, 39, and 44.
However, in the analogous field of endeavor in radiotherapy, Thomas teaches radiation treatment for target organs including heart ([0023]), and tracking periodic motion of the patient using a first detector (ECG [0025]) and a second detector (respiration detector [0182]).
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 target as taught by Clayton to incorporate teaching of Thomas, since cardiac radiation treatment was well known in the art as taught by Thomas. One of ordinary skill in the art could have combined the elements as claimed by Clayton with no change in their respective functions, using its radiation treatment device to treat cardiac tissues, and use two detectors for monitoring cardiac and respiratory movements, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide improved treatment fidelity and minimize the radiation dose outside the target volume of heart due to cardiac motion and respiratory motion ([0157]), and there was reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798