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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 62/873,155 filed July 11, 2019.
Status of Claims
This Office Action is responsive to the claims filed on 10/09/2025. Claims 4, 6, 7, 14, 15, 19, 21-23, 26, and 28 have been amended. Claims 1-3, 8, 11-13, 16-18, and 25 were previously cancelled. Claims 4-7, 9, 10, 14, 15, 19-24, and 26-29 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: apparatus to eliminate interference in claim 4, line 9; device for determining a surface model in claim 4, line 10.
The corresponding structure for the device for determining a surface model defined within the specification is a stereo camera, video processor, lidar unit including a laser and time-of-flight rangefinder, structured light and a camera, (Paragraph [0033]) and any functional equivalents. The corresponding structure for the apparatus to eliminate interference defined within the specification is a high-speed gateable room lighting controlled to be turned off when the proton beam is on, room lighting configured to use specific lighting wavelengths with filters to prevent these specific wavelengths from interfering with dose images (Paragraph [0030], Line 1-4) and any functional equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 7 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prieels (US 20180099154).
Regarding claim 7, Prieels teaches a method of determining a radiation dosage map of a patient exposed to a therapeutic proton beam (Paragraph [0147]; a method for locating the Bragg peak of a hadron beam having an initial beam energy, E0 and being emitted along a beam path to a target spot 40s within a target tissue 40), the method comprising:
positioning the patient in a treatment zone (Paragraph [0084]; Once a patient is positioned such that the target tissue 40 to be treated is located at the approximate position of the isocentre);
providing a therapeutic proton beam to the patient (Paragraph [0084]; controlling one or more of the intensity, I, of the hadron beam… to irradiate target spots 40si,j; Paragraph [0075]; the hadron may be a proton, and the corresponding hadron therapy may be referred to as proton therapy.);
imaging light generated by interaction of the therapeutic proton beam with a skin surface of the patient (Paragraph [0110]; The PG system may comprise a detector 3d configured for detecting a signal generated by a hadron beam 1h upon interaction with the subject of interest) using a camera (Paragraph [0078]; images may be obtained with a hadron radiography system (HRS); Paragraph [0110]; prompt gamma detector 3d, Fig. 7; The prompt gamma detector described in paragraphs [0110]-[0112] is used to measure the position of emitted γ-radiation which is considered to be imaging light using a camera as understood in its broadest reasonable interpretation) to form dose images (Paragraph [0110] and [0112]; hadron beam may travel from the nozzle 12n of the beam delivery system and through a subject of interest to a target spot; The detector 3d of the PG system may detect a signal generated by the PG emitted along the beam path);
and generating a surface model of the patient (Paragraph [0118]; the MR image of the imaging volume, Vp, acquired with the MRI along the beam path from an outer surface 41S of the subject of interest to the target spot 40s; The portions of the outer surface of the patient is considered to be a surface mode as understood in its broadest reasonable interpretation);
registering the dose images to the surface model (Paragraph [0128]; The MR image may be used to identify the position of the outer surface 41S of the subject of interest) and using the dose images with the surface model to derive corrected dose images (Paragraph [0116]; The computation of the position of the Bragg peak within the subject of interest may be performed by simulating the PG emission of a simulated hadron beam. The simulation may then be compared with the measured emission and, in case of discrepancy, be corrected; Paragraph [0132]; controller may then use the signal provided by the PG system and the information from the MR image to compute the actual position, BP1 of the Bragg Peak of the hadron beam… emission of PG of a hadron beam in the traversed tissue may be simulated. The simulation may be compared to the measured signal. In case of a difference, the simulation may be adapted);
registering the corrected dose images to a three-dimensional voxel-based model of the patient (Paragraph [0118]-[0124]; locating the actual position, BP1, of the Bragg peak on the MR image of the imaging volume, Vp, acquired with the MRI along the beam path from an outer surface 41S of the subject of interest to the target spot 40s; Paragraph [0139]; and the controller may be configured to represent, on a same coordinate scale, the MR image obtained from the MRI and the position of the Bragg peak obtained from the PG system.);
determining quantified beam vectors in the three-dimensional voxel-based model of the patient from the corrected dose images (Paragraph [0107]; further improve the efficacy of a PT-MRI apparatus by providing the information required for correcting beam path, Xp, directions of the hadron beams; Paragraph [0127]; The MR image may be used to (at least in part) determine the nature of the tissues m traversed by the hadron beam and to determine the thicknesses Lm of the tissues m traversed by the hadron beam. In some embodiments, then, the MRI may image the plan in which the imaging hadron beam passes; Paragraph [0128]-[0129]; acquire the signal provided by the PG system… tissue traversed by the hadron beam may be selected on the MR image); and
using an absorption model to determine radiation dose at voxels of the three-dimensional voxel-based model of the patient based upon the quantified beam vectors (Paragraph [0134]-[0142]; position of the Bragg peak generally depends on the initial energy E0 of a hadron beam and on a water equivalent path length of the hadron beam. Knowing the position of the Bragg peak and the initial energy E0 of the hadron beam may allow for computing the water equivalent path length WEPL40s corresponding to the water equivalent path length between the outer surface 41S of the subject of interest and the target spot 40s; Paragraph [0148]; The images may permit identifying the position, P0, of a target spot of the target tissue 40 and characterizing the tissues traversed by the hadron beam. A treatment plan system may then compute the initial beam energy, E0, such that the position, BP0, of the Bragg peak corresponds to the position, P0, of the target sport of the target tissue. These operations may be repeated for several target spots 40si,j; Paragraph [0084]-[0089]; The dose, Di, delivered to an iso-energy treatment volume, Vti, may be the sum over the n target spots scanned in said iso-energy treatment volume of the doses, Dij, delivered to each target spot, Di=Σ Dij, for j=1 to n. The total dose, D, delivered to a target tissue 40 may thus be the sum over the p irradiated iso-energy treatment volumes, Vti, of the doses, Di, delivered to each energy treatment volume).
Regarding claim 20, Prieels teaches all of the limitations of claim 7 as noted above.
Prieels further teaches pulses of the therapeutic proton beam are identified by detecting scattered radiation from the therapeutic proton beam (Paragraph [0111]-[0115]; The atomic nuclei typically rapidly return to their ground state by emitting a prompt γ-ray (PG). The emission of PG typically occurs along the beam path, and its intensity may depend on the probability of interaction of a hadron with an atomic nuclei and, therefore, on the energy of the hadron; the prompt gamma ray is detected to identify the beam position).
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.
Claims 4, 5, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Prieels (US 20180099154) in view of Kilby (US 20170252579).
Regarding claim 4, Prieels teaches a system for performing radiation treatment of a patient (Paragraph [0020]-[0026]; a medical apparatus may comprise: [0021] (A) a hadron therapy device; a beam path to a target spot located inside a subject of interest; Paragraph [0075]; the hadron may be a proton, and the corresponding hadron therapy may be referred to as proton therapy) comprising:
a camera (Paragraph [0110] and [0117]; PG system may comprise a detector 3d configured for detecting a signal generated by a hadron beam 1h upon interaction with the subject of interest; prompt gamma detector 3d, Fig. 7) and positioned to capture dose images of the patient exposed to the pulsed proton beam (Paragraph [0110] and [0112]; The detector 3d of the PG system may detect a signal generated by the PG emitted along the beam path; uses the incidence of the detected γ to determine its emission point; The beam path may also cross an outer surface 41S of the subject of interest), the camera configured to image light to capture the dose images (Paragraph [0112]-[0117]; The detector 3d of the PG system may detect a signal generated by the PG emitted along the beam path; a detector 3d of the PG system 3 comprising a collimator 3c, a scintillator 3s, and a photon counting device 3p. The scintillator may comprise a scintillating material which interacts with PG to generate visible photons… A PG, selected by the collimator, may interact with the scintillator. Then, visible photons may be multiplied with the photomultiplier to increase the signal that is acquired with the photon counting device);
a device for determining a surface model of the patient (Paragraph [0128]; The MR image may be used to identify the position of the outer surface 41S of the subject of interest; The portions of the outer surface of the patient is considered to be a surface mode as understood in its broadest reasonable interpretation);
and a video processor (Paragraph [0128] and [0139]; the controller 5) configured to register the dose images to the surface model of the patient (Paragraph [0118]-[0124]; computing an actual position, BP1, of the Bragg peak of said hadron beam, based on the signal acquired by the PG system; and locating the actual position, BP1, of the Bragg peak on the MR image of the imaging volume, Vp, acquired with the MRI along the beam path from an outer surface 41S of the subject of interest to the target spot 40s), and provide corrected dose images (Paragraph [0116]; The computation of the position of the Bragg peak within the subject of interest may be performed by simulating the PG emission of a simulated hadron beam. The simulation may then be compared with the measured emission and, in case of discrepancy, be corrected);
register corrected dose images to a three-dimensional voxel-based model of the patient (Paragraph [0118]-[0124]; locating the actual position, BP1, of the Bragg peak on the MR image of the imaging volume, Vp, acquired with the MRI along the beam path from an outer surface 41S of the subject of interest to the target spot 40s; Paragraph [0139]; and the controller may be configured to represent, on a same coordinate scale, the MR image obtained from the MRI and the position of the Bragg peak obtained from the PG system.),
use the corrected dose images to determine quantified beam vectors within the three-dimensional voxel-based model of the patient (Paragraph [0107]; further improve the efficacy of a PT-MRI apparatus by providing the information required for correcting beam path, Xp, directions of the hadron beams; Paragraph [0127]; The MR image may be used to (at least in part) determine the nature of the tissues m traversed by the hadron beam and to determine the thicknesses Lm of the tissues m traversed by the hadron beam. In some embodiments, then, the MRI may image the plan in which the imaging hadron beam passes), and
apply a beam energy-deposition model to the quantified beam vectors in the voxel-based model of the patient (Paragraph [0134]-[0142]; position of the Bragg peak generally depends on the initial energy E0 of a hadron beam and on a water equivalent path length of the hadron beam. Knowing the position of the Bragg peak and the initial energy E0 of the hadron beam may allow for computing the water equivalent path length WEPL40s corresponding to the water equivalent path length between the outer surface 41S of the subject of interest and the target spot 40s; Paragraph [0148]; The images may permit identifying the position, P0, of a target spot of the target tissue 40 and characterizing the tissues traversed by the hadron beam. A treatment plan system may then compute the initial beam energy, E0, such that the position, BP0, of the Bragg peak corresponds to the position, P0, of the target sport of the target tissue. These operations may be repeated for several target spots 40si,j), and preparing a three-dimensional energy deposition map of beam energy in the patient (Paragraph [0083]; The egg-shaped volumes in FIG. 4B schematically illustrate the volumes of target tissue receiving a therapeutic dose of hadron by exposure of one target spot 40si,j to a beam of initial energy Ek,I; Paragraph [0084]-[0089]; The dose, Di, delivered to an iso-energy treatment volume, Vti, may be the sum over the n target spots scanned in said iso-energy treatment volume of the doses, Dij, delivered to each target spot, Di=Σ Dij, for j=1 to n. The total dose, D, delivered to a target tissue 40 may thus be the sum over the p irradiated iso-energy treatment volumes, Vti, of the doses, Di, delivered to each energy treatment volume).
Prieels does not explicitly teach a beam-on signal indicating when each pulse of a pulsed proton beam is provided by a particle accelerator;
the camera is triggered by the beam-on signal;
Kilby, however, teaches a system for performing radiation treatment of a patient (Paragraph [0001]; a Cerenkov emission detector used in radiation treatment delivery systems) comprising: a video processor configured to receive the dose images of the patient (Paragraph [0033]; processing logic acquires a set of images of optical Cerenkov emission); and a device for determining a surface model of the patient during treatment (Paragraph [0034]; processing logic determines a delivered dose from the set of images; Paragraph [0044]; a 3D patient model is defined), the surface model being updated to show patient movements (Paragraph [0066]; the diagnostic imaging system 605 and the motion detecting system are combined into a single unit; Paragraphs [0087]-[0089]; may detect external patient motion (such as chest movement during respiration)… when motion of the LEDs and/or surface region is detected, it can be determined that the target location 120 has also moved sufficiently to require another diagnostic x-ray image… The Cerenkov emission detector 100 may acquire measurement data indicative of target motion in real-time);
a beam-on signal indicating when each pulse of a pulsed proton beam is provided by a particle accelerator (Paragraph [0057]; pulses of the treatment beam of the LINAC 101… capable of gated acquisition that is synchronized with gated pulses);
the camera is triggered by the beam-on signal (Paragraph [0054] and [0055]; the Cerenkov emission detector 100 may be synchronized with pulses of the treatment beam of the LINAC 101 to capture images between pulses of the treatment beam; The gating and synchronization signal for the detector is considered to be a beam-on signal trigger as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Prieels to have included a beam-on signal indicating when each pulse of a pulsed proton beam is provided by a particle accelerator and further triggered the camera by the beam-on signal as taught by Kilby because it would have increasing the signal-to-noise ratio of the detectors by ensuring the imaging is only captured during times with scattered radiation is collected (Kilby, Paragraph [0057]).
Regarding claim 5, together Prieels and Kilby teach all of the limitations of claim 4 as noted above.
Prieels further teaches the three-dimensional voxel-based model of the patient is generated by a computed X-Ray tomography (CT) system or a nuclear magnetic resonance imaging (MRI) system (Paragraph [0120]; MRI for acquiring a magnetic resonance (MR) image within an imaging volume, Vp, comprising the target spot; Paragraph [0148]; First, a classical treatment plan may be established at a time t0, using a CT scan (and/or an MR image) described above).
Regarding claim 19, together Prieels and Kilby teaches all of the limitations of claim 10 as noted above.
Prieels discloses the invention as claimed and discussed above, but fails to explicitly disclose the camera is an intensified camera.
Kilby further teaches a camera is an intensified camera (Paragraph [0019]; Cerenkov emission detector is an intensified CCD (ICCD); is an electron multiplied ICCD (emICCD) camera).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the camera of Prieels in view of Kilby to have been an intensified camera because it would have further allowed collection and detection of few numbers of photons and thus improved the signal and measurement of the scattered radiation, thereby allowing improved estimation of beam path through the patient volume.
Claims 6, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Prieels in view of Kilby as applied to claims 4 and 5 above, respectively, and further in view of Cami (US 20150077601).
Regarding claims 6, 14, and 15, together Zhang and Kilby teach all of the limitations of claims 4 and 5, respectively, as noted above.
Together Prieels and Kilby do not teach the camera is configured to read out a first frame while photosensors of the camera integrate light for a second frame.
Cami, however, teaches a camera (Abstract) configured to read out a first frame (Paragraphs [0044]-[0046]; Frame 1 Readout Period, Fig. 7B #163) while photosensors of the camera (Paragraphs [0044]-[0046]; image sensor) integrate light for a second frame (Paragraphs [0044]-[0046]; Frame 2 Integration Time; Fig. 7B #165; As demonstrated by the overlap of events 163 and 165, readouts can be in parallel with the next frame integration time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the camera of Prieels in view of Kilby to read out a first frame while photosensors of the camera integrate light for a second frame as it would have been a predictable combination of conventional optical imaging techniques that would maximize the amount of integration time a system can allow without affecting the frame rate of the image sensor. This ability is useful for imaging low-light scenes, where longer integration times may be necessary (Cami, Paragraph [0046]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Prieels as applied to claims 7 above, and further in view of Zhang (US 20160263402).
Regarding claim 9, Prieels teaches all of the limitations of claim 7 as noted above.
Prieels does not explicitly teach generating the surface model of the patient is performed by capturing stereo image pairs of the patient and extracting the surface model from the stereo image pairs.
Zhang, however, teaches a method of determining a radiation dosage map comprising generating the surface model of the patient is performed by capturing stereo image pairs of the patient (Paragraph [0094] and [0157]; light imaged by cameras #166, #168, is recorded as image pairs; stereo camera captures a stereo image) and extracting the surface model from the stereo image pairs (Paragraph [0157]; surface model processor #1860 processes stereo image #1848 to generate the 3D surface model of surface region).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method Prieels to have included the steps of generating the surface model of the patient is performed by capturing stereo image pairs of the patient and extracting the surface model from the stereo image pairs as taught by Zhang because it would improve registration of the 3D model with the detected scattered radiation and thus increase the accuracy of determining which tissues the beam passes through (Zhang, Paragraphs [0171]), and further improve the process of determining the same target tissue in subsequent operations.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Prieels as applied to claims 7 above, and further in view of Veigel (US 20200375661).
Regarding claim 10, Prieels teaches all of the limitations of claim 7 as noted above.
Prieels does not teach generating the surface model of the patient is performed with an infrared lidar.
Prieels, however, teaches generating a surface model (Paragraph [0019]-[0021]; a metric 3D model is obtained from a series of two-dimensional images of the at least one part of the patient) of the patient (Paragraph [0126]; patient, Fig. 2 #3) performed with an infrared lidar (Paragraphs [0020] and [0126]; The three-dimensional image data may be generated (determined) using one or more surface cameras, including infrared, LIDAR; Examiner notes the imaging device is an infrared camera).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Prieels to have generated the surface model of the patient using an infrared lidar as it would have been a predictable substitution of conventional methods for obtaining the image data required for generating 3D models, thus allowing one to determine the surface of the at least a part of the patient (Veigel, Paragraph [0020]) and further more accurately determining the 3D contour of a portion of the patient, thereby improving the accuracy of the surface position where the hadron beam interacts and overall increase accuracy of the energy interactions in the model.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Prieels as applied to claim 7 above, and further in view of Ota (US 20190243010).
Regarding claim 21, Prieels teaches all of the limitations of claim 7 as noted above.
Prieels does not teach the high sensitivity camera is a single-photo avalanche photodiode (SPAD) camera.
Ota, however, teaches a high sensitivity camera that is a single-photo avalanche photodiode (SPAD) camera (Paragraph [0029]; The light detection unit 13 includes a first photodetector 14… and detects the Cherenkov light. Each pixel 14b may be constituted by, for example, a single photon avalanche diode (SPAD)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Zhang in view of Kilby such that the high sensitivity camera is a single-photo avalanche photodiode (SPAD) camera as taught by Ota because it would have been a predictable substitution of high sensitivity cameras, thus allowing one to accurately measure single photons, and further detect time information to when the light is detected (Ota, Paragraph [0029]) thus improving time-of-flight calculations.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Prieels as applied to claim 7 above, and further in view of Kilby (US 20190243010).
Regarding claim 22, Prieels teaches all of the limitations of claim 7 as noted above.
Prieels does not explicitly teach the high sensitivity camera is an intensified camera.
Kilby, however, teaches a camera is an intensified camera (Paragraph [0019]; Cerenkov emission detector is an intensified CCD (ICCD); is an electron multiplied ICCD (emICCD) camera).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the camera of Prieels to have been an intensified camera because it would have further allowed collection and detection of few numbers of photons and thus improved the signal and measurement of the scattered radiation, thereby allowing improved estimation of beam path through the patient volume.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Prieels in view of Kilby as applied to claims 4; and Prieels as applied to claim 7 above, respectively, and further in view of Givehchi (US 20220203134).
Regarding claim 23, together Prieels and Kilby teach all of the limitations of claim 4 as noted above.
It is not clear if together Prieels and Kilby teach the integrated three-dimensional deposition map of the patient is responsive to patient movement during treatment.
Givehchi, however, teaches an integrated three-dimensional deposition map of the patient is responsive to patient movement during treatment (Paragraph [0053]; included in such imaging can be employed to correct target position 805 during radiation therapy phase 503 for more accurate calculation of dose received by non-target tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Prieels in view of Kilby such that the integrated three-dimensional deposition map of the patient is responsive to patient movement during treatment as taught by Givehchi because it would ensure reducing dose received by non-target tissue without imposing overly strict beam-off conditions that result in frequent beam holds during radiation treatment (Givehchi, Paragraph [0053]).
Regarding claim 24, Prieels teach all of the limitations of claim 7 as noted above.
It is not clear if Prieels teaches the determined dose at voxels of the three-dimensional model of the patient is responsive to patient movement during treatment.
Givehchi, however, teaches the determined dose at voxels of the three-dimensional model (Paragraph [0037]; image information associated with each voxel 401 of digital volume 400 is constructed via projection images) of the patient is responsive to patient movement during treatment (Paragraph [0053]; included in such imaging can be employed to correct target position 805 during radiation therapy phase 503 for more accurate calculation of dose received by non-target tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Prieels such that the determined dose at voxels of the three-dimensional model of the patient is responsive to patient movement during treatment as taught by Givehchi because it would ensure reducing dose received by non-target tissue without imposing overly strict beam-off conditions that result in frequent beam holds during radiation treatment (Givehchi, Paragraph [0053]).
Claims 26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Prieels (US 20180099154) in view of Kilby (US 20170252579) and Zhang (US 20160263402).
Regarding claim 26, Prieels teaches a system for performing radiation treatment of a patient (Paragraph [0020]-[0026]; a medical apparatus may comprise: [0021] (A) a hadron therapy device; a beam path to a target spot located inside a subject of interest; Paragraph [0075]; the hadron may be a proton, and the corresponding hadron therapy may be referred to as proton therapy) comprising:
a particle accelerator (Paragraph [0076]; Charged hadrons may be generated from an injection system 10i, and may be accelerated in a particle accelerator 10a) configured to provide a pulsed proton beam (Paragraph [0083]; hadron beam of initial energy, Ek,1, may be directed to a first target spot 40s1,1, during a pre-established delivery time. The hadron beam may then be moved to a second target spot 40s1,2, during a pre-established delivery time. The process may be repeated on a sequence of target spots 40s1,j to scan a first iso-energy treatment volume);
a camera (Paragraph [0110] and [0117]; PG system may comprise a detector 3d configured for detecting a signal generated by a hadron beam 1h upon interaction with the subject of interest; prompt gamma detector 3d, Fig. 7) and positioned to capture dose images of the patient exposed to the pulsed proton beam (Paragraph [0110] and [0112]; The detector 3d of the PG system may detect a signal generated by the PG emitted along the beam path; uses the incidence of the detected γ to determine its emission point; The beam path may also cross an outer surface 41S of the subject of interest), the camera configured to image light to capture the dose images (Paragraph [0112]-[0117]; The detector 3d of the PG system may detect a signal generated by the PG emitted along the beam path; a detector 3d of the PG system 3 comprising a collimator 3c, a scintillator 3s, and a photon counting device 3p. The scintillator may comprise a scintillating material which interacts with PG to generate visible photons… A PG, selected by the collimator, may interact with the scintillator. Then, visible photons may be multiplied with the photomultiplier to increase the signal that is acquired with the photon counting device);
a video processor (Paragraph [0128] and [0139]; the controller 5) configured to receive the dose images of the patient (Paragraph [0118]-[0124]; computing an actual position, BP1, of the Bragg peak of said hadron beam, based on the signal acquired by the PG system; and locating the actual position, BP1, of the Bragg peak on the MR image of the imaging volume, Vp, acquired with the MRI along the beam path from an outer surface 41S of the subject of interest to the target spot 40s) and provide corrected dose images (Paragraph [0116]; The computation of the position of the Bragg peak within the subject of interest may be performed by simulating the PG emission of a simulated hadron beam. The simulation may then be compared with the measured emission and, in case of discrepancy, be corrected);
and a device for determining a surface model of the patient during treatment (Paragraph [0128]; The MR image may be used to identify the position of the outer surface 41S of the subject of interest; The portions of the outer surface of the patient is considered to be a surface mode as understood in its broadest reasonable interpretation);
wherein the pulsed proton beam comprises protons of energy less than 450 MeV (Paragraphs [0076] and [0110]; hadron beam may be a treatment hadron beam having an initial beam energy E0, for example, between 0 and 230 MeV.).
Prieels does not explicitly teach a beam-on signal indicating when each pulse of the pulsed proton beam is being provided by the particle accelerator, the beam-on signal provided by a radiation detector;
the camera is triggered by the beam-on signal;
a device configured to eliminate interference of room lighting with the dose images;
and the surface model being updated to show patient movements.
Kilby, however, teaches a system for performing radiation treatment of a patient (Paragraph [0001]; a Cerenkov emission detector used in radiation treatment delivery systems) comprising: a video processor configured to receive the dose images of the patient (Paragraph [0033]; processing logic acquires a set of images of optical Cerenkov emission); and a device for determining a surface model of the patient during treatment (Paragraph [0034]; processing logic determines a delivered dose from the set of images; Paragraph [0044]; a 3D patient model is defined), the surface model being updated to show patient movements (Paragraph [0066]; the diagnostic imaging system 605 and the motion detecting system are combined into a single unit; Paragraphs [0087]-[0089]; may detect external patient motion (such as chest movement during respiration)… when motion of the LEDs and/or surface region is detected, it can be determined that the target location 120 has also moved sufficiently to require another diagnostic x-ray image… The Cerenkov emission detector 100 may acquire measurement data indicative of target motion in real-time);
a beam-on signal indicating when each pulse of a pulsed proton beam is provided by a particle accelerator (Paragraph [0057]; pulses of the treatment beam of the LINAC 101… capable of gated acquisition that is synchronized with gated pulses);
the camera is triggered by the beam-on signal (Paragraph [0054] and [0055]; the Cerenkov emission detector 100 may be synchronized with pulses of the treatment beam of the LINAC 101 to capture images between pulses of the treatment beam; The gating and synchronization signal for the detector is considered to be a beam-on signal trigger as understood in its broadest reasonable interpretation);
and the surface model being updated to show patient movements (Paragraph [0087]; the motion detecting device 814 acquires measurement data indicative of target motion in real-time; Paragraph [0088]; directly track a surface region (e.g., skin surface 116) of patient 125,).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Prieels to have included a beam-on signal indicating when each pulse of a pulsed proton beam is provided by a particle accelerator and further triggered the camera by the beam-on signal as taught by Kilby because it would have increasing the signal-to-noise ratio of the detectors by ensuring the imaging is only captured during times with scattered radiation is collected (Kilby, Paragraph [0057]).
It further would have been obvious to have further modified the system of Prieels such that the surface model is updated to show patient movements as taught by Kilby because it would allow determining that the target location has also moved sufficiently to require another diagnostic x-ray or MRI image to precisely determine the location of the target location (Kilby, Paragraph [0088]).
The system of Prieels in view of Kilby does not explicitly teach a device configured to eliminate interference of room lighting with the dose images.
Zhang, however, teaches a system for performing radiation treatment (Paragraph [0043]; system for providing radiotherapy, Fig. 1 #100) of a patient (Paragraph [0044]; a subject, Fig. 1 #102) comprising:
an apparatus configured to eliminate interference of room lighting with the dose images (Paragraphs [0080], [0081], and [0088]-[0090]; Timing interfaces #120 are provided for determining intervals of beam transmission, and for controlling pulsed room lighting; pulses room lighting such that the shutter interval does not overlap pulses #208 of the room lighting).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Prieels in view of Kilby to have included a device configured to eliminate interference of room lighting with the dose images as taught by Zhang because it would improve detection of light produced during detection of scattered radiation by reducing noise from light from the room lights when the dose from the particle beam is applied (Zhang, Paragraph [0096]).
Regarding claim 28, together Prieels, Kilby, and Zhang teach all of the limitations of claim 26 as noted above.
Prieels further teaches the video processor is further configured to register the surface model of the patient to a three-dimensional voxel-based model of the patient (Paragraph [0118]-[0124]; locating the actual position, BP1, of the Bragg peak on the MR image of the imaging volume, Vp, acquired with the MRI along the beam path from an outer surface 41S of the subject of interest to the target spot 40s; Paragraph [0139]; and the controller may be configured to represent, on a same coordinate scale, the MR image obtained from the MRI and the position of the Bragg peak obtained from the PG system.),
to use the corrected dose images to determine beam vectors within the three-dimensional voxel-based model of the patient (Paragraph [0107]; further improve the efficacy of a PT-MRI apparatus by providing the information required for correcting beam path, Xp, directions of the hadron beams; Paragraph [0127]; The MR image may be used to (at least in part) determine the nature of the tissues m traversed by the hadron beam and to determine the thicknesses Lm of the tissues m traversed by the hadron beam. In some embodiments, then, the MRI may image the plan in which the imaging hadron beam passes),
to apply a beam energy-deposition model to the voxel-based model of the patient (Paragraph [0134]-[0142]; position of the Bragg peak generally depends on the initial energy E0 of a hadron beam and on a water equivalent path length of the hadron beam. Knowing the position of the Bragg peak and the initial energy E0 of the hadron beam may allow for computing the water equivalent path length WEPL40s corresponding to the water equivalent path length between the outer surface 41S of the subject of interest and the target spot 40s; Paragraph [0148]; The images may permit identifying the position, P0, of a target spot of the target tissue 40 and characterizing the tissues traversed by the hadron beam. A treatment plan system may then compute the initial beam energy, E0, such that the position, BP0, of the Bragg peak corresponds to the position, P0, of the target sport of the target tissue. These operations may be repeated for several target spots 40si,j), and
to prepare an integrated three-dimensional energy deposition map of beam energy in the patient based on the corrected dose images and beam vectors Paragraph [0083]; The egg-shaped volumes in FIG. 4B schematically illustrate the volumes of target tissue receiving a therapeutic dose of hadron by exposure of one target spot 40si,j to a beam of initial energy Ek,I; Paragraph [0084]-[0089]; The dose, Di, delivered to an iso-energy treatment volume, Vti, may be the sum over the n target spots scanned in said iso-energy treatment volume of the doses, Dij, delivered to each target spot, Di=Σ Dij, for j=1 to n. The total dose, D, delivered to a target tissue 40 may thus be the sum over the p irradiated iso-energy treatment volumes, Vti, of the doses, Di, delivered to each energy treatment volume).
Regarding claim 29, together Prieels, Kilby, and Zhang teach all of the limitations of claim 28 as noted above.
Prieels further teaches the three-dimensional voxel-based model of the patient is generated by a computed X-Ray tomography (CT) system or a nuclear magnetic resonance imaging (MRI) system (Paragraph [0120]; MRI for acquiring a magnetic resonance (MR) image within an imaging volume, Vp, comprising the target spot; Paragraph [0148]; First, a classical treatment plan may be established at a time t0, using a CT scan (and/or an MR image) described above).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Prieels in view of Kilby as applied to claim 4 above, and further in view of Sossong (US 20150246244).
Regarding claim 27, together Prieels and Kilby teach all of the limitations of claim 4 as noted above.
Prieels and Kilby do not teach a scintillator positioned in the proton beam, the scintillator being imaged to provide to provide a scintillator reference point along the proton beam and where the beam vectors in the patient are determined in part using the scintillator reference point.
Sossong, however, teaches a scintillator positioned in the proton beam (Paragraph [0027]; tomography scanner unit 120 can include a charged particle tomography detector 120a positioned about the patient to receive the emitted charged particle beam; Paragraph [0028]; tracking arrays can include one-dimensional strip-type scintillation fiber), the scintillator being imaged to provide to provide a scintillator reference point along the proton beam (Paragraph [0028]; The sensor arrays can detect the momentum, incident point coordinates) and where the beam vectors in the patient are determined in part using the scintillator reference point (Paragraph [0028]; incident angles for the incident and exit charged particles; Paragraph [0037]; measure positions and directions of incident charged particles that penetrate the first set of position sensitive detectors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Prieels in view of Kilby to have included a scintillator positioned in the proton beam, the scintillator being imaged to provide to provide a scintillator reference point along the proton beam and where the beam vectors in the patient are determined in part using the scintillator reference point as taught by Sossong because it would have improved method of determining the particle path by including determining, based on the measured energy loss, a spatial distribution of the charged particles that enter the volume of interest and are stopped inside the volume of interest without penetrating through the volume of interest. Furthermore the particle detection method can include using the spatial distribution of charged particles that enter the volume of interest and are stopped inside the volume of interest to reconstruct the spatial distribution of materials in the inspection volume (Sossong, Paragraph [0034]).
Response to Arguments
Claim Interpretation under – 35 U.S.C. § 112(f)
Applicant’s arguments with respect to claim interpretation of the term “video processor” under 35 USC 112(f) have been fully considered and are persuasive. The interpretation of “video processor” is understood to be a processor and is interpreted in its broadest reasonable interpretation.
Examiner maintains claim interpretations under 35 U.S.C. § 112(f) for the terms “apparatus to eliminate interference” and “device for determining a surface model”.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to the claims and withdraws all objections to the claims.
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Regarding claims 7, 4, and 26, Applicant argues the cited reference of Prieels does not teach a “imaging light generated by interaction of the therapeutic proton beam… using a camera…”. Specifically Applicant points to the prompt-γ detection system described by Prieels as being a camera which images light. Applicant appears to argue that the term light refers to only visible radiation. Examiner respectfully disagrees. The camera detecting only visible light is not explicitly recited in the claims. Examiner would like to point out the term light is broadly recited and any electromagnetic radiation including γ-radiation generated by a hadron beam upon interaction with the subject of interest, as described in Prieels Paragraph [0110], is understood to read on the claimed limitation of “light generated by interaction of the therapeutic proton beam” as understood in its broadest reasonable interpretation. Furthermore, the prompt-γ system described by Prieels in at least Paragraphs [0110]-[0113], is used to image the position of the emitted γ-ray and is considered to be a camera as understood in its broadest reasonable interpretation. Examiner would further like to point out that there is no limitations that the light generated by the interaction of the proton beam and the patient is the light collected by the camera, just merely that the camera images this light. As such the prompt-γ used for imaging the generated γ-rays by indirectly measuring photons created by interaction of the γ-rays with a scintillator plate and detected by a light detector is further considered to read on the claimed limitations as understood in its broadest reasonable interpretation. For these reason, claim 7 remains anticipated by Prieels and rejection of claims 7 and 20 under 35 USC 102(a)(1) are maintained; and rejection of claims 4 and 26 under 35 USC 103 are maintained.
Rejections of claims 5, 6, 14, 15, 9, 10, 23, 24, 28, 29, and 27 under 35 USC 103 are maintained for similar reasons stated above.
Regarding claims 19, 21, and 22, Applicant argues the SPAD camera of Ota and the intensified camera of Kilby are respectively not capable of operating with the system of Prieels. Examiner respectfully disagrees. The reference of Prieels describes the prompt-γ detection system being a scintillator plate and a photon counting device for detecting visible photons. SPAD and intensified cameras are well understood components used for detecting low or single photon count signals as produced by the γ-ray interacting with the scintillator, and would have been obvious substitutes for the imaging device of Prieels. One would have been motivated for modifying the detector of Prieels to have included a SPAD as it would have further allowed measuring time information and thus improving time-of-flight calculations for the radiation detection. One would have been motivated for modifying the detector of Prieels to have included an intensified camera because it would be sensitive to low photon count and thus improved signal for beam path estimation. For these reasons, rejections of claims 19, 21, and 22 under 35 USC 103 are maintained.
All rejections under 35 USC 102 and 103 are maintained.
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.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/10/26
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