DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/13/2026 has been entered.
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 03/16/2026. Claims 4, 6, 7, 14, 15, 23, 26, and 27 have been amended. Claims 1-3, 8, 11-13, 16-18, and 25 were previously cancelled. Claims 30 and 31 are newly presented. Claims 4-7, 9, 10, 14, 15, 19-24, and 26-31 are presently pending in this application.
Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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: device for determining a surface model in claim 4, line 8; and device configured to eliminate interference in claim 26, line 11.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15, line 2 recites the limitation "the additional light". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is indefinite because it is unclear if this “additional light” is the same “additional light” that is already recited in claim 6, line 2, and that claim 15 further depends on claim 6; OR the same “additional light” that is already recited in claim 14, line 2 and claim 15 further depends on claim 14; OR is a newly recited limitation.
Claim 30, line 1 recites the limitation "the visible light". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear whether this “visible light” refers to the light recited in claim 4, line 5 and whether it is a further limitation of this light to be within the visible spectrum; OR if this light can be any wavelength as understood by claim 4. For the purpose of examination, this is understood to mean the light is within the visible spectrum; OR this light can be any wavelength as understood by claim 4.
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, 7, 9, 20, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hale (US 20160332000 A1) in view of Prieels (US 20180099154).
Regarding claim 4, Hale teaches a system for performing radiation treatment of a patient (Paragraph [0007]; provided a radiation dosage monitoring system for determining internal radiation dosages received by a patient undergoing radiation treatment) comprising:
a beam-on signal (Paragraph [0043]; suitable timing can be achieved by utilizing the activation signal for activating the radiation beam as a trigger for activating the image detector) indicating when each pulse of a pulsed proton beam (Paragraph [0041]; the patient is irradiated by a radiation beam; Paragraph [0008]; Charged particles, such as electrons, positrons, protons, or alpha particles; fast-moving charged particles release Cherenkov radiation after entering such tissue) is provided by a particle accelerator (Paragraph [0029]; treatment apparatus 16 such as a linear accelerator for applying radiotherapy; Fig. 1);
a camera (Paragraph [0029]; a stereoscopic camera system 10, Fig. 1) triggered by the beam-on signal (Paragraph [0043]; suitable timing can be achieved by utilizing the activation signal for activating the radiation beam as a trigger for activating the image detector) and positioned to capture dose images of the patient exposed to the pulsed proton beam (Paragraph [0034]; in addition to obtaining images of a patient and generating a model of the surface of a patient being monitored, in this embodiment, the stereoscopic camera 10 also obtains images of Cherenkov radiation emitted from a patient by virtue of radiation from the treatment apparatus 16 entering the patient's body), the camera configured to image light to capture the dose images (Paragraph [0035]; records the cumulative levels of Cherenkov radiation emitted from portions of a patient being monitored. This can provide an indication of cumulative skin radiation dose.), the light originating from one or more of scintillation, auto-fluorescence, or Cherenkov processes within the patient (Paragraph [0034]; the stereoscopic camera 10 also obtains images of Cherenkov radiation emitted from a patient by virtue of radiation from the treatment apparatus 16 entering the patient's body);
a device for determining a surface model of the patient (Paragraph [0040]; speckle projector 52… images of a patient 20 are captured by the two image detectors corresponding portions of captured images can be distinguished; Paragraph [0046]; a model generation module 58 for processing data generated by the 3D position determination module 56 and converting the data into a 3D wire mesh model of an imaged surface); and
a video processor (Paragraph [0045]; computer 14 to process images received from the stereoscopic camera system 10) configured to:
register the dose images to the surface model of the patient (Paragraph [0050]; a wire mesh model of the surface of a patient 20 has been stored, the matching module 64 is then invoked to determine a matching translation and rotation between the generated model based on the current images being obtained by the stereoscopic cameras 10 and a previously generated model surface of the patient stored in the target model store 62) and provide corrected dose images (Paragraph [0066]; Preferably any estimates of patient radiation dosage based on Cherenkov radiation emissions are corrected to take into account the concentration of chromophores in the patient's skin,),
use the corrected dose images to determine quantified beam vectors within the three- dimensional model of the patient (Paragraph [0055]; By knowing the orientation of the radiation beam at any time, and the location and position of the emitted radiation at the surface of the patient as described above, it is possible to model the path of the radiation at the surface along the known radiation beam orientation to generate a 3D internal representation of the location of the portions of a patient irradiated).
Hale does not explicitly teach the three-dimensional model of the patient is a voxel based model,
registering the corrected dose images to a three-dimensional voxel-based model of the patient, and
applying a beam energy-deposition model to the quantified beam vectors in the voxel-based model of the patient to prepare a three-dimensional energy deposition map of beam energy in the patient.
Prieels, however, 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:
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.),
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).
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 Hale to include a three-dimensional model of the patient that is a voxel based model, registering the corrected dose images to the three-dimensional voxel-based model of the patient, and applying a beam energy-deposition model to the quantified beam vectors in the voxel-based model of the patient to prepare a three-dimensional energy deposition map of beam energy in the patient as taught by Prieels because it would better allow determining the amount of radiation delivered to portions of tissue deep within the patient and thereby ensure the proper amount of radiation is applied to treatment areas while reducing risk of additional exposure to other targets, thereby improving the quality and precision of the treatment (Paragraph [0160]).
Regarding claim 5, together Hale and Prieels teach all of the limitations of claim 4 as noted above.
Hale does not explicitly teach 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.
Prieels, however, 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).
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 Hale in view of Prieels such that 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 as further taught by Prieels because it would help provide images that would identify the nature and thickness of the tissue traversed by the radiation beam, thereby allowing more accurate determination of radiation dose delivered to the tissue (Paragraph [0160]).
Regarding claim 7, Hall teaches a method of determining a radiation dosage map of a patient (Paragraph [0007]; provided a radiation dosage monitoring system for determining internal radiation dosages received by a patient undergoing radiation treatment) exposed to a therapeutic proton beam ((Paragraph [0041]; the patient is irradiated by a radiation beam; Paragraph [0008]; Charged particles, such as electrons, positrons, protons, or alpha particles; fast-moving charged particles release Cherenkov radiation after entering such tissue), the method comprising:
positioning the patient in a treatment zone (Paragraph [0029]; A mechanical couch 18 is provided as part of the treatment apparatus upon which a patient 20 lies during treatment.);
providing a therapeutic proton beam to the patient (Paragraph [0029]; treatment apparatus 16 such as a linear accelerator for applying radiotherapy; Fig. 1);
imaging light generated by interaction of the therapeutic proton beam with a skin surface of the patient (Paragraph [0034]; in this embodiment, the stereoscopic camera 10 also obtains images of Cherenkov radiation emitted from a patient by virtue of radiation from the treatment apparatus 16 entering the patient's body) using a camera (Paragraph [0029]; a stereoscopic camera system 10, Fig. 1) to form dose images (Paragraph [0035]; records the cumulative levels of Cherenkov radiation emitted from portions of a patient being monitored. This can provide an indication of cumulative skin radiation dose.), the light originating from one or more of scintillation, auto-fluorescence, or Cherenkov processes within the patient (Paragraph [0034]; the stereoscopic camera 10 also obtains images of Cherenkov radiation emitted from a patient by virtue of radiation from the treatment apparatus 16 entering the patient's body);
generating a surface model of the patient (Paragraph [0046]; a model generation module 58 for processing data generated by the 3D position determination module 56 and converting the data into a 3D wire mesh model of an imaged surface);
registering the dose images to the surface model (Paragraph [0050]; a wire mesh model of the surface of a patient 20 has been stored, the matching module 64 is then invoked to determine a matching translation and rotation between the generated model based on the current images being obtained by the stereoscopic cameras 10 and a previously generated model surface of the patient stored in the target model store 62) and using the dose images with the surface model to derive corrected dose images (Paragraph [0066]; Preferably any estimates of patient radiation dosage based on Cherenkov radiation emissions are corrected to take into account the concentration of chromophores in the patient's skin);
determining quantified beam vectors in the three-dimensional model of the patient from the corrected dose images (Paragraph [0055]; By knowing the orientation of the radiation beam at any time, and the location and position of the emitted radiation at the surface of the patient as described above, it is possible to model the path of the radiation at the surface along the known radiation beam orientation to generate a 3D internal representation of the location of the portions of a patient irradiated); and
Hale does not explicitly teach the three-dimensional model of the patient is a voxel based model,
registering the corrected dose images to a three-dimensional voxel-based model of the patient, 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.
Prieels, however, 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:
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.); 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).
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 Hale such that the three-dimensional model of the patient is a voxel based model, and to include registering the corrected dose images to a three-dimensional voxel-based model of the patient, 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 as taught by Prieels because it would better allow determining the amount of radiation delivered to portions of tissue deep within the patient and thereby ensure the proper amount of radiation is applied to treatment areas while reducing risk of additional exposure to other targets, thereby improving the quality and precision of the treatment (Paragraph [0160]).
Regarding claim 9, together Hale and Prieels teach all of the limitations of claim 7 as noted above.
Hale further teaches generating the surface model of the patient is performed by capturing stereo image pairs of the patient (Paragraph [0047]; pairs of images obtained by the stereoscopic camera system 10) and extracting the surface model from the stereo image pairs (Paragraph [0047]; This is achieved by the 3D position determination module 56 identifying corresponding points in pairs of images obtained by the stereoscopic camera system 10 and then determining 3D positions for those points based on the relative positions of corresponding points in obtained pairs of images and stored data identifying the relative positions of cameras obtaining the images.).
Regarding claim 20, together Hale and Prieels teaches all of the limitations of claim 7 as noted above.
Hale further teaches pulses of the therapeutic proton beam are identified by detecting scattered radiation from the therapeutic proton beam (Claim 1; an image detector operable to detect Cherenkov radiation and any subsequent secondary and scattered radiation originating due to the initial Cherenkov radiation emitted from a surface of the patient undergoing radiation treatment).
Regarding claim 30, together Hale and Prieels teach all of the limitations of claim 4 as noted above.
Hale further teaches the visible light having been generated by interaction of the pulsed proton beam with a skin surface of the patient (Paragraph [0008]; Charged particles, such as electrons, positrons, protons, or alpha particles, moving at greater than the effective speed of light in a medium tend to slow down while releasing Cherenkov radiation; Paragraph [0073]; recording the emission of Cherenkov radiation by a surface of a patient would be to process the measured level of Cherenkov radiation data to convert it into an estimate of radiation skin dose; Paragraph [0069]; The optical system may work in the visual spectrum, or over an extended spectrum to include non-visible wavelengths.).
Claims 6, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hale in view of Prieels as applied to claims 4 and 5 above, respectively, and further in view of Cami (US 20150077601)..
Regarding claims 6, 14, and 15, together Hale and Prieels teach all of the limitations of claims 4 and 5, respectively, as noted above.
Hale further teaches the camera integrate additional light, the additional light originating from one or more of scintillation, auto-fluorescence, or Cherenkov processes within the patient (Paragraph [0043]; he image detector arranged to capture images of emitted Cherenkov radiation can be arranged to be activated for the periods of time when the Cherenkov radiation is expected to be emitted.; the light imaged during plurality of images is considered to be additional light as understood in its broadest reasonable interpretation).
Together Hale and Prieels 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 Hale in view of Prieels 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hale in view of Prieels as applied to claim 7 above, and further in view of Veigel (US 20200375661).
Regarding claim 10, together Hale and Prieels teach all of the limitations of claim 7 as noted above.
Together Hale and Prieels do not teach generating the surface model of the patient is performed with an infrared lidar.
Veigel, 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 Hale in view 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.
Claims 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hale in view of Prieels as applied to claims 4 and 7 above, respectively, and further in view of Kilby (US 20170252579).
Regarding claim 19, together Hale and Prieels teaches all of the limitations of claim 4 as noted above.
Hale discloses the invention as claimed and discussed above, but fails to explicitly disclose the 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 further modified the camera of Hale in view 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.
Regarding claim 22, together Hale and Prieels teaches all of the limitations of claim 7 as noted above.
Together Hale and Prieels do 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 Hale in view 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hale in view of Prieels as applied to claim 7 above, and further in view of Ota (US 20190243010).
Regarding claim 21, together Hale and Prieels teaches all of the limitations of claim 7 as noted above.
Together Hale and Prieels do 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 Hale in view of Prieels 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.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hale in view of Prieels as applied to claims 4 and 7 above, respectively, and further in view of Givehchi (US 20220203134).
Regarding claim 23, together Hale and Prieels 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 Hale in view of Prieels 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, together Hale and Prieels teach all of the limitations of claim 7 as noted above.
It is not clear if Hale and 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 Hale in view 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, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hale (US 20160332000 A1) in view of Prieels (US 20180099154) in view of Kilby (US 20170252579).
Regarding claim 26, Hale teaches a system for performing radiation treatment of a patient (Paragraph [0007]; provided a radiation dosage monitoring system for determining internal radiation dosages received by a patient undergoing radiation treatment) comprising:
a particle accelerator (Paragraph [0029]; treatment apparatus 16 such as a linear accelerator for applying radiotherapy; Fig. 1) configured to provide a pulsed proton beam (Paragraph [0041]; the patient is irradiated by a radiation beam; Paragraph [0008]; Charged particles, such as electrons, positrons, protons, or alpha particles; fast-moving charged particles release Cherenkov radiation after entering such tissue);
a beam-on signal indicating when each pulse of the pulsed proton beam is being provided by the particle accelerator (Paragraph [0043]; suitable timing can be achieved by utilizing the activation signal for activating the radiation beam as a trigger for activating the image detector);
a camera (Paragraph [0029]; a stereoscopic camera system 10, Fig. 1) triggered by the beam-on signal (Paragraph [0043]; suitable timing can be achieved by utilizing the activation signal for activating the radiation beam as a trigger for activating the image detector) and positioned to capture dose images of the patient exposed to the pulsed proton beam (Paragraph [0034]; in addition to obtaining images of a patient and generating a model of the surface of a patient being monitored, in this embodiment, the stereoscopic camera 10 also obtains images of Cherenkov radiation emitted from a patient by virtue of radiation from the treatment apparatus 16 entering the patient's body), the camera configured to image light to capture the dose images (Paragraph [0035]; records the cumulative levels of Cherenkov radiation emitted from portions of a patient being monitored. This can provide an indication of cumulative skin radiation dose.), the light originating from one or more of scintillation, auto-fluorescence, or Cherenkov processes within the patient (Paragraph [0034]; the stereoscopic camera 10 also obtains images of Cherenkov radiation emitted from a patient by virtue of radiation from the treatment apparatus 16 entering the patient's body);
a video processor (Paragraph [0045]; computer 14 to process images received from the stereoscopic camera system 10) configured to receive the dose images of the patient and provide corrected dose images (Paragraph [0066]; Preferably any estimates of patient radiation dosage based on Cherenkov radiation emissions are corrected to take into account the concentration of chromophores in the patient's skin,);
a device configured to eliminate interference of room lighting with the dose images (Paragraph [0043]; At the same time external light sources such as room lighting or the speckle projector 52 can be switched off so as to reduce competing sources of light.); and
a device for determining a surface model of the patient during treatment (Paragraph [0040]; speckle projector 52… images of a patient 20 are captured by the two image detectors corresponding portions of captured images can be distinguished; Paragraph [0046]; a model generation module 58 for processing data generated by the 3D position determination module 56 and converting the data into a 3D wire mesh model of an imaged surface);
wherein the pulsed proton beam comprises protons of energy less than 450 MeV.
Hale does not explicitly teach the beam-on signal provided by a radiation detector;
the surface model being updated to show patient movements;
and wherein the pulsed proton beam comprises protons of energy less than 450 MeV.
Prieels, however, teaches 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);
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.).
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 Hale such that a the pulsed proton beam comprises protons of energy less than 450 MeV as taught by Prieels because it would have been a known energy at which to irradiate a patient for therapy with hadrons such as protons (Paragraph [0076]) that further would have been advantageous as the energy is released according to a decreasing exponential curve as a function of the distance of tissue traversed by the photon beam, which would improve the ability to model the exposure of radiation delivered to the tissue (Paragraph [0003]).
Together Hale and Prieels do not explicitly teach the beam-on signal is provided by a radiation detector;
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 Hale in view 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 Hale in view 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]).
Regarding claim 28, together Hale, Prieels, and Kilby 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).
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 Hale in view of Prieels and Kilby to have further included registering the surface model of the patient to a three-dimensional voxel-based model of the patient, using the corrected dose images to determine beam vectors within the three-dimensional voxel-based model of the patient, applying a beam energy-deposition model to the voxel-based model of the patient, and to preparing an integrated three-dimensional energy deposition map of beam energy in the patient based on the corrected dose images and beam vectors as taught by Prieels because it would better allow determining the amount of radiation delivered to portions of tissue deep within the patient and thereby ensure the proper amount of radiation is applied to treatment areas while reducing risk of additional exposure to other targets, thereby improving the quality and precision of the treatment (Paragraph [0160]).
Regarding claim 29, together Hale, Prieels, and Kilby 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).
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 Hale in view of Prieels and Kilby such that 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 as further taught by Prieels because it would help provide images that would identify the nature and thickness of the tissue traversed by the radiation beam, thereby allowing more accurate determination of radiation dose delivered to the tissue (Paragraph [0160]).
Regarding claim 31, together Hale, Prieels, and Kilby teach all of the limitations of claim 26 as noted above.
Hale further teaches the light having been generated by interaction of the pulsed proton beam with a skin surface of the patient (Paragraph [0008]; Charged particles, such as electrons, positrons, protons, or alpha particles, moving at greater than the effective speed of light in a medium tend to slow down while releasing Cherenkov radiation; Paragraph [0073]; recording the emission of Cherenkov radiation by a surface of a patient would be to process the measured level of Cherenkov radiation data to convert it into an estimate of radiation skin dose; Paragraph [0069]; The optical system may work in the visual spectrum, or over an extended spectrum to include non-visible wavelengths.).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hale in view of Prieels as applied to claim 4 above, and further in view of Sossong (US 20150246244).
Regarding claim 27, together Hale and Prieels teach all of the limitations of claim 4 as noted above.
Together Hale and Prieels 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 Hale in view of Prieels 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)
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)
The amendments to the claims raises new rejections under 35 USC 112(b) which are now presented.
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 and 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/26/26
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