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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/26/2024 was being considered by the examiner.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1) in view of Foulquier et al. (US Pub. No. 2006/0239414 A1).
With regard to claim 1, Yoo teaches a phantom dosimeter 100 including a chest phantom 20 and multiple X-ray detection probes 10 for measuring a two-dimensional planar dose distribution in one beam irradiation. Yoo states that the phantom dosimeter includes a plurality of X-ray detection probes 10 and a chest phantom 20, and that the probes are inserted into holes 30 of a first panel 20a so the probe ends are exposed at the upper surface of the panel [0040]-[0043], [0056]-[0062], (Figs. 1 and 3).
Yoo further teaches 3x3 and 5x5 grid arrangements of holes/detectors and real-time scintillation imaging / dose information readout [0067]-[0072], [0075]-[0082], (Figs. 4-6). Yoo also teaches that the chest phantom panels may include a solid water phantom [0058], (Fig. 3).
Yoo does not expressly teach that the phantom has a one-piece square cross-section whose width varies monotonically along the height of the phantom; Yoo instead shows separated panel structures 20a/20b with grid holes [0056]-[0062], (Figs. 1 and 3).
Foulquier supplies the missing phantom geometry by teaching square/cubic phantom components and fitted truncated-pyramid elements [0032] of different densities [0025]-[0032], (Figs. 3a and 3b)
In view of the utility of using a phantom shape and internal density geometry to simulate tissues/organs and verify radiotherapy or simulation functions, it would have been obvious to modify Yoo’s detector-in-phantom dosimeter with Foulquier’s square/truncated geometry. The combination predictably uses Yoo’s known detector array for dose measurement within a phantom and Foulquier’s known phantom geometry to provide a shaped water-equivalent phantom body for radiation QA (Yoo [0012]-[0015], [0040]-[0043]; Foulquier [0009]-[0019], [0033]-[0036]).
Claim(s) 2 and 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1) and Foulquier et al. (US Pub. No. 2006/0239414 A1) in view of Simon et al. (US Pub. No. 2009/0250618 A1).
With regard to claim 2, Yoo in view of Foulquier discloses the device of claim 1. Yoo teaches detector probes in a grid of holes in the phantom panel, including a 3x3 arrangement and a 5x5 arrangement of holes/probes [0067]-[0072], (Figs. 4-5).
Yoo modified fail to teach expressly recite a radiation detector “about every 1 cm in each plane of the phantom.”
Simon relates to radiation measurement equipment for radiation therapy and treatment, and in particular to systems and methods for measuring and localizing, spatially and/or temporally, a dose in a phantom for supporting quality assurance (QA) in radiation therapy beam delivery [0002].
Simon teaches a system 10 for measuring radiation dose including a dosimeter 12 including an ionizing radiation detector array 14, wherein the array 14 may comprise a passive detector array or an active detector array. For example, the active detector array 14 comprises each detector 18 within the array 14 formed from diodes [0034].
Most importantly, Simone teaches the array has a repeating geometric pattern of detectors with inactive regions between the detector locations. For example, on the circumference of the cylinder there exists a detector at every one cm increment, and there are circumferential rows along the length of the cylinder spaced every one cm [0039].
Simone further teaches that the detector array 14 spirals along the length cylinders with a detector spacing of 1 cm along the circumference and a 1 cm spacing of the spiraled circumferential arrays. The array length will extend 21 cm along the cylinder, wherein the detectors 18 are mounted on 22 rigid circuit boards, each of which form a cylinder, resulting in a closed cylindrical regular polygon solid shape and 1386 diode detectors in the array [0062].
In view of the utility, to obtain practical 3-dimensional dose sampling for radiotherapy QA or where needed, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Yoo with the teachings such as that taught by Simone to select approximately 1 cm detector spacing in each plane of the phantom as a routine sampling-density choice for a radiation-detector array.
With regard to claim 4, Yoo in view of Foulquier discloses the device of claim 1. Yoo’s modified teaches a plastic scintillating fiber probe, including plastic scintillating fiber 11 and optical fiber 12 [0043]-[0049], (Figs. 2a-2b).
Yoo modified fail to expressly teach the detector alternatives including diode detectors, MOSFETs, TLD chips, radiochromic films, or combinations thereof.
Simone teaches that the detector array 14 may comprise an active detector array, wherein the active detector array 14 comprises each detector 18 within the array 14 formed from diodes [0034], [0052], [0059], [0062], [0063].
In view of the utility of using diode/pixel detectors for spatial intensity and energy deposition measurement in a phantom, it would have been obvious to modify Yoo with the teachings such as that taught by Simone to use known diode detector pixels in Yoo’s phantom detector array with good reproducibility and acceptable angular response.
With regards to claims 5 and 6, refer to the rejection of claim 4 as both claims are directed to the radiation detectors comprising diode detectors addressed in claim 4.
With regard to claim 7, Yoo in view of Foulquier discloses the device of claim 1. Claim 7 adds the detector spacing limitation addressed in claim 2 with the diode detector limitation addressed in claimed 4.
In view of the utility of providing a regular, practical spatial sampling grid with diode detectors, it would have been obvious to provide the Yoo modified phantom with diode detectors spaced at about 1 cm in each plane such as that taught by Simone (Yoo [0067]-[0072]; Simone [0002], [0039], [0062]).
Claim(s) 3, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1) and Foulquier et al. (US Pub. No. 2006/0239414 A1) in view of Baiu et al. (US Pub. No. 2016/0015836 A1).
With regards to claim 3, Yoo modified discloses the device of claim 1. Yoo teaches that the chest phantom panels may include a solid water phantom [0058], (Fig. 3).
Yoo modified fail to expressly teach that the phantom consists essentially of solid water material.
Baiu teaches a water-equivalent solid phantom material for calibration and QA applications, including radiotherapy, and discloses that the material can be used in phantom devices [0007]-[0015], [0020]-[0023], [0039]-[0043].
In view of the utility of mimicking water/tissue response for radiotherapy calibration and reducing uncertainty in dose measurement, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Yoo with the teachings such as that taught by Baiu to form the phantom body of Yoo/Foulquier so that it consists essentially of the Baiu solid water material which exhibit a high degree of accuracy to natural water over the entire range of diagnostic and therapeutic energies (Yoo [0058]; Baiu [0007], [0022]-[0023], [0037]-[0043]).
With regard to claim 12, Yoo in view of Foulquier discloses the device of claim 1 and teaches a phantom comprising solid water or water-equivalent material as discussed above [0058], (Fig. 3).
Yoo modified fail to expressly teach the specific claimed solid-water composition ranges. Notice that the court held that adjustability, where needed, is not a patentable advance, and because there was an art-recognized need for the adjustment.
Baiu teaches a tissue-equivalent / water-equivalent phantom composition for radiographic calibration and quality assurance (Abstract). The water equivalent phantom comprising glass microbubbles, epoxy, CaCO3, MgO, and polyethylene, including compositions having 2.9-3.3% glass microbubbles, 60-90% epoxy/acrylic/polyurethane, 3-5% CaCO3, 1-3% MgO, and 8-12% polyethylene [0009]- [0011], [0023]-[0029], [0031]-[0037],[0040] – [0041] (claim 12.)
In view of the utility of using a known solid/tissue-equivalent phantom material to mimic water/tissue attenuation and provide a solid phantom suitable for radiographic calibration, it would have been obvious to use the known Baiu material system in the phantom of the base combination. The claimed ranges overlap or substantially encompass the ranges taught by Baiu, and the present record does not show that the claimed subranges produce an unexpected result or are critical [0007]-[0015], [0022]-[0023], [0023]-[0029], [0031]-[0037].
As such, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the phantom adjustable as needed to match the water consistency as needed, since it has been held that adjustability, where needed, involves only routine skill in the art.
With regard to claim 13, Yoo modified discloses the device of claim 1.
Yoo modified fails to expressly teach the specific solid-water composition recited in claim 13.
Baiu teaches the specific composition recited in claim 13: 3.09% glass microbubbles, 57.88% Araldite, 23.15% Jeffamine, 3.89% CaCO3, 1.80% MgO, 9.98% polyethylene, and 0.2% Na6Al6Si6O24S4 or Si4O10(OH)2Mg3-Co3Ca-Al, with elemental composition including 65.81% carbon, 19.36% oxygen, 8.14% hydrogen, 2.21% nitrogen, 1.78% calcium, 1.14% silicon, and 1.11% magnesium [0015], [0028]-[0029], (claim 8).
To the extent any numerical value is viewed as a selection within the broader Baiu material disclosure, it would have been obvious to optimize the known phantom-material formulation within the disclosed ranges to obtain desired water/tissue-equivalent attenuation, density, electron density, and radiographic performance. The reason to use the material is the same water-equivalence and calibration utility discussed above.
Claim(s) 8 - 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1) and Foulquier et al. (US Pub. No. 2006/0239414 A1) in view of Simon et al. (US Pub. No. 2009/0250618 A1) and Baiu et al. (US Pub. No. 2016/0015836 A1).
With regard to claim 8, Yoo in view of Foulquier discloses the device of claim 1. Claim 8 adds the three limitations of about 1 cm detector spacing of claim 2, diode detectors of claim 4, and a phantom consisting essentially of solid water material of claim 3. Yoo teaches regular grid detector placement [0067]-[0072], (Figs. 4-5).
See the rejections of claims 2 – 4 above.
In view of the combined utility of regular spatial sampling, diode detection, and water-equivalent phantom response, the combination would have been obvious since the use of a phantom that exhibits a high degree of accuracy to natural water over the entire range of diagnostic and therapeutic energies in combination to allowing improved and enhanced x-ray/radiation imaging is an obvious optimization in the art.
With regard to claim 9, refer to the rejections of claims 1, 3 and 4.
With regard to claim 10, refer to the rejections of claims 1 - 3.
With regard to claim 11, the claim repeats the same three limitations addressed for claim 8.
Claim(s) 14 - 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1) and Foulquier et al. (US Pub. No. 2006/0239414 A1) in view of Schiefer (US Pub. No. 2012/0305793 A1).
With regard to claim 14, Yoo in view of Foulquier discloses the device of claim 1. Foulquier further teaches the directionality of the tapered/truncated-pyramid geometry: element 11 is a truncated pyramid having a large square base and length L, while element 12 surrounds it with different thicknesses; Figs. 3a and 3b show the smaller/larger widths along the element length (Foulquier [0028], Figs. 3a-3b).
Yoo modified fails to expressly teach the claimed monotonic-width relationship, and Yoo modified does not expressly state the exact orientation “from a beam side surface to an opposing surface” in the same words as claim 14.
Foulquier teaches a radiotherapy phantom having core elements in the form of fitted truncated pyramids of different densities, including an element with a large square base and a length dimension, where the geometry produces a width variation along the height/length of the phantom element (Foulquier [0027]-[0028], Figs. 2-3).
Schiefer also teaches that phantom shapes may be varied and may include shapes whose surface and density distribution are defined by a function, with the 2D array positioned relative to the phantom geometry and incident beam. (Schiefer [0084]-[0087], [0090]-[0095], Figs. 13A-13B and 14.)
In view of the utility of selecting a phantom geometry that simulates patient/body attenuation and accommodates beam scanning through a defined phantom volume, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Yoo to include the teachings such as that taught by Foulquier and Schiefer to use a truncated-pyramid/frustum geometry along with the phantom so that the width increases monotonically from the beam-side surface toward the opposing surface. This modification uses a known phantom shape for its known radiotherapy QA purpose and would have produced predictable beam-attenuation geometry (Foulquier [0009]-[0019], [0033]-[0036]; Schiefer [0084]-[0087], [0090]-[0095]).
With regard to claim 15, Yoo in view of Foulquier discloses the device of claim 1.
Yoo modified fails to expressly teach to configure the device to be inserted within a head of a gantry of a linear accelerator. Yoo modified shows use with a diagnostic radiation imaging system/DR system rather than a LINAC gantry-head accessory (Yoo [0075]-[0078], Fig. 6; Foulquier [0001]-[0009]).
Schiefer teaches a quality control accessory for use in linear accelerator quality control and verification of a patient treatment plan, where the accessory includes a phantom/absorber and a 2D detector array fixed relative to the linear accelerator gantry/beam focus (Schiefer [0013]-[0017], [0058]-[0064], Figs. 2-4.)
Schiefer further teaches the QC accessory attached to the gantry and structures fixed to the gantry/head 36 (Schiefer [0072]-[0077], Figs. 5-9).
In view of the utility of reproducibly positioning the phantom/detector relative to the LINAC beam for fast QA, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to configure the Yoo modified phantom detector device to be inserted within or mounted at the gantry head such as that taught by Schiefer (Schiefer [0015]-[0017], [0061]-[0064], [0068]-[0077]).
With regard to claim 16, refer to the rejection of claim 15.
With regard to claim 17, Yoo in view of Foulquier and Schiefer discloses the linear accelerator of claim 16.
Yoo modified fail to expressly teach software for the linear accelerator that interfaces with the phantom/detector device to transform detector data into dose distribution or patient-plan verification information
Schiefer teaches that software is required to transform the 2D measurement information from the 2D array into a 3D dose distribution in the RSC phantom and finally into the measured dose distribution in patient anatomy, and also teaches data transfer / software evaluation for the QC accessory (Schiefer [0014], [0017], [0064], [0114]-[0118], [0178]-[0187], Fig. 16).
In view of the utility of interpreting dose measurements and verifying a patient treatment plan, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Yoo with the teachings such as that taught by Schiefer to include software interfacing the phantom detector device with the linear accelerator to obtain/interpret dose measurements and patient-plan verification
Claim(s) 18 - 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1) and Foulquier et al. (US Pub. No. 2006/0239414 A1) in view of Schiefer (US Pub. No. 2012/0305793 A1) and Casse et al (US Pub. No. 2019/0369268 A1).
With regard to claim 18, Yoo in view of Foulquier discloses the device of claim 1. Yoo modified teaches irradiating the phantom with an X-ray beam and using detector/probe scintillation signals to obtain real-time dose distribution information (Yoo [0075]-[0082], Fig. 6.), but fail to expressly teach the full method of injecting a LINAC beam into the device and using the detector array to obtain dose response depth/profile data in a LINAC patient-plan QA environment.
Schiefer teaches use in a linear accelerator QC/patient-plan verification environment and software for transforming 2D measurement information into dose distribution information (Schiefer [0013]-[0017], [0064], [0114]-[0118], [0178]-[0187]).
Casse teaches a phantom method in which detector 140 is moved along the beam path, the position is logged, radiation is detected, and radiation beam vector information is processed to determine range and Bragg peak/depth information; Casse also teaches the detector determines intensity/energy deposition in at least two dimensions and may produce a three-dimensional picture of the radiation (Casse [0027]-[0030], [0048]-[0057], Figs. 4-5).
In view of the utility of measuring beam depth/profile data for radiation QA and treatment verification, it would have been obvious to use the Yoo/Foulquier detector phantom in Schiefer’s LINAC QA setting and to apply Casse’s detector-position/depth-profile processing.
With regard to claim 19, Yoo modified discloses the method of claim 18, but fails to expressly disclose comparing an obtained dose response depth/profile data to a treatment plan for a patient.
Schiefer teaches that before a tumor patient is irradiated, the calculated dose distribution of the treatment plan is checked, and the measured dose distribution in the phantom/patient anatomy may be compared with the calculated dose distribution or treatment plan using common evaluation tools (Schiefer [0004]-[0006], [0017], [0132]-[0133], [0178]-[0187]).
In view of the utility of verifying patient treatment plans before irradiation, it would have been obvious to compare the obtained dose response depth/profile data to a treatment plan for a patient.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US Pub. No. KR 10-1823958 B1), Foulquier et al. (US Pub. No. 2006/0239414 A1), Casse et al (US Pub. No. 2019/0369268 A1) and Schiefer (US Pub. No. 2012/0305793 A1) in view of Baiu et al. (US Pub. No. 2016/0015836 A1).
With regards to claim 20, refer to the rejections of claims 1, 8 and 18.
Conclusion
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/DJURA MALEVIC/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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