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 .
Election/Restrictions
Applicant’s election without traverse of Invention I and Species A in the reply filed on 05/26/2026 is acknowledged.
Claims 26, 52, and 66-78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
Claim Interpretation
Claim 1 recites the contingent limitation “determining that BgRT is suitable if a value of at least one of the first, second, and the third metric is within a range of acceptable values”. Examiner notes that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (See MPEP 2111). Thus it is interpreted that the prior art need not teach determining the BgRT is suitable when the condition of one of the values being within a range of acceptable values has not been met.
Claim 2 recites the contingent limitation “determining that BgRT is suitable if a value of at least one of the new first metric value, the new second metric value, and the new third metric value is within the range of acceptable values”. Examiner notes that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (See MPEP 2111). Thus it is interpreted that the prior art need not teach determining the BgRT is suitable when the condition of one of the values being within a range of acceptable values has not been met.
Claim 12 recites the contingent limitation “when the suitability of using BgRT is not indicated, obtaining an additional diagnostic PET imaging data using a different type of PET tracer than a type of PET tracer that is used for obtaining the diagnostic PET imaging data” Examiner notes that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (See MPEP 2111). Thus it is interpreted that the prior art need not teach obtaining an additional diagnostic PET imaging data… when the condition of suitability using BgRT is not indicated has not been met.
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 2-11, 13-14, and 16-22 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 2 recites the limitation “for a tumor”. It is unclear if the tumor is the same as th e tumor recited previously or if this is a different “tumor”. In other words, it is unclear if the limitation is intending to refer to calculating a new first metric value for the same tumor of claim 1 or if this is for a different/distinct tumor. For examination purposes, it has been interpreted to mean either the same or different, however, clarification is required.
Claim 2 recites the limitation “determining that BgRT is suitable if a value of at least one of the new first metric value, the new second metric value, and the new third metric value is within the range of acceptable values”. The limitation is unclear as to how the condition of determining that BgRT is suitable relates to or corresponds with the previously recited determining. In other words, claim 1 previously sets forth determining that BgRT is suitable if a value of at least one of the first, the second, and the third metric is within a range of acceptable values, however, claim 2 does not appear to include this condition. Therefore, in the instance where all of the first, the second, and the third metrics are outside of the range of acceptable values, it is whether the BgRT is determined to be suitable even if at least one of the new first metric value, the new second metric value, and the new third metric value is within the range. For examination purposes, it has been interpreted that BgRT is determined to be suitable if any of the previously recited metrics is within a range of acceptable values, however, clarification is required.
Claims 3 and 10 recite the limitation “the determining the suitability of using the BgRT”. There is insufficient antecedent basis for the limitation in the claim. For example, claims 1-2 recite “determining that BgRT is suitable if…”, however, does not explicitly recite determining a suitability. It is therefore unclear if the limitation is intending to set forth determining a suitability or if the limitation is intending to refer to the determination that BgRT is suitable. For examination purposes, it has been interpreted to mean any determination of suitability, however, clarification is required.
Claim 5 recites the limitation “a mean signal in a target region”. It is unclear if the mean signal corresponds with or is the same as the PET signal recited in claim 1 or if this is a different signal. It is further unclear what the mean signal refers to and if the mean signal is of the diagnostic PET imaging data or the simulated imaging data or is a different/distinct mean signal. If the mean signal refers to the diagnostic imaging data or data other than the simulated imaging data, it is unclear how the first metric is determined using the simulated imaging data as recited in claim 1. It is further unclear if the target region is the same as or different from the tumor recited in claim 1. For examination purposes, it has been interpreted to mean any mean signal of any target region, however, clarification is required.
Claim 5 recites the limitation “a mean signal in a background region”. It is unclear if the mean signal corresponds with or is the same as the PET signal recited in claim 1 or if this is a different signal. It is further unclear what the mean signal refers to and if the mean signal is of the diagnostic PET imaging data or the simulated imaging data or is a different/distinct mean signal. If the mean signal refers to the diagnostic imaging data or data other than the simulated imaging data, it is unclear how the first metric is determined using the simulated imaging data as recited in claim 1. For examination purposes, it has been interpreted to mean any mean signal, however, clarification is required.
Claim 5 recites the limitation “a variance of the signal in the background region”. It is unclear if the signal corresponds with or is the same as the PET signal recited in claim 1, the mean signal, or if this is a different signal. It is further unclear what the signal refers to and if the signal is of the diagnostic PET imaging data or the simulated imaging data or is a different/distinct signal. If the mean signal refers to the diagnostic imaging data or data other than the simulated imaging data, it is unclear how the first metric is determined using the simulated imaging data as recited in claim 1. For examination purposes, it has been interpreted to mean any signal, however, clarification is required.
Claim 6 recites the limitation “the signal in a target region”. It is unclear if the signal corresponds with or is the same as the PET signal recited in claim 1, the mean signal, or if this is a different signal. It is further unclear what the signal refers to and if the signal is of the diagnostic PET imaging data or the simulated imaging data or is a different/distinct signal. If the mean signal refers to the diagnostic imaging data or data other than the simulated imaging data, it is unclear how the first metric is determined using the simulated imaging data as recited in claim 1. For examination purposes, it has been interpreted to mean any signal, however, clarification is required.
Claim 6 recites the limitation “a value of a PET signal”. It is unclear if the PET signal is the same as the PET signal recited in claim 1 or if this is a different/distinct PET signal. For examination purposes, it has been interpreted to mean any PET signal, however, clarification is required.
Claim 8 recites the limitation “a target region (PTV)”. It is unclear if the target region is the same as or different from the tumor recited in claim 1. For examination purposes, it has been interpreted to mean any target region, however, clarification is required.
Claim 8 recites the limitation “a mean signal in a background region”. It is unclear if the mean signal corresponds with or is the same as the PET signal recited in claim 1 or if this is a different signal. It is further unclear what the mean signal refers to and if the mean signal is of the diagnostic PET imaging data or the simulated imaging data or is a different/distinct mean signal. If the mean signal refers to the diagnostic imaging data or data other than the simulated imaging data, it is unclear how the first metric is determined using the simulated imaging data as recited in claim 1. For examination purposes, it has been interpreted to mean any mean signal, however, clarification is required.
Claim 10 recites the limitation “the contrast normalization signal”. There is insufficient antecedent basis for the limitation in the claim. For example, claim 1 recites the limitation “a first metric indicating a contrast noise ratio”, however, no such contrast normalization signal is recited. It is therefore unclear if the limitation is intending to refer to the first metric or if the limitation is intending to further narrow the first metric or contrast noise ratio to be a contrast normalization signal, or if the limitation intends to mean some other contrast normalization signal. For examination purposes, it has been interpreted to mean any contrast normalization signal or the first metric, however, clarification is required.
Claim 10 recites the limitation “the determined radiation dose”. There is insufficient antecedent basis for the limitation in the claim. For example, claim 1 recites the limitation “a third metric indicating a radiation dose”, however, no such radiation dose is recited as being determined. In other words, a third metric is calculated which indicates a radiation dose, but such a limitation does not necessarily recited determining the radiation dose. It is therefore unclear if the limitation is intending to refer to the third metric or if the limitation is intending to further narrow the third metric to be the radiation dose, or if the limitation intends to mean some other determined radiation dose. For examination purposes, it has been interpreted to mean the third metric or radiation dose, however, clarification is required.
Claim 10 recites the limitation “a required threshold”, “a minimal concentration threshold”, and “a pre-defined dose range”. It is unclear if any of these are the same as or included in the range of acceptable value recited in claim 1 or if these are different thresholds/ranges. For examination purposes, it has been interpreted that they may be the same or different, however, clarification is required.
Claim 13 recites the limitation “a first metric”. It is unclear if the first metric is any of the previously recited metrics or if this is a different first metric. For examination purposes, it has been interpreted to mean any first metric, however, clarification is required.
Claim 14 recites the limitation “a tumor tissue”. It is unclear if this is the same as the tumor recited previously or if this is a different tumor tissue. For examination purposes, it has been interpreted to mean any tumor tissue, however, clarification is required.
Claim 16 recites the limitation “an identified target region”. It is unclear if the identified target region is the same as the tumor of claim 1 or if this is a different region/element. For examination purposes, it has been interpreted to mean any identified target region, however, clarification is required.
Claim 16 recites the limitation “PET imaging data”. It is unclear if the PET imaging data is the same as the diagnostic PET imaging data, the simulated imaging data or if this is different/distinct imaging data. For examination purposes, it has been interpreted to mean any imaging data, however, clarification is required.
Claim 16 recites the limitation “the identified tissue”. There is insufficient antecedent basis for the limitation in the claim. It is therefore unclear if the identified tissue is intended to be the tumor, the identified target region, or some other identified tissue which has not yet been set forth. For examination purposes, it has been interpreted to mean any identified tissue, however, clarification is required.
Claim 17 recites the limitation “modifying the expected counts by adding noise modeled by poisson statistics”. It is unclear if the modifying by adding noise is the same as the modifying based on parameters of the BgRT radiotherapy system or if the modifying by adding noise is a different modification. It is further unclear in the case where this is a different modification to the expected counts if the adding of noise is done to the expected counts (without having been modified already) alone or if the already modified expected counts is further modified by adding noise. For examination purposes, it has been interpreted to be a further modification to the already modified expected counts, however, clarification is required.
Claim 17 recites the limitation “the modified expected counts”. It is unclear if the modified expected counts refers to the expected counts modified based on the parameters or by adding noise or both. For examination purposes, it has been interpreted to mean the expected counts modified based on the parameters and by adding noise, however, clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 10-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Owens et al. (US 20180369611 A1), hereinafter Owens.
Regarding claim 1,
Owens teaches a method for determining suitability of biology-guided radiotherapy (BgRT),
the method comprising:
converting diagnostic positron emission tomography (PET) imaging data of a tumor to simulated imaging data consistent with images obtained using PET detectors of a BgRT radiotherapy system, the simulated imaging data and the diagnostic PET imaging data representing a PET signal from a tracer ([0056] which discloses method 200 may comprise acquiring 202 imaging data of the patient at the start of the treatment session and/or during the treatment session, and extracting 204 biological activity and/or physiological data from the acquired imaging data. Imaging data may include, for example, positron annihilation emission paths emitted from a PET tracer injected into the patient prior to the treatment session. Biological activity and/or physiological data may include a tracer uptake value (e.g., standard uptake value or SUV), PET tracer kinetics, tissue metabolism data, osteogenic activity data, oxygenation data, genetic expression data (e.g., human growth father receptor type 2 (HER2) expression), free fatty acid uptake data, blood flow data, vascularity data, morphological shifts in tumor geometry (e.g., spiculation), and/or lymphatic activity data, etc. The SUV of a particular 2D or 3D region in an image may be calculated from imaging data by multiplying the intensity of the pixels or voxels in that region calibrated to represent a known tissue tracer activity (typically, in mCi/g) divided by the injected dose (typically, in mCi) per patient body weight (typically, in kg) at a specific time since the original injection (the time of the scan acquisition). See also [0019] which discloses generating a plurality of images X’1,2,3…. Generating the plurality of images X’j may comprise simulating j three-dimensional rigid shifts of the PTV within the RFZ for each of the images X’j. Examiner notes that any/all of the processed imaging data used to extract the biological activity, the biological activity itself, and the images x’1,2,3 is considered a conversion of the PET imaging data (i.e. acquired imaging data) into simulated imaging data consistent with images acquired using PET detectors of BgRT radiotherapy system as both represent a PET signal from a tracer);
calculating a first metric indicating a contrast noise ratio for the tumor using the simulated imaging data ([0045] which discloses the size and shape of tumor regions may be determined at least in part by the size and shape of regions of tracer uptake that exceed a pre-determined threshold. [0059] which discloses changes in tumor region hypoxia may be measured using a 18F-fluoromisonidazole (e.g., FMISO, FETNIM) and/or a 18F-fluoroazomycinarabinoside tracer (e.g., FETNIM). A gradient of SUVmax method may be used to delineate between the tumor tissue and non-tumor tissue, for example, using a gradient of about 30-50% SUVmax. A threshold may be set at a value along the gradient, which may identify or delineate region(s) of elevated SUV levels, and therefore, region(s) of increased hypoxia. Examiner notes that such a gradient of SUVmax is considered a first metric which indicates a contrast to noise ratio (i.e. difference in signal between tumor and non-tumor) in its broadest reasonable interpretation);
calculating a second metric indicating a PET tracer activity concentration using the simulated imaging data ([0045] regarding the accumulation of the tracer (qualitatively and/or quantitatively). The tracer accumulation location, size and shape of the tracer accumulation volumes, as well as tracer kinetics may provide an indication of various biological activity levels and/or physiological phenomena in the patient. For example, cellular metabolism levels and the presence (or absence) of oxygen in a tissue region may be calculated from the amount and/or rate of tracer uptake, as indicated by the intensity of the imaging data. See also Optionally, in addition to calculating the DVH curves as the location of the PTV varies within the RFZ, in some variations, the intensity of the PTV in X.sub.j.sup.′ may vary, which may simulate the effect of different uptake values (e.g., SUV) of a PET tracer on the day of treatment. For example, the intensity of the voxels in the PET image X.sub.j.sup.′ may vary by ±25% from the nominal value (i.e., intensity from the planning PET image X));
calculating a third metric indicating a radiation dose to the tumor using the simulated imaging data ([0015] which discloses Some variations of a method for adapting a radiotherapy treatment plan may alternatively or additionally comprise calculating a dose volume histogram (DVH) for a patient target region based on the radiotherapy treatment plan and the measured biological activity data, comparing the calculated DVH with a pre-determined bounded DVH, and updating the radiotherapy treatment plan if the calculated DVH is not within the pre-determined bounded DVH and [0019] which discloses calculating a dose D.sub.j for each of the images X′.sub.1, 2, 3, . . . , j by multiplying a dose calculation matrix A with a radiation-firing matrix P and X′.sub.j (D.sub.j=A.Math.P.Math.X.sub.j.sup.′), plotting a dose-volume histogram (DVH) curve for each dose D.sub.j to generate a family of j DVH curves, where the DVH curve for each dose D.sub.j may represent a volume fraction for each dose value, and generating a minimum boundary curve (min-DVH curve) and a maximum boundary curve (max-DVH curve) of the family of DVH curves);
and determining that BgRT is suitable if a value of at least one of the first, the second, and the third metric is within a range of acceptable values ([0082] which discloses depending on whether the simulated dose distribution map or DVH meet certain criteria or thresholds, the controller and/or clinician may determine whether the treatment plan should be updated and [0016] which discloses applying radiation to the patient region if the measured biological activity data is within the calculated range of biological activity values).
Regarding claim 2,
Owens further discloses obtaining additional diagnostic PET imaging data ([0072] which discloses if the acquired biological activity and/or physiological data extracted from image data acquired at the start of the treatment session indicate that a treatment plan generated at an earlier planning session is still applicable the radiation treatment system may begin radiation dose delivery according to that treatment plan. As functional image data is acquired during the treatment session, the treatment plan may be updated or adapted according to any changes detected in biological activity and/or physiological data);
converting the additional diagnostic PET imaging data to new simulated imaging data consistent with images obtained when performing BgRT ([0072] disclosing the acquired biological activity and/or physiological data extracted from image data acquired at the start of the treatment session. Examiner notes that by acquiring biological activity and/or physiological activity and determining changes thereof extracted from the image data acquired at the start of treatment session. See also [0099] which discloses at the time of treatment DVH curves may be calculated and [0070] which discloses In some variations, recalculating or adapting a treatment plan to incorporate biological activity and/or physiological data acquired at the time of treatment may comprise simulating one or more testing treatment plans with the acquired biological activity and/or physiological data, and selecting an updated treatment plan from the one or more testing treatment plans that meet clinical objectives and/or provides a desired dose distribution. In some variations, an updated or adapted treatment plan may adhere to specified or approved PQI ranges and/or biological activity and/or physiological data ranges);
calculating a new first metric value indicating a contrast normalization signal for a tumor ([0070] which discloses recalculating or adapting a treatment plan to incorporate biological activity and/or physiological data acquired at the time of treatment may comprise simulating one or more testing treatment plans with the acquired biological activity and/or physiological data, and selecting an updated treatment plan from the one or more testing treatment plans that meet clinical objectives and/or provides a desired dose distribution. In some variations, an updated or adapted treatment plan may adhere to specified or approved PQI ranges and/or biological activity and/or physiological data ranges. Examiner notes that recalculating data and the plans would necessarily include calculating a new first metric);
calculating a new second metric value indicating a PET tracer activity concentration ([0070 which discloses recalculating or adapting a treatment plan to incorporate biological activity and/or physiological data acquired at the time of treatment may comprise simulating one or more testing treatment plans with the acquired biological activity and/or physiological data, and selecting an updated treatment plan from the one or more testing treatment plans that meet clinical objectives and/or provides a desired dose distribution. In some variations, an updated or adapted treatment plan may adhere to specified or approved PQI ranges and/or biological activity and/or physiological data ranges. Examiner notes that recalculating data and the plans would necessarily include calculating a new second metric));
calculating a new third metric value indicating a radiation dose for a volume of the tumor ([0070 which discloses recalculating or adapting a treatment plan to incorporate biological activity and/or physiological data acquired at the time of treatment may comprise simulating one or more testing treatment plans with the acquired biological activity and/or physiological data, and selecting an updated treatment plan from the one or more testing treatment plans that meet clinical objectives and/or provides a desired dose distribution. In some variations, an updated or adapted treatment plan may adhere to specified or approved PQI ranges and/or biological activity and/or physiological data ranges. Examiner notes that recalculating data and the plans would necessarily include calculating a new third metric);
and determining that BgRT is suitable if a value of at least one of the new first metric value, the new second metric value, and the new third metric value is within the range of acceptable values ([0070] which discloses in some variations, an updated or adapted treatment plan may adhere to specified or approved PQI ranges and/or biological activity and/or physiological data ranges).
Regarding claim 3,
Owens further discloses wherein the determining the suitability of using the BgRT is further based on a difference between the new first metric value and the first metric value, the new second metric value and the second metric value, and the new third metric value and the third metric value ([0007] which discloses decisions on whether to proceed with a treatment plan may depend on various clinical parameters such as geometrical changes (e.g., volume and/or shape changes) of one or more patient target regions, geometrical changes in one or more radiation-sensitive regions (e.g., organs-at-risk or OARs), changes in the relative distances between the targets and the OARs, changes in patient external contour such as dimension or shape, standard uptake values (SUVs), changes in textural features of patient target regions (e.g. cluster shade, cluster prominence, cellular homogeneity), and whether such factors are within a prescribed range at the time of (or just prior to) treatment. See also That is, biological activity and/or physiological values derived from PET tracer kinetics and SUV measurements (e.g., mean uptake values, changes in SUV, etc.) may optionally be calculated as a function of time).
Regarding claim 4,
Owens further discloses wherein the additional diagnostic PET imaging data is obtained prior to performing a BgRT treatment, the BgRT treatment not forming part of the method ([0007] which discloses PQI values and/or dose-volume histograms may be calculated based on biological activity and/or physiological data and/or anatomical data acquired at the time of (and/or just prior to) treatment and [0069] which discloses an online adaptive radiotherapy method 230 may comprise acquiring 232 imaging data, such as functional imaging scans, at the time of treatment delivery. This may include, for example, acquiring imaging data using any imaging modality (e.g., PET, SPECT, MRI, CT, X-ray, etc.) at the start of a treatment session, before the first radiation beam is applied to the patient. The controller may then evaluate 234 whether the biological activity and/or physiological data extracted from the imaging data indicates that a change to the current treatment plan is needed. See also [0070] disclosing that the method may then comprise delivering radiation in accordance with the updated or adapted treatment plan)).
Regarding claim 10,
Owens further discloses wherein determining the suitability of using the BgRT comprises determining that: the contrast normalization signal is above a required threshold for the signal ([0057] which discloses a threshold may be set at a value along the gradient, which may identify or delineate a region of elevated SUV levels and [0059] which discloses A threshold may be set at a value along the gradient, which may identify or delineate region(s) of elevated SUV levels, and therefore, region(s) of increased hypoxia); the PET tracer activity concentration is above a minimal concentration threshold ([0045] which discloses The size and shape of tumor regions may be determined at least in part by the size and shape of regions of tracer uptake that exceed a pre-determined threshold); and the determined radiation dose is within a pre-defined dose range ([0020] which discloses generating a notification that is displayed on the monitor if the radiation dose distribution D.sub.x is not within a dose distribution range defined by a minimum dose threshold and a maximum dose threshold).
Regarding claim 11,
Owens further discloses wherein the pre-defined dose range is represented by an upper dose-volume histogram (DVH) curve and a lower DVH curve of a bounded DVH ([0052] which discloses DVHs and/or PQI(s) deemed to be acceptable for treatment plan delivery may vary by clinician and/or clinic. In one variation, a DVH and/or PQI(s) is considered a PASS/GO if 95% of all DVH points above 10% of Prescription Dose on the nominal DVHs of OARs and the BgROI are within the Minimum and Maximum DVH points on the two bounds of the Bounded DVH (within a ±1° % tolerance) and [0019] which discloses the method may further comprise generating a notification if the DVH curve of the second patient image Y is not bounded between the min-DVH curve and the max-DVH curve).
Regarding claim 12,
Examiner notes regarding the limitation “when the suitability of using BgRT is not indicated, obtaining an additional diagnostic PET imaging data using a different type of PET tracer than a type of PET tracer that is used for obtaining the diagnostic PET imaging data”, it is noted that the prior art method is directed towards the method in which applying radiation to the patient region if the measured biological activity is within the calculated range of biological activity values as disclosed in [0016], thus the condition that suitability of using BgRT is not indicated has not been met as suitability of using BgRT is indicated in the disclosed method. Examiner thus notes that since the condition has not been met that the prior art method reads on the claimed invention.
Regarding claim 13,
Owens further discloses wherein, a first metric is further verified by obtaining visual representation of the tumor using CT imaging ([0102] which discloses Method 800 may comprise acquiring 802 a patient CT image, defining 804 dose constraints, prescription, PTV and/or RFZ and OAR contours and other data. Examiner notes that any of the defined elements (e.g. dose constraints, prescription, PTV, etc.) are considered a first metric which is verified. See also 8B and corresponding disclosure in at least [0106])
Regarding claim 14,
Owens further discloses wherein the radiation dose comprises a function determining acceptable radiation doses for a given volume fraction of a tumor tissue ([0103] which discloses The dose calculation matrix A may be calculated column-by-column, for example, by ray-tracing each beamlet's aperture (or trajectory) along the path through a RFZ or patient volume, and calculating the contribution of a unity-weighted beamlet to each of the n sampling points or voxels. A beamlet aperture may be a MLC aperture defined by a single MLC leaf opening (i.e., of a binary MLC or a 2-D MLC). Examples of dose calculation algorithms may include Monte-Carlo simulation, collapsed-cone convolution superposition, pencil-beam convolution, and others).
Regarding claim 16,
Owens further discloses further comprising generating a BgRT plan ([0069] which discloses Prior to a treatment session (blocks 231a-231c), a treatment plan may be generated for the patient based on images or image data acquired using any desired imaging modality (e.g., PET, SPECT, MRI, CT, X-ray, etc.)), the BgRT plan including: an identified target region ([0061] whicvh discloses some variations may also comprise calculating and/or extracting anatomical data, for example, size and location of any target regions, bone structures, irradiation-avoidance regions, patient weight, etc and [0062] which discloses determining whether a current treatment plan is deliverable by calculating the expected delivered dose to the one or more target regions in the patient); and firing filters that convert PET imaging data into a radiation fluence map that results in the prescribed dose being delivered to the identified tissue ([0102] which discloses acquiring 806 patient PET image (X), calculating 808 a dose calculation matrix (A), and calculating 810 a radiation-firing matrix (P) that designates the conversion from imaging data to a fluence map that may include beamlet pattern and/or beamlet intensities to be applied to the patient during a treatment session).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Owens in view of NPL Takahashi et al. (“Comparison of TOF-PET and Bremsstrahlung SPECT images of Yttrium-90: a Monte Carlo Simulation Study”), hereinafter Takahashi.
Regarding claim 5,
Owens teaches the elements of claim 1 as previously stated. Owens further teaches wherein the first metric is determined based on a signal in a target region and a signal in a background region ([0057] which discloses ([0057] which discloses measuring the metabolism of a tumor region by measuring FDG PET data may comprise using a gradient of SUVmax to delineate between the tumor tissue and non-tumor tissue, for example, using a gradient of about 30-50% SUVmax). Owens fails to explicitly teach wherein the first metric is determined as a difference between a mean signal in a target region <Tx> and a mean signal in a background region <Bg> divided by a variance of the signal σBg in the background region (<Ts>-<Bg>/σBg)
Takahashi teaches determining a first metric indicating a contrast to noise ratio for a tumor using simulated imaging data, wherein first metric is determined as a difference between a mean signal in a target region <Tx> and a mean signal in a background region <Bg> divided by a variance of the signal σBg in the background region (<Ts>-<Bg>/σBg) (pg. 26 Image analysis which discloses the simulated Yimages were quantitatively evaluated using the CNR, Vh, where CNR,VH is calculated as CH,j-CB/SDB and CH,j is the mean activity concentration in the jth hot sphere ROI, CB is the mean activity concentration (i.e. signal) in the background ROI, and SDB is the standard deviation (i.e. variation) of the activity concentration (i.e. signal) in the background ROI).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Owens to include determining the first metric as taught by Owens in order to quantitatively evaluate the simulated image data of Owens accordingly.
Regarding claim 6,
Owens further teaches wherein the signal in the target region TS is calculated in a portion of a clinical target volume in which a value of a PET signal is less than a target threshold percent of a peak value of the PET signal as measured in the clinical target volume ([0057] which discloses measuring the metabolism of a tumor region by measuring FDG PET data may comprise using a gradient of SUVmax to delineate between the tumor tissue and non-tumor tissue, for example, using a gradient of about 30-50% SUVmax. Examiner notes that a gradient of 30-50% SUVmax is considered a target threshold percent of a peak value of the PET signal and the tumor (i.e. target region) is calculated in a portion of a clinical target volume in which the value of the PET signal is less than 30-50% SUVmax).
Regarding claim 7,
Owens further teaches wherein the target threshold percent is fifty percent [0057] which discloses measuring the metabolism of a tumor region by measuring FDG PET data may comprise using a gradient of SUVmax to delineate between the tumor tissue and non-tumor tissue, for example, using a gradient of about 30-50% SUVmax)
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Owens in view of NPL Rogasch et al. (“The association of tumor-to-background ratios and SUVmax deviations related to point spread function and time-of-flight F18-FDG-PET/CT reconstruction in colorectal liver metastases”), hereinafter Rogasch.
Regarding claim 8,
Owens teaches the elements of claim 1 as previously stated. Owens further teaches wherein the first metric is determined based on a signal of a target region and a background region ([0057] which discloses measuring the metabolism of a tumor region by measuring FDG PET data may comprise using a gradient of SUVmax to delineate between the tumor tissue and non-tumor tissue, for example, using a gradient of about 30-50% SUVmax).
Owens fails to explicitly teach wherein the first metric is determined as a median activity concentration of a target region (PTV) divided by a mean signal in a background region <Bg> MedianAC[PTV]/< Bg..
Rogasch, in a similar field of endeavor involving PET imaging, teaches the a first metric determined as a median activity concentration of a target region (PTV) divided by a mean signal in a background region (pg. 2 which discloses TBR was defined as the ratio of the lesions' SUVmax and the SUVmean of healthy liver tissue (background) determined for each reconstruction algorithm and Table 1 which depicts SUVmax is a median value).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Owens to include determining a first metric as taught by Rogasch in order to determine a tumor to background ratio accordingly. Such a modification would provide additional diagnostic/treatment planning information to a user in order to evaluate the respective relationship between the tumor and background thereby enhancing the overall procedure of Owens.
Regarding claim 9,
Owens teaches the elements of claim 8 as previously stated. Owens further teaches wherein Bg is calculated over a shell region , the shell region being a portion of a biological targeting zone and not a part of a clinical target volume ([0059] which discloses a gradient of SUVmax method may be used to delineate between the tumor tissue and non-tumor tissue, for example, using a gradient of about 30-50% SUVmax. Where non-tumor tissue is considered a shell region in its BRI and is considered a portion of a biological targeting zone and not part of a clinical target volume (i.e. not part of the tumor)).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Owens in view of NPL Voronenko et al. (US 20180345042 A1), hereinafter Voronenko.
Regarding claim 15,
Owens teaches the elements of claim 1 as previously stated. Owens fails to explicitly teach further comprising converting the simulated imaging data to single line-of-response (LOR) data between a pair of detector elements.
Voronenko, in a similar field of endeavor involving radiotherapy planning, teaches converting simulated imaging data to single line-of-response (LOR) data between a pair of detector elements ([0013] which discloses the positron emission activity data may comprise a plurality of synthetic lines-of-response (LORs) generated based on diagnostic PET imaging data acquired on a PET imaging system and [0118] which discloses Simulated or synthetic LORs may be generated based on a diagnostic PET image and/or the geometry of the PET imaging system that acquired the diagnostic PET image and/or PET detectors on the radiotherapy system).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified been obvious to a person having ordinary skill in the art before the effective filing date to have modified Owens to include converting imaging data to single line-of-response data between a pair of detector elements as taught by Voronenko in order to provide additional positron emission activity to the system of Owens for simulating PET tracer uptake in tumor regions and background respectively (Voronenko [0119]). Such a modification amounts to merely additional positron emission activity which would be beneficial for use in treatment planning for radiotherapy.
Allowable Subject Matter
Claims 17-22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner notes that as best understood, Owens remains the closest prior art of record and teaches a general teaching of generating a sinogram in [0067] and [0046]. Owens, however, fails to explicitly teach wherein converting the diagnostic PET imaging data to the simulated imaging data consistent with images obtained using PET detectors of a BgRT radiotherapy system comprises: calibrating sensitivity of the PET detectors of the BgRT radiotherapy system; generating a sinogram based on the PET imaging data, wherein the generating includes correcting for an attenuation using computer tomography (CT) data; converting the sinogram to expected counts per sinogram-bin; modifying the expected counts based on parameters of the BgRT radiotherapy system, wherein the parameters include at least the sensitivity of the BgRT radiotherapy system subject to an efficiency of the BgRT radiotherapy system and a time used by the BgRT radiotherapy system for collecting data; modifying the expected counts by adding noise modeled by Poisson statistics; and reconstructing the simulated imaging data based on the modified expected counts.
Wollenweber et al. (US 20040167387 A1) teaches wherein converting the diagnostic PET imaging data to the simulated imaging data consistent with images obtained using PET detectors of a BgRT radiotherapy system comprises:generating a sinogram based on the PET imaging data, wherein the generating includes correcting for an attenuation using computer tomography (CT) data ([0038] which discloses the emission sinogram was then multiplied by the attenuation sinogram); modifying the expected counts by adding noise modeled by Poisson statistics ([0038] which discloses poisson noise was added to the attenuation emission sinograms such that the total sinogram counts equaled 1.0e4, 1.0e5 and 1.0e6 total counts to allow a critique of the methods described herein at different noise); and reconstructing the simulated imaging data based on the modified sinogram (Abstract which discloses retrospectively correcting data prior to image reconstruction using an imaging system).
Wollenweber et al. (US 20040260176 A1) teaches generating a sinogram based on the PET imaging data including correcting for an attenuation using Computer tomography (CT) data ([0046] which discloses the method includes a step 186 of constructing PET emission image 188 from the corrected PET emission data. Histogramming the corrected PET emission data produces a PET emission sinogram from which a PET emission image can be reconstructed.)
Panin et al. (US 20150036789 A1), hereinafter Panin teaches calibrating sensitivity of the PET detectors ([0065] which discloses acquiring an additional bed position (the third one shown in FIG. 4) or moving the bed over a greater range in continuous bed motion (see FIG. 6), so as to make the axial sensitivity uniform throughout the CT defined volume (see FIG. 8), thus calibrating sensitivity of the PET detectors in its broadest reasonable interpretation); Generating a sinogram based on the PET imaging data ([0056]) Modifying the sinogram by adding noise modeled by Poisson statistics ([0086]) and reconstructing the simulated imaging data based on the modified sinogram and attenuation using computer tomography (CT) data ([0069]).
NPL Nuyts et al. (“Maximum-Likelihood Expectation-Maximization…”) generally teaches that for PET emission data, random coincidence subtraction, correction for scanner sensitivity and dead time, attenuation, and scatter corrections destroy the initial Poisson distribution in the Introduction and teaches Poisson noise added to a sinogram with Bi = 250 in B. Simulated transmission protocol.
The prior art collectively fails to teach the combination of elements recited by claim 17 including the features of claim 1. Furthermore, it would not have been obvious to have modified Owens to include all of the features including calibrating sensitivity…, generating a a sinogram, correcting for an attenuation, converting the sinogram to expected counts per sinogram-bin and modifying the expected counts based on parameters of the BgRT radiotherapy system and further modifying the expected counts by adding noise modeled by Poisson statistics then reconstructing the simulated imaging data based on the modified expected counts and using such reconstructed simulated imaging data in determining the first metric, second metric, and third metric taught by at least Owens. Such a modification would have required impermissible hindsight reasoning.
Conclusion
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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