Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/25/2024, 03/13/2025 and 05/20/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 26, 28, 29, 33, and 36-38 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1).
With regard to claim 26, Pelizzari teaches a radiotherapy method comprising a base integrated apparatus including a movable gantry 18, radiotherapy accelerator 20, and PET imaging device 21 having opposed PET detectors 34, 35. Pelizzari further teaches a method that uses a ring 22 to rotate an accelerator and PET detectors about the patient, and the accelerator emits a treatment beam from different positions ([0019]-[0021], [0028]-[0029], [0033]-[0037], [0046], [0048]-[0049], [0062]-[0064]; Figs. 1-4).
Pelizzari further combines CT anatomical images with PET functional images and uses the resulting image information to position the accelerator and direct radiation to the target ([0019]-[0021], [0028]-[0029], [0033]-[0037], [0046], [0048]-[0049], [0062]-[0064]; Figs. 1-4).
Pelizzari, however, does not expressly teach the claimed accumulation of event-defined LOR data using a chronological/list-mode reconstruction workflow, or modification of a later treatment session using the generated image.
Manjeshwar teaches detecting coincidence events, assigning detector/location identifiers and timestamps, storing the events chronologically with LOR coordinates and angles, optionally sorting the list by LOR angle or other criteria, and applying an iterative algorithm to compute a PET image ([0002]-[0004], [0007]-[0008], [0028]-[0034]; Figs. 1, 3-5).
In view of the utility of Manjeshwar’s list-mode PET processing for preserving the time and geometry of coincidence data while avoiding wasteful computation on empty sinogram bins, a person of ordinary skill would have implemented Pelizzari’s disclosed PET subsystem using Manjeshwar’s conventional LOR collection and reconstruction. The modification uses compatible PET detector data for its established imaging function and predictably produces the functional target image Pelizzari already uses to position the therapeutic source.
Yan teaches constructing daily and cumulative dose information for image subvolumes, storing the daily result after a treatment session, combining it with results from previous sessions, comparing the accumulated result and anatomy with the reference plan, and revising the reference plan through online or offline adaptive planning using individual treatment history ([0055]-[0060]; Figs. 6-7).
In view of the utility of Yan’s adaptive use of session-acquired volumetric information for compensating for anatomical and delivered-dose changes across fractions, a person of ordinary skill would have supplied Pelizzari’s registered PET/CT image produced by Manjeshwar’s reconstruction as an input to Yan’s adaptive-planning process. The predictable result is revision of a subsequent fraction using the most recent registered functional/anatomical image without changing the established function of any component.
With regard to claim 28, identifying the target volumes further comprises mapping activity of the detected positron annihilation emission paths.
Manjeshwar maps accumulated LOR event data to image locations through the system matrix and iterative forward/back projection, thereby producing an activity image from the detected paths ([0007]-[0008], [0033]-[0034]; Figs. 3-4). Claim 28 therefore inherits the rationale stated for claim 26.
With regard to claim 29, delivering radiation comprises constructing a map from the detected positron annihilation emission paths and directing radiation based on the map.
Manjeshwar teaches constructing the PET activity map from the detected LOR data ([0028]-[0034]). Pelizzari teaches using the PET/CT image information to place the accelerator at a desired position and generate the treatment beam at the target ([0046], [0062]-[0064]; Figs. 3-4). The claimed map-to-source relationship is therefore supplied by the same compatible image-guided workflow and motivation stated for claim 26.
With regard to claim 33, Pelizzari teaches registered CT anatomical and PET functional information and uses that image information to locate the target and position the accelerator, i.e., location information for the target volumes ([0046], [0048]-[0049], [0062]-[0064]; Figs. 3-4).
With regard to claim 36, Pelizzari expressly integrates CT/X-ray imaging with PET imaging and uses the combined images for target positioning ([0048]-[0049], [0062]-[0064]; Figs. 3-4). Because the claim requires “one or more,” the CT/X-ray and PET modalities satisfy the limitation.
With regard to claim 37, detecting the emission paths comprises acquiring path data using PET detectors from multiple firing angles.
Pelizzari rotates opposed PET detectors 34, 35 (and, in the two-ring embodiment, PET detectors 134, 135) through multiple circumferential positions around the same treatment axis used by the movable accelerator ([0033]-[0037], [0046], [0048]-[0049], [0062]-[0064]; Figs. 1-4).
Manjeshwar supplies the event-defined LOR meaning for the acquired path data ([0002]-[0004]). Thus, the detector perspectives correspond to the multiple angular source positions recited as firing angles.
In view of the utility to enhance data points and the system, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Pelizzari’s to include the teachings such as that taught by Manjeshwar’s to improve the radiotherapy.
With regard to claim 38, Pelizzari expressly rotates the paired PET detectors about the patient area and acquires PET images from multiple locations ([0035]-[0037], [0046], [0062]; Figs. 1-2).
Claim(s) 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1) and further in view of Bailey et al. (US 3,322,950).
With regard to claim 27, Pelizzari modified teaches the claimed invention according to claim 26 but does not expressly identify a set of lower beam-defining jaws.
Bailey teaches lower jaw members 67, 67′ and upper jaws 53, 53’, separate drive motors 74 and 33, and operator control that continuously adjusts the beam field. Bailey states that both upper and lower sets of jaws are similarly controlled and radially aligned to sharply define the therapeutic beam field (col. 7, ll. 1-6 and 35-60; col. 8, ll. 5-21; Figs. 2, 3, 5, 8).
In view of the utility of Bailey’s controlled lower jaw set for continuously defining the size and direction of a therapeutic radiation field while limiting penumbra and leakage, a person of ordinary skill would have used that known beam-defining jaw assembly at Pelizzari’s therapeutic source. The predictable result is directing Pelizzari’s radiation toward the image-identified target through a conventional adjustable aperture.
23. Claim(s) 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1) and further in view of Yu (US 5,818,902).
With regard to claim 30, Pelizzari modified discloses the claimed invention according to claim 29 but fails to expressly disclose synchronizes source/gantry motion with contemporaneous changes to the collimator-defined field shape.
Yu teaches continuous gantry motion while the MLC-conformed field shape changes during gantry rotation, and expressly synchronizes radiation delivery, gantry rotation, and field-shape alteration by slaving rotation and field-shape changes to delivered monitor units (col. 3, ll. 17-25; col. 4, ll. 60-65; Fig. 4).
In view of the utility of Yu’s synchronized dynamic MLC arc delivery for improving dose conformity while maintaining efficient continuous source motion, a person of ordinary skill would have applied Yu’s control technique to Pelizzari’s movable source and map-based treatment plan. The predictable result is a collimator configuration that follows the target map as the source moves through the planned firing angles.
Claim(s) 31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1) and further in view of Xu et al. (US 2007/0265528 A1) and Scott (US 3,794,840).
With regard to claim 31, Pelizzari modified provides chronological event storage and angular sorting, but does not by itself establish both a short target-associated LOR queue/selection and therapeutic delivery along the selected event-defined lines.
Xu teaches real-time PET tracking during radiation therapy using detector pairs mounted on a linac gantry. Each valid coincident event forms an individual coincidence line; acquired lines are divided into collections of 50-1000 lines, approximately 80 events may be acquired within 100 ms, and only lines within a defined spatial tolerance of a target-associated marker are permitted to contribute while other lines receive zero probability ([0022]-[0024], [0027], [0030]-[0036], [0041]-[0045], [0056], [0059]-[0060]; Figs. 1, 3, 5A-8). This teaches a nonzero collection interval and selection of individual target-associated LORs.
Scott teaches implanting a radioactive source in a tumor, sensing a straight-line emission path to the source, and making the centerline of the therapeutic radiation beam coincide with that detected path before delivering therapy (col. 1, ll. 48-61; col. 2, ll. 2-30; col. 3, l. 30-col. 4, l. 21; Figs. 1-2). Unlike the withdrawn Carroll theory, Scott does not merely align a camera field of view with a beam; it expressly uses the detected radioactive ray path as the beam-alignment path.
In view of the utility of Xu’s short LOR collections and per-line spatial filtering for rejecting random/scattered or wrong-target events, and Scott’s use of a detected radioactive emission path as the therapeutic beam trajectory, a person of ordinary skill would have collected Pelizzari/Manjeshwar LORs over a short interval, selected the lines associated with the target, and aligned Pelizzari’s movable source along the selected lines. Substituting PET coincidence-line geometry for Scott’s collimated single-ray direction is a predictable use of a more precise known emission-path detector for the same tumor-targeting function. The result is delivery only along emission paths supported by a short, filtered target-associated data queue.
30. Claim(s) 32 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1) and further in view of Scott (US 3,794,840).
With regard to claim 32, Pelizzari modified discloses the claimed invention according to claim 26 and further teaches positioning the source for PET/CT image information, and Manjeshwar defines the detected event LOR, but both fails to expressly disclose that the base set does not make the therapeutic beam axis coincide with the event-defined LOR itself.
Scott teaches sensing a straight-line radioactive emission path from a tumor and making the therapeutic beam centerline coincide with that path (col. 1, ll. 48-61; col. 2, ll. 2-30; Figs. 1-2).
In view of the utility of Scott’s emission-path/beam coincidence for removing directional mismatch between a radioactive tumor signal and the therapeutic beam, a person of ordinary skill would have used Manjeshwar’s more precise two-detector PET LOR as the detected emission path for aligning Pelizzari’s movable source. The modification substitutes one known radioactive-emission direction measurement for another and predictably places the therapeutic beam along the detected PET LOR.
Claim(s) 34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1) and further in view of Xu et al. (US 2007/0265528 A1).
With regard to claim 34, Pelizzari supplies registered CT/PET target-location information, and Manjeshwar supplies LOR coordinates and angles, but the base set does not expressly perform the claimed per-LOR target-intersection determination.
Xu teaches forming an individual coincidence line for each valid event, computing the perpendicular distance between each line and a target-associated marker location, and excluding a line from the target cluster when it lies outside a defined spatial tolerance. Xu also uses marker-position knowledge from treatment-planning CT and short successive line collections during treatment ([0032]-[0036], [0041]-[0045], [0056], [0059]-[0060]).
In view of the utility of Xu’s express per-line spatial gate for rejecting coincidence lines that do not geometrically correspond to the treatment target, a person of ordinary skill would have compared Manjeshwar’s LOR coordinates with Pelizzari’s registered three-dimensional target-volume coordinates and retained a line only when it intersects the target volume. Replacing Xu’s marker-centered tolerance region with Pelizzari’s already-known CT target boundary is a predictable application of the same line-to-target test and improves target-specific event selection. This rationale does not rely merely on an assertion that geometry is routine; Xu supplies the actual per-LOR spatial-selection operation and its targeting purpose.
Claim(s) 35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelizzari et al. (US 2006/0113482 A1) in view of Manjeshwar et al. (US 2007/0040122 A1) and Yan et al. (US 2008/0031406 A1) and further in view of Schildkraut et al. (US 2006/0182326 A1).
With regard to claim 35, Pelizzari modified teaches reducing dose outside the target and adaptively controlling dose but does not expressly identify an avoidance volume and withhold the intended primary beam when that volume would be exposed.
Schildkraut teaches detecting critical anatomy that must be spared from therapeutic-radiation exposure and refraining from irradiation with the therapeutic beam when the critical anatomy is detected within the volume to be exposed ([0070]-[0071]; Figs. 2-3).
In view of the utility of Schildkraut’s critical-anatomy gate for preventing the primary therapeutic beam from irradiating sensitive tissue, a person of ordinary skill would have included the detected critical-anatomy volume as an avoidance volume in Yan’s adaptive plan for Pelizzari’s source. The predictable result is beam delivery to the target only when the planned beam path excludes the identified avoidance volume. Under the broadest reasonable interpretation, “will not be irradiated” refers to exclusion from the intended primary beam, not the physically impossible absence of all scatter dose.
Conclusion
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/DJURA MALEVIC/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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