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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because when giving its BRI in light of the specification, the scope of the claim could be interpreted to include a transitory signal.
Turning to the speciation, the applicant does not limit what can be interpreted as the recording medium. In paragraph [0098] “Example 18 is at least one machine-readable medium including instructions for generating a radiotherapy treatment plan”, paragraph [0108] “Example 28 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1-27.”, and paragraph [0115] , “ Method examples described herein may be machine or computer- implemented at least in part. Some examples may include a computer- readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. The code may form portions of computer
program products. Further, in an example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer- readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.” Are open-ended examples of what the computer medium “may” include and do not preclude the medium being a transitory signal.
The MPEP 2106 I states: “Even when a product has a physical or tangible form, it may not fall within a statutory category. For instance, a transitory signal, while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine, is not a tangible article or commodity under the definition of a manufacture (even though it is man-made and physical in that it exists in the real world and has tangible causes and effects), and is not composed of matter such that it would qualify as a composition of matter. Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, a transitory, propagating signal does not fall within any statutory category. Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, 1294, 112 USPQ2d 1120, 1133 (Fed. Cir. 2017); Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03”
Therefore, when giving claims 11-20 their broadest reasonable interpretation in light of the specification the CRM can be interpreted to include a transitory signal.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swerdloff( US 20200276456) hereinafter Swerdloff.
Swerdloff teaches continuously delivering (1402) successive particle beams as the gantry rotates, such that each particle beam of the successive particle beams has an associated arc, with a center of the associated arc corresponding to a particular gantry angle for each particle beam. Multiple beamlets are delivered (1404) from a beginning of a respective arc to an end of the respective arc for a respective particle beam of the successive particle beams. Multiple predefined spots are determined (1406) in the target for the respective gantry angle for a respective gantry angle. The predefined spots are ordered (1408) in the spiral pattern from those closest to an isocentric axis for the respective gantry angle to those most distant from the isocentric axis. The successive particle beams are delivered (1410) includes the beamlets are delivered for the respective particle beam according to the spiral pattern of the predefined spots. [0037] FIG. 1 illustrates generally an example of a system 100, such as may include a particle therapy system controller, in accordance with an embodiment. The system 100 may include a database or a hospital database. The particle therapy system controller may include a processor, communication interface, or memory. The memory may include treatment planning software, an operating system, or a delivery controller. The delivery controller may include a beamlet module for determining or planning spot delivery (e.g., using a spot delivery module) or line segment delivery (e.g., using a line segment delivery module).
Regarding claims 1 and 11, Swerdloff teaches identifying a target location within a tumor of a patient;
providing a particle beam configured to deliver radiotherapy treatment to the tumor along a trajectory using at least two energies including a first energy and a second energy, the first energy greater than the second energy; determining a first location along the trajectory past the target location and a second location before the target location along the trajectory; determining a configuration for the particle beam to deliver the first energy to the first location and the second energy to the second location; and outputting a radiotherapy treatment plan according to the configuration. Note figs 11A – 14 and paragraphs, [0013] and [0014], A line segment is configured to uniformly deliver a plurality of particles between a starting position and an ending position. [0037] The delivery controller may include a beamlet module for determining or planning spot delivery (e.g., using a spot delivery module) or line segment delivery (e.g., using a line segment delivery module). [0055] FIG. 9 provides an illustration of beamlet delivery as line segments. The delivery mode of line segments of particle beamlets sometimes referred to as line scanning is a type of scan mode that is linear. Each beamlet that is delivered to the target has a starting point and an ending point. As illustrated, a beamlet is continuously scanned from a spot on the right to a spot on the left. The size and spacing of the line segments allow for a uniform dose delivery. The scanning may be controlled in any combination of continuous and/or incremented fashion, and independently control the particle beamlet intensity, generating an arbitrary pattern. Paragraphs [0060] – [0062] [0061] FIG. 11A illustrates a linear spot delivery path with differing spot sizes( different energies) and a raster pattern, in accordance with an embodiment. FIG. 11B illustrates a spiral spot delivery path with differing spot sizes. [0128] Method examples described herein may be machine or computer-implemented at least in part. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.
Regarding claims 2 and 12, Swerdloff teaches wherein the radiotherapy treatment plan includes a planned rotation of the particle beam about the patient and a planned dose distribution to be delivered to the target via multiple sets of two energies delivered by the particle beam at a particular rotation angles. Note figs 11A – 14 and paragraphs, [0013] and [0014] ,[0035] The systems and methods described herein account for both of these issues by introducing a spiral pattern for delivery of the beamlets. The spiral pattern may be used with planned angles at a range of degrees (e.g., five, ten, fifteen, etc.). In an example, the spiral pattern may include delivering the particle beam to a central portion of the target when at a highest error and to an outer portion of the target when at a lowest error. The amount of error may depend on angle difference between the actual gantry angle and the planned angle, for example with a higher error corresponding to a larger difference between angles, and a lower error corresponding to a smaller difference between angles. [0063] and [0068] In an example, beamlets may be delivered at the edges of an arc range may while the spiral is in the center of the target. For example, in an arc from 0 degrees to 10 degrees, the target may be planned as if the gantry was stationary at 5 degrees. In this example, the outside of the spiral occurs as the gantry approaches and leaves 5 degrees, while the center of the spiral occurs as the gantry leaves 0 degrees and as the gantry approaches 10 degrees. For example, starting at 0 degrees, the spiral may begin at the center of the target and spiral outward until ending (at an outward point of the spiral) around 5 degrees. Then, in an example, the spiral may reverse (e.g., move clockwise from 0 to 5 degrees, then counter-clockwise from 5 to 10 degrees, or vice versa) on the way back to the center of the target as the gantry moves from 5 to 10 degrees. The process may be repeated on a different layer of the target at another arc, for example from 10 to 20 degrees, etc., until the dose is completed.
Regarding claims 3 and 13, Swerdloff teaches wherein the radiotherapy treatment plan includes a plan to deliver the first energy at the first location at a first offset of a particular rotation angle and a plan to deliver the second energy at the second location at a second offset of the particular rotation angle. Note figs 11A – 14 and paragraphs, [0013] and [0014] and [0064] discusses the “error position” or “offset” thru different angles, FIGS. 12A-12B illustrate positioning errors when using spiral spot delivery, in accordance with an embodiment. FIG. 12A illustrates a positioning error 1204 according to an error angle 1202, which may be equal to a gantry angle rotation relative to a planned gantry angle. For example, for a planned angle of 5 degrees, as the gantry rotates to ten degrees, the positioning error 1204 may be at a maximum. When the gantry rotates to 5 degrees, the error may be at a minimum (or non-existent). The gantry may rotate continuously at a constant rotation speed, with a constant angular velocity. The change in position (error) may be equal to the angular velocity divided by cosine of the gantry angle. Path differences due to energy absorption (which may be minor) may be ignored, due to difficulties in determining the energy absorption of each path. To remove these errors, the particle beam may be directed at a central portion of the target when the error is highest (e.g., at positioning error 1204) to minimize the error, and the particle beam may be directed at outer portions of the target when the positioning error 1204 is lower (e.g., when closer to the central arc angle).
Regarding claims 4 and 14, Swerdloff teaches wherein the first offset is between a quarter of a degree and five degrees before the particular rotation angle, and wherein the second offset is between a quarter of a degree and five degrees after the particular rotation angle. . Note figs 11A – 14 and paragraphs, [0013] and [0014] and [0064] discusses the “error position” or “offset” thru different angles, FIGS. 12A-12B illustrate positioning errors when using spiral spot delivery, in accordance with an embodiment. FIG. 12A illustrates a positioning error 1204 according to an error angle 1202, which may be equal to a gantry angle rotation relative to a planned gantry angle. For example, for a planned angle of 5 degrees, as the gantry rotates to ten degrees, the positioning error 1204 may be at a maximum. When the gantry rotates to 5 degrees, the error may be at a minimum (or non-existent). The gantry may rotate continuously at a constant rotation speed, with a constant angular velocity. The change in position (error) may be equal to the angular velocity divided by cosine of the gantry angle. Path differences due to energy absorption (which may be minor) may be ignored, due to difficulties in determining the energy absorption of each path. To remove these errors, the particle beam may be directed at a central portion of the target when the error is highest (e.g., at positioning error 1204) to minimize the error, and the particle beam may be directed at outer portions of the target when the positioning error 1204 is lower (e.g., when closer to the central arc angle).
Regarding claims 5 and 15, Swerdloff teaches configuring the particle beam to deliver the first energy to the first location and the second energy to the second location according to the radiotherapy treatment plan. Note figs 11A – 14 and paragraphs, [0013] and [0014], [0061] – [0071].
Regarding claims 6 and 16, Swerdloff teaches wherein outputting the radiotherapy treatment plan includes displaying the radiotherapy treatment plan on a user interface. Note figs 11A – 14 and paragraphs, [0013] and [0014], [0061] – [0071]. [0037], [0039] FIG. 1 illustrates generally an example of a system 100, such as may include a particle therapy system controller, in accordance with an embodiment. The system 100 may include a database or a hospital database. The particle therapy system controller may include a processor, communication interface, or memory. The memory may include treatment planning software, an operating system, or a delivery controller. The delivery controller may include a beamlet module for determining or planning spot delivery (e.g., using a spot delivery module) or line segment delivery (e.g., using a line segment delivery module).
Regarding claims 7 and 17, Swerdloff teaches wherein the radiotherapy treatment plan includes delivering treatment according to a raster or spiral pattern. Note figs 11A – 14 and paragraphs, [0013] and [0014], [0034] and [0061].
Regarding claims 8 and 18, Swerdloff teaches wherein the particle beam is configured to deliver radiotherapy treatment to the tumor using a mini-ridge filter (MRF). Note figs 11A – 14 and paragraphs, [0013] and [0014], [0044] The energy selector 307 (e.g., a range scatter) may be used to select the energies of the protons to be delivered to the patient. In an embodiment called passive scattering, an optional range modulator 308 (e.g., also called a ridge filter or a range modulation wheel) may be utilized to broaden the beam to fit the tumor.
Regarding claims 9 and 19, Swerdloff teaches wherein the particle beam emits protons. Note figs 11A – 14 and paragraphs, [0013] and [0014], [0044] The energy selector 307 (e.g., a range scatter) may be used to select the energies of the protons to be delivered to the patient. In an embodiment called passive scattering, an optional range modulator 308 (e.g., also called a ridge filter or a range modulation wheel) may be utilized to broaden the beam to fit the tumor.
Regarding claims 10 and 20, Swerdloff teaches wherein the radiotherapy treatment plan requires a robustness factor, the robustness factor including a minimum error in dose distribution defined by comparing an actual dose distribution to an intended dose distribution. Note figs 11A – 14 and paragraphs, [0013] and [0014] and paragraphs [0064] – [0069] Error increases as distance from central planned gantry angle increases. At zero distance from the central planned gantry angle, zero error occurs. For an arc of ten degrees, for example, from five degrees before the central planned gantry angle to five degrees after the central planned gantry angle, maximum error occurs at the five degrees before and the five degrees after. This error is compounded when a raster-scan approach is used. This error is lowered, for example compared to the raster-scan approach, when a spiral pattern approach is used.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boeh et al.( US 20090296885) teaches a method of irradiating a target in a subject using charged particle therapy includes the steps of positioning a subject on a supporting device, positioning a delivery device adapted to deliver charged particles, and delivering charged particles to a target in the subject wherein the delivery device rotates around the target during delivery of at least a portion of the charged particles. [0031] The energy modifiers 24A are configured to modify the energy of the beam such that the beam range within the targeted tumor is controlled. The energy modifiers 24A can be made of suitable energy absorbing materials such as carbon (a low-Z material), lead (a high-Z material) or other suitable materials. The energy modifiers 24A may be in various forms including shifters, wheels, wedges, or filters. By varying the thickness and/or form of the energy absorbing materials, the beam energy can be modified in a time and/or spatial dependent manner. For example, a spread-out Bragg peak (SOBP) filter is a range modulator made of energy absorbing materials of variable thickness. By sequentially passing the beam through the energy absorbing material of variable thickness, the Bragg peaks are spread out along the depth of the target volume.
Ollila et al.( US 20180154179) teaches a method for determining MLC leaf sequences for radiation treatment includes obtaining BEV projections of a first target volume and a second target volume along one or more treatment paths of a radiation treatment plan, analyzing the BEV projections to determine one or more contiguous ranges of spatial points where there exists an interstitial region between the first target volume and the second target volume in the direction of MLC leaf motion, and determining a first set of MLC leaf sequences such that an aperture formed by the MLC in a first portion of the one or more contiguous ranges of spatial points exposes radiation to the first target volume but not the second target volume, and an aperture formed by the MLC in a second portion of the one or more contiguous ranges of spatial points exposes radiation to the second target volume but not the first target volume.
Traneus(EP 3766540) teaches a radiotherapy treatment plan for grid therapy in which a patient is radiated from a source of radiation with a set of spatially fractionated beams of charged particles such as protons, including varying the direction of each beam in the set of beams. Generating the plan comprises the steps of determining a first path through the patient to a first Bragg peak position and determining a second path through the patient, at least a part of the second path being directed at an angle from the first path to a first deflected Bragg peak position. The beam directions may be varied by means of magnetic fields or by varying the relative angle between the gantry and the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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