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 Group I (claims 1-15) in the reply filed on 10/10/2025 is acknowledged.
Response to Amendment
The amendment filed 10/10/2025 has been entered. Claims 1-15 remain pending in the application.
Claim Objections
Claims 4, 7, 13, and 15 are objected to because of the following informalities:
In claim 4, " pre-treatment image(s) not representative of the expected patient movement” should read --one or more of the pre-treatment images not representative of expected patient movement --.
In claim 7, line 3, "GI” should read –gastrointestinal--.
In claim 13, line 2, "adjusts or stops” should read –comprises adjusting or stopping--.
In claim 15, line 2, "aims” should read –comprises aiming--.
Appropriate correction is required.
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 1-10 and 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Although the claims fall within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter), claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection as judicial exceptions.
Regarding claim 1, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “generating a prognostic motion model based on at least the pre-treatment images; and generating a prognostic motion adapted radiation treatment plan based at least on the prognostic motion model” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. In particular, a type of motion can be ascertained mentally by reviewing the pre-treatment images. A person of ordinary skill in the art could formulate a treatment plan and adapt it mentally to the observed type of motion thereby generating a prognostic motion adapted radiation treatment plan. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “storing instructions which, when executed by at least one programmable processor, cause the at least one programmable processor to perform operations comprising: acquiring pre-treatment images with a magnetic resonance imaging system, the pre-treatment images capturing movement of a patient", which are the steps of data gathering and mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 1 is therefore non-statutory and not patent eligible.
Regarding claim 2, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the pre-treatment images comprise cine MRI”, which is further limiting the pre-solution data gathering. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 2 is therefore non-statutory and not patent eligible.
Regarding claim 3, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and “wherein the prognostic motion model comprises a model of expected patient movement during treatment”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 3 is therefore non-statutory and not patent eligible.
Regarding claim 4, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “excluding pre-treatment image(s) not representative of the expected patient movement during treatment”, which is further limiting the pre-solution data gathering. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 4 is therefore non-statutory and not patent eligible.
Regarding claim 5, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and “including multiple types of motion observed in the pre-treatment images”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 5 is therefore non-statutory and not patent eligible.
Regarding claim 6, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and “wherein the multiple types of motion include expected patient movement and irregular patient movement”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 6 is therefore non-statutory and not patent eligible.
Regarding claim 7, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and “wherein the multiple types of motion include one or more of: regular motion due to breathing, motion due to deep breathing, motion due to GI system gas movement, motion due to bladder filling, motion due to patient movement, motion due to swallowing, chest-wall breathing, diaphragm breathing, talking, eye movement, cardiac motion, or voluntary muscle motion”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 7 is therefore non-statutory and not patent eligible.
Regarding claim 8, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the prognostic motion adapted radiation treatment plan takes into account the prognostic motion model's expected patient movement during treatment”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 8 is therefore non-statutory and not patent eligible.
Regarding claim 9, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the expected patient movement during treatment includes deformation of a target or an organ of interest”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 9 is therefore non-statutory and not patent eligible.
Regarding claim 10, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the expected patient movement during treatment includes movement of a target”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 10 is therefore non-statutory and not patent eligible.
Regarding claim 12, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the prognostic motion adapted radiation treatment plan takes into account the prognostic motion model's expected patient movement and irregular patient movement during treatment”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 12 is therefore non-statutory and not patent eligible.
Regarding claim 13, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the prognostic motion adapted radiation treatment plan adjusts or stops delivery when the irregular patient movement of the prognostic motion model is observed during treatment”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 13 is therefore non-statutory and not patent eligible.
Regarding claim 14, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the prognostic motion adapted radiation treatment plan takes into account a latency between patient movement observed with the magnetic resonance imaging system and radiation beam delivery to the patient”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 14 is therefore non-statutory and not patent eligible.
Regarding claim 15, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the prognostic motion adapted radiation treatment plan aims the radiation beam where the target is expected to be based on the prognostic motion model and the latency rather than to a specific point in space”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 15 is therefore non-statutory and not patent eligible.
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 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.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raleigh et al (US20150182760), hereinafter Raleigh.
Regarding claim 1, Raleigh teaches a non-transitory, machine-readable medium storing instructions (“The software code may be stored as a series of instructions … random access memory” [0160]) which, when executed by at least one programmable processor (“Any of the methods described herein may be totally or partially performed with a computer system including a processor, which can be configured to perform the steps." [0162]; “one or more processors in communication with the beam assembly and the one or more detectors” claim 1), cause the at least one programmable processor to perform operations comprising:
acquiring pre-treatment images (220) with a magnetic resonance imaging system (“The functional models can be prepared using accurate pre-treatment scans, which can be taken at various body positions (e.g., rotations and/or translations).” Abstract; “prior to a treatment session, one or more scans (e.g. MRI or CT) of a patient can be taken to determine a location of a tumor relative to markers of a patient's body.” [0008] “As mentioned above, a digital pre-treatment body image of a patient can be created using various techniques (such as CT, MRI, and ultrasound).” [0143]; Fig. 2A), the pre-treatment images capturing movement of a patient (“FIG. 2A is a flowchart of a method 200 for determining a location of diseased tissue (e.g. a tumor) according to embodiments of the present invention. In one aspect, method 200 uses imaging scans (such as MRI or CT) to develop a 3D model of the location of the tumor for different physical positions of the patient. The physical positions of the patient can be defined using markers at a surface of the patient's body. Sensors at these marker positions (or at a defined position relative to the marker positions) can be used to determine the physical position of the patient's body during treatment.” [0033]; “In step 220, the patient is scanned to determine the positions of tissue (diseased or healthy) relative to the markers. For example, the absolute positions of the tissue and the markers can be determined in a particular reference frame. Scans can choose any coordinate system .... The absolute coordinates of the tissue and the markers can then be determined in this coordinate system. For example, the coordinates of tumor 310 and of markers 320 can be determined.” [0038]; “multiple scans can be performed at different body positions,” [0039]);
generating a prognostic motion model (“develop a 3D model of the location of the tumor for different physical positions of the patient.” [0033]. “Besides models that are based on laws of motion, time-dependent functions for predicting the next location of the tissue at a future time period can have other functional forms… Fourier functions (such as sine and cosine) Legendre polynomials, spherical harmonics, or any other basis functions can be used to approximate the data points obtained from measuring the location of the tissue over time.” [0087] “Accordingly, a time-dependent function can have the generic form of X.sub.I,J(t)=F(C,t), where X is a matrix with one dimension (e.g. I) being three and the other dimension (e.g. J) being the number of locations whose motion is being modeled,” [0110]) based on at least the pre-treatment images (“Some embodiments can provide freedom of movement to a patient undergoing radiation beam treatment. For example, prior to a treatment session, one or more scans (e.g. MRI or CT) of a patient can be taken to determine a location of a tumor relative to markers of a patient's body.” [0008]); and
generating a prognostic motion adapted radiation treatment plan (“beam assembly 120 may be moved during treatment so that healthy tissue is not irradiated for too long…If the beam assembly moved while staying focused, the same healthy tissue would not be continuously exposed." [0030]; “The desired treatment path can include a series of future pointing locations and/or pointing angles that will result in more exposure to the desired radiation target than is delivered to other body features including the one or more undesired radiation targets." [0153] “calculate a trajectory for the radiation beam” Claim 1; Figs. 7 and 8A-B) based at least on the prognostic motion model (“At time 0.2 s, the beam 820 is again focused on the tumor 810. Given that the sensors were sampled at 0.2 s, the location of the tumor was deduced, for example, from the relative coordinates of the sensors using a model as described” [0085], Fig. 8A; “use the motion model to calculate a trajectory for the radiation beam; and adjust the beam assembly such that the radiation beam follows the calculated trajectory” Claim 1; Fig. 10).
Regarding claim 3, Raleigh teaches the machine-readable medium of claim 1, wherein the prognostic motion model comprises a model of expected patient movement during treatment (“the equations of motion for the updates can use a time offset so that the position is the expected tumor location at the end of the re-positioning process.” [0099] “In step 1040, the position of each location J of tissue is determined at time t+.DELTA.t.sub.J, where t is the current time. The result is that the location of the tissue is computed for a future time. Since the beam is expected to take .DELTA.t.sub.J to move to the position at t+.DELTA.t.sub.J, the beam is expected to move along a similar trajectory that that the tissue is moving. Thus, the error is reduced compared to using the position of the tissue at the current time.” [0116]).
Regarding claim 5, Raleigh teaches the machine-readable medium of claim 1, wherein generating the prognostic motion model further comprises including multiple types of motion observed in the pre-treatment images (“other equations of motion can be used. For example, circular motion could be detected, or other curvilinear motion. In one embodiment, a computer system can have a predetermined number of equations for various types of motion. Each type of motion can be associated with a particular equation. Once the location information is matched to a type of motion (e.g. linear, curvilinear, rotational)" [0090]).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Raleigh as applied to claim 1 in view of D'Souza et al (US 20120004518), hereinafter D’Souza.
Regarding claim 2, Raleigh teaches the machine-readable medium of claim 1.
Raleigh does not teach that the pre-treatment images comprise cine MRI.
However, in the intraoperative magnetic resonance imaging field of endeavor, D’Souza discloses techniques for compensating movement of a treatment target in a patient, which is analogous art. D’Souza teaches that the pre-treatment images comprise cine MRI (“In step 362, the patient-specific correlation is used with a current real-time patient state measurement to obtain a current inferred position of target site. For example, the PLS model based on a tumor trajectory that was acquired during the pre-treatment cine MRI analysis is used to infer tumor position during treatment delivery.” [0080]).
Therefore, based on D’Souza’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Raleigh to have the pre-treatment images that comprise cine MRI, as taught by D’Souza, in order to facilitate determining movement of a treatment target in a patient for improved treatment planning.
Claims 4, 6-10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Raleigh as applied to claims 1 and 5 in view of Fan (US 20160324500), hereinafter Fan.
Regarding claim 4, Raleigh teaches the machine-readable medium of claim 1.
Raleigh does not teach excluding pre-treatment image(s) not representative of the expected patient movement during treatment.
However, in the magnetic resonance imaging field of endeavor, Fan characterization of respiratory motion in the abdomen using a 4d MRI technique with 3d radial sampling and respiratory self-gating, which is analogous art. Fan teaches excluding pre-treatment image(s) not representative of the expected patient movement during treatment (“a respiratory cycle with abnormal duration or outlier end-expiratory location is discarded” [0006]; “The retrospective k-space sorting-based technique allows for the exclusion of irregular breathing cycles after scanning and facilitates the reconstruction of an averaged phase-resolved volumetric image series that is robust against irregular breathing patterns and maintains image quality.” [0068]).
Therefore, based on Fan’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Raleigh to employ the step of excluding pre-treatment image(s) not representative of the expected patient movement during treatment, as taught by Fan, in order to facilitate magnetic resonance imaging of a region of interest for improved treatment planning.
Regarding claim 6, Raleigh teaches the machine-readable medium of claim 5.
Raleigh does not teach that the multiple types of motion include expected patient movement and irregular patient movement.
However, in the magnetic resonance imaging field of endeavor, Fan characterization of respiratory motion in the abdomen using a 4d MRI technique with 3d radial sampling and respiratory self-gating, which is analogous art. Fan teaches that the multiple types of motion include expected patient movement and irregular patient movement (“The healthy volunteer showed a relatively stable breathing pattern, while the patient showed occasional irregularities.” [0012] FIG. 3A and 3B; “the subject is breathing irregularly and/or deeply compared to a normal subject during imaging.” [0028]).
Therefore, based on Fan’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Raleigh to consider the multiple types of motion that include expected patient movement and irregular patient movement, as taught by Fan, in order to improve treatment planning for subjects with various movement patterns.
Regarding claim 7, Raleigh modified by Fan teaches the machine-readable medium of claim 6.
Raleigh does not teach that the multiple types of motion include one or more of:
regular motion due to breathing, motion due to deep breathing, motion due to GI system gas movement, motion due to bladder filling, motion due to patient movement, motion due to swallowing, chest-wall breathing, diaphragm breathing, talking, eye movement, cardiac motion, or voluntary muscle motion.
However, in the magnetic resonance imaging field of endeavor, Fan characterization of respiratory motion in the abdomen using a 4d MRI technique with 3d radial sampling and respiratory self-gating, which is analogous art. Fan teaches a motion due to deep breathing (“the subject is breathing irregularly and/or deeply compared to a normal subject during imaging.” [0028]).
Therefore, based on Fan’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Raleigh to consider the multiple types of motion that include one or more of:
regular motion due to breathing, motion due to deep breathing, motion due to GI system gas movement, motion due to bladder filling, motion due to patient movement, motion due to swallowing, chest-wall breathing, diaphragm breathing, talking, eye movement, cardiac motion, or voluntary muscle motion, as taught by Fan, in order to improve treatment planning for subjects with various movement patterns.
Regarding claim 8, Raleigh modified by Fan teaches the machine-readable medium of claim 6, wherein the prognostic motion adapted radiation treatment plan takes into account the prognostic motion model's expected patient movement during treatment (“the equations of motion for the updates can use a time offset so that the position is the expected tumor location at the end of the re-positioning process.” [0099] “In step 1040, the position of each location J of tissue is determined at time t+.DELTA.t.sub.J, where t is the current time. The result is that the location of the tissue is computed for a future time. Since the beam is expected to take .DELTA.t.sub.J to move to the position at t+.DELTA.t.sub.J, the beam is expected to move along a similar trajectory that that the tissue is moving. Thus, the error is reduced compared to using the position of the tissue at the current time.” [0116]).
Regarding claim 9, Raleigh modified by Fan teaches the machine-readable medium of claim 8, wherein Raleigh teaches that the expected patient movement during treatment includes deformation of a target or an organ of interest ("the shape of the tumor, as determined from scan(s), can be superimposed onto the tumor coordinate. In one implementation, changes in the shape or orientation of the tumor can also be determined as outputs to a functional model. For example, the orientation can be computed as a separate mapping, as defined by one or more parameters, such as the three Euler angles." [0064]).
Regarding claim 10, Raleigh modified by Fan teaches the machine-readable medium of claim 8, wherein Raleigh teaches that the expected patient movement during treatment includes movement of a target ("the shape of the tumor, as determined from scan(s), can be superimposed onto the tumor coordinate. In one implementation, changes in the shape or orientation of the tumor can also be determined as outputs to a functional model. For example, the orientation can be computed as a separate mapping, as defined by one or more parameters, such as the three Euler angles.” [0064]).
Regarding claim 14, Raleigh modified by Fan teaches the machine-readable medium of claim 10, wherein Raleigh teaches that the prognostic motion adapted radiation treatment plan takes into account a latency (“a delay” [0092]) between patient movement observed with the magnetic resonance imaging system and radiation beam delivery to the patient (“FIG. 9A shows a constant error in beam positioning due to movement of a tumor 910 according to embodiments of the present invention. FIG. 9B shows an example of a prediction of a location of a tumor between sampling times where the prediction accounts for a delay between sampling and positioning of a beam” [0025]. “A delay can exist between the time that the locations of the sensors are determined and the time that a new tumor location is determined from coordinates of the sensors (e.g. relative coordinates of the sensors). There can also be a delay between the time that the new tumor location is provided to a beam positioning mechanism and the time that the beam is positioned at the input tumor location. After these delays, the tumor may have already moved to a new location. For example, in FIG. 8A or 8B after a sampling at 0.2 s, the beam may not be re-positioned until 0.21 seconds, and thus the tumor would have moved to a new location based on a particular acceleration and velocity during the intervening 0.01 seconds.” [0092]).
Regarding claim 15, Raleigh modified by Fan teaches the machine-readable medium of claim 14, wherein Raleigh teaches that the prognostic motion adapted radiation treatment plan aims the radiation beam where the target is expected to be (“where the beam should ideally be positioned at the end of the time lag" [0093]) based on the prognostic motion model and the latency rather than to a specific point in space (“FIG. 9B shows an example of a prediction of a location of a tumor between sampling times where the prediction accounts for a delay between sampling and positioning of a beam” [0025]. “There can also be a delay between the time that the new tumor location is provided to a beam positioning mechanism and the time that the beam is positioned at the input tumor location. After these delays, the tumor may have already moved to a new location. For example, in FIG. 8A or 8B after a sampling at 0.2 s, the beam may not be re-positioned until 0.21 seconds, and thus the tumor would have moved to a new location based on a particular acceleration and velocity during the intervening 0.01 seconds.” [0092]; “By knowing how long the lag is for this sequence of measurement, processing and positioning steps, the beam can be positioned according to an estimate of where the beam should ideally be positioned at the end of the time lag" [0093]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Raleigh and Fan asapplied to claim 10, and further in view of Wu et al (CN 104587609), hereinafter Wu.
Regarding claim 12, Raleigh modified by Fan teaches the machine-readable medium of claim 10, wherein Raleigh teaches that the prognostic motion adapted radiation treatment plan takes into account the prognostic motion model's expected patient movement during treatment (“the equations of motion for the updates can use a time offset so that the position is the expected tumor location at the end of the re-positioning process.” [0099] “In step 1040, the position of each location J of tissue is determined at time t+.DELTA.t.sub.J, where t is the current time. The result is that the location of the tissue is computed for a future time. Since the beam is expected to take .DELTA.t.sub.J to move to the position at t+.DELTA.t.sub.J, the beam is expected to move along a similar trajectory that that the tissue is moving. Thus, the error is reduced compared to using the position of the tissue at the current time.” [0116]).
Raleigh modified by Fan does not teach that that the prognostic motion adapted radiation treatment plan takes into account the irregular patient movement during treatment.
However, in the intraoperative magnetic resonance imaging field of endeavor, Wu discloses non-invasive autonomic nervous system modulation, which is analogous art. Wu teaches that that the prognostic motion adapted radiation treatment plan (“the movement relevance model predicting the position of the position deviation” [0023]) takes into account the irregular patient movement during treatment (“if the position deviation is greater than the initially set threshold value” [0023]) (“e, image guided tracking in the treatment process, double image C arm at interval of certain time starting two groups of X light image system, online obtaining two patient dynamic tumor target or mark point DR image. calculating the dynamic tumor target or mark point of current position, obtaining the line the DR image in correlation with the motion model at the time corresponding to the plan image generation of the DRR image registration to obtain dynamic tumor target or current position of the mark point according to the movement relevance model predicting the position of the position deviation. first designing the treatment if the position deviation is less than threshold, the control system will automatically adjust the therapy head to motion compensation, updating and correcting the irradiating direction, if the position deviation is greater than the initially set threshold value I the treatment is discontinued temporarily, repeating the steps of updating and establishing a respiratory motion model, then repeating step e to image guided tracking” [0023]).
Therefore, based on Wu’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Raleigh and Fan to have the prognostic motion adapted radiation treatment plan that takes into account the irregular patient movement during treatment, as taught by Wu, in order to facilitate radiation treatment of a moving target.
Regarding claim 13, Raleigh modified by Fan and Wu teaches the machine-readable medium of claim 12.
Raleigh modified by Fan does not teach that that the prognostic motion adapted radiation treatment plan adjusts or stops delivery when the irregular patient movement of the prognostic motion model is observed during treatment.
However, in the intraoperative magnetic resonance imaging field of endeavor, Wu discloses non-invasive autonomic nervous system modulation, which is analogous art. Wu teaches that that the prognostic motion adapted radiation treatment plan (“the movement relevance model predicting the position of the position deviation” [0023]) adjusts or stops delivery when the irregular patient movement of the prognostic motion model is observed during treatment (“if the position deviation is greater than the initially set threshold value I the treatment is discontinued temporarily” [0023]).
Therefore, based on Wu’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Raleigh and Fan to have the prognostic motion adapted radiation treatment plan that adjusts or stops delivery when the irregular patient movement of the prognostic motion model is observed during treatment, as taught by Wu, in order to facilitate radiation treatment of a moving target.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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, Pascal Bui Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798