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 .
Response to Arguments
Applicant’s arguments filed 03/03/2026 have been fully considered and are persuasive.
Rejections under previously-found reference of Liu have been withdrawn. However, previously-found reference of Laurence has been maintained as the primary reference. Additionally, newly-found reference of Dougherty has been introduced, and newly-found reference of Zheng has been introduced to replace previously-found reference of Meaney.
Claim Objections
Objections to the claims have been withdrawn in response to Applicant’s amendments filed 03/03/2026.
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 1-10, 14, & 16-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Laurence (US 2019/0143145).
Regarding claim 1, Laurence teaches a method for magnetic resonance imaging (MRI)-guided radiotherapy, comprising:
obtaining first auxiliary signals (3-D model generated during patient set up (e.g., just before the session), [0036]) and second auxiliary signals (3-D model generated during an imaging or treatment session, [0036]) collected by an MRI device (MRI scanning system, [0058]) during an MRI scan of a target subject ([0058]), wherein the first auxiliary signals are collected by the MRI device at a first time (earlier time interval, [0010]) before radiotherapy rays are emitted ([0036]), and the second auxiliary signals are collected by the MRI device at a second time (specified time interval, [0010]) after the radiotherapy rays are emitted ([0036]);
determining, based on the first auxiliary signals and the second auxiliary signals, whether a first motion amplitude (identified difference in the 3-D models, [0010]) of the target subject from the first time to the second time is greater than a threshold (predetermined movement threshold, [0010]); and
determining, based on a determination result of whether the first motion amplitude is greater than the threshold, whether to stop emitting the radiotherapy rays ([0010]).
Regarding claim 2, Laurence teaches the method of claim 1, further comprising:
obtaining first imaging signals ([0010], [0033], & [0058]) collected by the MRI device ([0058]) before the radiotherapy rays are emitted ([0036]);
Paragraph [0010] teaches that the 3-D models are created using images taken of the patient. Paragraph [0058] teaches that these patient-monitoring images may be MRI images.
determining, based on the first auxiliary signals and the first imaging signals, an initial temporal factor and an initial spatial factor ([0010]);
The earlier time interval at which the first 3-D model is taken represents the initial temporal factor, and the first 3-D model to which future 3-D models will be compared represents the initial spatial factor.
in response to determining that the first motion amplitude is smaller than or equal to the threshold, determining a first updated temporal factor based on the second auxiliary signals ([0010], [0036]); and
Per [0010], the session stops when the movement threshold is exceeded; thus, to progress to the point of generating a second 3-D model, the motion amplitude must have been smaller than or equal to the threshold. Additionally, the time at which the second 3-D model is obtained (specified time interval in [0010]) represents the first updated temporal factor.
generating, based on the first updated temporal factor and the initial spatial factor, a first MRI image of the target subject, wherein the first MRI image corresponds to the second time ([0036]).
Paragraph [0036] teaches that the second 3-D model is generated during an imaging session and the first 3-D model is generated during patient set up. Thus, the first MRI image is taken during the second time.
Regarding claim 3, Laurence teaches the method of claim 2, wherein the initial temporal factor is determined by:
obtaining a transformation coefficient, the transformation coefficient representing a relationship between auxiliary signals and temporal factors ([0010]); and
Paragraph [0010] teaches encoding each 3-D model to its own time interval. In order for the system to do this, a transformation coefficient or equivalent thereof must exist.
determining, based on the transformation coefficient and the first auxiliary signals, the initial temporal factor ([0010]).
Regarding claim 4, Laurence teaches the method of claim 2, wherein the initial temporal factor relates to at least one time-varying dimension of the target subject ([0010]), and the initial spatial factor reflects a relationship between pixel information of the target subject in the image domain and spatial information of the target subject in the physical domain ([0010]).
It is expected that the 3-D models are digital representations of the patient’s physical dimensions and geometries.
Regarding claim 5, Laurence teaches the method of claim 2, wherein the first MRI image of the target subject is a three-dimension (3D) image ([0010], [0036], & [0058]).
Regarding claim 6, Laurence teaches the method of claim 1, further comprising:
in response to determining that the first motion amplitude is greater than the threshold:
instructing a radiotherapy device (radiation therapy system, [0033]) to stop emitting the radiotherapy rays ([0010]);
obtaining third auxiliary signals ([0065]) collected by the MRI device at a third time, wherein the third time is later than the second time;
Paragraph [0065] teaches that 3-D models are continuously obtained. Thus, there exists a third set of auxiliary signals obtained at a third time.
determining, based on the first auxiliary signals and the third auxiliary signals, whether a second motion amplitude of the target subject from the first time to the third time is greater than the threshold ([0036] & [0052]); and
Paragraphs [0036] & [0052] teach that the model obtained during set up, corresponding to the first set of auxiliary signals, serves as the baseline position by which all future models are compared.
in response to determining that the second motion amplitude is smaller than or equal to the threshold, instructing the radiotherapy device to continue emitting the radiotherapy rays ([0061] & [0067]).
Paragraph [0067] teaches “a breathing cycle phase suitable for radiation delivery”. In addition to the respiratory gating taught in [0061], it can be assumed that certain parts of the respiratory cycle are appropriate for therapy delivery, while other parts of the cycle are not, creating a cyclical pattern of therapy delivery. Therefore, when the motion threshold is exceeded, one having ordinary skill in the art would understand that the therapy may be resumed once the patient’s motion falls below the threshold once again.
Claim 7 is rejected for similar reasons to claim 2. The method of Laurence will proceed identically regardless of whether the motion envelope had previously been exceeded or not.
Regarding claim 8, Laurence teaches the method of claim 6, wherein in response to determining that the second motion amplitude is greater than the threshold, the method further comprises:
determining, based on the second auxiliary signals and the third auxiliary signals ([0067]), whether a third motion amplitude of the target subject from the second time to the third time is greater than the threshold ([0036] & [0052]); and
Paragraph [0067] teaches that the reference model to which subsequent models are compared may be “a patient 3-D model generated at an earlier time point and/or at the start of a treatment session”. Thus, Laurence teaches that the comparison can be made using any previously-generated model, not just the first one.
in response to determining that the third motion amplitude is smaller than or equal to the threshold, instructing the radiotherapy device to continue emitting the radiotherapy rays ([0061 & [0067], See rejection of claim 6).
Claim 9 is rejected for similar reasons to claims 2 & 7.
Regarding claim 10, Laurence teaches the method of claim 9, wherein the determining, based on second imaging signals collected by the MRI device between the second time and the third time and the second updated temporal factor, an updated spatial factor comprises:
determining, based on the second updated temporal factor and the second imaging signals, a reference spatial factor (reference model, [0067]); and
determining the updated spatial factor based on the initial spatial factor and the reference spatial factor ([0067]).
Regarding claim 14, Laurence teaches the method of claim 9, wherein the in response to determining that the third motion amplitude is smaller than the threshold, instructing the radiotherapy device to continue emitting the radiotherapy rays includes:
determining, based on the third MRI image, position information of a region of interest (ROI) (tumor position, [0068]) of the target subject at the third time;
updating, based on the position information, radiation parameters of the radiotherapy rays ([0067]); and
instructing, based on the updated radiation parameters, the radiotherapy device to continue emitting the radiotherapy rays ([0067]).
Claim 16 is rejected for similar reasons to claim 1. Laurence further teaches:
at least one storage device (memory, [0088]) including a set of instructions (instructions, [0088]); and
at least one processor (processor, [0088]) configured to communicate with the at least one storage device ([0088]).
Claim 17 is rejected for similar reasons to claim 2.
Claim 18 is rejected for similar reasons to claim 3.
Claim 19 is rejected for similar reasons to claim 4.
Claim 20 is rejected for similar reasons to claim 16.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Laurence, as applied to claim 9, above, in view of Dougherty (US 2009/0105582).
Regarding claim 11, Laurence teaches the method of claim 9, wherein the determining, based on second imaging signals collected by the MRI device between the second time and the third time and the second updated temporal factor, an updated spatial factor comprises: determining the updated spatial factor based on the second updated temporal factor and the second imaging signals ([0036]).
However, Laurence fails to disclose: updating, based on the second imaging signals, coil sensitivity maps of coils; and determining the updated spatial factor based on the updated coil sensitivity maps.
Dougherty teaches:
updating, based on the second imaging signals, coil sensitivity maps of coils ([0083]); and
Generating a separate coil sensitivity map for each image, as is taught in [0083] of Dougherty, comprises updating the coil sensitivity map for the second image.
determining the updated spatial factor based on the updated coil sensitivity maps ([0083]).
The spatial factors are based on the models generated by Laurence, which use image data in their reconstructions. Because the coil sensitivity maps are used in image generation, the spatial factors are based on them.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Laurence to include: updating, based on the second imaging signals, coil sensitivity maps of coils; and determining the updated spatial factor based on the updated coil sensitivity maps, as taught by Dougherty. Updating the coil sensitivity maps improves the quality of image data received. This, in turn, results in more accurate models, and allows patient positioning to be better monitored.
Claims 12-13 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Laurence, as applied to claim 1, above, in view of Zheng (US 2019/0086498).
Regarding claims 12-13, Laurence teaches the method of claim 9.
However, Laurence fails to disclose: the second updated temporal factor is determined based on the third auxiliary signals within a time period of 50 milliseconds; and the updated spatial factor is determined based on the second imaging signals within a time period of 500 milliseconds.
Zheng teaches:
the second updated temporal factor is determined based on the third auxiliary signals within a time period of 50 milliseconds ([0002]); and
the updated spatial factor is determined based on the second imaging signals within a time period of 500 milliseconds ([0002]).
The temporal and spatial factors are based on the models generated by Laurence, which use image data in their reconstructions. By generating the images within 30 milliseconds, as is taught by Zheng, the temporal and spatial factors will be generated in this time frame as well.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Laurence to include: the second updated temporal factor is determined based on the third auxiliary signals within a time period of 50 milliseconds; and the updated spatial factor is determined based on the second imaging signals within a time period of 500 milliseconds, as taught by Zheng. Generating the images, and, thus, the models, in near-real-time allows a more accurate tracking of patient movement, resulting in a more effective delivery of therapeutic radiation.
Regarding claim 15, Laurence teaches the method of claim 1, wherein the determining, based on the first auxiliary signals and the second auxiliary signals, whether a first motion amplitude of the target subject from the first time to the second time is greater than a threshold includes: determining whether the first motion amplitude of the target subject from the first time to the second time is greater than the threshold based on the first auxiliary signals and the second auxiliary signals ([0010]).
However, Laurence fails to disclose: the first auxiliary signals have a first readout direction; and obtaining first reference auxiliary signals collected by the MRI device, wherein the first reference auxiliary signals are collected after the first time, the first reference auxiliary signals have a second readout direction.
Zheng teaches:
the first auxiliary signals (odd echoes, [0087], Figure 7B) have a first readout direction ([0087] & Figure 7B); and
obtaining first reference auxiliary signals (even echoes, [0087], Figure 7B) collected by the MRI device (magnetic resonance imaging (MRI) system 100, [0055]), wherein the first reference auxiliary signals are collected after the first time (Figure 7B, [0096]), the first reference auxiliary signals have a second readout direction ([0087] & Figure 7B).
Paragraph [0096] teaches that the data is collected iteratively. Thus, the first reference auxiliary signals would be collected after the first auxiliary signals. This is further represented in Figure 7B.
References in the claim to the “second” of something (second auxiliary signals, second time, etc.) refer to a second image using the same method. If the method of Zheng is repeated, these “seconds” will exist.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Laurence to include: the first auxiliary signals have a first readout direction; and obtaining first reference auxiliary signals collected by the MRI device, wherein the first reference auxiliary signals are collected after the first time, the first reference auxiliary signals have a second readout direction, as taught by Zheng. Per [0002] of Zheng, obtaining data with different readout directions can help reduce artifacts. This would result in a more accurate tracking of patient position.
Conclusion
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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