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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 is rejected because it recites the limitation “wherein the irradiation device is configured to emit and apply a radiation to a target area, wherein the radiation is in a form that is modulated in intensity in an acoustic frequency range, synchronized with image capture by the magnetic resonance tomography unit”. It is unclear if the emitting and applying the radiation to the target area is synchronized with the image capture or if the acoustic frequency range is synchronized with the image capture. For examination purposes, the examiner assumes the emitting and applying (hence the timing of the emitting and applying) is synchronized with the image capture.
Claims 9-14 are rejected because they inherit deficiencies by nature of their dependency, directly or indirectly, on claim 8.
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.
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(s) 1, 6, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2023/0125842 to Dempsey et al. “Dempsey”, in view of Non-Patent Literature (NPL): “Evaluation of the Dynamic Mechanical Behavior of Polymer Gel Dosimeter” to Vieira et al. “Vieira”, and further in view of NPL: “Ionizing radiation-induced acoustics for radiotherapy and diagnostic radiology applications” to Hickling et al. “Hickling”.
Regarding claims 1 and 15, Dempsey discloses a method and computer program product (system, method, and computer software, for determining accumulated dose to tissues during radiotherapy, Abstract) for monitoring (Paragraph 0063, “track accumulated dose during radiotherapy”) in real time (Paragraph 0063, real-time imaging and dose calculations), by a magnetic resonance tomography unit (Fig. 1, Ref. 101, MRI),
a radiation dose (delivery of radiation therapy, Paragraph 0032) applied by an irradiation device (radiotherapy device, Fig. 1, Ref. 150) in a target area (deliver radiotherapy to a patient, Paragraph 0053; Paragraph 0044, target such as a tumor receives the radiation), the method and computer program product, when executed by the controller (Paragraph 0013, processor performs the operations of the instructions), comprising:
applying radiation to the target area (deliver radiotherapy to a patient, Paragraph 0053; Paragraph 0044, target such as a tumor receives the radiation) by the irradiation device (radiotherapy device, Fig. 1, Ref. 150) (also see Fig. 6, Step 610);
capturing, by the magnetic resonance tomography unit, a magnetic resonance image of the target area during application of the radiation (Fig. 6, Step 620; Paragraph 0053, “At 620, the system can acquire images of the patient from a magnetic resonance imaging system during the radiotherapy”); and
ascertaining a dose distribution of the radiation in the target area (Fig. 6, Step 640, and Paragraphs 0056, 0063, determining accumulated dose or actual dose delivered during radiotherapy, in the form of 2D and/or 3D mappings).
However, Dempsey does not disclose:
wherein the magnetic resonance tomography unit employs a sequence that captures an amplitude of a deflection of tissue in the target area; and
ascertaining the dose distribution of the intensity-modulated radiation in the target area based on the captured amplitude of the deflection.
Vieira a similar method of determining the potential of magnetic resonance elastography (MRE) elastograms to visualize and quantify dose distribution of a gel dosimeter (Page 287, Abstract) that is irradiated with a radiation beam (Page 103, left column, 2.2 Phantom irradiation procedure) and imaged with a magnetic resonance imager (Page 103, right column, sections 2.3 and 2.4).
Vieira teaches the magnetic resonance tomography unit employs a sequence (Page 288, left column, using a 1.5T whole-body MRI scanner and a gradient echo based pulse sequence with one cyclic motion encoding gradient pair) that captures an amplitude of a deflection of the sample in the target area (See Fig. 3, right image, and Fig. 5, elastography image and plot showing the displacement in µm of regions of the sample gel); and
ascertaining the dose distribution of the radiation in the target area based on the captured amplitude of the deflection (Fig. 4 and Page 289, determining the shear stiffness distribution map, which were based on the displacement/wave map of Fig. 3, and wherein the shear stiffness map has a strong correlation with the R2 maps, Page 290, left column, and Fig. 6, wherein the R2 map is currently the most reliable imaging dosimetry technique, Page 289, left column, first paragraph under Fig. 3; Page 290, Conclusion, therefore Vieira concludes that quantitative estimation of shear stiffness [in the sample] can be obtained from dynamic measurements of micrometer displacements, which would read on the claimed amplitude of deflection, and the shear stiffness distributions have a good correlation with the dose distribution map, i.e. the R2 map, which as stated in the Abstract, last sentence, suggests that MRE elastograms can visualize and quantify dose distribution in the sample gel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Dempsey's invention, wherein the method includes wherein the magnetic resonance tomography unit employs a sequence that captures an amplitude of a deflection of a sample in the target area and ascertaining the dose distribution of the intensity-modulated radiation in the target area based on the captured amplitude of the deflection, as taught by Vieira, in order to take advantage of the effect of shear modulus, which can provide remarkable contrast for different absorbed doses of radiation, to quantify and visualize does distribution, which can be useful for applications in radiotherapy planning (Page 287, right column).
However, the modifications of Dempsey and Vieira do not disclose wherein the applied radiation is intensity-modulated in an acoustic frequency range.
Hickling teaches wherein the applied radiation is intensity-modulated in an acoustic frequency range (typical therapeutic dose of photon beams in radiotherapy is in the frequency range of 10-100kHz of proton-induced acoustic emissions, Page e716, right column, future outlook; and dosimetry is often used with intensity modulated radiation therapy, Page e711, right column, section 4.A.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey and Vieira wherein the applied radiation is intensity-modulated in an acoustic frequency range, as taught by Hickling, since it is inherent that radiotherapy applied to an irradiated object deposits dose and heat energy, which leads to a temperature rise, and thermoelastic expansion, that generates and propagates acoustic waves (Page e708, right column, top section), and intensity modulated radiation therapy is associated with dosimetry (Page e711, right column, section 4.A).
Further, it would have been obvious to apply the teachings of Vieira, in view of Hickling, of using a dosimetry technique to tissue of a patient due to the suggestion from the International Atomic Energy Agency of performing in vivo dosimetry, especially for patients receiving treatment via novel delivery techniques, where the does received is potentially close to surrounding normal tissue tolerance (Page e711, right column, section 4.A).
Regarding claim 6, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 1 above.
Dempsey discloses ascertaining a position of a target tissue from one of the captured magnetic resonance images; and carrying out further irradiation depending on the ascertained position of the target tissue (Fig. 9, step 910, acquiring pre-treatment images with a magnetic resonance imaging system; Paragraph 0078, and Fig. 10, determining a position of a target 1010 and position of a neighboring organ 1030, to determine a motion model, and Paragraph 0079, stopping the treatment when the movement is identified/observed by the imaging system during treatment; Paragraph 0089, resuming treatment when motion of the patient returns to the expected patient movement or Paragraph 0090, when the location of anatomical structures returns to a state similar to that prior to the treatment being interrupted)
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, and further in view of Hickling, as applied to claim 1 above, and further in view of NPL: “Quantitative magnetic resonance elastography for polymer-gel dosimetry phantoms” to Vieira et al “Vieira 2019”.
Regarding claim 2, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 1 above.
Vieira teaches capturing a reference magnetic resonance image of the target area without radiation applied (capturing images of the gel dosimeters samples using the 1.5T whole-body MRI scanner, wherein one of the sample gel was unirradiated, Page 288, left column),
However, the modifications of Dempsey, Vieira, and Hickling do not disclose wherein the dose distribution is ascertained based on the magnetic resonance image and the reference magnetic resonance image.
Vieira 2019 presents teachings that extend was disclosed in Vieira. Vieira 2019 teaches wherein the dose distribution is ascertained based on the magnetic resonance image and the reference magnetic resonance image (Page 103, right column, last paragraph first paragraph of Page 104, left column, “In quantitative analysis (i.e. dosimetry), calibration curves are often used to estimate the level of absorbed dose of a sample… The estimated areas of each shear modulus curve were subsequently obtained by subtracting the value of An, which was the shear modulus of the irradiated samples (10, 20, 30, 40 and 50 Gy), from A0, which was the shear modulus of the nonirradiated sample (0 Gy).”; wherein the shear modulus were obtained from the wave-displacement images and converted to elastograms, Abstract, which reads the examiner interprets as respective wave-displacement images and elastograms, i.e. each applied dosage, including a dose of 0, would have their own wave-displacement image and elastogram).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the dose distribution is ascertained based on the magnetic resonance image and the reference magnetic resonance image, as taught by Vieira 2019, in order to also determine the sensitivity of the method as a function of frequency of the frequency of the modulation of the sample (Vieira 2019, Page 104, left column).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, and further in view of Vieira 2019, as applied to claim 2 above, and further in view of US2014/0114177 to Chen et al. “Chen”.
Regarding claim 3, the modifications of Dempsey, Vieira, Hickling, and Vieira 2019 disclose all the features of claim 2 above.
As disclosed in the claim 1 rejection above, Vieira teaches wherein all the MRE data is acquired using a gradient echo based pulse sequence with one cyclic motion encoding gradient pair (Page 288, left column). This reads on a sequence containing motion encoding gradients is used in the capturing of the magnetic resonance image and in the capturing the reference magnetic resonance image.
However, the modifications of Dempsey, Vieira, Hickling, and Vieira 2019 do not disclose wherein the capturing of the magnetic resonance image and/or the capturing the reference magnetic resonance image is performed with an inverted polarity of a phase encoding gradient.
Chen teaches a GRE pulse sequence that is used for acquiring MRE data (Paragraph 0044), wherein the sequence includes motion encoding gradients (Fig. 6, Ref. 608, Paragraph 0045) and a rewinder gradient (Fig. 6, Ref. 222, Paragraph 0049) that is equal in magnitude, but opposite in polarity with the phase-encoding gradient 614 (Paragraph 0049; also see Fig. 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, Hickling, and Vieira 2019 wherein the MRE sequence of Vieira, uses an inverted polarity of a phase encoding gradient, such as the rewinder gradient, as taught by Chen, in order to prepare the magnetization for the next repetition of the pulse sequence (Chen, Paragraph 0049).
Therefore, in the combination of Dempsey, Vieira, Hickling, and Vieira 2019, Vieira uses the MRE GRE sequence to acquire both the reference (no irradiation) image and the irradiated images, and in view of Chen would include the rephasing gradient, which is a gradient with an inverted polarity of a phase encoding gradient.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, and further in view of Hickling, as applied to claim 1 above, and further in view of Chen.
Regarding claim 4, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Vieira teaches wherein all the MRE data is acquired using a gradient echo based pulse sequence with one cyclic motion encoding gradient pair (Page 288, left column). This reads on a sequence containing motion encoding gradients is used in the capturing of the magnetic resonance image.
However, the modifications of Dempsey, Vieira, and Hickling do not disclose wherein the capturing of the magnetic resonance image is performed with an inverted polarity of a phase encoding gradient.
Chen teaches a GRE pulse sequence that is used for acquiring MRE data (Paragraph 0044), wherein the sequence includes motion encoding gradients (Fig. 6, Ref. 608, Paragraph 0045) and a rewinder gradient (Fig. 6, Ref. 222, Paragraph 0049) that is equal in magnitude, but opposite in polarity with the phase-encoding gradient 614 (Paragraph 0049; also see Fig. 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the MRE sequence of Vieira, uses an inverted polarity of a phase encoding gradient, such as the rewinder gradient, as taught by Chen, in order to prepare the magnetization for the next repetition of the pulse sequence (Chen, Paragraph 0049).
Therefore, in the combination of Dempsey, Vieira, and Hickling, Vieira uses the MRE GRE sequence to acquire the magnetic resonance elastography images, and in view of Chen would include the rephasing gradient, which is a gradient with an inverted polarity of a phase encoding gradient.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, and further in view of Hickling, as applied to claim 1 above, and further in view of US2017/0000376 to Partanen et al. “Partanen”.
Regarding claim 5, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 1 above.
However, the modifications of Dempsey, Vieira, and Hickling do not disclose capturing a temperature magnetic resonance image of the target area by image capture using a temperature-sensitive sequence and ascertaining a temperature map of the target area from the temperature magnetic resonance image.
Partanen teaches in a similar field of endeavor of using magnetic resonance imaging for planning, monitoring, and controlling treatment using high intensity focused ultrasound (Abstract).
Partanen teaches capturing a temperature magnetic resonance image of the target area by image capture using a temperature-sensitive sequence and ascertaining a temperature map of the target area from the temperature magnetic resonance image (Figs. 9A and 9B, Paragraph 0121, acquiring with MRI sequence to obtain MR phase images, which is then used to create temperature maps of the imaged area as seen in Figs. 9A and 9B).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the method further includes capturing a temperature magnetic resonance image of the target area by image capture using a temperature-sensitive sequence and ascertaining a temperature map of the target area from the temperature magnetic resonance image, as taught by Partanen, in order to be able to prove real time monitoring of the treatment of biological material (Partanen, Abstract and Paragraph 0121).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, and further in view of Hickling, as applied to claim 1 above, and further in view of US2010/0125191 to “Sahin”.
Regarding claim 7, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 1 above.
However, the modifications of Dempsey, Vieira, and Hickling do not disclose achieving predefined heating in the target area by a radiofrequency signal from the magnetic resonance tomography unit.
Sahin teaches achieving predefined heating in the target area (See Fig. 8A, selecting a volume of interest, VOI, and setting a heating prescription, causing heating of the VOI, and exit when prescription is complete; heating the VOI by completing the set heating prescription reads on achieving predefined heating in the target area) by a radiofrequency signal from the magnetic resonance tomography unit (Paragraph 0038, a system alike a magnetic resonance imaging system that is used intentionally to deposit energy into a selected volume of interest in a member that can be a body via absorption of electromagnetic radiation such as RF selectively within the volume of interest; wherein the energy deposition heats the tissue, Paragraph 0040)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the method and system includes achieving predefined heating in the target area by a radiofrequency signal from the magnetic resonance tomography unit, as taught by Sahin, in order to provide a way to heat remote tissue that can reach every tissue in the body, no matter how deep within the body (Sahin, Paragraph 0039).
Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, and further in view of US2015/0217136 to Stanescu et al. “Stanescu”.
Regarding claim 8, Dempsey discloses a system method (system and method for determining accumulated dose to tissues during radiotherapy, Abstract) for monitoring (Paragraph 0063, “track accumulated dose during radiotherapy”) in real time (Paragraph 0063, real-time imaging and dose calculations) a radiation dose (Paragraph 0063, “track accumulated dose during radiotherapy”), the system comprising:
an irradiation device (radiotherapy device, Fig. 1, Ref. 150); and
a magnetic resonance tomography unit (Fig. 1, Ref. 101, MRI),
wherein the irradiation device (radiotherapy device, Fig. 1, Ref. 150) is configured to emit and apply a radiation to a target area (deliver radiotherapy to a patient, Paragraph 0053; Paragraph 0044, target such as a tumor receives the radiation; asl se Fig. 6, Step 610),
wherein the magnetic resonance tomography unit is configured to capture a magnetic resonance image of the target area during application of the radiation (Fig. 6, Step 620; Paragraph 0053, “At 620, the system can acquire images of the patient from a magnetic resonance imaging system during the radiotherapy”), and
wherein the system is configured to ascertain a dose distribution of the radiation in the target area (Fig. 6, Step 640, and Paragraphs 0056, 0063, determining accumulated dose or actual dose delivered during radiotherapy, in the form of 2D and/or 3D mappings).
However, Dempsey does not disclose wherein the magnetic resonance tomography unit employs a sequence configured to capture an amplitude of a deflection of tissue in the target area, and wherein the system is configured to ascertain a dose distribution of the radiation in the target area based on the captured amplitude of the deflection of the tissue.
Vieira teaches a similar method and system for determining the potential of magnetic resonance elastography (MRE) elastograms to visualize and quantify dose distribution of a gel dosimeter (Page 287, Abstract) that is irradiated with a radiation beam (Page 103, left column, 2.2 Phantom irradiation procedure) and imaged with a magnetic resonance imager (Page 103, right column, sections 2.3 and 2.4).
Vieira teaches the magnetic resonance tomography unit employs a sequence (Page 288, left column, using a 1.5T whole-body MRI scanner and a gradient echo based pulse sequence with one cyclic motion encoding gradient pair) that captures an amplitude of a deflection of the sample in the target area (See Fig. 3, right image, and Fig. 5, elastography image and plot showing the displacement in µm of regions of the sample gel); and
ascertaining the dose distribution of the radiation in the target area based on the captured amplitude of the deflection (Fig. 4 and Page 289, determining the shear stiffness distribution map, which were based on the displacement/wave map of Fig. 3, and wherein the shear stiffness map has a strong correlation with the R2 maps, Page 290, left column, and Fig. 6, wherein the R2 map is currently the most reliable imaging dosimetry technique, Page 289, left column, first paragraph under Fig. 3; Page 290, Conclusion, therefore Vieira concludes that quantitative estimation of shear stiffness [in the sample] can be obtained from dynamic measurements of micrometer displacements, which would read on the claimed amplitude of deflection, and the shear stiffness distributions have a good correlation with the dose distribution map, i.e. the R2 map, which as stated in the Abstract, last sentence, suggests that MRE elastograms can visualize and quantify dose distribution in the sample gel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Dempsey's invention, wherein the magnetic resonance tomography unit employs a sequence configured to capture an amplitude of a deflection of tissue in the target area, and wherein the system is configured to ascertain a dose distribution of the radiation in the target area based on the captured amplitude of the deflection of the tissue, as taught by Vieira, in order to take advantage of the effect of shear modulus, which can provide remarkable contrast for different absorbed doses of radiation, to quantify and visualize does distribution, which can be useful for applications in radiotherapy planning (Page 287, right column).
However, the modifications of Dempsey and Vieira do not disclose wherein the applied radiation is intensity-modulated in an acoustic frequency range.
Hickling (Ionizing radiation-induced acoustics for radiotherapy and diagnostic radiology applications) teaches wherein the applied radiation is intensity-modulated in an acoustic frequency range (typical therapeutic dose of photon beams in radiotherapy is in the frequency range of 10-100kHz of proton-induced acoustic emissions, Page e716, right column, future outlook; and dosimetry is often used with intensity modulated radiation therapy, Page e711, right column, section 4.A.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey and Vieira wherein the applied radiation is intensity-modulated in an acoustic frequency range, as taught by Hickling, since it is inherent that radiotherapy applied to an irradiated object deposits dose and heat energy, which leads to a temperature rise, and thermoelastic expansion, that generates and propagates acoustic waves (Page e708, right column, top section), and intensity modulated radiation therapy is associated with dosimetry (Page e711, right column, section 4.A).
Further, it would have been obvious to apply the teachings of Vieira, in view of Hickling, of using a dosimetry technique to tissue of a patient due to the suggestion from the International Atomic Energy Agency of performing in vivo dosimetry, especially for patients receiving treatment via novel delivery techniques, where the does received is potentially close to surrounding normal tissue tolerance (Page e711, right column, section 4.A)
However, the modifications of Dempsey, Vieira, and Hickling do not disclose wherein the application of the radiation is synchronized with the image capture by the magnetic resonance tomography unit.
Stanescu teaches a similar radiotherapy system integrating a radiation source with a magnetic resonance imaging apparatus (Title, Abstract). Stanescu teaches wherein the radiation is synchronized with the image capture by the magnetic resonance tomography unit synchronized with image capture by the magnetic resonance tomography unit (Paragraph 0082, synchronization of the linac RF-signal triggering and pulse shaping with the MR’s RF image sequence readout).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the application of the radiation is synchronized with the image capture by the magnetic resonance tomography unit, as taught by Stanescu, in order to overcome the effects of the RF generated by the linac radiation system on the imaging performance of the MRI scanner (Stanescu, Paragraph 0082).
Regarding claim 13, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 8 above.
Dempsey discloses ascertaining a position of a target tissue from one of the captured magnetic resonance images; and carrying out further irradiation depending on the ascertained position of the target tissue (Fig. 9, step 910, acquiring pre-treatment images with a magnetic resonance imaging system; Paragraph 0078, and Fig. 10, determining a position of a target 1010 and position of a neighboring organ 1030, to determine a motion model, and Paragraph 0079, stopping the treatment when the movement is identified/observed by the imaging system during treatment; Paragraph 0089, resuming treatment when motion of the patient returns to the expected patient movement or Paragraph 0090, when the location of anatomical structures returns to a state similar to that prior to the treatment being interrupted)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, and further in view of Stanescu, as applied to claim 8 above, and further in view of Vieira 2019.
Regarding claim 9, the modifications of Dempsey, Vieira, Hickling, and Stanescu disclose all the features of claim 8 above.
Vieira teaches wherein the magnetic resonance tomography unit is additionally configured to capture a reference magnetic resonance image of the target area without radiation applied (capturing images of the gel dosimeters samples using the 1.5T whole-body MRI scanner, wherein one of the sample gel was unirradiated, Page 288, left column),
However, the modifications of Dempsey, Vieira, Hickling, and Stanescu do not disclose wherein the dose distribution is ascertained based on the magnetic resonance image and the reference magnetic resonance image.
Vieira 2019 teaches wherein the dose distribution is ascertained based on the magnetic resonance image and the reference magnetic resonance image (Page 103, right column, last paragraph first paragraph of Page 104, left column, “In quantitative analysis (i.e. dosimetry), calibration curves are often used to estimate the level of absorbed dose of a sample… The estimated areas of each shear modulus curve were subsequently obtained by subtracting the value of An, which was the shear modulus of the irradiated samples (10, 20, 30, 40 and 50 Gy), from A0, which was the shear modulus of the nonirradiated sample (0 Gy).”; wherein the shear modulus were obtained from the wave-displacement images and converted to elastograms, Abstract, which reads the examiner interprets as respective wave-displacement images and elastograms, i.e. each applied dosage, including a dose of 0, would have their own wave-displacement image and elastogram).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, Hickling, and Stanescu, wherein the dose distribution is ascertained based on the magnetic resonance image and the reference magnetic resonance image, as taught by Vieira 2019, in order to also determine the sensitivity of the method as a function of frequency of the frequency of the modulation of the sample (Vieira 2019, Page 104, left column).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, further in view of Stanescu, and further in view of Vieira 2019, as applied to claim 9 above, and further in view of Chen.
Regarding claim 10, Dempsey, Vieira, Hickling, Stanescu, and Vieira 2019 disclose all the features of claim 9 above.
As disclosed in the claim 8 rejection above, Vieira teaches wherein all the MRE data is acquired using a gradient echo based pulse sequence with one cyclic motion encoding gradient pair (Page 288, left column). This reads on a sequence containing motion encoding gradients is used in the capturing of the magnetic resonance image and in the capturing the reference magnetic resonance image.
However, the modifications of Dempsey, Vieira, Hickling, Stanescu, and Vieira 2019 do not disclose wherein the capturing of the magnetic resonance image and/or the capturing the reference magnetic resonance image is performed with an inverted polarity of a phase encoding gradient.
Chen teaches a GRE pulse sequence that is used for acquiring MRE data (Paragraph 0044), wherein the sequence includes motion encoding gradients (Fig. 6, Ref. 608, Paragraph 0045) and a rewinder gradient (Fig. 6, Ref. 222, Paragraph 0049) that is equal in magnitude, but opposite in polarity with the phase-encoding gradient 614 (Paragraph 0049; also see Fig. 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, Hickling, Stanescu, and Vieira 2019, wherein the MRE sequence of Vieira, uses an inverted polarity of a phase encoding gradient, such as the rewinder gradient, as taught by Chen, in order to prepare the magnetization for the next repetition of the pulse sequence (Chen, Paragraph 0049).
Therefore, in the combination of Dempsey, Vieira, Hickling, Stanescu, and Vieira 2019, Vieira uses the MRE GRE sequence to acquire both the reference (no irradiation) image and the irradiated images, and in view of Chen would include the rephasing gradient, which is a gradient with an inverted polarity of a phase encoding gradient.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, and further in view of Stanescu, as applied to claim 8 above, and further in view of Chen.
Regarding claim 11, the modifications of Dempsey, Vieira, Hickling, and Stanescu disclose all the features of claim 8 above.
As disclosed in the claim 8 rejection above, Vieira teaches wherein all the MRE data is acquired using a gradient echo based pulse sequence with one cyclic motion encoding gradient pair (Page 288, left column). This reads on a sequence containing motion encoding gradients is used in the capturing of the magnetic resonance image.
However, the modifications of Dempsey, Vieira, Hickling, and Stanescu do not disclose wherein the capturing of the magnetic resonance image is performed with an inverted polarity of a phase encoding gradient.
Chen teaches a GRE pulse sequence that is used for acquiring MRE data (Paragraph 0044), wherein the sequence includes motion encoding gradients (Fig. 6, Ref. 608, Paragraph 0045) and a rewinder gradient (Fig. 6, Ref. 222, Paragraph 0049) that is equal in magnitude, but opposite in polarity with the phase-encoding gradient 614 (Paragraph 0049; also see Fig. 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, Hickling, and Stanescu wherein the MRE sequence of Vieira, uses an inverted polarity of a phase encoding gradient, such as the rewinder gradient, as taught by Chen, in order to prepare the magnetization for the next repetition of the pulse sequence (Chen, Paragraph 0049).
Therefore, in the combination of Dempsey, Vieira, Hickling, and Stanescu, Vieira uses the MRE GRE sequence to acquire the magnetic resonance elastography images, and in view of Chen would include the rephasing gradient, which is a gradient with an inverted polarity of a phase encoding gradient.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, and further in view of Stanescu, as applied to claim 8 above, and further in view of Partanen.
Regarding claim 12, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 8 above.
However, the modifications of Dempsey, Vieira, and Hickling do not disclose capturing a temperature magnetic resonance image of the target area by image capture using a temperature-sensitive sequence and ascertaining a temperature map of the target area from the temperature magnetic resonance image.
Partanen teaches in a similar field of endeavor of using magnetic resonance imaging for planning, monitoring, and controlling treatment using high intensity focused ultrasound (Abstract).
Partanen teaches capturing a temperature magnetic resonance image of the target area by image capture using a temperature-sensitive sequence and ascertaining a temperature map of the target area from the temperature magnetic resonance image (Figs. 9A and 9B, Paragraph 0121, acquiring with MRI sequence to obtain MR phase images, which is then used to create temperature maps of the imaged area as seen in Figs. 9A and 9B).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the method further includes capturing a temperature magnetic resonance image of the target area by image capture using a temperature-sensitive sequence and ascertaining a temperature map of the target area from the temperature magnetic resonance image, as taught by Partanen, in order to be able to prove real time monitoring of the treatment of biological material (Partanen, Abstract and Paragraph 0121).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey, in view of Vieira, further in view of Hickling, and further in view of Stanescu, as applied to claim 8 above, and further in view of Sahin.
Regarding claim 14, the modifications of Dempsey, Vieira, and Hickling disclose all the features of claim 8 above.
However, the modifications of Dempsey, Vieira, and Hickling do not disclose achieving predefined heating in the target area by a radiofrequency signal from the magnetic resonance tomography unit.
Sahin teaches achieving predefined heating in the target area (See Fig. 8A, selecting a volume of interest, VOI, and setting a heating prescription, causing heating of the VOI, and exit when prescription is complete; heating the VOI by completing the set heating prescription reads on achieving predefined heating in the target area) by a radiofrequency signal from the magnetic resonance tomography unit (Paragraph 0038, a system alike a magnetic resonance imaging system that is used intentionally to deposit energy into a selected volume of interest in a member that can be a body via absorption of electromagnetic radiation such as RF selectively within the volume of interest; wherein the energy deposition heats the tissue, Paragraph 0040)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Dempsey, Vieira, and Hickling, wherein the method and system includes achieving predefined heating in the target area by a radiofrequency signal from the magnetic resonance tomography unit, as taught by Sahin, in order to provide a way to heat remote tissue that can reach every tissue in the body, no matter how deep within the body (Sahin, Paragraph 0039).
Conclusion
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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798