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 Objections
Claim 18 is objected to because of the following informalities: claim 18 recites “two or more switchable gradient coil” however this should be read as “two or more switchable gradient coils”.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 9-13, 17, 20-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US20200305758) and further in view of Chen (US20200355765).
Regarding claim 1, McDaniel discloses a portable […] magnetic resonance imaging (MRI) system ([0003] – “The present disclosure relates generally to magnetic resonance imaging (MRI) systems and in particular, to portable MRI systems”) comprising:
a static (B0) magnet comprising a plurality of magnetic elements arranged in a bulb array ([0030] – “magnet 102 (a B0 magnet)… the magnet 102 is designed from a plurality of rare-earth (NdFeB) permanent magnet blocks”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”);
a gradient coil ([0032] – “MRI system 130 includes…gradient coils 134”);
a patient bed ([0029] – “enabling application such as continuous bedside monitoring of a patient”); and
an imaging radiofrequency coil ([0032] – “MRI system 130 includes a magnet assembly having a magnet 132, gradient coils 134, and RF coil 136”).
Conversely McDaniel does not teach a portable neonatal magnetic resonance imaging (MRI) system.
However Chen discloses a portable neonatal magnetic resonance imaging (MRI) system ([0077] – “a system configured to facilitate imaging infants (e.g., neonates and older infants)”), [0113] – “the system 10 may be used in combination with an MRI device to facilitate imaging of the infant…a portable low-field MRI system”).
The disclosure of Chen is an analogous art considering it is in the field of a portable MRI system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 2, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 1.
Conversely McDaniel does not explicitly teach wherein at least one of the B0 magnet or the patient bed is movable relative to the other of the B0 magnet or the patient bed.
However Chen discloses wherein at least one of the B0 magnet or the patient bed is movable relative to the other of the B0 magnet or the patient bed ([0178] – “the infant support is moved in a direction along the longitudinal axis so that the arms of the infant support are inserted into a coupling mechanism coupled to the RF coil assembly”, [0009] – “the coupling mechanism is coupled to the MRI device and the RF coil assembly”, [0114] – “MRI device 60 may form a part of all of an MRI system…MRI system 2200 comprises…magnetic components 2220”, [0115] – “magnetic components 2220 comprise B0 magnet 2222”, the infant support is interpreted as the patient bed and therefore the infant support is moveable relative to the MRI device which comprises a B0 magnet).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the patient bed being movable relative to the B0 magnet of Chen to achieve the same results. One would have motivation to combine because it allows the device to be used on infants that are in a Neonatal Intensive Care Unit. “Infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 3, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 1.
McDaniel further discloses wherein the gradient coil is positioned outside or inside the Bo magnet (Fig. 4, [0132] – “Gradient coils 134 are configured to be positioned on the outer surface (e.g., surface 114 shown in FIG. 1) of the magnet 132”).
Regarding claim 4, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 1.
McDaniel further discloses wherein each of the plurality of magnetic elements is oriented within a Halbach bulb array to produce a homogeneous static magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0047] – “The B0 magnet may be designed by optimizing the distribution of rare-earth magnets needed to maximize homogeneity over a brain-shaped ROI…FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”).
Regarding claim 5, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 1.
McDaniel further discloses wherein each of the plurality of magnetic elements is oriented within a Halbach bulb array to produce a functionally linear permanent magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0042] – “An improved magnet design with higher linearity (but limited gradient strength) may be used”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”).
Regarding claim 9, McDaniel discloses a portable […] magnetic resonance imaging (MRI) system ([0003] – “The present disclosure relates generally to magnetic resonance imaging (MRI) systems and in particular, to portable MRI systems”) comprising:
a static (B0) magnet comprising a plurality of permanent magnetic elements arranged in an array ([0030] – “magnet 102 (a B0 magnet)…the magnet 102 is designed from a plurality of rare-earth (NdFeB) permanent magnet blocks”);
a gradient coil positioned outside the B0 magnet (Fig. 4, [0132] – “Gradient coils 134 are configured to be positioned on the outer surface (e.g., surface 114 shown in FIG. 1) of the magnet 132”);
a patient bed ([0029] – “enabling application such as continuous bedside monitoring of a patient”); and
an imaging radiofrequency coil ([0032] – “MRI system 130 includes a magnet assembly having a magnet 132, gradient coils 134, and RF coil 136”).
Conversely McDaniel does not teach a portable neonatal magnetic resonance imaging (MRI) system.
However Chen discloses a portable neonatal magnetic resonance imaging (MRI) system ([0077] – “a system configured to facilitate imaging infants (e.g., neonates and older infants)”), [0113] – “the system 10 may be used in combination with an MRI device to facilitate imaging of the infant…a portable low-field MRI system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 10, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 9.
Conversely McDaniel does not explicitly teach wherein at least one of the B0 magnet or the patient bed is movable relative to the other of the B0 magnet or the patient bed.
However Chen discloses wherein at least one of the B0 magnet or the patient bed is movable relative to the other of the B0 magnet or the patient bed ([0178] – “the infant support is moved in a direction along the longitudinal axis so that the arms of the infant support are inserted into a coupling mechanism coupled to the RF coil assembly”, [0009] – “the coupling mechanism is coupled to the MRI device and the RF coil assembly”, [0114] – “MRI device 60 may form a part of all of an MRI system…MRI system 2200 comprises…magnetic components 2220”, [0115] – “magnetic components 2220 comprise B0 magnet 2222”, the infant support is interpreted as the patient bed and therefore the infant support is moveable relative to the MRI device which comprises a B0 magnet).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the patient bed being movable relative to the B0 magnet of Chen to achieve the same results. One would have motivation to combine because it allows the device to be used on infants that are in a Neonatal Intensive Care Unit. “Infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 11, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 9.
McDaniel further discloses wherein the array forms a Halbach bulb ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”).
Regarding claim 12, McDaniel and Chen disclose all the elements of the claimed invention as cited in claims 9 and 11.
McDaniel further discloses wherein each of the plurality of magnetic elements is oriented within the Halbach bulb array to produce a homogeneous permanent magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0047] – “The B0 magnet may be designed by optimizing the distribution of rare-earth magnets needed to maximize homogeneity over a brain-shaped ROI…FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”).
Regarding claim 13, McDaniel and Chen disclose all the elements of the claimed invention as cited in claims 9 and 11.
McDaniel further discloses wherein each of the plurality of magnetic elements is oriented within a Halbach bulb array to produce a functionally linear permanent magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0042] – “An improved magnet design with higher linearity (but limited gradient strength) may be used”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”).
Regarding claim 17, McDaniel discloses a method for […] magnetic resonance imaging (MRI) ([0007] – “a system and method for MRI that is portable”), wherein the method comprises:
[…] wherein the portable […] MRI system comprises a controller ([0033] – “A controller 142”), a permanent Bo magnet comprising a plurality of permanent magnetic elements arranged in a Halbach bulb array ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”), a gradient coil positioned outside the permanent Bo magnet (Fig. 4, [0132] – “Gradient coils 134 are configured to be positioned on the outer surface (e.g., surface 114 shown in FIG. 1) of the magnet 132”), a patient bed ([0029] – “enabling application such as continuous bedside monitoring of a patient”), and an imaging radiofrequency coil ([0032] – “MRI system 130 includes a magnet assembly having a magnet 132, gradient coils 134, and RF coil 136”);
placing the subject on the patient bed and positioning the subject such that the Halbach bulb array partially surrounds a head of the subject ([0033] – “may allow the magnet assembly 144 to be, for example, positioned on the head of a bed-bound subject”);
controlling, by the controller, the gradient coil and the imaging radiofrequency coil to acquire MRI data of the subject ([0033] – “controller 142 is configured to drive the gradient coils 134 and RF coil 136 for gradient waveform generation and RF waveform generation, respectively, using known hardware and methods. In addition, controller 142 is configured to record MR signals received by the RF coil 136 from the subject 140”); and
reconstructing the MRI data to produce images of the subject ([0033] – “Controller 142 may also be configured to generate images based on the received MR signals using known reconstruction methods”).
Conversely McDaniel does not teach a method for neonatal magnetic resonance imaging (MRI),
transporting a portable neonatal MRI system to a bedside of a subject.
However Chen discloses a method for neonatal magnetic resonance imaging (MRI) (Abstract – “systems, devices, and methods to facilitate imaging an infant using a magnetic resonance imaging (MRI) device”).
transporting a portable neonatal MRI system to a bedside of a subject ([0178] – “the infant support is moved in a direction along the longitudinal axis so that the arms of the infant support are inserted into a coupling mechanism coupled to the RF coil assembly”, [0009] – “the coupling mechanism is coupled to the MRI device and the RF coil assembly”, [0114] – “MRI device 60 may form a part of all of an MRI system…MRI system 2200 comprises…magnetic components 2220”, [0115] – “magnetic components 2220 comprise B0 magnet 2222”, the MRI device used to facilitate imaging of the infant is shown in Fig. 10A and one with ordinary skill in the art would recognize it can be transported to the bedside of an infant).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 20, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 17.
McDaniel further discloses wherein the Halbach bulb array is configured to produce a permanent homogeneous magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0047] – “The B0 magnet may be designed by optimizing the distribution of rare-earth magnets needed to maximize homogeneity over a brain-shaped ROI…FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”).
Regarding claim 21, McDaniel discloses a method for manufacturing a […] MRI system ([0046] – “whole-brain MRI system may be constructed with a whole-brain MRI magnet having a uniform B0-field over a head-sized region of interest (ROI)”), wherein the method comprises:
determining a target magnetic field within a target scanning volume ([0030] – “Magnet 102 has a transverse-oriented B0 field 108 with an imaging region of interest (ROI) 106 that includes part of the subject's skull and superficial cortex”, [0036] – “The optimal magnet design (e.g., the example optimized design shown in FIG. 8), may then be converted into a physically-realizable assembly of NdFeB permanent magnet blocks…FIG. 9 also shows an optimized ROI 222”);
performing an optimization to determine an arrangement of a plurality of magnetic elements positioned within a Halbach bulb array ([0034] – “Halbach sphere for optimization of magnet design… the optimization may be performed by allowing the genetic algorithm to alter the sizes, block magnetization grade, compositions, and translational position of each magnet block 206”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”), wherein the optimization comprises optimizing, within the target scanning volume, a simulated magnetic field based on the target magnetic field to determine at least one of positions each of the magnetic elements, orientations of each of the magnetic elements, sizes of each of the magnetic elements, or a total number of magnetic elements, and arranging the plurality of magnetic elements in a bulb array according to the optimization ([0034] – “the optimization may be performed by allowing the genetic algorithm to alter the sizes, block magnetization grade, compositions, and translational position of each magnet block 206”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0034] – “the arrangement of the plurality of rare-earth permanent magnet blocks is optimized”).
Conversely McDaniel does not teach a neonatal magnetic resonance imaging (MRI) system.
However Chen discloses a neonatal magnetic resonance imaging (MRI) system ( [0113] – “the system 10 may be used in combination with an MRI device to facilitate imaging of the infant”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 22, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 21.
McDaniel further discloses further comprising positioning a gradient coil outside the Halbach bulb array of magnetic elements (Fig. 4, [0132] – “Gradient coils 134 are configured to be positioned on the outer surface (e.g., surface 114 shown in FIG. 1) of the magnet 132”).
Regarding claim 23, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 21.
McDaniel further discloses wherein the optimization is constrained by at least one of a total size of the bulb array, a size of each of the plurality of magnetic elements, or a total weight of the plurality of magnetic elements ([0034] – “the optimization may be performed by allowing the genetic algorithm to alter the sizes, block magnetization grade, compositions, and translational position of each magnet block 206”, [0046] – “the whole-brain magnet may have a B0 of 86 mT and weigh under 25 kg. The whole-brain MRI magnet may be constructed of NdFeB blocks configured in a helmet-shape and to closely fit on the subject's head”).
Regarding claim 24, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 21.
McDaniel further discloses wherein the target magnetic field is a homogeneous magnetic field within the target scanning volume ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0047] – “The B0 magnet may be designed by optimizing the distribution of rare-earth magnets needed to maximize homogeneity over a brain-shaped ROI…FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”).
Regarding claim 25, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 21.
McDaniel further discloses wherein each of the plurality of magnetic elements is oriented within a Halbach bulb array to produce a functionally linear permanent magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0042] – “An improved magnet design with higher linearity (but limited gradient strength) may be used”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”).
Regarding claim 26, McDaniel discloses a portable […] magnetic resonance imaging (MRI) system ([0003] – “The present disclosure relates generally to magnetic resonance imaging (MRI) systems and in particular, to portable MRI systems”) comprising:
a static (B0) magnet comprising a plurality of magnetic elements arranged in a Halbach array configured to surround at least a portion of a […] patient ([0030] – “magnet 102 (a B0 magnet)… the magnet 102 is designed from a plurality of rare-earth (NdFeB) permanent magnet blocks”, [0047] – “a helmet-shaped Halbach geometry. FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”);
a gradient coil ([0032] – “MRI system 130 includes…gradient coils 134”);
a patient bed ([0029] – “enabling application such as continuous bedside monitoring of a patient”); and
an imaging radiofrequency coil ([0032] – “MRI system 130 includes a magnet assembly having a magnet 132, gradient coils 134, and RF coil 136”).
Conversely McDaniel does not teach a portable neonatal magnetic resonance imaging (MRI) system,
configured to surround at least a portion of a neonatal patient.
However Chen discloses a portable neonatal magnetic resonance imaging (MRI) system ([0077] – “a system configured to facilitate imaging infants (e.g., neonates and older infants)”), [0113] – “the system 10 may be used in combination with an MRI device to facilitate imaging of the infant…a portable low-field MRI system”).
configured to surround at least a portion of a neonatal patient (Abstract – “a helmet for supporting at least a portion of the infant's head”, [0080] – “The RF coil assembly may include components (e.g., a helmet) for positioning and restraining the infant during MR imaging”, Figs. 5A and 5B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 28, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 26.
McDaniel further discloses wherein the Halbach array forms a partial sphere configured to surround at least a portion of a head of the […] patient (Fig. 5 shows a partial sphere shape for the portable MRI system configured to surround a portion of the patients head, [0047] – “a helmet-shaped Halbach geometry”).
Conversely McDaniel does not teach configured to surround at least a portion of the neonatal patient.
However Chen discloses configured to surround at least a portion of a neonatal patient (Abstract – “a helmet for supporting at least a portion of the infant's head”, [0080] – “The RF coil assembly may include components (e.g., a helmet) for positioning and restraining the infant during MR imaging”, Figs. 5A and 5B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Regarding claim 29, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 26.
McDaniel further discloses wherein the Halbach array forms a bulb configured to surround at least a portion of a head of the […] patient ([0047] – “a helmet-shaped Halbach geometry. FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”).
Conversely McDaniel does not teach configured to surround at least a portion of the neonatal patient.
However Chen discloses configured to surround at least a portion of a neonatal patient (Abstract – “a helmet for supporting at least a portion of the infant's head”, [0080] – “The RF coil assembly may include components (e.g., a helmet) for positioning and restraining the infant during MR imaging”, Figs. 5A and 5B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US20200305758) and Chen (US20200355765) as applied to claims 1 and 9 above, and further in view of Rosen (US20170010339).
Regarding claims 6 and 14, McDaniel and Chen disclose all the elements of the claimed invention as cited in claims 1 and 9.
Conversely McDaniel does not teach wherein the imaging radiofrequency coil comprises a single channel spiral transmit/receive radiofrequency coil with variable winding density.
However Rosen discloses wherein the imaging radiofrequency coil comprises a single channel spiral transmit/receive radiofrequency coil with variable winding density ([0027] – “a transmit/receive coil is formed by a single conducting path”, [0049] – “The coil 304 may be arranged to have a uniform or substantially uniform distance (D) between adjacent portions of the spiral. In other configurations, the distance D may be non-uniform and may vary as the spiral moves from the center 306 to the perimeter 308”).
The disclosure of Rosen is an analogous art considering it is in the field of a helmet shaped RF coil.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the single channel spiral transmit/receive radiofrequency coil with variable winding density of Rosen to achieve the same results. One would have motivation to combine because it “can be tuned to provide high homogeneity, while maintaining high sensitivity over large field of views in a streamlined design” (Rosen [0049]).
Claims 7, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US20200305758) and Chen (US20200355765) as applied to claims 5, 13, and 17 above, and further in view of O’Halloran (US20200041588).
Regarding claims 7, 15, and 18, McDaniel and Chen disclose all the elements of the claimed invention as cited in claims 1, 5, 9, 11, 13, and 17.
McDaniel further discloses wherein the Halbach bulb array is configured to produce a permanent functionally linear magnetic field ([0034] – “the optimization process starts with an equatorial portion (or “cap-shaped” section) or of an ideal Halbach sphere”, [0042] – “An improved magnet design with higher linearity (but limited gradient strength) may be used”, [0047] – “FIG. 18 shows a bulb-shaped surface surrounding a subject's head used in optimization of a portable whole-head magnet”, [0030] – “permanent magnet blocks”);
Conversely McDaniel does not teach wherein the MRI data of the subject comprises diffusion weighed imaging (DWI) data, and wherein acquiring the DWI data comprises:
acquiring an image with negligible diffusion weighting by applying dummy refocusing pulses; and
applying diffusion encoding along three approximately orthogonal directions using the permanent […] magnetic field and two or more switchable gradient coil.
However O’Halloran discloses wherein the MRI data of the subject comprises diffusion weighed imaging (DWI) data (Abstract – “Methods and apparatus for operating a low-field magnetic resonance imaging (MRI) system to perform diffusion weighted imaging”), and wherein acquiring the DWI data comprises:
acquiring an image with negligible diffusion weighting by applying dummy refocusing pulses ([0042] – “using magnetic resonance data acquired during the readout period 220 immediately following the RF pulse 210 to correct image blurring due to B0 field drift”); and
applying diffusion encoding along three approximately orthogonal directions using the permanent […] magnetic field and two or more switchable gradient coil (Fig. 2, [0026] – “conventional low-field B0 magnets are implemented using permanent magnets”, paragraph [0027] discloses three gradient coils for each of the x direction, y direction, and z direction, [0040] – “a gradient time sequence indicating times when the x-, y-, and z-gradients are activated to provide spatial encoding of the emitted MR signals”).
The disclosure of O’Halloran is an analogous art considering it is in the field of a low-field MRI system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the diffusion weighed imaging of O’Halloran to achieve the same results. One would have motivation to combine because “diffusion-weighted imaging (DWI) is the only MRI contrast that can directly assess tissue microstructure” (O’Halloran [0038]).
Claims 8, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US20200305758) and Chen (US20200355765) as applied to claims 1, 9, and 17 above, and further in view of Sacolick (US20210153765).
Regarding claims 8, 16, and 19, McDaniel and Chen disclose all the elements of the claimed invention as cited in claims 1, 9, and 17.
Conversely McDaniel does not teach further comprising a shield positioned between the Bo magnet and the imaging radiofrequency coil and an externally mounted radiofrequency coil, and wherein:
the imaging radiofrequency coil is configured to acquire imaging data while the externally mounted radiofrequency coil simultaneously acquires environmental signal; and
the portable neonatal MRI system is further configured to retrospectively remove the environmental signal from the imaging data.
However Chen discloses a portable neonatal MRI system ([0077] – “a system configured to facilitate imaging infants (e.g., neonates and older infants)”, [0113] – “the system 10 may be used in combination with an MRI device to facilitate imaging of the infant…a portable low-field MRI system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Conversely McDaniel and Chen do not teach further comprising a shield positioned between the Bo magnet and the imaging radiofrequency coil and an externally mounted radiofrequency coil, and wherein:
the imaging radiofrequency coil is configured to acquire imaging data while the externally mounted radiofrequency coil simultaneously acquires environmental signal; and
the portable […] MRI system is further configured to retrospectively remove the environmental signal from the imaging data.
However Sacolick discloses further comprising a shield positioned between the Bo magnet and the imaging radiofrequency coil ([0099] – “in circumstances where one or more RF coils are used as sensors, none, some, or all of the coils may be shielded”) and an externally mounted radiofrequency coil ([0066] – “auxiliary RF coil(s) 306 is/are located a distance 305 apart from primary RF coil 202. The distance 305 may be selected such that auxiliary coil(s) 306 is/are sufficiently far away from the sample 204”), and wherein:
the imaging radiofrequency coil is configured to acquire imaging data while the externally mounted radiofrequency coil simultaneously acquires environmental signal ([0076] – “a MRI system obtains MR data by using a primary RF coil (e.g., RF coil 202) and obtains noise data using one or more auxiliary sensors…any number of auxiliary sensors of any type may be used to characterize the noise in the environment of the MRI system”); and
the portable […] MRI system is further configured to retrospectively remove the environmental signal from the imaging data ([0061] – “a low-field MRI system including any of the example systems described in U.S. Pat. No. 10,222,434, dated Mar. 5, 2019, titled “Portable Magnetic Resonance Imaging Methods and Apparatus,””, [0092] – “the noise data obtained at act 604 and the PA transfer function obtained at act 606 may be used to suppress or cancel noise in the MR data obtained at act 602”).
The disclosure of Sacolick is an analogous art considering it is in the field of a portable MRI system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of McDaniel to incorporate removing the environmental signal of Sacolick to achieve the same results. One would have motivation to combine because it can “operate in unshielded or partially shielded environments and are not limited to specialized shielded rooms.” (Sacolick [0047]).
Claim 27 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US20200305758) and Chen (US20200355765) as applied to claim 26 above, and further in view of Wald (US20140111202).
Regarding claim 27, McDaniel and Chen disclose all the elements of the claimed invention as cited in claim 26.
Conversely McDaniel does not teach wherein the Halbach array forms a cylinder configured to surround at least a portion of a head of the neonatal patient.
However Chen discloses configured to surround at least a portion of a neonatal patient (Abstract – “a helmet for supporting at least a portion of the infant's head”, [0080] – “The RF coil assembly may include components (e.g., a helmet) for positioning and restraining the infant during MR imaging”, Figs. 5A and 5B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the neonatal magnetic resonance imaging system of Chen to achieve the same results. One would have motivation to combine because “infant care is one area in which MR imaging would be beneficial, but which is often inaccessible. In particular, for neonates (e.g., infants within the first 28 days after birth) alone” (Chen [0078]).
Conversely McDaniel and Chen do not teach wherein the Halbach array forms a cylinder configured to surround at least a portion of a head of the […] patient.
However Wald discloses wherein the Halbach array forms a cylinder configured to surround at least a portion of a head of the […] patient ([0024] – “The magnet assembly 12 generally includes a plurality of permanent magnets 30 arranged in an annular Halbach array”, as shown in Fig. 1 the magnet assembly surrounds a head of the patient, [0027] – “Examples of parameters that can be varied in the magnet design include the size and quantity of the magnets 30; the size of the magnet assembly 12”, therefore one with ordinary skill in the art would recognize the device can be sized for an infant).
The disclosure of Wald is an analogous art considering it is in the field of a portable MRI system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of McDaniel to incorporate the Halbach array forming a cylinder of Wald to achieve the same results. One would have motivation to combine because it “the magnet assembly of the portable MRI system achieves reasonable homogeneity” (Wald [0047]).
Conclusion
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/R.C.L./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797