DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 13 February 2026 is acknowledged.
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 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.
Claims 1, 3-7, 9-14, 16, 18-21, and 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US PGPUB 20210311146; hereinafter "Keenan") in further view of Cima et al. (US PGPUB 20220218221 having an effective filing date of 14 April 2019; hereinafter "Cima") .
With regards to Claim 1, Keenan discloses a magnetic imaging apparatus (MRI system 100; see Keenan FIG. 1 & ¶ [0024]), comprising:
a housing (in FIG. 1 of Keenan, magnet assembly 124 is illustrated has having a longitudinal axis through an imaging bore);
an array ofpolarizing magnet positioned in the housing, wherein an inherent gradient magnetic field extends from the array ofpolarizing magnet relative to the first axis into the field of view (polarizing magnetic 126 which generates a polarizing magnetic field about a portion of the subject, i.e. within the imaging bore; see Keenan FIG. 1 & ¶ [0007]);
a gradient coil set (gradient coil assembly 122; see Keenan FIG. 1 & ¶ [0025]);
at least one radio frequency coil (RF coil 128; see Keenan FIG. 1 & ¶ [0025]);
a power circuit (gradient system 118 for controlling the gradient coil assembly 122 & RF system 120 for controlling the RF coil 128; it should be appreciated that one of ordinary skill in the art would understand that the gradient system 118 energizes the gradient coil assembly 122 and RF system 120 energizes the RF coil 128, i.e. amount to power supplies);
a memory storing (instructions for magnetic resonance fingerprinting thermometry {i.e. including dictionary of signal models} according to the above-described methods may be stored on a form of computer readable media; see Keenan ¶ [0056]) a relaxation model for a tissue type (dictionary of signal models, or templates, that have been generated for different acquisition parameters from magnetic resonance signal models, generating a relevant property map {e.g. temperature} based on the acquired data and the dictionary that best corresponds to signal evolution; see Keenan ¶ [0020]); and
a control circuit in signal communication with the gradient coil set, the at least one radio frequency coil, the power circuit, and the memory (processor 108 of workstation 102 supplies instructions to the gradient system 118 & RF system 120 to control the gradient coil assembly 122 & RF coils 128; see Keenan ¶ [0025-0026]), wherein the control circuit is configured to:
obtain a T2 data set related to a structure positioned in the field of view, wherein the structure corresponds to the tissue type (acquire frequency swept T2 quantitative properties {i.e. T2 relaxation times}; see Keenan ¶ [0039]);
generate a T2-weighted image of the structure (generate a map of the quantified parameter; see Keenan ¶ [0042]); and
convert the T2-weighed image of the structure to a heat map based on the relaxation model for the tissue type (convert the quantified parameter to a temperature map; see Keenan ¶ [0042]).
While Keenan discloses an array of polarizing magnets, it appears that Keenan may be silent to an array of permanent magnets. Moreover, it appears that Keenan may be silent to housing comprising a face, wherein a first axis extends through the face. However, Cima teaches of a single-sided MR sensor device may include permanent magnets arranged in a unilateral linear Halbach array this sensor to produce a static magnetic field (0.28 Tesla) with <2% field variation; and RF coils and a processor which are configured to produce a depth-resolved, diffusion-weighted, multicomponent T2 relaxometry measurements of intramuscular fluid shifts in a patient, wherein the permanent magnet array forms a concave arrangement having a face with an axis that extends into the field of view of the subject leg (see Cima Abstract & FIG 23B-23C along with ¶ [0070 & 0075-0076]; wherein gradient encoding coils 320/420 are disposed on a face of the housing; see Cima FIGS. 24A-24B and ¶ [0059]).
Cima also teaches of pulsed gradient echo (see Cima ¶ [0093]); a series of spin echo images for T2 relaxometry were acquired with MEMS (multi echo multi slice) with TR 7600 ms, TE 10 ms, 151 echoes, 4 averages, 64×32×5 acquisition matrix, 40×40 mm field of view, and 1 mm slice thickness (see Cima ¶ [0163]); and CPMG pulse sequence with a repetition time of 1517 ms, a measurement time of 1065 ms, a pulse duration of 12 μs, an acquisition bandwidth of 1 MHz (dwell time of 1 μs), and 16 acquired points per echo. The first, second, third and fourth scans were performed with an RF excitation frequency of 11.43 MHz, 11.60 MHz, 11.60 MHz, and 11.83 MHz, respectively (see Cima ¶ [0165]).
Keenan and Cima are both considered to be analogous to the claimed invention because they are in the same field of T2 relaxation mapping. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Keenan to incorporate the above teachings of Cima to provide at least the struck-through limitations above. Doing so would aid in high sensitivity, remote MR measurements via compact permanent magnet array (see Cima ¶ [0053]).
Claim 16 recite similar limitations and are rejected under the same rationale as Claim 1.
With regards to Claim 31, modified Keenan teaches of wherein the gradient coil and the at least one radio frequency coil are coupled to the power circuit (FIG. 1 of Keenan illustrates gradient system 118 coupled to the gradient coil assembly 122 & RF system 120 coupled to the RF coil 128).
With regards to Claim 41, modified Keenan teaches of wherein the control circuit is further configured to transmit a pulse sequence comprising a plurality of sweeping frequency pulses (sweeping a range of off-resonance frequencies during a plurality of pulses; see Keenan ¶ [0039]).
With regards to Claim 54, modified Keenan teaches of wherein the T2 data set is generated from the plurality of sweeping frequency pulses (sweeping a range of off-resonance frequencies during a plurality of pulses; see Keenan ¶ [0039]).
With regards to Claim 64, wherein each sweeping frequency pulse produces an echo comprising a duration between 2 milliseconds and 20 milliseconds (A series of spin echo images for T2 relaxometry were acquired with MEMS (multi echo multi slice) with TR 7600 ms, TE 10 ms {i.e. echo duration}, 151 echoes, 4 averages, 64×32×5 acquisition matrix, 40×40 mm field of view, and 1 mm slice thickness; see Cima ¶ [0163]).
Claim 20 recites similar limitations and are rejected under the same rationale as Claim 6.
With regards to Claim 76, while modified Keenan teaches of 151 echoes (see Cima ¶ [0161]), it appears that modified Keenan may be silent to wherein the plurality of sweeping frequency pulses produces between 10 echoes and 100 echoes.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Keenan to provide at least between 10 and 100 echoes. Doing so would amount to routine optimization due to lack of disclosed criticality for the number of echoes and would aid in reducing acquisition time.
Claim 21 recites similar limitations and are rejected under the same rationale as Claim 7.
With regards to 91, The magnetic imaging apparatus of Claim 1, wherein the radio frequency coil is configured to transmit pulses having a frequency between 1 Megahertz and 21 Megahertz (a CPMG pulse sequence with a repetition time of 1517 ms, a measurement time of 1065 ms, a pulse duration of 12 μs, an acquisition bandwidth of 1 MHz (dwell time of 1 μs), and 16 acquired points per echo. The first, second, third and fourth scans were performed with an RF excitation frequency of 11.43 MHz, 11.60 MHz, 11.60 MHz, and 11.83 MHz, respectively; see Cima ¶ [0165]).
Claim 23 recites similar limitations and are rejected under the same rationale as Claim 9.
With regards to Claim 101, modified Keenan teaches of wherein the magnetic field strength in the field of view is less than 1 Tesla (this sensor consists of an array of 180 permanent magnets arranged to produce a static magnetic field (0.28 Tesla) with <2% {i.e. 20,000 ppm} field variation over a volume spanning approximately 12×6×6 mm; see Cima ¶ [0070]).
Claim 24 recites similar limitations and are rejected under the same rationale as Claim 10.
With regards to Claim 111, modified Keenan teaches of wherein the inhomogeneity of the magnetic field in the field of view is between 200 ppm and 200,000 ppm (this sensor consists of an array of 180 permanent magnets arranged to produce a static magnetic field (0.28 Tesla) with <2% {i.e. 20,000 ppm} field variation over a volume spanning approximately 12×6×6 mm; see Cima ¶ [0070]).
Claim 25 recites similar limitations and are rejected under the same rationale as Claim 11.
With regards to Claim 121, modified Keenan teaches of wherein the relaxation model is generated from calibration data comprising a plurality of T2 relaxation data for different temperatures for the tissue type (generate dictionary based on the acquired baseline temperature data {i.e. calibration data} over a time interval; see FIG. 4 and ¶ [0048-0050]).
Claim 26 recites similar limitations and are rejected under the same rationale as Claim 12.
With regards to Claim 131, modified Keenan teaches of wherein the magnetic imaging apparatus is a single-sided magnetic imaging apparatus, and wherein the housing and the gradient coil set are positioned on a first side of field of view (a single-sided MR sensor device may include permanent magnets arranged in a unilateral linear Halbach array; see Cima Abstract & FIG 23B-23C along with ¶ [0075-0076]; wherein gradient encoding coils 320/420 are disposed on a face of the housing; see Cima FIGS. 24A-24B and ¶ [0059]).
Claims 27-28 recite similar limitations and are rejected under the same rationale as Claim 13.
With regards to Claim 141, modified Keenan teaches of further comprising a user input device configured to receive the tissue type of the structure (acquiring MR data from either aqueous or adipose tissue region of interest; see Keenan ¶ [0035 & 0045]; wherein the selection of the region of interest amounts to a user input).
Claim 29 recites similar limitations and are rejected under the same rationale as Claim 14.
With regards to Claim 1816, wherein the echo train sequence comprises phase encodes (pulsed gradient echo, i.e. each echo in the train is uniquely phase-encode in GRE sequence; see Cima ¶ [0093])).
Claim 19 recites similar limitations and are rejected under the same rationale as Claim 18.
Claims 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan in view of Cima as applied to claim 1 & 16 above, respectively, and further in view of Hilbert et al. (US PGPUB 20190371465; hereinafter "Hilbert").
With regards to Claim 21, while modified Keenan discloses all of the limitations of intervening claim 1 as shown above, it appears that modified Keenan may be silent to wherein the relaxation model comprises a monoexponential model.
However, Hilbert teaches of quantitative MRI in which quantitative maps are generated by a signal model describing the relation between image intensities and relevant tissue properties is fitted onto these series of images (in the case of the MESE sequence that could e.g. be a simple mono-exponential T2-signal decay model) (see Hilbert ¶ [0005]).
Modified Keenan and Hilbert are both considered to be analogous to the claimed invention because they are in the same field of MR quantitative mapping. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Keenan to incorporate the above teachings of Hilber to provide at least a mono-exponential model. Doing so would aid in absolute measure of one or more separate physical properties (see Hilbert ¶ [0004]).
Claim 17 recites similar limitations and are rejected under the same rationale as Claim 2.
Claims 15 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan in view of Cima as applied to claim 1 & 16 above, respectively, and further in view of Boernert et al. (US PGPUB 20210109180; hereinafter " Boernert") .
With regards to Claim 151, while modified Keenan discloses all of the limitations of intervening claim 1 as shown above, it appears that modified Keenan may be silent to further comprising an automated tissue type recognition module configured to:
identify a tissue type model corresponding to the structure; and
register the tissue type model with the structure.
However, Boernert teaches of magnetic resonance fingerprinting acquisition (see Boernert Step 200; ¶ [0068-0067]) in which an anatomical model automatically identifies an anatomical region (see Boernert Step 204; ¶ [0068-0067]) and a fingerprinting dictionary is selected for the identified anatomical region (see Boernert Step 206; ¶ [0068-0067]).
Modified Keenan and Boernert are both considered to be analogous to the claimed invention because they are in the same field of MRF. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Keenan to incorporate the above teachings of Boernert to provide at least the limitations of Claim 15. Doing so would aid in identify important biomarkers that can ease diagnostics, therapy monitoring and follow up decisions (see Boernert ¶ [0073]).
Claim 30 recites similar limitations and are rejected under the same rationale as Claim 15.
Allowable Subject Matter
Claims 8 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art Cima teaches of CPMG pulse sequence with various parameters, such as a bandwidth of 1Mhz, but is silent to a swept bandwidth of 10-200 kHz. While there is not disclosed criticality of this claimed bandwidth range, it would not be obvious to one of ordinary skill in the art to further modify Keenan in view of Cima to obviate this range because it would not be achievable via routine optimization because of the dissimilar pulse sequences.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798