DETAILED ACTION
Response to Arguments
Applicant’s amendments to the claims submitted 1/26/2026 have been recorded. As such Examiner’s previous objections to claim 10 are withdrawn.
Applicant has amended claims 1, 10, and 13; added claims 14-17; and canceled claim 8 claims 1-7 and 9-17 are currently pending.
Applicant’s arguments with respect to claim(s) 35 U.S.C. 103 rejection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Therefore this action is made FINAL.
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.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being unclear. The claim recites “wherein the treatment drive signal is of a second waveform type that matches a frequency and a waveform type of the ultrasound waves.” However, a first waveform type is not claimed rendering the claim unclear if more than one waveform is utilized.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plewes (US 6246895B1) in view of O’Donnell (O'Donnell M, Edelstein WA. NMR imaging in the presence of magnetic field inhomogeneities and gradient field nonlinearities. Medical physics. 1985 Jan;12(1):20-6.) and Markl (Markl M, Bammer R, Alley MT, Elkins CJ, Draney MT, Barnett A, Moseley ME, Glover GH, Pelc NJ. Generalized reconstruction of phase contrast MRI: analysis and correction of the effect of gradient field distortions. Magnetic Resonance in Medicine: An Official Journal of the International Society for Magnetic Resonance in Medicine. 2003 Oct;50(4):791-801.).
Regarding claim 13, Plewes discloses An apparatus, comprising: at least one processor; and at least one memory storing instructions that, when executed by the at least one processor, cause the apparatus at least to: (Plewes Col 4 line 65- Col 5 line 14; reconstructing an MRI utilizing a processor and commands in conjunction with memory is disclosed.) determine, during a calibration phase (Plewes Col. 5 lines 31-50; MR measurements of the gradient distribution are disclosed. ) generate, during a treatment phase, a magnetic field gradient that is applied to a treatment area by using a treatment drive signal applied to the magnetic coil, wherein the treatment drive signal is different from the calibration drive signal; (Plewes Col 6 lines 18-34; a phase image is collected with application of ultrasound waves. See also Fig. 3 which shows the pulse sequence utilized. The phase image and measurement of the gradient distribution (treatment phase and calibration phase) happen at different times therefore the treatment drive signal is different from the calibration drive signal.) determine, based on the treatment drive signal applied to the magnetic coil, per-pixel phases of a treatment image of the treatment area, wherein the per-pixel phases of the treatment image are based on spin displacement at each pixel resulting from the applied ultrasound waves; (Plewes Col. 2 Lines 5-17; motion of a spin is measured by the phase. Col. 7 lines 8-67; explanation of how ultrasound induced motion can be measured is described. Images are obtained while the ultrasound is applied as can be seen in Figs. 5 and 6.) and adjust, for each pixel of the treatment image, the per-pixel phases of the treatment image based on the per-pixel magnetic field gradient for a corresponding pixel, to obtain a gradient-adjusted treatment image. (Plewes Col. 5 lines 31-50; MR measurements of the gradient distribution are disclosed. Plewes Col 7 Lines 6-7; the phase image is corrected for gradient magnitude variations.)
Although Plewes discloses MR measurements of the gradient distribution, Plewes does not explicitly disclose determine, during a calibration phase without application of ultrasound waves, a per-pixel magnetic field gradient of a magnetic field that is generated using a calibration drive signal applied to a magnetic coil;
O’Donnell, however discloses determine, during a calibration phase without application of ultrasound waves, a per-pixel magnetic field gradient of a magnetic field that is generated using a calibration drive signal applied to a magnetic coil; (O’Donnell Section I. Introduction ¶1 on right hand Col of p. 21; gradient fields are calculated for each pixel. Note in the pulse sequence diagrams Fig. 1 and Fig. 2 there is no application of ultrasound.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the apparatus of Plewes with teachings of O’Donnell by including measurement of field variations to be able to account for non-idealities in the system (O’Donnell Section I. Introduction ¶1).
The combination of Plewes and O’Donnell does not explicitly disclose scale, for each pixel of the treatment image, the per-pixel phases of the treatment image determined during the treatment phase by the per-pixel magnetic field gradient determined during the calibration phase for a corresponding pixel, to obtain a gradient-adjusted treatment image.
Markl, however, discloses scale, for each pixel of the treatment image, the per-pixel phases of the treatment image determined during the treatment phase by the per-pixel magnetic field gradient determined during the calibration phase for a corresponding pixel, to obtain a gradient-adjusted treatment image. (Markl Section Generalized reconstruction – found on p. 792; characterizing gradient field nonuniformity and reconstruction phase contrast images is disclosed. Velocity induced phase shifts are measured and compensated for. It can be seen in equation 4 that the ideal gradient values are scaled by the field variations. These phase variations are corrected as in equation 7, by scaling the desired velocity image by the field variation (i.e. gradient of magnetic field).)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the apparatus of the combination of Plewes and O’Donnell with teachings of Markl by including correction of non-linear gradients in phase contrast images in order to account for non-idealities to obtain accurate phase contrast images (Marl ¶5 – on p. 791)).
Claim 1 is the corresponding method claim to claim 13 and is rejected for similar reasons.
Regarding claim 2, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the calibration drive signal has a waveform with a non-zero time-integral. (O’Donnell Fig. 1; non-zero gradients applied to Gy and Gx can be seen. These are utilized in the correction factor calculation (see eqs. (23), (24), and (25)). Where in it would have been obvious to include measurement of field variations to be able to account for non-idealities in the system.)
Regarding claim 3, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose, wherein the treatment drive signal has a waveform type that matches a waveform type of ultrasound waves that are applied to the treatment area during the treatment phase. (Plewes Figs. 5 and 6 and Col. 2 line66 – Col. 3 line 15 and Col. 3 lines 34-45; oscillatory motion is detected using a harmonic gradient of frequency equal to that of the motion of interest. Therefore the treatment drive signal includes a gradient with harmonic frequency matching US.)
Regarding claim 4, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the gradient-adjusted treatment image includes, for each pixel in the gradient-adjusted treatment image, a gradient-adjusted per-pixel phase. (Plewes Col. 7 lines 6-7; the phase image is corrected for variations in the gradient magnitude throughout the imaging volume.)
Regarding claim 5, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 2. They further disclose wherein the waveform of the calibration drive signal, which has a non-zero time-integral, is one of the following waveform types: an exponential waveform; a trapezoidal waveform; a square waveform; a ramp waveform; a triangle waveform; a damped sinusoidal waveform. (O’Donnell Fig. 1; non-zero gradients applied to Gy and Gx can be seen. These are utilized in the correction factor calculation (see eqs. (23), (24), and (25)). A square waveform can be seen for Gx. Where in it would have been obvious to include measurement of field variations to be able to account for non-idealities in the system.)
Regarding claim 6, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 3. They further disclose wherein the waveform of the treatment drive signal and the waveform of the ultrasound waves are both sinusoidal waveforms. (Plewes Figs. 5 and 6; it can be seen that the treatment drive signal (Gradient) is sinusoidal and so is the ultrasound wave .)
Regarding claim 7, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the determining a per-pixel magnetic gradient comprises: applying, during the calibration phase without application of ultrasound waves, the calibration drive signal to the magnetic coil to generate the magnetic field during the calibration phase; and determining, during the calibration phase based on the applied calibration drive signal, the per-pixel magnetic field gradient as a gradient of the magnetic field at each pixel of a calibration image. (O’Donnell Section I. Introduction ¶1 on right hand Col of p. 21; gradient fields are calculated for each pixel. Note in the pulse sequence diagrams Fig. 1 and Fig. 2 there is no application of ultrasound. Where in it would have been obvious to include measurement of field variations to be able to account for non-idealities in the system.)
Regarding claim 9, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the magnetic coil generates a non-linear magnetic field gradient over the treatment area. (O’Donnell ¶2 on the right hand side of p. 25 continuing onto p. 26; the effects of nonlinear gradient fields are corrected for. Wherein it would have been obvious to measurement of field variations to be able to account for non-idealities in the system.)
Regarding claim 10, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the magnetic coil generates a magnetic field having: an increasing or positive slope of the magnetic field gradient over a first region of the treatment area or a positive second derivative of the magnetic field over a first region of the treatment area; and a decreasing or negative slope of the magnetic field gradient over a second region of the treatment area, or a negative second derivative of the magnetic field over the second region of the treatment area. (Plewes Fig. 3; gradients increasing and decreasing can be seen.)
Regarding claim 11, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the gradient-adjusted treatment image includes, for each pixel in the gradient-adjusted treatment image, a gradient-adjusted per-pixel phase, the method further comprising: determining, per-pixel, at least one acoustic parameter for the treatment area based on the gradient-adjusted per-pixel phase of the gradient-adjusted treatment image; wherein the at least one acoustic parameter includes at least one of the following: acoustic pressure amplitude; sound speed; or acoustic intensity. (Plewes Col. 7 Lines 33-67 including equations (5) and (6); acoustic pressure and intensity can be measured. Col. 8 line 42- Col. 9 line7; measuring the speed of sound in disclosed.)
Regarding claim 12, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the gradient-adjusted treatment image includes, for each pixel in the gradient-adjusted treatment image, a gradient-adjusted per-pixel phase, the method further comprising: determining, per-pixel, a bulk modulus for the treatment area based on the gradient-adjusted per-pixel phase of the gradient-adjusted treatment image. (Plewes Col. 9 line7; calculating K (bulk modulus) is disclosed.)
Regarding claim 14, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the scaling comprises multiplying or dividing the per-pixel phases of the treatment image by the per-pixel magnetic field gradient determined during the calibration phase. (Markl Section Generalized reconstruction – found on p. 792; it can be seen in equation 7 that the field gradient is used to scale)
Regarding claim 15, the combination of Plewes, O’Donnell, and Markl disclose the claim limitations with respect claim 1. They further disclose wherein the treatment drive signal is of a second waveform type that matches a frequency and a waveform type of the ultrasound waves. (Plewes Figs. 5 and 6; it can be seen that the treatment drive signal (Gradient) is sinusoidal and so is the ultrasound wave. Plewes Col. 3 lines 34-45; the frequency matches the ultrasound frequency with harmonics.)
Allowable Subject Matter
Claims 16 and 17 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEREDITH TAYLOR whose telephone number is (571)270-5805. The examiner can normally be reached M-Th 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vincent Rudolph can be reached at (571)272-8243. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEREDITH TAYLOR/Examiner, Art Unit 2671
/VINCENT RUDOLPH/Supervisory Patent Examiner, Art Unit 2671
Prosecution Insights