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 § 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) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over PRUS (US 20100268088 A1) in view of HYNYNEN (US 20160106395 A1).
Regarding claim 28, PRUS teaches a method (PRUS teaches a method of delivering multimode ultrasound waves to a target through at least one tissue layer, abstract) comprising:
providing a first set of ultrasound waves through an arbitrarily heterogenous media and to a region of interest propagating at a first sound speed (PRUS teaches providing ultrasound waves through an arbitrarily heterogeneous media, specifically a patient's skull and soft brain tissue, to a selected region of interest or focus in the brain. Furthermore, PRUS teaches that these waves include a longitudinal wave mode that propagates at a sound velocity of approximately 2700 m/s in the skull, para. 0021-29);
providing a second set of ultrasound waves through the arbitrarily heterogenous media and to the region of interest propagating at a second sound speed being different than the first sound speed (PRUS teaches utilizing a second set of waves, specifically shear waves (or transverse components), that also penetrate through the skull to reach the target area. PRUS explicitly states that these shear waves have a sound velocity of approximately 1400 m/s in the skull, which is different from the longitudinal waves, causing the two components to propagate through the skull at different angles due to their different propagation velocities, para. 0005,21-29); and
calculating a phase shift and attenuation of signals emanating from the region of interest and through the arbitrarily heterogenous media, the phase shift and attenuation at least in part based on the first sound speed and the second sound speed (PRUS teaches calculating the wave propagation, phase shifts, and attenuations for both the longitudinal and shear modes separately based on their differing propagation velocities to determine an overall phase shift and attenuation. PRUS also discloses a diagnostic application utilizing a detector device that measures transmitted or reflected ultrasound signals emanating from the tissue, which are then provided to a driver for processing, para. 0021-31).
PRUS is silent to teaching that calculating a phase shift and attenuation of signals comprising
calculating a spatial frequency-domain of signals; and
generating passive acoustic map with the spatial frequency-domain.
In the same field of endeavor, HYNYNEN a method comprising
calculating a spatial frequency-domain of signals emanating from the region of interest and through the arbitrarily heterogenous media (HYNYNEN teaches receiving acoustic signals emitted from the excited microbubbles and performing calculations in the frequency-domain by taking the discrete Fourier transform of the time-delayed waveforms received by the elements. HYNYNEN explicitly shows that the time delay equation relies on the speed of sound, para. 0017-27); and
generating passive acoustic map with the spatial frequency-domain (HYNYNEN explicitly teaches generating "three-dimensional passive maps of the bubbles". Furthermore, HYNYNEN teaches that the intensity values assigned to voxels in these reconstructed images (maps) are calculated mathematically by summing the magnitude of the power spectrum over a frequency band, directly utilizing the frequency-domain data calculated via the discrete Fourier transform, para. 0013-23).
Therefore, a Person Having Ordinary Skill in the Art (PHOSITA) would be motivated to combine the teachings of PRUS and HYNYNEN because both references are directed at solving the same fundamental challenge in transcranial ultrasound procedures: overcoming the severe beam aberration, phase distortion, and attenuation caused by the human skull's irregular geometry, density, and sound speed.
PRUS addresses this problem by delivering a multimode ultrasound beam (longitudinal and shear waves) and computing the necessary phase shifts and attenuations to accurately focus energy into the brain. However, to calculate how these waves propagate through the skull, PRUS relies on predictive theoretical models, such as: Numerical simulations (e.g., finite elements methods based on CT/MRI scans), which PRUS admits are computationally expensive and typically performed off-line during treatment planning. Simplified analytical models (e.g., ray tracing using concentric spherical layers), which may not fully account for a realistic, complex skull geometry.
HYNYNEN addresses the same transcranial aberration problem but offers a highly accurate, empirical method to measure and correct for these distortions from the "inside out." HYNYNEN teaches introducing a microbubble contrast agent into the target region (e.g., blood vessels) and passively beamforming the acoustic emissions from single excited microbubbles. Crucially, HYNYNEN teaches how to empirically calculate precise skull delay parameters (phase shifts) and amplitude correction terms by processing these microbubble emissions using frequency-domain calculations (discrete Fourier transforms).
A PHOSITA would be motivated to incorporate HYNYNEN’s empirical microbubble-based phase and amplitude correction techniques into PRUS’s multimode ultrasound therapy system to replace or supplement PRUS's computationally expensive, off-line theoretical simulations with HYNYNEN's precise, real-time empirical measurements. By exciting microbubbles at the target region and passively mapping their acoustic responses, PRUS’s system could utilize HYNYNEN's calculations to dynamically and accurately map the true, patient-specific heterogeneous nature of the skull. This combination would eliminate the reliance on simplified geometric approximations and directly improve PRUS's stated objective of maximizing the amount of energy safely and accurately focused at a desired transcranial target using both longitudinal and shear waves.
Allowable Subject Matter
Claims 1-5, 7, 9-11, 14, 15, and 21-27 are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 28 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20120165670 A1 (SHI) teaches ultrasound imaging systems.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 WEN WU HUANG whose telephone number is (571)272-7852. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wesley Kim can be reached at (571) 272-7867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WEN W HUANG/Primary Examiner, Art Unit 2648
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