NON-FINAL REJECTION
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 Group I (claims 1-3, 7, 8, 10, 12-14, and 19) in the reply filed on 4/13/2026 is acknowledged.
It is noted that claims 39-47 have been newly added (hereinafter “new claims”). The subject matter of the new claims appears to be nearly identical to that of claims 23-25, 28, 30, 34-37 of non-elected Group II, the essential difference is the new claims are in the form of a method instead of an apparatus.
Group I and the new claims do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for essentially the same reasons why Groups I and II lack the same or corresponding special technical features as discussed in the Restriction Requirement dated 2/12/2026:
Group I and the new claims lack unity of invention because even though they both require the technical feature of obtaining particle velocities from generated mechanical waves in tissue of a subject; reconstructing a stiffness map of soft tissue in a region of interest (ROI) from the particle velocities; and generating an image of the stiffness map for rendering on a user device, this technical feature is not special technical feature as it does not make a contribution over the prior art in view of Yoshikawa, US 2017/0333004 A1 which discloses:
obtaining particle velocities from generated mechanical waves in tissue of a subject (measuring a stress index, ¶ [0051]; the stress index may be particle velocity, ¶ [0057]);
reconstructing a stiffness map of soft tissue in a region of interest (ROI) from the particle velocities (¶ [0113]-[0114]; e.g., “The above explanations have been made on the basis of a phase velocity V0(ω) in a stress-free state V0 and, as information obtained by an elasticity evaluation unit 18 according to the present example from a propagation velocity, a stress index, and an index having frequency dependency (a numerical value such as a phase velocity or a frequency-dependent attenuation obtained from waveform analysis) that are the outputs from a velocity measurement like, a group velocity, a phase velocity, a complex modulus (storage elastic modulus and loss elastic modulus), and a frequency-dependent attenuation in a stress-free state are mentioned. All of those are elasticity evaluation indexes related to the elasticity of a test object and to display them as a numerical value, a graph, or a two-dimensional map of each of them on a display unit 19 is effective as diagnostic information to support the qualitative diagnosis of the test object.”; “Two-dimensional maps of the elasticity evaluation indexes displayed on a display unit in a device according to the present example are shown schematically in FIG. 25.”); and
generating an image of the stiffness map for rendering on a user device (¶ [0113]-[0114]; e.g., “All of those are elasticity evaluation indexes related to the elasticity of a test object and to display them as a numerical value, a graph, or a two-dimensional map of each of them on a display unit 19 is effective as diagnostic information to support the qualitative diagnosis of the test object”; “Two-dimensional maps of the elasticity evaluation indexes displayed on a display unit in a device according to the present example are shown schematically in FIG. 25.”).
Therefore, claims 39-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/13/2026.
Claim Objections
Claim 8 is objected to because of the following informalities. Appropriate correction is required.
Claim 8 recites the phrase “one or more stiffness map” but should be corrected to read as --one or more stiffness maps--.
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.
Claims 8 and 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8 recites “one or more stiffness map from lower frequency data is used as an initial estimate for refined stiffness maps from broader frequency data”. The terms “lower frequency data” and “broader frequency data” have uncertain relational boundaries. The term “lower” necessarily raises the question: as compared to what or lower than what? Likewise, the term “broader” necessarily raises the question: as compared to what or broader than what?
Additionally, the claim doesn’t expressly establish the relationship between the “lower frequency data” and subsequently used “broader frequency data”. For example, in the case where the first reconstruction is 100 Hz data with a 10 Hz bandwidth, does broader frequency data mean:
multiple frequencies or a range of frequencies; e.g., 50 and 200 Hz?
a higher frequency as compared to the “lower frequency data”; e.g., 200 Hz?
a wider bandwidth; e.g., 20 Hz bandwidth?
Regarding claim 14: the viscoelastic mechanical model itself does not appear to be within the scope of the claim. The model is not referred to or used in any method step. Since claim 14 is written as a dependent claim that depends on claim 12, it seems that claim 14 was (presumably) intended to further limit the scope of claim 12. However, since the viscoelastic mechanical model is not within the scope of the claim, it is unclear in what manner claim 14 further limits the scope of claim 12.
Additionally, It is unclear what is meant by a “general frequency dependent complex modulus”. In other words, what is the difference between a “general frequency dependent complex modulus” as recited in the claim, and merely a frequency dependent complex modulus (e.g., non-general).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshikawa, US 2017/0333004 A1 (hereinafter “Yoshikawa”).
Regarding claim 1: Yoshikawa discloses a method comprising:
obtaining particle velocities from generated mechanical waves in tissue of a subject (measuring a stress index, ¶ [0051]; the stress index may be particle velocity, ¶ [0057]);
reconstructing a stiffness map of soft tissue in a region of interest (ROI) from the particle velocities (¶ [0113]-[0114]; e.g., “The above explanations have been made on the basis of a phase velocity V0(ω) in a stress-free state V0 and, as information obtained by an elasticity evaluation unit 18 according to the present example from a propagation velocity, a stress index, and an index having frequency dependency (a numerical value such as a phase velocity or a frequency-dependent attenuation obtained from waveform analysis) that are the outputs from a velocity measurement like, a group velocity, a phase velocity, a complex modulus (storage elastic modulus and loss elastic modulus), and a frequency-dependent attenuation in a stress-free state are mentioned. All of those are elasticity evaluation indexes related to the elasticity of a test object and to display them as a numerical value, a graph, or a two-dimensional map of each of them on a display unit 19 is effective as diagnostic information to support the qualitative diagnosis of the test object.”; “Two-dimensional maps of the elasticity evaluation indexes displayed on a display unit in a device according to the present example are shown schematically in FIG. 25.”); and
generating an image of the stiffness map for rendering on a user device (¶ [0113]-[0114]; e.g., “All of those are elasticity evaluation indexes related to the elasticity of a test object and to display them as a numerical value, a graph, or a two-dimensional map of each of them on a display unit 19 is effective as diagnostic information to support the qualitative diagnosis of the test object”; “Two-dimensional maps of the elasticity evaluation indexes displayed on a display unit in a device according to the present example are shown schematically in FIG. 25.”).
Claims 1, 10, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mace et al., “In Vivo Mapping of Brain Elasticity in Small Animals Using Shear Wave Imaging” IEEE Transactions on Medical Imaging, Vol. 30, No. 3, March 2011 (hereinafter “Mace”).
Regarding claim 1: Mace discloses a method, comprising:
obtaining particle velocities from generated mechanical waves in tissue of a subject (“The propagation of the shear wave is imaged with ultrasound at a very high frame rate (>5 kHz) using the same probe. The axial component of tissue particle velocity
V
z
(see Fig. 2) can be measured at each point in the imaging plane by cross-correlations between two consecutive ultrafast ultrasound images [19].” page 551);
reconstructing a stiffness map of soft tissue in a region of interest (ROI) from the particle velocities (“the group speed of the shear wave
c
g
(i.e., the wave speed of the wave packet) is estimated for each pixel from the axial velocity of the tissues
V
z
. This local group speed is measured using a time of flight algorithm… Applying the time of flight algorithm to each pixel of the 2-D image sequence of shear wave propagation enables the deduction of a complete map of the value of
G
^
characterizing the local mechanical properties of the tissue.” page 552; “A combination of radiation force and ultrafast ultrasound imaging is used to both generate and track the propagation of a shear wave in the brain whose local speed is directly related to stiffness, characterized by the dynamic shear modulus G*.” Abstract); and
generating an image of the stiffness map for rendering on a user device (see Figs. 4, 6, 7, and 9 which show images of the stiffness/elasticity maps).
Regarding claim 10: the image of the stiffness map is a three-dimensional (3D) image (“Medical imaging software AMIDE was used for 3-D image reconstruction (http://amide.sourceforge.net/). Each SWI scan of the brain resulted in a stack of 2-D elasticity maps that were interpolated with AMIDE to reconstruct a 3-D elasticity map. A 3-D median filtering (kernel size 3) was applied. In this paper, to aid in the visualization of 3-D elasticity maps, we chose to always present coronal sections for scans performed both in the coronal and the sagittal plane.” page 553).
Regarding claim 12: Mace further discloses that the stiffness map comprises elastic modulus variation in the sense that the images of the maps shown in various figures shows spatial variation in the elastic modulus values (i.e., different spatial regions have different elastic modulus values).
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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Mace in view of Liu et al., “Robust time-domain full waveform inversion with normalized zero-lag cross-correlation objective function” Geophysical Journal International, Vol. 209, Iss. 1, April 2017, pages 106-122 (hereinafter “Liu”).
Regarding claims 2 and 3: Mace discloses the invention of claim 1 as discussed above. Mace further teaches that the reconstruction of the stiffness map of soft tissue in the ROI is based on a cross-correlation (“To estimate the shear velocity for each pixel, the time of flight algorithm calculates the correlation function between two displacement vectors separated by a distance of 1 mm. If the SNR is poor, the correlation coefficient between these two vectors is low (typically 0.7), meaning that the estimation of the shear velocity is not possible, and the pixel is rejected. The quality of the correlation is also used to optimize the combination of the partial elasticity maps.” page 553) but does expressly teach this as a cross-correlation based cost function let alone minimizing it within a defined threshold.
The examiner takes OFFICIAL NOTICE that reconstruction approaches such as least-squares (L2) cost functional and its gradient are well-understood, routine, and conventional and therefore obvious to implement. This appears to be consistent with Applicant’s own Specification which admits to one or more conventional reconstruction approaches based on the least-squares (L2) cost functional and its gradient (see ¶ [0061]-[0065]).
However, even using the standard/conventional reconstruction approach of L2 cost functional and its gradient and applying it to Mace, the modified Mace still lacks a cross-correlation based cost function, let alone minimizing it to within a defined threshold. In this sense, the modified Mace method reads on a “base” device (method, or product) upon which the claimed invention can be seen as an “improvement”.
Liu teaches a cross-correslation based cost function (normalized zero-lag cross-correlation-based full waveform inversion (CFWI)) which is quite similar to Applicant’s disclosed cost function, and that it performs better than the standard/conventional L2 and its gradient because, for example, it is insensitive to noise and amplitude errors. More specifically, Liu teaches at page 108:
Essentially, FWI aims to find a velocity model that allows us to interpret the available data correctly. This process is carried out by calculating synthetic seismic records from a previously assumed model with the purpose of comparing with the observed data. If the fit is not acceptable, the model is updated so that the synthetic data are regenerated, and the procedure is repeated until the convergence is achieved. It is a powerful technique in seeking images and properties (such as velocity and impedance) of complex geological structures. The important criterion to measure the error between the simulated (or predicted) and observed data is an objective function.
The standard implementation of FWI relies on the use of the L2 norm as the objective function that expresses the difference between the simulated and observed data. The L2 norm strongly emphasizes the matching of the amplitudes between the simulated and observed data. However, with real data, it is not easy to match the amplitudes directly because of several factors. First, the real earth is viscoelastic so that the amplitudes and phases of the propagating seismic waves are severely distorted (Duttaetal.2014). As a result, the resolution of the inverted models decreases (Causseetal.1999). Although viscoelastic simulations can mitigate this issue, it is computationally expensive. In addition, the estimation of the attenuation parameter is really difficult. Second, it is difficult to obtain a good estimation of the source signature and indeed the source strength varies at different shot locations.
Here, we consider full waveform inversion with the normalized zero-lag cross-correlation function (i.e. correlative full waveform inversion, hereafter CFWI).This function can be written as
E
c
=
-
1
N
s
N
r
∑
s
∑
r
∫
d
(
x
r
;
t
;
x
s
;
c
)
∙
D
x
r
;
t
;
x
s
d
t
∫
d
(
x
r
;
t
;
x
s
;
c
)
2
d
t
D
x
r
;
t
;
x
s
2
d
t
where c is the velocity model; Ns and Nr represent the number of shots and receivers, respectively; d(xr;t;xs;c) and D(xr;t;xs) are the simulated and observed data at the receiver xr and the time instant t, respectively, which are excited by a source located at position xs. The summation is performed over sources (subscript s) and receivers (subscript r). The negative sign on the right-hand side means that the minus value of the normalized zero-lag cross-correlation function is minimized or the normalized zero-lag cross-correlation function itself is maximized. Since this function measures the similarity between the simulated and observed data, it relaxes on the amplitude adjustment criterion required by the L2 norm and emphasizes the phase-mismatch. This objective function is equivalent to a time-domain phase inversion method where the phase spectra of the simulated data are matched with those of the observed data (Schuster1991; Sun & Schuster 1993; Routh et al. 2011a,b; Zhang et al. 2013; Dutta et al. 2014). Thus, it reduces the importance of the amplitude and provides the basis for using the phase information to measure the closeness between the observed and simulated seismic data. Therefore, it encloses high expectations to be insensitive to noise and unpredicted data that cannot be modelled by the wavefield extrapolation operator.
Liu further teaches minimizing the cross-correlation based cost function to within a defined threshold (“Identical stopping criteria are set for FWI with different objective functions: the relative change in the value of the objective function value must be less than 0.0001” page 111; “This demonstrates that FWI with any of these objective functions and applying the multiscale inversion is a convergent process instead of a divergent one (meets the pre-defined stopping criterion)” page 118; “The corresponding curves converge to the predefined stopping threshold” page 118).
Although Liu is concerned with seismic studies and not soft tissue, Liu teaches the same improvements as the disclosed/claimed invention as discussed above (i.e., FWI with CFWI minimized to within a defined threshold applied to wave propagation studies such as for wave propagation velocity for determining mechanical properties of the propagation medium). In this sense Liu can be considered a “comparable” device (method, or product that is not the same as the base device) that has been improved in the same way as the claimed invention.
Furthermore, the ordinarily skilled artisan could have applied the improvement technique of Liu to the modified Mace invention as discussed above (i.e., modified in view the well-understood, routine, and conventional reconstruction approach of L2 cost functional and its gradient) because Liu teaches that the FWI with CFWI minimized to within a defined threshold offers improvements over the standard/conventional L2 cost functional and its gradient as applied to wave propagation studies such as for wave propagation velocity for determining mechanical properties of the propagation medium and the modified Mace invention as discussed above uses the L2 cost functional and its gradient for shear wave studies, more particle and shear wave velocities to determine mechanical properties of the propagation medium (i.e., stiffness/elasticity of tissue).
Applying the improvement technique of Liu to the modified Mace invention would have predictably resulted in improvements because Liu teaches that FWI with CFWI minimized to within a defined threshold it is insensitive to noise and amplitude errors as compared to the standard/conventional L2 cost functional and its gradient.
It would have been obvious to one having ordinary skill in the art to further modify the invention of Mace such that reconstructing the stiffness map of soft tissues in the ROI is based on a cross-correlation based cost functional, and further that reconstructing the stiffness map comprises minimizing the cross-correlation based cost functional to within a defined threshold, because it would have merely involved use of a known technique to improve similar devices (methods, or products) in the same way.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mace in view of Otesteanu et al., “Robust Reconstruction of Elasticity Using Ultrasound Imaging and Multi-Frequency Excitations” IEEE Transactions on Medical Imaging, Vol. 37, No. 11, November 2018 (hereinafter “Otesteanu”).
Regarding claim 7, Mace teaches the invention of claim 1 but does not teach that the reconstruction is carried out over a plurality of frequencies.
Otesteanu teaches reconstruction carried out over a plurality of frequencies which improves robustness and reduces reconstruction artifacts (“As the wave patterns in individually selected frequencies may introduce artifacts, a joint inverse-problem solution of multi-frequency excitations is introduced as a robust solution, where CNR improvements of up to 11.9 dB are observed.” Abstract; “An experiment of ablation via heating an ex-vivo bovine liver shows that reconstruction artifacts are reduced with our proposed method.” Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mace such that reconstruction is carried out over a plurality of frequencies, as taught by Otesteanu; and the ordinarily skilled artisan would have been motivated to make this modification in order to improve robustness and reduce reconstruction artifacts.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mace in view of Bayat et al., US “Diagnostic features of quantitative comb-push shear elastography for breast lesion differentiation” PLoS ONE 12(3), March 3, 2017 (hereinafter “Bayat”).
Mace teaches the invention of claim but does not expressly teach that the ROI is determined based upon initial inspection of acoustic information.
Bayat teach that ROIs (FOVs for SWE acquisition and/or ROIs shear speed calculation) are determined based upon initial inspection of acoustic information (B-mode ultrasound) (see section titled “US imaging and shear wave elastography” on page 3).
The ordinarily skilled artisan would have realized that initial inspection of acoustic information such as B-mode imaging before elastography/shear wave studies can help with more precise targeting of the ROI and/or ensuring proper positioning of the ultrasound probe prior to elastography/shear wave studies.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Mace such that the ROI is determined based upon initial inspection of acoustic information, as taught by Bayat; and the ordinarily skilled artisan would have been motivated to make this modification in order to help with precise targeting of the ROI and/or ensure proper positioning of the ultrasound probe elastography/shear wave studies.
Allowable Subject Matter
Claim 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Regarding claim 13: Within the context of claim 12, the prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan that a viscosity map is constructed after finalizing an elastic modulus map. While it is known to (re)construct both maps1, the temporal/sequential ordering as recited in the claim does not appear to be taught in the prior art. It is noted that this ordering may not necessarily be arbitrary in the sense that constructing the viscosity map only after finalizing the elastic modulus map allows for the finalized elastic modulus map to be used to construct the viscosity map.
Examiner Remarks
MPEP 2173.06 recites in part:
II. PRIOR ART REJECTION OF CLAIM REJECTED AS INDEFINITE
All words in a claim must be considered in judging the patentability of a claim against the prior art. In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA 1970). The fact that terms may be indefinite does not make the claim obvious over the prior art. When the terms of a claim are considered to be indefinite, at least two approaches to the examination of an indefinite claim relative to the prior art are possible.
First, where the degree of uncertainty is not great, and where the claim is subject to more than one interpretation and at least one interpretation would render the claim unpatentable over the prior art, an appropriate course of action would be for the examiner to enter two rejections: (A) a rejection based on indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph; and (B) a rejection over the prior art based on the interpretation of the claims which renders the prior art applicable. See, e.g., Ex parte Ionescu, 222 USPQ 537 (Bd. App. 1984). When making a rejection over prior art in these circumstances, it is important for the examiner to point out how the claim is being interpreted. Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
The first approach is recommended from an examination standpoint because it avoids piecemeal examination in the event that the examiner’s 35 U.S.C. 112, second paragraph rejection is not affirmed, and may give applicant a better appreciation for relevant prior art if the claims are redrafted to avoid the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph rejection.
In this case, there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of claims 8 and 14 and therefore it would not be proper to reject such claims on the basis of prior art. Any attempt to reject such claims would necessarily involve considerable speculation about the meaning of terms employed in the claims or assumptions that must be made as to the scope of the claims.
That being said, the following references appear relevant to claims 8 and 14 (or at least the intended subject matter thereof as best understood by the examiner at this time):
Regarding claim 8:
Otesteanu et al., “Robust Reconstruction of Elasticity Using Ultrasound Imaging and Multi-Frequency Excitations” IEEE Transactions on Medical Imaging, Vol. 37, No. 11, November 2018.
Mohammed et al., “Multifrequency 3D Elasticity Reconstruction with Structured Sparsity and ADMM” Nov. 23, 2021.
Bunks et al., “Multiscale seismic waveform inversion” Geophysics, Vol. 60, No. 5, pages 1457-1473, October 1995.
Sun et al., “Deep learning for low frequency extrapolation of multicomponent data in elastic full waveform inversion” December 2020.
Regarding claim 14: Yengul et al., “Dispersion in Tissue-Mimicking Gels Measured with Shear Wave Elastography and Torsional Vibration Rheometry” Ultraound in Medicine and Biology, Vol. 45, No. 2, pages 586-604, 2019
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (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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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
8 August 2026
1 Bhatt et al., “Reconstruction of Viscosity Maps in Ultrasound Shear Wave Elastography” IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control, Vol. 66, No. 6, June 2019
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