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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Response to Arguments
Regarding 35 U.S.C. 112
The 112(b) rejections previously set forth are withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment.
Regarding prior art
Applicant’s arguments with respect to claims 1-2 and 23-27 have been considered but are moot in view of the new grounds of rejection necessitated by amendment, however, examiner will address any arguments which remain relevant to the current rejection.
Specifically, examiner notes that applicant’s arguments against Cunitz alone and/or Cunitz in view of Detmer are moot as the rejection does not rely on Cunitz alone nor does it rely on Cunitz in view of Detmer, however, applicant's arguments filed 10/24/2025 with respect to the teachings of Cunitz and Gu have been fully considered but they are not persuasive.
For example, applicant argues “Cunitz’s method lacks any defined simulation threshold or ensemble comparison and does not apply a second temporal derivative across repeated identical insonifications to isolate nonlinear, stimulus induced motion” (REMARKS pg. 13). Examiner respectfully disagrees in that the initial burst of Cunitz causes oscillation/displacement of the stone/microbubbles and therefore necessarily requires an ultrasound pulse to be above a stimulation threshold, otherwise such oscillation/displacement could not occur. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “ensemble comparison” and “apply a second temporal derivative across repeated identical insonifications to isolate nonlinear, stimulus induced motion”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, examiner notes that no ensemble comparison is required of claim 1 and claim 1 further does not require applying a second temporal derivative across repeated identical insonifications to isolate nonlinear, stimulus induced motion, but rather a second temporal derivative of the amplitude or phase which is identified as not being taught by Cunitz but rather is taught by additional references Gu or Katsuyama (see below rejection).
Applicant further argues “Applicant’s method isolates stimulus-induced displacement above a quantifiable stimulation threshold. When ensembles are compared above and below this threshold, residual signals from unrelated motion can be removed algorithmically, providing high confidence discrimination of particle-induced echoes”. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., isolates stimulus-induced displacement above a quantifiable stimulation threshold and when ensembles are compared above and below this threshold, residual signals from unrelated motion can be removed algorithmically, providing high confidence discrimination of particle-induced echoes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner notes that the method of claim 1 does not require any isolated displacement nor does it required comparison of ensembles above and below this threshold for removing residual signals.
With respect to Gu, applicant argues “Gu computes a second derivative of contrast-mode envelope power over many frames to assess perfusion kinetics. In contrast to Applicant’s method, it does not perform a slow-time second derivative of repeated, threshold stimulation pulses or include any sub-threshold control ensemble. Applicant’s method differs by applying a defined threshold stimulation regime and slow-time derivative analysis in the rf or IQ domain to identify nonlinear motion responses of impedance-mismatched particles” (REMARKS pg. 14-15). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “performing a slow-time second derivative of repeated, threshold stimulation pulses or include any sub-threshold control ensemble”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, examiner notes that the claim merely recites computing a second temporal derivative of the received reflected signal or phase without specifying which reflected signal or phase the claim is referring to, thus the claim does not required the slow-time derivative to be of repeated, threshold stimulation pulses nor does the claim require any sub-threshold control ensemble. Furthermore, although Gu does not teach the stimulation pulse above the threshold, such feature is already taught by primary Cunitz, where Gu is recited for merely applying the second temporal derivative to the received signal of Cunitz. Thus applicant’s arguments against the references alone are not found persuasive. Finally, it is noted that the second-derivative of Gu is over many frames and is thus considered a temporal second derivative in slow-time. For at least the reasons listed above, applicant’s arguments with respect to the teachings of Cunitz and Gu are not found persuasive.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 16/749,728 hereinafter ‘728 and Provisional Application No. 62/795,419 hereinafter ‘419 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Examiner notes that instant claim 1 is drawn to a genus of “a particle having a large acoustic impedance variation”, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Fii Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353-54 (‘[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed (See MPEP 2163(3)(a)(ii)).
Examiner notes that the parent applications listed above do not provide sufficient support for the entire genus with respect to “a particle having large acoustic impedance variation” which may be interpreted as including any particles having a large acoustic impedance variation in any tissue/material (such as microcalcifications, iron deposits in certain types of breast cancer, kidney stones, bone fragments, contrast bubbles, bubble defects in materials, surface defects/cracks, or material impurities as disclosed in [0109] of applicant’s instant specification, crystals, or other impedance changes in a material as disclosed in [0032] of applicant’s instant specification or other particles having a “large acoustic impedance difference from its surrounding media) and only appear to provide sufficient support for the specific species of microcalcifications. In other words, the parent applications do not provide sufficient support for using the methods recited herein to identify any number of particles (such as those listed above), but rather only provide sufficient support for specific species of such particles (i.e. a microcalcification) (see [0008]-[0009] of 16749728)
For at least the reasons listed above, for examination purposes, the effective filing date of the instant claims 1-22 is considered to be 08/22/2022, the filing date of the instant application.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-2 and 23-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the received signal amplitude or phase”. The limitation lacks sufficient antecedent basis and it is therefore unclear which signal amplitude or phase the claim is referring to. In other words, claim 1 previously sets forth receiving reflected signals in step (a) and received signal sets in step (b), therefore it is unclear which signal of the signals/sets and the amplitude or phase thereof that the claim is referring to. For examination purposes, it has been interpreted to mean any signal amplitude or phase, however, clarification is required.
Claim 23 recites the limitation “the additional ensemble being formed in accordance with steps (b)-(d), except that one or more transmit parameters, including the spatial location of the spatial focal region and/or a change in acoustic power level, are adjusted so that for at least a subset of spatial locations, the local acoustic power of the transmitted pulses in the first ensemble at each of the those spatial locations is above the stimulation threshold, the local acoustic power of the transmitted pulses in the second ensemble at each of those spatial locations is below the stimulation threshold”. The limitation is unclear for multiple reasons. First is it is unclear how the additional ensemble is formed in accordance with steps (b)-(d) with adjusted transmit parameters which include a spatial location of the spatial focal region or change in acoustic power level. For example, steps b-d require the same transmit and receive conditions to obtain an ensemble corresponding to the spatial focal region. Thus step (b) requires the transmit parameters use the same transmit and receive conditions as step (a) and further relies on antecedent basis of the spatial focal region from step (a). Furthermore, it is unclear if the claim is attempting to define that that data is received from the portion of the region that at least partiall encompasses the spatial focal region of step (a) from claim 1, with a different transmission location of the spatial focal region or if the location of the spatial focal region is changed and thus the portion from which reflected signals is changed as well. Furthermore, regarding the subset of spatial locations, it is unclear if the spatial locations is or includes the one or more spatial locations recited previously in claim 1 or if this is a different spatial locations. Furthermore, examiner notes that steps b-d are not directed to forming an additional ensemble as only step b is directed to forming an additional ensemble. Thus making it unclear how forming an ensemble is done in accordance with steps b-d. For examination purposes, it has been interpreted that an additional ensemble is formed using adjusted transmit parameters, including the spatial location of the spatial focal region and/or a change in acoustic power level, for any subset of any spatial locations, however, clarification is required. Examiner recommends clearly defining the steps of the additional ensemble and how they relate to the spatial locations recited previously as opposed to referring back to previously recited steps in order to enhance clarity of the limitation.
Claim 23 recites the limitations “the first ensemble” and the second ensemble”. There is insufficient antecedent basis for the limitations. It is therefore unclear if the claim is attempting to refer to the ensemble of claim 1 and the additional ensemble of claim 23 or if these are different ensembles. For examination purposes, it has been interpreted that the ensemble recited in claim 1 is the first ensemble and the additional ensemble is the second ensemble, however, clarification is required.
Claim 23 recites the limitation “an above-threshold ensemble and a below-threshold ensemble”. It is unclear if the claim is referring to the first and second ensemble recited previously or if these are different ensembles.
Claim 23 recites the limitation “the magnitudes of the second derivatives through slow time as determined in accordance with step (d)”. Examiner notes that the limitation is unclear as to which “magnitudes” the claim is referring to as step (d) only recites a magnitude. For examination purposes, it has been interpreted that the method comprises computing a second derivative and determining a magnitude of the second/below-threshold ensemble, however, clarification is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Cunitz et al. (US 20150320384 A1), hereinafter Cunitz in view of Gu et al. (US 20180185010 A1), hereinafter Gu or Katsuyama (US 20100087736 A1), hereinafter Katsuyama.
Regarding claim 1,
Cunitz teaches a method of using ultrasound to identify one or more particles in a region of a material having an acoustic impedance that is different than the material or background of the material comprising:
Using an ultrasonic imaging system (at least fig. 1 (100) and corresponding disclosure in at least [0040]) to transmit a simulation pulse comprising 2 to 32 cycles focused towards a spatial focal region within the region of the material and an acoustic pressure amplitude being sufficient to exceed a stimulation threshold required to elicit a measurable localized displacement or oscillation of the one or more particles relative to a surrounding medium, and receive reflected signals from the stimulation pulse from a portion of the region of the material that at least partially encompasses the spatial focal region (at least fig. 2 (210) and corresponding disclosure in at least [0052] ([0051] which discloses the ultrasound pulses may be delivered to the body in a Doppler ensemble. A doppler ensemble comprises a number or pulses per cycle, and a number of cycles per burst. An initial excitation pulse may be different in the number of cycles, frequency, and amplitude. In one example embodiment, the number of bursts in an ensemble ranges from 2-20. Where [0036] discloses that doppler comprises multiple pulses in a burst or ensemble, the initial burst excites (i.e. stimulates) the bubbles to oscillate and also discloses the bubbles may be micron-sized gas pockets on hydrophobic stone surface regions. Examiner notes that micron-sized gas pockets (i.e. micro-bubbles) are considered particles having an acoustic impedance that is different from the material or background of the material and that the initial excitation pulse having a number of cycles is a stimulation pulse comprising an acoustic pressure amplitude being sufficient to exceed a stimulation threshold in order to oscillate the bubbles accordingly) and receive reflected signals from the stimulation pulse from a portion of the region of the material that at least partially encompasses the spatial focal region([0052] which discloses the method then includes receiving one or more reflection signals, wherein the one or more reflection signals comprise reflection signals corresponding to the one or more ultrasound pulses reflected from the object and reflection signals corresponding to the one or more ultrasound pulses reflected from the at least one object of interest on the object at block 220);
Repeating step (a) two or more additional times using the same transmit and receive conditions to obtain an ensemble of three or more received signal sets corresponding to the spatial focal region ([0051] which discloses an initial excitation pulse may be different in the number of cycles, frequency, and amplitude. In one example embodiment, the number of bursts in an ensemble ranges from 2-20. The amplitude for the pulses sent in the ensemble comprises the same amplitude and [0052] The method 200 then includes receiving one or more reflection signals, wherein the one or more reflection signals comprise reflection signals corresponding to the one or more ultrasound pulses reflected from the object and reflection signals corresponding to the one or more ultrasound pulses reflected from the at least one object of interest on the object, at block 220. Examiner thus notes that that an ensemble is created from 2-20 bursts each comprising an initial excitation pulses which having a number of cycles and having received reflected signals therefrom (i.e. repeatedly))
Displaying or otherwise identifying locations of the one or more particles exhibiting an acoustic-impedance variation relative to the surrounding material ([0055] which discloses the method then includes displaying a magnitude of interpulse variability at block 240. Once the areas of high variability are identified in the image, the system may use a method to make them apparent to the viewer such as adding a color to the location potentially corresponding to the magnitude of the variability or Doppler power)
Cunitz fails to explicitly teach (c) computing a second temporal derivative of the received signal amplitude or phase across the slow time dimension at one or more spatial locations within the spatial focal region; and in (d) determining a magnitude of the second derivative at each spatial location.
Gu, in a similar field of endeavor involving ultrasound imaging, teaches computing a second temporal derivative of a received signal amplitude or phase across the slow time dimension at one or more spatial locations within a spatial focal region ([0018] which discloses second derivatives of the original time-intensity curves) and determining a magnitude of the second derivative at each spatial location (at least fig. 2(c) and corresponding disclosure in at least [0018] which discloses second derivatives of the original time-intensity curves (interpreted to be through slow time) and further discloses a function image using the second derivative of the time-intensity curves at each point in a parametric image. Where the curves of fig. 2C are considered to be or include a magnitude which is determined in order to obtain such a curve).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cunitz to include second derivative and determining a magnitude as taught by Gu in order to generate a parametric image which more greatly distinguishes normal tissue from abnormal tissues (e.g. lesions). Such a modification would thus allow for generation of an image that readily distinguishes normal tissue from abnormalities experiencing different physical properties than normal tissue (e.g. stones, calcifications, foreign objects envisioned by Cunitz). Thereby providing additional image data for a user to evaluate the object with respect to the normal tissue, thereby enhancing diagnostic evaluation.
Alternatively, Katsuyama, in a similar field of endeavor involving ultrasound imaging, teaches a method of computing a second derivative of a phase one or more spatial locations ([0093] which discloses More specifically, the attenuation factor deriving section 44 derives the attenuation factor .alpha. by determining a second-order differential value (d.sup.2.phi./dt.sup.2) of the phase .phi.(t). A specific example of this attenuation factor derivation processing is described in detail later and [0098] which discloses the second-order phase difference calculation section 73 calculates second-order phase differences (second-order differential value of phase) of an ultrasound echo corresponding to each reflection position within a subject by differentiating a center value of the phase differences calculated by the phase difference center value calculation section 72 with respect to t, that is, by differentiating a center value of the phase differences with respect to the depth direction inside the subject. Examiner notes that a second-order differential expresses a second derivative) and determining a magnitude of the second derivative at each spatial location ([0105] a differential value (second-order phase difference), thus a magnitude of the second-order differential, of the representative values of the phase differences corresponding to each reflection position in the depth direction (distance direction) of the subject is determined by the second-order phase difference calculation section 73.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cunitz to include computing a second derivative of phase and determining a magnitude as taught by Katsuyama in order to derive an attenuation factor that corresponds to tissue characteristics of the subject (Katsuyama [0010]). Such a modification would provide for additional diagnostic information of non-speckle regions in an ultrasound echo (Katsuyama [0013]). Therefore, such additional information regarding the tissue, an enhanced diagnostics of the tissue/region of interest in the subject can be provided.
Regarding claims 24-27,
Cunitz further teaches wherein said material is a mammalian tissue, mammalian organ, human tissue and human organ ([0039] which discloses the system may be used, among other things, to measure an object within a body of a subject. A subject may be a human subject)
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cunitz and Gu or Cunitz and Katsuyama applied to claim 1 above and further in view of Rambod et al. (US 20090247869 A1 and cited in applicant’s IDS filed 09/12/2022), hereinafter Rambod.
Regarding claim 2,
Cunitz, as modified, teaches the elements of claim 1 as previously stated.
While Cunitz describes in detail the method for identifying a stone by oscillating bubbles on a surface of the stone ([0012] and [0036]), it is noted that the stone is merely an exemplary embodiment and Cunitz further discloses wherein the object may be a calcification and that the tissue may be fatty tissue ([0009] which discloses in one embodiment, the object may be a kidney stone, a gall stone, a calcification, a crevice, a crack, a calculus, a foreign object, or an ossification, and the tissue may be a kidney tissue, a fatty tissue, a bone, or a cyst) Nonetheless, in the embodiment in which the object is a calcification, such disclosure still appears to be directed to delivering acoustic waves to excite bubbles (i.e. microbubbles) on the surface of the object (i.e. the calcification) and fails to disclose the calcifications as microcalcifications. Thus Cunitz fails to explicitly disclose a method of visualizing a microcalcification in a tissue or organ of a mammal comprising in step (b) delivering acoustic waves to stimulate microcalcification to spatially displace in step (d) stimulation pulses comprised of transmit pulses forming 2 or more cycles to stimulate the microcalcification to displace or oscillate and build of energy in displacements of the microcalcification to a detectable displacement level and using displacements to identify a microcalcifications from said background tissue or said material by a variation in the displacement across ensembles at one or more spatial locations.
Rambod, in a similar field of endeavor involving, ultrasound detection, teaches a method of visualizing microcalcifications in a tissue or organ of a mammal ([0061] FIG. 5I shows that the recorded response frequency reaches a peak indicating an area with certain micro-calcification mass detected within the breast. The detected area of micro-calcification is then marked on the B-mode image according to a pre-defined color-code scheme and subsequently, the exact three-dimensional position of the area with micro-calcification is determined and marked on the B-mode image and recorded for future follow ups) comprising the steps of:
Using an ultrasonic imaging system to transmit a stimulation pulse comprising an acoustic pressure amplitude being sufficient to exceed a stimulation threshold required to elicit a measurable localized displacement or oscillation of the microcalcification and receive reflected signals from the stimulation pulse ([0038] which discloses the area of interest will then be stimulated by a swept band of frequencies at a given range corresponding to the natural frequency of said micro-calcifications and modulated with a megahertz (1-14 MHz) carrier frequency. When micro-calcification is present, it will be stimulated by the sequential frequency schemes of the present invention resulting in a characteristic response proportional to its mass density and [0038] which discloses the area of interest will then be stimulated by a swept band of frequencies at a given range corresponding to the natural frequency of said micro-calcifications and modulated with a megahertz (1-14 MHz) carrier frequency. When micro-calcification is present, it will be stimulated by the sequential frequency schemes of the present invention resulting in a characteristic response proportional to its mass density)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Cunitz to include delivering acoustic waves to stimulate microcalcifications to spatially displace and visualize the microcalcifications as taught by Rambod in order to provide for a method of visualizing other micro-structures in the tissue. Such a modification would thus extend the method of Cunitz for additional diagnostic purposes such as evaluating the presence/existence of other small objects (e.g. microcalcifications) in fatty tissue (disclosed in [0009] of Cunitz) such as the breast (Rambod [0002]).
Allowable Subject Matter
Claim 23 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: Examiner notes that the closest prior art remains to be Cunitz, however, while Cunitz teaches additional pulses having a different amplitude/power and receiving reflected signals therefrom, Cunitz fails to explicitly teach for each spatial location in a subset having data from both an above-threshold ensemble and a below-threshold ensemble, comparing the magnitudes of the second derivatives through slow time as determined in accordance with step (d), to identify the one or more particles exhibiting the acoustic-impedance variation by determining that the magnitude present in the above-threshold ensemble diminishes or disappears in the below-threshold ensemble, and rejecting signals that persist in the below-threshold ensemble as not caused by the stimulation pulse. Such a modification would not have been obvious to a person having ordinary skill in the art at the time of the invention and would have required impermissible hindsight reasoning to have applied to the teachings of Cunitz. For at least the reasons listed above, the combination of elements distinguishes over the prior art collectively.
Conclusion
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/BROOKE LYN KLEIN/Examiner, Art Unit 3793