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 .
Response to Amendment
The amendment of 07/14/2025 has been entered and fully considered by the examiner. Claim 1, 6, 8, 9, 12, and 15 has been amended. Claims 4, 5, and 18 have been canceled. Claims 1-3 and 6-17 are currently pending in the application with claims 1,12 and 15 being independent.
Claim Rejections - 35 USC § 112
(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 1-3, and 5-17 is 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.
Claims 1, 12, and 15 recite: “ultrasound pulses are generated such that the pressure filed has a minimum in the inner area”. It is entirely unclear and indefinite as to what the limitations intends. In particular, what does the claim mean by the pressure field having a minimum in the focal area? Is the minimum referring to the intensity of the pressure created? A minimum in the angle at which the pressure waves are aimed? A minimum in the duration of the pressure? A minimum in the movement of the bubbles caused by the pressure field? Further, is the minimum related to the pressure field itself? Or that the tissue area which is located at the focal point has a minimum (in elevation, or some other parameter)? As a result, the claim is considered indefinite as the metes and bounds of the claim are not clear. for the purposes of examination, the broadest reasonable interpretation has been used.
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.
Claim 1-3, and 6-12 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sapozhnikov et al. (US Publication No. 9,743,909) hereinafter “Sapozhnikov” in view of Yoshizawa et al. (“Enhancement of High intensity focused ultrasound heating by short pulse generated cavitation”, Appl. Sci. 2017, 7, 288”) hereinafter “Yoshizawa”.
Regarding claim 1, Sapozhnikov discloses an imaging method for mapping a tissue area of a human or an animal [see abstract of Sapozhnikov], the imaging method comprising:
generating, in a liquid, in the tissue area, a plurality of cavitation bubbles, [see column 12, lines 43-50 and FIG. 5, block 502] the generating of the plurality of cavitation bubbles comprising irradiating ultrasound pulses into the tissue area using at least one ultrasound source; [see column 9, lines 29-33 discloses using high intensity focused ultrasound (HIFU) waves generated by a transducer 214; see also column 9, lines 25-27 disclosing that the probe can be a transducer]
positioning a center of a focus area of the irradiated ultrasound pulses within a first subarea [object 610; see FIG. 6A] of the tissue area, [see column 14, lines 9-15 disclosing that the vibrations are focused into a region 604 which includes object 610; see FIG. 6A] wherein the first subarea [blood clot] is separated from a second subarea [blood flow] of the tissue area by a tissue boundary [tissue boundary of the blood clot], and [see column 14, lines 24-35 discloses that the object 610 being focused on can be a blood clot (first subarea) in a blood flow (second subarea)]
mapping a spatial distribution, [see FIG. 12a and 12c showing a spatial distribution of the bubbles using a high speed camera and Doppler; see column 26, last 4 lines-column 27, line 5] movement of the plurality of cavitation bubbles developing in the tissue area on account of a pressure field caused by the irradiated ultrasound pulses,[see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles] or the spatial distribution and the movement of the plurality of cavitation bubbles using an imaging modality. [see column 17, last 4 lines continued in column 18, lines 1-34]
wherein the first subarea [blood clot 612] is separated from the second subarea [blood flow] by the tissue boundary [boundary of the blood clot],
wherein the first subarea corresponds to an inner area of an object [the inner area of the blood cloth] within the tissue area [the blood vessel], and the second subarea corresponds to an outer area surrounding the object at least partially. [see column 14, lines 24-35 discloses that the object 610 being focused on can be an area including a blood clot (first subarea) in a blood flow (second subarea); therefore, the blood flow would surround the blood clot]
Sapozhnikov does not expressly disclose that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area.
Yoshizawa, directed towards enhancement of HIFU treatment of lesions using cavitation microbubbles [see abstract of Yoshizawa] further discloses that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area [see FIG. 2b and caption; the ultrasound pressure field shows a minimum in the center of the focus].
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the method of Sapozhnikov further such that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area according to the teachings of Yoshizawa in order to control the spatial distribution of ultrasound bubbles inside the area to enhance the ultrasound effect [see page 2, second full paragraph]
Regarding claim 2, Sapozhnikov further discloses that the mapping of the spatial distribution, the movement of the plurality of cavitation bubbles, or the spatial distribution and the movement of the plurality of cavitation bubbles includes an x-ray based imaging, a magnetic resonance tomography, or an ultrasound-based imaging. [see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement and speed of the particles; see also column 17, last 4 lines continued in column 18, lines 1-34 disclosing that color doppler over B-mode ultrasound imaging can be used]
Regarding claim 3, Sapozhnikov further discloses that the mapping of the spatial distribution, the movement of the plurality of cavitation bubbles, or the spatial distribution and the movement of the plurality of cavitation bubbles is carried out without administration of contrast agent. [see column 5, lines 13-30 of Sapozhnikov teaches against using the contrast agents and discloses that instead the imaging is done by creation of cavitation microbubbles]
Regarding claim 6, Sapozhnikov further discloses that the ultrasound pulses are generated such that at least one part of the plurality of cavitation bubbles is generated in the outer area [see FIG. 6A and column 14, lines 9-15 disclosing the area 604 that the ultrasound is focused on is bigger than the inner area 612; therefore at least part of the second outer area is irradiated resulting in bubbles]
Regarding claim 7, Sapozhnikov further discloses that determining, based on a result of the mapping of the movement of the plurality of cavitation bubbles, a movement direction, a movement speed, [see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles] or the movement direction and the movement speed of one or more cavitation bubbles of the at least one part of the plurality of cavitation bubbles generated in the outer area through a vessel, and wherein the vessel extends through the tissue boundary and fluidically connects the inner area with the outer area. [see FIG. 12; the vessel extends beyond the focal point]
Regarding claim 8, Sapozhnikov further discloses that the ultrasound pulses are generated such that at least one part of the plurality of cavitation bubbles is generated in the outer area. [see FIG. 6A and column 14, lines 9-15 disclosing the area 604 that the ultrasound is focused on is bigger than the inner area 612; therefore at least part of the second outer area is irradiated resulting in bubbles]
Regarding claim 9, Sapozhnikov further discloses that the first subarea is separated from the second subarea by the tissue boundary, and wherein the flow of liquid is present in the first subarea, [the first subarea is a subarea of the blood vessel and therefore, there is blood flow within it; see column 14, lines 24-35 discloses that the object 610 being focused on can be an area including a blood clot (first subarea) in a blood flow (second subarea); therefore, the blood flow would surround the blood clot] and the ultrasound pulses are generated such that at least one part of the plurality of cavitation bubbles is generated in the inner area. [see FIG. 6A and column 14, lines 9-15 disclosing the area 604 that the ultrasound is focused on is bigger than the inner area 612 but the beam is focused on the inner area 612; therefore at least some of the bubbles are originated from the inner area 612]
Regarding claim 10, Sapozhnikov further discloses that determining a flow direction, a flow speed, [see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement and speed of the particles] a viscosity, or any combination thereof of the liquid in the inner area based on a result of the mapping of the spatial arrangement[see FIG. 12a and 12c showing a spatial distribution of the bubbles using a high speed camera and Doppler; see column 26, last 4 lines-column 27, line 5] movement of the plurality of cavitation bubbles,[see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles] or the spatial distribution and the movement of the plurality of cavitation bubbles using an imaging modality. [see column 17, last 4 lines continued in column 18, lines 1-34]
Regarding claim 11, Sapozhnikov further discloses that the position of the center of the focus area within the inner area is moved [see column 25, lines 5-12 disclosing moving the focal area] and wherein the flow direction, the flow speed, the viscosity, or the respective combination thereof within the inner area is determined in a location-dependent manner. [see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles; see column 25, lines 12-35 discloses continuing the measurement and mapping after position change of the focal point.]
Regarding claim 12, Sapozhnikov discloses an imaging device for mapping a tissue area of a human or an animal, [see abstract of Sapozhnikov] the imaging device comprising:
an imaging modality comprising: at least one ultrasound source; and [see column 10, lines 1-25; probe 214 includes transducers used for imaging the irradiated area]
a positioning system for the at least one ultrasound source; and [at least a holder for positioning probe in an angled way; see column 15. Lines 2-35 and FIG. 6a showing the probe being positioned relative to the area]
a controller configured to: control the at least one ultrasound source, such that ultrasound pulses are irradiated into the tissue area; and [see column 9, lines 29-55; computing device 100 is the controller]
adjust at least one configuration parameter for controlling the at least one ultrasound source, such that a plurality of cavitation bubbles is generated by the irradiated ultrasound pulses in a liquid in the tissue area, [see column 9, lines 29-33 discloses using high intensity focused ultrasound (HIFU) waves generated by a transducer 214; see also column 9, lines 25-27 disclosing that the probe can be a transducer]
wherein the positioning system is configured to position a center of a focus area of the irradiated ultrasound pulses within a [object 610; see FIG. 6A] of the tissue area, [see column 14, lines 9-15 disclosing that the vibrations are focused into a region 604 which includes object 610; see FIG. 6A], wherein the first subarea [area of blood including blood clot] is separated from a second subarea [blood flow] of the tissue area by a tissue boundary [tissue boundary of the blood clot],
wherein the imaging modality is configured to map a spatial distribution, [see FIG. 12a and 12c showing a spatial distribution of the bubbles using a high speed camera and Doppler; see column 26, last 4 lines-column 27, line 5] movement of the plurality of cavitation bubbles [see column 12, lines 43-50 and FIG. 5, block 502] developing in the tissue area on account of a pressure field caused by the irradiated ultrasound pulses, ,[see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles] or the spatial distribution and the movement of the plurality of cavitation bubbles using an imaging modality. [see column 17, last 4 lines continued in column 18, lines 1-34]
wherein the first subarea [blood clot 612] is separated from the second subarea [blood flow] by the tissue boundary [boundary of the blood clot],
wherein the first subarea corresponds to an inner area of an object [the inner area of the blood cloth] within the tissue area [the blood vessel], and the second subarea corresponds to an outer area surrounding the object at least partially. [see column 14, lines 24-35 discloses that the object 610 being focused on can be an area including a blood clot (first subarea) in a blood flow (second subarea); therefore, the blood flow would surround the blood clot]
Sapozhnikov does not expressly disclose that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area.
Yoshizawa, directed towards enhancement of HIFU treatment of lesions using cavitation microbubbles [see abstract of Yoshizawa] further discloses that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area [see FIG. 2b and caption; the ultrasound pressure field shows a minimum in the center of the focus].
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the method of Sapozhnikov further such that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area according to the teachings of Yoshizawa in order to control the spatial distribution of ultrasound bubbles inside the area to enhance the ultrasound effect [see page 2, second full paragraph]
Regarding claim 14, Sapozhnikov further discloses that the imaging modality is configured as an x- ray-based imaging modality, as a magnetic resonance tomography device, or as an ultrasound-based imaging modality. [see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles; see also column 17, last 4 lines continued in column 18, lines 1-34 disclosing that color doppler over B-mode ultrasound imaging can be used]
Regarding claim 15, Sapozhnikov discloses in a non-transitory computer-readable storage medium that stores instructions executable [see column 8, lines 14-35; computing device 100 is a processor 202 that includes memory; see FIG. 2] by an imaging device to map a tissue area of a human or an animal, the instructions comprising:
generating, in a liquid, in the tissue area, a plurality of cavitation bubbles, [see column 12, lines 43-50 and FIG. 5, block 502] the generating of the plurality of cavitation bubbles comprising irradiating ultrasound pulses into the tissue area using at least one ultrasound source; [see column 9, lines 29-33 discloses using high intensity focused ultrasound (HIFU) waves generated by a transducer 214; see also column 9, lines 25-27 disclosing that the probe can be a transducer]
positioning a center of a focus area of the irradiated ultrasound pulses within a first subarea [object 610; see FIG. 6A] of the tissue area, [see column 14, lines 9-15 disclosing that the vibrations are focused into a region 604 which includes object 610; see FIG. 6A] wherein the first subarea is separated from a second subarea of the tissue area by a tissue boundary,
mapping a spatial distribution,[see FIG. 12a and 12c showing a spatial distribution of the bubbles using a high speed camera and Doppler; see column 26, last 4 lines-column 27, line 5] movement of the plurality of cavitation bubbles developing in the tissue area on account of a pressure field caused by the irradiated ultrasound pulses,[see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles] or the spatial distribution and the movement of the plurality of cavitation bubbles using an imaging modality. [see column 17, last 4 lines continued in column 18, lines 1-34]
wherein the first subarea [blood clot 612] is separated from the second subarea [blood flow] by the tissue boundary [boundary of the blood clot],
wherein the first subarea corresponds to an inner area of an object [the inner area of the blood cloth] within the tissue area [the blood vessel], and the second subarea corresponds to an outer area surrounding the object at least partially. [see column 14, lines 24-35 discloses that the object 610 being focused on can be an area including a blood clot (first subarea) in a blood flow (second subarea); therefore, the blood flow would surround the blood clot]
Sapozhnikov does not expressly disclose that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area.
Yoshizawa, directed towards enhancement of HIFU treatment of lesions using cavitation microbubbles [see abstract of Yoshizawa] further discloses that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area [see FIG. 2b and caption; the ultrasound pressure field shows a minimum in the center of the focus].
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the method of Sapozhnikov further such that the ultrasound pulses are generated such that the pressure field has a minimum in the inner area according to the teachings of Yoshizawa in order to control the spatial distribution of ultrasound bubbles inside the area to enhance the ultrasound effect [see page 2, second full paragraph]
Regarding claim 16, Sapozhnikov further discloses that the mapping of the spatial distribution, the movement of the plurality of cavitation bubbles, or the spatial distribution and the movement of the plurality of cavitation bubbles includes an x- ray based imaging, a magnetic resonance tomography, or an ultrasound-based imaging.[see column 27, lines 14-25; color Doppler Ultrasound imaging can be used to detect movement of the particles; see also column 17, last 4 lines continued in column 18, lines 1-34 disclosing that color doppler over B-mode ultrasound imaging can be used]
Regarding claim 17, Sapozhnikov further discloses that the mapping of the spatial distribution, the movement of the plurality of cavitation bubbles, or the spatial distribution and the movement of the plurality of cavitation bubbles is carried out without administration of contrast agent. [see column 5, lines 13-30 of Sapozhnikov teaches against using the contrast agents and discloses that instead the imaging is done by creation of cavitation microbubbles]
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sapozhnikov et al. (US Publication No. 9,743,909) hereinafter “Sapozhnikov” in view of Yoshizawa et al. (“Enhancement of High intensity focused ultrasound heating by short pulse generated cavitation”, Appl. Sci. 2017, 7, 288”) hereinafter “Yoshizawa” as applied to claim 12 above, and further in view of Cannata et al. (U.S. Publication No. 2020/0164231) hereinafter “Cannata”.
Regarding claim 13, Sapozhnikov as modified by Yoshizawa discloses all the limitations of claim 12 [see rejection of claim 12]
Sapozhnikov as modified by Yoshizawa does not expressly disclose at least one histotripsy converter that includes the at least one ultrasound source.
Cannata, directed towards a histotripsy method for producing cavitation bubbles [see abstract of Cannata] discloses at least one histotripsy converter that includes the at least one ultrasound source. [see [0135] disclosing a DC/DC converter]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the method of Sapozhnikov as modified by Yoshizawa further such that at least one histotripsy converter that includes the at least one ultrasound source according to the teachings of Cannata in order to provide the high voltage short pulses need for the method [see [0135] of Cannata]
Response to Arguments
Applicant’s arguments, see Remaks, filed 07/14/2025, with respect to drawing objections and rejection of claims under 112(a) have been fully considered and are persuasive. The objection to the drawings and 112(a) rejection of claims has been withdrawn.
Applicant's arguments filed 07/14/2025 with regards to 112(b) and 103 rejections of the claims have been fully considered but they are not persuasive.
Rejection under U.S.C. 112(b)
With regards to rejection of former claim 5, which is now incorporated in claim 1 for being indefinite, the applicant has argued that the claim is clear in light of [0077] of specification.
In response, the examiner respectfully disagrees and notes that firstly the claims are examined in light of the specification but the specification is not brought into the claims. Further, even [0077] does not help in further clarifying the claim language as it merely reiterates the language of the claim. In particular, what does the claim mean by having a minimum in the focal area? Is the minimum referring to the intensity of the pressure? A minimum in the angle of the pressure wave vector? A minimum in the movement of the bubbles? Or something else is intended? As a result, the indefinite rejection of the claim is maintained.
Rejection under U.S.C. 103
With regards to the limitations added to claim 1 which were previously included in canceled claim 5, the applicant has argued that the combination of references does not disclose the claim since neither of the references teach that “ultrasound pulses are generated such that the pressure fields have a minimum in the inner area.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Here, the primary refence, Sapozhnikov, discloses that “a center of the focus area is within a first subarea, ... wherein the first sub area corresponds to an inner area”. Therefore, the primary reference teaches that the focal point is in the inner area. [see column 14, lines 24-35 discloses that the object 610 being focused on can be an area including a blood clot (first subarea) in a blood flow (second subarea)]
Therefore, the examiner emphasizes that Sapozhnikov already teaches that the inner area is the focal point.
The only part which is missing from Sapozhnikov is that there is a minimum in the focal point (i.e. inner area)
The secondary refence, Yoshizawa, fills the gap by showing that the minimum can be formed in the focal point of the ultrasound wave.
Therefore, the combination of Sapozhnikov and Yoshizawa teaches that there can be a minimum in the focal point and the focal point can be the inner area, and as a result, the combination of references teach the limitation.
Conclusion
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 MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ashley Buran can be reached on (571) 270-5284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795