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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species I (claims 1-7 and 10-12) in the reply filed on 2/13/2026 is acknowledged. Claim(s) 8-9 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups and Species, there being no allowable generic or linking claim. Claims 21-22 are cancelled by Applicant. Accordingly, claim(s) 1-7 and 10-12 remain pending for examination on the merits.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 6 is/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(s) 7 is/are also rejected at least by virtue of dependency upon a rejected base claim.
Claim 6 recites “the first and second heating transducer arrays are height adjustable along the main body of the at least one imaging transducer” which renders the claim indefinite. It is not clear how the ‘main body’ is a part of or coupled with the ‘at least one imaging transducer’. In an interpretation the ‘main body’ may refer to the structure of the ultrasound probe introduced in claim 4, and in another interpretation the ‘main body’ may be an aspect of the ‘at least one imaging transducer’ (e.g., a handle of the imaging transducer, a housing of the imaging transducer, etc.) which is distinct from the structure recited in claim 4. For the purposes of examination the broadest reasonable interpretation of the ‘main body’ may be any structure relating to the ‘imaging transducer’.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 10 and 12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US20150327835A1, 2015-11-19; hereinafter “Kim”) as provided by Applicant.
The applied reference has a common Inventor and Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Kim teaches an ultrasound probe for rapidly heating a target area of a subject (“A system for identifying, in vivo, fat-containing tissue in a liver of a subject, the system comprising: […] a temperature variation device for modulating the temperature of a target area of the liver of the subject” [clm 14]; “The temperature variation source can comprise a device capable of heating the targeted area by a desired amount […] for example, heating/cooling pads, light sources, or focused ultrasound energy.” [0075]; “temperature variation source, such as an US and/or NIR heating source, can be coupled to the ultrasound scanner. For example, a custom designed heating array transducer of 6 elements can be coupled to an imaging US probe,” [0077]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A; see fig. 22, 27 reproduced below]), the probe comprising:
at least one imaging transducer array for imaging the target area (“an ultrasound imaging device for providing high-resolution, phase-sensitive speckle tracking;” [clm 14]; “an exemplary dual-mode US system for US-TSI is provided. The system can comprise an imaging array of choice (P), one or more US heating array elements (e),” [0166]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A; see fig. 22, 27 reproduced below]); and
a first heating transducer array for heating the target area and a second heating transducer array for heating the target area, the first heating transducer array and the second heating transducer array being spaced apart from one another (“a temperature variation device for modulating the temperature of a target area of the liver of the subject between about three degrees Celsius.” [clm 14]; “a custom designed heating array transducer of 6 elements can be coupled to an imaging US probe” [0077]; “an exemplary dual-mode US system for US-TSI is provided. The system can comprise an imaging array of choice (P), one or more US heating array elements (e), […] the system uses a collection of single elements, all driven with the same phase with overlapping beam foci.” [0166]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A; see fig. 22, 27 reproduced below]),
wherein the at least one imaging transducer array and the first and second heating transducer arrays are aligned to have a common focus area (“the system uses a collection of single elements, all driven with the same phase with overlapping beam foci.” [0166]; “each of the 6 individual heating elements (1a) inserted into the manifold (1b) to permit insonation of a heated region (X-Z heating plane is shown) in the tissue while allowing clear visualization with a imaging transducer.” [0177]; The heating array elements are supported by a 3D printed manifold and separated/split from another by the imaging transducer, wherein the focus of imaging beam coincides with and is aligned to the target area of the overlapping heating array elements [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A; see fig. 22, 27 reproduced below]).
PNG
media_image1.png
447
613
media_image1.png
Greyscale
PNG
media_image2.png
694
607
media_image2.png
Greyscale
Dual mode US system for thermal strain imaging featuring separated heating array elements with overlapping foci positioned about US imaging transducer via a manifold (Kim [fig. 22, 27])
Regarding claim 2, Kim teaches the ultrasound probe of claim 1,
Kim further teaching wherein the first and second heating transducer arrays are separated by the at least one imaging transducer array (“The system can comprise an imaging array of choice (P), one or more US heating array elements (e), a single output power source (RF), and a splitter (Split). The A key contribution of this work is combining a 3D printed manifold designed to support and align the heating elements with a high efficiency RF power splitter […] the system uses a collection of single elements, all driven with the same phase with overlapping beam foci.” [0166]; “each of the 6 individual heating elements (1a) inserted into the manifold (1b) to permit insonation of a heated region (X-Z heating plane is shown) in the tissue while allowing clear visualization with a imaging transducer.” [0177]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A], [see claim 1 rejection]).
Regarding claim 3, Kim teaches the ultrasound probe of claim 1,
Kim further teaching wherein the at least one imaging transducer array is centered between the first and second heating transducer arrays (“The system can comprise an imaging array of choice (P), one or more US heating array elements (e), a single output power source (RF), and a splitter (Split). The A key contribution of this work is combining a 3D printed manifold designed to support and align the heating elements with a high efficiency RF power splitter […] the system uses a collection of single elements, all driven with the same phase with overlapping beam foci.” [0166]; “each of the 6 individual heating elements (1a) inserted into the manifold (1b) to permit insonation of a heated region (X-Z heating plane is shown) in the tissue while allowing clear visualization with a imaging transducer.” [0177]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A], [see claim 1 rejection]).
Regarding claim 4, Kim teaches the ultrasound probe of claim 1,
Kim further teaching further comprising: a main body, a first arm that extend from the main body and supports the first heating transducer, and a second arm that extends from the main body and supports the second heating transducer (“The system can comprise an imaging array of choice (P), one or more US heating array elements (e), […] A key contribution of this work is combining a 3D printed manifold designed to support and align the heating elements with a high efficiency RF power splitter” [0166]; “each of the 6 individual heating elements (1a) inserted into the manifold (1b) to permit insonation of a heated region (X-Z heating plane is shown) in the tissue while allowing clear visualization with a imaging transducer.” [0177]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A; see fig. 26 reproduced below], [see claim 1 rejection]).
PNG
media_image3.png
602
904
media_image3.png
Greyscale
Manifold has a central tube for imaging probe (i.e., main body) and aperture positions (i.e., first and second arms) to accommodate the heating elements (Kim [fig. 26], annotated)
Regarding claim 5, Kim teaches the ultrasound probe of claim 4,
Kim further teaching further comprising: a centrally-extending member that extends from the main body and supports the at least one imaging transducer array at a position below that of the positions of the first and second heating transducer arrays (“(a) shows an individual circular element recessed in its alignment tube, (b) shows the manifold from the top showing the precision formed bay for the MS250 imaging probe body, and (c) shows the bottom with a plaster probe dummy where the imaging probe resides.” [0176]; “the aperture positions of the heating elements were determined and a CAD design of the manifold was created with cavities to accommodate the imaging probe and heating array elements” [0177]; [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A; see fig. 27 reproduced below], [see claim 4 rejection]).
PNG
media_image4.png
616
578
media_image4.png
Greyscale
’
The imaging probe is positioned within the alignment tube (i.e., centrally-extending member) and sits below the level of the heating array elements when all are supported by manifold (Kim [fig. 27])
Regarding claim 6, Kim teaches the ultrasound probe of claim 4,
Kim further teaching wherein the first and second heating transducer arrays are height adjustable along the main body of the at least one imaging transducer (“A key contribution of this work is combining a 3D printed manifold designed to support and align the heating elements with a high efficiency RF power splitter which simplifies the power source requirements for this application. This heating manifold can be easily adapted to a chosen system. […] the system uses a collection of single elements, all driven with the same phase with overlapping beam foci. As discussed below, the frequency band of 3-4 MHz was used in order to conservatively optimize power delivery for a total beam path length of 35 to 40 mm and element sizes of 6-10 mm” [0166]; “A heating array comprised of 6 elements with 2 mm nominal focal beam diameters is expected to adequately heat a 2×8 mm XY region at a tissue depth of 20-30 mm with a total beam path length of approximately 35-40 mm.” [0180]; The beam path of the heating array elements may be between 35 and 40 mm long (i.e., height adjustable) from recessed position of element to the target volume at depth within the tissue [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A], [see claim 1, 4 rejections]).
Regarding claim 7, Kim teaches the ultrasound probe of claim 6,
Kim further teaching wherein the first and second heating transducer arrays are movably coupled to a side of the main body (“The manifold design fixes the position of the element such that only the rotation can be adjusted.” [0202]; The heating array elements may be rotated to adjust and compensate beam positions [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A]).
Regarding claim 10, Kim teaches the ultrasound probe of claim 4,
Kim further teaching further comprising an integrated cooling system that extends into the first and second arms (“wherein the temperature variation device comprises a cooling source.” [clm 19]; “The temperature variation source can comprise a device capable of […] cooling the targeted area by a desired amount (e.g., −2 degrees Celsius). Various noninvasive heating and/or cooling sources can be used including, for example, heating/cooling pads,” [0075]; The heating element array is a temperature variation device which may comprise a cooling source for cooling the targeted area [0073-0079, 0161-0209], [fig. 1, 22, 26-27, 37A]).
Regarding claim 12, Kim teaches the ultrasound probe of claim 1,
Kim further teaching further comprising at least one acoustically conductive flexible membrane positioned adjacent the at least one imaging transducer array and the first and second heating transducer arrays (“One way of ensuring proper axial alignment in the short term is to use a custom 3D film […] mounted in the X-Y plane at 25 mm in depth from the expected placement of the imaging array. The manifold, with a single element printed “cradle” for the manifold. The cradle supports a 15 mm by 20 mm thermochromic liquid crystal (TLC, 25-30C film, ThermometerSite.com, Glenview, Ill.) connected to an RF generator,” [0206]; A TLC crystal (i.e., acoustically conductive flexible membrane) may be supported by a cradle for the manifold [0073-0079, 0161-0209]).
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(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, in view of Thapliyal et al. (US20200155192A1, 2020-05-21; hereinafter “Thapliyal”) as provided by Applicant.
Regarding claim 11, Kim teaches the ultrasound probe of claim 1,
Kim further teaching the first heating transducer array and the second heating transducer array [see claim 1 rejection];
but Kim may fail to teach an acoustic lens received on the heating transducer array.
However, in the same field of endeavor, Thapliyal teaches an ultrasound probe (“A system for ablating tissue, […] an ablation element comprising an ultrasound transducer” [clm 1]; [fig. 1-7]);
Thapliyal further teaching further comprising a first acoustic lens received on the first heating transducer array (“wherein the ultrasound transducer is configured to deliver a collimated beam of ultrasound energy comprising ablation energy to ablate the target tissue” [clm 1]; “The energy delivery system 10 of the preferred embodiments may also include a lens or mirror, […] The lens is preferably a standard acoustic lens,” [0060]; [0016-0020, 0035-0047, 0058-0061], [fig. 1-7]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the ultrasound probe comprising first and second heating transducer arrays as taught by Kim with an acoustic lens as taught by Thapliyal. Unfortunately, conventional techniques for detecting and quantifying substances in the liver, arteries, and other tissue and organs of the body have many disadvantages. Many are invasive and/or expensive. Accordingly, there is a need for improved systems and methods for assessing the condition of tissues and organs, and in particular, for detecting and quantifying the accumulation of these substances therein (Kim [0005-0006]). US-TSI of relatively superficial arteries may be a modality, which could be easily integrated into a commercial US system to complement other methods for AP characterization (Kim [0095]). An acoustic lens can create a beam that is more uniformly collimated and may provide a more uniform energy density in the ablation window, and therefore more uniform lesions as the tissue depth varies within the window. A lens could also be used to move the position of the minimum beam width for those applications that may need either shallower or deeper lesion (Thapliyal [0060]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mougenot (US20150375016A1, 2015-12-31) teaches improvements for high-intensity focused ultrasonic irradiation heating [0007].
Ebbini et al. (US20130144165A1, 2013-06-06) teaches a dual-mode ultrasound system providing real-time imaging and therapy delivery using the same transducer elements of a transducer array. The system uses a real-time monitoring and feedback image control of the therapy based on imaging data acquired using the dual-mode ultrasound array (DMUA) of transducer elements [abst].
Ebbini et al. (US20190160309A1, 2019-05-30) teaches a dual-mode ultrasound system providing real-time imaging and therapy delivery using a transducer array. The system may use various imaging modes to provide image data that may be used to select control points within an imaging field of view. Virtual arrays may be defined and cascaded to provide flexibility in solving the optimization problem [abst].
Sumi (US20110204893A1, 2011-08-25) teaches an apparatus and method for low-destructively (low-invasively) measuring mechanical properties within object such as structures, substances, materials, living tissues (liver, prostate, breast, etc.) [0004].
Konofagou et al. (US20150297188A1, 2015-10-22) teaches systems and techniques for estimating acoustic attenuation in a tissue from time-varying radiation force information generated through the application of acoustic energy to the tissue from at least first and second focal depths [abst].
Burdette et al. (US20160015417A1, 2016-01-21) teaches a system for thermal treatment or ablation of tissue which includes an ultrasonic thermal ablation probe, and an ultrasonic three-dimensional imaging probe that captures an image from radio frequency image data obtained before the radio frequency image data is processed [abst].
Li et al. (US20210212743A1, 2021-07-15) teaches an apparatus and method for estimating a level of thermal ablation using ultrasound echo data [0001].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797