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
This action is in response to Applicant’s remarks, filed on 6/18/2026. The amendments to claim(s) 1, 5-6, 8, 10 and 13 have been entered. Claim(s) 2, 4, 15, 21-22 is/are cancelled by Applicant and therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). Corresponding rejections of the cancelled claim(s) from the prior office action are withdrawn as moot in light of the Applicant’s cancellation. Claims 8-9, 13-14 and 16-20 are withdrawn from consideration. Accordingly, claim(s) 1, 3, 5-7 and 10-12 remain pending for examination.
Response to Arguments
Applicant’s arguments, see p. 6-8, with respect to claim(s) 1, 3, 5-7 and 10-12 have been fully considered. After review of the amendment to the claim(s) and Applicant’s remarks, Examiner respectfully agrees with the Applicant and the prior 35 USC § 112(b) rejections have been withdrawn.
Regarding the prior art rejection of claim(s) 1, 3, 5-7 and 10-12 under 35 U.S.C. § 102 and 35 U.S.C. § 103, Examiner respectfully disagrees with the remarks and does not find Applicant’s arguments persuasive; however, the prior rejections have been withdrawn in view of new grounds of rejection. Applicant’s arguments with respect to claim(s) 1, 3, 5-7 and 10-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New grounds of rejection are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of pertinent, eligible prior art; and/or different interpretation of the previously applied references.
Examiner respectfully notes that Applicant’s arguments only address independent claim(s) 1, and no remarks regarding the subject matter of the dependent claim(s) have been presented. Accordingly, the rejections to dependent claims are modified to address Applicant’s amendments and the new rejection to independent claim(s) and are sustained. The rejections of claim(s) 1, 3, 5-7 and 10-12 under 35 U.S.C. § 102 are maintained.
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, 3 and 10-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Emery et al. (US20200188705A1, 2020-06-18; hereinafter “Emery”).
Regarding claim 1, Emery teaches an ultrasound probe for rapidly heating a target area of a subject (“An ultrasound transduction system,” [clm 1]; “a dermatological cosmetic treatment and/or imaging system and method can include use of transducer to create a linear thermal treatment zone at a focal depth to form a band shaped treatment area. The system can include one or more ultrasound transducers, a cylindrical transduction element, an imaging element, a hand wand, a removable transducer module, a control module, and/or graphical user interface” [abst]; [0094-0171], [fig. 1-2, 21-22, 31-38]), the probe comprising:
at least one imaging transducer array for imaging the target area (“An ultrasound transduction system,” [clm 1]; “The module 200 can include one or more ultrasound elements 281. The elements 281 can be therapy elements, and/or imaging elements. The hand wand 100 can include imaging-only modules 200, treatment-only modules 200, imaging-and-treatment modules 200” [0100]; “The module 200 can comprise various probe and/or transducer configurations. For example, the module 200 can be configured for a combined dual-mode imaging/therapy transducer, coupled or co-housed imaging/therapy transducers, separate therapy and imaging probes, and the like.” [0101]; “a transducer 280 comprises a cylindrical transduction element 281 and one or more imaging elements 284. The imaging element 284 is configured to image a region of interest at any suitable tissue depths 279. In one embodiment, an imaging element is centered on a therapy element.” [0119]; “the coated region 287 coats part or all of a surface of the cylindrical transduction element 281. In various embodiments, a coated transducer 600 comprises one or more imaging elements 284” [0126]; [0098-0138, 0142-0172], [fig. 1-2, 21-22, 31-38]); and
a first heating transducer array for heating the target area and a second heating transducer array for heating the target area (“a cylindrical transduction element […] wherein the cylindrical transduction element is configured to apply ultrasonic energy” [clm 1]; “The module 200 can comprise various probe and/or transducer configurations. For example, the module 200 can be configured for a combined dual-mode imaging/therapy transducer, coupled or co-housed imaging/therapy transducers, separate therapy and imaging probes, and the like.” [0101]; “first and second removable transducer modules are provided. In one embodiment, each of the first and second transducer modules are configured for both ultrasonic imaging and ultrasonic treatment. In one embodiment, a transducer module is configured for treatment only.” [0120]; Separate coated regions for ultrasound therapy may be disposed on the face of transducer array [0131-0138, 0142-0172], [fig. 1-2, 21-22, 31-38; see fig. 34 reproduced below]),
the first heating transducer array and the second heating transducer array being spaced apart from one another by the at least one imaging transducer array and positioned on opposite sides of the at least one imaging transducer array (“a partially coated transducer 600 comprising a cylindrical transduction element 281 has one, two or more square, rectangular, and/or polygon coated regions 287. In various embodiments, the coated region 287 has a lateral edge 293, a side edge 290, and a medial edge 291.” [0135]; [0098-0138, 0142-0172], [fig. 1-2, 21-22, 31-38; see fig. 34 reproduced below]),
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Imaging element 284 is centrally disposed between coated regions 287 (i.e., first and second heating transducer array) on opposite ends of the transducer (Emery [fig. 34])
wherein the ultrasound probe further comprises a main body, a first arm that laterally extends from the main body and supports the first heating transducer array, and a second arm that laterally extends from the main body and supports the second heating transducer array (“a probe housing of a cosmetic treatment system” [0037]; “The module 200 can be mechanically coupled to the hand wand 100 using a latch or coupler 140. An interface guide 235 can be used for assisting the coupling of the module 200 to the hand wand 100. […] The elements 281 can be therapy elements, and/or imaging elements. The hand wand 100 can include imaging-only modules 200, treatment-only modules 200, imaging-and-treatment modules 200, and the like.” [0100]; “the module 200 can be configured for a combined dual-mode imaging/therapy transducer, coupled or co-housed imaging/therapy transducers, separate therapy and imaging probes, and the like.” [0101]; “a transducer is held by a transducer holder. In one embodiment, the transducer holder includes a sleeve […] the transducer holder is driven by a motion mechanism 285, which may be located in a hand wand or in a module, or in a probe” [0109]; A module 200 having a housing and transducer holder (i.e., main body and arms) which supports the ultrasound transducer 280 and attaches at opposite ends of array [0098-0138, 0142-0172], [fig. 1-2, 6-8, 21-22, 31-38; see fig. 7, 8 reproduced below]),
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Transducer holder mechanically couples and supports the ultrasound transducer array 280 to the mechanism 285 and module 200 (Emery [fig. 7, 8])
wherein the at least one imaging transducer array and the first and second heating transducer arrays are aligned to have a common focus area (“wherein the cylindrical transduction element is configured to apply ultrasonic energy to a linear focal zone at a focal depth,” [clm 1]; “the cylindrical surface has a radius at a focal depth (z-axis) at the center of the curvature of the cylindrical surface, such that the TTZ 550 is focused at the center of the radius.” [0105]; “an ultrasound system 20 generates ultrasound energy which is directed to and focused below the surface 501. This controlled and focused ultrasound energy 50 creates the thermal treatment zone (TTZ) 550. […] In one embodiment, the TTZ 550 is a volume.” [0113]; The imaging element and therapy transducers share a common focal depth [0098-0138, 0142-0172], [fig. 1-10, 21-22, 31-38]).
Regarding claim 3, Emery teaches the ultrasound probe of claim 1,
Emery further teaching wherein the at least one imaging transducer array is centered between the first and second heating transducer arrays (“In one embodiment, an imaging element is centered on a therapy element. In one embodiment, an imaging element is axis symmetric with a therapy element. […] a combined imaging and cylindrical therapy transducer 280 comprises a cylindrical transduction element 281 with an opening 285 through which one imaging element 284 is configured to operate. In one embodiment, the opening 284 is a circular hole through the wall thickness of the cylindrical transduction element 281 at the center of the X-axis (azimuth) and Y-axis (elevation) of the cylindrical transduction element 281.” [0119]; The imaging element is disposed in the center of the transducer array between the coated regions [0098-0138, 0142-0172], [fig. 1-3, 21-22, 31-38], [see claim 1 rejection]).
Regarding claim 10, Emery teaches the ultrasound probe of claim 1,
Emery further teaching further comprising an integrated cooling system that extends into the first and second arms (“In some embodiments, a temperature sensor is used for safety, for example, to reduce or cease energy application if a threshold or maximum target temperature is reached. In one embodiment, a cooling device or system can be employed to cool a tissue temperature if a certain temperature is reached.” [0156]; [0098-0138, 0142-0172], [fig. 1-2, 7-10, 21-22, 31-38], [see claim 1 rejection]).
Regarding claim 11, Emery teaches the ultrasound probe of claim 1,
Emery further teaching further comprising a first acoustic lens received on the first heating transducer array and a second acoustic lens received on the second heating transducer array (“The module 200 can comprise various probe and/or transducer configurations. For example, the module 200 can be configured for a combined dual-mode imaging/therapy transducer, coupled or co-housed imaging/therapy transducers, separate therapy and imaging probes, and the like.” [0101]; “A transducer may be comprised of one or more individual transducers and/or elements in any combination of […] or array transducers, including 1-D, 2-D, and annular arrays; linear, curvilinear, sector, or spherical arrays; spherically, cylindrically, and/or electronically focused, defocused, and/or lensed sources” [0103]; “a compound lens system produces various peak intensities and different depths. In various embodiments, a mechanical and/or electronic focus lens can be used in any one or more of the azimuth, elevation, and/or depth directions.” [0168]; [0098-0138, 0142-0172], [fig. 1-2, 7-10, 21-22, 31-38], [see claim 1 rejection]).
Regarding claim 12, Emery teaches the ultrasound probe of claim 1,
Emery 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 (“the module 200 can include a transducer 280 which can emit energy through an acoustically transparent member 230. […] an acoustically transparent member 230 is configured at a position on the module 200 or the ultrasound system 20 for contacting the skin surface 501.” [0114]; “a coated cylindrical transducer 600 comprising one or more coated regions 287 is configured for ultrasonic impact treatment for the enhancement of properties of a material, such as a metal, compound, polymer, adhesive, liquid, slurry, industrial material” [0140]; The coated regions have a coating (i.e., acoustically conductive flexible membrane) to permit material heating by transmitting ultrasound through acoustically transparent member [0098-0138, 0142-0172], [fig. 1-2, 7-10, 21-22, 31-38], [see claim 1 rejection]).
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery as applied to claim 1 above, in view of Kim et al. (US20150327835A1, 2015-11-19; hereinafter “Kim”) as provided by Applicant.
Regarding claim 5, Emery teaches the ultrasound probe of claim 1,
but Emery may fail to explicitly teach the centrally-extending member that supports the at least one imaging transducer array at a position below that of the positions of the heating transducer arrays.
However, in the same field of endeavor, 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]);
Kim further teaching 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]).
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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])
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 taught by Emery with the centrally-extending member as taught by Kim. 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]). Additionally many cosmetic procedures involve invasive procedures that may require invasive surgery, which can places more requirements on biocompatibility and sterility (Emery [0003]). 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]). The combination may also address potential challenges posed by administration of ultrasound therapy and the amount of time and/or energy to create a thermal treatment zone for a desired cosmetic and/or therapeutic treatment for a desired clinical approach at a target tissue is reduced (Emery [0095]).
Regarding claim 6, Emery teaches the ultrasound probe of claim 1,
Emery further teaching wherein the first and second heating transducer arrays are height adjustable (“the motion mechanism 285 can move the transducer in one, two, and/or three linear dimensions and/or one, two, and/or three rotational dimensions. In one embodiment, a motion mechanism 285 can move in up to six degrees of freedom. Movement of the TTZ 550 can be with the transducer continuously delivering energy to create a treatment area 552.” [0108]; [0098-0138, 0142-0172], [fig. 1-2, 7-10, 21-22, 31-38], [see claim 1 rejection]);
but Emery may fail to explicitly teach the arrays are height adjustable along the main body.
However, in the same field of endeavor, Kim teaches wherein the first and second heating transducer arrays are height adjustable along the main body (“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]).
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 taught by Emery wherein the arrays are height adjustable along the main body as taught by Kim. 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]). The combination may also address potential challenges posed by administration of ultrasound therapy and the amount of time and/or energy to create a thermal treatment zone for a desired cosmetic and/or therapeutic treatment for a desired clinical approach at a target tissue is reduced (Emery [0095]).
Regarding claim 7, Emery and Kim teach the ultrasound probe of claim 6,
Emery further teaching wherein the first and second heating transducer arrays are movably coupled to a side of the main body (“the motion mechanism 285 can move the transducer in one, two, and/or three linear dimensions and/or one, two, and/or three rotational dimensions. In one embodiment, a motion mechanism 285 can move in up to six degrees of freedom. Movement of the TTZ 550 can be with the transducer continuously delivering energy to create a treatment area 552.” [0108]; [0098-0138, 0142-0172], [fig. 1-2, 7-10, 21-22, 31-38], [see claim 1 rejection]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pahk et al. (US20190366126A1, 2019-12-05) teaches a hybrid high-low intensity focused ultrasound treatment apparatus for simultaneous lesion detection and removal [0002].
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 James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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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.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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