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 the remarks filed on 04/07/2025.
The amendments filed on 04/07/2025 have been entered. Applicant has canceled claims 14-15. Accordingly claims 1, 3-12, and 16-18 remain pending. Claims 1 and 16-18 are presently amended.
The previous rejections of claim 18 under 35 U.S.C 112(b) have been withdrawn in light of applicant's amendments. However, the amendments introduce new issues of indefiniteness which are detailed below.
Response to Arguments
Applicant's arguments filed 04/07/2025 regarding the prior art rejections of the claims have been fully considered but they are not persuasive.
Applicant argues, see page 17 of the Remarks, that Sverdlik does not disclose the treatment of tissues comprising the superficial fascia and fibrous septa. Examiner respectfully disagrees because Sverdlik discloses in paragraph [0145]: “a thermally damaged region extends between the spaced apart lesion and optionally connects the regions. For example, a thermally damaged layer of connective tissue (e.g. fat tissue) may extend between two or more cylindrical lesions produced in the reticular dermis of the skin, extending for example at the bottom of the lesions”.
Applicant’s arguments regarding Barthe are not persuasive because Barthe was merely relied on to teach wherein said system is configured for treatments at depths in a range of 3-30 mm below the skin surface.
Applicant’s arguments regarding Angelsen are not persuasive. With respect to claim 1, Angelsen is not relied on to teach the n linear segments as that is disclosed by Sverdlik. However, examiner notes, that as shown with respect to claim 18, Sverdlik also teaches n linear segments of the e.g., tumor tissue of Angelsen as shown in e.g., Figs. 4A-4B below on the left. Applicant’s depiction of n linear segments in Fig. 5B is reproduced below on the right.
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In response to applicant's arguments against the references individually, e.g., Angelsen and Wang, 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).
Claim Objections
Claim 18 in an interpretation may be construed as an independent claim and it also could be construed as a dependent claim since the claim refers back to claim 1. If the applicant intends to have the claim be interpreted as an independent claim, it is suggested to bring in the entire limitations of claim 1 in to claim 18. Alternatively if the applicant intends to have the claim interpreted as a dependent claim it is suggested to re-write the claim as a proper dependent form.
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 18 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.
Claim 18 recites the limitations “the treatment” and “said treatment” throughout the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitations “said neural network algorithm” and “the neural network algorithm through the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-12 , and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al. (US 2019/0143149, corresponding PCT filed June 6, 2017, hereinafter “Sverdlik) in view of Ross (US 2014/0012161, January 9, 2014), Barthe et al. (US 2019/0262634, August 29, 2019, hereinafter “Barthe”), and Angelsen (US 2014/0135681, May 15, 2014).
Regarding claim 1, Sverdlik discloses a system for providing an ultrasonic skin-tightening or body-shaping treatment (“an applicator for applying ultrasound energy to a tissue volume” Abstract), comprising
said organ comprising a treated volume of a layer of tissues underneath an area of skin surface of said organ (“a dermis layer at a depth of 0.5-3 mm from the epidermis.” [0086]), said tissues comprise superficial fascia and fibrous septa (“a thermally damaged region extends between the spaced apart lesion and optionally connects the regions. For example, a thermally damaged layer of connective tissue (e.g. fat tissue) may extend between two or more cylindrical lesions produced in the reticular dermis of the skin, extending for example at the bottom of the lesions” [0145]), said treated volume comprises n linear segments of said layer, where n > 1 (lesions 1124 in Fig. 11, reproduced below, and corresponding description);
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b. an arrangement of plurality of treatment panels (ultrasound applicator 102, Fig. 1 and corresponding description; also see “applicator 102 comprises an array of ultrasound transducers” [0170]) configured to provide ultrasound-based treatment to at least one segment of said n linear segments ([0194]), each of said plurality of treatment panels comprising
i. an ultrasonic element, configured to provide ultrasound waves to at least one segment of said n linear segments within said treated volume that is underneath said treatment panel (“applicator 102 comprises one or more ultrasound emitting elements, such as one or more ultrasound transducers 104” [0170]);
ii. a cooling plate (i.e., thermo electric cooler (TEC) element; thermal reservoir block, etc.; also see [0300]), configured to remove heat from said at least one segment of the treated volume (“In some embodiments, the transducers and/or tissue surface contacting the applicator are actively cooled, for example by a thermo electric cooler (TEC) element used in conjunction with a heat exchanger, and/or by circulation of fluid such as water and/or antifreeze and/or by a gas. .. the transducers and/or tissue surface are passively cooled, for example by a thermal reservoir block (e.g. a cooled block of copper).” [0133]);
iii. a temperature sensor configured to monitor temperature on an outside surface of said at least one segment of the treated volume (“the applicator further comprises one or more temperature sensors disposed at or in proximity to the distal face and configured to indicate a temperature of one or both of an emitting surface of at least one transducer and a surface of the tissue.” [0012]); and
d. a controller (controller 108, Fig. 1 and corresponding description), electrically connected to said plurality of treatment panels (ultrasound applicator 102, Fig. 1 and corresponding description), said controller employs an algorithm that allows the controller to:
i. receive temperature data from the temperature sensor (“a controller configured to receive an indication of temperature from the temperature sensors” [0051]);
wherein said controller, is configured to independently (“each transducer is configured to be excited independently of the other transducers.” [0184] control each of said ultrasonic elements by adjusting the intensity, frequency, and duty cycle of the ultrasound waves (“controlling the heating of the tissue further comprises powering the first transducer at a first power level and the second transducer at a second power level.” [0073]; also see “a controller configured to excite, concurrently, at least two transducers out of the plurality of transducers at different frequencies to control heating of the treated tissue to reduce thermal damage to a surface of the tissue” [0076]; also see “In some embodiments, energy is applied intermittently, for example with time intervals between 5-30 seconds between emission periods. Optionally, energy is applied in a duty cycle of between 1-50%. Alternatively, energy is applied in a continuous mode.” [0356]); and regulate the temperature of the cooling plates (“Optionally, cooling is controlled in accordance with temperature feedback provided by the one or more temperature sensors.” [0136]), in real-time (“the tissue condition is assessed during treatment” [0216]), as a function of said cumulative effect, allowing for localized real-time adjustments of said treatment for each of said n linear segments within the treated volume to achieve desirable treatment conditions;
Sverdlik fails to disclose the system being wearable; a. a sleeve configured for fixedly wrapping around an organ of a mammalian body; and the arrangement being disposed on an inside surface of said sleeve, further wherein said system enables a hands-free treatment.
However, Ross teaches, in the same field of endeavor, the system being wearable; a. a sleeve configured for fixedly wrapping around an organ of a mammalian body; and the arrangement being disposed on an inside surface of said sleeve (“A therapeutic sleeve device apparatus has a flexible sleeve shaped to be worn around the arm of the user.” Abstract; also see “FIG. 6 is a perspective view of the therapeutic sleeve device 10 in which ultrasound treatment devices 120 are operably attached to the shoulder area 62, elbow area 72, and wrist area 82 of the therapeutic sleeve device 10. The ultrasound treatment devices 120 may be attached to or integrated into the flexible sleeve 22 to provide physical therapy on the user's arm 14.” [0049]), further wherein said system enables a hands-free treatment (“FIG. 2 is a perspective view of a user 12 wearing the therapeutic sleeve device 10 of FIG. 1.” [0033], examiner notes that because the treatment devices are worn they enable a hands-free treatment).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sverdlik with the system being wearable; a. a sleeve configured for fixedly wrapping around an organ of a mammalian body; and the arrangement being disposed on an inside surface of said sleeve, further wherein said system enables a hands-free treatment as taught by Ross in order to operably attach the treatment system directly to a patient for direct targeted treatment ([0049] of Ross).
Sverdlik also fails to disclose c. an arrangement of plurality of ultrasound imaging transducers configured to acquire real-time ultrasound images of said n linear segments of the treated volume, before, during, and/or after said treatment; said controller employs a neural network that allows the controller to: ii. receive said real-time ultrasound images from said plurality of ultrasound imaging transducers; iii. compute depth of said treatment for each of said n linear segments during the treatment; and, iv. analyze said ultrasound images during the treatment to determine cumulative effects of said treatment at said depth of each of said n linear segments.
However, Angelsen teaches, in the same field of endeavor, c. an arrangement of plurality of ultrasound imaging transducers (“an ultrasound probe that is able to steer an ultrasound transmit/receive beam 102 from a linear array 103” [0073]) configured to acquire real-time ultrasound images of said n linear segments of the treated volume, before, during, and/or after said treatment (“The instrument may further comprise means for generating an image of the diseased tissue and means for defining the region of diseased tissue in the image, the means for calculating the transmit parameters can in this case be configured to use the defined location of the diseased tissue as input.” [0035]; also see “during insonification” in claims 9 and 11; also see [0105]); said controller employs a neural network (“The instrument may then, based on such newly received data, alter and adapt the way it proposes transmit parameters. Computer implemented ways of learning from such data are known and can for example include neural networks.” [0021]; also see “From an input of the type of diseased and surrounding tissue (e.g. breast tissue, prostate tissue, myocardium, etc.), and the depth range of the selected treatment region, for example by direct input form the operator or through the processors analysis of images, or a combination of both, the processor 303 calculates a choice of transmit parameters such as transmit aperture, transmit focus, transmit pressure and frequency, (e.g. .about.10 MHz for the set-up in FIG. 6a) for high URF, and potentially also a different choice of transmit parameters for high UH (e.g. .about.3 MHz for the set-up in FIG. 6b), or a good choice of transmit parameters for combined URF and UH beam scanning.” [0102]) that allows the controller to: ii. receive said real-time ultrasound images from said plurality of ultrasound imaging transducers (“The instrument may further comprise means for generating an image of the diseased tissue and means for defining the region of diseased tissue in the image, the means for calculating the transmit parameters can in this case be configured to use the defined location of the diseased tissue as input.” [0035]; also see “during insonification” in claims 9 and 11; also see [0105]); iii. compute depth of said treatment for each of said n linear segments during the treatment (“After obtaining adequate quality of the image, the instrument is switched to an image analysis mode (504), where the outer boundaries of the diseased tissue, particularly the depth range, are determined” [0100]); and, iv. analyze said ultrasound images during the treatment to determine cumulative effects of said treatment at said depth of each of said n linear segments (“The instrument can further be configured to increase MI to, based on acquired cavitation images, increase cavitation and/or to decrease MI to decrease cavitation and/or to adjust MI to obtain a cavitation level close to a selected level and/or to, based on temperature images of insonified tissue, select UH beam transmit parameters to obtain a tissue temperature close to or not exceeding a desired/predetermined temperature. Several imaging modalities, such as ultrasound imaging, photo-acoustic imaging, magnetic resonance imaging, X-ray imaging, nuclear imaging, and optical imaging, can be used.” [0035]; also see “depth range” and “respective depths” [0011], [0012; also see [0021]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sverdlik with c. an arrangement of plurality of ultrasound imaging transducers configured to acquire real-time ultrasound images of said n linear segments of the treated volume, before, during, and/or after said treatment; said controller employs a neural network that allows the controller to: ii. receive said real-time ultrasound images from said plurality of ultrasound imaging transducers; iii. compute depth of said treatment for each of said n linear segments during the treatment; and, iv. analyze said ultrasound images during the treatment to determine cumulative effects of said treatment at said depth of each of said n linear segments as taught by Angelsen in order to ensure a desired/predetermined thereapeutic effect is achieved ([0035] of Angelsen) and in order to automatically set treatment parameters.
Sverdlik also fails to disclose wherein said system is configured for treatments at depths in a range of 3-30 mm below the skin surface. Although, Sverdlik does disclose various depths within the claimed range and that other depths may also be selected (“In some embodiments, a target tissue layer to be heated is selected according to the desired effects (1702). For example, a layer that is at a depth of 1 mm, 1.5 mm, 2 mm, 3 mm or intermediate, larger or smaller depths from the epidermis is selected as target. In some embodiments, one or more tissue layers (e.g. hypodermis, dermis, epidermis) are selected as target.” [0443]).
However, Barthe teaches, in the same field of endeavor, wherein said system is configured for treatments at depths in a range of 3-30 mm below the skin surface (“For ultrasound energy 21 delivery, transducer 19 may be mechanically and/or electronically scanned to place treatment zones over an extended area in ROI 12. A treatment depth may be adjusted between a range of approximately 1 to 30 millimeters, and/or the greatest depth of tissue 1 or subcutaneous tissue 2.” [0138]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sverdlik with wherein said system is configured for treatments at depths in a range of 3-30 mm below the skin surface as taught by Barthe in order to minimize the change of damaging deep structures ([0261] of Barthe). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide treatments at depths in a range of 3-30 mm below the skin surface, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 3, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above and Sverdlik further discloses wherein said controller is further configured to receive one or more of preliminary inputs from the user according to anatomical area and size of said patient (“In some embodiments, system 100 comprises a user interface 114 for receiving input from a user such as a physician and/or for providing information to the user. In some embodiments, user interface 114 is configured for receiving operation parameters, for example including energy parameters such as frequency, intensity, and/or usage parameters such as treatment duration. In some embodiments, user interface 114 is configured to receive patient data (e.g. age, weight, height, gender, medical condition, and/or other patient related data). Optionally, user interface 114 is configured to automatically select a treatment regimen in accordance with the patient parameters.” [0173]).
Regarding claim 4, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above, in particular Ross teaches the claimed sleeve as stated above. Ross further teaches, in the same field of endeavor, wherein said sleeve comprises a wrap-around cuff or a closed elastic loop (“The therapeutic sleeve device includes a flexible sleeve shaped to be worn around the arm and shoulder of the user.” [0016]; also see e.g. Fig 3 and corresponding description). Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sverdlik with wherein said sleeve comprises a wrap-around cuff or a closed elastic loop as taught by Ross in order to operably attach the treatment system directly to a patient ([0049] of Ross).
Regarding claim 5, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above, in particular Ross teaches the claimed sleeve as stated above. Ross further teaches, in the same field of endeavor, wherein said sleeve is configured for wrapping around one or more of an arm, the neck, the abdomen, the back, a thigh, and the face (“The therapeutic sleeve device includes a flexible sleeve shaped to be worn around the arm and shoulder of the user.” [0016]; also see e.g. Fig 3 and corresponding description; also see “sleeve device 10 includes a shirt body 20 that is shaped for covering an abdomen of a user 12” [0034]). Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sverdlik with wherein said sleeve is configured for wrapping around one or more of an arm, the neck, the abdomen, the back, a thigh, and the face as taught by Ross in order to operably attach the treatment system directly to a patient ([0049] of Ross).
Regarding claim 6, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above, in particular Ross teaches the claimed sleeve as stated above. Sverdlik further discloses wherein said treatment panels are arranged on said sleeve inside surface in a one dimension, two-dimensions, or any combination thereof (“In some embodiments, emitting elements 602 are arranged in series, for example in a chain like configuration, through the elements may not be linked to each other by an element other than one or both of the film layers. Alternatively, the emitting elements are arranged in a two-dimensional array.” [0278]).
Regarding claim 7, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above, in particular Ross teaches the claimed sleeve as stated above. Sverdlik further discloses wherein said treatment panels cover a portion of skin underneath said sleeve (see Fig. 11 and corresponding description).
Regarding claim 8, Sverdlik modified by Ross and Barthe discloses the limitations of claim 1 as stated above and Sverdlik further discloses wherein said controller is configurable to disable one or more of said treatment panels during any time interval of said treatment (“In some embodiments, the circuitry comprises one or more electrical components (e.g. resistors, coils and/or capacitors) for controlling powering of each of the transducers, for example by setting an impedance on a branch leading to one of the transducers.” [0189]).
Regarding claim 9, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1as stated above and Sverdlik further discloses wherein said controller is further configured to change ultrasound parameters to change treatment mode from skin tightening mode to fat destruction mode (“In some embodiments, a thermally damaged region extends between the spaced apart lesion and optionally connects the regions. For example, a thermally damaged layer of connective tissue (e.g. fat tissue) may extend between two or more cylindrical lesions produced in the reticular dermis of the skin, extending for example at the bottom of the lesions.”[0145]; also see “In some embodiments, the unfocused energy selectively targets fibrotic tissue (e.g. collagen fibers), while its effect on other types of tissue such as fat and/or connective tissue is relatively small since a sensitivity of these tissue types to the applied heat is reduced relative to the sensitivity of the fibrotic tissue, so that fat forms a natural barrier to the thermal damage” [0146]; also see [0029], [0031], [0073]).
Regarding claim 10, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above and Sverdlik further discloses further comprising a tether providing electrical connections to said ultrasonic elements and said cooling plate from said control module (“In some embodiments, system 1100 comprises a hand unit 1102 operably coupled to a console 1104. In some embodiments, hand unit 1102 is coupled to the console by a wired connection.” [0344]; also see [0345] and Fig. 1 and corresponding description).
Regarding claim 11, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above and Sverdlik further discloses wherein depths below skin surface of a layer of said treatment, in a portion of said treated volume underneath one or more of said treatment panels (“In some embodiments, treatment parameters are selected to produce thermal damage at a certain depth or depth range from the tissue surface” [0446]), is controlled by varying one or more of said intensity, frequency, and temperature (“In some embodiments, one or more treatment parameters such as ultrasound intensity, ultrasound frequency, a duration of treatment, and/or other parameters are selected for obtaining the desired effect and/or for avoiding non-desired effects.” [0444]; also see “In an example, in order to get the desired effect of skin tightening and wrinkle reduction, without causing any damage to the epidermis, the treatment frequency will be selected to be 11.5 MHz; the treatment duration will be 4 sec, the ultrasonic intensity will be 18-22 W/cm̂2, and the transducer base cooling will be set to (−10) Celsius.” [0445]).
Regarding claim 12, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 11 as stated above, in particular Barthe was relied on to teach the treatment depth range of 3-30 mm below the skin surface with respect to claim 1. Although Sverdlik discloses wherein said system is configured for treatment of skin laxity; and of fat deposits (“In some embodiments, a thermally damaged region extends between the spaced apart lesion and optionally connects the regions. For example, a thermally damaged layer of connective tissue (e.g. fat tissue) may extend between two or more cylindrical lesions produced in the reticular dermis of the skin, extending for example at the bottom of the lesions.”[0145]; also see “In some embodiments, the unfocused energy selectively targets fibrotic tissue (e.g. collagen fibers), while its effect on other types of tissue such as fat and/or connective tissue is relatively small since a sensitivity of these tissue types to the applied heat is reduced relative to the sensitivity of the fibrotic tissue, so that fat forms a natural barrier to the thermal damage” [0146]; also see [0029], [0031], [0073]; also see “In some embodiments, a target tissue layer to be heated is selected according to the desired effects (1702). For example, a layer that is at a depth of 1 mm, 1.5 mm, 2 mm, 3 mm or intermediate, larger or smaller depths from the epidermis is selected as target. In some embodiments, one or more tissue layers (e.g. hypodermis, dermis, epidermis) are selected as target.” [0443]), Sverdlik fails to disclose wherein for skin laxity said depths are in a range of 3-20 mm below the skin surface; and for fat deposits said depths are in a range of 10-30 mm below the skin surface.
However, Barthe further teaches, in the same field of endeavor, wherein for skin laxity said depths are in a range of 3-20 mm below the skin surface; and for fat deposits said depths are in a range of 10-30 mm below the skin surface (“laxity” in [0142], [0249], [0258]; also see “For example, pockets of fat near the patient's eyelids can be targeted and treated by the application of ultrasound energy at specific depths. These pockets of fat can be ablated and reabsorbed into the body during the treatment.” [0030]; also see “For ultrasound energy 21 delivery, transducer 19 may be mechanically and/or electronically scanned to place treatment zones over an extended area in ROI 12. A treatment depth may be adjusted between a range of approximately 1 to 30 millimeters, and/or the greatest depth of tissue 1 or subcutaneous tissue 2.” [0138]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sverdlik with wherein for skin laxity said depths are in a range of 3-20 mm below the skin surface; and for fat deposits said depths are in a range of 10-30 mm below the skin surface as taught by Barthe in order to minimize the change of damaging deep structures ([0261] of Barthe). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide treatments at depths in a range of 3-20 and 10-30 mm below the skin surface, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above and Sverdlik further discloses wherein said system is further configured to determine a depth of treatment prior to the treatment (“the parameters of the unfocused ultrasound are selected to generate thermal damage in a layer at a depth of 0.5-5 mm from the epidermis.” [0030]; also see “selected depth” in [0125]; also see [0139]).
Regarding claim 17, Sverdlik modified by Ross, Barthe, and Angelsen discloses the limitations of claim 1 as stated above and Sverdlik further discloses wherein said controller comprises a user interface that displays said real-time image and/or said depth indication (“A display and/or a user input device such as a keyboard or mouse are optionally provided as well.” [0100]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Angelsen in view of Wang et al. (US 2020/0107812, filed December 5, 2018, hereinafter “Wang”), Sverdlik, Ross, and Barthe.
Regarding claim 18, as best understood in light of the 35 U.S.C. 112(b) rejections stated above, Angelsen discloses a method for providing real-time in-treatment depth indications from real-time ultrasound images of a treatment volume (“Embodiments are directed towards an ultrasound instrument and a method of operating an ultrasound instrument” [0002]), said treatment volume comprises n linear segments of a tissue layer, where n > 1 (see Figs, 4A-B and corresponding descriptions), the method comprising steps of
a. obtaining the system according to claim 1 (see rejection of claim 1 above),
b. acquiring real-time ultrasound images taken during the treatment by said system (“The instrument may further comprise means for generating an image of the diseased tissue and means for defining the region of diseased tissue in the image, the means for calculating the transmit parameters can in this case be configured to use the defined location of the diseased tissue as input.” [0035]; also see “during insonification” in claims 9 and 11; also see [0105]);
Although Angelsen further discloses e. deploying the neural network algorithm to indicate a treatment depth in a depth-monitoring image taken during said treatment (“The instrument may then, based on such newly received data, alter and adapt the way it proposes transmit parameters. Computer implemented ways of learning from such data are known and can for example include neural networks.” [0021]; also see “From an input of the type of diseased and surrounding tissue (e.g. breast tissue, prostate tissue, myocardium, etc.), and the depth range of the selected treatment region, for example by direct input form the operator or through the processors analysis of images, or a combination of both, the processor 303 calculates a choice of transmit parameters such as transmit aperture, transmit focus, transmit pressure and frequency, (e.g. .about.10 MHz for the set-up in FIG. 6a) for high URF, and potentially also a different choice of transmit parameters for high UH (e.g. .about.3 MHz for the set-up in FIG. 6b), or a good choice of transmit parameters for combined URF and UH beam scanning.” [0102]), Angelsen fails to c. annotating said real-time ultrasound images with observed depths of each of said n linear segments during the treatment; d. processing an aggregation of said annotated real-time ultrasound images by said neural network algorithm for indicating the treatment depth of each of said n linear segments based on said real-time ultrasound images.
However, Wang teaches, in the same field of endeavor, c. annotating said real-time ultrasound images with observed depths of each of said n linear segments during the treatment; d. processing an aggregation of said annotated real-time ultrasound images by said neural network algorithm for indicating the treatment depth of each of said n linear segments based on said real-time ultrasound images (“Moreover, the blood flow waveform image of FIG. 3 may also be used for determining a vascular position (for example, Chon, Gwan and Check in the TCM domain) and depth (floating, moderate, sinking in the TCM domain). Generally, the pulse strengths measure at Chon, Gwan and Ckeck are stronger. Therefore, the computation module 510 may determine whether the vascular position sensed by the ultrasonic sensor 100 is at Chon, Gwan and Ckeck according to the peak values of the waveform curves in the blood flow waveform image. On the other hand, the vascular depth may also influence the peak values of the waveform curves. Generally, the deeper the vascular position is, the weaker the measured pulse strength is. Conversely, the shallower the vascular position is, the stronger the measured pulse strength is. Therefore, the computation module 510 may determine whether the vascular depth sensed by the ultrasonic sensor 100 is in a floating, moderate or sinking state according to the peak values of the waveform curves in the blood flow waveform image. In some embodiments, pulse-taking device 10 may train the neural network 530 according to historical data, such that the computation module 510 may determine the pulse rhythm and the vascular position and depth according to the blood flow waveform image and the neural network 530.” [0029]; also see [0030]; also see “color Doppler image” in [0031]; also see Fig. 5 and corresponding description).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Angelsen with bc. annotating said real-time ultrasound images with observed depths of each of said n linear segments during the treatment; d. processing an aggregation of said annotated real-time ultrasound images by said neural network algorithm for indicating the treatment depth of each of said n linear segments based on said real-time ultrasound images as taught by Wang in order to improve the accuracy of the neural network algorithm.
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 AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm 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, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797