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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the vents, venting assembly, channel, radial openings and bore, must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 2D, element 267 is not described in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 17 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without the venting assembly, which is critical or essential to the practice of the invention but not included in the specification or drawings . See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The venting assembly is an essential component in the recited claims from which claim 17 depends, that in claim 17 further discloses a distal surface being concave. Yet the specification and drawings only refer to the handles of the treatment head and the description of the shape as being concave. From the specification and drawings one of ordinary skill would not be able to discern the desired shape with respect to the coupling assembly from which the venting assembly is disposed within from the recited claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 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.
Regarding Claim 1, it is unclear the metes and bounds of the limitations. It is unclear if the limitations are intended to be interpreted as the “and” or “or” of the recited limitations following the “…therapy transducer array and/or the coupling assembly…” limitations. For the purpose of examination “and/or” will be interpreted as “or”.
Regarding Claim 12,limitation “wherein the one or more channels are configured to direct the air bubbles towards one or more radial openings along a radial surface of the coupling assembly”, is unclear the connection of the channel and radial openings with respect to the one or more vents and transducer array from claim 1 with respect to the coupling assembly such that air bubbles are both displaced from a distal surface of the transducer array as recited in claim 1 as well as being directed towards one or more radial openings as recited in claim 12. The metes and bounds are unclear.
Regarding claim 13, limitation “wherein the coupling assembly further includes a venting assembly disposed within a distal portion of the coupling assembly”, the “venting assembly” is unclear the connection with the one or more vents of recited claim 1. It is unclear the interconnections of the vents and venting assembly that are both within the coupling assembly when considering the limitations of recited claim 1 and 13. The metes and bounds are unclear.
Regarding claim 15, limitation “wherein the venting assembly includes a bore configured to receive the imaging probe” is unclear the connection of the bore with respect to the one or more vents and transducer array from claim 1 with respect to the coupling assembly such that the transducer array is received as recited in claim 15.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-4, 7-12 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konofagou et. al. (U.S. 20180028841, February 1, 2018)(hereinafter, “Konofagou”).
Regarding Claim 1, Konofagou teaches: An ultrasound treatment head (see reproduced Fig. 1 below), comprising: a therapy transducer array including an opening (“…the system can include an ultrasound assembly 102 for providing FUS having one or more ultrasound parameters to a location on the peripheral nerve. The ultrasound assembly can include a FUS transducer, a function generator, and an amplifier. As embodied herein, the FUS transducer can be a high intensity focused ultrasound (HIFU) transducer with a 3.57 MHz center frequency, a 0.46×3.55 mm focal area and a 35 mm focal depth…” [0044]; see reproduced Fig. 1 below) a coupling assembly disposed within the opening of the therapy transducer array, the coupling assembly configured to receive an imaging probe (“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054]; see reproduced Fig. 1 below), the coupling assembly further including one or more vents configured to displace air bubbles from a distal surface of the therapy transducer array and/or the coupling assembly when the treatment head is submerged in a fluid (see reproduced Fig. 1 below, [0054][0077][0082][0122][0123]).
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Regarding Claim 2, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the coupling assembly is generally cylindrically shaped (“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054]; see reproduced Fig. 1 above).
Regarding Claim 3, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the coupling assembly includes a distal portion configured to receive the imaging probe (“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above).
Regarding Claim 4, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the one or more vents are disposed on the distal portion (“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054]; see reproduced Fig. 1 above).
Regarding Claim 7, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein one or more of the vents are configured to displace air bubbles from the distal surface, through the coupling assembly, and out of a proximal portion of the coupling assembly (“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above).
Regarding Claim 8, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: further comprising one or more channels disposed along at least a portion of a longitudinal length of the coupling assembly (“ Referring to FIG. 1, the system can further include a mechanical positioning system 110 for placing the ultrasound assembly and the imaging probe. As embodied herein, the positioning system can be used to place both the ultrasound transducer and the imaging probe with submillimeter resolution. The positioning system can be a 3D positioner mount system…which can be used to align the FUS from the transducer with a target area on the subject. The 3D positioner mount system can move the transducer in the x-, y-, and z-directions. For example, the 3D positioner mount system can include a motor and a controller.” [0047];“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054]; [0077][0082][0122][0123]; see reproduced Fig. 1 above.).
Regarding Claim 9, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the one or more channels are fluidly coupled to the one or more vents on the distal portion of the coupling assembly (“Referring to FIG. 1, the system can further include a mechanical positioning system 110 for placing the ultrasound assembly and the imaging probe. As embodied herein, the positioning system can be used to place both the ultrasound transducer and the imaging probe with submillimeter resolution. The positioning system can be a 3D positioner mount system…which can be used to align the FUS from the transducer with a target area on the subject. The 3D positioner mount system can move the transducer in the x-, y-, and z-directions. For example, the 3D positioner mount system can include a motor and a controller.” [0047];“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054]; [0077][0082][0122][0123]; see reproduced Fig. 1 above.).
Regarding Claim 10, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the one or more channels are configured to direct the air bubbles into a cavity of the coupling assembly (“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054]; [0077][0082][0122][0123]; see reproduced Fig. 1 above.).
Regarding Claim 11, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the one or more channels are configured to direct the air bubbles towards one or more vents on a proximal portion of the coupling assembly (“Referring to FIG. 1, the system can further include a mechanical positioning system 110 for placing the ultrasound assembly and the imaging probe. As embodied herein, the positioning system can be used to place both the ultrasound transducer and the imaging probe with submillimeter resolution. The positioning system can be a 3D positioner mount system…which can be used to align the FUS from the transducer with a target area on the subject. The 3D positioner mount system can move the transducer in the x-, y-, and z-directions. For example, the 3D positioner mount system can include a motor and a controller.” [0047];“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];[0077][0082][0122][0123]; see reproduced Fig. 1 above.).
Regarding Claim 12, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the one or more channels are configured to direct the air bubbles towards one or more radial openings along a radial surface of the coupling assembly (“Referring to FIG. 1, the system can further include a mechanical positioning system 110 for placing the ultrasound assembly and the imaging probe. As embodied herein, the positioning system can be used to place both the ultrasound transducer and the imaging probe with submillimeter resolution. The positioning system can be a 3D positioner mount system…which can be used to align the FUS from the transducer with a target area on the subject. The 3D positioner mount system can move the transducer in the x-, y-, and z-directions. For example, the 3D positioner mount system can include a motor and a controller.” [0047];“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];[0077][0082][0122][0123]; see reproduced Fig. 1 above.).
Regarding Claim 21, Konofagou teaches the claim limitations as noted above.
Konofagou further teaches: wherein the coupling assembly is configured for axial translation with respect to the therapy transducer array (“Referring to FIG. 1, the system can further include a mechanical positioning system 110 for placing the ultrasound assembly and the imaging probe. As embodied herein, the positioning system can be used to place both the ultrasound transducer and the imaging probe with submillimeter resolution. The positioning system can be a 3D positioner mount system…which can be used to align the FUS from the transducer with a target area on the subject. The 3D positioner mount system can move the transducer in the x-, y-, and z-directions. For example, the 3D positioner mount system can include a motor and a controller.” [0047];“…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];[0077][0082][0122][0123]; see reproduced Fig. 1 above.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-6, 13-20 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou in view of Jahnke et. al. (U.S. 9061131, June 23, 2015)(hereinafter, “Jahnke”).
Regarding Claim 5, Konofagou teaches the claim limitations as noted above.
With regards to limitations: wherein the one or more vents is selected from the group consisting of two, three, and four vents, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Konofagou does not teach three, and four vents.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Konofagou to include three and four vents as taught in Jahnke for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 6, Konofagou teaches the claim limitations as noted above.
with regards to limitations: further comprising at least four vents, wherein the four vents are disposed approximately 90 degrees apart around a bore in the coupling assembly configured to receive the imaging probe, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Konofagou does not teach at least four vents, wherein the four vents are disposed approximately 90 degrees apart.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Konofagou to include at least four vents, wherein the four vents are disposed approximately 90 degrees apart as taught in Jahnke for the intended purpose of displacing air bubbles from a distal surface of the therapy transducer array and to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 13, Konofagou teaches the claim limitations as noted above.
Konofagou does not teach: wherein the coupling assembly further includes a venting assembly disposed within a distal portion of the coupling assembly.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly of Konofagou to further include a venting assembly disposed within a distal portion of the coupling assembly as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 14, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the one or more vents are formed within the venting assembly.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination such that the one or more vents are formed within the venting assembly as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 15, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the venting assembly includes a bore configured to receive the imaging probe, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the venting assembly in the combination to include a bore configured to receive the imaging probe taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 16, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the venting assembly comprises two halves which collectively form the bore, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bore in the combination of references to comprise two halves which collectively form the bore as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 17, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the venting assembly includes a distal surface that is concave, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the venting assembly in the combination of references to include a distal surface that is concave as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 18, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the venting assembly is in fluid communication with an interior of the coupling assembly Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the venting assembly in the combination of references to be in fluid communication with an interior of the coupling assembly as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 19, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the coupling assembly includes a cavity positioned proximally from the venting assembly, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly in the combination of references to include a cavity positioned proximally from the venting assembly as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 20, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein the venting assembly is configured to direct air bubbles from the one or more vents into the cavity, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the venting assembly in the combination of references to be configured to direct air bubbles from the one or more vents into the cavity as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 22, Konofagou teaches the claim limitations as noted above.
wherein a distal surface of the coupling assembly is beveled or sloped inwards towards the one or more vents, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify a surface of the coupling assembly in Konofagou to be beveled or sloped inwards towards the one or more vents as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Regarding Claim 23, the combination of Konofagou and Jahnke teach the claim limitations as noted above.
wherein a distal surface of the venting assembly is beveled or sloped inwards towards the one or more vents, Konofagou further teaches: “…the system can further include a chamber 140 containing a couplant, such as oil or water, for transmitting the ultrasound. Additionally or alternatively, a conductive material 142 can be placed on the subject 150. For example, such conductive material includes ultrasound gel and/or water. The chamber 140 can include a membrane 144 located adjacent to the position of the subject 150, to facilitate the transmission of the ultrasound through the chamber.” [0054];“FIG. 1 depicts the targeting of the ultrasound transducers on the sciatic nerve 155, as well as the position of the mouse leg 150 under the water bath 140 and stimulation transducer 102. B-mode images are acquired initially by switching out the transducer probe on the 3D positioner mount.” [0084]; see reproduced Fig. 1 above.
Jahnke in the field of medical imaging therapy devices teaches: “Vents 856 can be provided at the top or at other locations in the ultrasound therapy transducer to facilitate conformance of the bladder to the concave surface. In some embodiments, the vents can include a one way valve that allows air to escape and not return from the space between the bladder and concave surface. In this manner, the one way valve vent can create a vacuum in the space between the bladder and the concave surface. Similarly, a vent 856 in the skin adapter at the patient skin surface 858 can be provided to facilitate conformance of the bladder to the curves on the skin surface. This vent may also include a one way valve to facilitate creation of a vacuum between the bladder and patient skin surface.”; see Figs. 7-8. Column 9, lines 42-54).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify a surface of the venting assembly in the combination of references to be beveled or sloped inwards towards the one or more vents as taught in Jahnke to facilitate creation of a vacuum between a container structure and the patient skin surface (Jahnke, Column 9, lines 52-54).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou as applied to claim 1 above, and further in view of Janovjak et. al. (U.S. 20190062761, February 28, 2019)(hereinafter, “Janovjak”).
Regarding Claim 24, Konofagou teaches the claim limitations as noted above.
Konofagou does not teach: wherein the coupling assembly comprises a zero-swell material.
Janovjak in the field of ultrasound-based systems teaches: “A thin walled (8 mm wall thickness) aluminum chamber was constructed to fit on top of the transducer element. The chamber was filled with water as the heating material and the temperature increase in response to stimulation was measured using a digital thermometer.” [0267].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling assembly in Konofagou to comprise a zero-swell material as taught in Janovjak for high thermal conductivity and low density for efficient and uniform degassing and cleaning.
Regarding Claim 25, the combination of Konofagou and Janovjak teach the claim limitations as noted above.
Konofagou does not teach: wherein the zero-swell material comprises aluminum.
Janovjak in the field of ultrasound-based systems teaches: “A thin walled (8 mm wall thickness) aluminum chamber was constructed to fit on top of the transducer element. The chamber was filled with water as the heating material and the temperature increase in response to stimulation was measured using a digital thermometer.” [0267].
Janovjak in the field of ultrasound-based systems teaches: “A thin walled (8 mm wall thickness) aluminum chamber was constructed to fit on top of the transducer element. The chamber was filled with water as the heating material and the temperature increase in response to stimulation was measured using a digital thermometer.” [0267].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the zero-swell material in the combination of refences to comprise aluminum as taught in Janovjak for high thermal conductivity and low density for efficient and uniform degassing and cleaning.
Conclusion
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798