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 .
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnis et al. (US20140276083, hereafter McKinnis) and Qingwu (CN106178290A, hereafter citing a machine translation).
Regarding claim 1, McKinnis discloses an ultrasound apparatus of a body cavity insertable type (McKinnis, Para 17; “Referring now generally to the drawings, there is shown an embodiment of a device 20 for application of ultrasound internally to a patient. As particular examples, device 20 is or is part of a device or system for imaging, such as for intravascular ultrasound (IVUS) imaging. Other embodiments can include devices for therapeutic or diagnostic uses within the body, or for ultrasound devices used outside of the body. In the embodiment indicated schematically in FIG. 1, device 20 is a catheter or other flexible elongated or tubular housing or member 22 having an application end with a wall 24 defining an internal chamber 26, with catheter 22 being sized and configured in a particular example for insertion into and/or travel along the vascular system”) comprising:
a handpiece (McKinnis, Para 19; “The proximal end of wall 24 and/or catheter 22 may extend outside of the patient during use, and the control end may include a handle or other operating portion (e.g. an imaging system and/or a maneuvering system (not shown))”);
a supporting rod (catheter 22 or other flexible elongated or tubular housing) that is elongated from the handpiece (McKinnis, Para 19; “The proximal end of wall 24 and/or catheter 22 may extend outside of the patient during use, and the control end may include a handle or other operating portion (e.g. an imaging system and/or a maneuvering system (not shown))”) (McKinnis, Para 17; “Referring now generally to the drawings, there is shown an embodiment of a device 20 for application of ultrasound internally to a patient. As particular examples, device 20 is or is part of a device or system for imaging, such as for intravascular ultrasound (IVUS) imaging. Other embodiments can include devices for therapeutic or diagnostic uses within the body, or for ultrasound devices used outside of the body. In the embodiment indicated schematically in FIG. 1, device 20 is a catheter or other flexible elongated or tubular housing or member 22 having an application end with a wall 24 defining an internal chamber 26, with catheter 22 being sized and configured in a particular example for insertion into and/or travel along the vascular system”);
an ultrasound probe that includes a housing that is connected to the supporting rod and an ultrasound transducer that is fixed to the housing (McKinnis, Para 17-20; “Within catheter 22 and chamber 26 in this embodiment is a transducer 28 for sending and/or receiving ultrasound signals. […] Transducer 28 is indicated schematically in the drawings. The term “transducer” should be understood to include an assembly of two or more parts as well as a single piece. For instance, transducer 28 can include a body or backing 40 with a transducer element 42 attached to one side of body 40, and a matching layer (not shown) attached to one side of element 42. The matching layer is attached to one side of element 42 and may be focused or non-focused”); and
an ultrasound transmission medium circulation mechanism (syringe with a needle or other appropriate injection device) that is configured to discharge an ultrasound transmission medium filled in an ultrasound transmission space that is formed at a front of the ultrasound transducer and to inflow the discharged ultrasound transmission medium to the ultrasound transmission space again (McKinnis, Para 28; “this embodiment of device 20 is charged or injected with a coupling medium prior to initial insertion into the body. An appropriate coupling medium is selected, such as saline, oils, alcohols or other appropriate acoustic coupling fluids. The coupling medium is loaded into a syringe with a needle (not shown) or other appropriate injection device […] , the needle is inserted through injection port 60, so that the open tip of the needle is within chamber 26. The coupling medium is then forced through the needle and into chamber 26, as by pressing a syringe plunger. As the coupling medium enters chamber 26, it increases the pressure on the gas (e.g. air) within chamber 26. The increased pressure forces the gas out of chamber 26 through exhaust port 62. Injection of coupling medium continues until chamber 26 is filled to a satisfactory degree, for example when a maximum amount of the gas previously in chamber 26 has been replaced with coupling medium. An optimum result would be to have the entire chamber 26 filled with coupling medium, so that no visible gas pockets or bubbles are present, as gas pockets or bubbles have an acoustic impedance significantly different from the coupling medium, and thus can reflect or otherwise attenuate ultrasound waves”),
wherein the housing and the ultrasound transducer are configured such that the ultrasound transmission medium filled in the ultrasound transmission space is prevented from inflowing to a rear space of the ultrasound transducer (McKinnis, Para 24; “One or more seals 50 may be provided. For example, respective seal(s) 50 are provided in this embodiment forward of motor(s) 30 (e.g. engaging or adjacent to the forward-most part of each of motors 30 a and 30 b in the illustrated embodiment) to separate chamber 26 from motor 30. Seal 50 in the illustrated embodiment is a wall or membrane that extends across the entire diameter or width of the space within wall 24, e.g. chamber 26. Seal 50 may be unitary, formed with wall 24 and of the same material as wall 24, or may be separately formed and inserted into and joined with the inside of wall 24. As indicated in the drawings, one or more shafts (e.g. shafts 44 a and/or 44 b, associated with motors 30 a and/or 30 b) extend through seal 50 in order to link or connect to transducer 28. In such embodiments, a seal 50 thus provides not only a general wall bounding chamber 26, but seal(s) 50 also inhibit or prevent flow of fluid out of chamber 26 and/or around shaft(s) 44 extending through seal(s) 50. Particular configurations and examples of seals are shown in Application Ser. No. 61/787,357, entitled “Internal Ultrasound Assembly Fluid Seal” and filed on Mar. 15, 2013, which is incorporated herein by reference in its entirety”) (McKinnis, Para 6; “Accordingly, in such embodiments to prevent fluid from contacting the motor a seal is included between the motor and the transducer, to prevent leakage of the coupling medium from the volume around the transducer toward the motor. Such seals can fail over time, which is one potential factor in shelf life for such products”).
McKinnis does not clearly and explicitly disclose that a front space and a rear space of the ultrasound transducer are fluidically separated from each other.
In an analogous ultrasound device field of endeavor Qingwu discloses a front space and a rear space of the ultrasound transducer are fluidically separated from each other (Qingwu, Page 2-3; “Described transducer architecture at least includes ultrasonic transducer and launches panel, described ultrasonic transducer and the surface of emission Form airtight cavity between plate, described ultrasonic transducer is provided with the inlet connected with described cavity and liquid outlet, institute Stating inlet to be connected with described liquid pump by feed tube, described liquid outlet is connected with described liquid case by drain pipe […] Transducer architecture 10 at least includes ultrasonic transducer 11 and launches panel 12, ultrasonic transducer 11 and the surface of emission Form airtight cavity 13 between plate 12, ultrasonic transducer 11 is provided with the inlet connected with cavity 13 and liquid outlet (figure In do not show), inlet is connected with liquid pump 30 by feed tube 50, and liquid outlet passes through drain pipe 60 and connects with liquid case 20, feed tube 50 and drain pipe 60 preferably employ flexible pipe”) (Qingwu, Figure 3 showing this).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein a front space and a rear space of the ultrasound transducer are fluidically separated from each other as taught by Qingwu in order to prevent fluid from reaching the electronic components behind the transducer and therefore reduce the need for insulation, which reduces weight and simplifies manufacturing and to keep the fluid in front of the transducer which improves SNR and performance.
Regarding claim 2, McKinnis as modified by Qingwu discloses all of the limitations of claim 1 as discussed above.
McKinnis does not clearly and explicitly disclose wherein the housing is configured to support entirely an edge of the ultrasound transducer so as to fluidically separate a front space and the rear space of the ultrasound transducer.
Qingwu further discloses wherein a housing is configured to support entirely an edge of an ultrasound transducer so as to fluidically separate a front space and a rear space of the ultrasound transducer (Qingwu, Page 2-3; “Described transducer architecture at least includes ultrasonic transducer and launches panel, described ultrasonic transducer and the surface of emission Form airtight cavity between plate, described ultrasonic transducer is provided with the inlet connected with described cavity and liquid outlet, institute Stating inlet to be connected with described liquid pump by feed tube, described liquid outlet is connected with described liquid case by drain pipe […] Transducer architecture 10 at least includes ultrasonic transducer 11 and launches panel 12, ultrasonic transducer 11 and the surface of emission Form airtight cavity 13 between plate 12, ultrasonic transducer 11 is provided with the inlet connected with cavity 13 and liquid outlet (figure In do not show), inlet is connected with liquid pump 30 by feed tube 50, and liquid outlet passes through drain pipe 60 and connects with liquid case 20, feed tube 50 and drain pipe 60 preferably employ flexible pipe”) (Qingwu, Figure 3 showing this).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein the housing is configured to support entirely an edge of the ultrasound transducer so as to fluidically separate a front space and the rear space of the ultrasound transducer as taught by Qingwu in order to prevent fluid from reaching the electronic components behind the transducer and therefore reduce the need for insulation, which reduces weight and simplifies manufacturing and to keep the fluid in front of the transducer which improves SNR and performance.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnis and Qingwu as applied to claim 1 above, and in further view of Sanghvi et al. (US20110201976, hereafter Sanghvi).
Regarding claim 3, McKinnis as modified by Qingwu discloses all of the limitations of claim 1 as discussed above.
McKinnis does not clearly and explicitly disclose wherein the housing is configured to support entirely lateral edges of the ultrasound transducer and longitudinal edge of the ultrasound transducer are sealed by sealing material, in order to fluidically separate a front surface and a rear surface of the ultrasound transducer.
In an analogous ultrasound device field of endeavor Sanghvi discloses wherein a housing is configured to support entirely lateral edges of an ultrasound transducer and longitudinal edge of the ultrasound transducer are sealed by sealing material (shim 120 and heating shrinking tubes 122 and 124, in order to fluidically separate two areas (Sanghvi, Para 29-33; “Bolus 118 is illustratively a tubular membrane with a sealed end 141 best shown in FIG. 3. A shim 120 is then located over the bolus membrane 118 on an opposite side of a treatment aperture 117. Shim 120 is coupled to the tip 111 only by two heat shrinking tubes 122 and 124 best shown in FIGS. 3 and 4 […] he housing 135, the tubes 122, 124 and the shim 120 work together to cause the bolus 118 to expand only in the treatment direction 137 in FIG. 4. The shim 120 forces the bolus 118 to expand in the direction of the opening 117 in the removable tip 111 as shown in FIG. 2. The heat shrink tubes 122, 124 hold the shim 120 in the desired position as well as constraining the ends of the bolus membrane 118 […] As discussed above, the stainless steel shim 120 is an element used to control expansion of the water bolus 118 during a treatment. Removing the stainless steel shim 120 would result in a uniform expansion of the water bolus 118 around the probe tip 111 in the presence of no external objects. With no shim 120 applying pressure to hold the probe against tissue for treatment at a specific distance would result in the bolus 118 reacting by shifting water behind the probe tip and away from the tissue. This may result in a poor and uncontrolled acoustic coupling of the transducer 100 to the tissue and the inability to accurately place the HIFU Treatment zones in their desired locations”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein the housing is configured to support entirely lateral edges of the ultrasound transducer and longitudinal edge of the ultrasound transducer are sealed by sealing material, in order to fluidically separate a front surface and a rear surface of the ultrasound transducer in order to prevent poor acoustic coupling due to water being shifted behind away from the target area (Sanghvi, Para 33).
Regarding claim 4, McKinnis as modified by Qingwu above discloses all of the limitations of claim 2 as discussed above.
McKinnis does not clearly and explicitly disclose wherein lateral edges of the ultrasound transducer are formed to have a concave curved surface shape, and wherein the housing has a supporting portion having a shape corresponding to the concave curved surface shape of the lateral edges so as to support the lateral edges.
In an analogous ultrasound device field of endeavor Sanghvi discloses in Figure 1 wherein lateral edges of tan ultrasound transducer are formed to have a concave curved surface shape, and wherein a housing has a supporting portion having a shape corresponding to the concave curved surface shape of the lateral edges so as to support the lateral edges (Sanghvi, Para 26; “As shown in FIG. 1, the probe 90 includes a segmented, curved rectangular elliptical transducer 100 of the general type described in, for example, WO 99/49788”) (Sanghvi, Figure 1; showing the housing have a shape to support the lateral edges of the concave transducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis as modified by Qingwu above wherein lateral edges of the ultrasound transducer are formed to have a concave curved surface shape, and wherein the housing has a supporting portion having a shape corresponding to the concave curved surface shape of the lateral edges so as to support the lateral edges as taught by Sanghvi in order to allow for a focused ultrasound signal as needed.
The use of the techniques of a concave curved transducer taught by Sanghvi in the invention of an inserted ultrasound device would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of providing focused ultrasound waves; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 5, McKinnis discloses all of the limitations of claim 1 as discussed above.
McKinnis further discloses wherein the ultrasound transmission medium circulation mechanism comprises:
a reservoir storing the ultrasound transmission medium (McKinnis, Para 34; “Once an appropriate coupling medium is selected, a supply of it (e.g. in a syringe (not shown) or other appropriate supply device)”);
a pump that is configured to move the ultrasound transmission medium from the reservoir to the ultrasound transmission space (McKinnis, Para 34; “The coupling medium is forced through tube 70 and lumen 72 into chamber 26, as by […] operating a pump”);
an inlet passage (tube 70) forming a passage through which the ultrasound transmission medium discharged from the reservoir inflows into the ultrasound transmission space (McKinnis, Para 34; “The coupling medium is forced through tube 70 and lumen 72 into chamber 26, as by pressing a syringe plunger or operating a pump”); and
an outlet passage (tube 80) (McKinnis, Para 32; “One or more valves 86 may be placed in or over tube 80, e.g. at the interface between tube 80 and chamber 26, so as to permit exit of gas and/or liquid from chamber 26 into tube 80, and to prevent re-entry of gas or liquid into chamber 26 from tube 80”).
McKinnis does not clearly and explicitly disclose wherein the outlet passage forms a passage through which the ultrasound transmission medium discharged from the ultrasound transmission space inflows into the reservoir.
In an analogous ultrasound device field of endeavor Sanghvi discloses wherein an outlet passage forms a passage through which an ultrasound transmission medium discharged from an ultrasound transmission space inflows into a reservoir (Sanghvi, Para 36; “after passing through the pump 208, the tubing enters the sterile field surrounding the patient. The tubing is connected to the back of the probe and water is pumped through the water bolus 118 and back out to the water reservoir 200”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein the outlet passage forms a passage through which the ultrasound transmission medium discharged from the ultrasound transmission space inflows into the reservoir in order to keep the ultrasound transmission medium in a sterile environment and to allow for the temperature of the ultrasound transmission medium to be maintained as needed as taught by Sanghvi (Sanghvi, Para 36-37) and in order allow the same medium to be used rather than continuously providing more medium.
Regarding claim 6, McKinnis as modified by Sanghvi above discloses all of the limitations of claim 5 as discussed above.
McKinnis as modified by Sanghvi above further discloses wherein the inlet passage (tube 80) comprises an inlet conduit passing through the supporting rod and the outlet passage tube 70) comprises an outlet conduit passing through the supporting rod, and wherein the housing comprises: an inlet connection passage that is connected to the inlet conduit; an inlet hole that connects the inlet connection passage and the ultrasound transmission space; an outlet connection passage that is connected to the outlet conduit; and an outlet hole that connects the outlet connection passage and the ultrasound transmission space (McKinnis, Annotated Figure 3 showing this).
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Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnis, Qingwu, and Sanghvi as applied to claims 5-6 above, and in further view of Bosler (US20110190635) and Rothberg et al. (US20190069842, hereafter Rothberg).
Regarding claim 7, McKinnis as modified by Qingwu and Sanghvi above discloses all of the limitations of claim 6 as discussed above.
McKinnis as modified by Qingwu and Sanghvi above further discloses adding more ultrasound transmission medium based on the posture of the handpiece (McKinnis, Para 34; "way to help limit or eliminate the opportunity for gas pockets to form within chamber 26, during the injecting the user may have device 20 oriented (to the extent practical in a given situation) with exhaust port 62′, and particularly opening 84, generally upward, so that it is at or near the vertically highest location of wall 24. With that orientation, coupling medium will generally pool away from opening 84, naturally maintaining gas within chamber 26 between the pool of coupling medium and opening. In some embodiments, gas from the chamber can be evacuated prior to insertion or injection of coupling medium, rather than by the pressure of the applied coupling medium. For example, a source of vacuum can be applied to tube 80, to withdraw gas through port 62′, and then coupling medium can be added to chamber 26 via tube 70").
McKinnis does not clearly and explicitly disclose a gyro sensor that detects a posture of the handpiece and a controller that controls an operation of the pump, wherein the reservoir is installed within the handpiece, and wherein the controller controls such that an alarm signal is output or controls to operate the pump so that the ultrasound transmission space is filled with the ultrasound transmission medium.
In an analogous ultrasound device field of endeavor Bosler discloses wherein a controller that controls an operation of the pump such the ultrasound transmission space is filled with the ultrasound transmission medium (Bosler, Para 36; “The invention as described offers with the potential equipment in the casing 18 containing the pump 9, a means of electronically controlling the pump 9, the concentration and homogeneity of the gel, the pressure and speed of flow of the gel, and allows the formulation of the gel to be modified in order to allow the optimization of the results of certain ultrasound procedures”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein the controller controls such the ultrasound transmission space is filled with the ultrasound transmission medium in order to spare an operator the need for manually delivering gel (Bosler, Para 20).
McKinnis as modified by Qingwu, Sanghvi, and Bosler above does not clearly and explicitly disclose a gyro sensor that detects a posture of the handpiece and wherein the reservoir is installed within the handpiece.
In an analogous ultrasound device field of endeavor Rothberg discloses in Figures 1 and 8 a gyro sensor that detects a posture of the handpiece (Rothberg, Para 63; “The primary module 102 may include other sensors, such as […] gyroscope”) (Rothberg, Para 51; “The apparatus 100 is wearable by a user around the user's wrist and includes a primary module 102”) and wherein the reservoir is installed within the handpiece (Rothberg, Para 92; “FIG. 8 shows an example in which the ultrasound module 104 includes reservoirs for refreshing the coupling strip 148 in accordance with certain embodiments described herein”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis to include a gyro sensor that detects a posture of the handpiece as taught by Rothberg in order to detect an orientation of the device as needed to improver operability and wherein the reservoir is installed within the handpiece in order to produce a device with increased portability and reduced cost as taught by Rothberg (Rothberg, Para 41).
Regarding claim 8, McKinnis as modified by Qinqwu and Sanghvi above discloses all of the limitations of claim 5 as discussed above.
McKinnis as modified by Qinqwu and Sanghvi above further discloses wherein the housing comprises an inlet hole through which the ultrasound transmission medium inflows into the ultrasound transmission space and an outlet hole through which the ultrasound transmission medium is discharged from the ultrasound transmission space (McKinnis, Figure 3; showing this; McKinnis and Sanghvi above is interpreted as disclosing this limitation in the claim because Sanghvi modifies McKinnis such that tube 70 flows to the reservoir as discussed in the rejection of claim 5 above.), and
wherein the handpiece is in a position in that the ultrasound transmission medium is full to an outlet of the reservoir and the outlet hole faces upward, the ultrasound transmission medium is added so that the ultrasound transmission space is filled with the ultrasound transmission medium to discharge air bubbles remaining in the ultrasound transmission space (McKinnis, Para 34; "way to help limit or eliminate the opportunity for gas pockets to form within chamber 26, during the injecting the user may have device 20 oriented (to the extent practical in a given situation) with exhaust port 62′, and particularly opening 84, generally upward, so that it is at or near the vertically highest location of wall 24. With that orientation, coupling medium will generally pool away from opening 84, naturally maintaining gas within chamber 26 between the pool of coupling medium and opening. In some embodiments, gas from the chamber can be evacuated prior to insertion or injection of coupling medium, rather than by the pressure of the applied coupling medium. For example, a source of vacuum can be applied to tube 80, to withdraw gas through port 62′, and then coupling medium can be added to chamber 26 via tube 70").
McKinnis does not clearly and explicitly disclose a gyro sensor that detects a posture of the handpiece and a controller that controls an operation of the pump, wherein the reservoir is installed within the handpiece, and wherein the controller controls such that an alarm signal is output or controls to operate the pump so that the ultrasound transmission space is filled with the ultrasound transmission medium.
In an analogous ultrasound device field of endeavor Bosler discloses wherein a controller that controls an operation of the pump such the ultrasound transmission space is filled with the ultrasound transmission medium (Bosler, Para 36; “The invention as described offers with the potential equipment in the casing 18 containing the pump 9, a means of electronically controlling the pump 9, the concentration and homogeneity of the gel, the pressure and speed of flow of the gel, and allows the formulation of the gel to be modified in order to allow the optimization of the results of certain ultrasound procedures”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein the controller controls such the ultrasound transmission space is filled with the ultrasound transmission medium in order to spare an operator the need for manually delivering gel (Bosler, Para 20).
McKinnis as modified by Qingwu, Sanghvi, and Bosler above does not clearly and explicitly disclose a gyro sensor that detects a posture of the handpiece and wherein the reservoir is installed within the handpiece.
In an analogous ultrasound device field of endeavor Rothberg discloses in Figures 1 and 8 a gyro sensor that detects a posture of the handpiece (Rothberg, Para 63; “The primary module 102 may include other sensors, such as […] gyroscope”) (Rothberg, Para 51; “The apparatus 100 is wearable by a user around the user's wrist and includes a primary module 102”) and wherein the reservoir is installed within the handpiece (Rothberg, Para 92; “FIG. 8 shows an example in which the ultrasound module 104 includes reservoirs for refreshing the coupling strip 148 in accordance with certain embodiments described herein”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis to include a gyro sensor that detects a posture of the handpiece as taught by Rothberg in order to detect an orientation of the device as needed to improve operability and wherein the reservoir is installed within the handpiece in order to produce a device with increased portability and reduced cost as taught by Rothberg (Rothberg, Para 41).
Regarding claim 9, McKinnis as modified by Qingwu, Sanghvi, Bosler, and Rothberg above discloses all of the limitations of claim 8 as discussed above.
McKinnis as modified by Qingwu, Sanghvi, Bosler, and Rothberg above further discloses wherein the housing comprises an inlet hole through which the ultrasound transmission medium inflows into the ultrasound transmission space and an outlet hole through which the ultrasound transmission medium is discharged from the ultrasound transmission space (McKinnis, Figure 3; showing this; McKinnis and Sanghvi above is interpreted as disclosing this limitation in the claim because Sanghvi modifies McKinnis such that tube 70 flows to the reservoir as discussed in the rejection of claim 5 above.), and
wherein the handpiece is in a position in that the ultrasound transmission medium is full to an outlet of the reservoir and the outlet hole faces upward, the ultrasound transmission medium is added so that the ultrasound transmission space is filled with the ultrasound transmission medium to discharge air bubbles remaining in the ultrasound transmission space (McKinnis, Para 34; "way to help limit or eliminate the opportunity for gas pockets to form within chamber 26, during the injecting the user may have device 20 oriented (to the extent practical in a given situation) with exhaust port 62′, and particularly opening 84, generally upward, so that it is at or near the vertically highest location of wall 24. With that orientation, coupling medium will generally pool away from opening 84, naturally maintaining gas within chamber 26 between the pool of coupling medium and opening. In some embodiments, gas from the chamber can be evacuated prior to insertion or injection of coupling medium, rather than by the pressure of the applied coupling medium. For example, a source of vacuum can be applied to tube 80, to withdraw gas through port 62′, and then coupling medium can be added to chamber 26 via tube 70").
McKinnis does not clearly and explicitly disclose a gyro sensor that detects a posture of the handpiece and a controller that controls an operation of the pump, wherein the reservoir is installed within the handpiece, and wherein the controller controls such that an alarm signal is output or controls to operate the pump so that the ultrasound transmission space is filled with the ultrasound transmission medium.
Bosler further discloses wherein a controller that controls an operation of the pump such the ultrasound transmission space is filled with the ultrasound transmission medium (Bosler, Para 36; “The invention as described offers with the potential equipment in the casing 18 containing the pump 9, a means of electronically controlling the pump 9, the concentration and homogeneity of the gel, the pressure and speed of flow of the gel, and allows the formulation of the gel to be modified in order to allow the optimization of the results of certain ultrasound procedures”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis wherein the controller controls such the ultrasound transmission space is filled with the ultrasound transmission medium in order to spare an operator the need for manually delivering gel (Bosler, Para 20).
McKinnis does not clearly and explicitly disclose a gyro sensor that detects a posture of the handpiece and wherein the reservoir is installed within the handpiece.
Rothberg further discloses in Figures 1 and 8 a gyro sensor that detects a posture of the handpiece (Rothberg, Para 63; “The primary module 102 may include other sensors, such as […] gyroscope”) (Rothberg, Para 51; “The apparatus 100 is wearable by a user around the user's wrist and includes a primary module 102”) and wherein the reservoir is installed within the handpiece (Rothberg, Para 92; “FIG. 8 shows an example in which the ultrasound module 104 includes reservoirs for refreshing the coupling strip 148 in accordance with certain embodiments described herein”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McKinnis to include a gyro sensor that detects a posture of the handpiece as taught by Rothberg in order to detect an orientation of the device as needed to improve operability and wherein the reservoir is installed within the handpiece in order to produce a device with increased portability and reduced cost as taught by Rothberg (Rothberg, Para 41).
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798