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 § 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 15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation wherein the reservoir is filled with ultrasound propagation fluid, and the claim also recites substantially filled with ultrasound propagation fluid which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-8, and 15-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cermak (US 2019/0328357 A1; search report).
Regarding claim 1, Cermak discloses an apparatus for facilitating ultrasound scanning of objects, the apparatus comprising:
a housing defining a reservoir, the housing comprising [[fig. 2] [fig. 4][0014] compression/scanning assembly #106 includes a generally rectangular housing #110; [0022] [[0022] a water tray or bladder bag may be provided within the cover]:
a body comprising a transducer mounting, the transducer mounting configured to support an ultrasound transducer [[0017] compression/scanning assembly 106 includes an ultrasound transducer 118 mounted within housing 110. During use, ultrasound transducer 118 is swept across the top of the cover 112 in a generally arcuate trajectory to ultrasonically scan];
a flange extending from the body to define side walls of the reservoir [[0018][0020] frame #114 and outer frame #402]; and
a first flexible membrane mounted on a free end of the flange [[0011] ultrasound transducer cover may include an outer frame formed of a "soft touch" material, and a nonporous or porous film that extends across the outer frame. In another embodiment, the cover may be configured to receive an advanceable roll of film material], the first membrane defining an external contact surface for making contact with an object to be scanned [[0015] outer frame 114 is formed or is at least partially formed of a soft touch plastic or polymer material. Such a material substantially increases patient comfort during the scanning process, since, as mentioned above, compression/scanning assembly 106 is applies a compressive force to a patient during the procedure], and the first flexible membrane configured to allow ultrasound waves to propagate there through [[0003] scanning systems typically include a transducer unit that compresses the breast using a partially conformable, substantially taut membrane or film sheet, such as a fine polyester mesh membrane. An acoustic gel is applied to the side of the sheet in contact with the breast to assist in acoustically coupling the tissue to the ultrasound assembly]; wherein the reservoir is configured to retain ultrasound propagation fluid to facilitate ultrasound wave propagation between the transducer and the first flexible membrane [[0022] a water tray or bladder bag may be provided within the cover (e.g., cover 112, 300, or 400) and that directly contacts the inner surface of the film material. Transducer 118 may be positioned within the water tray or bladder bag, which provides sufficient acoustic coupling between the transducer and the film material.].
Regarding claim 2, Cermak teaches the apparatus of claim 1, wherein the transducer mounting is disposed within the reservoir of the housing [[0017] compression/scanning assembly 106 includes an ultrasound transducer 118 mounted within housing 110.].
Regarding claim 4, Cermak teaches the apparatus of claim 1, wherein the first flexible membrane comprises an elastomeric material [[0011] outer frame formed of a “soft touch” material, and a nonporous or porous film that extends across the outer frame; [0015] outer frame 114 is formed or is at least partially formed of a soft touch plastic or polymer material; [0023] film portion includes a substrate layer … substrate layer 510 comprises a polyurethane carrier].
Regarding claim 5, Cermak teaches the apparatus of claim 1, wherein the first flexible membrane comprises a sheet of silicone having a thickness of about 0.1mm to 3mm [[0023] film portion includes a substrate layer … substrate layer 510 comprises a polyurethane carrier or material having a thickness ranging from approximately 0.025 to 1.0 millimeters (mm) and a hydrophilic coating layer 520 applied on a side of substrate layer 510 that is positioned to contact the patient.].
Regarding claim 6, Cermak teaches the apparatus of claim 1, wherein the free end of the flange comprises a substantially curved surface such that the first flexible member mounted thereon provides a substantially curved external contact surface [[fig. 3] shows #304 and #114 with curved surfaces].
Regarding claim 7, Cermak teaches the apparatus of claim 1, wherein the flange comprises, or is composed of, moulded silicone [[0027] film portions 500-1 and 500-2 described above, substrate layer 510 may include a polyurethane film carrier or material, such as polyether polyurethane having a thickness ranging from approximately 0.025 to 1.00 millimeters (mm). Adhesive layer 540 may include a silicone-based adhesive, having, for example, an adhesion ( or removal force) of between 0.2 and 0.8 Newtons (N) per 25 millimeters (mm). The relatively low removal force of such a silicon-based adhesive renders film portion 500-3 generally repositionable after initial deployment.].
Regarding claim 8, Cermak teaches the apparatus of claim 1, wherein the flange and/or the first flexible membrane are removably coupled to the housing [[0015] film portion 116 may be heat sealed to outer frame 114. In other embodiments, alternative fastening mechanisms may be used, such as adhesives, or other bonding agents, or mechanical fastening devices, such as clips or grooves; [0019] portion of film material 310 completely extends over frame 114 … cover 300 may be used with multiple patients without requiring the device to be cleaned or cover 300 to be disposed of or replaced; [0021] film portion 410 may be secured (e.g., adhered) to rods or dowels, formed of a rigid or semi-rigid material (e.g., plastic or metal), which collectively are sized to be received within grooves 410. Such a configuration allows for rapid removal and replacement of film portion 410, while reusing outer frame 402].
Regarding claim 15, Cermak teaches the apparatus of claim 1, wherein the reservoir is filled or substantially filled with ultrasound propagation fluid, and wherein the ultrasound propagation fluid is configured to propagate ultrasounds waves between the transducer and the first membrane [[0022] a water tray or bladder bag may be provided within the cover … Transducer 118 may be positioned within the water tray or bladder bag, which provides sufficient acoustic coupling between the transducer and the film material.].
Regarding claim 16, Cermak teaches the apparatus of claim 1, further comprising: an ultrasound transducer mounted on the transducer mounting [[0017] compression/scanning assembly 106 includes an ultrasound transducer 118 mounted within housing 110.].
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) as applied to claim 1 above, and further in view of Guo (CN 104095657 A; search report).
Regarding claim 3, Cermak does not explicitly teach and yet Guo teaches the apparatus of claim 1, wherein the housing comprises a second membrane opposite to the first flexible membrane, and wherein the transducer mounting is disposed on an external surface of the housing such that ultrasound waves emitted from the transducer are configured to propagate through the second membrane into the reservoir, through ultrasound propagation fluid in the reservoir and through the first flexible membrane [[0045] ultrasonic coupling device 3 includes a support frame 31, an upper elastic membrane 32, and a lower elastic membrane 33. The support frame 31 is connected to the edge of the opening 5 at the bottom of the housing. The edges of the upper elastic membrane 32 and the lower elastic membrane 33 are both connected to the support frame 31. There is a sealed cavity 34 between the upper elastic membrane 32 and the lower elastic membrane 33. The sealed cavity 34 is filled with coupling fluid (the sealed cavity 34 is filled with coupling fluid). The ultrasonic probe 4 is located above the ultrasonic coupling device 3 and is in close contact with the upper surface of the upper elastic membrane 32.].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to modify the membrane as taught by Cermak with the first and second membrane as taught by Guo so that a sealed cavity may contain coupling fluid to improve ultrasound transducer coupling to the probe.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) as applied to claim 1 above, and further in view of Colley (US 2023/0404529 A1).
Regarding claim 9, Cermak does not explicitly teach and yet Colley teaches the apparatus of claim 1, further comprising a track disposed along an inner wall of the housing, the track being configured to cooperate with the transducer mounting to allow the transducer mounting to be selectively moved along the track and assume a range of positions within the reservoir [[abstract] ultrasound probe and a transport mechanism for moving the ultrasound probe in at least one direction; [0089] transport mechanism for a single ultrasound probe will now be described in relation to FIG. 9 , which shows a transport mechanism 900, and FIG. 10 which shows a carriage 935. The transport mechanism 900 may be located in the fluid filled portion of the robotic ultrasound system. The transport mechanism 900 has an outer rail 905 located further away from an anatomic region of interest of a patient than an inner rail 910. The carriage 935 is mounted on the outer rail 905 and the inner rail 910 and driven by an outer rail motor 915 and an inner rail motor 920 respectively. The carriage 935 connects to the outer rail motor 915 and the inner rail motor 920 using an outer rail belt 925 and an inner rail belt 930. The outer rail motor 915 and the inner rail motor 920 drive the carriage 935 independently of each other to control yaw, also referred to as rotation or slew, of the carriage 935].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer as taught by Cermak with the carriage and rails as taught by Colley so that an ultrasound probe may be moved in multiple directions (Colley) [[abstract]].
Regarding claim 10, Cermak does not explicitly teach and yet Colley teaches the apparatus of claim 9, wherein the track is configured to allow the mounting to move in a first direction and to move in a second direction, wherein the second direction is orthogonal to the first direction [[abstract] ultrasound probe and a transport mechanism for moving the ultrasound probe in at least one direction; [0019] movement of the ultrasound probe in a direction selected from a set of directions comprising lateral, longitudinal, vertical, pitch, roll, and yaw.].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer as taught by Cermak with the carriage and rails as taught by Colley so that an ultrasound probe may be moved in multiple directions (Colley) [[abstract]].
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) and Colley (US 2023/0404529 A1) as applied to claim 9 above, and further in view of Burchardt (US 2017/0153207 Al; search report).
Regarding claim 11, Cermak does not explicitly teach and yet Burchardt teaches the apparatus of claim 9, wherein the transducer mounting comprises at least one shaft, and wherein the apparatus further comprises: at least one motor, external to the reservoir; at least one magnetic motor coupling connected to the motor and configured to magnetically engage at least one magnetic shaft coupling attached to the at least one shaft [[figs. 3A-3C]; ultrasound probe with an external motor #315 utilizing a magnetic coupling #360 to drive a shaft #365 within the fluid filled container; [0040, 0041]].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer with reservoir as taught by Cermak with the magnetic coupling motor as taught by Burchardt to prevent leakage from the reservoir. (Burchardt) [[0037]].
Regarding claim 12, Cermak does not explicitly teach and yet Colley teaches the apparatus of claim 11, wherein the at least one motor comprises: (i) at least one stepper motor; or (ii) at least one servomotor [[0124] alternative is to use a servo motors which provides a closed loop configuration for the motors, or a combination of stepper motors and servo motors].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer as taught by Cermak with the carriage and rails as taught by Colley so that an ultrasound probe may be moved in multiple directions (Colley) [[abstract]].
Claims 17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) as applied to claim 1 above, and further in view of Cai (CN 211583233 U; search report).
Regarding claim 17, Cermak does not explicitly teach and yet Cai teaches the apparatus of claim 1, further comprising: a pump provided within the housing, configured to mix ultrasound propagation fluid stored within the reservoir [[0012] in the ultrasound coupling agent loading container provided by this utility model, a first temperature sensing element is disposed in the box body, and a second temperature sensing element is disposed in the hot water tank; it also includes a microcontroller, which is signal-connected to the first and second temperature sensing elements for receiving temperature signals, is control-connected to the hot water tank for controlling the operating status of the hot water tank, and is control-connected to the micro water pump for controlling the start and stop of the micro water pump].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to modify the reservoir as taught by Cermak with the fluid pump as taught by Cai so that temperature of the mixed ultrasound coupling agent may be controlled to be more comfortable (Cai) [[0004]].
Regarding claim 19, Cermak does not explicitly teach and yet Cai teaches the apparatus of claim 1, further comprising: (i) at least one heating element, provided within the housing, and configured to selectively heat ultrasound propagation fluid stored within the reservoir; (ii) at least one temperature sensor, within the housing, configured to determine a temperature of ultrasound propagation fluid stored within the reservoir; or (iii) at least one heating element, provided within the housing, and configured to selectively heat ultrasound propagation fluid stored within the reservoir and at least one temperature sensor, within the housing, configured to determine a temperature of ultrasound propagation fluid stored within the reservoir [[0012] preferably, in the ultrasound coupling agent loading container provided by this utility model, a first temperature sensing element is disposed in the box body, and a second temperature sensing element is disposed in the hot water tank; it also includes a microcontroller, which is signal-connected to the first and second temperature sensing elements for receiving temperature signals, is control-connected to the hot water tank for controlling the operating status of the hot water tank, and is control-connected to the micro water pump for controlling the start and stop of the micro water pump.; [0031]].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to modify the reservoir as taught by Cermak with the fluid pump as taught by Cai so that temperature of the mixed ultrasound coupling agent may be controlled to be more comfortable (Cai) [[0004]].
Regarding claim 21, Cermak does not explicitly teach and yet Cai teaches the apparatus of claim 1, further comprising: at least one heating element, provided within the housing, and configured to selectively heat ultrasound propagation fluid stored within the reservoir; at least one temperature sensor, within the housing, configured to determine a temperature of ultrasound propagation fluid stored within the reservoir; and a controller having a memory and one or more processors, wherein the controller is configured to: receive temperature data from the at least one temperature sensor, the temperature data being indicative of the temperature of the propagation fluid within the reservoir; responsive to the temperature of the propagation fluid being less than a first threshold level, activate the at least one heating element to thereby heat the propagation fluid; and responsive to the temperature of the propagation fluid being greater than a second threshold level, deactivate the at least one heating element [[0031][0032] this utility model also provides a microcontroller with control logic functions. The microcontroller is signal-connected to the first temperature sensing element and the second temperature sensing element to receive temperature signals as the basis for control logic. The microcontroller is control-connected to the hot water tank 1 to control the operating status of the hot water tank 1, such as controlling the start and stop of the hot water tank 1 and controlling the water temperature inside the hot water tank 1. The microcontroller is connected to the micro water pump 3 to control the start and stop of the micro water pump.].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to modify the reservoir as taught by Cermak with the fluid pump as taught by Cai so that temperature of the mixed ultrasound coupling agent may be controlled to be more comfortable (Cai) [[0004]].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) as applied to claim 1 above, and further in view of Vazquez (US 2020/0362838 A1).
Regarding claim 18, Cermak does not explicitly teach and yet Vazquez teaches the apparatus of claim 17, wherein the pump further comprises a shaft connected to at least one magnetic shaft coupling and a nut, wherein the at least one magnetic shaft coupling is configured to magnetically couple to a magnetic motor coupling arranged to be driven by a motor, and responsive to rotation of the magnetic motor coupling, the magnetic shaft coupling rotates, thereby causing the shaft to rotate and the nut to move back and forth along the shaft providing a piston pump action [[0005] pumping system includes a fluid inlet, a fluid outlet, and three or more pumping units. Each pumping unit includes a threaded shaft, an axially fixed nut, and one or more electric motors. The threaded shaft is fixed to a piston such that axial movement of the piston in a first direction draws fluid from the inlet and axial movement of the piston in a second direction expels fluid to the outlet. The piston may be fixed to one end of the shaft. A second piston may be affixed to an opposite end of the shaft such that axial movement of the second piston in the first direction expels fluid to the outlet and axial movement of the second piston in the second direction draws fluid from the inlet. The nut engages the threaded shaft such that rotation of the nut results in proportional axial movement of the shaft. The electric motors are drivably connected to the nut. For example, the one or more motors may include a ring gear fixed to the nut, a plurality of rotors, and a plurality of stators].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer with reservoir as taught by Cermak with the nut which turns by motor to cause a pumping via piston as taught by Vazquez so that shaft velocity is controlled such that a total flow of the pumping system is constant, eliminating flow ripple. (Vazquez) [[abstract]].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) as applied to claim 1 above, and further in view of Stouffer (GB 2,304,191 A; search report).
Regarding claim 23, Cermak does not explicitly teach and yet Stouffer teaches a system comprising: the apparatus of claim 1, wherein the apparatus further comprises a winch mounting, and a winch configured to couple to the winch mounting [[fig. 5] shows winch #10 and counter balance hook #8 from which ultrasound scanner #2 is attached by watertight cable #9 and cable #15].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer as taught by Cermak with the winch attached ultrasound scanner as taught by Stouffer so that the carcass of an animal may be mechanically examined (Stouffer) [[pg. 1]].
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Cermak (US 2019/0328357 A1) and Stouffer (GB 2,304,191 A) as applied to claim 23 above, and further in view of Surendran (2017, ICICICT).
Regarding claim 25, Cermak does not explicitly teach and yet Surendran teaches the system of claim 23, wherein the system further comprises: a controller having a memory and one or more processors, wherein the memory comprises instructions for operating the winch according to one or more predefined settings; and wherein the one or more processors are configured to execute the instructions to operate the winch [[abstract] sensor box is suspended by a cable from the floating platform and an automatic winch mechanism is used for lowering the box for vertical profiling. Two Arduino microcontrollers are used for data collection, wireless transmission and winch control … depth of the box is obtained from the ultrasound sensors].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success, to combine the ultrasound transducer as taught by Cermak with the automatic winch control using ultrasound sensor as taught by Surendran so that the length of the cable may be automatically adjusted (Surendran) [[abstract]].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D ARMSTRONG whose telephone number is (571)270-7339. The examiner can normally be reached M - F 9am-5pm.
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/JONATHAN D ARMSTRONG/ Examiner, Art Unit 3645
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