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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/637,966 filed 04/24/2024.
Status of Claims
This Office Action is responsive to the claims filed on 04/24/2025. Claims 1-20 are presently pending in this application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 14, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eibl (US 20230011862 A1).
Regarding claim 1, Eibl teaches a portable imaging system (Paragraph [0076]; a portable ultrasound unit, Fig. 12) comprising:
a portable medical imaging device (Paragraph [0092]; The portable ultrasound unit; Paragraph [0168]; unit 1200, Fig. 12) including:
a base including a base surface (Paragraph [0168]; base 1206, Fig. 12; Fig. 12 A and 13 A shows the base has a top surface);
a mounting post coupled to base and extending from the base surface (Figs. 12A and 13A shows the neck 1210 is connected to a post which extends from the surface of the base.);
an extension arm (Paragraph [0168]; an adjustable neck 1210/1305, Figs. 12 and 13) coupled to the mounting post and including an extension arm surface that cooperatively forms a treatment area with the base surface (Figs 12 and 13 depict the base and adjustable neck are placed against the patient which is considered to read on the claimed limitation of an extension arm surface that cooperatively forms a treatment area with the base surface as understood in its broadest reasonable interpretation); and
an image generation device mount coupled to at least one of the base, the mounting post, or the extension arm (Paragraph [0163]; A coupled probe; Fig. 12 show the probe 1204 is connected to the neck. The portion connecting the neck and probe is considered to read on the claimed limitation of an image generation device mount as understood in its broadest reasonable interpretation).
Regarding claim 2, Eibl teaches all of the limitations of claim 1 as noted above.
Eibl further teaches an image generation device (Paragraph [0168]; a probe 1204) coupled to the image generation device mount (Fig. 12 shows the probe coupled to the mount), the image generation device configured to generate image data (Paragraph [0099]; The probe may utilize ultrasound signal processing methods (e.g., Doppler signal processing functions); Paragraph [0119]; sample images 408 (greyscale) and 410 (color) are shown, Fig. 4).
Regarding claim 3, Eibl teaches all of the limitations of claim 2 as noted above.
Eibl further teaches the image data is ultrasonic image data (Paragraph [0092]; The portable ultrasound unit may, for example, be a continuous wave Doppler ultrasound module that is capable of emitting ultrasonic waves in a continuous beam, and that is accurate and fast enough to provide a real or near-real-time analysis of parameters of the fluid flow in the blood vessel).
Regarding claim 14, Eibl teaches a portable medical imaging device (Paragraph [0076]; a portable ultrasound unit, Fig. 12) comprising:
a base (Paragraph [0168]; base 1206, Fig. 12);
a mounting post coupled to and extending from the base (Figs. 12A and 13A shows the neck 1210 is connected to a post which extends from the surface of the base.);
an extension arm (Paragraph [0168]; an adjustable neck 1210/1305, Figs. 12 and 13) coupled to the mounting post cooperatively forming a treatment area with the base (Figs 12 and 13 depict the base and adjustable neck are placed against the patient which is considered to read on the claimed limitation of an extension arm surface that cooperatively forms a treatment area with the base surface as understood in its broadest reasonable interpretation); and
an image generation device mount coupled to at least one of the base, the mounting post, or the extension arm (Paragraph [0163]; A coupled probe; Fig. 12 show the probe 1204 is connected to the neck. The portion connecting the neck and probe is considered to read on the claimed limitation of an image generation device mount as understood in its broadest reasonable interpretation), the image generation device mount configured to couple to an image generation device (Paragraph [0168]; a probe 1204; Fig. 12 shows the probe coupled to the mount), the image generation device configured to generate image data (Paragraph [0099]; The probe may utilize ultrasound signal processing methods (e.g., Doppler signal processing functions); Paragraph [0119]; sample images 408 (greyscale) and 410 (color) are shown, Fig. 4).
Regarding claim 20, Eibl teaches one or more tangible non-transitory computer-readable storage media (Paragraph [0193]; These embodiments may be implemented on programmable computers, each computer including… storage system) storing computer-executable instructions (Paragraph [0193]; implemented in a combination of both hardware and software) for performing a computer process on a computing system (Paragraph [0193]-[0194]; implemented on programmable computers, each computer; Program code is applied to input data to perform the functions described herein), the computer process comprising:
receiving image data (Paragraph [0027]; ultrasonic waves into the patient at the blood vessel and to record the signals in the form of raw data; and a processor adapted for receiving the raw data and transforming the data for output at an interface) captured using an image generation device (Paragraph [0168]; a probe 1204), the image generation device coupled to a portable medical imaging device (Paragraph [0092]; The portable ultrasound unit; Paragraph [0168]; unit 1200, Fig. 12) via an image generation device mount, the image generation device mount coupled to at least one of a base, a mounting post, or an extension arm of the portable medical imaging device (Paragraph [0163]; A coupled probe; Fig. 12 show the probe 1204 is connected to the neck. The portion connecting the neck and probe is considered to read on the claimed limitation of an image generation device mount as understood in its broadest reasonable interpretation);
processing the image data to generate processed image data (Paragraph [0027]; processor adapted for receiving the raw data and transforming the data for output at an interface);
generating output data using the processed image data (Paragraph [0080]; The received reflected signals, when processed, may produce an output indicative of hemodynamic properties of blood flow from the patient's heart 108, through the vessel of interest. The device 102 may output through the user interface 110); and
transmitting the output data to a display (Paragraph [0168]; a display 1208/1306) to cause an output of a representation of the output data (Paragraph [0191]; using an ultrasound imaging screen; Paragraph [0119]; A probe 402 is shown for measuring flow in relation to vessels 404, being incident flow at plane 406. Accordingly, sample images 408 (greyscale) and 410 (color) are shown, Fig. 4).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Eibl in view of Maracaja (US 20220133270 A1).
Regarding claim 4, Eibl teaches all of the limitations of claim 2 as noted above.
Eibl does not explicitly teach a display mount rotatably coupled to at least one of the base, the mounting post, or the extension arm.
Maracaja, however, teaches a display mount (Paragraph [0092]; a mounting system that connects the probe (6), with the ultrasound system; Fig. 17; Paragraph [0093]; the assembly of probe (6), smartphone (8), and mounting system) rotatably coupled (Paragraph [0112]; The mounting system allows smartphone tilt, rotation, and different portrait orientations.) to at least one of the base, the mounting post, or the extension arm (Paragraph [0095]-[0097]; Two pins (43) for alignment and attachment to the back of the mounting (36) for the smartphone; of the assembly inside the package (40)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Eibl to have further included a display mount rotatably coupled to at least one of the base, the mounting post, or the extension arm as taught by Maracaja because it would have been a known method of mounting a smart device as a display system between the ultrasound probe and another surface and further minimize the risk of contamination during the procedure (paragraph [0029]). Furthermore it would allow the use a smart device for visualization and display which would be more versatile in use of emergency situations and would be ideal for placing the display close to the site of the procedure (Paragraph [0008] and [0013]).
Regarding claim 5, together Eibl and Maracaja teaches all of the limitations of claim 4 as noted above.
Eibl further teaches a display (Paragraph [0168]; a display 1208/1306) configured to present a representation of the image data generated by the image generation device (Paragraph [0191]; using an ultrasound imaging screen; Paragraph [0119]; A probe 402 is shown for measuring flow in relation to vessels 404, being incident flow at plane 406. Accordingly, sample images 408 (greyscale) and 410 (color) are shown, Fig. 4).
Eibl does not explicitly teach the portable medical imaging device is in communication with a user device having a display disposed in the display mount.
Maracaja, however, further teaches the portable medical imaging device (Paragraph [0093]; probe (6), Fig. 18) is in communication with a user device (Paragraph [0093]; smartphone (8), Fig. 18; Paragraph [0091]; process of imaging using portable ultrasound probe (6), respective cable (7), and the viewing device (8), e.g., a smartphone used as a display screen or viewer for real time imaging) having a display disposed in the display mount (Paragraph [0091]; a smartphone used as a display screen or viewer for real time imaging; Paragraph [0092]; ball, attaches to a second attachment component (35), e.g, a socket, with, in this circumstance, a threaded bolt and nut (34) for tightening the mounting (36) for the smartphone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Eibl in view of Maracaja such that the portable medical imaging device is in communication with a user device having a display disposed in the display mount because it would allow the use a smart device for visualization and display which would be more versatile in use of emergency situations and would be ideal for placing the display close to the site of the procedure (Paragraphs [0008] and [0013]).
Regarding claim 15, Eibl teaches all of the limitations of claim 14 as noted above.
Eibl further teaches a display (Paragraph [0168]; a display 1208/1306) configured to present a representation of the image data generated by the image generation device (Paragraph [0191]; using an ultrasound imaging screen; Paragraph [0119]; A probe 402 is shown for measuring flow in relation to vessels 404, being incident flow at plane 406. Accordingly, sample images 408 (greyscale) and 410 (color) are shown, Fig. 4).
Eibl does not explicitly teach a display mount coupled to at least one of the base, the mounting post, or the extension arm, the display mount configured to receive a display.
Maracaja, however, teaches a display mount (Paragraph [0092]; a mounting system that connects the probe (6), with the ultrasound system; Fig. 17; Paragraph [0093]; the assembly of probe (6), smartphone (8), and mounting system) rotatably coupled (Paragraph [0112]; The mounting system allows smartphone tilt, rotation, and different portrait orientations.) to at least one of the base, the mounting post, or the extension arm (Paragraph [0095]-[0097]; Two pins (43) for alignment and attachment to the back of the mounting (36) for the smartphone; of the assembly inside the package (40)), the display mount configured to receive a display (Paragraph [0091]; a smartphone used as a display screen or viewer for real time imaging; Paragraph [0092]; ball, attaches to a second attachment component (35), e.g, a socket, with, in this circumstance, a threaded bolt and nut (34) for tightening the mounting (36) for the smartphone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Eibl to have included a display mount coupled to at least one of the base, the mounting post, or the extension arm, the display mount configured to receive a display as taught by Maracaja because it would have been a known method of mounting a smart device as a display system between the ultrasound probe and another surface and further minimize the risk of contamination during the procedure (paragraph [0029]). Furthermore it would allow the use a smart device for visualization and display which would be more versatile in use of emergency situations and would be ideal for placing the display close to the site of the procedure (Paragraph [0008] and [0013]).
Claims 6-10 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Eibl in view of Shaw (US 12396704 B1).
Regarding claim 6, Eibl teaches all of the limitations of claim 1 as noted above.
Eibl does not explicitly teach a compression block coupled to the extension arm via an actuator, wherein actuation of the actuator causes the compression block to move relative to the extension arm and the base.
Shaw, however, teaches a compression block (Col. 16, ln. 64-Col. 17, ln. 30; base member flange 406 and base member arm 408, Fig. 16 and 17) coupled to the extension arm (Col. 17, ln. 38-50; first stand arm 412, Fig. 16) via an actuator (Col. 16, ln. 64-Col. 17, ln. 30; adjustment knob 418 may threadably engage the base member arm 408), wherein actuation of the actuator causes the compression block to move relative to the extension arm and the base (Col. 16, ln. 64-Col. 17, ln. 30; base adjustment knob 418 may threadably engage the base member arm 408… to facilitate extension and retraction of the base member arm 408 with respect to the stand base 402 by rotation of the base adjustment knob 418).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Eibl to have included a compression block coupled to the extension arm via an actuator, wherein actuation of the actuator causes the compression block to move relative to the extension arm and the base as taught by Shaw because it would have allowed the stand base to be attached to a rail, panel, or other structural component on the support by placement of the component between the main base member and the base member flange (Col. 16, ln. 64-Col. 17, ln. 30), thereby keeping the entire device stable.
Regarding claim 7, together Eibl and Shaw teach all of the limitations of claim 6 as noted above.
Eibl does not explicitly teach the actuator is a threaded knob.
Shaw, however, further teaches the actuator is a threaded knob (Col. 16, ln. 64-Col. 17, ln. 30; base adjustment knob 418 may threadably engage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the actuator of Eibl in view of Shaw to have been a threaded knob as further taught by Shaw because it would have been a known method of facilitating extension and retraction and further allow selectively adjusting the base to accommodate various thicknesses and placement of the stand (Col. 16, ln. 64-Col. 17, ln. 30).
Regarding claim 8, Eibl teaches all of the limitations of claim 1 as noted above.
Eibl further teaches the image generation device mount includes a flexible arm (Paragraph [0168]; adjustable neck 1210/1305, Fig. 12 and 13).
Eibl does not explicitly teach a clamp.
Shaw, however, teaches the image generation device mount (Col. 13, ln. 29-44; a stand assembly 200, Fig. 7) includes a flexible arm (Col. 13, ln. 29-44; elongated cradle gooseneck 224, Fig. 7) and a clamp (Col. 13, ln. 29-44; A cradle 226; the cradle 226 may be suitably sized and configured to support the ultrasonic transducer probe 150; The cradle for holding the probe is considered to read on the claimed limitation of a clamp as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the image generation device mount of Eibl to have included a clamp as taught by Shaw because it would allow removing and repositioning the probe on the patient as selected by the sonographer (Col. 13, ln. 29-44). Furthermore, it would allow the probe to be removed while the gooseneck and base stays in position (Col. 15, ln. 46-Col. 16, ln. 3).
Regarding claim 9, together Eibl and Shaw teach all of the limitations of claim 8 as noted above.
Eibl does not explicitly teach the flexible arm is a gooseneck.
Shaw, however, further teaches the flexible arm is a gooseneck (Col. 13, ln. 29-44; elongated cradle gooseneck 224, Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the flexible arm of Eibl in view of Shaw to have been a gooseneck as further taught by Shaw because it would have been a known method of supporting an ultrasound probe that further would have allowed holding a fixed shape after adjustment, and further allowed the probe to be removed while the gooseneck and base stays in position (Col. 15, ln. 46-Col. 16, ln. 3).
Regarding claim 10, Eibl teaches all of the limitations of claim 1 as noted above.
Eibl further teaches the base surface is a planar surface (Fig. 12A shows the top surface of the base is a planar surface).
Eibl does not explicitly teach the extension arm surface a planar surface.
Shaw, however, teaches the base surface (Col. 13, ln. 45-58; lower base member 204, Fig. 11 and 12) and the extension arm surface (Col. 13, ln. 29-Col. 14, ln. 4; upper base member 206 may be selectively adjustable) are each a planar surface (Figs. 8 and 11 show the surfaces are planar surfaces).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the extension arm surface a planar surface as taught by Shaw because it would have allowed the device to engage with a support such as a frame or other structural component on a bed or table (Col. 13, ln. 45-58).
Regarding claim 16, Eibl teaches all of the limitations of claim 1 as noted above.
Eibl does not explicitly teach a compression block coupled to the extension arm and including an actuator, wherein actuation of the actuator causes the compression block to move relative to the extension arm and the base.
Shaw, however, teaches a compression block (Col. 16, ln. 64-Col. 17, ln. 30; base member flange 406 and base member arm 408, Fig. 16 and 17) coupled to the extension arm (Col. 17, ln. 38-50; first stand arm 412, Fig. 16) via an actuator (Col. 16, ln. 64-Col. 17, ln. 30; adjustment knob 418 may threadably engage the base member arm 408), wherein actuation of the actuator causes the compression block to move relative to the extension arm and the base (Col. 16, ln. 64-Col. 17, ln. 30; base adjustment knob 418 may threadably engage the base member arm 408… to facilitate extension and retraction of the base member arm 408 with respect to the stand base 402 by rotation of the base adjustment knob 418).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Eibl to have included a compression block coupled to the extension arm via an actuator, wherein actuation of the actuator causes the compression block to move relative to the extension arm and the base as taught by Shaw because it would have allowed the stand base to be attached to a rail, panel, or other structural component on the support by placement of the component between the main base member and the base member flange (Col. 16, ln. 64-Col. 17, ln. 30), thereby keeping the entire device stable.
Regarding claim 17, together Eibl and Shaw teaches all of the limitations of claim 16 as noted above.
Eibl does not explicitly teach the actuator is a threaded knob.
Shaw, however, further teaches the actuator is a threaded knob (Col. 16, ln. 64-Col. 17, ln. 30; base adjustment knob 418 may threadably engage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the actuator of Eibl in view of Shaw to have been a threaded knob as further taught by Shaw because it would have been a known method of facilitating extension and retraction and further allow selectively adjusting the base to accommodate various thicknesses and placement of the stand (Col. 16, ln. 64-Col. 17, ln. 30).
Regarding claim 18, Eibl teaches all of the limitations of claim 14 as noted above.
Eibl further teaches the image generation device mount includes a flexible arm (Paragraph [0168]; adjustable neck 1210/1305, Fig. 12 and 13).
Eibl does not explicitly teach a clamp.
Shaw, however, teaches the image generation device mount (Col. 13, ln. 29-44; a stand assembly 200, Fig. 7) includes a flexible arm (Col. 13, ln. 29-44; elongated cradle gooseneck 224, Fig. 7) and a clamp (Col. 13, ln. 29-44; A cradle 226; the cradle 226 may be suitably sized and configured to support the ultrasonic transducer probe 150; The cradle for holding the probe is considered to read on the claimed limitation of a clamp as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the image generation device mount of Eibl to have included a clamp as taught by Shaw because it would allow removing and repositioning the probe on the patient as selected by the sonographer (Col. 13, ln. 29-44). Furthermore, it would allow the probe to be removed while the gooseneck and base stays in position (Col. 15, ln. 46-Col. 16, ln. 3).
Regarding claim 19, together Eibl and Shaw teach all of the limitations of claim 18 as noted above.
Eibl does not explicitly teach the flexible arm is a gooseneck.
Shaw, however, further teaches the flexible arm is a gooseneck (Col. 13, ln. 29-44; elongated cradle gooseneck 224, Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the flexible arm of Eibl in view of Shaw to have been a gooseneck as further taught by Shaw because it would have been a known method of supporting an ultrasound probe that further would have allowed holding a fixed shape after adjustment, and further allowed the probe to be removed while the gooseneck and base stays in position (Col. 15, ln. 46-Col. 16, ln. 3).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Eibl in view of Grice (US 20170325787 A1).
Regarding claim 11, Eibl teaches all of the limitations of claim 1 as noted above.
Eibl does not teach a training system including:
a body; and
an artery simulator assembly.
Grice, however, teaches a training system (Paragraph [0005]; apparatus and methods for testing of Doppler ultrasound function… a Doppler phantom is provided.) including:
a body (Paragraph [0039]; the phantom 100 would also include at least one tissue mimicking material, Fig. 4 and 5); and
an artery simulator assembly (Paragraph [0038]; the lines 114 and 116, first reservoir 102, second reservoir 108, Fig. 1, 4, and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Eibl to have further included a training system including: a body; and an artery simulator assembly as taught by Grice because test phantoms demonstrate a phantom that can provide rapid and convenient assessment of stability and variation of a Doppler ultrasound system. The phantom design of the various embodiments provides an absolute fluid-flow velocity that is within the range of relevant blood velocities in the human body (Paragraph [0079]). Furthermore, this phantom design would allow angle correction and evaluation of measuring the flow and mean velocity (Paragraph [0080]).
Regarding claim 13, together Eibl and Grice teach all of the limitations of claim 11 as noted above.
Eibl does not explicitly teach the artery simulator assembly is one of a plurality of artery simulator assemblies.
Grice, however, further teaches the artery simulator assembly is one of a plurality of artery simulator assemblies (Paragraph [0059]; although the phantom illustrated here includes only a single fluid line and a single pressure line, the various embodiments are not limited in this regard. In some configurations, there may be multiple fluid lines, multiple pressure lines or both. Further in other configurations, multiple selectable lines can be provided. That is, one or more valves or other flow control mechanisms can be provided to allow a user to select which fluid lines to allow liquid to flow through).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the artery simulator assembly of Eibl in view of Grice to have been one of a plurality of artery simulator assemblies as further taught by Grice because it would have allowed a user to select between multiple flow and pressure configurations (Paragraph [0059]) which would further allow testing the Doppler system with different flow states.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Eibl in view of Grice as applied to claim 11 above, and further in view of Hsu (US 20250312015 A1).
Regarding claim 12, together Eibl and Grice teach all of the limitations of claim 11 as noted above.
Grice further teaches the artery simulator assembly includes a plurality of tubes (Paragraph [0039]; the lines 114 and 116, Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the artery simulator assembly of Eibl in view of Grice to include a plurality of tubes because it would have allowed fluids to transfer between multiple reservoirs (Paragraph [0013]) and form a flow.
Together Eibl and Grice do not explicitly teach the artery simulator assembly includes a pump.
Hsu, however, further teaches the artery simulator assembly includes a pump (Paragraph [0040]; the piston-based pulsatile pump is able to drive BMF simulating cardiac contractions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the artery simulator assembly of Eibl in view of Grice to have further included a pump because it would have allowed simulating a cardiac contractions (Paragraph [0040]), thereby allowing testing the ultrasound probe with flow at cardiac conditions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 02/09/26