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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US12491003B2 (hereinafter “Patent124”. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 1 of Patent124 anticipates claim 1 of the instant application.
Regarding claim 1, Patent124 teaches A system for ultrasonic needle guidance, the system comprising (col. 29 lines 57-58): a handheld ultrasound probe comprising a probe housing comprising at least a top surface and bottom surface located on opposite sides of the probe housing (col. 29 lines 58-62) ; a display physically coupled to the probe housing by a rigid or collapsible interface, the display operable to display ultrasound images generated by the probe, wherein the display is operable, via the rigid or collapsible interface, to be positioned away from the probe housing and wherein a viewable surface of the display is operable to be positioned such that a line drawn through the viewable surface is orthogonal to and passes through both the viewable surface of the display and the top surface of the probe housing, wherein the viewable surface comprises a surface of the display configured to display visual content (col. 30 lines 16-29).
Regarding claim 2, Patent124 teaches the system of claim 1, wherein Patent124 further teaches the rigid interface comprises a rigid arm for positioning the display at a fixed distance from the probe housing (claim 2).
Regarding claim 3, Patent124 teaches the system of claim 1, wherein Patent124 further teaches wherein the display is movably coupled with the probe housing via a display arm for extending the display away from the probe housing, wherein the display arm comprises a hinge and/or telescoping components, the hinge and/or telescoping components configured to allow the display position and/or orientation to be adjusted relative to the probe housing (claim 3).
Regarding claim 4, Patent124 teaches the system of claim 3, wherein Patent124 further teaches a sheath configured to surround the display and display arm when the display is in an extended position (claim 4).
Regarding claim 5, Patent124 teaches the system of claim 1, wherein Patent124 further teaches a user control operable to cause the display to switch between displaying longitudinal and transverse images or to display both longitudinal and transverse images simultaneously (claim 5).
Regarding claim 6, Patent124 teaches the system of claim 1, wherein Patent124 further teaches a user control operable to receive an input to mark a desired puncture site on a displayed image and cause a recommended needle path to be displayed in the longitudinal image and/or in the transverse image (claim 6).
Regarding claim 7, Patent124 teaches the system of claim 1, wherein Patent124 further teaches a boot comprising a boot housing, wherein the probe housing interfaces with the boot housing to releasably couple the probe and boot together, the boot comprising: an acoustic coupling medium positioned in the base of the boot, wherein the releasable coupling engages the acoustic coupling medium with the ultrasound probe in a manner that securely maintains acoustic coupling between the transducer array and the acoustic coupling medium (col. 30 lines 30-39).
Regarding 8, Patent124 teaches the system of claim 7, wherein Patent124 further teaches wherein the boot comprises a notch providing a rigid surface against which a needle can be advanced into a position viewable by the transducer array (claim 8).
Regarding 9, Patent124 teaches the system of claim 7, wherein Patent124 further teaches wherein the acoustic coupling medium is configured to provide a fixed standoff between the probe and the skin of an individual when the probe is in use and wherein the transducer array geometry is configured to account for the thickness of the acoustic coupling medium (claim 9).
Regarding 10, Patent124 teaches the system of claim 7, wherein Patent124 further teaches wherein the acoustic coupling medium comprises a gel pad, or is a unitary piece (claim 10).
Regarding 11, Patent124 teaches the system of claim 7, wherein Patent124 further teaches wherein the transducer array comprises a linear longitudinal array and a plurality of transverse phased arrays, the phased arrays aligned perpendicular to the longitudinal array, each phased array located at a different position along the longitudinal direction of the longitudinal array, each phased array configured for imaging a different transverse plane along the longitudinal direction of the linear longitudinal array (claim 11).
Regarding 12, Patent124 teaches the system of claim 11, wherein Patent124 further teaches wherein a software module identifies an inserted needle in at least the longitudinal imaging plane and at least one of the transverse imaging planes (claim 12).
Regarding 13, Patent124 teaches the system of claim 1, wherein Patent124 further teaches wherein the probe housing further comprises a position sensing array operable to determine a needle guide angle based on a position indicator (claim 13).
Regarding 14, Patent124 teaches the system of claim 3, wherein Patent124 further teaches wherein the position sensing array comprises a magnetic field sensing array (claim 14).
Regarding 15, Patent124 teaches the system of claim 1, wherein Patent124 further teaches wherein the ultrasound probe comprises a needle guide assembly detection sensor configured to determine whether a needle guide assembly is present and positioned in a desired location relative to the probe housing, wherein a software module uses output from the sensor to determine needle tracking techniques to be used, wherein the techniques comprise image processing and/or needle guide geometry characteristics for determining needle trajectory.
Regarding 16, Patent124 teaches the system of claim 1, wherein Patent124 further teaches a needle guide assembly, wherein the needle guide assembly comprises a needle guide and a position indicator (col. 30 lines 47-48).
Regarding 17, Patent124 teaches the system of claim 16, wherein Patent124 further teaches, wherein the position indicator comprises a first indicator and a second indicator, wherein the first indicator is configured to move relative to the second indicator as the needle guide angle is adjusted, wherein the software module is operable to use the sensed location of the first indicator to determine the needle guide angle (claim 17).
Regarding 18, Patent124 teaches the system of claim 17, wherein Patent124 further teaches, wherein the first and second indicators comprise first and second magnets, respectively (claim 18).
Regarding 19, Patent124 teaches the system of claim 16, wherein Patent124 further teaches wherein the needle guide assembly comprises a turn screw that adjusts the angle of the needle guide by raising or lowering a wedge piece which slides within a channel in a needle guide rail (claim 19).
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 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mauldin et al., (US20180153513A1).
Regarding claim 1, Mauldin teaches A system for ultrasonic needle guidance, the system comprising ([0005] handheld device used for directing a needle):
a handheld ultrasound probe comprising a probe housing comprising at least a top surface and bottom surface located on opposite sides of the probe housing (see annotated fig. 2B);
a display physically coupled to the probe housing by a rigid interface (fig. 2B the display 112 is located on a rigid pivot 114), the display operable to display ultrasound images generated by the probe, wherein the display is operable, via the rigid interface, to be positioned away from the probe housing (see annotated fig. 2B the display is positioned away from the probe housing) and wherein a viewable surface of the display is operable to be positioned such that a line drawn through the viewable surface is orthogonal to and passes through both the viewable surface of the display and the top surface of the probe housing (fig. 2b a line can be drawn through the viewable surface of the display and the probe), wherein the viewable surface comprises a surface of the display configured to display visual content ([0061] the visual content is displayed on display 112).
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Regarding claim 10, Mauldin teaches the system of claim 1, wherein Mauldin further teaches a position sensing array operable to determine a needle guide angle based on a position indicator located in or on the needle guide assembly ([0009] The rotation angle sensor is configured at or near the pivot point and connected with the needle guide assembly or sufficiently close to the needle guide assembly to approximate the needle angle within the assembly).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Liu (US20160213398A1).
Regarding claim 2, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the rigid interface comprises a rigid arm for positioning the display at a fixed distance from the probe housing.
In the same ultrasound probe field of endeavor, Liu teaches wherein the rigid interface comprises a rigid arm for positioning the display at a fixed distance from the probe housing (fig. 5 display screen 32 is attached to the a rigid arm and is positioned a fixed distance from the probe housing 22a [0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the probe of Mauldin with the display device of Liu, as this would improve puncturing accuracy (see Liu [0006]).
Regarding claim 3, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the display is movably coupled with the probe housing via a display arm for extending the display away from the probe housing, wherein the display arm comprises a hinge and/or telescoping components, the hinge and/or telescoping components configured to allow the display position and/or orientation to be adjusted relative to the probe housing.
In the same ultrasound probe field of endeavor, Liu teaches wherein the display is movably coupled with the probe housing via a display arm for extending the display away from the probe housing (fig. 5 display screen 32 is attached to the a rigid arm and is positioned a fixed distance from the probe housing 22a [0022]), wherein the display arm comprises a hinge components, the hinge components configured to allow the display orientation to be adjusted relative to the probe housing (fig. 5 the display device 110 is attached to the shell 22 by hinged connectors 51 and 52 ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the probe of Mauldin with the display device of Liu, as this would improve puncturing accuracy (see Liu [0006]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin and Liu as applied to claim 3 above, and further in view of OuYang et al., (US 20150157387 A1).
Regarding claim 4, Mauldin teaches the system of claim 3, but fails to explicitly disclose wherein the sheath is configured to surround the display and display arm when the display is in an extended position.
In the same ultrasound field of endeavor, OuYang teaches wherein the sheath is configured to surround the display and display arm when the display is in an extended position (fig. 11c sheath 400 is over the monitor and the monitor cover, as well as the arm it is extended on [0249]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the sterile sheath of Mauldin with the sheath of OuYang, as this would prevent any effects that would potentially comprising the detail and accuracy of the imaging tool (see OuYang [0015]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Solek et al., (US10928494B1).
Regarding claim 5, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the user control is operable to cause the display to switch between displaying longitudinal and transverse images or to display both longitudinal and transverse images simultaneously.
In the same ultrasound field of endeavor, Solek teaches wherein the user control is operable to cause the display both longitudinal and transverse images simultaneously (fig. 7 the display shows a simultaneous transverse and longitudinal view of the ultrasound image col. 8 line 17-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the scanning of Solek, as this would enable simultaneous visualization of the different views of the veins and allow for precise targeting of the interior vein without going too far (see col. 4 line 64-col. 5 line 1-3).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in as applied to claim 1 above, and further in view of Bharat et al., (US20210259660A1).
Regarding claim 6, Mauldin teaches the system of claim 1, but fails to teach wherein the user control is operable to receive an input to mark a desired puncture site on a displayed image and cause the recommended needle path to be displayed in the image.
However in the same ultrasound field of endeavor, Bharat teaches wherein the user control is operable to receive an input to mark a desired puncture site on a displayed image and cause the recommended needle path to be displayed in the image ([0054] the clinician may select the target location, and the deep learning network will identify a needle path; [0059] the display can show the biopsy needle paths).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the marking of the target and display the needle paths of Bharat, as this would help improve the prediction performance of the software used for such systems (see Bharat [0084]). One of ordinary skill would understand that this modification would apply to the display of Mauldin that includes the transverse and longitudinal images, and would therefore read upon the limitation of the recommended needle path to be displayed in the longitudinal image and/or in the transverse image.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Robbins et al., (US20210100625A1).
Regarding claim 7, Mauldin teaches the system of claim 1, but is silent regarding wherein the boot releasably couples to the probe via at least one of a protrusion on the boot which engages with a groove or notch on the probe or a protrusion on the probe which engages with a groove or notch on the boot.
In the same ultrasound field of endeavor, Robbins teaches wherein the boot releasably couples to the probe via at least one of a protrusion on the probe which engages with a groove or notch on the boot (fig. 2A probe head 32 contains a protruding structure that secures onto the aperture of the needle shield 100 [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the engagement feature between the boot and probe head of Mauldin with the engagement feature of Robbins, as both inventions relate to ultrasound devices that have components attached to the probe head and would yield the predictable result of the an ultrasound probe having a protrusion that allows it to engage a protrusion of the boot to engage the two components to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a substitution, and the results of Mauldin having such engagement feature are reasonably predictable.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Park et al., (US20070276253A1),
Regarding claim 8, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the boot comprises a notch providing a rigid surface against which a needle can be advanced into a position viewable by the transducer array.
In the same ultrasound field of endeavor, Park teaches, wherein the boot comprises a notch providing a rigid surface against which a needle can be advanced into a position viewable by the transducer array (fig. 11 cradle 61 a receives the needle and allows the needle to advance [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the cradle of Park, as this would facilitate a longitudinal or transverse type ultrasound guided needle insertion procedures (see Park [0005]).
Regarding claim 10, modified Abrams teaches the system of claim 1, but is silent regard wherein the acoustic coupling medium comprises a gel pad, or is a unitary piece.
In the same ultrasound field of endeavor, Park teaches wherein the acoustic coupling medium comprises a gel pad ([0031] an acoustic coupling gel is placed the interior surface of 5 d of the shell 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Adams with the cradle of Park, as this would ensure consistent contact between the sound transmitting end of the transducer and the sleeve (see Park [0004]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Park and Seitz et al., (US4877033A).
Regarding claim 9, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the acoustic coupling medium is configured to provide a fixed standoff between the probe and the skin of an individual when the probe is in use and wherein the transducer array geometry is configured to account for the thickness of the acoustic coupling medium.
However in the same ultrasound field of endeavor, Park teaches wherein the acoustic coupling medium is configured to provide a fixed standoff between the probe and the skin of an individual when the probe is in use (fig. 3 acoustic window 7 is a fixed stand of between the probe 40 and the skin of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the cradle of Park, as this would facilitate a longitudinal or transverse type ultrasound guided needle insertion procedures and ensure that the head is held in place during the procedure (see Park [0005] and [0031]).
However the combination of references are silent regarding wherein the transducer array geometry is configured to account for the thickness of the acoustic coupling medium.
In the same ultrasound field of endeavor, Seitz teaches wherein the transducer array geometry is configured to account for the thickness of the acoustic coupling medium (col. 8 line 35-39 the wall thickness is reduce to create a window to permit free passage of ultrasound waves from the ultrasound transducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the thickness of the window of Seitz to the acoustic window of Mauldin, as both inventions relate to ultrasound devices and would yield the predictable result of the an ultrasound probe with an acoustic window that has a thickness that allows free passage of ultrasound waves to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such an application, and the results of Mauldin having such a thickness for the acoustic window are reasonably predictable. The benefit would be that the acoustic window would therefore not interfere with any ultrasound signals sent by the probe.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable Mauldin as applied to claim 1 above, and further in view of Adams et al., (US 20240173009 A1) and Harada et al., (US20100210946A1).
Regarding claim 11, Mauldin teaches the system of claim 1, but fails to teach a linear array and phased arrays.
In the same ultrasound field of endeavor, Adams further teaches a linear array and phased arrays ([0124] the probes 105 can be a combination of linear transducers and phased array transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the transducer arrays of Mauldin with the linear and phased arrays of Adams, as both inventions relate to ultrasound imaging and would yield the predictable result of an ultrasound system with linear and phased arrays to one of ordinary skill. One of ordinary skill would be able to perform such a substitution, and the results of Mauldin having linear and phased arrays are reasonably predictable.
However, the combination of references fails to explicitly disclose wherein the transducer array comprises a longitudinal array and a plurality of transverse arrays, the transverse arrays aligned perpendicular to the longitudinal array, each transverse array located at a different position along the longitudinal direction of the longitudinal array, each transverse array configured for imaging a different transverse plane along the longitudinal direction of the longitudinal array.
In the same ultrasound field of endeavor, Harada teaches wherein the transducer array comprises a longitudinal array (fig. 2 C is the long axis ultrasonic array probe [0090]) and a plurality of transverse arrays (fig. 2 A and B are the transverse arrays [0090]), the transverse arrays aligned perpendicular to the longitudinal array (fig. 2 A and B are orthogonal to C [0091]), each transverse array located at a different position along the longitudinal direction of the longitudinal array (fig. 2 A and B are at different locations), each transverse array configured for imaging a different transverse plane along the longitudinal direction of the longitudinal array (fig. 22(a) and (b) B and A take scans at different positions of the vessel [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the linear and phased array transducers of Mauldin with the transducer configuration of Harada, as this would facilitate the positioning of an ultrasonic probe and acquire sufficient positioning accuracy (see Harada [0006]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Adams and Harada as applied to claim 11 above, and further in view of Burkholz et al., (US20200230391A1).
Regarding claim 12, Mauldin teaches the system of claim 11, but fails to explicitly disclose wherein the software module identifies an inserted needle in at least the longitudinal imaging plane and at least one of the transverse imaging planes.
In the same ultrasound field of endeavor, Burkholz teaches wherein the software module identifies an inserted needle in at least the longitudinal imaging plane and at least one of the transverse imaging planes ([0069] the processor receives the data of the internal structures used to form the transverse plane 120 and coronal plane 140 to calculate the needle trajectory; fig. 7A-7B the video display device would show the inserted needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the magnetic field detector of Burkholz, as this would allow for the ability to effectively and properly insert the vascular access device, such as a needle, into the patient (see Burkholz [0003]).
Claims 14, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Solek as applied to claim 13 and claim 1, respectively, above, and further in view of Burkholz.
Regarding claim 14, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the position sensing array comprises a magnetic field sensing array.
In the same ultrasound field of endeavor, Burkholz teaches wherein the position sensing array comprises a magnetic field sensing array ([0006] the ultrasound probe includes a magnetic field detector to determine the position of a needle tip of a needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the magnetic field detector of Burkholz, as this would allow for the ability to effectively and properly insert the vascular access device, such as a needle, into the patient (see Burkholz [0003]).
Regarding claim 15, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the ultrasound probe comprises a needle guide assembly detection sensor configured to determine whether the needle guide assembly is present and positioned in a desired location relative to the probe housing, wherein the software module uses output from the sensor to determine needle tracking techniques to be used, wherein the techniques comprise image processing.
In the same ultrasound field of endeavor, Burkholz teaches wherein the ultrasound probe comprises a needle guide assembly detection sensor configured to determine whether the needle guide assembly is present and positioned in a desired location relative to the probe housing ([0075]-[0076] the processor detects if the VAD is at a correct depth or coordinate location), wherein the software module uses output from the sensor to determine needle tracking techniques to be used, wherein the techniques comprise image processing for determining needle trajectory ([0075]-[0076] the processor may visually indicate if there is an improper trajectory).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the magnetic field detector of Burkholz, as this would allow for the ability to effectively and properly insert the vascular access device, such as a needle, into the patient (see Burkholz [0003]).
Regarding claim 16, Mauldin teaches the system of claim 15, but fails to explicitly disclose wherein the needle guide assembly detection sensor comprises a magnetic field sensor.
In the same ultrasound field of endeavor, Burkholz teaches wherein the needle guide assembly detection sensor comprises a magnetic field sensor. ([0006] the ultrasound probe includes a magnetic field detector to determine the position of a needle tip of a needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the magnetic field detector of Burkholz, as this would allow for the ability to effectively and properly insert the vascular access device, such as a needle, into the patient (see Burkholz [0003]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Muller et al., (US20200281563A1).
Regarding claim 17, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the position indicator comprises a first indicator and a second indicator, wherein the first indicator is configured to move relative to the second indicator as the needle guide angle is adjusted, wherein the software module is operable to use the sensed location of the first indicator to determine the needle guide angle.
In the same ultrasound field of endeavor, Muller teaches wherein the position indicator comprises a first indicator and a second indicator (fig. 2 instrument guide device 125 contains a magnet that is included within the instrument guide device 125 and can change orientation and a first sensor 123a [0037] and [0044]), wherein the first indicator is configured to move relative to the second indicator as the needle guide angle is adjusted (fig. 2 instrument guide device 125 contains a magnet that is included within the instrument guide device 125 and can change orientation[0037]), wherein the software module is operable to use the sensed location of the first indicator to determine the needle guide angle ([0044] the computing device can determine an angle of the instrument guide device 125 based on the magnet and first sensor 123a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the magnet and magnetic sensors of Muller, as this would make it easier for physicians, as it would reduce procedure time and reduce liability from inflicting unnecessary pain to patients (see Muller [0003]).
Regarding claim 18, Mauldin teaches the system of claim 17, but fails to explicitly disclose wherein the first and second indicators comprise first and second magnets, respectively.
In the same ultrasound field of endeavor, Muller teaches wherein the first and second indicators comprise first and second magnets, respectively (fig. 2 instrument guide device 125 contains a magnet that is included within the instrument guide device 125 [0044] and a first sensor 123a, which can be a magnetic potentiometer [0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the magnet and magnetic sensors of Muller, as this would make it easier for physicians, as it would reduce procedure time and reduce liability from inflicting unnecessary pain to patients (see Muller [0003]).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mauldin as applied to claim 1 above, and further in view of Ta (US 20230000462 A1) and Cermak (US20160128719A1).
Regarding claim 19, Mauldin teaches the system of claim 1, but fails to explicitly disclose wherein the needle guide assembly comprises a turn screw that adjusts the angle of the needle guide by raising or lowering a wedge piece
In the same ultrasound field of endeavor, Ta teaches wherein the needle guide assembly comprises a turn screw that adjusts the angle of the needle guide by raising or lowering a wedge piece (fig. 1 angle adjustment knob sets the angle of the swing arm, and would raise or lower the arm depending on the angle [0063]; the adjustment knob, under BRI, acts as a turn screw).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the angle adjusting mechanism of Mauldin with the angle adjusting mechanism of Ta, as this would make it easier to perform accurate needle insertions (see Ta [0061]).
However the combination of references are silent regarding a wedge piece which slides within a channel in a needle guide rail.
In the same ultrasound field of endeavor, Cermak teaches a wedge piece which slides within a channel in a needle guide rail (fig. 12 ears 92 moves up and down the tracks 70 [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Mauldin with the needle wedge piece of Cermak, as this would increase accuracy and decrease time used when guiding the needle (see Cermak [0003]).
Conclusion
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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