DETAILED ACTION
This office action is in response to the communication received on February 9, 2026 and March 30, 2026 concerning application No. 18/608,412 filed on March 18, 2024.
Claims 1-14 and 16-40 are currently pending.
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 .
Response to Amendment
The supplemental response filed March 30, 2026 has been entered.
Response to Arguments
Applicant's arguments filed 02/09/2026 regarding the drawings objection have been fully considered. The amendments to the specification have been entered and overcome the drawings objection of fig. 11 previously set forth.
Applicant's arguments filed 02/09/2026 regarding the 35 USC 112 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claim 34 previously set forth and the rejection regarding the use of the term “near” in claim 1. However, applicant did not amend the claim to address the limitation “a medical instrument” recited in lines 5 and 7 of claim 1. While “a medical instrument” is a defined term as discussed by applicant it is still not clear to the examiner whether “a medical instrument” recited in line 7 of claim 1 is the same as or different from the “a medical instrument” recited in line 5 of claim 1. Therefore the 35 USC 112b rejection of claim 1 stands.
Applicant’s arguments with respect to claim(s) 1 regarding the newly filed claim amendments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New reference Sandy is being relied upon to teach claim 1.
Examiner notes that since independent claim 1 is rejected by a new prior art reference the dependent claims are not separately patentable and are still rejected by the prior art.
Claim Objections
Claims 1, 35, and 38 are objected to because of the following informalities:
Claim 1, line 14, “into the patient” should read “into the patient anatomy”,
Claim 35, line 3 and claim 38, line 3, “a medical instrument insertion trajectory” should read “the insertion trajectory of the medical instrument”.
Appropriate correction is required.
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.
Claims 1-14 and 16-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 7, recites “a medical instrument” which is considered indefinite. It is not clear whether the “a medical instrument” recited in line 7 is the same as or different from “a medical instrument” recited in line 5. For the purpose of examination and this office action it is being interpreted that they are the same medical instrument.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
(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.
Claim(s) 1, 11, 13-14, 17-20, and 35-37 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Sandy et al. (US 20140187945, hereinafter Sandy).
Regarding claim 1, Sandy teaches an ultrasound imaging apparatus ([0042] ultrasound probe 10 in figs. 4-6) comprising:
a probe housing comprising two or more ultrasound transducer arrays ([0042] discloses the probe 10 includes transducer modules 1 and 2. Figs. 4-6 show the probe has a housing comprising the transducer and [0045] discloses the transducers are linear arrays);
wherein the two or more ultrasound transducer arrays are separated by a physical gap of at least 1 mm ([0025] discloses the gap between the transducer arrays is between 2mm to 15mm);
wherein the physical gap is positioned to provide for insertion of a medical instrument with an in-plane orientation relative to an ultrasound imaging plane (figs. 4-6 show the gap is positioned to provide insertion of the needle 20 (medical instrument) with an in-plane orientation to the ultrasound plane. [0002] and [0048] further disclose the needle point is in-plane), and wherein the physical gap is dimensioned for accepting a medical instrument for insertion into a patient anatomy (figs. 4-6 and [0003] discloses the needle is inserted as directly to the target as possible, meaning the gap is dimensioned for insertion of the needle into patient anatomy);
wherein the probe housing further comprises a guide for accepting the medical instrument in the physical gap and inserting the medical instrument into the patient anatomy (figs. 4-6 show the physical gap has edges/boundaries that are used to guide the needle to be inserted into the patient anatomy);
wherein the guide allows for adjusting a insertion trajectory angulation of the medical instrument relative to a central axis of the guide ([0055] discloses the user is free to work within the extended gap. Therefore, since the needle is free to be manipulated within the gap, the guide allows for adjusting a insertion trajectory angle of the needle relative to a central axis of the guide);
wherein the probe housing position and orientation can be adjusted independently of the medical instrument prior to, during, and after, inserting the medical instrument into the patient ([0055] and figs. 4-6, since the needle 20 is not directly attached to the probe, the position and orientation of the housing can be adjusted independently of the needle); and
wherein the physical gap is configured relative to the two or more ultrasound transducer arrays and a patient contact surface such that a medical instrument insertion site on the patient contact surface is visible to an individual inserting the medical instrument into the patient anatomy ([0047] and figs. 4-6 show the insertion site is visible to an individual inserting the needle into the patient anatomy since there are no obstructions blocking the view of the gap while the probe is in use).
Regarding claim 11, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches each of the two or more ultrasound transducer arrays are configured to provide an acoustic angle of incidence of at most 75 degrees at a shallowest point of intersection between the medical instrument and the ultrasound imaging plane ([0024] discloses the angle between the planes of the transducer is 110 degrees, meaning the incident angle between the imaging plane and the needle is 55 degrees. ).
Regarding claim 13, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches the guide is configured within the probe housing to enable a midline medical instrument insertion trajectory (figs. 4-6 show the guide is configured to enable a midline medical instrument insertion trajectory).
Regarding claim 14, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches the guide is integral to the probe housing (figs. 4-6 show the guide is integral to the probe housing).
Regarding claim 17, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches a central axis of sound propagation of each of the two or more ultrasound transducer arrays differs (figs. 4-6 show the central axis of each of the transducer arrays is different meaning the central axis of sound propagation of each of the transducers is different).
Regarding claim 18, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches a direction of sound propagation of each of the two or more ultrasound transducer arrays creates an overlapping view plane over the patient anatomy or a target location within the patient anatomy (figs. 1-3 show the direction of sound propagation creates an overlapping view plane over the target location).
Regarding claim 19, Sandy teaches the apparatus of claim 18, as set forth above. Sandy further teaches the overlapping view plane includes a point where the medical instrument enters the patient contact surface or the patient anatomy (fig. 1 shows the overlapping view starts above the skin surface, therefore the overlapping view includes a point where the needle enters the patient).
Regarding claim 20, Sandy teaches the apparatus of claim 18, as set forth above. Sandy further teaches a processor operative to geometrically reconstruct images from the two or more ultrasound transducer arrays by compounding data at spatial locations sampled by more than one ultrasound transducer array of the two or more ultrasound transducer arrays ([0026]-[0027] discloses generating an ultrasound image by recombining data obtained from each of the arrays using compounding. The part of the apparatus that performs the compounding is considered the processor).
Regarding claim 35, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches the probe housing further comprises one or more user grip element located to avoid obstructing a medical instrument insertion trajectory (figs. 4-6 show the probe housing is angled and provides a user grip element located to avoid obstructing the medical instrument insertion trajectory).
Regarding claim 36, Sandy teaches the apparatus of claim 35, as set forth above. Sandy further teaches the one or more user grip element is located to avoid obstructing a visual path to a point at which the medical instrument contacts the patient contact surface or the patient anatomy (figs. 4-6 show the probe housing is angled and provides a user grip element located to avoid obstructing a visual point at which the needle contacts the patient).
Regarding claim 37, Sandy teaches the apparatus of claim 35, as set forth above. Sandy further teaches the medical instrument is one or more of a needle, a catheter, a trocar, an ablation instrument, a cutting instrument, or a therapy applicator (Abstract, [0003] and figs. 4-6 disclose the instrument is a needle).
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.
Claim(s) 2-8, 10, 12, 16, and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Grim et al. (US 20200305927, hereinafter Grim).
Regarding claim 2, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach the two or more ultrasound transducer arrays are separated from the patient anatomy by one or more intervening acoustically transmissive layers.
However,
Grim in a similar field of endeavor teaches the two or more ultrasound transducer arrays are separated from the patient anatomy by one or more intervening acoustically transmissive layers ([0047] and figs. 3-6 disclose a coupling wedge 142 which is made of an acoustically transparent material which separates the skin surface of the patient and the ultrasound transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the two or more ultrasound transducer arrays be separated from the patient anatomy by one or more intervening acoustically transmissive layers of Grim to the apparatus of Sandy to allow for the predictable results of improving the transmission of the ultrasound signals from the transducers to the patient, thereby improving the quality of the obtained images.
Regarding claim 3, Sandy in view of Grim teaches the apparatus of claim 2, as set forth above. Grim further teaches the two or more ultrasound transducer arrays do not make direct physical contact with the patient anatomy ([0047] and figs. 3-6 disclose the coupling wedge 142 which fills the gap between the transducers and the skin of the patient, meaning the transducers do not make direct physical contact with the patient anatomy).
Regarding claim 4, Sandy in view of Grim teaches the apparatus of claim 2, as set forth above. Grim further teaches the one or more intervening acoustically transmissive layers comprise a patient contact interface and an acoustic filler material ([0047]-[0049] disclose coupling wedge has a planar surface which is oriented towards tissue and the wedge is fabricated from an acoustically-transparent material which is considered an acoustic filler material).
Regarding claim 5, Sandy in view of Grim teaches the apparatus of claim 4, as set forth above. Grim further teaches the patient contact interface is comprised of one or more rigid, semi-rigid, or substantially rigid materials ([0047] discloses the wedge is fabricated from PEEK which is considered to be at least a substantially rigid material).
Regarding claim 6, Sandy in view of Grim teaches the apparatus of claim 4, as set forth above. Grim further teaches the patient contact interface is comprised of one or more elastic, semi-elastic, or substantially elastic materials ([0047] discloses the wedge is fabricated from silicone which is considered to be at least a substantially elastic material).
Regarding claim 7, Sandy in view of Grim teaches the apparatus of claim 4, as set forth above. Grim further teaches the one or more intervening acoustically transmissive layers comprises an ultrasound transducer array lens coating (figs. 4 and 6 show the transducers are in direct contact with the wedge 142, therefore the wedge provides a lens coating for the transducers to protect the transducer arrays).
Regarding claim 8, Sandy in view of Grim teaches the apparatus of claim 2, as set forth above. Grim further teaches one or more surfaces of the intervening acoustically transmissive layers is angled non-parallel to an elevational plane of the one or more ultrasound transducer arrays (fig. 6 shows the base surface 154 of the wedge 142 is angled non-parallel to the planes of the transducers. [0045] further discloses the planes of the transducers intersect, meaning the planes are at angle compared to the base surface 154).
Regarding claim 10, Sandy in view of Grim teaches the apparatus of claim 2, as set forth above. Grim further teaches a material in contact with one or more surfaces of the one or more intervening acoustically transmissive layers has an acoustic impedance within 50% of at least one of the one or more intervening acoustically transmissive layers ([0047] discloses the wedge is fabricated from PEEK and [0041] discloses the handle body which is in contact with the wedge is fabricated from PEEK. Therefore the material in contact with the intervening acoustically transmissive layers has an acoustic impedance within 50% since they are made of the same material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having a material in contact with one or more surfaces of the one or more intervening acoustically transmissive layers has an acoustic impedance within 50% of at least one of the one or more intervening acoustically transmissive layer of Grim to the apparatus of Sandy in view of Grim to allow for the predictable results of improving the transmission of the ultrasound signals from the transducers to the patient, thereby improving the quality of the obtained images.
Regarding claim 12, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach the two or more ultrasound transducer arrays are configured to provide an acoustic angle of incidence of at most 50 degrees at a shallowest point of intersection between the medical instrument and the ultrasound imaging plane.
However,
Grim in a similar field of endeavor teaches each of the two or more ultrasound transducer arrays are configured to provide an acoustic angle of incidence of at most 50 degrees at a shallowest point of intersection between the medical instrument and the ultrasound imaging plane. ([0021] and fig. 6 disclose the angle between the transducers is 80 degrees meaning the incident angle between the imaging plane and the medical instrument is 40 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the two or more ultrasound transducer arrays be configured to provide an acoustic angle of incidence of at most 50 degrees at a shallowest point of intersection between the medical instrument and the ultrasound imaging plane to allow for the predictable results of increasing image quality and visualization of the needle.
Regarding claim 16, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach the medical instrument guide detachably interfaces with the probe housing to enable a paramedian and/or oblique medical instrument insertion trajectory.
However,
Grim in a similar field of endeavor teaches the medical instrument guide detachably interfaces with the probe housing to enable a paramedian and/or oblique medical instrument insertion trajectory ([0050]-[0051] and figs. 7-8 disclose needle guide assembly which can be detachably coupled to the probe housing in order to enable at least a paramedian instrument insertion trajectory).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the guide detachably interface with the probe housing to enable a paramedian and/or oblique medical instrument insertion trajectory of Grim to the apparatus of Sandy to allow for the predictable results of ensuring the user can place the probe in the correct position, thereby increasing the accuracy of the apparatus.
Regarding claim 25, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach a medical instrument retention component mechanically interfaces with the probe housing and the guide to restrict the medical instrument to in-plane trajectories.
However,
Grim in a similar field of endeavor teaches a medical instrument retention component mechanically interfaces with the probe housing and the guide to restrict the medical instrument to in-plane trajectories ([0050] needle guide assembly 160 which is configured to be coupled with the probe head to facilitate positioning of the biopsy needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of a medical instrument retention component mechanically interfaces with the probe housing and the guide to restrict the medical instrument to in-plane trajectories of Grim to the apparatus of Sandy to allow for the predictable results of increasing the accuracy of the needle guidance by ensuring the needle is consistently within view.
Regarding claim 26, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach a medical instrument retention component mechanically interfaces with the probe housing and the guide to preserve alignment of the medical instrument with the patient anatomy or a target location within the patient anatomy.
However,
Grim in a similar field of endeavor teaches a medical instrument retention component mechanically interfaces with the probe housing and the guide to preserve alignment of the medical instrument with the patient anatomy or a target location within the patient anatomy ([0050] needle guide assembly 160 which is configured to be coupled with the probe head to facilitate positioning of the biopsy needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of a medical instrument retention component mechanically interfaces with the probe housing and the guide to preserve alignment of the medical instrument with the patient anatomy or a target location within the patient anatomy of Grim to the apparatus of Sandy to allow for the predictable results of increasing the accuracy of the needle guidance by ensuring the target is consistently within view.
Regarding claim 27, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach a medical instrument retention component detachably interfaces with the probe housing and provides a quick-release mechanism for separating the medical instrument from the probe housing.
However,
Grim in a similar field of endeavor teaches a medical instrument retention component detachably interfaces with the probe housing and provides a quick-release mechanism for separating the medical instrument from the probe housing ([0050] discloses a needle guide assembly is coupled to the probe head. [0051] further teaches the needle guide assembly has a pair of tabs for detachable snap-fit engagement with the probe head. The snap-fit mechanism is considered a quick-release mechanism).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of medical instrument retention component detachably interfaces with the probe housing and provides a quick-release mechanism for separating the medical instrument from the probe housing of Grim to the apparatus of Sandy to allow for the predictable results of increasing the accuracy of the needle guidance by ensuring the needle is has the ability to be consistently within view.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Grim as applied to claim 2 above, and further in view of Schafer et al. (US 20220331612, hereinafter Schafer).
Regarding claim 9, Sandy in view of Grim teaches the apparatus of claim 2, as set forth above. Sandy in view of Grim does not specifically teach a material in contact with one or more surfaces of the one or more intervening acoustically transmissive layers has an acoustic attenuation rate greater than at least one of the one or more intervening acoustically transmissive layers.
However,
Schafer in a similar field of ultrasound imaging teaches a material in contact with one or more surfaces of the one or more intervening acoustically transmissive layers has an acoustic attenuation rate greater than at least one of the one or more intervening acoustically transmissive layers ([0032]-[0034] disclose using a gel pad (intervening acoustically transmissive layers with a foam disk (material) embedded (in contact with) in the gel that has a higher acoustic attenuation than the material of the gel pad).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus disclosed by Sandy in view of Grim to have a material in contact with one or more surfaces of the one or more intervening acoustically transmissive layers has an acoustic attenuation rate greater than at least one of the one or more intervening acoustically transmissive layers in order to reduce the heating of the patient region, as recognized by Schafer (Abstract).
Claim(s) 21-22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Randulescu et al. (US 20170168148, hereinafter Randulescu).
Regarding claim 21, Sandy teaches the apparatus of claim 1, as set forth above. Sandy further teaches a processor operative to control image acquisition by the two or more ultrasound transducer arrays ([0026]-[0027] discloses obtaining data from the two arrays, the part of the apparatus that controls the acquisition is considered the processor).
Sandy does not specifically teach the processor interleaves image acquisition such that the two or more ultrasound transducer arrays are not acquiring images at a same time.
However,
Randulescu in a similar field of endeavor teaches the processor interleaves image acquisition such that the two or more ultrasound transducer arrays are not acquiring images at a same time ([0017] “the scanning of the two probes 104, 108 interleaves beam by beam”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the image acquisition disclosed by Sandy to have the processor interleaves image acquisition such that the two or more ultrasound transducer arrays are not acquiring images at a same time in order to generate a composite scan ([0017]).
Regarding claim 22, Sandy in view of Randulescu teaches the apparatus of claim 21, as set forth above. Randulescu further teaches an ultrasound transducer array of the two or more ultrasound transducer arrays acquiring images is the same ultrasound transducer array that transmits ultrasound energy into the patient anatomy ([0044] discloses each of the probes transmits a beam and receives its own return beam).
Regarding claim 24, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach a processor operative to control a propagation direction of sound waves from the two or more ultrasound transducer arrays at one or more non- zero angles relative to a central axis of the probe housing, the two or more ultrasound transducer arrays, or both, using electronic beam steering.
However,
Randulescu in a similar field of endeavor teaches a processor (the electronic circuitry of the system 100 in fig. 1) operative to control a propagation direction of sound waves from the two or more ultrasound transducer arrays at one or more non- zero angles relative to a central axis of the probe housing, the two or more ultrasound transducer arrays, or both, using electronic beam steering ([0015] “since the probe 104 has a phased array, many beams 112 are, via the steering capability, emitted in differently angle directions during the course of a scan”, see fig. 2. [0044] further teaches shifting the beam steering to direct the scan beam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus disclosed by Sandy to have a processor control a propagation direction of sound waves from the two or more ultrasound transducer arrays at one or more non- zero angles relative to a central axis of the probe housing, the two or more ultrasound transducer arrays, or both, using electronic beam steering in order to image the entire volume without having to move the probe, thereby making the image acquisition more efficient.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Randulescu as applied to claim 21 above, and further in view of Haddad (US 20020099290).
Regarding claim 23, Sandy in view of Randulescu teaches the apparatus of claim 21, as set forth above. Sandy in view of Randulescu does not specifically teach the ultrasound transducer array of the two or more ultrasound transducer arrays acquiring images is different from the ultrasound transducer array of the two or more ultrasound transducer arrays that transmits ultrasound energy into the patient anatomy.
However,
Haddad in a similar field of endeavor teaches the ultrasound transducer array of the two or more ultrasound transducer arrays acquiring images is different from the ultrasound transducer array of the two or more ultrasound transducer arrays that transmits ultrasound energy into the patient anatomy ([0019] and [0024] disclose performing transmitting with a first transmitter array and receiving echoes with a receiver array different from the transmitter array).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the transducer arrays of Sandy in view of Randulescu for the transmit and receive arrays of Haddad because it amounts to simple substitution of one known element for another to obtain the predictable results of obtaining an image of the object of interest.
Claim(s) 28-29 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Sokulin et al. (US 20210015448, hereinafter Sokulin).
Regarding claim 28, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach a processor operative to implement a medical instrument detection algorithm to detect image samples depicting the medical instrument.
However,
Sokulin in a similar field of endeavor teaches a processor operative to implement a medical instrument detection algorithm to detect image samples depicting the medical instrument ([0051] “the image transform may be utilized to identify the needle depicted in the image and store the location thereof”. The process of implementing the image transform is considered the algorithm, see [0024]. [0019] discloses the processing operations include the image transform).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor disclosed by Sandy to implement a medical instrument detection algorithm to detect image samples depicting the medical instrument in order to know the location where the ultrasound needs to be to view the needle.
Regarding claim 29, Sandy in view of Sokulin teaches the apparatus of claim 28, as set forth above. Sokulin further teaches the processor is further operative to convey and overlay a medical instrument location on a graphical display unit via pixel intensity adjustment, pixel coloration, graphical overlays, or combinations thereof, upon an ultrasound image displayed on the graphical display unit ([[0060] and fig. 9 show a medical instrument (needle 908) being overlayed upon an ultrasound image displayed on the graphical display unit).
Regarding claim 31, Sandy in view of Sokulin teaches the apparatus of claim 28, as set forth above. Sokulin further teaches the processor is further operative to adaptively reconfigure a direction of sound propagation of the ultrasound transducer array to optimize sensitivity to the medical instrument based on output of the medical instrument detection algorithm ([0035]-[0036] discloses adjusting a steering angle of the ultrasound beam towards the needle angle so that the needle is within the image. [0008], [0024]. Applying the teachings of Sokulin would result in both of the ultrasound transducer arrays being reconfigured to image the medical instrument).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor disclosed by Sandy in view of Sokulin to have the processor adaptively reconfigures a direction of sound propagation of the ultrasound transducer array to optimize sensitivity to the medical instrument based on output of the medical instrument detection algorithm in order to maintain imaging of the needle.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Sokulin as applied to claim 28 above, and further in view of Ardnt et al. (US 20080058702, hereinafter Ardnt).
Regarding claim 30, Sandy in view of Sokulin teaches the apparatus of claim 28, as set forth above. Sandy in view of Sokulin does not specifically teach the medical instrument is a hyperechoic medical instrument, and wherein the medical instrument detection algorithm differentiates between the hyperechoic medical instrument and tissue echoes on a basis of spatiotemporal analysis of sequential image data to detect samples that correspond regions of intensity and motion trajectories consistent with insertion of the medical instrument in the patient anatomy.
However,
Arndt in a similar field of endeavor teaches the medical instrument is a hyperechoic medical instrument ([0031] hyperechoic needle 1 in fig. 1), and wherein the medical instrument detection algorithm differentiates between the hyperechoic medical instrument and tissue echoes on a basis of spatiotemporal analysis of sequential image data to detect samples that correspond regions of intensity and motion trajectories consistent with insertion of the medical instrument in the patient anatomy ([0031] “needle 1 is provided with an irregular surface that enhances the reflection of ultrasound waves toward an emitter receiver array of a 2D ultrasound machine, thereby allowing enhanced visualization with the ultrasound machine”. Also see [0036], [0048]-[0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical instrument disclosed by Sandy in view of Sokulin to have the medical instrument be a hyperechoic medical instrument, and wherein the medical instrument detection algorithm differentiates between the hyperechoic medical instrument and tissue echoes on a basis of spatiotemporal analysis of sequential image data to detect samples that correspond regions of intensity and motion trajectories consistent with insertion of the medical instrument in the patient anatomy in order to better visualize the instrument as it is inserted into the patient anatomy, as recognized by Arndt ([0031]).
Claim(s) 32-34 and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandy in view of Mauldin et al. (US 20120296213, hereinafter Mauldin).
Regarding claim 32, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach the probe housing comprises electronic components that measure changes in a spatial position of the two or more ultrasound transducer arrays along the patient contact surface or the patient anatomy between image acquisitions.
However,
Mauldin in a similar field of endeavor teaches the probe housing comprises electronic components ([0035] motion tracking circuit 106) that measure changes in a spatial position of the two or more ultrasound transducer arrays along the patient contact surface or the patient anatomy between image acquisitions ([0035] “the motion tracking circuit 106 can use one or more other techniques to determine a relative motion or absolute position of the apparatus 100” which includes the two or more ultrasound transducer arrays, therefore a spatial position of the transducer arrays is measured).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe housing disclosed by Sandy to have the probe housing comprise electronic components that measure changes in a spatial position of the two or more ultrasound transducer arrays along the patient contact surface or the patient anatomy between image acquisitions in order to provide information that can be used is constructing the ultrasound image, thereby making the ultrasound image more accurate, as recognized by Mauldin ([0036]).
Regarding claim 33, Sandy in view of Mauldin teaches the apparatus of claim 32, as set forth above. Mauldin further teaches a processor (the electronic circuitry of apparatus 100 in fig. 1) operative to reconstruct volumetric image data from a series of two-dimensional images with discrete spatial positions as captured by the two or more ultrasound transducer arrays ([0036] “the motion tracking circuit 106 can be used track a location or motion of one or more scanned ultrasonic transducers, such as to provide information for construction of a composite or “mosaic” of depth samples or other imaging information based on received ultrasonic echo information from the transducer during or after it mechanically scanned to two or more locations”. Claim 5 and 7 further discloses the constructed composite image is a three-dimensional image (volumetric) constructed from ultrasound data from a first position and a second position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having a processor reconstruct volumetric image data from a series of two-dimensional images with discrete spatial positions as captured by the two or more ultrasound transducer arrays of Mauldin to the apparatus of Sandy in view of Mauldin to allow for the predictable results of viewing the entire image volume at once without having to flip between different images of the volume, thereby making the analysis of the region more efficient.
Regarding claim 34, Sandy in view of Mauldin teaches the apparatus of claim 33, as set forth above. Mauldin further teaches the volumetric image data are rendered to a graphical display unit (claims 5 and 7 discloses presenting the composite image (volumetric 3D image) to the user via a display).
Regarding claim 38, Sandy teaches the apparatus of claim 1, as set forth above. Sandy does not specifically teach the probe housing further comprises one or more button element located to avoid obstructing a medical instrument insertion trajectory.
However,
Mauldin in a similar field of endeavor teaches the probe housing comprises one or more button element located to avoid obstructing a medical instrument insertion trajectory ([0041], figs. 2A-B show buttons 224A-C which are located on the probe housing an avoid obstructing the medical instrument insertion trajectory shown by instrument 234).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the probe housing comprise one or more button element located to avoid obstructing a medical instrument insertion trajectory of Mauldin to the probe housing of Sandy to allow for the predictable results of being able to adjust a parameter or transfer ultrasonic imaging information from the probe housing itself, thereby eliminating the need for an additional display with user input. Resulting in a more streamlined system.
Regarding claim 39, Sandy in view of Mauldin teaches the apparatus of claim 38, as set forth above. Mauldin further teaches the one or more button element is located to avoid obstructing a visual path to a point at which the medical instrument contacts the patient contact surface or the patient anatomy (figs. 2A-B show the position of the buttons is located to avoid obstructing a visual path to a point at which the medical instrument 234 contacts the patient anatomy).
Regarding claim 40, Sandy in view of Mauldin teaches the apparatus of claim 38, as set forth above. Sandy further teaches the medical instrument is one or more of a needle, a catheter, a trocar, an ablation instrument, a cutting instrument, or a therapy applicator (Abstract, [0003] and figs. 4-6 disclose the instrument is a needle).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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