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 .
Response to Amendment
The amendment filed 09/22/2025 has been entered. Claim 17 has been canceled and new claim 20 has been added. Claims 1-16 and 18-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(a)/(b) rejections previously set forth in the Non-Final Office Action mailed 04/02/2025.
Response to Arguments
Applicant’s arguments with respect to claim 1 and claims dependent therefrom 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 Yamazaki (US5497776) is relied upon for teaching a linear actuator and a curved or angled tunnel or channel.
Applicant argues none of the cited references include a longitudinal slot wherein a motorized linear actuator can be used to move the ultrasound transducer arrays on either side of such a slot.
While this statement is true, cited reference Adams teaches a longitudinal slot (106) and ultrasound transducer arrays (105) positioned on both sides of the slot (106) (Figs. 1-3). Yamazaki and Toume both teach a motorized linear actuator configured to move ultrasound transducers. Therefore, the combination of Adams with Yamazaki and/or Toume would result in an apparatus comprising a longitudinal slot and a motorized linear actuator for moving each of the ultrasound transducer arrays on either side of the longitudinal slot. The invention of Adams (see Figs. 1-3) is similar to the Applicant’s invention (Figs. 1-2) except for the linear actuator and curved/angle tunnel/channel which Yamazaki teaches. Yamazaki further teaches a curved channel/tunnel (113) (Fig. 15). An ordinarily skilled artisan upon modifying the invention of Adams to include a linear actuator for linearly translating the ultrasound transducer arrays to scan a three-dimensional volume and a corresponding tunnel/channel, as taught by Yamazaki, would predictably result in the claimed invention, which is merely the invention of Adams plus a linear actuator and a curved or angled tunnel/channel.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “the one or more linear actuator operably connected to both of the at least two ultrasound transducer arrays using a curved or angled tunnel or channel configured to allow the one or more linear actuator to move the at least two ultrasound transducer arrays disposed on opposing sides of the longitudinal slot”. However, there is no mention in the specification filed 09/22/2022 of anything similar to “a curved or angled tunnel or channel” which the linear actuator uses to move the ultrasound transducer arrays. The drawings, i.e. figure 4, does not show a curved or angled tunnel or channel connected to the linear actuator 401 either. At most, figure 4 shows that the linear actuator includes a piston, rod, or shaft configured to drive movement of the ultrasound transducers. However, this this piston/rod/shaft does not appear to be curved nor angled and is not generally interpreted as a channel or tunnel. Moreover, this piston/rod/shaft structure is an inherent component of linear actuators. Figure 4 also includes another structure, depicted below, above the linear actuator 401 which may be interpreted as a curved channel or tunnel, but does not appear to be angled, and therefore cannot be described as a “curved or angled tunnel or channel”.
PNG
media_image1.png
245
449
media_image1.png
Greyscale
The specification and figures also disclose a needle guide 101 which may be interpreted as a “tunnel or channel”, but there is no mention of how the needle guide 101 is used by the linear actuator for movement of the ultrasound transducer arrays. In addition, there is no mention of the needle guide 101 being curved or angled. It is unclear what exactly is this “curved or angled tunnel or channel” recited in the claim as it does not appear in the specification nor drawings. Therefore, claim 1 contains subject matter which was not described in the specification in such a way as to reasonably convey to one of ordinary skill in the art that the inventors had possession of what is claimed.
Claim 20 recites “wherein the curved or angled tunnel or channel is U-shaped or V-shaped”. However, there is no mention in the specification of any structure being U-shaped or V-shape except for the longitudinal slot. Figure 4 of the drawings show a U-shaped curved tunnel/channel (as shown in the picture pasted above regarding claim 1) but does not show any V-shaped curved/angled tunnel/channel. Therefore, claim 20 contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors had possession of what is claimed.
Claims 2-16 and 18-20 are further rejected by virtue of dependency on rejected claim 1.
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 8 and 12 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 8 recites the limitation "the in-plane guidance for insertion and/or maneuvering of the medical instrument". There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the plurality of first ultrasound transducer array images” and “the plurality of the second ultrasound transducer array images”. There is insufficient antecedent basis for this limitation of the claim. For purposes of examination, it will be interpreted for the plurality of first ultrasound transducer array images to be the plurality of first images acquired from a first ultrasound transducer and for the plurality of the second ultrasound transducer images to be the plurality of second images acquired from a second ultrasound transducer.
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 1-6, 9-10, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki (US5497776).
Regarding claim 1, Adams teaches an apparatus (100) for inserting a medical instrument (102) into a patient anatomy (Fig. 1, [0005], [0045]), the apparatus (100) comprising:
an ultrasound-based imaging dual-array probe (104) comprising at least two ultrasound transducer arrays (105) disposed in a probe housing (104) (Fig. 3A-3B, Claim 1, [0046], “The ultrasound probe housing 104 contains a series of probes (not shown) that generate ultrasound waves to produce images of inside of body of a patient”, [0055-0056], “Ultrasound probe housing 104 contains probes 105 that generate ultrasonic waves… As shown by example in FIG. 3B, the array of probes 105 may be positioned within ultrasound probe housing 104”, wherein the array of probes 105 comprises a left and right array of probes as shown by figures 3A-3B, separated by the longitudinal slot 106 shown in figure 2), the probe housing (104) having a first side (112) and an opposing second side (114), the opposing second side substantially facing the patient anatomy (Figs. 1-2 & 7, [0046]);
a longitudinal slot (106) associated with the probe housing (104) configured such that a tip of the medical instrument (102) is inserted into the longitudinal slot (106) on the first side (112) of the probe housing (104), the tip of the medical instrument (102) passes through the longitudinal slot (106), and the tip of the medical instrument (102) exits the longitudinal slot (106) on the opposing second side (114) of the probe housing (104), and wherein the at least two ultrasound transducer arrays (105) are disposed on opposing sides of the longitudinal slot (106) (Figs. 1-3, [0045-0047]); and
wherein one or more space, cavity, or recess, within or in physical communication with the probe housing (104), includes the at least two ultrasound transducer arrays (105) (Figs. 1-3, [0046], [0056]).
However, Adams fails to teach one or more linear actuator for moving the at least two ultrasound transducer arrays along a line or plane of motion substantially parallel to the longitudinal slot, the one or more linear actuator operably connected to both of the at least two ultrasound transducer arrays using a curved or angled tunnel or channel configured to allow the one or more linear actuator to move the at least two ultrasound transducer arrays disposed on opposing sides of the longitudinal slot, such that the medical instrument is movable within the longitudinal slot, and the at least two ultrasound transducer arrays are moveable, when the medical instrument is inserted into the patient anatomy; and wherein the one or more space, cavity, or recess, within or in physical communication with the probe housing, includes the one or more linear actuator and the curved or angled tunnel or channel.
In an analogous ultrasound probe field of endeavor, Yamazaki teaches such a feature. Yamazaki teaches an ultrasound probe (111) including an ultrasound transducer (112) and a linear actuator (123) (Fig. 15, Column 16 lines 45-49, Column 18 lines 18-25). Yamazaki teaches the linear actuator (123) is connected to the ultrasound transducer (112) via a ball screw (122), flange (121), connectors (115, 117), and a shaft (114) for linearly translating the transducer (112) to perform a three-dimensional scan (Fig. 15, Column 18 lines 18-25). Yamazaki therefore teaches a linear actuator for moving an ultrasound transducer along a line, the linear actuator operably connected to the ultrasound transducer. Moreover, Yamazaki teaches a curved or angled tunnel or channel comprising the sheath (113) of the ultrasound probe (111), the sheath allowing space for the shaft (114) of the linear actuator (112) to linearly translate/move the ultrasound transducer (112) (Fig. 15, Column 16 lines 46-49). Yamazaki therefore further teaches wherein a space, cavity, or recess within or in physical communication with the probe housing, includes a linear actuator and a curved or angled tunnel or channel.
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 invention of Adams to further include a linear actuator connected to the ultrasound transducers and a corresponding curved channel/tunnel as taught by Yamazaki (Fig. 15, Column 16 lines 45-49, Column 18 lines 18-25). The curved channel/tunnel, i.e. sheath 113, may allow space for a shaft of the linear actuator to connect and thus linearly translate the ultrasound transducer as recognized by Yamazaki (Fig. 15). Moreover, the linear actuator allows for three-dimensional scanning as further recognized by Yamazaki (Column 18 lines 18-25). While Yamazaki fails to teach two ultrasound transducer arrays, a longitudinal slot, and a medical instrument, Adams teaches such. The modification of Adams with the teachings of Yamazaki would predictably result wherein the linear actuator is connected to each ultrasound transducer array, configuring them for movement along a line substantially parallel to the longitudinal slot. Since the linear actuator and ultrasound arrays are internal to the probe housing and the medical instrument/longitudinal slot are external, the linear actuator and movement of the ultrasound transducer arrays would not interfere with movement of the medical instrument within the longitudinal slot during operation, i.e. when the medical instrument is inserted into the patient’s anatomy.
Regarding claim 2, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
Adams further teaches wherein the medical instrument (102) is a needle, catheter, or an ablation instrument (Figs. 1-3, [0045], [0047], wherein the medical instrument is a needle 102).
Regarding claim 3, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
Adams further teaches wherein the longitudinal slot (106) acts as a guide for the insertion of the medical instrument (102) ([0045], [0047-0050], [0053], wherein the longitudinal slot 106 being referred to as a “guide channel cut-out or aperture” comprises it acting as a guide for the needle 102).
Regarding claim 4, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach, in the specific embodiment above, wherein the longitudinal slot (106) is a U-shaped slot.
Adams further teaches, in another embodiment, wherein the longitudinal slot may be a U shape cut ([0054], “In another embodiment of the present invention, guide channel cut-out or aperture 106 is a U shape cut at the edge of the ultrasound probe housing 104”).
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 invention of Adams to have the longitudinal slot be U-shaped as taught by Adams’ other embodiment ([0054]). Adams teaches it would be readily apparent, and therefore obvious, to those skilled in the art that various shapes to create the longitudinal slot (106) may be envisioned without deviating from the scope of the invention ([0054]).
Regarding claim 5, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
Adams further teaches the invention further comprising: a needle guide (108) disposed within the longitudinal slot (106), the needle guide (108) providing in-plane or in-line insertion of the medical instrument (102) into the patient anatomy by constraining a location, positioning, or a movement, of the medical instrument (102) relative to the longitudinal slot (106) (Figs. 1-2, 4, & 7, [0045], [0047], [0049], “Needle guide assembly 108 pivotally moves inside the guide channel cut-out or aperture 106 between a vertical setting and a shallow setting”, [0058], “It will be appreciated that examples of guide bearings 402 include but are not limited to 1 or more sliding bearings designed to allow needle 102 to move in the radial direction, restricts the needle from bending on insertion, and maintains the needle position in space”, [0076], Claim 1, “wherein the needle is adapted to slide in the needle guide assembly such that the needle is in a field of view of the array of ultrasound probes upon insertion into the patient”).
Regarding claim 6, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the movement of the at least two ultrasound transducer arrays is configured to generate a three-dimensional image of the patient anatomy.
In an analogous ultrasound probe field of endeavor, Yamazaki teaches such a feature. Yamazaki teaches an ultrasound probe (111) including an ultrasound transducer (112) and a linear actuator (123) (Fig. 15, Column 16 lines 45-49, Column 18 lines 18-25). Yamazaki teaches by linearly moving the ultrasound transducer (112), a three-dimensional scan may be performed (Column 18 lines 18-25). Yamazaki teaches by linearly moving the ultrasound transducer, echo data of a three-dimensional region may be acquired and a three-dimensional image may be displayed (Abstract).
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 invention of Adams to have the linear movement facilitate in generating three-dimensional images of the patient as taught by Yamazaki (Abstract, Column 18 lines 18-25). Three-dimensional images may be more useful for diagnosis and/or guidance as it provides a wider field of view of the patient anatomy as opposed to 2D images.
Regarding claim 9, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the at least two ultrasound transducer arrays are disposed at an angle relative to the patient anatomy.
Adams teaches, in another embodiment, the ultrasound transducer arrays (105) are disposed at an angle relative to the probe (104) to optimize the viewable image at the site of needle penetration beneath the probe (104) (Fig. 3B, [0024], [0056], wherein the site of needle penetration comprises the patient anatomy and therefore the transducers being angled relative to the probe comprises wherein the transducer arrays are disposed at an angle relative to the patient anatomy).
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 invention of Adams to have the ultrasound transducer arrays disposed at an angle relative to the probe and patient anatomy as taught by Adams’ other embodiment (Fig. 3B, [0024], [0056]). The angling of the ultrasound transducer arrays may optimize the viewable image of the insertion of the needle as recognized by Adams ([0056]).
Regarding claim 10, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein a first image from a first ultrasound transducer array of the at least two ultrasound transducer arrays has different imaging properties chosen from at least one of ultrasound frequency, beam angulation, focal depth, pressure amplitude, scanline density, and elevational scan plane, from a second image from a second ultrasound transducer array of the at least two ultrasound transducer arrays.
Adams teaches, in another embodiment, the ultrasound transducer arrays (105) may be positioned within the probe housing to alter the viewable image field, such as by angling the transducer arrays/probes (105) relative to the probe housing (Fig. 3B, [0056]). Adams teaches the ultrasound probe (104) may contain a mixed array of angled and perpendicular probes/transducers (105) to alter viewable image geometries ([0056]). Adams teaches the transducers (105) produce images of the interior of the body of a patient ([0046], [0059]). Because Adams teaches wherein the probe (104) may contain a mixed array of angled and perpendicular transducers (105) to alter viewable image geometries ([0056]), Adams therefore teaches wherein a first image from a first transducer array (i.e., left array) may have a different beam angulation from a second image from a second ultrasound transducer array (i.e., right array). Moreover, figure 3B shows wherein the beam angulation is altered when the transducers (105) are angled. Annotated Fig. 3A shown again below is to distinguish between the first transducer array from the second transducer array.
PNG
media_image2.png
444
358
media_image2.png
Greyscale
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 invention of Adams to have the ultrasound transducer arrays to be a mixed array of angled and perpendicular transducers thereby producing images having different beam angulations as taught by Adams’ other embodiment (Fig. 3B, [0024], [0046], [0056], [0059]). The angling of the ultrasound transducer arrays may optimize the viewable image of the insertion of the needle and perpendicular transducers may give a wider viewable image area as recognized by Adams ([0056]). Adams further states that those skilled in the art that various types and shapes of the probe (104) containing the transducers (105) may be envisioned without deviating from the scope of the invention ([0056]).
Regarding claim 18, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
Adams further teaches wherein the patient anatomy is one or more of: an anatomical region containing a lumbar spine, an anatomical region containing a thoracic spine, an anatomical region containing a cervical spine, an anatomical region containing one or more ribs, or an anatomical region containing a hip (Fig. 7, [0071-0072], wherein the ultrasound probe (104) being placed on the back of the patient (700) to perform a procedure on the spine (702) as shown in figure 7 comprises the anatomical region containing a lumbar and/or thoracic spine).
Regarding claim 19, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
Adams further teaches wherein the patient anatomy is one or more of: a bone, a cartilage, a nerve, a tendon, a ligament, a connective tissue, a joint, a muscle, a blood vessel, a kidney, a liver, a breast, or a lymph node (Fig. 7, [0071-0072], wherein figure 7 clearly shows insertion of a needle 102 into the patient’s spine, the patient’s spine comprising one or more of: a bone and/or nerves).
Regarding claim 20, Adams in view of Yamazaki fails to teach the invention as claimed above in claim 1.
However, Adams fails to teach wherein the curved or angled tunnel or channel is U-shaped or V-shaped.
While Adams fails to teach such a feature, this U-shaped or V-shaped design is a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration/shape of the claimed tunnel/channel is significant. See MPEP § 2144.04 B. Changes in Shape and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki (US5497776) as applied to claim 6 above, and further in view of Toume (US20190365348).
Regarding claim 7, Adams in view of Yamazaki teaches the invention as claimed above in claim 6.
However, Adams fails to teach the invention further comprising: a locking mechanism for securing the at least two ultrasound transducer arrays in a home position, wherein when the at least two ultrasound transducer arrays are in the home position, the at least two ultrasound transducer arrays are configured to generate a two-dimensional image of the patient anatomy.
In an analogous ultrasound device field of endeavor, Toume teaches such a feature. Toume teaches the ultrasound measurement apparatus (200) may include a plurality of ultrasound transducers and that an ultrasound transducer (230) may comprise an array of ultrasonic transducer elements (14) ([0191]). Toume teaches a system (700) including a housing (708) which includes therein an ultrasound transducer (704), and a cradle (706) that is coupled to the housing (708) (Fig. 7, [0203]). Toume teaches the cradle (706) adheres to the skin of the patient ([0206]). Toume teaches the housing (708) includes a linear motion mechanism (712) that adjusts the linear position of the housing (708) relative to the cradle (706) ([0207], wherein adjusting the linear position of the housing comprises moving the ultrasound transducer 704). Toume teaches the linear motion mechanism (714) is implemented by an elongated slot (826) of the cradle (806) and a securing element or screw (811) of a securing mechanism (711) ([0236], [0281]). Toume teaches the securing mechanism (711) or screw (811) secures the housing (708) within cradle (706) at a certain linear displacement ([0209-0210], [0281-0282]). Toume teaches setting the linear motion mechanism according to a selected linear displacement of the ultrasound transducer and/or housing relative to the suprasternal notch of a patient/cradle ([0288]). Toume teaches at a step 1004, screws may be inserted within an elongated slot of the cradle and tightened to secure the set displacement ([0288]). Toume then teaches at a step 1008, ultrasound images may be captured ([0291]). Toume teaches the image captured represents a two dimensional slice at a certain orientation, which may be used for 3D image reconstruction ([0293]). Toume therefore teaches a locking mechanism (e.g. screw), which may lock the transducer in any defined home position and wherein the ultrasound transducer is configured to generate two-dimensional images at a home position.
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 invention of Adams to include a locking mechanism such as a screw for locking/securing a linear displacement of the ultrasound transducers as taught by Toume ([0191], [0209-0210], [0281-0282], [0288], [0291], [0293]). By using a locking mechanism, inadvertent movement of the transducer may predictably be prevented, thereby maintaining a desired position of the transducer for imaging a desired region of interest. Moreover by generating a two-dimensional image, the anatomy/region of interest may predictably be visualized by a user, assisting in insertion and the surgical procedure. The two dimensional image may also be used in 3D image reconstruction as recognized by Toume ([0293]). Examiner further notes claim 7 is directed towards a device/apparatus rather than a method, therefore only structure, which may allow for certain uses, may be claimed. Toume therefore teaches a locking mechanism which is configured to secure the ultrasound transducer arrays to a home position, and wherein when the ultrasound transducers arrays are at the home position, the ultrasound transducer arrays are configured to generate two-dimensional images. Adams which teaches imaging the insertion of a needle and two ultrasound transducer arrays, modified by the teachings of Toume, would predictably result in including a locking mechanism which may secure the two transducer arrays to a home position and generate a two-dimensional images of the patient anatomy when secured to the home position.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki ‘776 (US5497776) and Toume (US20190365348) as applied to claim 7 above, and further in view of Yamazaki ‘899 (US6336899).
Regarding claim 8, Adams in view of Yamazaki ‘776 and Toume teaches the invention as claimed above in claim 7.
However, Adams fails to teach wherein the in-plane guidance for insertion and/or maneuvering of the medical instrument includes an overlap of the three-dimensional image and the two-dimensional image of the patient anatomy.
In an analogous ultrasound-based image guidance for insertion of an instrument field of endeavor, Yamazaki ‘899 teaches such a feature. Yamazaki ‘899 teaches an ultrasound probe (1) having a transducer array, a needle (100), and a needle holder (101) (Fig. 2, Column 6 line 32 – Column 7 line 4). Yamazaki ‘899 teaches constructing a 3D image which includes a 2D tomographic image (Column 7 lines 35-39). Yamazaki ‘899 teaches incorporating and overlapping a 2D tomographic image (IM3) with a 3D image (IM2) (Figs. 17A & 19B, Column 12 line 58 – Column 13 line 10, Column 15 lines 18-26, “the 2D tomographic image IM3 on the vertical cross section A passing through the tip part of the paracentetic needle 100 is overlapped with and displayed in the 3D projection image IM2”).
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 invention of Adams to overlap a 2D tomographic image slice with a 3D image as taught by Yamazaki ‘899 (Figs. 17A & 19B, Column 12 line 58 – Column 13 line 10, Column 15 lines 18-26). By overlapping the 2D image and 3D image, in-plane guidance may be provided and a user may know the location of objects within the 2D image, such as the needle, relative to anatomy pictured in the 3D image.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki (US5497776) as applied to claim 1 above, and further in view of Sandy (US20140187945).
Regarding claim 11, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach the invention further comprising one or more computer processors operative to assist with generating and/or acquiring imaging of the patient anatomy, including generating a first image from a first ultrasound transducer array of the at least two ultrasound transducer arrays and a second image from a second ultrasound transducer array of the at least two ultrasound transducer arrays and combining the first image and the second image to construct a composite two-dimensional ultrasound image of the patient anatomy.
In an analogous ultrasound-based image guidance for insertion of an instrument field of endeavor, Sandy teaches such a feature. Sandy teaches an ultrasound probe (10) for ultrasound guided interventional procedures including regional anesthesia (Figs. 4-6, [0001], [0042]). Sandy teaches the probe (10) comprises a twin array or pair of one dimensional ultrasound transducer arrays (1, 2) (Claim 2, [0042], [0044-0045], [0049], [0053], wherein the twin array comprises a first and second ultrasound transducer array). Sandy teaches each array of the twin array captures a standard B-mode image (Claim 6, [0028], wherein a standard B-mode image comprises a 2D image). Sandy teaches by using the images provided by the twin arrays, a processor forms one cohesive image (21) by overlapping and covering the extent of the acoustic beam width of the probe (Fig. 7, Abstract, Claims 4 & 6, [0028], [0049], wherein cohesive image 21 comprises a composite two-dimensional ultrasound image of the patient anatomy). As shown in figures 7 & 8, the combined view or cohesive image (21) is a 2D image (XY/ZY plane).
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 invention of Adams to include a processor for constructing a cohesive image by combining images from the first and second ultrasound transducer arrays as taught by Sandy (Figs. 1-8, Abstract, Claims 4 & 6, [0028], [0049]). By combining the images to form a cohesive or composite image, a full ultrasound image having a wider (combined) field of view that covers the extent of the acoustic beam width may be produced as recognized by Sandy (Fig. 7, [0045], [0049]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki (US5497776) as applied to claim 1 above, and further in view of Lazebnik (US20110125022).
Regarding claim 12, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach the invention further comprising one or more computer processors operative to assist with generating and/or acquiring imaging of the patient anatomy, including generating a plurality of first images and a plurality of second images from the at least two ultrasound transducer arrays as they are linearly translated along an axis by the one or more linear actuator, the one or more computer processors constructing a three-dimensional ultrasound image based on the plurality of first ultrasound transducer array images and the plurality of the second ultrasound transducer array images.
In an analogous ultrasound scanning using two ultrasound transducer arrays field of endeavor, Lazebnik teaches such a feature. Lazebnik teaches a system (10) including two or more transducers (12, 16) (Fig. 1, [0021]). Lazebnik teaches the two transducers (12 ,16) are wobbler arrays comprising an array of transducer elements ([0023]). Lazebnik teaches the arrays may be used to scan a region, and a motor may drive to move and translate the arrays along a plane ([0023], wherein the motor comprises a linear actuator). Lazebnik teaches different planes may be scanned by moving the array via translation ([0025]). Lazebnik teaches the different transducers (12, 16) may be translatable about the same or different dimensions ([0035]). Lazebnik teaches in act 44, one of the arrays may be used for scanning, and the transducer may be translated to scan different planes ([0074], wherein scanning different planes comprises generating a plurality of images). Lazebnik teaches in act 50, another array may start scanning once the first array is finished scanning ([0084]). Lazebnik teaches the same scan format may be used for the other array ([0085]). Moreover, Lazebnik teaches wherein simultaneous scanning may be used instead of sequential scanning ([0043]). Lazebnik therefore teaches generating a plurality of first and second images from two transducer arrays as they are linearly translated by a motor/linear actuator. Lazebnik further teaches the separate transducers (12, 16) generate separate images, and the data (images) may be combined into a set of data that represents a scan volume ([0044]). Lazebnik teaches constructing a composite volume using the data (images) from the two transducers (Abstract, [0045], [0087-0089], wherein the composite volume comprises a three-dimensional ultrasound image based on the plurality of first transducer array images and the second transducer array images). Lazebnik teaches multiple transducers with overlapping fields of views may be used for compounding a volume representing an extended/expanded field of view (Abstract, [0013-0014], [0042-0045, [0087]). Lazebnik teaches the dataset representing the composite volume may be output as image data for display ([0058], [0088]). Moreover, Lazebnik teaches a processor (20) configured to perform the methods described herein ([0007], [0066]).
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 invention of Adams to include a processor operative to translate the two ultrasound transducers to scan different imaging planes, thereby generating a plurality of images and a volume from both transducers, and to construct a composite volume as taught by Lazebnik ([0007], [0023], [0025], [0042-0045], [0058], [0066], [0074], [0087-0089]). Adams in view of Yamazaki modified by the teachings of Lazebnik would predictably result in constructing a composite three-dimensional image from a plurality of images generated from a first and second transducer during linear translation. Lazebnik teaches two ultrasound transducers (12, 16) may generate separate images, combine the separate images to form separate volumes, and constructing a composite volume from the volume data acquired by the two transducers ([0042-0045]). By constructing a composite volume from two ultrasound transducers, a larger (expanded/extended) field of view may be predictably obtained than that of a single transducer as recognized by Lazebnik (Abstract, [0013-0014], [0044-0045], [0087-0088]). Moreover, an array of transducers scanning overlapping regions may be used to reduce speckle and shadowing as further recognized by Lazebnik ([0015-0016], [0088]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki (US5497776) as applied to claim 1 above, and further in view of Zheng (US20220280244).
Regarding claim 13, Adams in view of Yamazaki teaches the invention as claimed above in claim 1.
However, Adams fails to teach the invention further comprising: a mounting assembly such that the apparatus is mounted to an adjustable mechanical holding arm allowing for hands-free adjustment of a position of the apparatus relative to the patient.
In an analogous ultrasound probe field of endeavor, Zheng teaches such a feature. Zheng teaches a system (1300) including a moveable cart (1390), a display (1310), and a mechanical holding arm (1340) configured to hold and move an ultrasound probe (1320 (Fig. 18, [0183-0184], [0186-0187], wherein actuator 1340 comprises a mounting assembly and an adjustable mechanical holding arm). Zheng teaches the mechanical holding arm/actuator (1340) is operable to move the ultrasound probe relative to a treatment zone of a subject (Abstract, [0006], [0072]). Zheng teaches a control unit (1304) is configured to move the ultrasound probe (1320; imaging device 1306) with the actuator ([0191]). Zheng teaches the control unit may control the position/motion of the imaging device/probe without the need for direct operator control of the imaging device/probe ([0182], wherein without direct operator control comprises hands-free). Moreover, Zheng teaches wherein the mechanical holding arm (1340) may be a robotic arm (1342) having 6 degrees of freedom and coupled to the moveable cart (1390) (Fig. 18, [0186], [0191]).
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 invention of Adams to use an actuator or robotic arm to hold and move the ultrasound probe as taught by Zheng (Fig. 18, [0182-0187], [0191]). By using an actuator or robotic arm, direct operator control may predictably not be required for moving the ultrasound probe as recognized by Zheng ([0182]).
Regarding claim 14, Adams in view of Yamazaki and Zheng teaches the invention as claimed above in claim 13.
However, Adams fails to teach wherein the adjustable mechanical holding arm is attached to a cart.
In an analogous ultrasound probe field of endeavor, Zheng teaches such a feature. Zheng teaches a system (1300) including a moveable cart (1390) (Fig. 18, [0184], [0186]). Zheng teaches an actuator (1340) comprising a robotic arm (1342) may be coupled to the moveable cart (1390) (Fig. 18, [0184], [0186], [0191]).
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 invention of Adams to couple the robotic arm to a moveable cart as taught by Zheng (Fig. 18, [0184], [0186], [0191]). By coupling the robotic arm to the moveable cart, the robotic arm may predictably be moveable with the moveable cart as recognized by Zheng ([0191]). As such, the robotic arm may be easily moved and moved with the cart.
Regarding claim 15, Adams in view of Yamazaki and Zheng teaches the invention as claimed above in claim 13.
However, Adams fails to teach wherein the adjustable mechanical holding arm is at least one of self-balancing and robotically-controlled.
In an analogous ultrasound probe field of endeavor, Zheng teaches such a feature. Zheng teaches a system (1300) including an actuator (1340) (Fig. 18, [0183-0184]). Zheng teaches the actuator (1340) may comprise a robotic arm (1342) (Fig. 18, [0186], [0191]). Moreover, Zheng teaches wherein a control unit (1304) is configured to move an ultrasound probe (1320) with the actuator (1340) including the robotic arm (1342) coupled to the probe (1320) (Fig. 18, [0182], [0187], [0191], [0193]). Zheng therefore teaches wherein the mechanical holding arm is robotically-controlled.
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 invention of Adams to use a robotically controlled arm as taught by Zheng (Fig. 18, [0186], [0191], [0193]). By using a robotically controlled arm, the arm may be automatically controlled to move an ultrasound probe as recognized by Zheng ([0191], [0193]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20200397399) in view of Yamazaki (US5497776) and Zheng (US20220280244) as applied to claim 13 above, and further in view of Hörndler (US20160319986) and Cannata (US20200164231).
Regarding claim 16, Adams in view of Yamazaki and Zheng teaches the invention as claimed above in claim 13.
Adams teaches the invention further comprising a monitor (610) (Figs. 6-7, [0066], [0069-0070], [0072], [0074]).
However, Adams fails to teach wherein both the adjustable mechanical arm and the monitor are positionally adjustable about the cart to orient the apparatus and monitor in various relative positions for a medical instrument guidance procedure.
In analogous ultrasound imaging fields of endeavor, Hörndler and Cannata teaches such a feature. Hörndler teaches an adjustable monitor bracket for a flat panel display of a mobile diagnostic device (Title, Abstract, [0003]). Hörndler teaches in ultrasound diagnostics, mobile diagnostic devices are known that comprise a monitor that allow an operator to view images ([0005]). Hörndler teaches a mobile diagnostic device (1) including a monitor bracket (15) (Fig. 1, [0022], wherein mobile diagnostic device 1 comprises a cart). Hörndler teaches the monitor bracket (15) comprises a shoulder joint (3), a first arm (5), an elbow joint (7), a second arm (9), and a hand joint (17) with a support plate (19) configured to hold a flat panel display (12) (Fig. 1, [0022-0024]). As shown in figure 1 and disclosed in ¶ [0022-0024], a plurality of pivots and rotations about an axis/direction may be performed by the bracket to reposition the flat panel display (12) relative to the cart (1) (Fig. 1, [0022-0024]).
Moreover, Cannata teaches a system (100) including an ultrasound imaging system (104) coupled to a cart (110) (Figs. 1A-1B, [0008], [0094-0095]). Cannata further teaches a robotic positioning arm (108) coupled to the cart (110) and the imaging system (104) (Fig. 1A, [0094]). Cannata teaches the robotic arm may comprise 6 degrees of freedom ([0169]). Canna teaches the robotic arm may comprise even further degrees of freedom that allow the robotic arm supporting base height to be adjusted up or down, allowing the position of the robotic arm to be modified relative to the cart ([0169]). Therefore, Hörndler and Cannata teach wherein both an adjustable mechanical arm and a monitor may be positionally adjustable about a cart to orient an imaging apparatus and a monitor in various relative positions.
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 invention of Adams to have the adjustable mechanical arm and monitor be positionally adjustable about the cart as taught by Hörndler (Fig. 1, [0022-0024]) and Cannata (Fig. 1A, [0094], [0169]). Having both the arms and monitor be positionally adjustable predictably improves maneuverability of the cart and its accessories (arm and monitor). Improved maneuverability may predictably make the cart more easily transportable and also adaptable to various surgical scenarios.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571)272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797