DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 62/933,216 filed November 8, 2019 and U.S. Non-Provisional App. Nos. 16/268,819 and 16/268,909 filed February 6, 2019.
Status of Claims
This Office Action is responsive to the claims filed on 05/28/2025. Claims 1, 19, and 22 have been amended. Claims 1-23 are presently pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 9, 10, 19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar (US 8585584) in view of Fowler (US 20100081875) and Munrow (US 9861336 B2).
Regarding claim 1, Ratnakar teaches an integrated visual and ultrasound device (Col. 2, ln. 64-67; an endoscopic system that provides both forward and rear view) comprising:
an ergonomic handle (Col. 5, ln. 50-Col. 6, ln. 3; It has a handle (4), Fig. 1) configured for grasping by hand (Col. 5, ln. 50-Col. 6, ln. 3; The handle (4) of the endoscope has a grip (16), Fig. 1) and having proximal (Col. 5, ln. 50-Col. 6, ln. 3; portion of the handle with the grip 16), Fig. 1) and distal portions (Col. 5, ln. 50-Col. 6, ln. 3; a handle (4) from which extends a flexible shaft (1); The portion from which the shafts extends is considered the distal portion, Fig. 1);
a cannula extending distally from the distal portion of the handle (Col. 5, ln. 50-Col. 6, ln. 3; a handle (4) from which extends a flexible shaft (1), Fig. 1) and having a distal portion extending along a longitudinal axis (Claim 1; a shaft extending along a longitudinal axis) and ending at a distal end (Col. 10, ln. 64-Col. 11, ln. 11; the distal end (14) of the endoscope, Fig. 14);
a distally facing camera (Col. 5, ln. 50-Col. 6, ln. 3; image lens (20) captures images of the illuminated area; Figs. 2 and 14) secured at the distal portion of the cannula (Col. 5, ln. 50-Col. 6, ln. 3; shaft terminates in the distal end (14), which typically houses one image lens (20); Figs. 2 and 14) and having a camera field of view (FOV) encompassing a selected solid angle (Col. 2, ln. 4-19; present endoscopes also have a narrow field of vision with an angle of vision of about 120 degrees) and a camera direction of view (DOV) (Claim 1; a first lens selectively fixedly positioned adjacent to the distal end of the shaft for receiving a first image in a first direction, the first direction generally being forward and parallel to the longitudinal axis of the shaft and the first image generally being a circumferential view of the hollow organ);
an probe (Col. 10, ln. 64-Col. 11, ln. 11; rear view module (51), Fig. 14) having a probe longitudinal axis (Col. 10, ln. 64-Col. 11, ln. 11; forward direction (140) Fig. 14), said probe includes a probe head protruding distally from the distal portion of the cannula (Col. 10, ln. 35-37 and Col. 10, ln. 64-Col. 11, ln. 11; moves the rear view module (51) away from and towards the support arm (130), Figs. 14-16) for both rotation about said probe longitudinal axis and relative to the distal portion of the cannula (Col. 10, ln. 64-Col. 11, ln. 11; the support arm can be rotated (160) as shown in FIG. 16; Fig. 16 shows the rotation is relative to the distal portion 14) and for tilting relative to said distal portion of the cannula (Col. 10, ln. 64-Col. 11, ln. 11; The rear view module (51) can be lifted from (150) and retracted towards the support arm (130), Fig. 15);
a probe steering mechanism (Col. 6, ln. 4-11; actuators (18), Fig. 1) positioned at the proximal end of the handle (Fig. 1 shows the actuators are connected to the grip portion 16 which is the proximal end) and operatively coupled with the probe head to selectively tilt the probe head (Col. 10, ln. 22-37; The distal end (132) of the rear view module is attached to the support arm (130) by a hinge joint or any other suitable mechanical articulation. It is also connected to a rear view module actuator by cables; Col. 10, ln. 64-Col. 11, ln. 11; rear view module (51) can be lifted… using the rear view module actuator, Fig. 15) in at least two directions relative to said probe longitudinal axis over a selected angular range (Col. 10, ln. 64-Col. 11, ln. 11; The rear view module (51) can be lifted from (150) and retracted towards the support arm (130); lifted away from and toward the support arm is considered to be two directions); and
a probe rotation mechanism mounted at the proximal end of the handle (Col. 6, ln. 4-11; actuators (18), Fig. 1; Fig. 1 shows the actuators are connected to the grip portion 16 which is the proximal end) and operatively coupled with the ultrasound probe (Col. 5, ln. 22-28; The rear view module is deployed using an actuator; Col. 10, ln. 22-37; support arm (130) also serves as an extension arm that can be extended, retracted and rotated, Fig. 16) to selectively rotate the ultrasound probe about said axis relative to the cannula (Col. 10, ln. 64-Col. 11, ln. 11; In addition, the support arm can be rotated (160) as shown in FIG. 16).
Ratnakar does not explicitly teach the probe comprises an ultrasound probe; and
the probe head having an ultrasound transducer oriented for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head.
Fowler, however, teaches an integrated visual and ultrasound device (Paragraph [0012]; a system and single or multi-functional element insertable instrument… to provide access to the site from multiple and different orientations/perspectives as the procedure dictates) comprising an ultrasound probe (Paragraph [0056]; an instrument or device that provides a desired functionality with regard to the minimal access procedure; e.g., a data acquisition device, such as a camera element, a sensor, an ultrasound probe; Paragraph [0097]; ultrasound for diagnosis, imaging, guidance or treatment; Paragraph [0087]; comprising a camera module 4 and a pan/tilt platform 15 that can be rotated in various directions to control the pan 13 and tilt 14 of the instrument, Fig. 7) having a probe longitudinal axis (Paragraph [0095]; be movable on one or more of the following: a pan axis, a tilt axis, a translation axis and a zoom axis; The forward translation direction is considered to be a longitudinal axis), said ultrasound probe includes a probe head protruding distally from the distal portion of the cannula (Paragraph [0087]; comprises an external end 2 comprising one or more orifices 5 for receiving instruments and an insertion end 3 comprising a camera module 4, Figs. 2-4 shows the camera module protruding through the distal end of the trocar section.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Ratnakar to have included an ultrasound probe as taught by Fowler because it would have been a known element for imaging (Fowler, Paragraph [0097]) that would have given an alternative method of viewing and tracking an object in the field of view.
Together Ratnakar and Fowler fail to teach the probe head having an ultrasound transducer oriented for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head.
Munrow, however, teaches an ultrasound device (Col. 9, ln. 14-42; a system 10… includes an imaging transducer 20, Fig. 3; Col. 17, ln. 1-14; an ultrasound data stream from the on-board imaging transducer provides both the normal image) comprising a cannula (Col. 10, ln. 14-33; imaging shaft 44, Fig. 2) extending distally from the distal portion of the handle and having a distal portion extending along a longitudinal axis and ending at a distal end (Col. 10, ln. 14-34; imaging component 28 comprises a handle portion 29, Fig. 3; Fig. 3 shows the imaging shaft extending from the distal end of the handle and ending at a distal end); and
an ultrasound probe (Col. 9, ln. 14-42; imaging transducer 20) having a probe longitudinal axis (Fig. 3 shows the imaging transducer is aligned along an axis of the probe 16.; Col. 14-25; axis line AL), said ultrasound probe includes a probe head protruding distally from the distal portion of the cannula (Fig. 3 shows the imaging transducer 20 protruding distally from the distal portion of the imaging shaft 44) for tilting relative to said distal portion of the cannula (Col. 12, ln. 56-Col. 13, ln. 6; to deflect the transducer 20 (as shown in broken line in FIG. 3)), the probe head having an ultrasound transducer orientated for side view imaging (Figs. 3 and 9 shows the imaging face of the imaging transducer is oriented to the side) where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head (Col. 14, ln. 18-25; the imaging transducer 20 deployed to image the fibroid within a field of view indicated by the broken lines.; Fig. 9 shows the imaging transducer images in a one direction that is at an angle relative to a longitudinal axis of the transducer 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the orientation of the probe head of Ratnakar in view of Fowler to have been orientated for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head as taught by Munrow because it would have improved imaging of tissue walls and viewing treatment needles and objects deployed to the tissues walls of the patient as well as the boundaries of treatment areas (Col. 14, ln. 43-67). Furthermore, the orientation allows the safety boundaries to be set relative to the actual position of the needle shaft which can be tracked by the system using the image of the shaft in tissue and proper viewing of the treatment area to ensure effective treatment (Col. 16, ln. 10-35).
Regarding claim 2, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Ratnakar further teaches the cannula further comprises at least one lumen (Col. 5, ln. 29-37; A rear instrument channel is provided in the present invention; Col. 11, ln. 12-28; main instrument channel (25) of the endoscope, Figs. 2 and 13-16 ) and further including a shaft connecting the probe steering mechanism and the ultrasound probe (Col 11, ln. 12-28; It has a shaft that comprises of a distal end (170); The bending section of the rear view module is connected to a rear view module actuator by cables) and configured to tilt the probe relative to said distal portion of the cannula (Col 11, ln. 12-28; The bending section of the rear view module is connected to a rear view module actuator by cables. Tension on these cables moves the bending section in vertical and horizontal planes), wherein said shaft is received in said at least one lumen (Col 11, ln. 12-28; This entire assembly is thin enough to pass through the main instrument channel (25) of the endoscope).
Regarding claim 9, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Ratnakar does not explicitly teach said cannula is flexible and bends when inserted into a patient's bladder or ureter.
Fowler, however, further teaches said cannula is flexible and bends (Paragraph [0049]; any portion or element of the surgical devices of the present invention (including the trocar and any part of the insertable instrument) may be rigid or flexible,) when inserted into a patient's bladder or ureter (Paragraph [0050]; may be the anatomical structure of a subject, such as a patient's heart, lungs, esophagus, stomach, intestines, thoracic cavity, abdominal cavity, blood vessels, ducts, vagina, bladder, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow to have been flexible and bends when inserted into a patient's bladder or ureter as taught by Fowler because it would have allowed providing images of a site for use in connection with minimally invasive surgical procedures (Fowler, paragraph [0050]).
Regarding claim 10, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Ratnakar further teaches including an ultrasound image processor operatively coupled with said ultrasound probe and an ultrasound image display configured to display ultrasound images provided by said ultrasound probe and processed by said ultrasound processor, and a camera image processor (Col. 5, ln. 50-Col.6, ln. 3; , the image is converted to a video signal and is then transmitted to an image processor by an electrical cable) and a camera image display configured to display images provided by said camera and processed by said camera image processor (Col. 5, ln. 50-Col.6, ln. 3; image is processed and displayed on a display unit like a computer monitor (not shown).).
Ratnakar does not explicitly teach including an ultrasound image processor operatively coupled with said ultrasound probe and an ultrasound image display configured to display ultrasound images provided by said ultrasound probe and processed by said ultrasound processor.
Fowler, however, further teaches including an ultrasound image processor operatively coupled with said ultrasound probe and an ultrasound image display configured to display ultrasound images provided by said ultrasound probe and processed by said ultrasound processor (Paragraph [0079]; driving device may also include an image processor/display adaptor, which receives data from at least one insertable instrument and converts image data received from the camera elements or sensors into a signal suitable for displaying the image on a monitor; Paragraph [0097]; ultrasound for diagnosis, imaging, guidance or treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Ratnakar in view of Fowler and Munrow to have further included an ultrasound image processor operatively coupled with said ultrasound probe and an ultrasound image display configured to display ultrasound images provided by said ultrasound probe and processed by said ultrasound processor as taught by Fowler because it would have further allowed for imaging, diagnosis, and guidance using known ultrasound techniques (Paragraphs [0056] and [0097]).
Regarding claim 19, Ratnakar teaches a medical device (Col. 2, ln. 64-67; an endoscopic system that provides both forward and rear view) comprising:
an elongated shaft (Col 11, ln. 12-28; It has a shaft that comprises of a distal end (170); The bending section of the rear view module is connected to a rear view module actuator by cables) having a distal portion (Col. 11, ln. 12-28; Rear image lens (52) and rear illumination bulb (53) are placed on the distal end (170), Fig. 17) extending along a longitudinal axis (Col. 10, ln. 64-Col. 11, ln. 11; forward direction (140) Fig. 14) and a proximal portion (proximal section, Fig. 17), wherein the shaft is shaped and dimensioned for insertion into a sheath or a working channel of an endoscope cannula (Col. 11, ln. 12-28; This entire assembly is thin enough to pass through the main instrument channel (25) of the endoscope.) configured for insertion into a patient (Col. 1, ln. 29-Col. 2, ln. 3; Endoscope is typically inserted into the patient either thorough a natural body orifice);
an probe head (Col. 10, ln. 64-Col. 11, ln. 11; rear view module (51), Fig. 14) that is at the distal portion of the shaft (Col. 11, ln. 12-28; rear view module (51)… has a shaft that comprises of a distal end (170)) and is configured to protrude from a distal end of the sheath or cannula (Col. 11, ln. 12-28; This entire assembly is thin enough to pass through the main instrument channel (25) of the endoscope.) and to provide images (Col. 10, ln. 38-45; It is used to pass surgical instruments to do various surgical procedures in areas under view of the rear image lens (52));
a housing secured to the proximal portion of the shaft (Col. 11, ln. 12-28; shaft is attached proximally to a handle… that connects the rear view module (51) to an image processor and a power source);
a probe rotation mechanism mounted on or in the housing (Col. 6, ln. 4-11; actuators (18), Fig. 1; Fig. 1 shows the actuators are connected to the endoscope handle portion 16) and operatively coupled with the shaft (Col. 5, ln. 22-28; The rear view module is deployed using an actuator; Col. 10, ln. 22-37; support arm (130) also serves as an extension arm that can be extended, retracted and rotated, Fig. 16) to rotate the shaft (Col. 10, ln. 64-Col. 11, ln. 11; In addition, the support arm can be rotated (160) as shown in FIG. 16) and thus the probe head about said axis over a selected rotation angular range (Col. 10, ln. 64-Col. 11, ln. 11; the support arm can be rotated (160) as shown in FIG. 16; Fig. 16 shows the rotation is relative to the distal portion 14); and
a probe steering mechanism mounted on or in the housing and operatively coupled with the ultrasound probe head such that when the ultrasound probe head protrudes from the distal end of the sheath or cannula the probe steering mechanism can tilt the ultrasound probe head in at least two directions relative to the longitudinal axis over a selected tilting angle range.
Ratnakar does not explicitly teach the probe comprises an ultrasound probe and provides ultrasound images; and
the probe head having an ultrasound transducer oriented for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head.
Fowler, however, teaches an integrated visual and ultrasound device (Paragraph [0012]; a system and single or multi-functional element insertable instrument… to provide access to the site from multiple and different orientations/perspectives as the procedure dictates) comprising an ultrasound probe (Paragraph [0056]; an instrument or device that provides a desired functionality with regard to the minimal access procedure; e.g., a data acquisition device, such as a camera element, a sensor, an ultrasound probe; Paragraph [0097]; ultrasound for diagnosis, imaging, guidance or treatment; Paragraph [0087]; comprising a camera module 4 and a pan/tilt platform 15 that can be rotated in various directions to control the pan 13 and tilt 14 of the instrument, Fig. 7) having a probe longitudinal axis (Paragraph [0095]; be movable on one or more of the following: a pan axis, a tilt axis, a translation axis and a zoom axis; The forward translation direction is considered to be a longitudinal axis), said ultrasound probe includes a probe head protruding distally from the distal portion of the cannula (Paragraph [0087]; comprises an external end 2 comprising one or more orifices 5 for receiving instruments and an insertion end 3 comprising a camera module 4, Figs. 2-4 shows the camera module protruding through the distal end of the trocar section.); and
providing ultrasound images (Paragraph [0079]; driving device may also include an image processor/display adaptor, which receives data from at least one insertable instrument and converts image data received from the camera elements or sensors into a signal suitable for displaying the image on a monitor; Paragraph [0097]; ultrasound for diagnosis, imaging, guidance or treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Ratnakar to have included an ultrasound probe as taught by Fowler because it would have been a known element for imaging (Fowler, Paragraph [0097]) that would have given an alternative method of viewing and tracking an object in the field of view and it would have further allowed for imaging, diagnosis, and guidance using known ultrasound techniques (Paragraphs [0056] and [0097]).
Together Ratnakar and Fowler fail to teach the probe head having an ultrasound transducer oriented for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head.
Munrow, however, teaches an ultrasound device (Col. 9, ln. 14-42; a system 10… includes an imaging transducer 20, Fig. 3; Col. 17, ln. 1-14; an ultrasound data stream from the on-board imaging transducer provides both the normal image) comprising a cannula (Col. 10, ln. 14-33; imaging shaft 44, Fig. 2) extending distally from the distal portion of the handle and having a distal portion extending along a longitudinal axis and ending at a distal end (Col. 10, ln. 14-34; imaging component 28 comprises a handle portion 29, Fig. 3; Fig. 3 shows the imaging shaft extending from the distal end of the handle and ending at a distal end); and
an ultrasound probe (Col. 9, ln. 14-42; imaging transducer 20) having a probe longitudinal axis (Fig. 3 shows the imaging transducer is aligned along an axis of the probe 16.; Col. 14-25; axis line AL), said ultrasound probe includes a probe head protruding distally from the distal portion of the cannula (Fig. 3 shows the imaging transducer 20 protruding distally from the distal portion of the imaging shaft 44) for tilting relative to said distal portion of the cannula (Col. 12, ln. 56-Col. 13, ln. 6; to deflect the transducer 20 (as shown in broken line in FIG. 3)), the probe head having an ultrasound transducer orientated for side view imaging (Figs. 3 and 9 shows the imaging face of the imaging transducer is oriented to the side) where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head (Col. 14, ln. 18-25; the imaging transducer 20 deployed to image the fibroid within a field of view indicated by the broken lines.; Fig. 9 shows the imaging transducer images in a one direction that is at an angle relative to a longitudinal axis of the transducer 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the orientation of the probe head of Ratnakar in view of Fowler to have been orientated for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head as taught by Munrow because it would have improved imaging of tissue walls and viewing treatment needles and objects deployed to the tissues walls of the patient as well as the boundaries of treatment areas (Col. 14, ln. 43-67). Furthermore, the orientation allows the safety boundaries to be set relative to the actual position of the needle shaft which can be tracked by the system using the image of the shaft in tissue and proper viewing of the treatment area to ensure effective treatment (Col. 16, ln. 10-35).
Regarding claim 21, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 19 as noted above.
Ratnakar further teaches said shaft is shaped and dimensioned for insertion into a working channel of an endoscope (Col. 1, ln. 29-Col. 2, ln. 3; Endoscope is typically inserted into the patient either thorough a natural body orifice) that has a camera at a distal end thereof a (Col. 5, ln. 50-Col. 6, ln. 3; shaft terminates in the distal end (14), which typically houses one image lens (20); Figs. 2 and 14), wherein the probe is configured to protrude distally from said camera when the shaft in inserted into said working channel (Col. 10, ln. 35-37 and Col. 10, ln. 64-Col. 11, ln. 11; moves the rear view module (51) away from and towards the support arm (130), Figs. 14-16).
Ratnakar does not explicitly teach the probe is an ultrasound probe.
Fowler further teaches the probe is an ultrasound probe (Paragraph [0056]; an instrument or device that provides a desired functionality with regard to the minimal access procedure; e.g., a data acquisition device, such as a camera element, a sensor, an ultrasound probe; Paragraph [0097]; ultrasound for diagnosis, imaging, guidance or treatment; Paragraph [0087]; comprising a camera module 4 and a pan/tilt platform 15 that can be rotated in various directions to control the pan 13 and tilt 14 of the instrument, Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Ratnakar to have included an ultrasound probe as taught by Fowler because it would have been a known element for imaging (Fowler, Paragraph [0097]) that would have given an alternative method of viewing and tracking an object in the field of view.
Regarding claim 22, Ratnakar teaches a medical device (Col. 2, ln. 64-67; an endoscopic system that provides both forward and rear view) comprising:
a handle (Col. 5, ln. 50-Col. 6, ln. 3; It has a handle (4), Fig. 1);
a flexible cannula that extends distally from the handle (Col. 5, ln. 50-Col. 6, ln. 3; a handle (4) from which extends a flexible shaft (1), Fig. 1) and is configured to bend to a desired shape (Col. 5, ln. 50-Col. 6, ln. 12; shaft is flexible and incorporates a multitude of wires that attach the bending portion… to move the bending portion (12) in various directions);
a distally facing camera (Col. 5, ln. 50-Col. 6, ln. 3; image lens (20) captures images of the illuminated area; Figs. 2 and 14) secured at the distal portion of the cannula (Col. 5, ln. 50-Col. 6, ln. 3; shaft terminates in the distal end (14), which typically houses one image lens (20); Figs. 2 and 14) and having a camera field of view (FOV) encompassing a selected solid angle (Col. 2, ln. 4-19; present endoscopes also have a narrow field of vision with an angle of vision of about 120 degrees) and a camera direction of view (DOV) (Claim 1; a first lens selectively fixedly positioned adjacent to the distal end of the shaft for receiving a first image in a first direction, the first direction generally being forward and parallel to the longitudinal axis of the shaft and the first image generally being a circumferential view of the hollow organ);
an probe (Col. 10, ln. 64-Col. 11, ln. 11; rear view module (51), Fig. 14) having a probe longitudinal axis (Col. 10, ln. 64-Col. 11, ln. 11; forward direction (140) Fig. 14), said probe having a probe head positioned at a distal portion of the cannula (Col. 10, ln. 35-37 and Col. 10, ln. 64-Col. 11, ln. 11; moves the rear view module (51) away from and towards the support arm (130), Figs. 14-16) for both rotation about said probe longitudinal axis and for tilting relative to said distal portion of the cannula (Col. 10, ln. 64-Col. 11, ln. 11; the support arm can be rotated (160) as shown in FIG. 16; Fig. 16 shows the rotation is relative to the distal portion 14);
an probe steering mechanism (Col. 6, ln. 4-11; actuators (18), Fig. 1) positioned at a proximal portion of the handle (Fig. 1 shows the actuators are connected to the grip portion 16 which is the proximal end) and operatively coupled with the probe head to selectively tilt the probe head (Col. 10, ln. 22-37; The distal end (132) of the rear view module is attached to the support arm (130) by a hinge joint or any other suitable mechanical articulation. It is also connected to a rear view module actuator by cables; Col. 10, ln. 64-Col. 11, ln. 11; rear view module (51) can be lifted… using the rear view module actuator, Fig. 15) in at least two directions relative to said probe longitudinal axis over a selected angular range (Col. 10, ln. 64-Col. 11, ln. 11; The rear view module (51) can be lifted from (150) and retracted towards the support arm (130); lifted away from and toward the support arm is considered to be two directions);
and an probe rotation mechanism mounted at the proximal portion of the handle (Col. 6, ln. 4-11; actuators (18), Fig. 1; Fig. 1 shows the actuators are connected to the grip portion 16 which is the proximal end) and operatively coupled with the ultrasound probe (Col. 5, ln. 22-28; The rear view module is deployed using an actuator; Col. 10, ln. 22-37; support arm (130) also serves as an extension arm that can be extended, retracted and rotated, Fig. 16) to selectively rotate the ultrasound probe about said axis extending along said distal portion of the cannula through a selected rotation angle (Col. 10, ln. 64-Col. 11, ln. 11; In addition, the support arm can be rotated (160) as shown in FIG. 16).
Ratnakar does not explicitly teach the probe comprises an ultrasound probe and;
the probe head having an ultrasound transducer oriented for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head.
Fowler, however, teaches an integrated visual and ultrasound device (Paragraph [0012]; a system and single or multi-functional element insertable instrument… to provide access to the site from multiple and different orientations/perspectives as the procedure dictates) comprising an ultrasound probe (Paragraph [0056]; an instrument or device that provides a desired functionality with regard to the minimal access procedure; e.g., a data acquisition device, such as a camera element, a sensor, an ultrasound probe; Paragraph [0097]; ultrasound for diagnosis, imaging, guidance or treatment; Paragraph [0087]; comprising a camera module 4 and a pan/tilt platform 15 that can be rotated in various directions to control the pan 13 and tilt 14 of the instrument, Fig. 7) having a probe longitudinal axis (Paragraph [0095]; be movable on one or more of the following: a pan axis, a tilt axis, a translation axis and a zoom axis; The forward translation direction is considered to be a longitudinal axis), said ultrasound probe includes a probe head protruding distally from the distal portion of the cannula (Paragraph [0087]; comprises an external end 2 comprising one or more orifices 5 for receiving instruments and an insertion end 3 comprising a camera module 4, Figs. 2-4 shows the camera module protruding through the distal end of the trocar section.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Ratnakar to have included an ultrasound probe as taught by Fowler because it would have been a known element for imaging (Fowler, Paragraph [0097]) that would have given an alternative method of viewing and tracking an object in the field of view.
Together Ratnakar and Fowler fail to teach the probe head having an ultrasound transducer oriented for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head.
Munrow, however, teaches an ultrasound device (Col. 9, ln. 14-42; a system 10… includes an imaging transducer 20, Fig. 3; Col. 17, ln. 1-14; an ultrasound data stream from the on-board imaging transducer provides both the normal image) comprising a cannula (Col. 10, ln. 14-33; imaging shaft 44, Fig. 2) extending distally from the distal portion of the handle and having a distal portion extending along a longitudinal axis and ending at a distal end (Col. 10, ln. 14-34; imaging component 28 comprises a handle portion 29, Fig. 3; Fig. 3 shows the imaging shaft extending from the distal end of the handle and ending at a distal end); and
an ultrasound probe (Col. 9, ln. 14-42; imaging transducer 20) having a probe longitudinal axis (Fig. 3 shows the imaging transducer is aligned along an axis of the probe 16.; Col. 14-25; axis line AL), said ultrasound probe includes a probe head protruding distally from the distal portion of the cannula (Fig. 3 shows the imaging transducer 20 protruding distally from the distal portion of the imaging shaft 44) for tilting relative to said distal portion of the cannula (Col. 12, ln. 56-Col. 13, ln. 6; to deflect the transducer 20 (as shown in broken line in FIG. 3)), the probe head having an ultrasound transducer orientated for side view imaging (Figs. 3 and 9 shows the imaging face of the imaging transducer is oriented to the side) where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head (Col. 14, ln. 18-25; the imaging transducer 20 deployed to image the fibroid within a field of view indicated by the broken lines.; Fig. 9 shows the imaging transducer images in a one direction that is at an angle relative to a longitudinal axis of the transducer 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the orientation of the probe head of Ratnakar in view of Fowler to have been orientated for side view imaging where ultrasound signals are emitted in at least one direction that is at an angle relative to a longitudinal axis of the probe head as taught by Munrow because it would have improved imaging of tissue walls and viewing treatment needles and objects deployed to the tissues walls of the patient as well as the boundaries of treatment areas (Col. 14, ln. 43-67). Furthermore, the orientation allows the safety boundaries to be set relative to the actual position of the needle shaft which can be tracked by the system using the image of the shaft in tissue and proper viewing of the treatment area to ensure effective treatment (Col. 16, ln. 10-35).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar in view of Fowler and Munrow as applied to claims 2 and 1 above, and further in view of Hossack (US 20090318003) and Haggerty (US 20170078583).
Regarding claim 3, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 2 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach a belt that is in said shaft is coupled to and driven by said probe rotation mechanism and further including gearing secured to said ultrasound probe and driven by said belt to selectively rotate the ultrasound probe about said longitudinal axis.
Hossack, however, teaches a torque member (Paragraph [0076]; a torque member 50) that is in said shaft is coupled to and driven by said probe rotation mechanism (Paragraph [0080]; The first actuator 22 is rotated around a first shaft 182 causing actuator gear 164 to turn shaft gear 166. Shaft gear 166 is attached to a stiff torque shaft 168, which torque shaft is in turn attached to the torque member 50 in the catheter shaft 12) to selectively rotate the ultrasound probe about said longitudinal axis (Paragraph [0080]; When the first actuator 22 is rotated in a second rotational direction 156, the stiff torque shaft 168 is rotated counter-clockwise).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have included a member that is in the shaft is coupled to and driven by said probe rotation mechanism to selectively rotate the ultrasound probe about said longitudinal axis because it would have been a known method of rotating the ultrasound probe that would allow 360 rotations in two directions (Hossack, paragraph [0078]).
Together Ratnakar, Fowler, Munrow, and Hossack do not teach a belt and gearing secured to said ultrasound probe and driven by said belt.
Haggerty, however, teaches an imaging device (Paragraph [0008]; An endoscope may comprise a proximal handle and a shaft having a distal insertion end at which a camera assembly is mounted in a rotatable housing) comprising for rotation about an axis (Paragraph [0244]; the axis of the pivot pin 366) including a belt (Paragraph [0244]; belt 384, Fig. 27) and further including gearing (Paragraph [0246]; pivot pin 366 which may be geared, Fig. 27) secured to said probe (Paragraph [0246]; ability to grip or positively engage a camera assembly) and driven by said belt to selectively rotate the probe about said axis (Paragraph [0244]; Use of a belt 384 may allow for a wide range of pivoting of the camera assembly 350, Fig. 27).
The only difference between the claimed invention and the device of Bayer in view of Hossack is that the claimed invention uses a belt and gearing to transfer rotational motion from the probe rotation mechanism to the probe whereas Hossack teaches the use of a torque member for transferring rotational motion. The use of a belt and gearing to transfer rotation is well understood in the art as demonstrated by the device of Haggerty.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the torque member for transferring rotation of Ratnakar in view of Fowler and Hossack with the belt and gearing as taught by Haggerty as it would have been a well understood and predictable substitution for transferring rotational motion thereby allowing the probe to rotate and thus scan specific areas of interest (Hagerty, Paragraph [0237]).
Regarding claim 5, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach a rotation plate to which the ultrasound probe is secured and which rotates about a pivot axis transverse to said longitudinal axis, and a bar inside said shaft, said bar coupling said probe steering mechanism to said rotation plate and responding to manual actuation of the steering mechanism to pivot the rotation plate and thus the ultrasound probe relative to said distal portion of the cannula.
Haggerty, however, teaches an imaging device (Paragraph [0008]; An endoscope may comprise a proximal handle and a shaft having a distal insertion end at which a camera assembly is mounted in a rotatable housing) comprising a rotation plate to which the ultrasound probe (Paragraph [0244]; camera assembly; Fig. 27) is secured and which rotates about a pivot axis transverse to said longitudinal axis (Paragraph [0244]; the axis of the pivot pin 366 is transvers to the outer sheath 318, Fig. 27), and a bar inside said shaft (Paragraph [0248]; the pivot actuator may be the rack of a rack and pinion arrangement; rack displaces longitudinally within the insertion section 14), said bar coupling said probe steering mechanism to said rotation plate (Paragraph [0230]; A pivot actuator may be an elongate member used to pull on or push the camera assembly 350 via a pivot attachment feature) and responding to manual actuation of the steering mechanism to pivot the rotation plate and thus the ultrasound probe relative to said distal portion of the cannula (Paragraph [0248]; this motion is translated into rotation of the camera assembly 350).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow such that a rotation plate to which the ultrasound probe is secured and which rotates about a pivot axis transverse to said longitudinal axis, and a bar inside said shaft, said bar coupling said probe steering mechanism to said rotation plate and responding to manual actuation of the steering mechanism to pivot the rotation plate and thus the ultrasound probe relative to said distal portion of the cannula. This would have been a well understood and predictable method of transferring motion to provide a tilting motion of the probe to allow scanning (Haggerty, Paragraph [0230]).
Claims 4, 6, 7, 16, 18, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar in view of Fowler and Munrow as applied to claim 1 above, and further in view of Hossack (US 20090318003).
Regarding claim 4, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach said probe rotation mechanism is configured to rotate the ultrasound probe through at least 180 degrees about said longitudinal axis.
Hossack, however, teaches the probe rotation mechanism is configured to rotate the ultrasound probe through at least 180 degrees about said longitudinal axis (Paragraph [0058]; tip 34 is rotated bidirectionally in a 360 degree field of view).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the ultrasound probe of Ratnakar in view of Fowler and Munrow to be configured to rotate the ultrasound probe through at least 180 degrees about said longitudinal axis because it would facilitate smooth panning movement and pinpoint accuracy in imaging the desired tissue with the transducer array 32 (Hossack, Paragraph [0059]).
Regarding claim 6, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach said steering mechanism is configured to selectively tilt said ultrasound probe in two opposite directions relative to said distal portion of the cannula through an angle up to 180 degrees in at least one of said directions.
Hossack, however, teaches the steering mechanism is configured to selectively tilt said ultrasound probe in two opposite directions (Paragraph [0064]; The catheter is capable of flexing in each direction) relative to said distal portion of the cannula through an angle up to 180 degrees in at least one of said directions (Paragraph [0064]; The catheter is capable of flexing past the 90 degree point in each direction; Flexing in 90 degrees in both directions is a total angle of 180 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the ultrasound probe of Ratnakar in view of Fowler and Munrow to be configured to selectively tilt said ultrasound probe in two opposite directions relative to said distal portion of the cannula through an angle up to 180 degrees in at least one of said directions because it would allow steering the catheter tip into a desired location of the body (Hossack, Paragraph [0065]).
Regarding claim 7, together Ratnakar, Fowler, Munrow, and Hossack teach all of the limitations of claim 6 as noted above.
Ratnakar does not explicitly teach said steering mechanism is configured to tilt said ultrasound probe through different angular ranges in said two opposite directions relative to said distal portion of the cannula.
Hossack further teaches the steering mechanism is configured to tilt said ultrasound probe through different angular ranges (Paragraph [0064]; The catheter is capable of flexing past the 90 degree point in each direction and has an angular range of 0 to 150 degrees from the straight or neutral configuration) in said two opposite directions relative to said distal portion of the cannula (Paragraph [0065]; Rotating the actuator 24 in the first direction causes steering in one direction. Rotating the actuator 24 in an opposing second rotational direction causes a bend in an opposite direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the steering mechanism of Ratnakar in view of Fowler, Munrow, and Hossack to be configured to tilt said ultrasound probe through different angular ranges in said two opposite directions relative to said distal portion of the cannula because it would allow steering the catheter tip into a desired location of the body (Hossack, Paragraph [0065]).
Regarding claim 16, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach said probe rotation mechanism is a probe rotation wheel.
Hossack, however, teaches the probe rotation mechanism is a probe rotation wheel (Paragraph [0086]; The first actuator 22, Fig. 21; Paragraph [0073]; the actuator is a wheel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow such that said probe rotation mechanism is a probe rotation wheel as taught by Hossack because the disclosed rotational steering mechanism facilitates smooth panning movement and pinpoint accuracy in imaging the desired tissue with the transducer array (Hossack, Paragraph [0059]). By using the combination of these two steering modes (rotational and flexing), steering is much more intuitive to the user than a steering mechanism based solely on either rotation or flexing (Hossack, Paragraph [0065]) thereby allowing an ideal position to be achieved by the clinician for imaging (Hossack, Paragraph [0100]).
Regarding claim 18, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar and Fowler do not explicitly teach said camera direction of view (DOV) is in the range of greater than 0 to 30 degrees.
Hossack, however, teaches said camera direction of view (DOV) is in the range of greater than 0 to 30 degrees (Paragraph [0128]; the mount oscillates a few degrees (for example 10 degrees),).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the camera direction of view of Ratnakar in view of Fowler and Munrow to have been in the range of greater than 0 to 30 degrees as taught by Hossack because it would allows sweeping the image to form a 3D image (Paragraph [0128]).
Regarding claim 23, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 22 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach the angular range of said tilting of the ultrasound probe relative to said distal portion of the cannula is 0-30 degrees and the rotation angle of the ultrasound probe is at least 180 degrees in each direction.
Hossack, however, teaches the angular range of said tilting of the ultrasound probe relative to said distal portion of the cannula is 0-30 degrees (Paragraph [0064]; the catheter 12's distal segment 14 is steerable into any number of flexed positions in between the straight configuration of FIG. 2D and the flexed configuration of FIG. 2E; The catheter is capable of flexing past the 90 degree point in each direction and has an angular range of 0 degrees to 150 degrees) and the rotation angle of the ultrasound probe is at least 180 degrees in each direction (Paragraph [0058]; the rotating tip 34 is rotated by manipulation of the first in-line steering actuator 22 of the handle 18, and is capable of approximately 180 degree of rotation in the clockwise direction and 180 degree rotation in the counter-clockwise direction; Paragraph [0058]; tip 34 is rotated bidirectionally in a 360 degree field of view).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the ultrasound probe of Ratnakar in view of Fowler and Munrow such that the angular range of said tilting relative to the distal portion of the cannula is 0-30 degrees and the rotation angle of the ultrasound probe is at least 180 degrees in each direction because it would have facilitate smooth panning movement and pinpoint accuracy in imaging the desired tissue with the transducer array 32 (Hossack, Paragraph [0059]) and would allow steering the catheter tip into a desired location of the body (Hossack, Paragraph [0065]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar in view of Fowler and Munrow as applied to claim 1 above, and further in view of Bayer (US 20090231419), Hossack (US 20090318003), and Schultz (US 20110009694).
Regarding claim 8, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Ratnakar does not explicitly teach said handle comprises (i) a multiple-use portion and image processing electronics therein coupled to said camera and said ultrasound probe and (ii) a single-use portion removably secured to the multiple-use portion and housing said rotation mechanism and steering mechanism.
Bayer however teaches the handle comprises a multiple-use portion (Paragraph [0050]; control handle) and further teaches processing electronics coupled to said camera and said ultrasound probe (Paragraph [0087]; The image and signal processing device may include one or more integrated circuits and memory devices along with associated discrete component; allows image signals from the imaging devices 14, 42 to be processed for images and video).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the handle of Ratnakar in view of Fowler and Munrow to have comprised a multiple-use portion because it would allow the part of the device to be reusable for multiple operations and reduce overall cost of performing multiple operations.
Hossack further teaches the handle comprises a single-use portion (120) removably secured (Paragraph [0055]; Fig. 1, catheter handle has a connector 30) to the multiple-use portion and housing said rotation mechanism and steering mechanism (Paragraph [0102]; the ICE catheter described is for single-use).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the handle of Ratnakar in view of Fowler, Munrow, and Bayer to have comprised a single-use portion removably secured to the multiple-use portion and housing said rotation mechanism and steering mechanism because it would allow the insertable portions to remain sterile and only be used for operation on one person, thereby reducing the risk of infection or spreading disease between patients and allowing for more easily maintaining a sterile environment for imaging.
Together Ratnakar, Fowler, Munrow, Bayer, and Hossack do not explicitly teach image processing electronics within a multiple-use portion.
Schultz, however, teaches an imaging device (Paragraph [0047]; Hand-held minimally dimensioned diagnostic devices) comprising a multiple-use portion (Paragraph [0084]; the hand-held control unit is reusable) and image processing electronics therein (Paragraph [0153]; electronics board 190 within the handle where its output would be processed, Fig. 1I; Paragraph [0154]; Video processor module 905 includes a processor/controller module 910) coupled to said camera (Paragraph [0101]; a video processor module configured to receive image data obtained by the one or more visualization sensors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Ratnakar in view of Fowler, Munrow, Bayer, and Hossack such that the image processing electronics within a multiple-use portion of the handle as it would have allowed outputting received images directly to a monitor attached to the handle or other convenient medium as a display means (Schultz, Paragraph [0160]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar in view of Fowler and Munrow as applied to claims 10 and 1 above, respectively, and further in view of Bayer (US 20090231419).
Regarding claim 11, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 10 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach said ultrasound image display and camera image display are configured to concurrently display said ultrasound images and camera images, including selectively displaying concurrently a camera image of the ultrasound probe.
Bayer, however, teaches said ultrasound image display and camera image display are configured to concurrently display said ultrasound images and camera images (Paragraph [0089]; the images from the main and auxiliary imaging devices 14, 42 may be displayed on two separate monitors or on the same monitor with a split screen), including selectively displaying concurrently a camera image of the ultrasound probe (Paragraph [0075]; provides a front view of the area; Figs. 3-6 shows the imaging device 42 is in view of the imaging device 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Ratnakar in view of Fowler and Munrow such that said ultrasound image display and camera image display are configured to concurrently display said ultrasound images and camera images, including selectively displaying concurrently a camera image of the ultrasound probe as taught by Bayer because it would have allowed a user to have seen the image from both views points at the same time, thereby improving the ability of the user to perform medical procedures in the area by removing the need to switch between viewpoints.
Regarding claim 12, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach the ultrasound and visual aspects are integrated by the ultrasound probe being inserted through a working channel formed within the cannula.
Bayer however teaches the ultrasound and visual aspects are integrated by the ultrasound probe being inserted through a working channel formed within the cannula (Paragraph [0058]; To this end, the minor endoscope 20 is placed inside the channel 22 of the main endoscope's insertion tube 12 with its auxiliary imaging device 42 disposed beyond the distal end 16 of the main endoscope 10, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow such that the ultrasound and visual aspects are integrated by the ultrasound probe being inserted through a working channel formed within the cannula as taught by Bayer because it would have been a known way of routing ultrasound and visual imaging elements that would allow implementation in the endoscope and thereby provide both ultrasound and visual imaging.
Regarding claim 13, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach said cannula comprises a set of three cannulas one of which is rigid, another semi-rigid and yet another flexible, wherein only a selected one of said three cannulas is secured to said handle at any one time.
Bayer however teaches the cannula comprises a set of multiple cannulas (Paragraph [0050]; insertion tube 12 may be detachable from the control handle 18… length and flexibility of the insertion tube 12 depend on the procedure for which the endoscope system 1 is used) one of which is rigid, another semi-rigid and yet another flexible (Paragraph [0050]; flexibility of the insertion tube 12 depend on the procedure for which the endoscope system 1 is used; Paragraph [0101]; other methods such as through a straight tube or cannula, by a flexible insertion tube), wherein only a selected one of said three cannulas is secured to said handle at any one time (Paragraph [0049]; a main endoscope 10 includes an insertion tube 12; Fig. 1 shows one insertion tube connected to the handle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the cannula to have been a cannula which is rigid, another semi-rigid, and yet another flexible, wherein only a selected one of said three cannulas is secured to said handle at any one time as taught by Bayer because it would allow the device to be used in a variety of medical procedures in which imaging of a body tissue, organ, cavity or lumen is required.
It is not clear if Bayer teaches the cannula comprises a set of three cannulas.
Bayer already teaches the choice of diameter, length, and flexibility of the insertion tube 12 depends on the procedure performed but does not explicitly disclose a set of at least three cannulas. One of ordinary skill in the art would have realized making an insertion tube for each of the procedures listed in paragraph [0048] (for example, anoscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, EGD, laparoscopy, and sigmoidoscopy) would have resulted in a set of at least 3 cannulas of varying flexibility.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have made the cannula of Ratnakar in view of Fowler, Munrow, and Bayer to further comprise a set of three cannulas. Doing so would have been a mere duplication of cannulas with varying sizes and flexibilities that would have had the advantage of allowing the operator to select an appropriate cannula to perform a specific endoscopy procedure.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar in view of Fowler and Munrow as applied to claim 1 above, and further in view of Schultz (US 20110009694).
Regarding claim 14, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach a cannula rotation mechanism positioned at the proximal portion of the handle and operatively coupled with the cannula to selectively rotate the cannula and thus the camera about said axis relative to the handle.
Schultz, however, teaches an imaging device (Paragraph [0047]; Hand-held minimally dimensioned diagnostic devices) comprising a cannula rotation mechanism (Paragraph [0121]; Geared motor 156, and a geared intermediary piece 154, Fig. 1G; Paragraph [0169]; manual wheel was provided on the hand-piece connected to the tube, and when actuated, rotated the tube) positioned at the proximal portion of the handle (Paragraph [0121]; Fig. 1G shows the mechanism in the proximal portion of the handle) and operatively coupled with the cannula (Fig. 1G shows the mechanism is connected to the cannula 110) to selectively rotate the cannula and thus the camera about said axis relative to the handle (Paragraph [0151]; The connection is oriented in such a way as to allow for the rotation of the probe piece both counterclockwise and clockwise).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow to further comprise a cannula rotation mechanism positioned at the proximal portion of the handle and operatively coupled with the cannula to selectively rotate the cannula and thus the camera about said axis relative to the handle because it would have allowed a full range of angles on either side of the axis of the probe to be accessible (Schultz, Paragraph [0078]) and thus allow the camera to view a full hemisphere of space (Paragraph [0169]).
Regarding claim 15, together Ratnakar, Fowler, Munrow, and Schultz teach all of the limitations of claim 14 as noted above.
Ratnakar further teaches the probe rotation mechanism is configured to rotate the probe about said longitudinal axis relative to the cannula (Col. 10, ln. 64-Col. 11, ln. 11; the support arm can be rotated (160) as shown in FIG. 16. This increases the rear field of vision).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ratnakar in view of Fowler and Munrow as applied to claims 1 and 19 above, respectively, and further in view of Taylor (US 20070038112).
Regarding claim 17, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 1 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach a rotation sensor operatively coupled with the probe rotation mechanism and configured to provide an electronic signal indicative of rotation of the ultrasound probe about said longitudinal axis.
Taylor, however, teaches an ultrasound device (Paragraph [0034]; a scanning probe) comprising a rotation sensor (Paragraph [0078] and [0107]; rotational axis encoder connection 651, Fig. 24) operatively coupled with the probe rotation mechanism (Paragraph [0107]; probe control board has position tracker 604 receives the information from the rotational axis encoder connection) and configured to provide an electronic signal indicative of rotation of the ultrasound probe (Paragraph [0107]; Thus, the controller transmits the control information to the digitizer, and receives the image data back, and it is all precisely determined as to location by means of the rotational and linear axes encoder connections, through the position tracker, as such information is further controlled by the controller, along the position information and control information connections) about said longitudinal axis (Paragraph [0080]; ultrasound transducer to rotate relative to the axis of the probe tip).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow to have included a rotation sensor operatively coupled with the probe rotation mechanism and configured to provide an electronic signal indicative of rotation of the ultrasound probe about said longitudinal axis. This would allow monitoring the exact rotational position of the transducer and further display the information on the control unit, thereby improving the operator’s ability to navigate the device and image the correct locations (Taylor, Paragraphs [0100] and [0107]).
Regarding claim 20, together Ratnakar, Fowler, and Munrow teach all of the limitations of claim 19 as noted above.
Together Ratnakar, Fowler, and Munrow do not explicitly teach a rotation sensor operatively coupled with the probe rotation mechanism and configured to provide an electronic signal indicative of rotation of the ultrasound probe about said axis.
Taylor, however, teaches an ultrasound device (Paragraph [0034]; a scanning probe) comprising a rotation sensor (Paragraph [0078] and [0107]; rotational axis encoder connection 651, Fig. 24) operatively coupled with the probe rotation mechanism (Paragraph [0107]; probe control board has position tracker 604 receives the information from the rotational axis encoder connection) and configured to provide an electronic signal indicative of rotation of the ultrasound probe (Paragraph [0107]; Thus, the controller transmits the control information to the digitizer, and receives the image data back, and it is all precisely determined as to location by means of the rotational and linear axes encoder connections, through the position tracker, as such information is further controlled by the controller, along the position information and control information connections) about said longitudinal axis (Paragraph [0080]; ultrasound transducer to rotate relative to the axis of the probe tip).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Ratnakar in view of Fowler and Munrow to have included a rotation sensor operatively coupled with the probe rotation mechanism and configured to provide an electronic signal indicative of rotation of the ultrasound probe about said longitudinal axis. This would allow monitoring the exact rotational position of the transducer and further display the information on the control unit, thereby improving the operator’s ability to navigate the device and image the correct locations (Taylor, Paragraphs [0100] and [0107]).
Response to Arguments
Claim Interpretation under – 35 U.S.C. § 112(f)
Applicant’s arguments, with respect to interpretation under 35 USC 112(f) have been fully considered and are persuasive. The interpretation of claim elements probe steering mechanism, probe rotation mechanism, and cannula rotation mechanism under 35 USC 112(f) have been withdrawn and are thus interpreted under the broadest reasonable interpretation.
Claim Rejections under – 35 U.S.C. §103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
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 Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/22/26