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 July 9th, 2026 has been entered. Applicant’s amendments to the Claims have overcome the claim objections previously set forth in the Non-Final Office Action mailed April 20th, 2026.
Response to Arguments
Applicant’s arguments, see pages 10-12, filed July 9th, 2026, with respect to the rejection(s) of claim(s) 1, 16 & 19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art.
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, 7, 10, 16, 19, 24, 26-30 & 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Aoki et al. (U.S. Pub. No. 20090318831), herein referred to as “Aoki” in view of Hastings et al. (U.S. Pub. 20160220296, cited in IDS) and further in view of Ratnakar (U.S. Pat. No. 8585584, previously cited), herein referred to as “Ratnakar”.
Regarding claim 1, Aoki discloses a device for vapor ablation (Abstract: An endoscope apparatus), the device comprising:
a sheath (insertion portion 9) extending from a proximal end (flexible tube 8) to a distal portion (distal end portion 6), wherein the sheath includes a lumen (second treatment instrument channel 63) terminating distally at a distal lumen opening (second opening 41b; [0023]: The forceps openings 11 and 12 in the operation portion 10 constitute openings on the operator's side of two unshown treatment instrument channels mainly passing through the insertion portion 9 to two channel openings provided in the distal end portion 6), and wherein the sheath includes a working channel (first treatment instrument channel 54) extending from the proximal end and terminating distally at a working channel opening (first opening 41a; [0023]: The forceps openings 11 and 12 in the operation portion 10 constitute openings on the operator's side of two unshown treatment instrument channels mainly passing through the insertion portion 9 to two channel openings provided in the distal end portion 6);
a first electronic component having a chip (ultrasound transducer array 61), and wherein the chip is disposed radially between the working channel opening and the distal lumen opening (see Fig. 2 where the ultrasound transducer array 61 is between the first opening 41a and second opening 41b), such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the electronic component, and the distal lumen opening, such that the working channel, the electronic component, and the distal lumen opening are in line with one another ([0031]: a contrast tube 100 protruded from the first treatment instrument channel 54 into the first opening 41a in a direction perpendicular to the insertion axis X; [0039]: The second opening 41b in which the second raising base 62 is provided is located on a rear side of the distal end portion 6 along the insertion axis X with respect to the scanning surface Z of the ultrasound transducer array 61; see Figs. 2-4 where the ultrasound transducer array 61, the first opening 41a and the second opening 41b are aligned along a straight line); and
a second electronic component (optical observation window 51),
wherein the working channel and the second electronic component are positioned on a first side of the first electronic component (see Fig. 2 where second opening 41a and optical observation window 51 is on a same side (the distal side) of the ultrasound transducer array 61), wherein the lumen is positioned on a second side of the first electronic component (see Fig. 2 where the second treatment instrument channel 63 is on an opposite side of the ultrasound transducer array 61), wherein the second side is opposite to the first side (see Fig. 2).
But Aoki fails to disclose a vapor delivery member received in the lumen, wherein the vapor delivery member includes a channel configured to receive vapor and at least one aperture configured to deliver the vapor to a body tissue.
However, Hastings discloses a vapor delivery member (vapor delivery needle 106) received in the lumen (lumen 148; [0034]: a vapor delivery needle 106 disposed in the shaft), wherein the vapor delivery member includes a channel configured to receive vapor and at least one aperture configured to deliver the vapor to a body tissue ([0037]: FIG. 2A shows a close-up view of the distal portion of the shaft of vapor delivery system 100, including the vapor delivery needle 106 extending beyond the shaft and exposing the vapor delivery ports 108. Vapor delivery ports 108 may be arranged in a pattern that optimizes the delivery of vapor to tissue in a given application).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki to include a vapor delivery member, as taught by Hastings, for the purpose of vapor enabling localized ablation of prostate tissue, and more particularly the applied thermal energy from vapor can be localized to ablate tissue adjacent the urethra without damaging prostate tissue that is not adjacent the urethra (Hastings: [0030]).
But Aoki in view of Hastings fail to disclose wherein the chip is fixedly disposed proximate to the distal lumen opening, and
the second electronic component fixedly disposed proximate to the distal lumen opening, wherein, relative to the central longitudinal axis of the sheath, the second electronic component is positioned radially outward of the working channel, and wherein, relative to the central longitudinal axis of the sheath, the lumen is positioned radially outward of to the first electronic component.
However, Ratnakar discloses wherein the electronic component/chip (main image lens 20, Fig. 5) wherein the chip is fixedly disposed proximate to the distal lumen opening (see Fig. 5 where image lens 20 is shown fixedly disposed proximate the opening of the main instrument channel 25), and
wherein the chip is disposed radially between the working channel opening (opening of air/water channel 24; wherein the labeling of the channels is seen as arbitrary, the lumens are capable of housing an inserted tool) and the distal lumen opening (opening of instrument channel 25; wherein the labeling of the channels is seen as arbitrary, the lumens are capable of housing an inserted tool), such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the electronic component, and the distal lumen opening (see annotated Fig. 5, below);
a second electronic component (rear image lens 52) fixedly disposed proximate to the distal lumen opening (see Fig. 5 where rear image lens 52 is shown fixedly disposed proximate the opening of the main instrument channel 25),
wherein, relative to the central longitudinal axis of the sheath (wherein the central longitudinal axis of the sheath is seen as running parallel to the main image lens 20), the second electronic component is positioned radially outward of the working channel (see Fig. 5 where the rear image lens 52 is positioned radially outward of the air/water channel 24), and wherein, relative to the central longitudinal axis of the sheath (wherein the central longitudinal axis of the sheath is seen as running parallel to the main image lens 20), the lumen is positioned radially outward of to the first electronic component (see Fig. 5 where the main instrument channel 25 is positioned radially outward of the main image lens 20).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki to have the first and second electronic components, working channel opening and distal lumen opening configuration of Ratnakar for the purpose of the camera capturing images of the illuminated area, the lumens providing passage of fluid(s) and instruments, and including the passage of surgical instruments to do various surgical procedures during examination and enabling the advantage of allowing a thorough examination of a hollow organ that includes both forward and rear views in a single passage (Ratnakar: Col. 6, lines 12-31; Col. 3, lines 26-29).
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Annotated Ratnakar’s Fig. 5 showing the straight line perpendicular to the longitudinal axis of the device.
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to disclose wherein the chip is disposed radially between the working channel opening and the distal lumen opening, such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the electronic component, and the distal lumen opening, such that the working channel, the electronic component, and the distal lumen opening are in line with one another, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The instant application teaches that any configuration or order of the components does not produce an unexpected result as paragraph [0030] describes “Working channel(s) 40 may have any appropriate shape or features and may be positioned in a variety of ways with respect to other components of distal tip 10, such as electronic components 30A, 30B, and lumen 20”.
Regarding claim 7, Aoki in view of Hastings discloses wherein the vapor delivery member is configured to be transitioned from a first configuration to a second configuration, wherein, in the first configuration, the vapor delivery member does not extend out of the distal portion and wherein, in the second configuration, the vapor delivery member extends out of an outer opening on a radial outer surface of the distal portion (Aoki: edge line R, Fig. 3; [0026]: The distal end rigid portion 41 has two exposed portions on one surface 43 of the distal end cover 42 of the insertion portion 9 as a longitudinal axis of the distal end portion 6; Hastings: [0037] FIG. 2A shows a close-up view of the distal portion of the shaft of vapor delivery system 100, including the vapor delivery needle 106 extending beyond the shaft and exposing the vapor delivery ports 108; [0034]: the actuation mechanism can be configured to extend/retract the vapor delivery needle).
Regarding claim 10, Aoki in view of Hastings and Ratnakar discloses wherein the first electronic component is disposed distally of the distal lumen opening (Aoki: see Fig. 2 where the ultrasound transducer array 61 is disposed distally of the second opening 41b), wherein each of the first electronic component and the second electronic component has a face directed distally (See Aoki Fig. 2 where the fields of view include a portion of the distal direction; see Ratnakar Fig. 5 where each of the main image lens 20 and rear image lens 52 have faces directed distally).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to disclose wherein the first electronic component is disposed distally of the distal lumen opening, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, supra. Additionally, the specific positioning of the electronic component functions the same as other positions with the predictable result of a different field of view, and this is evidenced by the instant application where paragraph [0021] describes “Electronic components 30A, 30B may face any suitable direction and may be positioned in any suitable manner. Electronic components 30A, 30B may assist in navigation of needle 24” such that the positioning does not produce an unexpected result.
Regarding claim 29, Aoki discloses a radial surface opening on a radial outer surface of a distalmost tip of the sheath (edge line R, Fig. 3; [0026]: The distal end rigid portion 41 has two exposed portions on one surface 43 of the distal end cover 42 of the insertion portion 9 as a longitudinal axis of the distal end portion 6), wherein the first electronic component faces the radial surface opening (see Figs. 2-4).
Regarding claim 30, Aoki discloses wherein the distalmost tip of the sheath includes a gap of open space (space under edge line R, Fig. 3) disposed longitudinally between (a) the distalmost tip and (b) the distal lumen opening and the working channel opening (see Fig. 3 where edge line R extends between first opening 41a, second opening 41b & optical observation window 51), wherein the first electronic component is positioned at a proximal end of the gap and faces the gap (see Figs. 2-4 where the ultrasound transducer array 61 is positioned on a proximal end of the space under edge line R and faces the space).
Regarding claim 16, Aoki discloses a device for vapor ablation (Abstract: An endoscope apparatus), the device comprising:
a sheath (insertion portion 9) extending from a proximal end (flexible tube 8) to a distal portion (distal end portion 6), wherein the sheath includes a working channel (first treatment instrument channel 54), the working channel extending from the proximal end to a working channel opening at the distal portion (first opening 41a; [0023]: The forceps openings 11 and 12 in the operation portion 10 constitute openings on the operator's side of two unshown treatment instrument channels mainly passing through the insertion portion 9 to two channel openings provided in the distal end portion 6),
a lumen extending (second treatment instrument channel 63) from the proximal end to a lumen opening at the distal portion (second opening 41b; [0023]: The forceps openings 11 and 12 in the operation portion 10 constitute openings on the operator's side of two unshown treatment instrument channels mainly passing through the insertion portion 9 to two channel openings provided in the distal end portion 6),
a chip (ultrasound transducer array 61), wherein the chip is disposed radially between the working channel opening and the lumen opening (see Fig. 2 where the ultrasound transducer array 61 is between the first opening 41a and second opening 41b), such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the chip, and the lumen opening ([0031]: a contrast tube 100 protruded from the first treatment instrument channel 54 into the first opening 41a in a direction perpendicular to the insertion axis X; [0039]: The second opening 41b in which the second raising base 62 is provided is located on a rear side of the distal end portion 6 along the insertion axis X with respect to the scanning surface Z of the ultrasound transducer array 61; see Figs. 2-4 where the ultrasound transducer array 61, the first opening 41a and the second opening 41b are aligned along a straight line),
an electronic component (optical observation window 51; [0028]: an optical observation window 51 that constitutes an optical observation system of an image pickup apparatus including an unshown solid-state image pickup device provided in the distal end portion 6),
wherein the electronic component is positioned between the working channel and an outer surface of the sheath (see Figs. 2-4 where the ultrasound transducer array 61 is positioned between first opening 41a and an outer surface of insertion portion 9);
wherein a distalmost tip of the sheath is disposed distally of the camera, the lumen opening, and the working channel opening (see Fig. 2 where the rounded end of distal end portion 6 is the distalmost end of the shaft).
But Aoki fails to disclose wherein a vapor delivery member is disposed within the lumen.
However, Hastings discloses wherein a vapor delivery member (vapor delivery needle 106) is disposed within the lumen (lumen 148; [0034]: a vapor delivery needle 106 disposed in the shaft).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki to include a vapor delivery member, as taught by Hastings, for the purpose of vapor enabling localized ablation of prostate tissue, and more particularly the applied thermal energy from vapor can be localized to ablate tissue adjacent the urethra without damaging prostate tissue that is not adjacent the urethra (Hastings: [0030]).
However, Aoki in view of Hastings fails to disclose
a camera having a chip, wherein the chip is disposed proximate to the lumen opening;
wherein the electronic component is disposed proximate to the lumen opening,
wherein, relative to the central longitudinal axis, the electronic component is disposed radially outward to and outside of the working channel.
However, Ratnakar discloses a camera (main image lens 20) having a chip, wherein the chip is disposed proximate to the lumen opening (see Fig. 5 where image lens 20 is shown fixedly disposed proximate the opening of the main instrument channel 25), wherein the chip (main image lens 20, Fig. 5) is disposed radially between the working channel opening (opening of air/water channel 24; wherein the labeling of the channels is seen as arbitrary, the lumens are capable of housing an inserted tool) and the lumen opening (opening of instrument channel 25; wherein the labeling of the channels is seen as arbitrary, the lumens are capable of housing an inserted tool), such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the chip, and the lumen opening (see annotated Fig. 5, above; additionally, “opening” is being interpreted broadly such that there is no clear delineation of the transition from what is considered the lumen vs the opening as they are both part of the same area of space such that the straight line intersects a portion of the openings); and
an electronic component (rear image lens 52), wherein the electronic component is disposed proximate to the lumen opening (see Fig. 5 where rear image lens 52 is shown fixedly disposed proximate the opening of the main instrument channel 25),
wherein, relative to the central longitudinal axis, the electronic component is disposed radially outward to and outside of the working channel (see Fig. 5 where the rear image lens is positioned radially outward of the air/water channel 24), wherein the electronic component is positioned between the working channel and an outer surface of the sheath (see Fig. 5 where the rear image lens is positioned between the air/water channel 24 and the outside of the endoscope/sheath).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki in view of Hastings to have the electronic component, working channel opening and distal lumen opening configuration of Ratnakar for the purpose of the camera capturing images of the illuminated area, the lumens providing passage of fluid(s) and instruments, and including the passage of surgical instruments to do various surgical procedures during examination and enabling the advantage of allowing a thorough examination of a hollow organ that includes both forward and rear views in a single passage (Ratnakar: Col. 6, lines 12-31; Col. 3, lines 26-29).
Regarding claim 24, Aoki discloses a gap of open space (space under edge line R in Fig. 3) disposed longitudinally between (a) the distalmost tip and (b) the distal lumen opening and the working channel opening ([0026]: The distal end rigid portion 41 has two exposed portions on one surface 43 of the distal end cover 42 of the insertion portion 9 as a longitudinal axis of the distal end portion 6; see Fig. 3 where edge line R extends between first opening 41a, second opening 41b & optical observation window 51).
Regarding claim 27, Aoki in view of Hastings and Ratnakar discloses wherein, the straight line intersects the electronic component (see annotated Fig. 5 of Ratnakar, above).
Regarding claim 28, Aoki in view of Hastings fail to disclose wherein the camera faces at least partially proximally, toward the lumen opening and the working channel opening.
However, Ratnakar discloses wherein the camera faces at least partially proximally, toward the lumen opening and the working channel opening (Col. 10, lines 64-67 & Col. 11, lines 1-2: FIG. 14-16 shows side view of the endoscope in FIG. 13 where the rear view module (51) has been deployed for rear view. The support arm (130) is extended forward (140) to an appropriate distance from the distal end (14) of the endoscope as shown in FIG. 14. The rear image lens (52) faces backward in this position and gives a rear view). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki in view of Hastings to have the camera facing at least partially toward the lumen opening and the working channel opening, as taught by Ratnakar, for the purpose of enabling a rear view even in organs with a narrow lumen without the need to retro flex the endoscope (Ratnakar: Col. 3, lines 4-6).
Regarding claim 19, Aoki discloses a device for vapor ablation (Abstract: An endoscope apparatus), the device comprising:
a sheath (insertion portion 9) extending from a proximal end (flexible tube 8) to a distal portion (distal end portion 6), wherein the sheath includes a lumen (second treatment instrument channel 63) terminating distally at a lumen opening (second opening 41b; [0023]: The forceps openings 11 and 12 in the operation portion 10 constitute openings on the operator's side of two unshown treatment instrument channels mainly passing through the insertion portion 9 to two channel openings provided in the distal end portion 6);
a working channel (first treatment instrument channel 54) extending from the proximal end to a working channel opening at the distal portion (first opening 41a; [0023]: The forceps openings 11 and 12 in the operation portion 10 constitute openings on the operator's side of two unshown treatment instrument channels mainly passing through the insertion portion 9 to two channel openings provided in the distal end portion 6);
a distal tip at a distal end of the sheath (distalmost end of distal end portion 6); and
a camera (optical observation window 51) fixedly disposed in the distal tip [0028]: optical observation function unit 50 includes an optical observation window 51 that constitutes an optical observation system of an image pickup apparatus including an unshown solid-state image pickup device provided in the distal end portion 6), wherein the camera fixedly faces at least partially in a proximal direction in a configuration in which a straight central longitudinal axis extends through the sheath and the distal tip, and in all configurations of the camera ([0029]: The endoscope 2 of the present embodiment has a configuration including a side-viewing optical image pickup system with a predetermined viewing angle .theta.1 as shown in FIG. 3; see longitudinal axis x in Fig. 3 and that the angle theta1 includes a portion of the proximal direction), and wherein the distal tip includes a gap (edge line R, Fig. 3) between (a) the lumen opening and the working channel opening and (b) the camera (see Fig. 3 where edge line R extends between first opening 41a, second opening 41b & optical observation window 51), wherein the camera is disposed on a distal side of the gap (see Fig. 3 where optical observation window 51 is positioned on a distal side of edge line R).
But Aoki fails to disclose wherein a vapor delivery member is disposed within the lumen.
However, Hastings discloses wherein a vapor delivery member (vapor delivery needle 106) is disposed within the lumen (lumen 148; [0034]: a vapor delivery needle 106 disposed in the shaft).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki to include a vapor delivery member, as taught by Hastings, for the purpose of vapor enabling localized ablation of prostate tissue, and more particularly the applied thermal energy from vapor can be localized to ablate tissue adjacent the urethra without damaging prostate tissue that is not adjacent the urethra (Hastings: [0030]).
But Aoki in view of Hastings fails to disclose wherein the camera faces at least partially toward the lumen opening and the working channel opening.
However, Ratnakar discloses wherein the camera faces at least partially toward the lumen opening and the working channel opening (Col. 10, lines 64-67 & Col. 11, lines 1-2: FIG. 14-16 shows side view of the endoscope in FIG. 13 where the rear view module (51) has been deployed for rear view. The support arm (130) is extended forward (140) to an appropriate distance from the distal end (14) of the endoscope as shown in FIG. 14. The rear image lens (52) faces backward in this position and gives a rear view). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Aoki in view of Hastings to have the camera facing at least partially toward the lumen opening and the working channel opening, as taught by Ratnakar, for the purpose of enabling a rear view even in organs with a narrow lumen without the need to retro flex the endoscope (Ratnakar: Col. 3, lines 4-6). Wherein in this modification, it is changing the direction that the optical observation window 51 of Aoki faces.
Regarding claim 26, Aoki in view of Hastings discloses wherein, in an extended configuration of the vapor delivery member, the vapor delivery member extends through the gap and through a radial surface opening on a radial outer surface of the distal tip, wherein the camera faces the radial surface opening (Aoki: edge line R, Fig. 3; [0026]: The distal end rigid portion 41 has two exposed portions on one surface 43 of the distal end cover 42 of the insertion portion 9 as a longitudinal axis of the distal end portion 6; Hastings: [0037]: FIG. 2A shows a close-up view of the distal portion of the shaft of vapor delivery system 100, including the vapor delivery needle 106 extending beyond the shaft and exposing the vapor delivery ports 108; [0034]: the actuation mechanism can be configured to extend/retract the vapor delivery needle).
Regarding claim 33, Aoki in view of Hastings and Ratnakar disclose wherein, in the extended configuration of the vapor delivery member, a field of view of the camera includes the vapor delivery member (Hastings: [0037]: FIG. 2A shows a close-up view of the distal portion of the shaft of vapor delivery system 100, including the vapor delivery needle 106 extending beyond the shaft and exposing the vapor delivery ports 108; Ratnakar: Col. 10, lines 64-67 & Col. 11, lines 1-2: FIG. 14-16 shows side view of the endoscope in FIG. 13 where the rear view module (51) has been deployed for rear view. The support arm (130) is extended forward (140) to an appropriate distance from the distal end (14) of the endoscope as shown in FIG. 14. The rear image lens (52) faces backward in this position and gives a rear view).
Regarding claim 34, Aoki discloses wherein a field of view of the camera includes the radial surface opening ([0029]: The endoscope 2 of the present embodiment has a configuration including a side-viewing optical image pickup system with a predetermined viewing angle .theta.1 as shown in FIG. 3).
Regarding claim 35, Aoki in view of Hastings and Ratnakar disclose wherein the sheath includes a central longitudinal axis extending from the proximal end of the sheath to the distal portion of the sheath (Aoki: axis X, see Figs. 3-4), wherein the camera is angled toward the proximal end (Ratnakar: see Fig. 14).
Claims 2 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Aoki in view of Hastings and Ratnakar, as applied to claim 1, above, and further in view of Rajagopalan et al. (U.S. Pub. No. 20210220045, earliest effective filing date & previously cited), herein referred to as “Rajagopalan”.
Regarding claim 2, Aoki fails to disclose wherein the first electronic component includes at least one of a camera, an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor.
However, Rajagopalan discloses wherein the first electronic component ([0813]: Modification or combinations of the above-described assemblies, other embodiments, configurations, and methods for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the art) includes at least one of a camera ([0300]: visual sensor such as a camera), an optical coherence tomography sensor ([0502]: Imaging device 410 can be configured to be inserted into the patient and can comprise … an optical coherence tomography (OCT) imager), a spectrum analyzing sensor ([0484]: visible sensors include but are not limited to: visible light camera; infrared camera), or a force sensor ([0605]: comprise a sensor configured to produce a signal, the sensor selected from the group consisting of: … force sensor).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the apparatus of Aoki in view of Hastings and Ratnakar to include the plurality of electronic components, as taught by Rajagopalan, for the purpose of information provided by imaging device can be provided to an operator of system and/or used by a component of system, such as controller, to automatically or semi-automatically adjust one or more system parameters such as one or more energy delivery parameters, the spectrum analyzing sensor to differentiate mucosal and submucosal tissue, such as to adjust one or more treatment parameters (e.g. to stop treatment and/or modify the temperature of treatment) based on the differentiation, and for each sensor can be configured to produce a signal that directly correlates to or is otherwise related to a patient parameter or a system parameter. One or more console settings can be manually adjusted (e.g. by a clinician or other operator of system) and/or automatically (e.g. by algorithm of system) based on the sensor signal (Rajagopalan: [0502], [0484], [0605]).
Regarding claim 11, Aoki in view of Hastings and Ratnakar fail to disclose wherein the working channel is a first working channel, wherein the sheath includes a second working channel extending from the proximal end to the distal portion.
However, Rajagopalan discloses wherein the working channel is a first working channel, wherein the sheath includes a second working channel extending from the proximal end to the distal portion ([0414]: Endoscope 50a includes multiple working channels, lumens 51 and 54). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sheath of Aoki in view of Hastings and Ratnakar to include two working channels, as taught by Rajagopalan, for the purpose of enabling insufflation of a body lumen, such as insufflation of a segment of the GI tract (Rajagopalan: [0477]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Aoki in view of Hastings and Ratnakar, as applied to claim 1, above, and further in view of Saadat et al. (U.S. Pub. No. 20150031946, previously cited), herein referred to as “Saadat”.
Regarding claim 6, Aoki discloses wherein the first electronic component has a face directed distally (see Fig. 2 where the field of view of ultrasound array 61 includes a portion in the distal direction), wherein the sheath includes an atraumatic tip at a distal end of the sheath (see Fig. 2 where the distal end is rounded), and wherein the atraumatic tip has a rounded shape (see Fig. 2 where the distal end is rounded), wherein the atraumatic tip of the sheath is disposed distally of the first electronic component, the distal lumen opening, and the working channel opening (see Fig. 2 where the atraumatic tip is located distally of the ultrasound transducer array 61, the first opening 41a and the second opening 41b).
Aoki in view of Hastings and Ratnakar fails to explicitly disclose wherein the atraumatic tip is transparent.
However, Saadat discloses wherein the atraumatic tip is transparent ([0056]: non-coring optically transparent needle tip 3; [0057]: Radiused edge 11 is configured to smooth the edge formed between large radiused surface 10 and fenestration 9 to prevent puncture or incision of tissue as surgical 1 is advanced in the distal direction between anatomical structures). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the atraumatic tip of Aoki in view of Hastings and Ratnakar to be transparent, as taught by Saadat, for the purpose of enabling the tip to house an optical imaging device that is connectable to an imaging display. The optical images are used by the surgeon identify a facial plane through which the surgical probe may safely be advanced towards a target distal region within the body (Saadat: [0056]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Aoki in view of Hastings and Ratnakar, as applied to claim 7, above, and further in view of Kraemer et al. (U.S. Pub. No. 20110218476, preciously cited), herein referred to as “Kraemer”.
Regarding claim 23, Aoki discloses an atraumatic tip (see Fig. 2 where the distal end of distal end cover 42 is rounded), wherein the atraumatic tip is distal to the distal lumen opening (see Fig. 2 where the atraumatic tip is distal to the second opening 41b), the working channel opening (see Fig. 2 where the atraumatic tip is distal to the first opening 41a), and the outer opening (edge line R, Fig. 3; [0026]: The distal end rigid portion 41 has two exposed portions on one surface 43 of the distal end cover 42 of the insertion portion 9 as a longitudinal axis of the distal end portion 6), such that a gap of open space (edge line R, Fig. 3) is disposed longitudinally between (a) the atraumatic tip and (b) the distal lumen opening (see Fig. 4), Aoki in view of Hastings and Ratnakar fails to disclose wherein a camera is mounted on the atraumatic tip, wherein the camera is mounted on the atraumatic tip, such that the camera is distal of the gap of open space and the outer opening, and wherein a line extending normally from a surface camera is angled proximally and toward the outer opening.
However, Kraemer discloses wherein a camera (camera 250) is mounted on the atraumatic tip (see Fig. 2A where camera 250 is on distal tip 272, which is shown as rounded), such that the camera is distal of the gap of open space and the outer opening (see Fig. 2A where camera 520 is distal of aperture 215 and any of the lumens shown in Fig. 2B), and wherein a line extending normally from a surface camera is angled proximally and toward the outer opening (see Fig. 2A where a line extending normally from a surface of the camera is angled such that it includes being angled proximally and includes the aperture 212 in its field of view such that this is seen as being toward the outer opening/aperture 212). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the tip of Aoki in view of Hastings and Ratnakar to have a camera, as taught by Kraemer for the purpose of the camera enabling a side-looking view for observing adjacent tissue and aiding the user to find the optimal tissue location (Kraemer: [0071], [0078]).
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Aoki in view of Hastings and Ratnakar, as applied to claim 30, above, and further in view of Kadamus et al. (U.S. Pub. No. 20200305972, previously cited), herein referred to as “Kadamus”.
Regarding claim 31, Aoki discloses wherein the first electronic component is fixedly attached to an interior surface of the distalmost tip (see Figs. 2-4 where ultrasound transducer array 61 is a fixed feature of surface 43), but Aoki fails to disclose wherein the first electronic component is a camera.
However, Kadamus discloses wherein the first electronic component is a camera ([0110]: functional element 109d can comprise a camera). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the first electronic component of Aoki in view of Hastings and Ratnakar to be a camera, as taught by Kadamus, for the purpose of allowing an operator to visualize or otherwise assess the tissue expansion or other injectate delivery procedure (Kadamus: [0083]).
Regarding claim 32, Aoki in view of Hastings discloses wherein the vapor delivery member is configured to be transitioned from a first configuration to a second configuration, wherein, in the first configuration, the vapor delivery member does not extend out of the distal portion and wherein, in the second configuration, the vapor delivery member extends out of the radial surface opening (Aoki: edge line R, Fig. 3; [0026]: The distal end rigid portion 41 has two exposed portions on one surface 43 of the distal end cover 42 of the insertion portion 9 as a longitudinal axis of the distal end portion 6; Hastings: [0037]: FIG. 2A shows a close-up view of the distal portion of the shaft of vapor delivery system 100, including the vapor delivery needle 106 extending beyond the shaft and exposing the vapor delivery ports 108; [0034]: the actuation mechanism can be configured to extend/retract the vapor delivery needle), wherein, while the vapor delivery member is in the second configuration, a field of view of the camera includes the vapor delivery member, the gap, and the radial surface opening (wherein this combination of Aoki and Hastings, the view of puncture needle 101 emerging out of second opening and the field of view of ultrasound transducer array 61 in Aoki Fig. 4 is being modified to Hastings’ vapor delivery needle is seen as meeting the claim’s limitation).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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