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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 2nd, 2026 has been entered.
Response to Amendment
Applicant’s amendments to the Claims have overcome the 112(b) rejection previously set forth in the Final Office Action mailed October 1st, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 16 & 19 on pages 10-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 7, 26 & 29 objected to because of the following informalities:
Claim 7, line 5: “radially” should read --radial--,
Claim 26, line 3: “radially” should read --radial--,
Claim 29, line 2: “radially” should read --radial--.
Appropriate correction is required.
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, 10-11 & 29 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (U.S. Pub. No. 20220000341, earliest effective filing date & previously cited) in view of Ratnakar (U.S. Pat. No. 8585584), herein referred to as “Ratnakar”.
Regarding claim 1, Zhang discloses a device for vapor ablation ([0077]: In some examples, the present disclosure provides methods and systems … water vapor therapy; [0213]: While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention), the device comprising:
a sheath (device shaft 103, Fig. 1) extending from a proximal end (portion of device shaft 103 closest to block 105) to a distal portion (portion of device shaft 103 furthest from block 105), wherein the sheath includes a lumen (lumen where needle-like tube 104 resides) terminating distally at a distal lumen opening (opening where needle-like tube 104 is projecting out of), and wherein the sheath includes a working channel extending from the proximal end and terminating distally at a working channel opening ([0089]: For example, in some cases, the device may comprise multiple channels for delivering multiple materials or instruments. The channels may be similar to one another or may be different; [0122]: In some examples, the one or more instruments (e.g., disposable instruments) may be one or more instruments selected from a morcellator, scissors, a needle; [0131]: the device 901 (such as the endoscope of the device) may further comprise a channel 910. In some cases, the channel may be referred to as the working channel. In some examples, the channel may be an implant delivery channel. The channel may comprise other purposes and/or applications. The channel may reside at the distal end or at other places on the device; see Fig. 9 where sheath 920 comprises working channel 910 such that it extends from the proximal end to the distal end of the device and terminates distally at a working channel opening & that while a morcellator is shown, the device may be a needle; see also [0125] & [0126]);
a vapor delivery member (needle-like tube 104) received in the lumen (see Fig. 1), 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 ([0089]: Referring to FIG. 1, another use of the channel 104 may allow steam to go from proximal end to distal tip of the bent needle (shown in FIG. 4B)); and
a first electronic component (camera module 101) having a chip ([0086]: camera module (e.g. camera sensor)), wherein the chip is fixedly disposed proximate to the distal lumen opening ([0086]: the camera module and/or the illumination source may be attached permanently; [0087] Referring to FIG. 1, in some examples, the camera module 101 can be tilted with a given angle inside the device (e.g., integrated device); see Fig. 1 where camera module 101 is disposed proximate the opening where the needle-like tube 104 resides), 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 (see Fig. 1 and Fig. 9 such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the camera module, and the distal lumen opening, such that the working channel, the camera module, and the distal lumen opening are in line with one another).
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Annotated Zhang Figs. 1 & 9 showing the alignment of the features.
But Zhang fails to disclose wherein the chip is disposed radially between the working channel opening and the distal lumen opening; and
a second electronic component fixedly disposed proximate to the distal lumen opening,
wherein the working channel and the second electronic component are positioned on a first side of the first electronic component, wherein the lumen is positioned on a second side of the first electronic component, and wherein the second side is opposite to the first side, 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) 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 Fig. 5 & annotated figure, below), such that the working channel (opening of air/water channel 24), the electronic component (image lens 20), and the distal lumen opening (opening of main instrument channel 25) are in line with one another (see annotated figure, below; 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
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 the working channel (air/water channel 24) and the second electronic component (rear image lens 52) are positioned on a first side of the first electronic component (main image lens 20; see Fig. 5 where the air/water channel 24 and the rear image lens are on a first side: in Fig. 5, this is the upper side relative the main image lens 20), wherein the lumen (main instrument channel 25) is positioned on a second side of the first electronic component (main image lens 20; see Fig. 5 where the main instrument channel 25 is positioned on a second side: in Fig. 5 this is the lower side relative to the main image lens 20), and wherein the second side is opposite to the first side (see Fig. 5 where relative to the main image lens 20, there is an upper side and a lower side & they are opposite sides to each other), 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 Zhang 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 2, Zhang discloses wherein the first electronic component includes at least one of a camera ([0086]: A camera sensor with lens 101, i.e. CMOS, CCD, or other types of sensors or camera modules may reside at distal of the device), an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor.
Regarding claim 7, Zhang 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 radially outer surface of the distal portion ([0088]: Referring to FIG. 1, Inside the device shaft 103 (e.g., multi-lumen shaft), one channel may be used to allow a semi-rigid, needle-like tube 104 to curve sideways and out of the shaft; [0122]: In some examples, the one or more instruments (e.g., disposable instruments) may be one or more instruments selected from a morcellator, scissors, a needle; see Fig. 1 where the needle-like probe 104 is extending out of an outer opening on an outer surface of the distal portion and see Fig. 9 where the morcellator/needle is not extending out of the distal portion).
Regarding claim 10, Zhang in view of Ratnakar discloses wherein the first electronic component is disposed distally of the distal lumen opening (Zhang: [0067]: the camera module may be at other locations of the device), wherein each of the first electronic component and the second electronic component has a face directed distally (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 11, Zhang 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 ([0089]: Alternatively, other channels in the device may be used to deliver such media, materials, and/or instruments into intended parts of subjects. For example, in some cases, the device may comprise multiple channels for delivering multiple materials or instruments. The channels may be similar to one another or may be different).
Regarding claim 29, Zhang discloses a radial surface opening on a radially outer surface of a distalmost tip of the sheath (Zhang: see Fig. 1 where there is an opening of the surface of the distal end 103 between the distal most rounded end of device shaft 103 and the lumen where needle-like probe 104 is in and Fig. 9 where the working channel is shown as being disposed), wherein the first electronic component faces the radial surface opening (see Zhang Fig. 1 where the lens 101 is facing the opening between the distal most rounded end of device shaft 103 and the lumen such that the lens is facing the opening).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of 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, Zhang discloses wherein the first electronic component has a face directed distally (see Fig. 1 where lens 101 of the camera module is facing distally), wherein the sheath includes an atraumatic tip at a distal end of the sheath (see Fig. 1 where the distal end is rounded), and wherein the atraumatic tip has a rounded shape (see Fig. 1 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. 1 where the distal most rounded end is the distalmost end of the device and in this interpretation of Zhang, the working channel of Fig. 9 is within the embodiment shown in Fig. 1).
While Zhang’s Fig. 4B shows a different view of the distal tip and that it appears transparent, but Zhang in view of 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 Zhang in view of 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 Zhang in view of Ratnakar, as applied to claim 7, above, and further in view of Kadamus et al. (U.S. Pub. No. 20200305972, previously cited), herein referred to as “Kadamus” and Kraemer et al. (U.S. Pub. No. 20110218476, preciously cited), herein referred to as “Kraemer”.
Regarding claim 23, Zhang discloses an atraumatic tip (see fig. 1 where the distal end of device shaft 103 is rounded), wherein the atraumatic tip is distal to the distal lumen opening (see Fig. 1 where the distal rounded tip of device shaft 103 is distal to the opening where the needle-like probe 104 resides), the working channel opening ([0089]: For example, in some cases, the device may comprise multiple channels for delivering multiple materials or instruments. The channels may be similar to one another or may be different; see position of working channel 910 relative to camera 908 in Fig. 9), and the outer opening (see Fig. 1 where the distal rounded tip of device shaft 103 is distal to the opening where the needle-like probe 104 emerges), and while Zhang discusses a gap of open space is disposed longitudinally between (a) the atraumatic tip and (b) the distal lumen opening (space between the camera module 102 and the needle-like probe 104), Zhang in view of Ratnakar fails to explicitly disclose such that a gap of open space is disposed longitudinally between (a) the atraumatic tip and (b) the distal lumen opening and the working channel opening.
However, Kadamus discloses a gap of open space (opening 136) disposed longitudinally between (a) the atraumatic tip (distal end 110) and (b) the distal lumen opening (lumen 112; where fluid delivery element 132 emerges from) and the working channel opening (lumen 111; wherein this lumen is seen as being capable of delivery). 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 Zhang in view of Ratnakar to have a gap of open space, as taught by Kadamus, for the purpose of the opening enabling a portion of tissue T is captured by (e.g. drawn into or otherwise tends toward) tissue capture port, and allowing for one or more injectates can be delivered into tissue T (Kadamus: [0137]).
But Zhang fails to disclose wherein a 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 Zhang in view of Ratnakar and Kadamus 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 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ratnakar, as applied to claim 7, above, and further in view of Kadamus.
Regarding claim 30, while Zhang discusses a gap of open space is disposed longitudinally between (a) the atraumatic tip and (b) the distal lumen opening (space between the camera module 102 and the needle-like probe 104), wherein the first electronic component is positioned at a proximal end of the gap and faces the gap (see Zhang Fig. 1 where the lens 101 is positioned at a proximal end of the space within the distal tip 103 and is facing the space within the distal tip 103), but Zhang in view of Ratnakar fails to explicitly disclose wherein the distalmost tip of the sheath includes a gap of open space disposed longitudinally between (a) the distalmost tip and (b) the distal lumen opening and the working channel opening, wherein the first electronic component is positioned at a proximal end of the gap and faces the gap.
However, Kadamus discloses the distalmost tip of the sheath includes a gap (opening 136) of open space disposed longitudinally between (a) the distalmost tip (distal end 110) and (b) the distal lumen opening (lumen 112; where fluid delivery element 132 emerges from) and the working channel opening (lumen 111; wherein this lumen is seen as being capable of delivery). 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 Zhang in view of Ratnakar to have a gap of open space, as taught by Kadamus, for the purpose of the opening enabling a portion of tissue T is captured by (e.g. drawn into or otherwise tends toward) tissue capture port, and allowing for one or more injectates can be delivered into tissue T (Kadamus: [0137]).
Regarding claim 31, Zhang discloses wherein the first electronic component is fixedly attached to an interior surface of the distalmost tip, wherein the first electronic component is a camera ([0086]: A camera sensor with lens 101, i.e. CMOS, CCD, or other types of sensors or camera modules may reside at distal of the device … In some examples, the camera module and the illumination source may be attached to the device distal tip).
Regarding claim 32, Zhang 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 ([0088]: Referring to FIG. 1, Inside the device shaft 103 (e.g., multi-lumen shaft), one channel may be used to allow a semi-rigid, needle-like tube 104 to curve sideways and out of the shaft; [0122]: In some examples, the one or more instruments (e.g., disposable instruments) may be one or more instruments selected from a morcellator, scissors, a needle; see Fig. 1 where the needle-like probe 104 is extending out of an outer opening on an outer surface of the distal portion and see Fig. 9 where the morcellator/needle is not extending out of the distal portion), 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 (see Zhang Fig. 1 where the needle-like probe 104 is extending out of the cap such that the field of view of the camera 101 includes the needle-like probe 104, the gap and the radial surface opening).
Claims 16 & 27 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ratnakar.
Regarding claim 16, Zhang discloses a device for vapor ablation ([0077]: In some examples, the present disclosure provides methods and systems … water vapor therapy; [0213]: While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention), the device comprising:
a sheath (device shaft 103, Fig. 1) extending from a proximal end (portion of device shaft 103 closest to block 105) to a distal portion (portion of device shaft 103 furthest from block 105), wherein the sheath includes a working channel ([0089]: For example, in some cases, the device may comprise multiple channels for delivering multiple materials or instruments. The channels may be similar to one another or may be different), the working channel extending from the proximal end to a working channel opening at the distal portion ([0089]: For example, in some cases, the device may comprise multiple channels for delivering multiple materials or instruments. The channels may be similar to one another or may be different; [0122]: In some examples, the one or more instruments (e.g., disposable instruments) may be one or more instruments selected from a morcellator, scissors, a needle; [0131]: the device 901 (such as the endoscope of the device) may further comprise a channel 910. In some cases, the channel may be referred to as the working channel. In some examples, the channel may be an implant delivery channel. The channel may comprise other purposes and/or applications. The channel may reside at the distal end or at other places on the device; see Fig. 9 where sheath 920 comprises working channel 910 such that it extends from the proximal end to the distal end of the device and terminates distally at a working channel opening & that while a morcellator is shown, the device may be a needle; see also [0125] & [0126]),
a lumen extending (lumen where needle-like tube 104 resides) from the proximal end (see Fig. 1) to a lumen opening at the distal portion (opening where needle-like tube 104 is projecting out of), wherein a vapor delivery member (needle-like tube 104) is disposed within the lumen ([0089]: Referring to FIG. 1, another use of the channel 104 may allow steam to go from proximal end to distal tip of the bent needle (shown in FIG. 4B));
a camera (camera module 101) having a chip ([0086]: camera module (e.g. camera sensor)), wherein the chip is disposed proximate to the lumen opening ([0086]: the camera module and/or the illumination source may be attached permanently; [0087] Referring to FIG. 1, in some examples, the camera module 101 can be tilted with a given angle inside the device (e.g., integrated device); see Fig. 1 where camera module 101 is disposed proximate the opening where the needle-like tube 104 resides), 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 Fig. 1 and Fig. 9 such that a straight line extending perpendicularly to a central longitudinal axis of the sheath intersects the working channel, the camera module, and the distal lumen opening, such that the working channel, the camera module, and the distal lumen opening are in line with one another),
wherein a distalmost tip of the sheath is disposed distally of the camera, the lumen opening, and the working channel opening (see Fig. 1 where the rounded end of device shaft 103 is the distalmost end of the shaft).
But Zhang fails to disclose wherein the chip is disposed radially between the working channel opening and the lumen opening,
an electronic component, 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, wherein the electronic component is positioned between the working channel and an outer surface of the sheath.
However, Ratnakar discloses 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 Zhang 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 27, Zhang in view of Ratnakar discloses wherein, the straight line intersects the electronic component (see annotated Fig. 5 of Ratnakar, above).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ratnakar, as applied to claim 16, 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 17, Zhang in view of Ratnakar fail to disclose a plurality of electronic components that includes the electronic component, wherein the plurality of electronic components includes an optical coherence tomography sensor, a spectrum analyzing sensor, and a force sensor.
However, Rajagopalan discloses a plurality of electronic components that includes the 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), wherein the plurality of electronic components includes 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), and 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 Zhang in view of 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]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ratnakar, as applied to claim 16, above, and further in view of Kadamus.
Regarding claim 24, Zhang discloses a gap of open space disposed longitudinally between (a) the distalmost tip and (b) the distal lumen opening (Zhang: see Fig. 1 where there is a gap between the distal most rounded end of device shaft 103 and the lumen where needle-like probe 104 is in and Fig. 9 where the working channel is shown as being disposed), but Zhang in view of Ratnakar fail to explicitly disclose a gap of open space disposed longitudinally between (a) the distalmost tip and (b) the distal lumen opening and the working channel opening.
However, Kadamus discloses a gap of open space (opening 136) disposed longitudinally between (a) the distalmost tip (distal end 110) and (b) the distal lumen opening (lumen 112; where fluid delivery element 132 emerges from) and the working channel opening (lumen 111; wherein this lumen is seen as being capable of delivery). 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 Zhang in view of Ratnakar to have a gap of open space, as taught by Kadamus, for the purpose of the opening enabling a portion of tissue T is captured by (e.g. drawn into or otherwise tends toward) tissue capture port, and allowing for one or more injectates can be delivered into tissue T (Kadamus: [0137]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ratnakar and Kadamus, as applied to claim 24, above, and further in view of Kraemer.
Regarding claim 28, Zhang in view of Ratnakar and Kadamus fail to disclose wherein the camera faces at least partially proximally, toward the lumen opening and the working channel opening.
However, Kraemer discloses wherein the camera (camera 250; Fig. 2A) faces at least partially proximally, toward the lumen opening and the working channel opening ([0071]: The viewing mechanism 250, or camera, can be disposed within the catheter 200. The camera 250 can provide a side-looking view … the camera 250 includes an articulating head that can be controlled by the controller 216; [0069]: The catheter can include separate internal lumens 224, 226, 228 that individually house the described features, the camera, the inflation gas, and the magnet driveshaft and electrical connections, respectively, for at least a portion of the catheter length; see Fig. 2A where camera window 214 is disposed on a side of distal tip 272 such that it is faced at least partially in a proximal direction and wherein the configuration is capable of fixing the direction the camera faces such that it is capable of facing a proximal direction, and towards lumen openings and working channel openings).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the camera of Zhang in view of Ratnakar and Kadamus to comprise the camera of 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 19 & 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey et al. (U.S. Pub. No. 20180168712, cited in IDS), herein referred to as “Hoey” in view of Fonger et al. (U.S. Pub. No. 20170319233), herein referred to as “Fonger”.
Regarding claim 19, Hoey discloses a device for vapor ablation (Abstract: A vapor delivery needle), the device comprising:
a sheath (introducer portion 110) extending from a proximal end to a distal portion ([0084]: The introducer body 144 extends to a distal working end portion 145; where anything proximal to the distal working end portion may be seen as a proximal end), wherein the sheath includes a lumen terminating distally at a lumen opening (passageway 148; see Fig. 8);
a lumen (passageway 148) extending from the proximal end to a lumen opening at the distal portion ([0084]: the extendable-retractable microcatheter 105 comprises a thin-wall flexible polymer tube with a sharp tip that is axially slidable in a passageway 148 in the introducer portion 110; see Fig. 4 where the introducer portion 110 is on the proximal portion of the device & that passageway 148 terminates at curvilinear region 177 of microcatheter 105), wherein a vapor delivery member is disposed within the lumen ([0084]: passageway 148 that accommodates the microcatheter member 105);
a working channel (bore 115) extending from the proximal end to a working channel opening at the distal portion ([0082]: The bore 115 in the rigid extension sleeve extends along longitudinal axis 116; [0083]: Referring to FIGS. 5-6, in which the molded handle left and right sides are not shown, it can be seen that bore 115 in sleeve 112 has a proximal open end 130 into which the endoscope 118 can be inserted; [0084]: Referring to FIGS. 8-9, the distal end portion 145 of the introducer body 144 is configured with openings 160 that open to central open region 162 that is distal to the distal lens 164 of endoscope 118 that allows for viewing of the urethra through the lens 164 of the endoscope during navigation; where endoscope 118 is disposed within bored 115);
a distal tip (distal working end portion 145) at a distal end of the sheath ([0084]: the introducer portion 110 comprises an elongate introducer body 144 of plastic or another suitable material that surrounds extension sleeve 112. The introducer body 144 extends to a distal working end portion 145);
but Hoey fails to disclose a camera fixedly disposed in the distal tip, 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, and wherein the distal tip includes a gap between (a) the lumen opening and the working channel opening and (b) the camera, wherein the camera is disposed on a distal side of the gap, wherein the camera faces at least partially toward the lumen opening and the working channel opening.
However, Fonger discloses a camera (camera 83, Figs. 22-26) fixedly disposed in the distal tip ([0078]: camera 83 is attached on an underside of the hinged shell 81), 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 ([0078]: oriented generally in a downward orientation to capture images of the treatment region and/or instruments used to perform treatment; see the rest of [0078] where the orientation of the shell 81 & camera 83 are disclosed & “at least partially in a proximal direction” is seen as a camera/field of view that is pointed in any other direction outside of the main longitudinal axis of the device (e.g. a camera at a 15 degree angle relative the longitudinal axis is still seen as facing “at least partially in a proximal direction”); see also guidewire 90 which occupies an axis of the device that passes through the sheath and distalmost tip), and in all configurations of the camera (see Figs. 23-25 to see the positions of the camera 83 and how it is positioned such that a portion of the camera views proximally), and wherein the distal tip includes a gap ([0078]: an underside of the hinged shell 81) between (a) the lumen opening (lumen opening 86) and the working channel opening and (b) the camera (camera 83) (see Figs. 23-26 where the underside of the hinged shell 81 extends between lumen opening 86 and camera 83), wherein the camera is disposed on a distal side of the gap (see Figs. 23-26), wherein the camera faces at least partially toward the lumen opening and the working channel opening (wherein “at least partially” is being interpreted broadly such that an angled camera is seen as facing at least partially towards the lumen opening; see Figs. 23-26 where the field of view of the camera is facing “at least partially” towards the openings 85 & 86 & see [0078 regarding the angle of the camera).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the distal tip of Hoey to comprise a camera, as taught by Fonger for the purpose of capturing images of the treatment region and/or instruments used to perform treatment and the camera orientation facilitating improved spatial reconciliation, allowing the user to see the treatment instrument and a topographical view of where the treatment instrument can be used to provide treatment with a region, for example, in relation to anatomical structures that should be treated or avoided (Fonger: [0078]).
Regarding claim 26, Hoey in view of Fonger 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 radially outer surface of the distal tip, wherein the camera faces the radial surface opening (Hoey: [0081]: The probe 100 further carries an extendable and retractable microcatheter member 105 (FIGS. 5-6) having a distal tip portion 108 (FIG. 4) that can be penetrated into precise targeted locations in prostate lobes to ablate targeted tissue volumes; [0084]: Referring to FIGS. 8-9, the distal end portion 145 of the introducer body 144 is configured with openings 160 that open to central open region 162 that is distal to the distal lens 164 of endoscope 118 that allows for viewing of the urethra through the lens 164 of the endoscope during navigation … In FIG. 8, it can be seen that the working end portion 105 of the flexible microcatheter shaft 105 is disposed adjacent to open region 162 and thus can be viewed through the endoscope lens 164; Fonger: [0080]: In one example, instrument opening 86 is configured to allow an ablation catheter 100 (FIG. 25) to extend to treat tissue in a treatment region of the patient and openings 89 are configured to provide a light from light channels (e.g., with fiber optic cables); see Fig. 25 where ablation catheter 100 is within the gap/the underside of the hinged shell 81 such that this is seen as extending through a radial surface opening on a radially outer surface of the distal tip & the camera 83 is facing where the ablation catheter 100 is emerging from).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Fonger, as applied to claim 19, above and further in view of Kadamus.
Regarding claim 20, Hoey in view of Fonger fails to disclose wherein the device further comprises a second electronic component, wherein the second electronic component includes at least one of an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor.
However, Kadamus discloses wherein the device further comprises a second electronic component (functional element 109/134b, see that there are two functional elements 109 in Fig. 3), wherein the second electronic component includes at least one of an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor ([0224]: System 10 can further include one or more imaging devices, such as imaging device 410. Imaging device 410 can be configured to be inserted into the patient and can comprise … an optical coherence tomography (OCT) imager, such as when integral to, attached to, contained within and/or proximate to shaft 110a). 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 Hoey in view of Fonger to include the second electronic component of Kadamus for the purpose of providing imaging information to the operator of the system (Kadamus: [0224]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey in view of Fonger and Kadamus as applied to claim 20, above, and further in view of Molnar.
Regarding claim 25, Hoey in view of Fonger and Kadamus disclose wherein the second electronic component is disposed radially between the working channel opening and the lumen opening (Kadamus: see Fig. 3 where functional element 109/134b is disposed between two channels, 112 & 111 such that in this combination, the radial location is taught by Kadamus but the lumens are still those of Hoey), but Hoey in view of Fonger and Kadamus fail to disclose such that a straight line extending perpendicularly to a straight central longitudinal axis of the sheath intersects the working channel, the camera, and the lumen opening.
However, Molnar discloses such that a straight line extending perpendicularly to a straight central longitudinal axis of the sheath intersects the working channel (ETT lumen 468; wherein ETT stand for endotracheal tube), the camera (distal opening 472A; [0173]: the camera channel 472 … camera can be inserted and slid along the camera channel 472. The camera can protrude distally from the distal opening 472A of the camera channel 472), and the lumen opening (esophageal channel 474) ([0173]: the camera channel 472 is positioned centrally or near the central axis of the oral airway device 460; [0174]: ETT lumen 468 which is positioned peripherally from the central location of the camera channel 472; [0178]: The esophageal channel 474 is positioned peripherally to the camera channel 472 and can be used with various tools, as discussed in connection with other embodiments; see annotated Fig. 1N, above).
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 Hoey in view of Fonger and Kadamus to have the straight line configuration of Molnar for the purpose of the peripheral location of the openings relative to the chip/distal opening 472 enabling continuous visualization from a camera inserted through distal opening 472A of devices inserted through the working channel opening/ETT lumen 468 and the distal lumen opening/esophageal opening 472 (Molnar: [0180], [0181]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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