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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/17/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “705” has been used to designate both “a proximal portion of tunneling shaft 713” and “an impedance sensor”.
FIG. 7B: This figure includes two labels 705, one corresponding to “a proximal portion of tunneling shaft 713” and the other corresponding to “an impedance sensor”. The examiner would recommend using two different labels to avoid potential confusion.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIG. 16: Although the specification states “In operation according to one example, method 1600 includes inserting a tunneling shaft 514 of tunneling tool 510 into a patient proximate the sternum (or some other part of the patient’s body (1605)” [0118] and “In operation according to one example, method 1600 includes activating one or more lighting elements 524 of tunneling shaft 514 (1606)” [0119]. However, this figure does not include labels “1605” and “1606”. Rather the step “Insert tunneling shaft into patient” is denoted with label 1604 and the step “Activate lighting elements of tunneling shaft” is denoted with label “1506”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0063]: As written it reads “In some examples, lighting elements 524 may be configured to emit light in a particular wavelength. For example, lighting element 524A may be a red LED, lighting element 524B may be a blue LED, and lighting element 524C may be a green LED”. However, this is the first instance of the term “LED”, therefore, the term should be spelled out to provide clarity.
[0098]: As written it reads “In the example of FIG. 11, lighting element 114 is disposed inside shaft lumen 1116 of tunneling shaft 1112. […] Light emitted in other directions may be blocked or suppressed by the opaque material of tunneling shaft 1012”. However, the examiner believes “1012” is a typo since this paragraph describes components within FIG. 11 (i.e. label 1012 is within FIG. 10).
[0109]: As written it reads “For example, the tunneling tool may include pin 1404 extending from tunneling shaft 14fnd resisting depression via a spring within tunneling shaft 1414”. However, to correct the typo “14fnd” should be “1414”.
Appropriate correction is required.
Claim Objections
Claims 5, 7, 13, 16-17 are objected to because of the following informalities:
Regarding claims 5 and 17, as written it reads ”wherein the predefined criteria include one or more of: a distance between the tunneling tool from and key tissues satisfying a threshold”. However, to be grammatically correct the examiner believes “from” should be removed.
Regarding claim 7, as written it reads “wherein the one or more lighting elements comprise one or more of: a discrete light component, a continuous linear light source; a fiberoptic component; a laser; and an LED”. However, this is the first indication of the term “LED” within the claims, therefore, the term should be spelled out to provide clarity.
Regarding claims 13, 16 and 17, as written the preambles state “The tunneling tool of claim 12” (Claims 13 and 16) and “The tunneling tool of claim 16” (Claim 17). However, claim 12 is directed to “An implant system”. Therefore, the examiner would recommend updating the claim language to recite “The implant system of claim 12” and “The implant system of claim 16”, accordingly.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7-9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ebersole et al. US 2022/0031390 A1 “Ebersole”.
Regarding claim 1, Ebersole teaches “A tunneling tool comprising:” (“FIGS. 3-6 are functional schematic diagrams illustrating an example bipolar tunneling tool 30 for gaining sub-sternal access and creating a sub-sternal tunnel in a patient, according to some examples. FIG. 3 illustrates bipolar tunneling tool 30 including a tunneling shaft 32 and a handle 34” [0034].
“a handle” (See [0034] above, and handle 34 in FIG. 3. Thus, the tunneling tool includes a handle.);
“a tunneling shaft extending from the handle and defining a length” (See [0034] above and tunneling shaft 32 in FIG. 3 and “As shown in FIG. 3, tunneling shaft 32 of bipolar tunneling tool 30 extends from proximal end 36 to distal end 38 (or “distal tip 38”). Bipolar tunneling tool 30 also includes handle 34, which is shown coupled to proximal end 36 of tunneling shaft 32. Tunneling shaft 32 may extend from proximal end 36 to distal end 38 in a linear or straight manner. In some examples, as shown in FIG. 3, at least a portion of tunneling shaft 32 extends in a curved orientation from proximal end 36 to distal end 38, e.g., relative to an axis 40” [0035]. As shown in FIG. 3, the tunneling shaft 32 extends from handle 34 and has a definite length (i.e. extends from proximal end 36 to distal end 38). Therefore, the tunneling tool includes a tunneling shaft extending from the handle and defining a length.);
“one or more lighting elements disposed along the length of the tunneling shaft, each of the one or more lighting elements configured to emit light detectable through tissue of a patient by an optical sensor” (“An optical window disposed at a distal end of the tunneling shaft may be configured to allow viewing therethrough to facilitate guidance of the bipolar tunneling tool along a desired dissection path. For example, a lighting element disposed within the tunneling shaft may emit light that passes through the optical window, illuminating an internal cavity of the patient. The emitted light may then return through the optical window to reach a camera (or other optical device) disposed within the tunneling shaft. In some cases, the lighting element is a fiber optic array, and the fiber optic array is configured to surround (e.g., encircle) the camera” [0024]; “FIG. 11 is a conceptual diagram showing one possible arrangement of a lighting element 112 disposed proximate a camera 110 of bipolar tunneling tool 30. In some examples, lighting element 112 may be disposed proximate optical window 44. Lighting element 112 may be configured to emit light through optical window 44. Camera 110 may be disposed proximate optical window 44; lighting element 112 may be disposed proximate camera 110. In the example of FIG. 11, lighting element 112 is a fiber optic array encircling camera 110. Camera 110 may be mounted to tunneling shaft 32 in any suitable way. Camera 110 may be centrically disposed between lighting element 112 or may be off-center depending upon a particular purpose” [0072].
Therefore, since the bipolar tunneling tool (i.e. 30) includes an optical window which allows light to pass from a lighting element disposed within the tunneling shaft (i.e. lighting element 112 shown in FIG. 11), the tunneling tool includes one or more lighting elements (i.e. lighting elements 112/fiber optic array) disposed along the length of the tunneling shaft (i.e. 32), each of the one or more lighting elements configured to emit light detectable through tissue of a patient by an optical sensor (i.e. camera 110).).
Regarding claim 7, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ebersole further teaches “wherein the one or more lighting elements comprise one or more of: a discrete light component; a continuous linear light source; a fiberoptic component; a laser; and an LED” (“In some cases, the lighting element is a fiber optic array, and the fiber optic array is configured to surround (e.g., encircle) the camera” [0024]. Therefore, the one or more lighting elements comprise one or more of: a discrete light component; a continuous linear light source; a fiberoptic component; a laser; and an LED; specifically, a fiberoptic component (i.e. fiber optic array.).
Regarding claim 8, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ebersole further teaches “wherein the one or more lighting elements are incorporated into the tunneling shaft” (“For example, a lighting element disposed within the tunneling shaft may emit light that passes through the optical window, illuminating an internal cavity of the patient” [0024]; “In some examples, lighting element 112 may be disposed proximate optical window 44. Lighting element 112 may be configured to emit light through optical window 44 Camera 110 may be disposed proximate optical window 44 […] Camera 110 may be mounted to tunneling shaft 32 in any suitable way” [0072]. Therefore, the one or more lighting elements (i.e. within lighting element 112) are incorporated into the tunneling shaft (i.e. 32).).
Regarding claim 9, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ebersole further teaches “wherein the one or more lighting elements encircle the tunneling shaft” (See [0024] as discussed in claim 8 and FIG. 11. As shown in FIG. 11, there are multiple lighting elements 112 around the camera 110, wherein this configuration is incorporated into the tunneling shaft 32 (see [0024]). Therefore, the one or more lighting elements encircle the tunneling shaft.).
Regarding claim 11, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ebersole further teaches “wherein the one or more lighting elements are disposed on a fiber within a lumen defined by the tunneling shaft” (See [0024] as discussed in claim 8 and “Tunneling shaft 32 defines an inner lumen 46 that extends from the proximal end 36 to distal end 38.” [0041]. As shown in FIG. 11 the lighting elements 112 are disposed around the camera 110 which is disposed within the tunneling shaft (i.e. within lumen 46, see FIG. 4) in order to allow light to pass through the optical window 44. Therefore, the one or more lighting elements are disposed on a fiber (i.e. fiber optic array) within a lumen (i.e. 46) defined by the tunneling shaft (i.e. 32).).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3, 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebersole et al. US 2022/0031390 A1 “Ebersole” as applied to claim 1 above, and further in view of O’Sullivan et al. US 2023/0057208 A1 “O’Sullivan”.
Regarding claim 2, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above, however, Ebersole does not teach “wherein the one or more lighting elements comprise at least two lighting elements disposed at different points along the length of the tunneling shaft”.
O’Sullivan is within a related field of endeavor to the claimed invention because it involves a catheter system with two flexible circuits containing light emitting diodes which are activated by a control unit/controller (see [Abstract], [0006], FIG. 3).
O’Sullivan teaches “wherein the one or more lighting elements comprise at least two lighting elements disposed at different points along the length of the tunneling shaft” (“The first flexible circuit and the second flexible circuit may be disposed about the distal end of the elongate shaft in a helical manner. […] The controller may be configured to sequentially vary power between the plurality of first LEDs and the plurality of second LEDs. […] The first LEDs may be configured to emit light at a first wavelength and the second LEDS are configured to emit light at a second wavelength different than the first wavelength. The first LEDs may be configured to emit ultraviolet or visible light. At least one LED of the first LEDs may be configured to emit a frequency of light different than a frequency of light emitted by another LED of the first LEDs” [0006]; “A catheter comprising a first plurality of light-emitting diodes (LEDs) and a second plurality LEDs may be inserted into the patient towards the tissue” [0009]; “A circuit 302 is disposed along the distal end 300d. The circuit 302 includes twelve LEDs 304, although in various embodiments, any number of LEDs may be employed, e.g., 1, 2, 5, 10, 20, 50, etc. […] The circuit controller is able to vary power provided to or otherwise adjust the intensity of the plurality of first LEDs 304 by adjusting an analog knob 356. Alternatively, the knob 356 may be configured for switching activation or adjusting oscillation rate or power level between multiple circuits 302 of LEDs 304” [0032]; “In various embodiments, multiple sets of LEDs may be arranged along and/or about a catheter in various patterns. For example, a first set may be arranged along a first portion and a second set (and/or additional sets) may be arranged along a second portion opposite the first portion. For another example, a first set may be arranged helically about a catheter and a second set (and/or additional sets) may be arranged helically about the catheter adjacent the first set. Sets of LEDs may be independently activatable such that they may, e.g., flash (i.e., be powered on and off or powered and then reduced in power), in a pattern” [0036].
As shown in FIG. 3, the catheter 300 includes multiple circuits 302 containing LEDs 304. Each of these circuits 302 is located at a different position along the length of the catheter 300 in a helical manner. Therefore, the one or more lighting elements (i.e. LEDs 304) comprise at least two lighting elements (i.e. 4 LEDs 304, for example, see FIG. 3) disposed at different points along the length of the tunneling shaft (i.e. catheter 300, see FIG. 3).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole such that the one or more light elements comprise at least two lighting elements disposed at different points along the length of the tunneling shaft as disclosed in O’Sullivan in order to allow light to be emitted in multiple locations along the catheter. Locating multiple sets of LEDs at different positions along the length of a catheter is one of a finite number of techniques which can be used to allow light to be delivered to multiple locations within a patient with a reasonable expectation of success. Thus, modifying the tunneling tool of Ebersole such that the one or more light elements comprise at least two lighting elements disposed at different points along the length of the tunneling shaft as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted in multiple locations along the catheter.
Regarding claim 3, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 2 above, and O’Sullivan further teaches “further comprising control circuitry, and wherein the control circuitry is configured to cause each of the one or more lighting elements to one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity” (See [0006], [0032] and [0036] as discussed in claim 2 above and “The controller may be configured to actuate a portion of the LEDs at a first frequency and another portion of the LEDs at a second frequency, e.g., a distal portion of LEDs at a higher frequency than a proximal portion of LEDs” [0039]. In this case, the controller (i.e. control unit) is configured to sequentially power the first and second LEDs (i.e. included in first and second flexible circuits 302, see [0006], FIG. 3) at different wavelengths. Additionally, the control unit 350 is configured to adjust the intensity of the plurality of LEDs 304 (i.e. adjusting oscillation rate or power) between multiple circuits 302 (i.e. first and second flexible circuits), see [0032]. Finally, the controller/control unit causes the sets of LEDs (i.e. circuits 302) to be independently activatable such that they may flash (see [0036]).
Therefore, the tunneling tool further comprises control circuitry (i.e. controller/control unit 350), and wherein the control circuitry is configured to cause each of the one or more lighting elements (i.e. LEDs 304 included in multiple sets/circuits 302, see FIG. 3) to one or more of: flash at different time intervals (i.e. see [0036]), emit light at a different wavelength (i.e. see [0006]); and emit light at a different intensity (i.e. see [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause each of the one or more lighting elements to one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the tunneling tool of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause each of the one or more lighting elements to one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) and at different locations within a patient’s body when performing a procedure.
Regarding claim 6, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above, and Ebersole further teaches “further comprising: one or more activation elements” (“An activation element, such as a trigger 56 of handle 34 may be selectively actuated by a user to initiate bipolar electrosurgical energy to active electrode 50 and return electrode 52” [0044]. Therefore, the tunneling tool further comprises one or more activation elements.).
However, Ebersole does not teach “control circuitry, wherein the actuation of the one or more activation elements causes the control circuitry to change an operation state of the one or more lighting elements”.
O’Sullivan teaches “control circuitry, wherein the actuation of the one or more activation elements causes the control circuitry to change an operation state of the one or more lighting elements” (See [0032] as discussed in claim 2 above. In this case, the control unit 350 (i.e. control circuity) is configured to adjust the intensity of the plurality of LEDs 304 (i.e. adjusting oscillation rate or power) between multiple circuits 302 (i.e. first and second flexible circuits) through adjusting an analog knob 356.
Therefore, the tunneling tool further comprises control circuitry (i.e. controller/control unit 350), wherein the actuation of the one or more activation elements (i.e. analog knob 356) causes the control circuitry (i.e. within control unit 350) to change an operation state of the one or more lighting elements (i.e. intensity of the plurality of LEDs).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole such that it includes control circuitry, wherein the actuation of the one or more activation elements (i.e. analog knob 356, See FIG. 3) causes the control circuitry (i.e. within control unit 350) to change an operation state of the one or more lighting elements (I.e. LEDs 304) as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the tunneling tool of Ebersole such that it includes control circuitry, wherein the actuation of the one or more activation elements (i.e. analog knob 356, See FIG. 3) causes the control circuitry (i.e. within control unit 350) to change an operation state of the one or more lighting elements (I.e. LEDs 304) as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) and at different locations within a patient’s body when performing a procedure.
Regarding claim 10, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above. While Ebersole does include a lighting element 112 with multiple lights (see FIG. 11), Ebersole does not teach “wherein the one or more lighting elements comprise a lighting element configured to emit light in a distinct, radial direction away from the tunneling shaft”.
O’Sullivan teaches “wherein the one or more lighting elements comprise a lighting element configured to emit light in a distinct, radial direction away from the tunneling shaft” (“Referring to FIG. 3, a catheter system is illustrated according to an embodiment of the present disclosure. The system includes a catheter 300 that is an elongate shaft having a proximal portion 300p and a distal portion 300d. A circuit 302 is disposed along the distal end 300d. The circuit 302 includes twelve LEDs 304, although in various embodiments, any number of LEDs may be employed, e.g., 1, 2, 5, 10, 20, 50, etc.” [0032]. As shown in FIG, 3, the circuit 302 is along the elongate shaft of the catheter 300 and its position causes light to be emitted in a distinct, radial direction away from the tunneling shaft (i.e. perpendicular to the catheter 300, not through the distal tip). Therefore, since any number of LEDs, including 1 LED, can be employed within the circuit 302 to emit light, the one or more lighting elements comprise a lighting element configured to emit light in a distinct, radial direction away from the tunneling shaft.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole such that the one or more lighting element comprise a lighting element configured to emit light in a distinct, radial direction away from the tunneling shaft as disclosed in O’Sullivan in order to deliver light to a specific, known location perpendicular to the tunneling shaft when performing a procedure. Utilizing one lighting element (LED), positioned along a shaft of a catheter to emit light therefrom, is one of a finite number of techniques which can be used to ensure that light is only provided to a distinct location and thereby avoid unnecessarily illuminating tissue with a reasonable expectation of success. Thus, modifying the tunneling tool of Ebersole, such that the one or more lighting element comprise a lighting element configured to emit light in a distinct, radial direction away from the tunneling shaft as disclosed in O’Sullivan would yield the predictable result of delivering light to a specific, known location perpendicular to the tunneling shaft when performing a procedure.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebersole et al. US 2022/0031390 A1 “Ebersole” as applied to claim 1 above, and further in view of O’Sullivan et al. US 2023/0057208 A1 “O’Sullivan” and Xu et al. US 2024/0237899 A1 “Xu”.
Regarding claim 4, Ebersole discloses all features of the claimed invention as discussed with respect to claim 1 above. However, Ebersole does not teach “further comprising control circuitry, wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met, wherein the operation states include one or more of: flash at a different time interval; emit light at a different wavelength; or emit light at a different intensity”.
O’Sullivan is within a related field of endeavor to the claimed invention because it involves a catheter system with two flexible circuits containing light emitting diodes which are activated by a control unit/controller (see [Abstract], [0006], FIG. 3).
O’Sullivan teaches “further comprising control circuitry, wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state […] wherein the operation states include one or more of: flash at a different time interval; emit light at a different wavelength; or emit light at a different intensity” (See [0006], [0032] and [0036] as discussed in claim 2 above and “The controller may be configured to actuate a portion of the LEDs at a first frequency and another portion of the LEDs at a second frequency, e.g., a distal portion of LEDs at a higher frequency than a proximal portion of LEDs” [0039]. In this case, the controller (i.e. control unit) is configured to sequentially power the first and second LEDs (i.e. included in first and second flexible circuits 302, see [0006], FIG. 3) at different wavelengths. Additionally, the control unit 350 is configured to adjust the intensity of the plurality of LEDs 304 (i.e. adjusting oscillation rate or power) between multiple circuits 302 (i.e. first and second flexible circuits), see [0032]. Finally, the controller/control unit causes the sets of LEDs (i.e. circuits 302) to be independently activatable such that they may flash (see [0036]).
Therefore, the tunneling tool further comprises control circuitry (i.e. controller/control unit 305), and wherein the control circuitry is configured to cause each of the one or more lighting elements (i.e. LEDs 304 included in multiple sets/circuits 302, see FIG. 3) to one or more of: flash at different time intervals (i.e. see [0036]), emit light at a different wavelength (i.e. see [0006]); and emit light at a different intensity (i.e. see [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state, wherein the operation sates include one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the tunneling tool of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state, wherein the operation sates include one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body when performing a procedure.
However, the combination does not teach wherein the control circuitry causes the one or more lighting elements to change “in response to a predefined criteria being met”.
Xu is within a related field of endeavor to the claimed invention because it involves a system 100 for endoscopic visualization which includes an emitter 102 and a controller (see [0058] and FIGS. 1A-1C).
Xu teaches that the control circuitry causes the one or more lighting elements to change “in response to a predefined criteria being met” (“The emitter 102 includes one or more EMR sources, which may include, for example, lasers, laser bundles, light emitting diodes (LEDs), electric discharge sources, incandescence sources, electroluminescence sources, and so forth” [0062]; “The controller 104 instructs the emitter 102 to cycle the plurality of EMR sources according to a variable pulse cycle. The controller 104 calculates the variable pulse cycle based at least in part upon a user input indicating the desired visualization scheme. […] In an alternative example, the desired visualization scheme may indicate the user wishes to be notified when nerve tissue can be identified in the scene and/or when a tool within the scene is within a threshold distance from the nerve tissue. […] Additionally, the variable pulse cycle may include pulses of EMR in a mapping pattern configured for laser mapping imaging to determine when the tool is within the threshold distance from the nerve tissue. The controller 104 may reconfigure the variable pulse cycle in real-time in response to receiving a revised desired visualization scheme from the user” [0078]; “The emitter 102 pulses according to a variable pulse cycle that includes one or more types of EMR. The variable pulse cycle may include visible EMR, which may include a white light emission, red light emission, green light emission, blue light emission, or some other waveband of visible EMR” [0091].
In this case, since the controller 104 instructs the emitter 102 (i.e. containing one or more EMR sources such as LEDs) to cycle the plurality of EMR sources according to a variable pulse cycle (i.e. emitter cycles electromagnetic sources on/off (i.e. causing flashing) according to variable pulse cycle, see FIG. 4) when a desired visualization scheme, corresponding to when a tool within the scene is within a threshold distance from the nerve tissue (i.e. key tissue), is achieved, the control circuitry is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met (i.e. a distance between the tunneling tool (i.e. tool) and key tissues (i.e. nerve tissue) satisfying a threshold (i.e. threshold distance)).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met as disclosed in Xu in order to conserve power when performing a procedure within a patient’s body. Emitting light in a variable pulse cycle when a desired visualization scheme (i.e. when a tool within the scene is within a threshold distance from the nerve tissue) is achieved is one of a finite number of techniques which can be used to ensure that light is delivered to the correct location without wasting power with a reasonable expectation of success. Thus, modifying tunneling tool of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met as disclosed in Xu would yield the predictable result of providing light to a desired area within a patient during a procedure while also conserving power.
Regarding claim 5, Ebersole in view of O’Sullivan and Xu discloses all features of the claimed invention as discussed with respect to claim 4 above, and Xu further teaches “wherein the predefined criteria include one or more of: a distance between the tunneling tool from and key tissues satisfying a threshold; a sensed pressure inside the patient satisfying a threshold; and a sensed impedance of patient tissue satisfying a threshold” (See [0062], [0078] and [0091] as discussed in claim 4 above.
In this case, since the controller 104 instructs the emitter 102 (i.e. containing one or more EMR sources such as LEDs) to cycle the plurality of EMR sources according to a variable pulse cycle (i.e. emitter cycles electromagnetic sources on/off (i.e. causing flashing) according to variable pulse cycle, see FIG. 4) when a desired visualization scheme, corresponding to when a tool within the scene is within a threshold distance from the nerve tissue (i.e. key tissue), is achieved, the control circuitry is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met, specifically a distance between the tunneling tool and key tissues satisfying a threshold.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tunneling tool of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met, the predefined criteria being a distance between the tunneling tool and key tissues satisfying a threshold as disclosed in Xu in order to conserve power when performing a procedure within a patient’s body. Emitting light in a variable pulse cycle when a desired visualization scheme (i.e. when a tool within the scene is within a threshold distance from the nerve tissue) is achieved is one of a finite number of techniques which can be used to ensure that light is delivered to the correct location without wasting power with a reasonable expectation of success. Thus, modifying tunneling tool of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met as disclosed in Xu would yield the predictable result of providing light to a desired area within a patient during a procedure while also conserving power.
Claim(s) 12-15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebersole et al. US 2022/0031390 A1 “Ebersole” and further in view of O’Sullivan et al. US 2023/0057208 A1 “O’Sullivan”.
Regarding claim 12, Ebersole teaches “An implant system comprising:” (“This disclosure provides tools and implant techniques utilizing such tools to gain access to spaces within a patient, such as an extravascular space, e.g., to facilitate implantation of medical devices or components thereof, such as a lead, within the space” [0005]; “FIGS. 1A-B are schematics showing an exemplary extravascular implant of an exemplary system 10 that includes a pulse generator 14 and an implantable medical electrical lead 16 coupled thereto” [0026]; “Although FIG. 1A and 1B are described in the context of the distal portion of lead 16 being placed within sub-sternal space 3, in other examples, the tools and implant techniques described herein may be used to implant a distal portion of lead 16 at other locations outside the heart. In one example, the tools may be used to place the distal portion of lead 16 intra-pericardially via a percutaneous subxiphoid approach. In some examples, the tools and implant techniques described herein could be used for implanting other medical devices or components thereof and/or for other spaces within the patient, such as, implanting a leadless pacemaker on or near outside of heart via substernal access” [0028], “In some examples, rigidity of tunneling shaft 32 may be described in the context of possible forces that may act of tunneling shaft 32, e.g., during an implant procedure” [0038]. Therefore, the tools utilized to facilitate implantation of medical devices or components within the patient represent an implant system.);
“a tunneling tool comprising:” (See bipolar tunneling tool 30 in [0034] as discussed in claim 1 above. Therefore, the implant system includes a tunneling tool (i.e. bipolar tunneling tool 30).);
“a handle comprising an activation element” (See handle 34 in [0034] and FIG. 3 as discussed in claim 1 and “An activation element, such as a trigger 56 of handle 34 may be selectively actuated by a user to initiate bipolar electrosurgical energy to active electrode 50 and return electrode 52” [0044]. Therefore, the tunneling tool includes a handle (i.e. 34) comprising an activation element (i.e. trigger 56).); and
“a tunneling shaft extending from the handle and defining a length” (See tunneling shaft 32 in [0034], [0035] and FIG. 3 as discussed in claim 1. As shown in FIG. 3, the tunneling shaft 32 extends from handle 34 and has a definite length (i.e. extends from proximal end 36 to distal end 38). Therefore, the tunneling tool includes a tunneling shaft extending from the handle and defining a length.);
“a plurality of lighting elements disposed along the length of the tunneling shaft” (See [0024] and [0072] as discussed in claim 1. Therefore, since the bipolar tunneling tool (i.e. 30) includes an optical window which allows light to pass from a lighting element disposed within the tunneling shaft (i.e. lighting element 112 shown in FIG. 11), the tunneling tool includes one or more lighting elements (i.e. lighting elements 112/fiber optic array) disposed along the length of the tunneling shaft (i.e. 32).) […] and
“an endoscope comprising a camera configured to visualize a dissection path of the tunneling tool through visualization of light emitted by the plurality of lighting elements through tissue of the patient using the camera” (“Such tunneling tools may also include an optical window for a surgeon or other user to visualize, e.g., using an endoscope inserted within the tunneling tool, the movement of a distal end of the tunneling tool through tissue. Such visualization may provide for better guidance of the tunneling tool during an implant procedure and allow for a clinician to identify locations in which it may be desirable to deploy the cutting tool, e.g., to cut tissue adjacent the distal end of the tunneling tool using sharp dissection rather than blunt dissection” [0032]; “During an implant procedure, an endoscope or other optical tool may be inserted into inner lumen 46 via proximal opening 48 in handle 34 and advanced through lumen 46 to distal end 38 of tunneling tool 32 adjacent optical window 44. In this manner, a surgeon or other user may visualize the path of distal end 38 when advanced through tissue of patient 12 during the insertion of bipolar tunnel tool 32 into patient 12.” [0041]; “Camera 110 may be selectively moveable relative to tunneling shaft 32 and/or lighting element 112 via one or more actuators (not shown) disposed on handle 34. Lighting element 112 may be configured to selectively emit light therefrom in varying intensities via one or more actuators (not shown) or may be configured to automatically adjust the light setting based on an algorithm or generator setting. Lighting element 112 may be configured to turn on with camera 110 or independently. Lighting element 112 may be configured to connect to a generator that supplies energy thereto. Camera 110 may be configured to connect to a display (not shown)” [0073]. As shown in FIG. 11, the lighting elements 112 surround the camera 110 (i.e. endoscope).
In order for the endoscope to be used to guide the tunneling tool during an implantation procedure and visualize the path of distal end 38 (i.e. of the tunneling shaft 32), the endoscope must comprise a camera. Therefore, the implant system comprises an endoscope comprising a camera (i.e. such as camera 110, see FIG. 11) configured to visualize a dissection path of the tunneling tool (i.e. bipolar tunneling tool 30, specifically the distal end 38 of the tunneling shaft 32) through visualization of light emitted by the plurality of lighting elements (i.e. 112) through tissue of the patient using the camera (i.e. camera 110).).
Ebersole does not teach “wherein each of the plurality of lighting elements is configured to emit light at a different wavelength or flash light at different time intervals”.
O’Sullivan is within a related field of endeavor to the claimed invention because it involves a catheter system with two flexible circuits containing light emitting diodes which are activated by a control unit/controller (see [Abstract], [0006], FIG. 3).
O’Sullivan teaches “wherein each of the plurality of lighting elements is configured to emit light at a different wavelength or flash light at different time intervals” (See [0006] and [0036] as discussed in claim 2 above. Therefore, the controller sequentially varies power between the first and second LEDs (i.e. included in separate circuits 302, see FIG. 3), such that the first LEDs emit light at a first wavelength and the second LEDs emit light at a second wavelength. Furthermore, the controller independently activates the sets of LEDs (i.e. within circuits 302, see FIG. 3) such that they may flash in a pattern (i.e. at different time intervals). Therefore, each of the plurality of lighting elements is configured to emit light at a different wavelength or flash light at different time intervals.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant system of Ebersole such that each of the plurality of lighting elements is configured to emit light at a different wavelength or flash light at different time intervals as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the implant system of Ebersole each of the plurality of lighting elements is configured to emit light at a different wavelength or flash light at different time intervals as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) and at different locations within a patient’s body when performing a procedure.
Regarding claim 13, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 12 above, and O’Sullivan further teaches “further comprising control circuitry, wherein the one or more lighting elements comprise at least two lighting elements disposed at different points along the length of the tunneling shaft” (See [0006]; [0009]; [0032]; [0036] as discussed in claim 2. As shown in FIG. 3, the catheter 300 includes multiple circuits 302 containing LEDs 304. Each of these circuits 302 is located at a different position along the length of the catheter 300 in a helical manner. Therefore, the one or more lighting elements (i.e. LEDs 304) comprise at least two lighting elements (i.e. 4 LEDs 304, for example, see FIG. 3) disposed at different points along the length of the tunneling shaft (i.e. catheter 300, see FIG. 3).) and
“wherein the control circuitry is configured to cause each of the one or more lighting elements to one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity” (See [0006], [0032] and [0036] as discussed in claim 2 above and [0039] as discussed in claim 3 above. In this case, the controller (i.e. control unit) is configured to sequentially power the first and second LEDs (i.e. included in first and second flexible circuits 302, see [0006], FIG. 3) at different wavelengths. Additionally, the control unit 350 is configured to adjust the intensity of the plurality of LEDs 304 (i.e. adjusting oscillation rate or power) between multiple circuits 302 (i.e. first and second flexible circuits), see [0032]. Finally, the controller/control unit causes the sets of LEDs (i.e. circuits 302) to be independently activatable such that they may flash (see [0036]).
Therefore, the tunneling tool further comprises control circuitry (i.e. controller/control unit 350), and wherein the control circuitry is configured to cause each of the one or more lighting elements (i.e. LEDs 304 included in multiple sets/circuits 302, see FIG. 3) to one or more of: flash at different time intervals (i.e. see [0036]), emit light at a different wavelength (i.e. see [0006]); and emit light at a different intensity (i.e. see [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant system of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause each of the one or more lighting elements to one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the implant system of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause each of the one or more lighting elements to one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) and at different locations within a patient’s body when performing a procedure.
Regarding claim 14, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 12 above, and Ebersole further teaches “further comprising a sheath defining a sheath lumen, wherein the tunneling shaft is configured to be disposed within the sheath lumen, and wherein the one or more lighting elements are incorporated into the sheath” (“During a procedure to gain sub-sternal access and create a sub-sternal tunnel in a patient, e.g., to implant a medical device such as lead 16, tunneling shaft 32 may be inserted into the inner lumen of an introducer sheath, e.g., wherein the sheath is sized to extend from approximately distal end 38 to approximately proximal end 36 of tunneling shaft 32 prior to insertion and advancement of tunneling shaft 32 in patient 12. An example of an introducer sheath 41 is illustrated in FIG. 7. Sheath 41 includes a body 43 and a handle 45. Body 43 of sheath 41 defines an inner channel” [0051]. Since the tunneling shaft 32, which includes the lighting elements 112 disposed therein, (see [0024]) is introduced into the inner lumen of introducer sheath 41, by virtue of the positioning of the tunneling shaft 32 within the introducer sheath 41, the one or more lighting elements are incorporated into the sheath.).
Regarding claim 15, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 12 above, and Ebersole further teaches “further comprising a display and processing circuitry configured to: output an image to the display based on sensed data from the camera; estimate a trajectory of the tunneling shaft; and project the trajectory onto the display” (“Camera 110 may be configured to connect to a display (not shown)” [0073]; The user may visualize the dissection path during operation of bipolar tunneling tool 30 using guide member 88 and/or camera 110 (1204). […] Additionally, or alternatively, the user may refer to a display connected to camera 110. Camera 110 and/or lighting element 112 may be selectively adjusted as needed (e.g., via one or more actuators disposed on handle 34) to ensure adequate visualization during dissection of tissue” [0076]. In order to display the dissection path to a user, processing circuitry must be present. Therefore, the implant system further comprises a display and processing circuity configured to: output an image to the display based on sensed data from the camera, estimate a trajectory (i.e. dissection path) of the tunneling shaft (i.e. 32); and project the trajectory onto the display.).
Regarding claim 18, Ebersole teaches “A method comprising:” (“FIGS. 8A-8D are conceptual diagrams illustrating a progression of bipolar tunneling tool 30 during an example tunneling technique in accordance with the disclosure to insert at least a portion of shaft 32 into the substernal space under sternum 13. As described herein, the surgeon or other operator may selectively deploy or recess active electrode 50 at distal end 38 of tunneling shaft 32 as desired during the tunneling procedure as well as visualize the tissue space through optical window 44 during the procedure” [0053]. Therefore, FIGS. 8A-8D illustrate a method of using bipolar tunneling tool 30.);
“inserting an endoscope into a patient, wherein the endoscope includes a camera” (“During an implant procedure, an endoscope or other optical tool may be inserted into inner lumen 46 via proximal opening 48 in handle 34 and advanced through lumen 46 to distal end 38 of tunneling tool 32 adjacent optical window 44. In this manner, a surgeon or other user may visualize the path of distal end 38 when advanced through tissue of patient 12 during the insertion of bipolar tunnel tool 32 into patient 12” [0041]; “As shown in FIG. 8A, a distal portion of tunneling shaft is inserted through an incision site, e.g., at access site A shown in FIG. 2, with active electrode 50 in the recessed position at distal end 38 of tunneling shaft 32, with the operator controlling the movement of shaft 32 by gripping handle 34, which is located externally. Handle 34 remains outside patient 12 to allow for a surgeon or other operator to maneuver tunneling shaft 32 along the desired path within the substernal space of patient 12. Distal end 38 of shaft 32 may be advanced superiorly, e.g., to the position shown in FIG. 8B, to create a portion of a passageway and a sub-sternal tunnel. The surgeon or other operator may view the path of distal end 38 of tunneling shaft 32 during the procedure through optical window 44 using an endoscope or other viewing device inserted within inner lumen 46 of shaft 32” [0054]; “Camera 110 may be selectively moveable relative to tunneling shaft 32 and/or lighting element 112 via one or more actuators (not shown) disposed on handle 34. Lighting element 112 may be configured to selectively emit light therefrom in varying intensities via one or more actuators (not shown) or may be configured to automatically adjust the light setting based on an algorithm or generator setting. Lighting element 112 may be configured to turn on with camera 110 or independently. Lighting element 112 may be configured to connect to a generator that supplies energy thereto. Camera 110 may be configured to connect to a display (not shown)” [0073].
In order for the endoscope to visualize the path of distal end 38 when advanced through tissue of patient 12 during the insertion of bipolar tunnel tool 32 into patient 12, it must first be inserted into the patient and must contain a camera (i.e. camera 110, for example). Therefore, the method involves inserting an endoscope into a patient, wherein the endoscope includes a camera.);
“inserting a tunneling shaft of a tunneling tool into a substernal space of the patient, wherein the tunneling tool comprises:” (See [0054] as discussed above. Therefore, the method involves inserting a tunneling shaft (i.e. 32) of a tunneling tool (i.e. 30) into a substernal space of the patient (See FIGS 8A-8D), wherein the tunneling shaft includes multiple components.)
“a handle” (See handle 34 in [0034] as discussed in claim 1. As shown in FIGS. 8A-8D, the handle 34 of the tunneling tool 30 remains outside of the patient.);
“the tunneling shaft extending from the handle and defining a length” (See tunneling shaft 32 in [0034] and [0035] as discussed in claim 1. Therefore, the tunneling tool includes the tunneling shaft extending from the handle and defining a length.);
“one or more lighting elements disposed along the length of the tunneling shaft” (See [0024] and [0072] as discussed in claim 1 above. Therefore, since the bipolar tunneling tool (i.e. 30) includes an optical window which allows light to pass from a lighting element disposed within the tunneling shaft (i.e. lighting element 112, shown in FIG. 11), the tunneling tool includes one or more lighting elements (i.e. lighting elements 112/fiber optic array) disposed along the length of the tunneling shaft (i.e. 32).); and […]
“visualizing a dissection path of the tunneling tool through visualization of light emitted by the one or more lighting elements using the camera” (See [0041], [0054] and [0073] above. Therefore, the method involves visualizing a dissection path of the tunneling tool through visualization of light emitted by the one or more lighting elements (i.e. 112) using the camera (i.e. 110).).
Although Ebersole includes an actuating trigger 56 (i.e. an actuation element) and selectively emitting light in varying intensities via one or more actuators (see [0073]), Ebersole does not explicitly teach “control circuitry” or “actuating an activation element to cause the control circuitry to activate the one or more lighting elements”.
O’Sullivan teaches “control circuitry” and “actuating an activation element to cause the control circuitry to activate the one or more lighting elements” (See [0006], [0032] and [0036] as discussed in claim 2 above and “The controller may be configured to actuate a portion of the LEDs at a first frequency and another portion of the LEDs at a second frequency, e.g., a distal portion of LEDs at a higher frequency than a proximal portion of LEDs” [0039]. In this case, the controller (i.e. control circuitry) is configured to sequentially power the first and second LEDs (i.e. included in first and second flexible circuits 302, see [0006], FIG. 3) at different wavelengths. Additionally, the control unit 350 is configured to adjust the intensity of the plurality of LEDs 304 (i.e. adjusting oscillation rate or power) between multiple circuits 302 (i.e. first and second flexible circuits), see [0032]. Finally, the controller/control unit (i.e. control circuitry) causes the sets of LEDs (i.e. circuits 302) to be independently activatable such that they may flash (see [0036]).
Therefore, the tunneling tool further comprises control circuitry (i.e. controller/control unit 350), and wherein the method involves actuating an activation element (i.e. analog knob 356 of the control unit 350) to cause the control circuitry to activate the one or more lighting elements (i.e. adjust the intensity of the plurality of LEDs 304 included in multiple sets/circuits 302, see FIG. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ebersole such that the tunneling tool includes control circuitry, and the method involves actuating an activation element to cause the control circuitry to activate the one or more lighting elements as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the method of Ebersole such that the tunneling tool includes control circuitry, and the method involves actuating an activation element to cause the control circuitry to activate the one or more lighting elements as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) within a patient’s body when performing a procedure.
Regarding claim 19, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 18 above, and Ebersole further teaches “wherein inserting the endoscope into the patient comprises inserting the endoscope into a pleural cavity of the patient” (See [0041] and [0054] as discussed in claim 18 and “FIG. 2 is a schematic showing an access site A for making a passageway between a patient's diaphragm 19 and xiphoid process 20 of sternum 13, for example, to create a sub-sternal tunnel in which to position a medical device, such as medical electrical lead 16. After making a superficial incision, an operator, using a tunneling tool, may open a passageway between diaphragmatic attachments 18 and diaphragm 19, for example, by blunt and/or sharp dissection, in which the operator may employ a tunneling tool, such as those example tools described herein, to both create the passageway and then form a sub-sternal tunnel (e.g. along the dotted line of FIG. 2). […] Because the bony structure of sternum 13 inhibits external palpation, the operator may need to take extra care, during the dissection (e.g., blunt and/or sharp) and/or tunneling, not to injure sub-sternal structures or the chest cavity, which could compromise the pleura of the lungs or heart 6” [0029].
Therefore, since the tunneling tool 30 (i.e. the endoscope being located within the lumen 46 thereof, see [0041], [0054]) is inserted through the access site A shown in FIG. 2, such that it does not injure sub-sternal structures or compromise the pleura of the lungs, inserting the endoscope into the patient comprises inserting the endoscope into a pleural cavity of the patient.).
Regarding claim 20, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 18 above, and Ebersole further teaches “wherein inserting the endoscope into the patient comprises inserting the endoscope into the substernal space of the patient, wherein the method further comprises advancing the endoscope and tunneling shaft in a parallel fashion” (See [0041] and [0054] as discussed in claim 18 and [0029] as discussed in claim 19.
Therefore, inserting the endoscope into the patient comprises inserting the endoscope (i.e. via the lumen 46 of the tunneling shaft 32, see [0041]) into the substernal space of the patient (i.e. see FIGS. 8A-8D). Furthermore, since the endoscope (i.e. adjacent to the optical window 44) is used to visualize the path of distal end 38 when advanced through tissue of patient 12 during the insertion of bipolar tunnel tool 32 into patient 12, this suggests that the method further comprises advancing the endoscope and tunneling shaft in a parallel fashion.).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebersole et al. US 2022/0031390 A1 “Ebersole” and O’Sullivan et al. US 2023/0057208 A1 “O’Sullivan” as applied to claim 12 above, and further in view of Xu et al. US 2024/0237899 A1 “Xu”.
Regarding claim 16, Ebersole in view of O’Sullivan discloses all features of the claimed invention as discussed with respect to claim 12 above, and O’Sullivan further teaches “further comprising control circuitry, wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state […], wherein the operation states include one or more of: flash at a different time interval; emit light at a different wavelength; or emit light at a different intensity” (“See [0006], [0032] and [0036] as discussed in claim 2 above and “The controller may be configured to actuate a portion of the LEDs at a first frequency and another portion of the LEDs at a second frequency, e.g., a distal portion of LEDs at a higher frequency than a proximal portion of LEDs” [0039]. In this case, the controller (i.e. control unit) is configured to sequentially power the first and second LEDs (i.e. included in first and second flexible circuits 302, see [0006], FIG. 3) at different wavelengths. Additionally, the control unit 350 is configured to adjust the intensity of the plurality of LEDs 304 (i.e. adjusting oscillation rate or power) between multiple circuits 302 (i.e. first and second flexible circuits), see [0032]. Finally, the controller/control unit causes the sets of LEDs (i.e. circuits 302) to be independently activatable such that they may flash (see [0036]).
Therefore, the tunneling tool further comprises control circuitry (i.e. controller/control unit 305), and wherein the control circuitry is configured to cause each of the one or more lighting elements (i.e. LEDs 304 included in multiple sets/circuits 302, see FIG. 3) to one or more of: flash at different time intervals (i.e. see [0036]), emit light at a different wavelength (i.e. see [0006]); and emit light at a different intensity (i.e. see [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant system of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state, wherein the operation sates include one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan in order to allow light to be emitted with different characteristics (i.e. flash, wavelengths intensity) at different locations within a patient’s body. Utilizing control circuitry to cause one or more lighting elements (i.e. LEDs 304, for example) to activate with different characteristics is one of a finite number of techniques which can be used to provide light to a patient with a reasonable expectation of success. Thus, modifying the implant system of Ebersole such that it includes control circuitry, and wherein the control circuitry is configured to cause the one or more lighting elements to change an operation state, wherein the operation sates include one or more of: flash at different time intervals; emit light at a different wavelength; and emit light at a different intensity as disclosed in O’Sullivan would yield the predictable result of allowing light to be emitted with different characteristics (i.e. flash, wavelengths, intensity) at different locations within a patient’s body when performing a procedure.
However, Ebersole in view of O’Sullivan does not teach that the control circuitry changes an operation stat of the one or more lighting elements “in response to a predefined criteria being met”.
Xu is within a related field of endeavor to the claimed invention because it involves a system 100 for endoscopic visualization which includes an emitter 102 and a controller (see [0058] and FIGS. 1A-1C).
Xu teaches that the control circuitry causes the one or more lighting elements to change “in response to a predefined criteria being met” (“The emitter 102 includes one or more EMR sources, which may include, for example, lasers, laser bundles, light emitting diodes (LEDs), electric discharge sources, incandescence sources, electroluminescence sources, and so forth” [0062]; “The controller 104 instructs the emitter 102 to cycle the plurality of EMR sources according to a variable pulse cycle. The controller 104 calculates the variable pulse cycle based at least in part upon a user input indicating the desired visualization scheme. […] In an alternative example, the desired visualization scheme may indicate the user wishes to be notified when nerve tissue can be identified in the scene and/or when a tool within the scene is within a threshold distance from the nerve tissue. […] Additionally, the variable pulse cycle may include pulses of EMR in a mapping pattern configured for laser mapping imaging to determine when the tool is within the threshold distance from the nerve tissue. The controller 104 may reconfigure the variable pulse cycle in real-time in response to receiving a revised desired visualization scheme from the user” [0078]; “The emitter 102 pulses according to a variable pulse cycle that includes one or more types of EMR. The variable pulse cycle may include visible EMR, which may include a white light emission, red light emission, green light emission, blue light emission, or some other waveband of visible EMR” [0091].
In this case, since the controller 104 instructs the emitter 102 (i.e. containing one or more EMR sources such as LEDs) to cycle the plurality of EMR sources according to a variable pulse cycle (i.e. emitter cycles electromagnetic sources on/off (i.e. causing flashing) according to variable pulse cycle, see FIG. 4) when a desired visualization scheme, corresponding to when a tool within the scene is within a threshold distance from the nerve tissue (i.e. key tissue), is achieved, the control circuitry is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met (i.e. a distance between the tunneling tool (i.e. tool) and key tissues (i.e. nerve tissue) satisfying a threshold (i.e. threshold distance)).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant system of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met as disclosed in Xu in order to conserve power when performing a procedure within a patient’s body. Emitting light in a variable pulse cycle when a desired visualization scheme (i.e. when a tool within the scene is within a threshold distance from the nerve tissue) is achieved, is one of a finite number of techniques which can be used to ensure that light is delivered to the correct location without wasting power with a reasonable expectation of success. Thus, modifying implant system of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met as disclosed in Xu would yield the predictable result of providing light to a desired area within a patient during a procedure while also conserving power.
Regarding claim 17, Ebersole in view of O’Sullivan and Xu discloses all features of the claimed invention as discussed with respect to claim 16 above, and Xu further teaches “wherein the predefined criteria include one or more of: a distance between the tunneling tool from and key tissues satisfying a threshold; a sensed pressure inside the patient satisfying a threshold; and a sensed impedance of patient tissue satisfying a threshold” (See [0062], [0078] and [0091] as discussed in claim 4 above.
In this case, since the controller 104 instructs the emitter 102 (i.e. containing one or more EMR sources such as LEDs) to cycle the plurality of EMR sources according to a variable pulse cycle (i.e. emitter cycles electromagnetic sources on/off (i.e. causing flashing) according to variable pulse cycle, see FIG. 4) when a desired visualization scheme, corresponding to when a tool within the scene is within a threshold distance from the nerve tissue (i.e. key tissue), is achieved, the control circuitry is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met, specifically a distance between the tunneling tool and key tissues satisfying a threshold.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant system of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met, the predefined criteria being a distance between the tunneling tool and key tissues satisfying a threshold as disclosed in Xu in order to conserve power when performing a procedure within a patient’s body. Emitting light in a variable pulse cycle when a desired visualization scheme (i.e. when a tool within the scene is within a threshold distance from the nerve tissue) is achieved is one of a finite number of techniques which can be used to ensure that light is delivered to the correct location without wasting power with a reasonable expectation of success. Thus, modifying implant system of Ebersole in view of O’Sullivan such that the control circuity is configured to cause the one or more lighting elements to change an operation state in response to a predefined criteria being met as disclosed in Xu would yield the predictable result of providing light to a desired area within a patient during a procedure while also conserving power.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shelton, IV et al. US 2023/0097906 A1 “Shelton” is pertinent to the applicant’s disclosure because it discloses “FIG. 1 illustrates one embodiment of a surgical visualization system 100. The surgical visualization system 100 is configured to create a visual representation of a critical structure 101 within an anatomical field. The critical structure 101 can include a single critical structure or a plurality of critical structures” [0117]; “The imaging device 120 can be configured to detect visible light, spectral light waves (visible or invisible), and a structured light pattern (visible or invisible). Examples of the imaging device 120 includes scopes, e.g., an endoscope” [0121], “The surgical visualization system 100 also includes a surgical device 102. The surgical device 102 can be any suitable surgical device. Examples of the surgical device 102 includes a surgical dissector, a surgical stapler, a surgical grasper, a clip applier, a smoke evacuator, a surgical energy device (e.g., mono-polar probes, bi-polar probes, ablation probes, an ultrasound device, an ultrasonic end effector, etc.)” [0125].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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