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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/24/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 8/24/2026.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 112(b) rejections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claim 1 and 11have 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. Previously, claims 1 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emmons. Now, based on amendments to the claim language, claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Emmons in view of Eggers.
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 9, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Emmons et al., US 20180325592, herein referred to as “Emmons”, in view of Eggers, US 5318564, herein referred to as “Eggers”.
Regarding claim 1, Emmons discloses a colonoscopy screening device ([0008]: “The systems and methods described herein are useful in a variety of medical procedures including various diagnostic and therapeutic procedures.” and [0250] and Figures 1AC-1AD), comprising: an elongated flexible probe having a proximal end and a distal end (Figures 1AC-1AD: arm 102), the distal end adapted for rectal insertion ([0018] and [0250]); a tethered loop extending from the distal end (Figures 1AC-1AD: tether 114), the tethered loop having a size based on a suspect tissue growth (Figures 1AC-1AD: tether 114 and [0163]: “In this embodiment, the shape and/or the size and/or the position and/or the orientation of the region of medical component 110 distal to the distal region of arm 102 can be further changed by robotically manipulating the distal region of arm 102.”) and having a pair of opposed electrodes (Figures 1AC-1AD: working element 112 closest to tether 114 and farthest from tether 114): the pair of opposed electrodes configured for contact with a suspect tissue growth (Figures 1AC-1AD: functional elements 112 and [0151]); an actuator (Figures 1AC-1AD: tether 114) for drawing at least one electrode of the pair of opposed electrodes in an opposed orientation towards the other opposed electrode for engaging the suspect tissue growth to pass an electrical signal through the suspect tissue growth (Transition from Figure 1AD to Figure 1AC and [0164] and [0151]); a respective wire terminating in each of the respective opposed electrodes (Figures 1AC-1AD and [0151]: wherein each working element must have a wire connecting it to an energy source or to deliver sensory information to the medical system) for measuring a resistance across the suspect tissue growth ([0151]: “For example, such elements can include one or more of: electrodes (that detect and/or measure voltage, current and/or impedance),”); an insulative coating on the loop, the insulative coating providing an electrical isolation between the pair of opposed electrodes for preventing electrical communication between the opposed electrodes via the loop ([0145]: “In one embodiment, the electrode wires are electrically insulated from the first circuit and working element 112.” And Figures 1AC-1AD: shaft 116 must be insulated so that different working elements 112 can function properly as described in paragraphs [0151]-[0152]); and a measurement circuit connected to the electrode for measuring an electrical characteristic of the suspect tissue growth based on delivery of an electrical signal between the pair of opposed electrodes (Figures 1AC-1AD: functional elements 112 and [0151]: “Alternatively, or in combination, medical component 110 may also comprise one or more sensors or information receiving elements. For example, such elements can include one or more of: electrodes (that detect and/or measure voltage, current and/or impedance), temperature sensors, pressure sensors, light measurement devices, infrared sensors, chemical sensors, radiation sensors, deformation sensors, or any other type of sensors that observe and/or measure a state or condition of tissue or the body. In one embodiment, the first portion and the second portion are parts of the same medical component 110.”). Emmons does not explicitly disclose a colonoscopy screening device comprising a tethered loop configured to dispose the opposed electrodes around and on opposite sides of the suspect tissue growth to pass an electrical signal though and across the suspect tissue growth.
However, Eggers teaches a colonoscopy screening device (Figure 1 and Col. 5, lines 40-42) comprising a tethered loop (Figure 3a: insulating loop 20) configured to dispose the opposed electrodes (Figure 3a: electrodes 14 and 15) around and on opposite sides of the suspect tissue growth (Col. 3, lines 15-18) to pass an electrical signal though and across the suspect tissue growth (Col. 3, lines 19-22).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Emmons so that the tethered loop is configured to dispose the opposed electrodes around and on opposite sides of the suspect tissue growth to pass an electrical signal though and across the suspect tissue growth as taught by Eggers to promote effective selective necrosis and hemostasis of tissue by providing uniformly equal lengths of bipolar electrodes during all phases of operation (Col. 2, lines 11-15).
Regarding claim 3, Emmons in view of Eggers discloses the device of claim 1, and Emmons further discloses a device wherein the actuator includes a tethered attachment to the opposed electrodes (Figures 1AC-1AD: tether 114), the opposed electrodes biased in an opposed orientation (Figure 1AC), the tether responsive to tension for disposing the opposed electrodes against the bias for closing the opposed electrodes against the suspect tissue growth ([0164]).
Regarding claim 4, Emmons in view of Eggers discloses the device of claim 1, and Emmons further discloses a device wherein the tethered loop extends from a sleeve (Figures 1AC-1AD: shaft 116), the sleeve surrounding a tether attached to the loop between the pair of opposed electrodes ([0164]: “For example, tether 114 may slide within a lumen of shaft 116 of medical component 110.”), the tether responsive to tensioned actuation for drawing the loop at least partially into the sleeve for compressing the loop for drawing the opposed electrodes together against the suspect tissue growth ([0164] and [0143]: “Similarly, working elements 112 in a substantially closed loop configuration may be used to create lesions that correspond to the shape of the perimeter of the substantially closed loop configuration or to the shape of the area enclosed by the substantially closed loop configuration. ”).
Regarding claim 6, Emmons in view of Eggers discloses the device of claim 1, and Emmons further discloses a device further comprising an outer sleeve enclosing the tether and the respective wires (Figures 1AC-1AD: arm 102), the outer sleeve adapted for passage in a biopsy channel of a colonoscope ([0163] and [0250]).
Regarding claim 9, Emmons in view of Eggers discloses the device of claim 6, and Emmons further discloses a device wherein the outer sleeve has a diameter based on a biopsy channel of a colonoscope ([0093]: “Examples of such imaging modalities include, but are not limited to endoscopes (e.g. colonoscopes, laparoscopes, thoracoscopes, bronchoscopes, cystoscopes, colposcopes, hysteroscopes, arthroscopes, etc.), ” and [0250]).
Regarding claim 11, Emmons discloses a method for colon screening ([0250] and Figures 1AC-1AD), comprising: applying an electrically insulative coating ([0145]: “In one embodiment, the electrode wires are electrically insulated from the first circuit and working element 112.” And Figures 1AC-1AD: shaft 116 must be insulated so that different working elements 112 can function properly as described in paragraphs [0151]-[0152]) to a tethered loop having a pair of electrodes (Figures 1AC-1AD: functional elements 112), the tethered loop having a size based on a suspect tissue growth (Figures 1AC-1AD: tether 114 and [0163]: “In this embodiment, the shape and/or the size and/or the position and/or the orientation of the region of medical component 110 distal to the distal region of arm 102 can be further changed by robotically manipulating the distal region of arm 102.”); extending an electrical probe to deploy the tethered loop into a colorectal diagnostic region ([0018] and [0250]); disposing the pair of electrodes in contact with opposed sides of a surface of a suspect tissue growth ([0304] and [0151]-[0152]); drawing, via the tethered loop, at least one of the electrodes in an opposed orientation towards the other electrode for engaging the suspect tissue growth to pass an electrical signal through the suspect tissue growth (Transition from Figure 1AD to Figure 1AC and [0164] and [0151]); measuring a resistance from an electrical signal passing through the suspect tissue growth between the pair of electrodes (Figures 1AC-1AD: functional elements 112 and [0151]: “Alternatively, or in combination, medical component 110 may also comprise one or more sensors or information receiving elements. For example, such elements can include one or more of: electrodes (that detect and/or measure voltage, current and/or impedance), temperature sensors, pressure sensors, light measurement devices, infrared sensors, chemical sensors, radiation sensors, deformation sensors, or any other type of sensors that observe and/or measure a state or condition of tissue or the body. In one embodiment, the first portion and the second portion are parts of the same medical component 110.”); and determining, based on the resistance indicative of bioelectric characteristics to determine whether the suspect tissue growth should be removed ([0141]: “Thus, mapping electrodes 118 may be used to confirm desired ablation of tissue and/or to determine the need for additional energy delivery to tissue.” And [0152]: “Examples of medical components 110, include, but are not limited to, therapeutic devices such as ablation devices for imparting a treatment to a target tissue, diagnostic devices such as mapping catheters for providing physiological information regarding a target tissue;”). Emmons does not explicitly disclose a method comprising a tethered loop configured to dispose the pair of electrodes around and on opposite sides of the suspect tissue growth to pass an electrical signal though and across the suspect tissue growth.
However, Eggers teaches a method (Figure 1 and Col. 5, lines 40-42) comprising a tethered loop (Figure 3a: insulating loop 20) configured to dispose the opposed electrodes (Figure 3a: electrodes 14 and 15) around and on opposite sides of the suspect tissue growth (Col. 3, lines 15-18) to pass an electrical signal though and across the suspect tissue growth (Col. 3, lines 19-22).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Emmons so that the tethered loop is configured to dispose the opposed electrodes around and on opposite sides of the suspect tissue growth to pass an electrical signal though and across the suspect tissue growth as taught by Eggers to promote effective selective necrosis and hemostasis of tissue by providing uniformly equal lengths of bipolar electrodes during all phases of operation (Col. 2, lines 11-15).
Regarding claim 12, Emmons in view of Eggers discloses the method of claim 11, and Emmons further discloses a method further comprising: engaging the pair of electrodes on opposed sides of a surface of the suspect tissue growth (Figures 1AC-1AD: working element 112 closest to tether 114 and farthest from tether 114), and measuring the resistance between the electrodes based on cell properties of the suspect tissue growth (Figures 1AC-1AD: functional elements 112 and [0151]: “Alternatively, or in combination, medical component 110 may also comprise one or more sensors or information receiving elements. For example, such elements can include one or more of: electrodes (that detect and/or measure voltage, current and/or impedance), temperature sensors, pressure sensors, light measurement devices, infrared sensors, chemical sensors, radiation sensors, deformation sensors, or any other type of sensors that observe and/or measure a state or condition of tissue or the body. In one embodiment, the first portion and the second portion are parts of the same medical component 110.”).
Regarding claim 13, Emmons in view of Eggers discloses the method of claim 11, and Emmons further discloses a method further comprising: separating the pair of electrodes by a distance based on a size of the suspect tissue growth (Transition from Figure 1AD to Figure 1AC and [0164]); extending the electrodes adjacent toward the respective opposed sides of the suspect tissue growth ([0164] and [0143]: “Similarly, working elements 112 in a substantially closed loop configuration may be used to create lesions that correspond to the shape of the perimeter of the substantially closed loop configuration or to the shape of the area enclosed by the substantially closed loop configuration. ”); and closing the electrodes around the respective tissue growth by reducing the distance for electrical contact of the electrodes with the respective opposed sides ([0143]: “Similarly, working elements 112 in a substantially closed loop configuration may be used to create lesions that correspond to the shape of the perimeter of the substantially closed loop configuration or to the shape of the area enclosed by the substantially closed loop configuration. ”).
Regarding claim 14, Emmons in view of Eggers discloses the method of claim 12, and Emmons further discloses a method further comprising: applying an electrically insulative coating ([0145]: “In one embodiment, the electrode wires are electrically insulated from the first circuit and working element 112.” And Figures 1AC-1AD: shaft 116 must be insulated so that different working elements 112 can function properly as described in paragraphs [0151]-[0152])to a tethered loop (Figures 1AC-1AD: shaft 116 and tether 114); attaching the electrodes to opposed sides of the tethered loop (Figures 1AC-1AD: working element 112 closest to tether 114 and farthest from tether 114), the electrically insulative coating providing an electrical separation between the electrodes (Figures 1AC-1AD: shaft 116 separates working elements 112); and retracting the tether to close the loop and draw the electrodes into contact with the suspect tissue growth ([0143]: “Similarly, working elements 112 in a substantially closed loop configuration may be used to create lesions that correspond to the shape of the perimeter of the substantially closed loop configuration or to the shape of the area enclosed by the substantially closed loop configuration. ”).
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Emmons in view of Eggers, further in view of Hassidov et al., US 20160324412, herein referred to as “Hassidov”.
Regarding claim 7, Emmons in view of Eggers discloses the device of claim 1, with Emmons disclosing a device further comprising: a biasing member for disposing the electrodes in a biased, opposed arrangement (Figures 1AC-1AD: tether 114 and [0164); a deformable, concave sleeve around the electrodes (Figures 1AC-1AD: arm 102 and [0163]: “The shape and/or the size and/or the position and/or the orientation of the region of medical component 110 distal to the distal region of arm 102 can be changed by one or more of: torquing arm 102, advancing or withdrawing arm 102, steering a steerable distal region of arm 102, torquing shaft 116 of medical component 110, advancing or withdrawing shaft 116 of medical component 110 and pulling or releasing tether 114. In one embodiment, arm 102 is steerable and is robotically controlled by a user.”). Emmons in view of Eggers does not explicitly disclose a device comprising a suction tube in fluidic communication with the concave sleeve; and a vacuum source attached to the suction tube and adapted for reducing a pressure in the concave sleeve, the concave sleeve adapted to contract in response to the reduced pressure upon a sealing engagement with the suspect tissue growth, the contraction of the sleeve forcing the electrodes against the suspect tissue growth.
However, Hassidov teaches a device (Figure 4) comprising a suction tube in fluidic communication with the concave sleeve (Figure 4: inflation module 402 and sleeve 400 and [0156]); and a vacuum source attached to the suction tube and adapted for reducing a pressure in the concave sleeve (Figure 4: pump 404 and pressure regulator 406), the concave sleeve adapted to contract in response to the reduced pressure upon a sealing engagement with the suspect tissue growth ([0156]), the contraction of the sleeve forcing the electrodes against the suspect tissue growth (In combination with Emmons, contracting sleeve 400 of Hassidov would squeeze the two side of shaft 116 of Emmons together, which would force the electrode against the tissue growth).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device of Emmons so that it includes a suction tube in fluidic communication with the concave sleeve; and a vacuum source attached to the suction tube and adapted for reducing a pressure in the concave sleeve, the concave sleeve adapted to contract as taught by Hassidov so that the sleeve fits tightly around the colonoscope (Hassidov [0154]).
Regarding claim 10, Emmons in view of Eggers discloses the device of claim 6 but does not explicitly disclose a device wherein the outer sleeve has a diameter between 3.0 - 3.6 mm.
However, Hassidov teaches a device wherein the outer sleeve has a diameter between 3.0 - 3.6 mm ([0153]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device of Emmons so that the outer sleeve has a diameter between 3.0 - 3.6 mm as taught by Hassidov so that the sleeve can be used with a colonoscope or a gastroscope (Hassidov [0153]).
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Emmons in view of Eggers, further in view of Kieturakis, US 20120116362, herein referred to as “Kieturakis”.
Regarding claim 8, Emmons in view of Eggers discloses the device of claim 4, but does not explicitly disclose a device wherein the tether further comprises a Bowden cable, further comprising a pair of wires attached, each wire of the pair of wires attached to a respective electrode, the Bowden cable and the pair of wires enclosed in a bundle within an outer sleeve, the outer sleeve extending from a colonoscope.
However, Kieturakis teaches a device (Figure 4) wherein the tether further comprises a Bowden cable (Figure 4: cable 24 and [0045]: “When the distal effector 20 is mechanically actuable, the cable 24 will typically comprise an outer tube and inner wire (a Bowden cable) to allow closing of the handle 22 to retract the wire and drive the tool.”), further comprising a pair of wires attached, each wire of the pair of wires attached to a respective electrode ([0045]: “Examples of such tools are scissors, graspers, clamps, forceps, electrodes, and other jaw-like effectors which may open and close by opening and closing the lever or trigger of the handle structure 22. If the distal effector 20 is electrically active, such as an electrode, resistance heater, motor driven element, or the like, cable 24 can be an electrical cable to provide the necessary electrical power.”), the Bowden cable and the pair of wires enclosed in a bundle within an outer sleeve (Figure 4: tubular sleeve 16), the outer sleeve extending from a colonoscope ([0010]: “The tools and systems will be particularly useful for performing laparoscopic cholecystectomy, but also be suitable for performing other procedures such hernia repair, hysterectomy, colectomy, appendectomy, gastric fundoplication, and the like, as well as in thoracoscopic and extra-peritoneal procedures.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device of Emmons so that it includes a Bowden cable, further comprising a pair of wires attached, each wire of the pair of wires attached to a respective electrode, the Bowden cable and the pair of wires enclosed in a bundle within an outer sleeve as taught by Kieturakis to allow the device to retract while providing the necessary electrical power (Kieturakis [0045]).
Regarding claim 16, Emmons in view of Eggers discloses the method of claim 14, but does not explicitly disclose a method wherein the tether further comprises a Bowden cable.
However, Kieturakis teaches a method (Figure 4) wherein the tether further comprises a Bowden cable (Figure 4: cable 24 and [0045]: “When the distal effector 20 is mechanically actuable, the cable 24 will typically comprise an outer tube and inner wire (a Bowden cable) to allow closing of the handle 22 to retract the wire and drive the tool.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device of Emmons so that the tether comprises a Bowden cable as taught by Kieturakis to allow the device to retract while providing the necessary electrical power (Kieturakis [0045]).
Conclusion
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
/N.W.R./Examiner, Art Unit 3794
