DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 07/21/26 has been entered. Claims 5, 9-10, 12-13, and 19 have been amended. Claims 1-20 are addressed in the following office action.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-6, 9-15, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vakharia et al. (US 2008/0183035), cited in previous office action.
Regarding claim 1, an invention relating to endoscopes, Vakharia discloses (Figs. 1-4 & 7-9) a medical device (100), comprising: a tube (110) having a proximal end (114) and a distal end (112), and comprising a lumen (120) extending from the proximal end to the distal end (Par. 0025-0026); a cap (130 & 148) at the distal end of the tube, the cap having a distal opening (see annotated figure below) corresponding to the lumen (Par. 0026 & 0028-0029); an imaging system (124) positioned on a distal-facing surface of the cap (Par. 0025); an instrument (118) at least partially disposed in the lumen that is non-removable from the medical device (Par. 0025); an instrument actuation mechanism (802-810, 902, 904) for controlling the instrument (Par. 0033); and a single handle (136 & 142) connected to the proximal end of the tube and housing the instrument actuation mechanism (Par. 0025), wherein a proximal end of the instrument is affixed to the instrument actuation mechanism and the instrument actuation mechanism is configured to be moved between a first position and a second position on the single handle to control an extension and retraction of the instrument relative to the tube, wherein a distal end of the instrument is retracted relative to the tube in a collapsed state when the instrument actuation mechanism is in the first position, and wherein the distal end of the instrument is extended relative to the tube in an expanded state when the instrument actuation mechanism is in the second position (Par. 0025 & 0033-0034).
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Regarding claim 2, Vakharia discloses the medical device of claim 1. Vakharia further discloses wherein the distal end of the tube includes an articulation joint [i.e. articulating segments], and the distal end of the instrument is positioned within the articulation joint when the instrument actuation mechanism is in the first position (Par. 0026-0027).
Regarding claim 3, Vakharia discloses the medical device of claim 2. Vakharia further discloses wherein the single handle further houses an articulation actuation mechanism for controlling the articulation joint, the articulation joint is configured to bend in at least two directions away from a longitudinal axis of the tube [see U.S. patent application Ser. No. 11/277,324] (Par. 0027).
Regarding claim 5, Vakharia discloses the medical device of claim 1. Vakharia further discloses (Fig. 7) further comprising a connector disposed within the single handle, wherein the connector includes: a plurality of connector ports (120, 122), wherein at least one of the plurality of connector ports includes an instrument connector port (120, 122) configured to receive the instrument from the instrument actuation mechanism (Par. 0033); and a distal opening connecting the single handle to the proximal end of the tube, wherein the instrument received via the instrument connector port extends into the lumen of the tube via the distal opening of the connector (see annotated figure below & Par. 0026).
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Regarding claim 6, Vakharia discloses the medical device of claim 1. Vakharia further discloses (Figs. 8-9) wherein the instrument actuation mechanism includes an instrument actuator (138) configured to be moved between the first position and the second position, a link (802, 804, 900), and a driver (902 & 904) connected to the instrument actuator via the link to which the proximal end of the instrument is attached (Par. 0033).
Regarding claim 9, Vakharia discloses the medical device of claim 1. Vakharia further discloses (Fig. 2) wherein: the instrument is a wire (118), a first end of the wire is attached to a fixation point [i.e. supplemental attachment point] on the distal-facing surface of the cap (Par. 0026), the wire extends from the fixation point through a second distal opening (120) of the cap, different from the distal opening corresponding to the lumen, into the single handle via the tube, and a second end of the wire opposite the first end of the wire is affixed to the instrument actuation mechanism (Par. 0026 & 0033-0035).
Regarding claim 10, Vakharia discloses the medical device of claim 9. Vakharia further discloses wherein: when the instrument actuation mechanism is in the first position, a first portion of the wire from the fixation point to the second distal opening forms a loop in the collapsed state that at least partially contacts the distal-facing surface; and when the instrument actuation mechanism is in the second position, a second portion of the wire is extended from the tube via the second distal opening to transition the loop to the expanded state (Par. 0030-0033).
Regarding claim 11, Vakharia discloses the medical device of claim 9. Vakharia further discloses wherein the distal-facing surface of the cap comprises a recess (see annotated figure below) arranged between the fixation point and the second distal opening, the recess configured to receive and secure an object captured by the instrument (Par. 0026).
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Regarding claim 12, Vakharia discloses the medical device of claim 1. Vakharia further discloses (Fig. 2) wherein: the instrument is a wire (118), a first end of the wire extends through a second distal opening (120) of the cap, different from the distal opening corresponding to the lumen, into the single handle via the tube to attach to the instrument actuation mechanism, and a second end of the wire extends through a third distal opening (122) in the cap, different from the distal opening corresponding to the lumen and the second distal opening, into the single handle via the tube to attach to the instrument actuation mechanism (Par. 0025 & 0032-0034).
Regarding claim 13, Vakharia discloses the medical device of claim 12. Vakharia further discloses wherein: when the instrument actuation mechanism is in the first position, a first portion of the wire from the second distal opening to the third distal opening forms a loop in the collapsed state that at least partially contacts the distal-facing surface; and when the instrument actuation mechanism is in the second position, a second portion of the wire is extended from the tube via the second distal opening and a third portion of the wire is extended from the tube via the third distal opening to transition the loop to the expanded state (Par. 0030-0033).
Regarding claim 14, Vakharia discloses the medical device of claim 1. Vakharia further discloses wherein the single handle further comprises a fluidics device (see annotated figure below) having a proximal end connectable to a fluid supply source and a distal end connected to the proximal end of the tube, the fluidics device configured to supply fluid to a patient’s body via the distal opening (Par. 0033 & 0035).
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Regarding claim 15, Vakharia discloses the medical device of claim 1. Vakharia further discloses (Fig. 2) wherein the imaging system includes an imaging device (124) positioned within an imaging port on the distal-facing surface of the cap, and an illumination device (126 & 128) positioned within an illumination port on the distal-facing surface of the cap (Par. 0025).
Regarding claim 19, Vakharia discloses (Figs. 1-4 & 7-9) a medical device, comprising: a tube (110) having a proximal end (114) and a distal end (112), and comprising a lumen (120) extending from the proximal end to the distal end (Par. 0025-0026); a cap (130 & 148) at the distal end of the tube, the cap having a distal opening (see annotated figure below) corresponding to the lumen (Par. 0026 & 0028-0029); a handle (136 & 142) connected to the proximal end of the tube and housing an actuation mechanism (802-810, 902, 904) configured to be moved between a first position and a second position on the handle (Par. 0025 & 0033-0034); and a wire (118) having a first end and a second end, wherein the wire is at least partially disposed in the lumen (Par. 0025), the first end of the wire is attached to a fixation point [i.e. supplemental attachment point] on a distal-facing surface of the cap (Par. 0026), the wire extends from the fixation point through a second distal opening (120) of the cap, different from the distal opening corresponding to the lumen, into the handle via the tube, and a second end of the wire opposite the first end of the wire is affixed to the actuation mechanism (Par. 0026 & 0033-0035), wherein, when the actuation mechanism is in the first position, a first portion of the wire from the fixation point to the second distal opening forms a loop in a collapsed state that at least partially contacts the distal-facing surface, and wherein, when the actuation mechanism is in the second position, a second portion of the wire is extended from the tube via the second distal opening to transition the loop to an expanded state (Par. 0030-0033).
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Regarding claim 20, Vakharia discloses the medical device of claim 19. Vakharia further discloses wherein the distal-facing surface of the cap comprises a recess (see annotated figure below) arranged between the fixation point and the second distal opening, the recess configured to receive at least a portion of an object captured by the wire (Par. 0026).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 7-8, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cahill et al. (US 2020/0359879) in view of Chu (US 2018/0125516), both cited in previous office action.
Regarding claim 1, an invention relating to endoscopes, Cahill discloses (Figs. 1, 2, 3A-B, 6) a medical device (100), comprising: a tube (150) having a proximal end [i.e. end connecting to element 510 (Par. 0044)] and a distal end (152), and comprising a lumen [i.e. working channel] extending from the proximal end to the distal end (Par. 0025); a cap (220) at the distal end of the tube, the cap having a distal opening (228) corresponding to the lumen (Par. 0030-0031); an imaging system (222) positioned on a distal-facing surface of the cap (Par. 0031-0032); an instrument [i.e. tools and instruments for therapeutic and diagnostic procedures] at least partially disposed in the lumen that is non-removable from the medical device (Par. 0023 & 0043). However, Cahill fails to disclose an instrument actuation mechanism for controlling the instrument; and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism, wherein a proximal end of the instrument is affixed to the instrument actuation mechanism and the instrument actuation mechanism is configured to be moved between a first position and a second position on the single handle to control an extension and retraction of the instrument relative to the tube, wherein a distal end of the instrument is retracted relative to the tube in a collapsed state when the instrument actuation mechanism is in the first position, and wherein the distal end of the instrument is extended relative to the tube in an expanded state when the instrument actuation mechanism is in the second position.
In the same field of endeavor, which is endoscopes, Chu teaches (Fig. 1) an instrument actuation mechanism (14) for controlling an instrument (26 & 32; Par. 0023, 0031, 0035); and a single handle (16) connected to the proximal end of a tube (18) and housing the instrument actuation mechanism, wherein a proximal end of the instrument is affixed to the instrument actuation mechanism and the instrument actuation mechanism is configured to be moved between a first position and a second position on the single handle to control an extension and retraction of the instrument relative to the tube, wherein a distal end of the instrument is retracted relative to the tube in a collapsed state when the instrument actuation mechanism is in the first position, and wherein the distal end of the instrument is extended relative to the tube in an expanded state when the instrument actuation mechanism is in the second position (Par. 0029, 0031, 0035).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cahill to have an instrument actuation mechanism for controlling the instrument; and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism, wherein a proximal end of the instrument is affixed to the instrument actuation mechanism and the instrument actuation mechanism is configured to be moved between a first position and a second position on the single handle to control an extension and retraction of the instrument relative to the tube, wherein a distal end of the instrument is retracted relative to the tube in a collapsed state when the instrument actuation mechanism is in the first position, and wherein the distal end of the instrument is extended relative to the tube in an expanded state when the instrument actuation mechanism is in the second position. Doing so would provide an instrument for delivery of medical therapy to a target site inside a subject (Par. 0024), as taught by Chu, and desired by Cahill, see paragraph 0023.
Regarding claim 4, Cahill, as modified by Chu, discloses the medical device of claim 1. Cahill further discloses wherein the instrument is extended relative to the tube via the distal opening, and the distal opening includes a clamshell shape to lock an orientation of the instrument relative to the medical device as the instrument is extended (Par. 0026, 0042-0043).
Regarding claim 7, Cahill, as modified by Chu, discloses further comprising: a sheath at least partially disposed within the lumen, wherein the instrument is disposed within the sheath [i.e. sheath (34) surrounding the instrument, see Chu figure 1 and paragraph 0023].
Regarding claim 8, Cahill, as modified by Chu, discloses further wherein the instrument actuation mechanism comprises: a sheath actuator that extends and retracts the sheath in which the instrument is disposed relative to the tube; and an instrument actuator that extends and retracts the instrument relative to the sheath to transition the instrument between the collapsed state and the expanded state [i.e. a sheath actuator (24) and an instrument actuator (22), see Chu figures 1-3 and paragraphs 0029, 0031, 0034-0035].
Regarding claim 16, an invention relating to endoscopes, Cahill discloses (Figs. 1, 2, 3A-B, 6) a medical device (100), comprising: a tube (150) having a proximal end [i.e. end connecting to element 510 (Par. 0044)] and a distal end (152), and comprising a lumen [i.e. working channel] extending from the proximal end to the distal end (Par. 0025); a cap (220) at the distal end of the tube, the cap having a distal opening (228) corresponding to the lumen (Par. 0030-0031); an instrument [i.e. tools and instruments for therapeutic and diagnostic procedures] at least partially disposed in the lumen that is non-removable from the medical device (Par. 0023 & 0043). However, Cahill fails to further disclose a sheath at least partially disposed within the lumen; the instrument disposed within the sheath, wherein the sheath and the instrument are non-removable from the medical device; an instrument actuation mechanism comprising a sheath actuator and an instrument actuator; and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism, wherein a proximal end of the sheath is affixed to the sheath actuator and the sheath actuator is configured to move between a first position and a second position on the single handle to control an extension and retraction of the sheath in which the instrument is disposed relative to the tube via the distal opening, and wherein a proximal end of the instrument is affixed to the instrument actuator and the instrument actuator is configured to move between a third position and a fourth position on the single handle to control an extension and retraction of a distal end of the instrument relative to the sheath to transition the distal end of the instrument between a collapsed state and an expanded state.
In the same field of endeavor, which is endoscopes, Chu teaches (Fig. 1) a sheath (34) at least partially disposed within a lumen of a tube (18; Par. 0027 & 0033); an instrument (26 & 32) disposed within the sheath, wherein the sheath and the instrument are non-removable from the medical device [i.e. non-removable once threaded onto element 46] (Par. 0023 & 0027); an instrument actuation mechanism (14) comprising a sheath actuator (24) and an instrument actuator (22); and a single handle (16) connected to the proximal end of the tube and housing the instrument actuation mechanism, wherein a proximal end of the sheath is affixed to the sheath actuator and the sheath actuator is configured to move between a first position and a second position on the single handle to control an extension and retraction of the sheath in which the instrument is disposed relative to the tube via the distal opening, and wherein a proximal end of the instrument is affixed to the instrument actuator and the instrument actuator is configured to move between a third position and a fourth position on the single handle to control an extension and retraction of a distal end of the instrument relative to the sheath to transition the distal end of the instrument between a collapsed state and an expanded state (Par. 0023, 0025, 0029, 0031, 0034-0035).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cahill to have a sheath at least partially disposed within the lumen; the instrument disposed within the sheath, wherein the sheath and the instrument are non-removable from the medical device; an instrument actuation mechanism comprising a sheath actuator and an instrument actuator; and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism, wherein a proximal end of the sheath is affixed to the sheath actuator and the sheath actuator is configured to move between a first position and a second position on the single handle to control an extension and retraction of the sheath in which the instrument is disposed relative to the tube via the distal opening, and wherein a proximal end of the instrument is affixed to the instrument actuator and the instrument actuator is configured to move between a third position and a fourth position on the single handle to control an extension and retraction of a distal end of the instrument relative to the sheath to transition the distal end of the instrument between a collapsed state and an expanded state. Doing so would provide an instrument for delivery of medical therapy to a target site inside a subject (Par. 0024), as taught by Chu, and desired by Cahill, see paragraph 0023.
Regarding claim 17, Cahill, as modified by Chu, discloses further discloses wherein the distal end of the tube includes an articulation joint, and a distal end of the sheath, in which the distal end of the instrument is disposed, is positioned within the articulation joint when the sheath actuator is in the first position [i.e. articulation joint (210), see Cahill figure 2; i.e. deflecting distal end of articulation joint tube with the sheath and instrument disposed when the sheath actuator is in the first position, see Chu paragraphs 0031 & 0034].
Regarding claim 18, Cahill, as modified by Chu, discloses wherein the instrument is a snare and the medical device is configured to be used for a percutaneous endoscopic gastrostomy (PEG) [i.e. snare, see Chu paragraph 0024].
Response to Arguments
Applicant’s arguments, see pages 10-11, filed 07/21/26, with respect to claim 5 and drawings have been fully considered and are persuasive. The claim objection of claim 5 and drawing objection have been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Concerning claim 1, applicant argues previously cited prior art reference Vakharia’s element 118 is not an instrument, the alleged instrument is not positioned within the lumen, and Vakharia fails to disclose that the end cap of the tube includes an imaging system. Examiner respectfully disagrees.
Vakharia’s control wire (118) can be effective to move a tool and applicant has not claimed any specific instrument or instrument function distinguishable from the control wire, given the broadest reasonable interpretation control wire is interpreted as an instrument. Furthermore, Vakharia discloses the control wire is positioned in lumen (120; Par. 0025), and the end cap is interpreted as elements (130 & 148) and element 130 includes an imaging system (124; Par. 0024-0025).
Concerning claim 1, applicant argues previously cited reference Cahill and Chu fail to disclose an instrument that is “non-removable from the medical device”, and Chu fails to teach “a cap at the distal end of the tube” or “an imaging system positioned on a distal-facing surface of the cap”. Examiner respectfully disagrees.
Applicant claims “an instrument at least partially disposed in the lumen that is non-removable from the medical device”. Given the broadest reasonable interpretation, the lumen is understood to be non-removable from the medical device, not the instrument. Furthermore, Cahill discloses an instrument [i.e. tools and instruments for therapeutic and diagnostic procedures] at least partially disposed in the lumen that is non-removable from the medical device (Par. 0023 & 0043). Also, Cahill discloses (Fig. 3A) an imaging system (222) positioned on a distal-facing surface of the cap (Par. 0031-0032).
Concerning claim 16, applicant argues Cahill and Chu, whether alone or in combination, do not disclose or suggest "a sheath at least partially disposed within the lumen," "an instrument disposed within the sheath, wherein the sheath and the instrument are non-removable from the medical device," "an instrument actuation mechanism comprising a sheath actuator and an instrument actuator," and "a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism". Examiner respectfully disagrees.
Chu teaches (Fig. 1) a sheath (34) at least partially disposed within a lumen of a tube (18; Par. 0027 & 0033); an instrument (26 & 32) disposed within the sheath, wherein the sheath and the instrument are non-removable from the medical device [i.e. non-removable once threaded onto element 46] (Par. 0023 & 0027); and an instrument actuation mechanism (14) comprising a sheath actuator (24) and an instrument actuator (22); and a single handle (16) connected to the proximal end of the tube and housing the instrument actuation mechanism (Par. 0023, 0025, 0029, 0031, 0034-0035).
Concerning claim 19, applicant argues Vakharia does not disclose "a wire having a first end and a second end, wherein the wire is at least partially disposed in the lumen, the first end of the wire is attached to a fixation point on a distal-facing surface of the cap, the wire extends from the fixation point through a second distal opening of the cap, different from the distal opening corresponding to the lumen, into the handle via the tube, and a second end of the wire opposite the first end of the wire is affixed to the actuation mechanism." Also, Vakharia does not disclose a loop that at least partially contacts the distal- facing surface in a collapsed state.
Vakharia discloses (Figs. 1-4 & 7-9) a wire (118) having a first end and a second end, wherein the wire is at least partially disposed in the lumen (Par. 0025), the first end of the wire is attached to a fixation point [i.e. supplemental attachment point] on a distal-facing surface of the cap (Par. 0026), the wire extends from the fixation point through a second distal opening (120) of the cap, different from the distal opening corresponding to the lumen, into the handle via the tube, and a second end of the wire opposite the first end of the wire is affixed to the actuation mechanism (Par. 0026 & 0033-0035). Also Vakharia discloses a loop in a collapsed state that at least partially contacts the distal-facing surface [i.e. the loop is part of element 118 which is flexible, and the control wire lumens can be configured to orient the control wire in a desired direction, hence when element 118 is collapsed it can flex and coming into contact with the distal -facing surface (Par. 0026 & 0030).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
