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 .
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.
Claim(s) 1, 3-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Igov (Pub. No.: US 2019/0082940)
Regarding claim 1, Igov discloses a scope system, comprising:
an elongate tube defining a lumen extending longitudinally therethrough, the elongate tube comprising a distal portion [see 0131, 0137] by disclosing an elongated channel having a longitudinal opening will mean the space in the cross section enclosed by the walls of the catheter and line joining the edges of the opening and/or openings [see 0137];
at least one accessory channel comprising at least one tubular structure defining an accessory lumen extending longitudinally therethrough, the at least one accessory channel movably disposed at least partially within the lumen of the elongate tube [see 0131, 0140];
a first steerable endoscopic instrument (a first tool or 734a or pincer tool 734a) extending at least partially through the at least one accessory channel [see 0131-0132, 0208] by disclosing tool 734a includes a forceps [see 0208];
the first steerable endoscopic instrument comprising a first distal instrument end that is movable relative to a distal channel end of the at least one accessory channel [see 0140, 0206, 0208] by disclosing the tool may be moved with respect to the axis of the guide and/or between lumens by twisting a carriage connected and/or inserted in the guide [see 0140, 0208];
a second steerable endoscopic instrument (second tool) extending at least partially through the at least one accessory channel [see abstract, 0142]
, the second steerable endoscopic instrument (second tool) comprising a second distal instrument end that is movable (via the second guide) relative to the distal channel end [see abstract, 0041, 0131-0132, 0206] by disclosing the second tool may subsequently be conveyed along a second guide [see abstract] and the catheter further includes a second distal finger for directing a distal end of a second guide of the elongated guides and wherein the control system is further for directing the second finger relative to an axis of the catheter [see 0041].
Regarding claim 3, Igov discloses wherein the first distal instrument end is configured to deflect (via distal finger/guides, 0147, abstract) from a longitudinal axis of the elongate tube in at least two directions [see 0053] by disclosing a plurality of fingers, each the finger including a distal opening of a channel of the plurality of channels; and a control mechanism at a proximal side of the catheter to direct at least two of the fingers in different directions [see 0053] and a user at the proximal end of sleeve 3342 may control tension on cables 3384 to point finger 3382 in one or another direction [see 0286];
wherein a deflection in each of the at least two directions is less than an angle of 180 degrees relative to the longitudinal axis [see 0196].
Regarding claim 4, Igov discloses wherein the second steerable endoscopic instrument is selected from the group consisting of a suction device, an irrigation device, an insufflation device, a camera lens washing device, an electrohydraulic lithotripsy probe, forceps [see 0208], a basket, snares, electrosurgical devices, wires, a dilation balloon, an extraction balloon, a needle knife, hemostasis clips, and laser-based devices.
Regarding claim 5, Igov discloses wherein the second steerable endoscopic instrument comprises a steerable sheath (outer sleeve) [see 0220].
Regarding claim 6, Igov discloses wherein the second steerable endoscopic instrument comprises an outer sheath comprising two or more steering wires [see 0220] by disclosing outer sleeve 1242 includes a working channel 1228 and a plurality of guides 1232 [see 0220].
Regarding claim 7, Igov discloses wherein the second distal instrument end is configured to deflect (pointing fingers 3282 and/or guides) from a longitudinal axis of the elongate tube in at least two directions [see 0283, 0325] by disclosing a user at the proximal end of sleeve 3342 may control tension on cables 3384 to point finger 3382 in one or another direction [see 0286];
wherein a deflection in each of the at least two directions is less than an angle of 180 degrees relative to the longitudinal axis [see 0196]
Regarding claim 8, Igov discloses wherein the first steerable endoscopic instrument and/or the second steerable endoscopic instrument comprises a steering mechanism (guides/fingers) [see 0144, 0191]
Regarding claim 9, Igov discloses wherein the steering mechanism is selected from the group consisting of a joystick, a rack and pinion [see 0191], and a thumb wheel.
Regarding claim 10, Igov discloses wherein the second steerable endoscopic instrument comprises forceps [see 0208] by disclosing tool 734a includes a forceps that are biased to an open position and tool 734b includes a pushing element to close the forceps of tool 734b. Tools 734a,b may be deployed independently. Optionally tools 734a, b function cooperatively. For example, the forceps may be moved near an object to be grasped and then the pushing element may be used to close the forceps, grasping the object [see 0208]
Regarding claim 11, Igov discloses wherein the second steerable endoscopic instrument comprises an actuator or a lever (pushing element) configured to open and close a first jaw and a second jaw of the forceps [see 0208, 0325] by disclosing tool 734a includes a forceps that are biased to an open position and tool 734b includes a pushing element to close the forceps of tool 734b. Tools 734a, b may be deployed independently. Optionally tools 734a, b function cooperatively. For example, the forceps may be moved near an object to be grasped and then the pushing element may be used to close the forceps, grasping the object [see 0208] and also disclose moving a pusher with relation to a pincer may open and/or close the pincer and/or a blade may be moved to cut and/or takes samples [see 0325].
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 (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 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.
Claim(s) 2 are rejected under 35 U.S.C. 103 as being unpatentable over Igov (Pub. No.: US 2019/0082940) in view of Dillon et al (Pub. No.: US 2018/0028778).
Regarding claim 2, Igov doesn’t disclose wherein the first steerable endoscopic instrument comprises a cholangioscope.
Nonetheless, Dillon et al disclose a cholangioscope [see 0035] by disclosing a small-diameter body configured for use as a steerable catheter equipped as a cholangioscope that is dimensioned for navigation through a working channel of a larger endoscope and for operation within the biliary tree of a human patient [see 0035].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Igov and Dillon et al by using a cholangioscope; it allows for direct visualization of the bile ducts, improving diagnostic accuracy.
Claim(s) 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Igov (Pub. No.: US 2019/0082940) in view of in view of Surti et al (Pub. No.: US 20170251908)
Regarding claim 12, Igov discloses a scope system, comprising:
an elongate tube defining a lumen extending longitudinally therethrough, the elongate tube comprising a distal portion [see 0131, 0137] by disclosing an elongated channel having a longitudinal opening will mean the space in the cross section enclosed by the walls of the catheter and line joining the edges of the opening and/or openings [see 0137];
at least two accessory channels, each of the at least two accessory channels comprising at least one tubular structure defining an accessory lumen extending longitudinally therethrough [see figs 7A-C through 9, 187-188];
the at least two accessory channels movably disposed at least partially within the lumen of the elongate tube [see figs 7A-C through 9, 187-188];
a first steerable endoscopic instrument (a first tool or 734a or pincer tool 734a) extending at least partially through a first accessory channel of the at least two accessory channels [see figs 7A-C through 9, 0131-0132, 0208] by disclosing tool 734a includes a forceps [see 0208];
the first steerable endoscopic instrument (forceps 734a/934a) comprising a first distal instrument end that is movable relative to a distal channel end of the at least two accessory channels [see 0140, 0206, 0208] by disclosing the tool may be moved with respect to the axis of the guide and/or between lumens by twisting a carriage connected and/or inserted in the guide [see 0140, 0208];
a second steerable endoscopic instrument (second tool or camera 546a-b) extending at least partially through a second accessory channel [see figs 7A-C through 9, 187-188];
the second steerable endoscopic instrument comprising a second distal instrument end that is movable relative to the distal channel end [see abstract, 0041, 0131-0132, 0206] by disclosing the second tool may subsequently be conveyed along a second guide [see abstract] and the catheter further includes a second distal finger for directing a distal end of a second guide of the elongated guides and wherein the control system is further for directing the second finger relative to an axis of the catheter [see 0041].
Reed et al don’t disclose a coupling mechanism configured to couple the first distal instrument end to the second distal instrument end.
Nonetheless, Surti et al disclose a coupling mechanism (pivot arm 104) configured to couple the first distal instrument end to the second distal instrument end [see 0063, fig 14]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Reed et al and Surti et al by using a coupling mechanism configured to couple the first distal instrument end to the second distal instrument end; ensuring that the accessory channels 112, 114 do not separate significantly from the duodenoscope 102.
Regarding claim 13, Reed et al don’t disclose wherein the coupling mechanism comprises a loop on the first distal instrument end, the loop configured to envelop and tighten around the second distal instrument end, or a loop on the second distal instrument end that is configured to envelop and tighten around the first distal instrument end.
Nonetheless, Surti et al disclose a loop on the first distal instrument end, the loop configured to envelop and tighten around the second distal instrument end, or a loop on the second distal instrument end that is configured to envelop and tighten around the first distal instrument end [see 0063] by disclosing a variety of other attachment methods may be used such as loops or rings that may be slide along the length of the duodenoscope 102 to a desired location [see 0063, figs 14-15].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Reed et al and Surti et al by using a loop on the first distal instrument end, the loop configured to envelop and tighten around the second distal instrument end, or a loop on the second distal instrument end that is configured to envelop and tighten around the first distal instrument end; ensuring that the accessory channels 112, 114 do not separate significantly from the duodenoscope 102 [see 0063].
Regarding claim 14, Igov doesn’t disclose wherein the first steerable endoscopic instrument comprises a cholangioscope.
Nonetheless, Surti et al disclose a cholangioscope [see 0063].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Igov and Surti et al by using a cholangioscope; it allows for direct visualization of the bile ducts, improving diagnostic accuracy.
Regarding claim 15, Igov discloses wherein the second steerable endoscopic instrument is selected from the group consisting of a suction device, an irrigation device, an insufflation device, a camera lens washing device, an electrohydraulic lithotripsy probe, forceps [see 0208], a basket, snares, electrosurgical devices, wires, a dilation balloon, an extraction balloon, a needle knife, hemostasis clips, and laser-based devices.
Regarding claim 16, Igov discloses wherein the first steerable endoscopic instrument and/or the second steerable endoscopic instrument comprises a steering mechanism selected from the group consisting of a joystick, a rack and pinion [see 0191], and a thumb wheel.
Regarding claim 17, Igov discloses wherein the second steerable endoscopic instrument comprises forceps and a lever configured to open and close a first jaw and a second jaw of the forceps [see 0208, 0325] by disclosing tool 734a includes a forceps that are biased to an open position and tool 734b includes a pushing element to close the forceps of tool 734b. Tools 734a, b may be deployed independently. Optionally tools 734a, b function cooperatively. For example, the forceps may be moved near an object to be grasped and then the pushing element may be used to close the forceps, grasping the object [see 0208] and also disclose moving a pusher with relation to a pincer may open and/or close the pincer and/or a blade may be moved to cut and/or takes samples [see 0325].
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.
Claim(s) 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et al (Pub. No.: US 2022/0095899).
Regarding claim 18, Reed et al disclose a method for performing endoscopy in a bile duct of a mammal [see 0006, 0042, 0052], comprising:
providing a scope system comprising:
an elongate tube defining a lumen extending longitudinally therethrough, the elongate tube comprising a distal portion [see 0066, fig 11];
at least one accessory channel comprising at least one tubular structure defining an accessory lumen extending longitudinally therethrough, the at least one accessory channel movably disposed at least partially within the lumen of the elongate tube [see 0066, fig 11];
a first steerable endoscopic instrument (instrument 1120) extending at least partially through the at least one accessory channel [see 0066, fig 11];
the first steerable endoscopic instrument (instrument 1120 or any one or the one or more expandable members) comprising a first distal instrument end that is movable relative to a distal channel end of the at least one accessory channel [see fig 11, 0066] by disclosing tool 1120 may be rotatable and axially translatable in order to achieve the desired position and angle of approach to a target area. The tool may also be rotatable and axially translatable with respect to a second tool (not shown) which may be passed through a channel of the instrument (not shown). The tool 1120 may be steerable at its tip [see 0066];
a second steerable endoscopic instrument (instrument 1100) extending at least partially through the at least one accessory channel [see 0066, fig 11];
the second steerable endoscopic instrument (instrument 1100 or any one or the one or more expandable members) comprising a second distal instrument end that is movable relative to the distal channel end of the at least one accessory channel [see 0066] by disclosing instrument 1100 extending through a channel guide 1110 of the device 1102 [see 0066] and the device is slidable along the instrument, such that the instrument may be rotated or axially translated while the radial positioning is fixed. In various embodiments, the device 1110 may be fixed along the instrument 1100 [see 0066];
steering the first distal instrument (1120) end and the second distal instrument end (1100) separately within the bile duct [see 0006, 0042, 0052, 0066] by disclosing the use of multiple devices allows for each device to be independently manipulated, allowing them to be axially extended with respect to each other device [see 0078, abstract].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Reed et al (Pub. No.: US 2022/0095899) in view of Dillon et al (Pub. No.: US 2018/0028778).
Regarding claim 19, Reed et al disclose wherein the first steerable endoscopic instrument is selected from the group consisting of a suction device, an irrigation device, an insufflation device, a camera lens washing device, an electrohydraulic lithotripsy probe, forceps, a basket, snares, electrosurgical devices, wires [see 0047], a dilation balloon [see 0047], an extraction balloon, a needle knife, hemostasis clips, and laser-based devices.
Reed et al don’t disclose wherein the second steerable endoscopic instrument comprises a cholangioscope.
Nonetheless, Dillon et al disclose a cholangioscope [see 0035] by disclosing a small-diameter body configured for use as a steerable catheter equipped as a cholangioscope that is dimensioned for navigation through a working channel of a larger endoscope and for operation within the biliary tree of a human patient [see 0035].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Reed et al and Dillon et al by using a cholangioscope; it allows for direct visualization of the bile ducts, improving diagnostic accuracy.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Reed et al (Pub. No.: US 2022/0095899) in view of Surti et al (Pub. No.: US 20170251908).
Regarding claim 20, disclose steering the first distal instrument end and the second distal instrument end together within the bile duct.
Reed et al don’t disclose translating the second distal instrument end distally through a loop on the first distal instrument end; tightening the loop around the second distal instrument end.
Nonetheless, Surti et al disclose translating the second distal instrument end distally through a loop on the first distal instrument end; tightening the loop around the second distal instrument end [see 0063] by disclosing a variety of other attachment methods may be used such as loops or rings that may be slide along the length of the duodenoscope 102 to a desired location [see 0063, figs 14-15].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Reed et al and Surti et al by translating the second distal instrument end distally through a loop on the first distal instrument end; tightening the loop around the second distal instrument end; ensuring that the accessory channels 112, 114 do not separate significantly from the duodenoscope 102 [see 0063].
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798