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 .
Notice of Amendment
The Amendment filed 11/26/2025 has been entered. Claims 1-20 are pending in the application with claim 1, 4-7, 9, 17 amended, claims 2, 10-15, 17-20 withdrawn.
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.
Claims 1, 3, 8, 9 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piskun et al. (US Patent Application Publication No. 2013/0274553, hereinafter Piskun).
In regard to claim 1, Piskun discloses a method for performing a minimally invasive procedure in a body lumen of a patient (Figs. 13-15), the method comprising:
inserting a flexible tubular member (1110) of a surgery system (1100) into a body lumen and navigating a distal end of the flexible tubular member toward a targeted lesion (Figs. 13-15), wherein the flexible tubular member comprises an endcap (1140) disposed on a distal end of the flexible tubular member and an adjustable cage (1150) disposed distal to the endcap, wherein the adjustable cage comprises a plurality of flexible members (1152, 1156) extendible from the endcap and a cap member (1148) coupled to the distal ends of the plurality of flexible members, and wherein the surgery system comprises a handle (1130) comprising a plurality of actuators each individually coupled to only one of the plurality of flexible members (Par. 195, via one actuator connected to flexible member (1152) and another actuator connected to flexible member (1156));
manipulating at least one actuator of the plurality of actuators to extend or retract one or more of the plurality of flexible elements of the adjustable cage to selectively adjust a shape of the adjustable cage dependent upon a position of the targeted lesion relative to a curvature of the body lumen (operating actuator (1132) changes the shape of flexible members (1152,1154) and therefore changes a shape of the adjustable cage for positioning the adjustable cage within a body cavity, Par. 195-Figs. 13-15); and
inserting a working instrument (1122) through the flexible tubular member to perform an operation on the targeted lesion (Figs. 18, 22),
wherein the shape is selected based on a location of the target lesion relative to a curve of the body lumen (via operating actuator (1132) to different degrees enables the adjustable cage to be shaped appropriately for positioning the adjustable cage relative to the polyp (C), Figs. 13-15).
In regard to claim 3, Piskun teaches further comprising selecting the working instrument from a plurality of working instruments based on the location of the target lesion relative to the curve of the body lumen (via choosing instrument (1210 or 1220) to perform an operation on the polyp).
In regard to claim 8, Piskun teaches wherein performing an operation on a lesion to comprises performing an operation on a lesion disposed proximal to the cap member and distal to the endcap (Fig. 12).
In regard to claim 9, Piskun discloses a method for performing a minimally invasive procedure in a body lumen of a patient (Figs. 13-15), the method comprising:
inserting a flexible tubular member (1110) of a surgery system (1100) into a body lumen and navigating a distal end of the flexible tubular member toward a targeted lesion (Figs. 13-15), wherein the flexible tubular member comprises an endcap (1140) disposed on a distal end of the flexible tubular member and an adjustable cage (1150) disposed distal to the endcap, wherein the adjustable cage comprises a plurality of flexible members (1152, 1156) extendible from the endcap and a cap member (1148) coupled to the distal ends of the plurality of flexible members, and wherein the surgery system comprises a handle (1130) comprising a plurality of actuators each individually coupled to only one of the plurality of flexible members (Par. 195, via one actuator connected to flexible member (1152) and another actuator connected to flexible member (1156));
manipulating at least one actuator of the plurality of actuators to extend or retract one or more of the plurality of flexible elements of the adjustable cage to selectively adjust a shape of the adjustable cage dependent upon a position of the targeted lesion relative to a curvature of the body lumen (Par. 195, Figs. 13-15); and
inserting a working instrument (1122) through the flexible tubular member to perform an operation on the targeted lesion (Figs. 18, 22),
wherein the shape is selected based on a location of the target lesion relative to a curve of the body lumen (via operating actuator (1132) to different degrees enables the adjustable cage to be shaped appropriately for positioning the adjustable cage relative to the polyp (C), Figs. 13-15).
In regard to claim 16, Piskun teaches wherein performing an operation on a lesion to comprises performing an operation on a lesion disposed proximal to the cap member and distal to the endcap (Figs. 13-15).
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.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Piskun et al. (US Patent Application Publication No. 2013/0274553, hereinafter Piskun) in view of Piskun et al. (US Patent Application Publication No. 2014/0142393, hereinafter Piskun2).
In regard to claims 4-7, Piskun teaches wherein a first one of the plurality of working instruments has a single bend hockey stick arrangement at a distal end (Fig. 18), but does not expressly teach wherein a second one of the plurality of working instruments has a double bend cobra arrangement at a distal end.
Piskun2 teaches an analogous system (100) comprising a flexible elongate member (105) having an adjustable cage (150) at the distal end. A variety of tool channels (110, 220) extend through the flexible elongate member into the adjustable cage with the first tool channel (110) having first and second curves (112,114) and the second tool channel (220, Fig. 6) having a single curve (Fig. 9). Piskun2 teaches that the first tool channel (110) allows a distance from the tool channel to the lesion to be maximized as compared to a single curve working channel (Par. 70).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the tool channels of Piskun to include a double curve tool channel (110) of Piskun2 enabling the distance from the tool channel to the lesion to be maximized (Par. 70).
Further regarding Claim 4, Piskun and Piskun2 teach the method further comprising: determining, based in part on visualization from the endoscope, whether the location of the target lesion is on an outer section of the curve of the body lumen (a physician is able to determine the location of the lesion via the endoscope (1200) disposed within the adjustable cage as taught by Piskun); selecting the second one of the plurality of working instruments as the working instrument based on a determination that the location of the target lesion is on an outer section of the curve of the body lumen (the physician is able to select either of the channel tools (110, 220) for performing the operation on the lesion as taught by Piskun2); and wherein manipulating the at least one actuator of the plurality of actuators to extend or retract one or more of the plurality of flexible elements of the adjustable cage to selectively adjust the shape of the adjustable cage comprises flexing the cage towards the outer curve of the body lumen based on the determination that the location of the target lesion is on an outer section of the curve of the body lumen (Piskun teaches of expanding the adjustable cage towards the target lesion and would therefore expand the adjustable cage towards the outer curved of the body lumen).
Further regarding Claim 5, Piskun and Piskun2 teach the method further comprising: determining, based in part on visualization from the endoscope, whether the location of the target lesion is between an inner and outer curve of the body lumen (a physician is able to determine the location of the lesion via the endoscope (1200) disposed within the adjustable cage); selecting the second one of the plurality of working instruments as the working instrument based on a determination that the location of the target lesion is between an inner and an outer curve of the body lumen (the physician is able to select either of the channel tools (110, 220) for performing the operation on the lesion as taught by Piskun2); and wherein manipulating the at least one actuator of the plurality of actuators to extend or retract one or more of the plurality of flexible elements of the adjustable cage to selectively adjust the shape of the adjustable cage comprises flexing the cage towards the outer curve of the body lumen based on the determination that the location of the target lesion is between an inner and an outer curve of the body lumen (Piskun teaches of expanding the adjustable cage towards the target lesion and would therefore expand the adjustable cage towards the outer curved of the body lumen).
Further regarding Claim 6, Piskun and Piskun2 teach the method further comprising: determining, based in part on visualization from the endoscope, whether the location of the target lesion is on an inner section of the curve of the body lumen (a physician is able to determine the location of the lesion via the endoscope (1200) disposed within the adjustable cage); selecting the first one of the plurality of working instruments as the working instrument based on a determination that the location of the target lesion is on an inner section of the curve of the body lumen (the physician is able to select either of the channel tools (110, 220) for performing the operation on the lesion as taught by Piskun2); and wherein manipulating the at least one actuator of the plurality of actuators to extend or retract one or more of the plurality of flexible elements of the adjustable cage to selectively adjust the shape of the adjustable cage comprises flexing the cage towards the outer curve of the body lumen based on the determination that the location of the target lesion is on an inner section of the curve of the body lumen (Piskun teaches of expanding the adjustable cage towards the target lesion and would therefore expand the adjustable cage towards the outer curved of the body lumen).
Further regarding Claim 7, Piskun and Piskun2 teach the method further comprising: determining, based in part on visualization from the endoscope, whether the location of the target lesion is on a straight section of the body lumen (a physician is able to determine the location of the lesion via the endoscope (1200) disposed within the adjustable cage); selecting the second one of the plurality of working instruments as the working instrument based on a determination that the location of the target lesion is on a straight section of the body lumen (the physician is able to select either of the channel tools (110, 220) for performing the operation on the lesion as taught by Piskun2); and wherein manipulating the at least one actuator of the plurality of actuators to extend or retract one or more of the plurality of flexible elements of the adjustable cage to selectively adjust the shape of the adjustable cage comprises flexing the cage towards the target lesion based on the determination that the location of the target lesion is on a straight section of the body lumen (Piskun teaches of expanding the adjustable cage towards the target lesion).
Response to Arguments
Applicant's arguments filed 11/26/202 have been fully considered but they are not persuasive.
Applicant argues:
“Applicant respectfully disagrees that Piskun identically discloses the claimed subject matter. For example, with respect to amended independent claim 1, the cited reference fails to teach at least the following language:
"the surgery system comprises a handle comprising a plurality of actuators each individually coupled to only one of the plurality of flexible elements"
To support this rejection in its entirety, the examiner turns to [0195] of Piskun, which teaches a catheter 1110 including a retractor actuator 1132 coupled to retractor elements 1152, 1154, the second set of retractor elements 1156, 1158 fixed to a proximal coupler 1140. Piskun does not teach a plurality of actuators, each coupled to one of the flexible elements. Instead, relying on one actuator coupled to multiple elements (e.g. 1156 and 1158 coupled to block 1146) [0195]-[0196].”
The examiner disagrees since the examiner has defined the flexible elements as element (1152) and element (1156), wherein Par. 195 teaches flexible element (1152) is controlled by actuator (1132) and flexible element (1156) can be controlled also by actuator (1132) or by a separate actuator.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 January 23, 2026