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 .
Applicant' s arguments, filed 09/09/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicants have amended their claims, filed 09/09/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-5 and 7-20 are the currently pending claims with claims 12-13 and 17-20 previously withdrawn and claim 6 was previously canceled. Claims 1-5, 7-11, and 14-16 are currently under examination.
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 1-2, 4-5, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over by Kortenbach et al. (US 20020068935 A1), hereto referred as Kortenbach, and further in view of Pona (US 20200046326 A1), hereto referred as Pona.
Regarding claim 1, Kortenbach teaches that a biopsy device adapted for use with an endoscope (Kortenbach, Abstract: "surgical tool attaches to the distal end of an endoscope", [0028] and [0032]: structural and functional description of a device with pivoting jaws that engage tissue, [0037] : the jaws may be other effectors such as "scissors" or "dissectors", the surgical tool also contains [0032]: "A grasper...such as... biopsy forceps, snare, suction device or other instrument for... retaining tissue") comprises: an adaptor adapted to be secured relative to the endoscope, the adaptor including an annular wall surrounding an interior of the adaptor, the annular wall having an inner surface facing the interior of the adaptor and an outer surface (Kortenbach, ¶[0033]: “upper ring portion 132 for coupling to the distal end 2 of an endoscope… The upper portion 132 may have an inner diameter which is substantially the same size as the outer diameter of the endoscope and cemented, press fit, or otherwise affixed to the distal end of the endoscope”, shows an adaptor with an annular ring that defines inner and outer surfaces and surrounds an interior at the distal end of the endoscope); a pair of jaws comprising a first jaw and a second jaw that are pivotably disposed by a first hinge pin and a second hinge pin (Kortenbach, [0028]: "A pair of jaws 26, 28 are rotatably coupled to the clevis"; describes jaws that are pivotably attached to the clevis, which is interpreted to be the adaptor; FIG. 8 and [0033] "Jaws 126, 128 are rotatably coupled to pivot pins 124a, 124b of the clevis 124", where the pivot pins (i.e. hinge pins) functionally protrude and are disposed on the interior surface of the clevis (FIG. 7a) and "the clevis means 124 includes an upper ring portion 132 for coupling to the distal end 2 of an endoscope", showing that the clevis is part of the adaptor); an actuator operably coupled with the pair of jaws and extending proximally therefrom, the actuator adapted to move the pair of jaws relative to the adaptor. (Kortenbach, FIG. 1, 8; [0028]: "Movement of one of the pull wire or the coil relative to the other causes the jaws to open or close", and [0034]: "The distal end of the pull wire moves distally relative to the distal end of the coil, causing the jaws to rotate about the pins 124a, 124b which constitute the rotation axis for both jaws"; describes an actuator (pull wire and coil) that is operably coupled to the jaws and extends proximally, as shown in the figure, allowing for their movement relative to the clevis (i.e. adaptor)).
Also regarding claim 1, Kortenbach does not fully teach that the first jaw and the second jaw are positioned entirely within the interior of the adaptor with the annular wall surrounding the pair of jaws when the pair of jaws are in an open configuration. Rather, Kortenbach discloses the adaptor ring, opposed jaws on clevis pins, and proximal actuation, and shows open and closed jaw positions (Kortenbach, ¶[0033], ¶[0034]; Figs. 7–9), but does not disclose that, in the open configuration, the jaws are positioned entirely within the adaptor with the annular wall surrounding them.
Pona teaches a distal head where movable cutting elements (jaws) pivot about inward pins and transition “from an upper retracted position… to a lower cutting position,” evidencing that the movable elements reside within the head when retracted/open, and further teaches inwardly directed pivot supports on the interior of the head (Pona, ¶[0063]: “The capture head has four inwardly directed pivot pins 130 geometrically spaced apart from one another”, ¶[0065]: “Each transverse cutting blade has a hole 161 so that it may pivot about pivot pin 130 that project from the capture head”, ¶[0069]: “blades 160 to rotate from an upper retracted position…”, Figs. 3, 4A–4G).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kortenbach in view of Pona to configure the open jaw position so that the jaws are positioned entirely within the interior of the adaptor with the annular wall surrounding the jaws. A skilled artisan could implement Pona’s enclosed-when-retracted/open layout on Kortenbach by a single, incremental packaging adjustment (further extending the annular wall distally (and, if needed, slightly widening that extension) so the wall encompasses the open jaw sweep) which is foreshadowed by Kortenbach’s drawings (Kortenbach, Figs. 7–9, showing the upper ring portion 132 projecting distally beyond the scope tip as compared to Fig. 1). Moreover, hinge location is configurable in Kortenbach, supporting modest centralization of the pins to preserve articulation clearance with the extended wall: “a second embodiment of the invention is disclosed which is substantially similar to the first embodiment but for the configuration of the clevis and the jaws (i.e., the proximal actuation mechanism is as shown in FIG. 1)” (Kortenbach, FIG. 1; ¶[0033]). These routine packaging adjustments retain Kortenbach’s pull-wire/coil actuation and jaw function (Kortenbach, ¶[0034]: “the distal end of the pull wire moves distally relative to the distal end of the coil… causing the jaws to rotate about the pins 124a, 124b”), and yield predictable benefits including shielding moving components, minimizing snagging or debris interference, and improving distal-tip safety and clearance.
Also regarding claim 1, the combined Kortenbach and Pona does not fully teach that the first hinge pin and the second hinge pin disposed on the inner surface of the adaptor and positioned entirely within the interior of the adaptor. As set forth above, Kortenbach in view of Pona teaches a distal adaptor ring (clevis) mounted to the endoscope with opposed jaws on clevis pins and proximal pull-wire/coil actuation, and (via Pona’s enclosure geometry) an annular wall extended distally to surround the open configuration (Kortenbach, ¶[0033]: “Jaws 126, 128 are rotatably coupled to pivot pins 124a, 124b of the clevis 124”; Kortenbach, ¶[0034]: “the distal end of the pull wire moves distally relative to the distal end of the coil… causing the jaws to rotate about the pins 124a, 124b”; Pona, ¶[0063]: “The capture head has four inwardly directed pivot pins 130”, ¶[0065]: “Each transverse cutting blade has a hole 161 so that it may pivot about pivot pin 130”, Figs. 3, 4A–4G). While Kortenbach shows the jaws pinned to the clevis, it does not expressly state that the pins are “positioned entirely within the interior of the adaptor.”
Pona teaches inwardly directed pivot supports on the inner surface of the head, which are fully within the head structure (Pona, ¶[0063], ¶[0065]; Figs. 3, 4A–4G).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Kortenbach and Pona in view of Pona to position the first and second hinge pins entirely within the interior of the adaptor. A skilled artisan could implement the inward, internalized pivot arrangement of Pona on the clevis/adaptor of Kortenbach by routine packaging adjustments (e.g., using inward-directed supports on the adaptor’s inner surface) in combination with the already-extended annular wall, while retaining Kortenbach’s pull-wire/coil actuation and jaw functionality. Moreover, Kortenbach confirms hinge/clevis geometry is configurable: “a second embodiment of the invention is disclosed which is substantially similar to the first embodiment but for the configuration of the clevis and the jaws (i.e., the proximal actuation mechanism is as shown in FIG. 1)” (Kortenbach, ¶[0033]), which supports modest centralization of the pins within the adaptor to maintain articulation clearance when the ring is extended. This combination provides predictable benefits including protection of the pivot hardware and reduced interference from tissue or debris by keeping the hinge structure within the adaptor interior.
Also regarding claim 1, the combined Kortenbach and Pona does not fully teach that an actuator extends through the interior of the adaptor. As set forth above, Kortenbach in view of Pona provides the proximal pull-wire/coil actuator driving the opposed jaws at the distal ring, and (via the Pona-motivated enclosure) an annular wall extended distally so that the jaws are surrounded when open (Kortenbach, ¶[0034]: “the distal end of the pull wire moves distally relative to the distal end of the coil… causing the jaws to rotate about the pins 124a, 124b”; Pona, ¶[0063]: “The capture head has four inwardly directed pivot pins 130”, ¶[0065]: “Each transverse cutting blade has a hole 161 so that it may pivot about pivot pin 130”, Figs. 3, 4A–4G). With the annular wall extended to enclose the open configuration, the existing actuator path passes within the space surrounded by the annular wall (i.e., through the interior of the adaptor) as it extends proximally relative to the adaptor.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Kortenbach and Pona in view of Pona to extend the annular wall so that the actuator extends proximally through the interior of the adaptor. A skilled artisan could implement the annular-wall extension (with slight radial widening if needed) as a routine packaging adjustment while retaining Kortenbach’s pull-wire/coil actuation and jaw function; and, consistent with Kortenbach’s embodiment flexibility, modest centralization of the hinge pins (supported by “a second embodiment… substantially similar… but for the configuration of the clevis and the jaws” (Kortenbach, ¶[0033])) can be employed as desired to ensure actuator and jaw clearance without impingement. The resulting configuration provides predictable benefits including improved protection of the actuator pathway at the distal tip and reduced snagging or interference from tissue or debris.
Regarding claim 2, Kortenbach teaches that the actuator is adapted to be moved in a first axial direction to open the pair of jaws and to be moved in an opposing second axial direction to close the jaws (Kortenbach, ¶[0028] and Fig. 1: An actuation device… is coupled to the proximal end 14 of the coil and the proximal end 22 of the pull wire for reciprocally moving one of the pull wire and the coil relative to the other… Movement of one of the pull wire or the coil relative to the other causes the jaws to open or close” and ¶[0030]: “The actuation device 20 is substantially the same as used in many conventional endoscopic biopsy forceps…”, where the figure and paragraphs depict an axial motion of the pull wire and coil causes the jaws to open or close).
Regarding claim 4, Kortenbach teaches that the adaptor comprises a first pivot point along a first side of the adaptor and a second pivot point along a second side of the adaptor (Kortenbach, ¶[0033] and Fig. 8: "jaws 126, 128 are rotatably coupled to pivot pins 124 a, 124 b of the clevis 124"; where the clevis, which forms the adaptor in combination with the upper ring (¶[0028]), is depicting having two pivot points, one on each side (i.e. first and second)).
Regarding claim 5, Kortenbach teaches that the first pivot point and the second pivot point are disposed on the inner surface of the adaptor (Kortenbach, ¶[0033] and Fig. 8: "jaws 126, 128 are rotatably coupled to pivot pins 124 a, 124 b of the clevis 124", where the figure depicts the pivot points on the inner surface of the clevis (i.e. adaptor)).
Regarding claim 7, Kortenbach teaches that the actuator comprises a first actuator member secured relative to the first jaw and a second actuator member secured relative to the second jaw such that applying an axial force to the first actuator member and/or the second actuator member causes the first jaw and/or the second jaw to pivot relative to the adaptor (Kortenbach, ¶[0033]: "The distal jaw 126 is provided with a rotator arm 127 to which the distal end of the coil is coupled at pivot pin 127a. The proximal jaw 128 is provided with a rotator arm 129 to which the distal end of the pull wire 118 is coupled at hole 129a." and ¶[0034]: "proximal movement of the spool will move the pull wire proximally causing the jaw 128 to move toward the jaw 126"; describes two actuator members (the coil and pull wire), each connected to one of the jaws (rotator arms 127 and 129), where the members apply axial force, causing the jaws to pivot around their respective axes in relation to the clevis (i.e. adaptor)).
Regarding claim 8, Kortenbach teaches that the first jaw includes a first actuator arm and the second jaw includes a second actuator arm, with the first actuator member secured to the first actuator arm and the second actuator member secured to the second actuator arm (Kortenbach, ¶[0033]: "The distal jaw 126 is provided with a rotator arm 127 to which the distal end of the coil is coupled at pivot pin 127 a", "The proximal jaw 128 is provided with a rotator arm 129 to which the distal end of the pull wire 118 is coupled at hole 129 a."; explicitly describing a first actuator arm (rotator arm 127) and a second actuator arm (rotator arm 129), with the coil (first actuator member) and pull wire (second actuator member) secured to these respective arms).
Regarding claim 9, Kortenbach teaches that the adaptor includes a first alignment feature that accommodates the first actuator member extending therethrough and a second alignment feature that accommodates the second actuator member extending therethrough (Kortenbach, ¶[0033] and Fig. 7: "The clevis means 124 also includes a lower side throughbore 133 which is dimensioned to allow the distal end of the coil to move therethrough"; where the throughbore acts as the first alignment feature for the coil (first actuator member) and the coil itself acts as the second alignment feature for the pull wire (second actuator member) which is contained within it (Fig. 1, Parts 12 and 18), the wire reciprocates relative to the coil and is functionally dependent on the coil's alignment through the throughbore).
Regarding claim 10, Kortenbach teaches that the biopsy device of claim 1, further comprising a coupler adapted to releasably secure the adaptor relative to the endoscope (Kortenbach, ¶[0033] and Fig. 8: "the clevis means 124 includes an upper ring portion 132 for coupling to the distal end 2 of an endoscope... and cemented, press fit, or otherwise affixed to the distal end of the endoscope"; where the upper ring functions as the coupler which is attached to the clevis (i.e. adapter) and it can be releasably secured to the endoscope).
Regarding claim 11, Kortenbach teaches that the biopsy device of claim 10, further comprising an actuator handle operably coupled with the actuator (Kortenbach, ¶[0030] and Fig 1: "A spool 46 having a cross member 48...[and] The proximal end 14 of the coil 12 is coupled to the shaft 38 and the proximal end 22 of the pull wire 18 is coupled to the cross member 48 of the spool"; where the spool acts as the handle and the pull wire and coil act as the actuating members, enabling the movement of the jaws).
Claims 3 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over by Kortenbach et al. (US 20020068935 A1), hereto referred as Kortenbach, and further in view of Pona (US 20200046326 A1), hereto referred as Pona, and further in view of Simpson et al. (US 6149607 A), hereto referred as Simpson.
The combined Kortenbach and Pona teaches claim 1 as described above.
Regarding claim 3, Kortenbach does not explicitly teach that the pair of jaws are biased to a first position, and the actuator is adapted to move the pair of jaws against a biasing force. Kortenbach provides a structural description of jaws that pivot to engage tissue when actuated by the pull wire and coil mechanism (Kortenbach, ¶[0033]). However, Kortenbach lacks explicit detail regarding how a biasing force can reliably control the jaws' movement to an open or closed position. Simpson, who discloses an endoscopic biopsy device, teaches the use of a spring biasing mechanism to manage the jaws' default positioning (Simpson, Col. 7, Lines 44–55). In Simpson, the spring bias ensures that the jaws remain in an open or closed biased position unless an axial force is applied to them. This approach guarantees precise control, allowing the jaws to return to their default state after actuation. The structural and functional similarities between the devices would have made it straightforward to adapt Simpson’s spring mechanism into Kortenbach’s configuration without requiring substantial modifications. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Kortenbach and Pona in view of Simpson to have the jaws biased to a first position, where the actuator moves the jaws against the biasing force. This would have the benefit of consistency in jaw positioning, improving surgical reliability and thus reducing the potential for clinical errors.
Regarding claim 14, Kortenbach teaches that a biopsy device adapted for use with an endoscope (Kortenbach, Abstract: "surgical tool attaches to the distal end of an endoscope", [0028] and [0032]: structural and functional description of a device with pivoting jaws that engage tissue, [0037]: the jaws may also be "scissors" or "dissectors", the surgical tool also contains [0032]: "A grasper...such as... biopsy forceps, snare, suction device or other instrument for... retaining tissue"); an adaptor adapted to be secured relative to an endoscope, the adaptor including an annular wall defining an inner surface forming a perimeter around an interior of the adaptor (Kortenbach, ¶[0033]: “upper ring portion 132 for coupling to the distal end 2 of an endoscope… The upper portion 132 may have an inner diameter which is substantially the same size as the outer diameter of the endoscope and cemented, press fit, or otherwise affixed to the distal end of the endoscope”, shows an adaptor with an annular ring that defines inner and outer surfaces and surrounds an interior at the distal end of the endoscope); a first jaw pivotably secured to the adaptor at a first hinge pin and at a second hinge pin (Kortenbach, [0028]: "A pair of jaws 26, 28 are rotatably coupled to the clevis"; describes jaws that are pivotably attached to the clevis, which is interpreted to be the adaptor; FIG. 8 and [0033] "Jaws 126, 128 are rotatably coupled to pivot pins 124a, 124b of the clevis 124", where the pivot pins (i.e. hinge pins) functionally protrude and are disposed on the interior surface of the clevis (FIG. 7a) and "the clevis means 124 includes an upper ring portion 132 for coupling to the distal end 2 of an endoscope", showing that the clevis is part of the adaptor); a second jaw pivotably secured to the adaptor at the first hinge pin and at the second hinge pin (Kortenbach, FIG. 8 and [0033]: "Jaws 126, 128 are rotatably coupled to pivot pins 124a, 124b of the clevis 124", where the pivot pins (i.e. hinge pins) functionally protrude the interior surface of the clevis and "the clevis means 124 includes an upper ring portion 132 for coupling to the distal end 2 of an endoscope", where the second jaw is similarly pivotably secured to the clevis which is part of the adaptor); a first actuator member secured to the first jaw such that moving the first actuator member causes the first jaw to pivot relative to the adaptor (Kortenbach, [0033] and Fig. 7-9: "The distal jaw 126 is provided with a rotator arm 127 to which the distal end of the coil is coupled at pivot pin 127a."; describing the first actuator member (coil) and its coupling to the first jaw, allowing for pivoting relative to the adaptor (clevis)); a second actuator member secured to the second jaw such that moving the second actuator member causes the second jaw to pivot relative to the adaptor (Kortenbach, [0033] and Fig. 7-9: "The proximal jaw 128 is provided with a rotator arm 129 to which the distal end of the pull wire 118 is coupled at hole 129 a"; describing the second actuator member (pull wire) and its coupling to the second jaw, allowing for pivoting relative to the adaptor (clevis)); and an actuator handle operably coupled with the first actuator member and the second actuator member such that manipulating the actuator handle causes the first jaw and the second jaw to pivot relative to the adaptor (Kortenbach, [0030]: "A spool 46 having a cross member 48... [and] The proximal end 14 of the coil 12 is coupled to the shaft 38 and the proximal end 22 of the pull wire 18 is coupled to the cross member 48 of the spool" and [0033]: "The spool 46 of the actuator 20... is moved distally... causing the jaws to open or close"; where the spool acts as the handle and the pull wire and coil act as the actuating members such that the members are operably coupled to the handle).
Also regarding claim 14, Kortenbach does not fully teach that the first jaw and the second jaw are positioned entirely within the interior of the adaptor such that the annular wall surrounds the first jaw and the second jaw when the first jaw and the second jaw are in an open configuration. Rather, Kortenbach discloses the adaptor ring, opposed jaws on clevis pins, and proximal actuation, and shows open and closed jaw positions (Kortenbach, [0033], [0034]; Figs. 7–9), but does not disclose that, in the open configuration, the jaws are positioned entirely within the adaptor with the annular wall surrounding them.
Pona teaches a distal head where movable cutting elements pivot about inward pins and transition "from an upper retracted position… to a lower cutting position", evidencing that the movable elements reside within the head when retracted/open, and further teaches inwardly directed pivot supports on the interior of the head (Pona, [0063]: "The capture head has four inwardly directed pivot pins 130 geometrically spaced apart from one another", [0065]: "Each transverse cutting blade has a hole 161 so that it may pivot about pivot pin 130 that project from the capture head", [0069]: "In operation a physician or other medical professional takes the biopsy harvesting instrument 7 and pushes down while twisting…", Figs. 3, 4A–4G).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kortenbach in view of Pona to configure the open jaw position so that the jaws are positioned entirely within the interior of the adaptor with the annular wall surrounding the jaws. A skilled artisan could implement Pona’s enclosed-when-retracted/open layout on Kortenbach by a single, incremental packaging adjustment—further extending the annular wall distally (and, if needed, slightly widening that extension) so the wall encompasses the open jaw sweep—which is foreshadowed by Kortenbach’s drawings (Kortenbach, Figs. 7–9 versus Fig. 1). Moreover, hinge location is configurable in Kortenbach, supporting modest centralization of the pins to preserve articulation clearance with the extended wall: "a second embodiment of the invention is disclosed which is substantially similar to the first embodiment but for the configuration of the clevis and the jaws (i.e., the proximal actuation mechanism is as shown in FIG. 1)" (Kortenbach, [0033]). These routine packaging adjustments retain Kortenbach’s pull-wire/coil actuation and jaw function (Kortenbach, [0034]: "the distal end of the pull wire moves distally relative to the distal end of the coil… causing the jaws to rotate about the pins 124a, 124b"), and yield predictable benefits including shielding moving components, minimizing snagging or debris interference, and improving distal-tip safety and clearance.
Also regarding claim 14, the combined Kortenbach and Pona does not fully teach that the first hinge pin and the second hinge pin disposed on the inner surface of the adaptor and positioned entirely within the interior of the adaptor. As set forth above, Kortenbach in view of Pona teaches a distal adaptor ring (clevis) mounted to the endoscope with opposed jaws on clevis pins and proximal pull-wire/coil actuation, and—via Pona’s enclosure geometry—an annular wall extended distally to surround the open configuration (Kortenbach, [0033]: "Jaws 126, 128 are rotatably coupled to pivot pins 124a, 124b of the clevis 124"; Kortenbach, [0034]: "the distal end of the pull wire moves distally relative to the distal end of the coil… causing the jaws to rotate about the pins 124a, 124b"; Pona, [0063]: "The capture head has four inwardly directed pivot pins 130", [0065]: "Each transverse cutting blade has a hole 161 so that it may pivot about pivot pin 130", Figs. 3, 4A–4G). While Kortenbach shows the jaws pinned to the clevis, it does not expressly state that the pins are "positioned entirely within the interior of the adaptor".
Pona teaches inwardly directed pivot supports on the inner surface of the head, which are fully within the head structure (Pona, [0063], [0065]; Figs. 3, 4A–4G).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Kortenbach and Pona in view of Pona to position the first and second hinge pins entirely within the interior of the adaptor. A skilled artisan could implement the inward, internalized pivot arrangement of Pona on the clevis/adaptor of Kortenbach by routine packaging adjustments (e.g., using inward-directed supports on the adaptor’s inner surface) in combination with the already-extended annular wall, while retaining Kortenbach’s pull-wire/coil actuation and jaw functionality. Moreover, Kortenbach confirms hinge/clevis geometry is configurable: "a second embodiment of the invention is disclosed which is substantially similar to the first embodiment but for the configuration of the clevis and the jaws (i.e., the proximal actuation mechanism is as shown in FIG. 1)" (Kortenbach, [0033]), which supports modest centralization of the pins within the adaptor to maintain articulation clearance when the ring is extended. This combination provides predictable benefits including protection of the pivot hardware and reduced interference from tissue or debris by keeping the hinge structure within the adaptor interior.
Also regarding claim 14, the combined Kortenbach and Pona does not fully teach that the first jaw and the second jaw are adapted to be pivotable to a closed configuration in which the first jaw and the second jaw interact to cut tissue. Rather, Kortenbach does not explicitly teach that the first jaw and the second jaw are adapted to be pivotable to a closed configuration in which the first jaw and the second jaw interact to cut tissue. Kortenbach discloses jaws that pivot to engage tissue when actuated by the pull wire and coil (Kortenbach, [0034]). However, it does not explicitly describe that the jaws sever or cut tissue although it does state that the jaws could be scissors or dissectors (Kortenbach, [0037]) and thus the device could cut tissue.
Simpson provides this missing detail, explicitly teaching jaws that sever tissue upon closure (Simpson, Col. 4, Lines 1-15). Combining Simpson's explicit teaching of cutting functionality with Kortenbach's description of pivoting jaws would have been an obvious improvement.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Kortenbach and Pona in view of Simpson to have the pivoting jaws cooperate to cut tissue. A person of ordinary skill in the art would have recognized that adding cutting functionality to Kortenbach's jaws would allow them to cut the tissue, making it capable of collecting tissue samples. This would have the benefit of enhancing the utility of the device by enabling precise tissue severance with the jaws instead of a separate attachment.
Regarding claim 15, Kortenbach teaches that the first actuator member and the second actuator member extend proximally to the actuator handle (Kortenbach, ¶[0030] and Fig 1: “The proximal end 14 of the coil 12 is coupled to the shaft 38 and the proximal end 22 of the pull wire 18 is coupled to the cross member 48 of the spool”, where the figure depicts the first actuator member (Part 12), the second actuator member (Part 18), and the actuator handle (Part 46) with the shaft (Part 38) operatively coupled with the handle (as connoted in ¶[0033])).
Regarding claim 16, Kortenbach partially teaches that the first actuator member and the second actuator member are coupled together, and only one of the first actuator member and the second actuator member extend proximally to the actuator handle. Kortenbach describes both actuating members, pull wire and coil, as extending to the handle (Kortenbach, ¶[0030] and ¶[0033]) instead of just one member. Simpson describes a "Handle 12 (FIG. 1) [that] is operatively linked… by way of a first actuating element such as actuator shaft 16, axially movably disposed with respect to a second actuating element such as an outer sleeve 18" and that is operationally coupled to the outer sleeve to enable axial translation (Simpson, Col 4, Lines 1-15). Only the actuator shaft extends proximally to the handle, and the two actuating elements (sleeve and shaft) are coupled with one inside the other to work as one to open and close the jaws (Simpson, Col 4, Lines 1-15). Simpson provides a clear and explicit teaching of actuator coupling and proximal extension. By adapting Simpson’s coupling mechanism to Kortenbach’s pull wire and coil configuration, the design would reduce mechanical complexity, while maintaining functionality. The modification would have been straightforward, predictable and obvious to a person of ordinary skill in the art. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Kortenbach and Pona in view of Simpson to couple the actuator members together and only have one extend all the way to the handle. This would have the benefit of simplification with less moving parts, improving reliability and manufacturability. This would also create a simpler mechanism for clinicians during endoscopic biopsy procedures making it more efficient and user-friendly.
Response to Arguments
Claim Rejections - 35 U.S.C. &103
Applicant's arguments filed 09/09/2025, pages 7-18, regarding the previous 103 rejections of independent claim 1 and dependent claims 2, 4-5, and 7-11, have been fully considered but are either 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 (that is, there are new grounds of rejection that were necessitated by the claim amendments) and/or the arguments were not persuasive.
Specifically regarding claim 1:
1. Mischaracterization of the combination.Applicant mischaracterizes the June 11, 2025 rejection as substituting Pona’s blade mechanism into Kortenbach. The combination does not replace Kortenbach’s jaws, actuation, or endoscopic use. Pona is cited only for the geometric teaching that pivot supports may be disposed on an inner surface of a distal head and that movable elements may reside fully within the head when in an open/retracted state (Pona, ¶[0063], ¶[0065]; Figs. 3, 4A–4G). The rejection retains Kortenbach’s opposed jaws, pull-wire/coil actuation, and endoscope-mounted adaptor (Kortenbach, ¶[0028], ¶[0032], ¶[0034]; Fig. 1).
2. Feasibility in Kortenbach without changing the principle of operation.Applicant’s position appears to be that implementing the amended “jaws positioned entirely within the interior of the adaptor with the annular wall surrounding the pair of jaws when open” limitation would require importing Pona’s blade mechanism into Kortenbach or otherwise fundamentally altering Kortenbach’s device. The rejection does not propose substituting Pona’s mechanism; Pona is cited only for the layout concept (pivot supports on an inner surface with movable elements fully within the head in an open/retracted state). Within Kortenbach, a person of ordinary skill in the art would implement that layout by routine packaging variations that preserve Kortenbach’s opposed jaws and proximal pull-wire/coil actuation, potentially including: a modest axial extension of distal end of the annular wall (ring portion) and, if needed, a slight radial widening of that extension to envelop the jaws’ open-state sweep; and/or localized inner-wall recesses to accept the swing arc; and/or jaw back-contouring so the open profile remains within the wall (Kortenbach, ¶[0028], ¶[0032], ¶[0034]; Figs. 1, 7–9). Moreover, hinge location is not fixed in Kortenbach, its alternate embodiments (e.g., Fig. 1 versus Figs. 7–9) demonstrate that the relative placement of the pivot pins with respect to the adaptor and actuation path is a design variable a person of ordinary skill in the art would optimize, including modest centralization of the pins within the adaptor to increase clearance for the open state, all without changing the device’s principle of operation (Kortenbach, ¶[0028], ¶[0034]; Figs. 1, 7–9).
3. No “fundamental redesign”: Kortenbach’s geometry is not fixed.Kortenbach itself evidences that clevis/jaw configuration is a design variable: it presents different embodiments and geometries (e.g., Fig. 1 vs. Figs. 7–9) while retaining jaws rotatably coupled to clevis pins and the same proximal actuation path (Kortenbach, ¶[0028], ¶[0034]; Figs. 1, 7–9). This shows that hinge placement and local clearances are routine variables a person of ordinary skill in the art would adjust to achieve predictable enclosure of the open-state sweep within the annular wall.
4. Motivation.Applicant further argues, in substance, that relying on Pona for enclosure would lack a reason to combine and would change the primary’s operation. This is unpersuasive. Pona provides the specific layout (pivot supports on an inner surface with movable elements fully within the head in an open/retracted state (Pona, ¶[0063], ¶[0065]; Figs. 3, 4A–4G)) which a person of ordinary skill in the art would apply to Kortenbach’s end-effector for predictable benefits of enclosing moving parts at the distal tip (e.g., component protection, reduced snagging/debris), while retaining Kortenbach’s pull-wire/coil actuation and jaw function. The rejection therefore does not import Pona’s punch-biopsy mechanism; it uses Pona only for the inner-surface/fully-inside-when-open geometry concept and the corresponding motivation to implement that geometry on Kortenbach’s adaptor.
Arguments Conclusion.
Applicant’s assertion that the amendment requires a “fundamental redesign” is unpersuasive. Kortenbach discloses the endoscope-mounted annular adaptor, opposed jaws on clevis pins, and proximal actuation; Pona provides the inner-surface/fully-inside-when-open geometry and motivation. Implementing routine packaging adjustments (and, if desired, modest pin centralization) to place the jaws entirely within the adaptor when open preserves Kortenbach’s principle of operation and would have been obvious to a person of ordinary skill in the art under KSR (Kortenbach, ¶[0028], ¶[0032], ¶[0034]; Pona, ¶[0063], ¶[0065]).
Applicant's arguments filed 09/09/2025, page 19, regarding the previous 103 rejections of independent claim 14 and dependent claims 15-16 as well as claim 3 (which is dependent from claim 1), have been fully considered but are not persuasive for at least the same reasons given above regarding claim 1.
Request for Rejoinder
Applicant's arguments filed 09/09/2025, page 19, regarding the Request for Rejoinder of claims 12-13 and 17-18 as well as claim 19, is acknowledged, but not granted at this time in light of the newly rejected claims 1-5, 7-11, and 14-16.
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.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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