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 May 22, 2026 has been entered. Applicant’s amendments have overcome the Drawing objection and the 112(a) rejection previously set-forth in the Non-Final Office Action mailed on 04/29/2026. Currently, claims 1, 8, and 16 have been amended, and claims 1, 3-10, 12-21, 25, 27-31 are pending in the application.
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, 3-4, 6, 21, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sims (U.S. Application No. 20200100833 A1), and further in view of Hughett (U.S. Application No. 20100185232 A1).
Regarding independent claim 1, Sims discloses a tissue grabbing apparatus (10) (pa. 0035 & Fig. 1), comprising:
a first jaw (120) comprising a first jaw member (see annotated Fig. 5B below) approximately parallel to a shaft (12a, 12b) (pa. 0036) of the tissue grabbing apparatus (see longitudinal axis on annotated Fig. 5B showing how the first jaw member is approximately parallel) and a second jaw member (see annotated Fig. 5B below) offset from approximately parallel to the shaft, the first jaw further comprising a first surface (152) having a base (i.e., bottom section/surface) of the first jaw member and a base (i.e., upper section/surface) of the second jaw member (pa. 0044), and a second surface (136) (pa. 0044) comprising an inner surface of the first jaw member and the second jaw member (see Fig. 5A),
a first insulating pad (138) along the second surface and between the first jaw member and the second jaw member (pa. 0044), wherein the first insulating pad is exposed to the tissue (at least central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the first jaw member and the base of the second jaw member. Examiner is interpreting the word “exposed” by its plain meaning to cause to be visible or open to view. Therefore, the central portion of the first insulating pad is exposed, or made visible or open to view, to the tissue at least in the configuration when the first jaw and the second jaw are in the closed position, grasping tissue therebetween, and the knife is in the retracted position, as seen in Fig. 2, before being in the extended position in order to divide the tissue grasped between the jaws (pa. 0039). Furthermore, the claim language is broad and does not require the entire first insulating pad to be exposed to the tissue;
a first face surface (see annotated Fig. 5A below) on the first jaw, the first face surface facing distally;
wherein the first jaw further comprises at least one first electrode (112) extending along the second surface including at least part of the first jaw member and the second jaw member (pa. 0037), and a first grasping surface comprising a first grasping pattern (i.e., a plurality of stop members 146) extending along the first insulating pad (pa. 0047), wherein the first surface and the first grasping pattern comprise a first gap therebetween (see annotated Fig. 5A below). Examiner is interpreting the phrase “extending along” by its plain meaning of a continuous spatial dimension, alignment, or linear projection tracing the length or boundary of a specific physical or geometric entity. It describes how a line, path, or phenomenon is oriented or stretched parallel to the defining form of a reference object. In this case, the plurality of stop members which comprise the first grasping pattern are tracing the length or boundary of the first insulating pad by stretching parallel to the defining form of the first insulating pad. Furthermore, the claim language is broad and does not require the first grasping pattern to directly contact any or all portions of the first insulating pad. Furthermore, Examiner is interpreting a “gap” as an unfilled space or filled distance/interval between two objects;
a second jaw (110) (pa. 0037) comprising a third jaw member (see annotated Fig. 5B below) at an angle to the shaft (i.e., in the open position), and a fourth jaw member (see annotated Fig. 5B below) offset from parallel to the third jaw member while the tissue grabbing apparatus is in an open position, the second jaw further comprising a third surface (i.e., 152 on the second jaw) having a base (i.e., upper section/surface, in a view where the second jaw is on top of the first jaw as seen in Fig. 2) of the third jaw member and a base (i.e., bottom section/surface, in a view where the second jaw is on top of the first jaw as seen in Fig. 2) of the fourth jaw member, and a fourth surface (i.e., 136 on the second jaw) (pa. 0044) facing the second surface and comprising an inner surface of the third jaw member and the fourth jaw member (see Fig. 5A),
a second insulating pad (i.e., 138 on the second jaw) (pa. 0044) along the fourth surface and between the third jaw member and the fourth jaw member (see Fig. 5A), wherein the second insulating pad is exposed to the tissue (see central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the third jaw member and the base of the fourth jaw member, wherein the second insulating pad and the first insulating pad are configured to grasp tissue when the tissue grabbing apparatus is in a closed position (pa. 0005-0006). Examiner is interpreting the term “configured” by its plain meaning as something being specifically designed, arranged, or programmed to perform a particular function or operate in a specific way. In this scenario, the first jaw and the second jaw each comprise the first insulating pad and the second insulating pad arranged inside each of the jaw structures, wherein the first and the second jaws are configured to hold/grasp tissue therebetween when in a closed position; thereby, allowing the insulating pads to also function or operate in a similar fashion in order aid in grasping the tissue when the jaws in are in the closed position. Furthermore, the claim language is broad and does not require either the first nor the second insulating pad to directly contact the tissue;
a second face surface (see annotated Fig. 5A below) on the second jaw, the second face surface facing distally;
wherein the second jaw further comprises at least one second electrode (i.e., 112 on the second jaw) extending along the fourth surface including at least part of the third jaw member and the fourth jaw member (pa. 0037), and a second grasping surface comprising a second grasping pattern (i.e., a plurality of stop members 146 on the second jaw) (pa. 0047) extending along the second insulation pad, wherein the fourth surface includes at least part of the third jaw member and the fourth jaw member (see Figs. 5A-5B), wherein the third surface and the second insulating pad comprise a second gap therebetween (see annotated Fig. 5A below);
a hinge assembly (103) connecting the first and second jaws and configured to move the second jaw relative to the first jaw in a direction transverse to an axis parallel to the shaft between the open position and a closed position where the second jaw is approximately parallel to the first jaw and the shaft (pa. 0036, 0043 & Fig. 2); and
a handle (17a, 17b) coupled to the hinge assembly, wherein actuation of the handle causes the second jaw to move in the direction (pa. 0036).
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However, Sims does not disclose the handle comprising a plunger, wherein the hinge assembly comprises a linkage coupling the second jaw to the plunger.
Hughett, in the same field of endeavor, teaches a medical device (800) comprising a first jaw (810), a second jaw (808), and a handle (802) comprising a plunger (816) coupled to a hinge assembly (806) (pa. 0089 & Figs. 17-19), wherein the hinge assembly comprises a linkage (i.e., rack (834, 842) and gears (838, 836)) coupling the second jaw to the plunger (pa. 0105).
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 added a plunger to improve tactile feedback from the jaws to the surgeon during a surgical procedure (Hughett, pa. 0082).
Regarding claim 3, Sims/Hughett combination discloses the first jaw member and the second jaw member meet at a first apex (Sims, See annotated Fig. 5B below) comprising an angle, and the third jaw member and the fourth jaw member meet at a second apex (Sims, See annotated Fig. 5B below) comprising the angle.
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Regarding claim 4, Sims discloses the invention substantially as claimed in claim 1 and discussed above.
However, Sims does not disclose wherein the hinge assembly comprises at least one of a bell crank hinge mechanism, a rack-and-pinion hinge mechanism, or a cam hinge mechanism.
Hughett, in the same field of endeavor, teaches a hinge assembly comprising a rack-and-pinion hinge mechanism (i.e., rack (834, 842) and gears (838, 836)) (pa. 0105).
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 substituted the hinge mechanism of Sims with the rack-and-pinion hinge mechanism of Hughett because they are both known equivalents in the art and they would yield the same predictable results of articulating individual jaw members to open and close.
Regarding claim 6, Sims/Hughett combination discloses an atraumatic tip (i.e., a curved distal tip) coupled to a distal end of the first jaw (Sims, pa. 0045 & Fig. 2).
Regarding claim 21, Sims discloses the invention substantially as claimed in claim 1 and discussed above.
However, Sims does not disclose wherein an angle between an outer surface of the second jaw member and the shaft is about 60 degrees.
Hughett, in the same field of endeavor, teaches wherein an angle between an outer surface of the second jaw member and the shaft is about 60 degrees (pa. 0068-0069 & Figs 3-4).
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 angle for the purpose of providing an optimal angle which are desirable when operating on or near complicated or sensitive anatomical features and in minimally invasive surgical procedures (Hughett, pa. 0073).
Regarding claim 30, Sims discloses the invention substantially as claimed in claim 1 and discussed above.
However, Sims does not disclose wherein the hinge assembly comprises a fixed angle.
Hughett, in the same field of endeavor, teaches wherein the hinge assembly comprises a fixed angle (pa. 0073).
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 angle for the purpose of providing an optimal angle which are desirable when operating on or near complicated or sensitive anatomical features and in minimally invasive surgical procedures (Hughett, pa. 0073).
Regarding claim 31, Sims discloses the invention substantially as claimed in claims 1 and 30 and discussed above.
However, Sims does not disclose wherein the fixed angle is about 30 degrees.
Hughett, in the same field of endeavor, teaches wherein the fixed angle is about 30 degrees (pa. 0068-0069, 0073 & Figs 3-4).
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 angle for the purpose of providing an optimal angle which are desirable when operating on or near complicated or sensitive anatomical features and in minimally invasive surgical procedures (Hughett, pa. 0073).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sims and Hughett, as applied to claim 1 above, and further in view of Shelton (C.N. Application No. 111526812 B).
Regarding claim 5, Sims/Hughett combination discloses the invention substantially as claimed in claim 1 discussed above
However, they do not disclose the first and the second jaw being removeable and replaceable from respective distal ends of the hinge assembly.
Shelton, in the same field of endeavor, teaches a removeable and replaceable first jaw and second jaw from the distal end of a hinge assembly (100104) (page 26, last paragraph & Fig. 59) for subsequent cleaning after at least one use (page 10, paragraph 2; page 42, last paragraph).
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 added a hinge for the purpose of allowing the surgical end effector to be able to engage, grasp, and/or manipulate tissue, and it would have been obvious to allow the user to remove the first and second jaw member for subsequent cleaning after at least one use.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sims and Hughett, as applied to claim 1 above, and further in view of Privitera (U.S. Application No. 20120323256 A1).
Regarding claim 7, Sims/Hughett combination the invention substantially as claimed in claims 1 and 6 discussed above.
However, they do not teach the atraumatic tip comprising a blue color, or a red color, or a white color for increasing visibility of the tip in contrast with surrounding tissues.
Privitera, in the same field of endeavor, teaches a medical device comprising an atraumatic tip (608, i.e., an LED) for increasing visibility of the tip in contrast with surrounding tissues (pa. 0087 & Fig. 13).
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 added the LED to the tip of the jaw members of Sims for the purpose of providing illumination at the distal tip (Privitera, pa. 0088).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Sims and Hughett, as applied to claim 1 above, and further in view of Tetzlaff (W.O. Application No. 0024330 A1).
Regarding claim 25, Sims/Hughett combination discloses an insulator component (i.e., insulative material of the first/third surface 152) (Sims, pa. 0044), wherein the insulator component is permanently attached (e.g., by an over-molding method or by other manufacturing methods) (Sims, pa. 0046) from the first and second jaws.
However, they do not disclose the two structures being permanently attached via mechanical snap fits.
Tetzlaff, in the same field of endeavor, teaches an insulator component (1008) (analogous to the first/third surface 152 of Sims), wherein the insulator component is permanently attached to the jaws frame via mechanical snap fits (page 15, paragraph 1 & Fig. 6). Examiner is interpreting the word ‘permanent’ as connecting two components together until an external force works to separate them.
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 substituted the over-molding attachment method of Sims with the mechanical snap fits of Tetzlaff since they are both known equivalents in the art and they would yield the same predictable results of connecting two components together.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sims and Hughett, as applied to claim 1 above, and further in view of Stone (E.P. Application No. 0624348 A2).
Regarding claim 27, Sims/Hughett combination discloses the jaw assembly being able to move the second jaw relative to the first jaw (Sims, pa. 0043).
However, they do not disclose a cam assembly.
Stone, in the same field of endeavor, teaches a cam assembly (cam slot (85) and bearing post (90)) (pa. 0059), wherein the cam assembly is configured to slide axially within the jaw assembly to move the second jaw relative to the first jaw (pa. 0020-0021 & Figs. 2-3).
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 hinge mechanism of Sims to include a cam assembly for the purpose of enhancing the seal by ensuring that tissue is securely clamped during ablation.
Regarding claim 28, Sims/Hughett combination discloses the invention substantially as claimed in claims 1 and 27 and discussed above.
However, they do not disclose wherein the second jaw comprises at least one bearing, wherein the at least one bearing is configured to slide within a track of the cam assembly.
Stone, in the same field of endeavor, teaches wherein the second jaw comprises at least one bearing (90), wherein the at least one bearing is configured to slide within a track (85) of the cam assembly (pa. 0058-0059).
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 hinge mechanism of Sims to include a cam assembly for the purpose of enhancing the seal by ensuring that tissue is securely clamped during ablation.
Claims 8-9, 12-14, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Sims (U.S. Application No. 20200100833 A1), in view of Hughett (U.S. Application No. 20100185232 A1), and further in view of Ward (U.S. Application No. 20200305962 A1).
Regarding independent claim 8, Sims discloses a surgical clamp system (10) for grabbing and ablating tissue (pa. 0035, 0037 & Fig. 1), comprising:
a handle (17a, 17b) (pa. 0036);
an elongated shaft (12a, 12b) (pa. 0036) comprising a proximal end (14a, 14b) coupled to the handle (pa. 0036) and a distal end (16a, 16b) (pa. 0036);
a jaw assembly (100) comprising:
a first jaw (120) comprising a first surface (152) having a base (i.e., bottom section/surface) of the first jaw, a second surface (136) comprising an inner surface of the first jaw (pa. 0044), at least one first electrode (112) extending along the second surface (pa. 0037), and a first grasping surface comprising a first grasping pattern (i.e., a plurality of stop members 146) extending along at least part of the first surface and at least part of the second surface (pa. 0047), wherein the first surface and the first grasping pattern comprise a first gap therebetween (see annotated Fig. 5A below). Examiner is interpreting the phrase “extending along” by its plain meaning of a continuous spatial dimension, alignment, or linear projection tracing the length or boundary of a specific physical or geometric entity. It describes how a line, path, or phenomenon is oriented or stretched parallel to the defining form of a reference object. In this case, the plurality of stop members that comprise the first grasping pattern are tracing the length or boundary of the first insulating pad by stretching parallel to the defining form of the first insulating pad. Furthermore, the claim language is broad and does not require the first grasping pattern to directly contact any or all portions of the first insulating pad. Furthermore, Examiner is interpreting a “gap” as an unfilled space or filled distance/interval between two objects;
a first insulating pad (138) along the second surface (pa. 0044), wherein the first insulating pad is exposed to the tissue (at least central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the first jaw member and the base of the second jaw member. Examiner is interpreting the word “exposed” as its plain meaning to cause to be visible or open to view. Therefore, the central portion of the first insulating pad is exposed, or made visible or open to view, to the tissue at least in the configuration when the first jaw and the second jaw are in the closed position, grasping tissue therebetween, and the knife is in the retracted position, as seen in Fig. 2, before being in the extended position in order to divide the tissue grasped between the jaws (pa. 0039). Furthermore, the claim language is broad and does not require the entire first insulating pad to be exposed to the tissue;
a first face surface (see annotated Fig. 5A below) on the first jaw, the first face surface facing distally;
a second jaw (110) comprising a third surface (i.e., 152 on the second jaw) having a base (i.e., upper section/surface, in a view where the second jaw is on top of the first jaw as seen in Fig. 2) of the second jaw, a fourth surface (i.e., 136 on the second jaw) (pa. 0044) comprising an inner surface of the second jaw (see Fig. 5A), at least one second electrode (i.e., 112 on the second jaw) extending along the fourth surface (pa. 0037), and a second grasping surface comprising a second grasping pattern (i.e., a plurality of stop members 146 on the second jaw) (pa. 0047) extending along at least part of the fourth surface and at least part of the third surface (see Figs. 5A-5B);
a second insulating pad (i.e., 138 on the second jaw) (pa. 0044) along the fourth surface (see Fig. 5A), wherein the third surface and the second insulating pad comprise a second gap therebetween (see annotated Fig. 5A below), wherein the second insulating pad is exposed to the tissue (see central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the third jaw member and the base of the fourth jaw member, wherein the second insulating pad and the first insulating pad are configured to grasp tissue when the tissue grabbing apparatus is in a closed position (pa. 0005-0006). Examiner is interpreting the term “configured” by its plain meaning as something being specifically designed, arranged, or programmed to perform a particular function or operate in a specific way. In this scenario, the first jaw and the second jaw each comprise the first insulating pad and the second insulating pad arranged inside each of the jaw structures, wherein the first and the second jaws are configured to hold/grasp tissue therebetween when in a closed position; thereby, allowing the insulating pads to also function or operate in a similar fashion in order aid in grasping the tissue when the jaws in are in the closed position. Furthermore, the claim language is broad and does not require either the first nor the second insulating pad to directly contact the tissue;
a second face surface (see annotated Fig. 5A below) on the second jaw, the second face surface facing distally;
a hinge assembly (103) coupled to the distal end of the shaft, connecting the first and second jaws and configured to move the second jaw relative to the first jaw in a direction transverse to an axis parallel to the shaft (pa. 0036, 0043 & Fig. 2).
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However, Sims does not disclose wherein the hinge assembly comprises a linkage coupling the second jaw to the handle.
Hughett, in the same field of endeavor, teaches a medical device (800) comprising a first jaw (810), a second jaw (808), and a handle (802) coupled to a hinge assembly (806) (pa. 0089 & Figs. 17-19), wherein the hinge assembly comprises a linkage (i.e., rack (834, 842) and gears (838, 836)) coupling the second jaw to the handle (pa. 0105).
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 added the linkage to the hinge assembly of Sims in order to more accurately control the opening and closing of the jaw members.
However, Sims/Hughett combination do not teach a seal within the shaft configured to provide an internal insufflation seal to the surgical clamp system in use.
Ward, in the same field of endeavor, teaches a seal (1058) within the shaft configured to provide an internal insufflation seal to the surgical clamp system in use (pa. 0149 & Fig 3C) so that the pressure differential between the body cavity in which the distal portion of forceps is positioned and the external environment in which the proximal portion of forceps is located, is maintained (e.g., pneumatically sealed, substantially pneumatically sealed) (pa. 0149).
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 added a seal so that the pressure differential between the body cavity and the external environment is maintained.
Regarding claim 9, Sims/Ward combination discloses the invention substantially as claimed in claim 8 and discussed above.
However, they do not teach a plunger coupled via the shaft to the hinge assembly, wherein actuation of the plunger causes the second jaw to move in the direction.
Hughett, in the same field of endeavor, teaches a medical device (800) comprising a first jaw (810), a second jaw (808), and a handle (802) comprising a plunger (816) coupled to a hinge assembly (806) (pa. 0089 & Figs. 17-19), wherein the hinge assembly comprises a linkage (i.e., rack (834, 842) and gears (838, 836)) coupling the second jaw to the plunger (pa. 0105).
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 added a plunger to improve tactile feedback from the jaws to the surgeon during a surgical procedure (Hughett, pa. 0082).
Regarding claim 12, Sims/Hughett/Ward combination discloses an atraumatic tip (i.e., a curved distal tip) coupled to a distal end of the first jaw (Sims, pa. 0045 & Fig. 2).
Regarding claim 13, Sims/Ward combination discloses the invention substantially as claimed in claim 8 and discussed above.
However, they do not disclose wherein the hinge assembly comprises at least one of a bell crank hinge mechanism, a rack-and-pinion hinge mechanism, or a cam hinge mechanism.
Hughett, in the same field of endeavor, teaches a hinge assembly comprising a rack-and-pinion hinge mechanism (i.e., rack (834, 842) and gears (838, 836)) (pa. 0105).
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 substituted the hinge mechanism of Sims with the rack-and-pinion hinge mechanism of Hughett because they are both known equivalents in the art and they would yield the same predictable results of articulating individual jaw members to open and close.
Regarding claim 14, Sims/Hughett/Ward combination discloses the first grasping surface and the second grasping surface each comprises a cuboidally-shaped teeth each culminating in a flat surface (Sims, See Fig. 5A).
Regarding claim 29, Sims/Hughett combination discloses the invention substantially as claimed in claim 8 and discussed above.
However, they do not disclose wherein the seal comprises a plug component, wherein the plug component reduces a cross-sectional area inside the shaft.
Ward, in the same field of endeavor, teaches the seal comprising a plug component (2530), wherein the plug component reduces a cross-sectional area inside the shaft (pa. 0149 & Fig. 31A) in order to prevent the leakage of air from the body cavity to the external environment (pa. 0149).
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 added a plug to prevent leakage of air from the body cavity to the external environment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sims, Hughett, and Ward as applied to claim 8 above, and further in view of Kappus (U.S. Application No. 20160074098 A1).
Regarding claim 10, Sims/Hughett/Ward combination discloses the invention substantially as claimed in claim 8 and discussed above.
However, they do not disclose a trocar slidably coupled around the shaft and configured to provide an insufflation seal to the surgical clamp system after insertion of the jaw assembly into a patient.
Kappus, in the same field of endeavor, teaches a trocar slidably coupled around the shaft and configured to provide an insufflation seal to the surgical clamp system after insertion of the jaw assembly into a patient (pa. 0056).
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 added a trocar for the purpose of providing a fluid-tight seal that helps maintain the internal surgical site in an insufflated state (Kappus, pa. 0056).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sims, Hughett, and Ward, as applied to claim 8 above, further in view of Shelton (C.N. Application No. 111526812 B).
Regarding claim 15, Sims/Hughett/Ward combination discloses the first and second grasping surfaces is biased in a direction based on a force profile of the surgical clamp system (Sims, pa. 0047).
However, they do not disclose the first and second grasping surfaces having pyramid-shaped teeth.
Shelton, in the same field of endeavor, teaches each pyramid-shaped tooth of the first and second grasping surfaces (page 27, paragraph 9 & Figs. 59-79) to engage, grasp, and/or manipulate tissue (page 18, paragraph 2).
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 substituted the first and second grasping surfaces of Sims with the pyramid-shaped teeth of Shelton since they are known equivalents in the art that would yield the same predictable results of allowing the surgical end effector to be able to engage, grasp, and/or manipulate tissue.
Claims 16-20 are ejected under 35 U.S.C. 103 as being unpatentable over Sims (U.S. Application No. 20200100833 A1), and further in view of Schmitz (U.S. Application No. 20100331883 A1).
Regarding independent claim 16, Sims discloses a tissue grabbing apparatus (10) (pa. 0035 & Fig. 1) comprising:
a first jaw (120) comprising a first surface (152) having a base (i.e., bottom section/surface) of the first jaw, a second surface (136) (pa. 0044) comprising an inner surface of the first jaw (see Fig. 5A), at least one first electrode (112) extending along the second surface (pa. 0037), and a first grasping surface comprising a first grasping pattern (i.e., a plurality of stop members 146) extending along at least part of the first surface and at least part of the second surface (pa. 0047), wherein the first surface and the first grasping pattern comprise a first gap therebetween (see annotated Fig. 5A below). Examiner is interpreting the phrase “extending along” by its plain meaning of a continuous spatial dimension, alignment, or linear projection tracing the length or boundary of a specific physical or geometric entity. It describes how a line, path, or phenomenon is oriented or stretched parallel to the defining form of a reference object. In this case, the plurality of stop members comprising the first grasping pattern are tracing the length or boundary of the first insulating pad by stretching parallel to the defining form of the first insulating pad. Furthermore, the claim language is broad and does not require the first grasping pattern to directly contact any or all portions of the first insulating pad. Furthermore, Examiner is interpreting a “gap” as an unfilled space or filled distance/interval between two objects;
a first insulating pad (138) along the second surface (pa. 0044), wherein the first insulating pad is exposed to the tissue (at least central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the first jaw member and the base of the second jaw member. Examiner is interpreting the word “exposed” as the plain meaning to cause to be visible or open to view. Therefore, the central portion of the first insulating pad is exposed, or made visible or open to view, to the tissue at least in the configuration when the first jaw and the second jaw are in the closed position, grasping tissue therebetween, and the knife is in the retracted position, as seen in Fig. 2, before being in the extended position in order to divide the tissue grasped between the jaws (pa. 0039). Furthermore, the claim language is broad and does not require the entire first insulating pad to be exposed to the tissue;
a first face surface (see annotated Fig. 5A below) on the first jaw, the first face surface facing distally;
a second jaw (110) (pa. 0037) coupled to the first jaw via a hinge assembly (103) (pa. 0036 & Fig. 2), the second jaw comprising a third surface (i.e., 152 on the second jaw) having a base (i.e., upper section/surface, in a view where the second jaw is on top of the first jaw as seen in Fig. 2) of the second jaw, a fourth surface (i.e., 136 on the second jaw) (pa. 0044) comprising an inner surface of the second jaw (see Fig. 5A), at least one electrode (i.e., 112 on the second jaw) extending along the fourth surface (pa. 0037), and a second grasping surface comprising a second grasping pattern (i.e., a plurality of stop members 146 on the second jaw) (pa. 0047) extending along a second grasping surface and at least part of the fourth surface and at least part of the third surface (see Fig. 5A);
a second insulating pad (i.e., 138 on the second jaw) (pa. 0044) along the fourth surface, wherein the third surface and the second insulating pad comprise a second gap therebetween (see annotated Fig. 5A below), wherein the second insulating pad is exposed to the tissue (see central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the third jaw member and the base of the fourth jaw member, wherein the second insulating pad and the first insulating pad are configured to grasp tissue when the tissue grabbing apparatus is in a closed position (pa. 0005-0006). Examiner is interpreting the term “configured” by its plain meaning as something being specifically designed, arranged, or programmed to perform a particular function or operate in a specific way. In this scenario, the first jaw and the second jaw each comprise the first insulating pad and the second insulating pad arranged inside each of the jaw structures, wherein the first and the second jaws are configured to hold/grasp tissue therebetween when in a closed position; thereby, allowing the insulating pads to also function or operate in a similar fashion in order aid in grasping the tissue when the jaws in are in the closed position. Furthermore, the claim language is broad and does not require either the first nor the second insulating pad to directly contact the tissue; and
a second face surface (see annotated Fig. 5A below) on the second jaw, the second face surface facing distally.
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However, Sims does not disclose wherein the first grasping surface and the second grasping surface each comprises a plurality of pyramid-shaped teeth each and comprising a pitch between centerpoints of each pyramid-shaped tooth of between one hundredth of an inch and five hundredths of an inch and a height of each pyramid-shaped tooth of between one hundredth of an inch and two hundredths of an inch.
Schmitz, in the same field of endeavor, teaches wherein the first grasping surface and the second grasping surface each comprises a plurality of pyramid-shaped teeth each and comprising a pitch between centerpoints of each pyramid-shaped tooth of between one hundredth of an inch and five hundredths of an inch (pa. 0852 & Fig. 56) and a height of each pyramid-shaped tooth of between one hundredth of an inch and two hundredths of an inch (pa. 0851 & Fig. 56).
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 dimensions of the grasping surfaces of Sims for the purpose of providing a height that is optimized for addressing soft tissue (Schmitz, pa. 0851).
Regarding claim 17, Sims discloses the first and second grasping surfaces is biased in a direction based on a force profile of the surgical clamp system (pa. 0047).
However, Sims does not disclose the first and second grasping surfaces having pyramid-shaped teeth.
Schmitz, in the same field of endeavor, teaches wherein the first grasping surface and the second grasping surface each comprises a plurality of pyramid-shaped teeth (pa. 0852 & Fig. 56).
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 substituted the first and second grasping surface of Sims with the pyramid shaped teeth of Schmitz since they are known equivalents in the art and they would yield the same predictable results of allowing the jaws to engage, grasp, and/or manipulate tissue.
Regarding claim 18, Sims discloses the invention substantially as claimed in claim 16 and discussed above.
However, Sims does not disclose wherein the plurality of teeth are in a cross or diamond grid configuration.
Schmitz, in the same field of endeavor, teaches wherein the plurality of teeth are in a cross or diamond grid configuration (pa. 0853 & Figs. 57).
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 configuration of the first and second grasping surfaces of Sims for the purpose of providing an effective grasping surface.
Regarding claim 19, Sims/Schmitz combination discloses the first grasping surface terminates with a first point at an edge of the first grasping surface adjacent to an edge of the second grasping surface, and the second grasping surface terminates with a second point at the edge of the second grasping surface adjacent the edge of the first grasping surface (Sims, pa. 0047).
Regarding claim 20, Sims/Schmitz combination discloses a hinge assembly (103) configured to move the second jaw relative to the first jaw in a direction transverse to an axis parallel to a shaft of the tissue grabbing apparatus between an open position and a closed position where the second jaw is approximately parallel to the first jaw and the shaft, the first and second grasping surfaces configured to grab tissue as the second jaw moves to the closed position (Sims, pa. 0036 & Fig. 2).
Response to Arguments
Applicant's arguments filed 05/22/2026 have been fully considered but they are not persuasive.
With regards to newly amended independent claims 1, 8, and 16, Applicant argues that the Sims reference does not teach or suggest any of the following features:
a first grasping surface comprising a first grasping pattern extending along the
first insulating pad;
wherein the second insulating pad is configured to be exposed to tissue
opposite the base of the third jaw member and the base of the fourth jaw
member; and
wherein the second insulating pad and the first insulating pad are configured
to grasp tissue when the tissue grabbing apparatus is in a closed position.
Specifically, Applicant argues that the exposed portion of the insulating pad does not have a grasping pattern nor is it exposed to tissue or configured to grasp tissue. However, Examiner, respectfully, disagrees.
Sims discloses a first grasping surface comprising a first grasping pattern (i.e., a plurality of stop members 146) extending along the first insulating pad (pa. 0047). Examiner is interpreting the phrase “extending along” by its plain meaning of a continuous spatial dimension, alignment, or linear projection tracing the length or boundary of a specific physical or geometric entity. It describes how a line, path, or phenomenon is oriented or stretched parallel to the defining form of a reference object. In this case, the plurality of stop members comprising the first grasping pattern are tracing the length or boundary of the first insulating pad by stretching parallel to the defining form of the first insulating pad. Furthermore, the claim language is broad and does not require the first grasping pattern to directly contact any or all portions of the first insulating pad.
The Sims reference furthermore discloses wherein the second insulating pad is exposed to the tissue (see central portion 162 defining a longitudinally-extending knife slot 164, pa. 0046 & Fig. 5A) opposite the base of the third jaw member and the base of the fourth jaw member. Examiner is interpreting the word “exposed” as the plain meaning to cause to be visible or open to view. Therefore, the central portion of the second insulating pad is exposed, or made visible or open to view, to the tissue at least in the configuration when the first jaw and the second jaw are in the closed position, grasping tissue therebetween, and the knife is in the retracted position, as seen in Fig. 2, before being in the extended position in order to divide the tissue grasped between the jaws (pa. 0039). Furthermore, the claim language is broad and does not require the entire second insulating pad to be exposed to the tissue.
Lastly, Sims discloses wherein the second insulating pad and the first insulating pad are configured to grasp tissue when the tissue grabbing apparatus is in a closed position (pa. 0005-0006). Examiner is interpreting the term “configured” by its plain meaning as something being specifically designed, arranged, or programmed to perform a particular function or operate in a specific way. In this scenario, the first jaw and the second jaw each comprise the first insulating pad and the second insulating pad arranged inside each of the jaw structures, wherein the first and the second jaws are configured to hold/grasp tissue therebetween when in a closed position; thereby, allowing the insulating pads to also function or operate in a similar fashion in order aid in grasping the tissue when the jaws in are in the closed position. Furthermore, the claim language is broad and does not require either the first nor the second insulating pad to directly contact the tissue. Therefore, for all the reasonings set-forth above the rejection is maintained.
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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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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