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 .
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hammerland, III et al. (US 2021/0022798).
Regarding claim 1, Hammerland discloses an electrosurgical device (see Figs. 1-8), comprising: a pair of opposing jaws including a first jaw and a second jaw (see jaws 110 and 120, Figs. 4-5B), the first and second jaws configured to move between an open position and a tissue clamping position (see [0027]), each of the first and second jaws comprising an electrically conductive core member (see electrically conductive structural frame, 121; [0038]) and a support member (see second structural frame 1121, Fig. 8; see also that jaw members 110 and 120 are configured similarly with structural frames, [0035]-[0036]), wherein the support member is separated proximally from the core member by a gap (see gap between the proximal section of 121 and 1121, Fig. 8), with an electrically insulative material disposed in the gap such that the support member is substantially electrically isolated from the core member (see insulative material disposed in the space between 121 and 1121, [0053]); and a pin (see pivot 103, Fig. 4), wherein the first and second jaw core members are pivotally coupled to the pin about which the first and second jaws rotate to move between the open position and the tissue clamping position (see [0036], [0041], and [0053]). Hammerland fails to specifically disclose the support member as electrically conductive, however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the second structural frame 1121 out of an electrically conductive material such as stainless steel as disclosed for the first structural frame in Hammerland in order to provide a suitable amount of structural support and thermal dissipation to the jaw member as sought by Hammerland (see [0053]), and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Regarding claim 2, Hammerland further discloses comprising an actuation mechanism operably coupled to the first and second jaw support members for enabling manipulation of the pair of opposing jaws (see [0027]).
Regarding claim 3, Hammerland further discloses wherein a surface section of at least one of the first and second jaw support members has a length that at least partially defines the respective jaw gap (see length of the gap along the longitudinal axis of each jaw, Fig. 8), and wherein the length is substantially orthogonal to a force vector exerted when a user manipulates the actuation mechanism (the length of the gap along the longitudinal axis of the jaw is orthogonal to the force vector extending towards or away from the opposite jaw when the actuation mechanism is manipulated to open or close the jaws).
Regarding claim 4, Hammerland further discloses wherein the force vector results in movement of the at least one support member relative to the respective core member (the force vector applied when moving the jaws relative to one another results in at least movement of the support member in one jaw relative to a respective core member in the opposite jaw, see also the force vector applied to individual jaws when closing upon an object between them).
Regarding claim 5, Hammerland further discloses wherein the relative movement of the at least one support member and the respective core member applies a compressive load on the electrically insulating material disposed in the respective jaw gap (since the jaws compress tissue when actuated towards one another, the relative movement of the respective support and core members in opposing jaws causes a the insulative material between the members on both jaws to experience a compressive force when grasping tissue).
Regarding claim 6, Hammerland further discloses wherein the gap is configured to spread the compressive load substantially uniformly along a length of the gap (see the gap being at least partially filled, which is interpreted as also allowing for the gap to be fully filled, thereby providing a substantially uniform spread of the compressive load experienced by the insulative material in the gap, [0053]).
Regarding claim 7, Hammerland further discloses wherein the relative movement of the at least one support member and the respective core member applies a shear load on the electrically insulating material disposed in the gap, wherein the shear load is substantially less than compressive load (the compressive and shear loads resulting movement of the structural supports 121 and 1121 when grasping non-uniform tissue is seen as reasonably meeting the claimed relationship when sufficient force is applied to provide small amounts of jaw flexure around non-uniform tissue geometry relative to the compressive force experienced by the jaw structures).
Regarding claim 8, Hammerland further discloses wherein the gap is non-linear (as shown in Fig. 8).
Regarding claim 9, Hammerland further discloses wherein an over-mold is partially disposed over the at least one support member and the respective core member (see overmold capturing 1121 to 121, [0053]). Hammerland fails to specifically disclose the overmold as a polymer overmold, however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the overmold out of a polymer in order to provide a suitable amount of structural support and reduced thermal heating to the jaw member as sought by Hammerland (see [0053]), and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Regarding claim 11, Hammerland discloses wherein the actuation mechanism comprises a linkage mechanism disposed proximal to the pin and operably coupled to the respective first and second jaw support members for enabling manipulation of the pair of opposing jaws (see at least one protrusion 117b that is configured for receipt within an aperture defined within a drive sleeve of the drive assembly, see also cam pins in cam slots; [0036]).
Claims 10 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hammerland in view of Garrison (US 2014/0100568).
Regarding claims 10 and 12, Hammerland discloses the limitations of claims 1 and 11, however fails to further disclose wherein the pin is substantially electrically isolated from the respective first and second jaw core members by a polymer or ceramic bushing; or wherein the linkage mechanism is electrically isolated from the pin and the first and second jaw core members.
Garrison teaches a surgical device comprising jaws that pivot about a pivot pin and a linkage mechanism for actuating the jaws (see Figs. 1-15), a jaw insert made of electrically insulative materials (see [0108]), wherein the pin is substantially electrically isolated from the respective first and second jaws members by a polymer or ceramic bushing (see electrically insulative bushing 1300, Figs. 10A-15); and wherein the linkage mechanism is electrically isolated from the pin and the first and second jaw core members (see linkage mechanism being electrically isolated from the pin and first and second jaw members via electrically-insulative bushing 1070, Figs. 10A and 15). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the jaw structure as disclosed by Hammerland such that the pin is substantially electrically isolated from the respective first and second jaw core members by a polymer or ceramic bushing; and the linkage mechanism is electrically isolated from the pin and the first and second jaw core members in light of Garrison, the motivation being to provide the additional advantage of electrically isolating the jaws from one another, and electrically isolating the jaws from the drive assembly that actuates them for increased safety and efficacy.
Regarding claims 13-18, Hammerland in view of Garrison teaches the limitations of the claims under the same citations and rationale relied upon in the rejections of claims 1-12 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
