DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claims 1-5, 8-9, 11, 13-15, 17-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bucciaglia (US 2019/0105100) in view GOODMAN et al. (US 2018/0325582).
Regarding claim 1, 13 and 17, Bucciaglia discloses a blood vessel harvesting device comprising: a cylindrical body fig.12; tube 180) extending along an axis (fig.12); a jaw structure coupled to a distal end portion of the cylindrical body and comprising a first jaw and a second jaw (a first jaw 102 and a second jaw 104) that are openable to an open state (fig.8) and closeable to a closed state (fig.9); and a cutter blade (fig.8; cutting mechanism 106) disposed between the first jaw and the second jaw (fig.8), the cutter blade being moveable in a direction of the axis along cutter grooves defined by the first jaw and the second jaw (fig.13B), wherein the first jaw and the second jaw each comprise a clamping surface located where the first jaw and the second jaw face each other while in the closed state, wherein at least a portion of each clamping surface comprises a planar electrode (sealing surface 120, 122) with a distal-most end (the distal most end of sealing surface 120, 122), wherein the clamping surface of at least one of the first jaw and the second jaw further comprises an insulating portion (fig.20; travel stop 112) located distal to the planar electrode [0089], the insulating portion being formed of an electrically insulating material, and wherein while the jaw structure is in the closed state [0054]: (i) portions of the clamping surfaces of the first jaw and the second jaw are in contact with each other (fig.10, see also [0054]) and (ii) the clamping surfaces of the first jaw and the second jaw define an inclination angle therebetween that prevents contact between the planar electrode of the first jaw and the planar electrode of the second jaw (fig.10, see also [0054]). However, Bucciaglia does not disclose the insulating portion located distal to the distal most end of the planar electrode.
GOODMAN teaches electrosurgical forceps comprising first and second jaw members 210, 220. The jaw members 210 and 220 include an electrically-conductive, tissue-contacting plate 214and an electrically-conductive, tissue-contacting plate 224 respectively. GOODMAN further teaches the insulating portion (fig.3B, beak section 218c) located distal to the distal most end of the planar electrode [0086]. Beak section 218c of distal portion 217a of insulative housing 216 is disposed distally of tissue-contacting plate 214 and extends to or beyond tissue-contacting plate 214. Beak section 218c inhibits tissue from entering the area between jaw members 210, 220 of end effector assembly 200 when end effector assembly 200 is disposed in the closed position and utilized for blunt dissection [0086]. The gap distance between the tissue-contacting plates 214, 224 of jaw members 210, 220 (as set by the one or more stop members 215b and/or beak sections 218c of jaw members 210, 220) in the approximated position thereof at various positions along the lengths of jaw members 210, 220; and/or performing electrical continuity testing [0139]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Bucciaglia with insulating portion located distal to the distal most end of the planar electrode as taught by GOODMAN for the purpose of preventing unwanted tissue entering to the tissue treatment area. The modified device of Bucciaglia/GOODMAN provides an additional insulating portion that extends beyond the distal most end of the electrodes (fig.3B of GOODMAN).
Regarding claim 2, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 1, wherein the clamping surface of the first jaw and the clamping surface of the second jaw both comprise the insulating portion located distal to the planar electrode ([0089] of Bucciaglia).
Regarding claim 3, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 2, wherein the cutter groove defined by the first jaw is defined by the planar electrode of the first jaw and has a distal end located proximal to the insulating portion of the first jaw (fig.20 of Bucciaglia).
Regarding claim 4, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 3, wherein the cutter groove defined by the second jaw is defined by the planar electrode of the second jaw and has a distal end located proximal to the insulating portion of the second jaw ([0089] of Bucciaglia).
Regarding claim 5, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 2, wherein the insulating portions of the first jaw and the second jaw are the portions of the clamping surfaces of the first jaw and the second jaw that are in contact with each other while the jaw structure is in the closed state ([0054] of Bucciaglia).
Regarding claim 8, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 1, wherein the clamping surface of only the first jaw comprises the insulating portion located distal to the planar electrode ([0054], “one or both of the jaws 102, 104 may have a non-conductive travel stop 112 at or near a distal portion 126, 130 of the jaw(s) 102, 104” of Bucciaglia).
Regarding claim 9, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 8, wherein the cutter groove defined by the first jaw is defined by the planar electrode of the first jaw and has a distal end located proximal to the insulating portion of the first jaw (fig.20 of Bucciaglia).
Regarding claim 11, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 1, wherein the jaw structure further comprises: (i) first inclined surfaces and second inclined surfaces which are inclined with respect to the axis, and (ii) ridgelines formed at a distal-most tip end of the first jaw and a distal-most tip end of the second jaw. The distal-most beak section 218c which are inclined with respect to the axis (fig.3B), and (ii) ridgelines formed at a distal-most tip end of the first jaw and a distal-most tip end of the second jaw (fig.3B of GOODMAN).
Regarding claim 14, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 13, wherein each planar electrode comprises a distal-most end, and wherein the insulating portion is located distal to the distal- most end of the planar electrode (fig.3B and 5A of GOODMAN).
Regarding claim 15, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 14, wherein the cutter groove defined by each jaw is defined by the planar electrode and has a distal-most end located proximal to the proximal-most end of the insulating portion (fig.20 of Bucciaglia). The proximal-most end of the travel stops 112, 174 is position at the distal most end of the channels (114 and 116).
Regarding claim 18, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 17, wherein a distal-most portion of the insulating portion is a distal tip of the clamping surface, and wherein the distal tips of the clamping surfaces of the first jaw and the second jaw are in contact with each other when the jaw structure is in the closed state (fig.3B and 5A of GOODMAN).
Regarding claim 19, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 17, wherein the insulating portion is located to the distal-most end of the planar electrode (fig.3B and 5A of GOODMAN).
Regarding claim 21, Bucciaglia/ GOODMAN teaches the blood vessel harvesting device of claim 17, wherein the clamping surface of only the first jaw comprises the insulating portion located distal to the distal-most end of the planar electrode (fig.3B of GOODMAN).
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.
Claim 6-7, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bucciaglia (US 2019/0105100) in view GOODMAN et al. (US 2018/0325582) in further view of Odom et al. (US 2006/0224158).
Regarding claim 6-7, 16 and 20, Bucciaglia/ GOODMAN does not disclose wherein the insulating portion of the first jaw and the planar electrode of the first jaw are flush with each other to comprise the clamping surface of the first jaw and wherein the insulating portion of the second jaw and the planar electrode of the second jaw are flush with each other to comprise the clamping surface of the second jaw.
Odom teaches an electrosurgical bipolar forceps is disclosed which includes at least one shaft member having a jaw member disposed at a distal end (fig.1A). Odom further teaches one or more adjustable stop members coupled to one or more controllers. The controllers are adapted for adjusting the adjustable stop members to close the sealing plates at a predetermined rate. The rate of closure of the sealing plates 112 and 122 to grasp and/or apply pressure to tissue is regulated by adjusting the gap distance during the surgical procedure. The stop members 150 are connected to a controller 155 that is configured to selectively adjust stop member control unit 145 (fig.1B-C). Each of the stop member control units 145 is connected to the stop member assembly 140 which regulates the gap distance by extending or retracting a plurality of stop members 150 based on the control signals received from the control source 300 and the feedback signals transmitted by a sensor assembly 170a and 170b. The controller 155 electrically, mechanically or electro-mechanically adjusts the distance the stop members 150 project by retracting or extending the stop members 150 from the sealing plate 112. The gap distance is adjusted as desired by changing the distance that the stop members 150 project from the sealing plate 112 [0039]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Bucciaglia/ GOODMAN with a system that is configured to adjust the height of the insulating portion from the planar electrode as taught by Odom for the purpose of having the desired gap between first jaw and second jaw. The combination of Bucciaglia/ GOODMAN/Odom is capable of having the insulating portion of the jaws and the planar electrodes to be flush with each other to comprise the clamping surface of the jaws when desired.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the amendment necessitated a new ground of rejection.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the Examiner has failed to identify any reference which that, either alone or in combination discloses, suggests or renders obvious of wherein the ridgelines are offset from the axis in a first direction such that the first jaw and the second jaw have asymmetric shapes with respect to the axis.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794