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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 17-19 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cornacchia et al., (US 20150342667; hereinafter Cornacchia).
Regarding claim 17, Cornacchia (Figures 5a-6) discloses an actuator assembly (30) adapted for use with a bipolar electrosurgical tool (10) comprising a forceps (14) having a handle portion (22) at a proximal region for operation of the forceps (14) by a hand of a user and extending generally between a tool plug (16) at the proximal region and at least two electrodes (18) at a distal region operatively connected to the tool plug (16) for applying to tissue electrical current introduced to the tool plug (16), wherein the actuator assembly (30) comprises: a switch body (34, 40) including (i) a plug mount (44) for removably securing the switch body (34, 40) to the tool plug (16) and permitting separation of the tool plug (16) and the switch body (34, 40), (ii) a switch (46) movable between an open position and a closed position, and (iii) a power cord (68) for placing the switch (46) in electrical contact with an electrical generating apparatus (60) to introduce electrical current to the tool plug (16) when the switch body (34, 40) is secured to the tool plug (16) and the switch (46) is in the closed position; and an actuator body (40) comprising an actuator housing (body of element 40) and a switch actuating member (36) mounted for movement relative to the actuator housing (body of element 40), wherein: the switch body (34, 40) and the actuator body (40) comprise a unitary structure, the switch actuating member (36) removably accepts an actuator lever arm (38), and the switch body (34, 40) and actuator body (40) are configured so that when the tool (10) is held in the user's hand with the switch body (34, 40) secured to the tool plug (16), the actuator lever arm (38) is positioned for movement by a finger of the user's hand to move the switch actuating member (36) and place the switch (46) in the closed position ([0025]-[0030]); wherein the power cord (68) includes power leads for connecting to power terminals of an electrical generating apparatus (60) and a control lead for connecting to a control input of the electrical generating apparatus (60) for introducing electrical current to the tool plug (16) when the switch body (34, 40) is secured to the tool plug (16) and the switch (46) is closed ([0025]-[0030], [0032]: as shown in Figures 5a-5b, power and control leads/wires extend in the power cord between the instrument 10 and the generator 60).
Regarding claim 18, Cornacchia (Figures 5a-6) further discloses wherein: the actuator lever arm (38) has a distal region spaced from the actuator housing (body of element 40) and positioned proximate to the tool handle portion (22) when the switch body (34, 40) is secured to the tool plug (16) and the actuator housing (40) is connected to the switch body (34, 40); and the switch actuating member (36) is pivotally mounted to the actuator housing (40) for rotation about a hinge point ([0029]: element 36 may by a rotating shaft or rocker switch, both of which are pivotally mounted for rotation about a hinge point) and the actuator lever arm (38) is pivoted toward the proximate tool handle portion (22) when moved by the user's finger ([0025]-[0030]).
Regarding claim 19, Cornacchia (Figures 5a-6) further discloses wherein: the switch actuating member (36) comprises a molded internal pivot arm extending from the hinge point generally in the direction of the longitudinal axis of the forceps ([0028]-[0029]: element 36 may be a rocker switch which would comprise a molded internal pivot arm extending from a hinge/central point) and includes a passage for accepting the actuator lever arm (38) to position the distal region of the actuator lever arm (38) a desired longitudinal distance from the actuator housing; and the internal pivot arm and the actuator lever arm (38) include cooperating positioning means for releasably holding the actuator lever arm in a plurality of positions relative to the internal pivot arm ([0025]-[0030]).
Regarding claim 22, Cornacchia (Figures 5a-6) further discloses wherein the actuator body (40) includes a guard (48) positioned in relation to the actuator lever arm (38) for protection from inadvertent movement by the user's hand ([0025]-[0030]: element 48 holds the arm 38 in place such that the user’s hand does not move the arm 38 in the horizontal direction, only the vertical direction).
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(s) 1-4, 11-12, 14, 16, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cornacchia in view of Lottick et al., (US 4552143; hereinafter Lottick).
Regarding claim 1, Cornacchia (Figures 5a-6) discloses an actuator assembly (30) adapted for use with a bipolar electrosurgical tool (10) comprising a forceps (14) having a handle portion (22) at a proximal region for operation of the forceps (14) by a hand of a user and extending generally between a tool plug (16) at the proximal region and at least two electrodes (18) at a distal region operatively connected to the tool plug (16) for applying to tissue electrical current introduced to the tool plug (16), wherein the actuator assembly (30) comprises: a switch body (34, 40) including (i) a plug mount (44) for removably securing the switch body (34, 40) to the tool plug (16) and permitting separation of the tool plug (16) and the switch body (34, 40), (ii) a switch (46) movable between an open position and a closed position, and (iii) a power cord (68) for placing the switch (46) in electrical contact with an electrical generating apparatus (60) to introduce electrical current to the tool plug (16) when the switch body (34, 40) is secured to the tool plug (16) and the switch (46) is in the closed position; an actuator body (40) comprising an actuator housing (body of element 40) and a switch actuating member (36) comprising a unitary structure with the switch actuating member (36) mounted for movement relative to the actuator housing (body of element 40); and an actuator lever arm (38) mounted to the switch actuating member (36), wherein: the switch body (34, 40) and actuator body (40) are configured so that when the tool (10) is held in the user's hand with the switch body (34, 40) secured to the tool plug (16) and the actuator housing (housing of element 40) connected to the switch body (34, 40), the actuator lever arm (38) is positioned for movement by a finger of the user's hand to move the switch actuating member (36) and place the switch (46) in the closed position ([0025]-[0030]); wherein the power cord (68) includes power leads for connecting to power terminals of an electrical generating apparatus (60) and a control lead for connecting to a control input of the electrical generating apparatus (60) for introducing electrical current to the tool plug (16) when the switch body (34, 40) is secured to the tool plug (16) and the switch (46) is closed ([0025]-[0030], [0032]: as shown in Figures 5a-5b, power and control leads/wires extend in the power cord between the instrument 10 and the generator 60).
Cornacchia fails to disclose that the switch body and the actuator body include respective connecting structure for removably connecting the actuator housing to the switch body. However, Lottick (Figure 2) teaches an actuator assembly (proximal actuating mechanism) comprising an actuator body (proximal actuator body) and a removable switch body (30), wherein the switch body (housing of switch 30) and the actuator body (proximal actuator body) include respective connecting structure (clamps 41/43 of the switch body and holding portion of the proximal actuator body onto which the clamps attach) for removably connecting the actuator housing (proximal actuator body) to the switch body (housing of switch 30), (Col. 4, lines 23-40). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia to include a removably connected switch body and actuator body, as taught by Lottick, because the modification would enable the switching means to be readily removed and replaced on the electrocautery instrument as required (Lottick; Col. 2, lines 5-10).
Regarding claim 2, Cornacchia (Figures 5a-6) further discloses wherein the actuator lever arm (38) is removably mounted to the switch actuating member (36), ([0025]-[0030]).
Regarding claim 3, Cornacchia (Figures 5a-6) further discloses wherein: the actuator lever arm (38) has a distal region spaced from the actuator housing (body of element 40) and positioned proximate to the tool handle portion (22) when the switch body (34, 40) is secured to the tool plug (16) and the actuator housing (body of element 40) is connected to the switch body (34, 40); and the switch actuating member (36) is pivotally mounted to the actuator housing (body of element 40) for rotation about a hinge point ([0029]: element 36 may by a rotating shaft or rocker switch, both of which are pivotally mounted for rotation about a hinge point) and the actuator lever arm (38) is pivoted toward the proximate tool handle portion (22) when moved by the user's finger ([0025]-[0030]).
Regarding claim 4, Cornacchia (Figures 5a-6) further discloses wherein: the actuator lever arm (38) extends toward the distal end of the forceps (14) generally in the direction of a longitudinal axis thereof when the switch body (34, 40) is secured to the tool plug (16) and the actuator housing (body of element 40) is connected to the switch body (34, 40); and the actuator lever arm (38) is movably mounted to the switch actuating member (36) for adjusting the distance between the distal region of the actuator lever arm (38) and the actuator housing (body of element 40), ([0025]-[0030]).
Regarding claim 11, Cornacchia (Figures 5a-6) further discloses wherein: the switch actuating member (36) comprises a molded internal pivot arm extending from the hinge point generally in the direction of the longitudinal axis of the forceps ([0028]-[0029]: element 36 may be a rocker switch which would comprise a molded internal pivot arm extending from a hinge/central point) and includes a passage for accepting the actuator lever arm (38) to position the distal region of the actuator lever arm (38) a desired longitudinal distance from the actuator housing; and the internal pivot arm and the actuator lever arm (38) include cooperating positioning means for releasably holding the actuator lever arm in a plurality of positions relative to the internal pivot arm ([0025]-[0030]).
Regarding claim 12, Cornacchia (Figures 5a-6) further discloses wherein the distal region of the actuator lever arm (38) includes an enlarged portion for contact by the user's finger to pivot the actuator lever arm ([0025]-[0030], particularly [0028]: lever arm 38 may be configured for operation by a human hand such that it conforms to the shape of the hand).
Regarding claim 14, Cornacchia (Figures 5a-6) further discloses wherein the actuator body (40) includes a guard (48) positioned in relation to the actuator lever arm (38) for protection from inadvertent movement by the user's hand ([0025]-[0030]: element 48 holds the arm 38 in place such that the user’s hand does not move the arm 38 in the horizontal direction, only the vertical direction).
Regarding claim 16, Cornacchia/Lottick further teaches wherein the connecting structure (between the switch body and the actuator body) includes at least one groove on one of the actuator housing and plug mount (groove formed within the clamps of the removable switch body as taught by Lottick, the removable switch body including the plug mount in the modified device) and at least one ridge on the other of the actuator housing and plug mount (the ridge on the actuator body connecting to the clamps of the switch body, as taught by Lottick), and wherein the at least one groove slidingly accepts the at least one ridge to removably connect the actuator body to the switch body (Lottick; (Col. 4, lines 23-40).
Regarding claim 23, Cornacchia (Figures 5a-6) discloses a power cord assembly (30, 68) including a switch body (34, 40) adapted for use with a bipolar electrosurgical tool (10) comprising a forceps (14) having a handle portion (22) at a proximal region for operation of the forceps by a hand of a user and a longitudinal axis extending generally between a tool plug (16) at the proximal region and at least two electrodes (18) at a distal region operatively connected to the tool plug (16) for applying to tissue electrical current introduced to the tool plug (16), wherein the switch body (34, 40) comprises: a plug mount (44) for removably securing the switch body (34, 40) to the tool plug (16) and permitting separation of the tool plug (16) and the switch body (34, 40); a switch (46) movable between an open position and a closed position; a power cord (68) for placing the switch (46) in electrical contact with an electrical generating apparatus (60) to introduce electrical current to the tool plug (16) when the switch body (34, 40) is secured to the tool plug (16) and the switch (46) is in the closed position; and an actuator body (40) having a switch actuating member (36) movable relative to the switch body (34, 40) when the actuator body (40) is connected to the switch body (34, 40) to close the switch (46) when the switch actuating member (36) is moved by a user of the forceps (14), ([0025]-[0030]); wherein the power cord (68) includes power leads for connecting to power terminals of an electrical generating apparatus (60) and a control lead for connecting to a control input of the electrical generating apparatus (60) for introducing electrical current to the tool plug (16) when the switch body (34, 40) is secured to the tool plug (16) and the switch (46) is closed ([0025]-[0030], [0032]: as shown in Figures 5a-5b, power and control leads/wires extend in the power cord between the instrument 10 and the generator 60).
Cornacchia fails to disclose that the switch body and the actuator body include respective connecting structure for removably connecting the switch body to the actuator body. However, Lottick (Figure 2) teaches an actuator assembly (proximal actuating mechanism) comprising an actuator body (proximal actuator body) and a removable switch body (30), wherein the switch body (housing of switch 30) and the actuator body (proximal actuator body) include respective connecting structure (clamps 41/43 of the switch body and holding portion of the proximal actuator body onto which the clamps attach) for removably connecting the actuator housing (proximal actuator body) to the switch body (housing of switch 30), (Col. 4, lines 23-40). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia to include a removably connected switch body and actuator body comprising a connecting structure, as taught by Lottick, because the modification would enable the switching means to be readily removed and replaced on the electrocautery instrument as required (Lottick; Col. 2, lines 5-10).
Claim(s) 5-9, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cornacchia/Lottick as applied to claim 4 above, and further in view of Rioux et al., (US 20110077640; hereinafter Rioux).
Regarding claim 5-9, Cornacchia/Lottick teaches the actuator assembly as in claim 4, but fails to disclose wherein the distal region of the actuator lever arm includes an enlarged portion for contact by the user's finger to pivot the actuator lever arm, wherein the enlarged portion of the actuator lever arm comprises a surface curved convex-outward relative to the forceps when the switch body is secured to the tool plug for contact by the finger of the user holding the forceps for operation, wherein the surface of the lever arm enlarged portion includes contours for providing a tactile sensation to the user's finger, wherein the contours include depressions in the surface of the enlarged portion, wherein the depressions are formed by openings formed through the enlarged portion. However, Rioux (Figures 1A-2) teaches an actuator assembly comprising an actuator lever arm (14) comprising an enlarged portion (large size of the arm 14) for contact by the user's finger to pivot the actuator lever arm (14), wherein the enlarged portion of the actuator lever arm (14) comprises a surface (28, 30) curved convex-outward relative to the tool, wherein the surface (28, 30) of the lever arm (14) enlarged portion includes contours (contours of the protrusions 28/30) for providing a tactile sensation to the user's finger, wherein the contours include depressions in the surface of the enlarged portion (as shown in Figures 1A-2), wherein the depressions are formed by openings formed through the enlarged portion of arm (14), as shown in Figures 1A-2, ([0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia/Lottick to include the distal region of the actuator lever arm including an enlarged portion for contact by the user's finger to pivot the actuator lever arm, wherein the enlarged portion of the actuator lever arm comprises a surface curved convex-outward relative to the forceps when the switch body is secured to the tool plug for contact by the finger of the user holding the forceps for operation, wherein the surface of the lever arm enlarged portion includes contours for providing a tactile sensation to the user's finger, wherein the contours include depressions in the surface of the enlarged portion, wherein the depressions are formed by openings formed through the enlarged portion, as taught by Rioux, because the modification would conform to the shape of the hand of the user, providing a more controlled user operation (Cornacchia; [0028]).
Regarding claim 13, Cornacchia/Lottick teaches the actuator assembly as in claim 12, but fails to disclose wherein the positioning means includes one of (i) a plurality of detent protrusions on one of the actuator lever arm and internal pivot arm and a plurality of detent receptacles on the other of the actuator lever arm and internal pivot arm for accepting the detent protrusions, or (ii) mating screw threads on a shaft portion of the actuator lever arm and the passage in the internal pivot arm. However, Rioux (Figures 1A-2) teaches an actuator assembly comprising positioning means includes one of (i) a plurality of detent protrusions (28/30) on the actuator lever arm (14) and a plurality of detent receptacles (42, 44) on an internal pivot arm (12) for accepting the detent protrusions (28), ([0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia/Lottick to include the positioning means including a plurality of detent protrusions on one of the actuator lever arm and internal pivot arm and a plurality of detent receptacles on the other of the actuator lever arm and internal pivot arm for accepting the detent protrusions, as taught by Rioux, because the modification would conform to the shape of the hand of the user, providing a more controlled user operation (Cornacchia; [0028]).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cornacchia as applied to claim 19 above, and further in view of Rioux.
Regarding claims 20-21, Cornacchia discloses the actuator assembly as in claim 19, but fails to disclose wherein the distal region of the actuator lever arm includes an enlarged portion for contact by the user's finger to pivot the actuator lever arm, wherein the positioning means includes one of (i) a plurality of detent protrusions on one of the actuator lever arm and internal pivot arm and a plurality of detent receptacles on the other of the actuator lever arm and internal pivot arm for accepting the detent protrusions, or (ii) mating screw threads on a shaft portion of the actuator lever arm and the passage in the internal pivot arm. However, Rioux (Figures 1A-2) teaches an actuator assembly comprising an actuator lever arm (14) including an enlarged portion (large size of the arm 14) for contact by the user’s finger to pivot the actuator lever arm (14), wherein the positioning means includes one of (i) a plurality of detent protrusions (28/30) on the actuator lever arm (14) and a plurality of detent receptacles (42, 44) on an internal pivot arm (12) for accepting the detent protrusions (28), ([0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia/Lottick to include the positioning means including a plurality of detent protrusions on one of the actuator lever arm and internal pivot arm and a plurality of detent receptacles on the other of the actuator lever arm and internal pivot arm for accepting the detent protrusions, as taught by Rioux, because the modification would conform to the shape of the hand of the user, providing a more controlled user operation (Cornacchia; [0028]).
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cornacchia/Lottick as applied to claims 1 and 9 above, and further in view of Beane et al., (US 5116333; hereinafter Beane).
Regarding claim 10, Cornacchia (Figures 5a-6) further discloses wherein the actuator lever arm (38) includes a shaft portion mounted to the switch actuating member (36), ([0025]-[0030]), but Cornacchia/Lottick fails to teach the actuator lever arm comprising a body molded around a deformable stainless steel core. However, Beane teaches an actuator assembly in which the conductive material used for a conductive component (12/14) comprises stainless steel (Col. 1, lines 48-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia/Lottick to include the actuator lever arm comprising a body molded around a deformable stainless steel core 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. MPEP 2144.07.
Regarding claim 15, Cornacchia/Lottick teaches the actuator assembly as in claim 1, but fails to disclose wherein the actuator lever arm comprises a body molded around a deformable stainless steel core ([0025]-[0030]). However, Beane teaches an actuator assembly in which the conductive material used for a conductive component (12/14) comprises stainless steel (Col. 1, lines 48-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cornacchia/Lottick to include the actuator lever arm comprising a body molded around a deformable stainless steel core 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. MPEP 2144.07.
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument that the cited references fail to teach the limitation “the power cord includes power leads for connecting to power terminals of an electrical generating apparatus and a control lead for connecting to a control input of the electrical generating apparatus for introducing electrical current to the tool plug when the switch body is secured to the tool plug and the switch is closed,” Examiner respectfully disagrees. As shown in Figures 5a-5b of Cornacchia, the power cord comprises auxiliary wires to connect the power terminals and control output ([0032]). These wires are the power leads for connecting to power terminals of the electrical generating apparatus and a control lead for connecting to a control input of the electrical generating apparatus for introducing electrical current to the tool plug when the switch body is secured to the tool plug and the switch is closed. Therefore, Examiner maintains that the Cornacchia reference teaches the above-mentioned limitation.
Conclusion
THIS ACTION IS MADE FINAL. 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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794