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
This office action is responsive to the amendment filed on 04/21/2025. As directed by the amendment: claims 1, 3, 4, 13, 15, and 18 have been amended. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 04/21/2025, with respect to the objections of claims 13, 15, and 18 have been fully considered and are persuasive. The objections of claims 13, 15, and 18 have been withdrawn.
Applicant’s arguments, see pg. 7, filed 04/21/2025, with respect to the rejection of claims 3-4 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 3-4 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pg. 9-10, filed 04/21/2025, with respect to the rejection(s) of claim(s) 18 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a variant interpretation of Morely and Lee.
Applicant’s arguments, see pg. 12-13, filed 04/21/2025, with respect to the rejection(s) of claim(s) 13 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tapia Espriu and Seex.
Applicant's arguments filed 04/21/2025 have been fully considered but they are not persuasive. Applicant argues that Blumenkranz does not disclose the first flexible interconnect intersects the longitudinal axis of the shaft. The Office respectfully disagrees. Claim 1 recites “the shaft defines a longitudinal axis”. Under broadest reasonable interpretation, a longitudinal axis of the shaft can be any axis that extends along the long portion of the shaft. In this instance the longitudinal axis is being interpreted as an axis that extends through 642. This axis extends along the long portion of the shaft. Therefore, The Office submits that Blumenkranz does disclose the first flexible interconnect intersects the longitudinal axis of the shaft. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the longitudinal axis is a central axis of the shaft) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blumenkranz (WO 2013/025831 A2).
Regarding claim 1, Blumenkranz discloses an articulating surgical instrument (100)(¶ 0052, 0063), comprising:
a housing (actuator system 118);
a shaft (tube 112) extending distally from the housing (118) (fig. 1; ¶ 0053), wherein the shaft defines a longitudinal axis (an axis extending along the length of 112, fig. 1);
an end effector assembly (unitary jaw structure 110) (figs. 1 and 5; ¶ 0052-0053); and
an articulating component (wrist mechanism 124) interconnecting the shaft (112) and end effector assembly (110) (figs. 1, 5 and 6; ¶ 0054) and including:
a proximal disk (first connector portion 632) connected to the shaft (112) (figs. 1 and 6; ¶ 0054 and 00131);
a distal disk (third connector portion 636) connected to the end effector assembly (110) (distal disk is indirectly connected to the end effector; figs. 1 and 6; ¶ 0054 and 00131);
an intermediate disk (third connector portion 634) (figs. 1 and 6; ¶ 0054 and 00131);
a first flexible interconnect (first pair of flexible hinges 642) connecting the proximal and intermediate disks (632 and 634) (fig. 6; ¶ 00131); and
a second flexible interconnect (fourth pair of flexible hinges 644) connecting the intermediate and distal disks (634 and 636) (fig. 6; ¶ 00131),
wherein the first flexible interconnect (642) intersects the longitudinal axis (fig. 6, an axis extending along the length of 112 intersects 642) and defines a single plane (622) of bending to enable articulation of the end effector assembly (110) relative to the shaft (112) within a first plane (figs. 5 and 6; ¶ 00132-00133 and 00135), and
wherein the second flexible interconnect (644) defines a single plane (620) of bending substantially perpendicular to the single plane (622) of bending of the first flexible interconnect (642) to enable articulation of the end effector assembly (110) relative to the shaft (112) within a second plane substantially perpendicular to the first plane (fig. 6; ¶ 00132-00133 and 00135).
Regarding claim 2, Blumenkranz discloses the surgical instrument of claim 1, wherein the articulating component (124) is a monolithic, single piece of material (¶ 0054).
This limitation is a product by process limitation, and thus is considered as much as it affects the final product. In the instant case, forming the articulating component from a single piece of material would result in a monolithic product. Blumenkranz teaches that the articulating component can be manufactured from a single material as a single unit (Blumenkranz ¶ 0054).
Regarding claim 3, Blumenkranz discloses the surgical instrument of claim 1, wherein each of the first and second flexible interconnects (642 and 644) defines a beam configuration having a pair of opposed narrow sides (flexure thickness 652) and a pair of opposed broad sides (flexure width 650) (fig. 6; ¶ 00134), wherein the broad sides are broader than the narrow sides (fig. 6).
Regarding claim 4, Blumenkranz discloses the surgical instrument of claim 3, wherein each of the first and second flexible interconnects (642 and 644) is aligned relative to the longitudinal axis (fig. 6; ¶ 00137-00138).
Regarding claim 5, Blumenkranz discloses the surgical instrument of claim 1, wherein a first pair of opposed articulation cables (actuating members/cables 114) extending from the shaft (112) through the proximal and intermediate disks (632 and 634) (fig. 1), the first pair of opposed articulation cables (114) anchored distally of the intermediate disk (634) and configured to move in opposite directions to articulate the end effector assembly (110) relative to the shaft (112) within the first plane (figs. 1 and 6; ¶ 0060, 00125 and 00148-00150).
Regarding claim 6, Blumenkranz discloses the surgical instrument of claim 5, wherein a second pair of opposed articulation cables (actuating members/cables 114) extending from the shaft (112) through the proximal, intermediate, and distal disks (632, 634, and 636), the second pair of opposed articulation cables (114) anchored distally of the distal disk (636) and configured to move in opposite directions to articulate the end effector assembly (110) relative to the shaft (112) within the second plane (figs. 1 and 6; para. 0060, 00125, and 00148-00150).
Regarding claim 7, Blumenkranz discloses the surgical instrument of claim 6, wherein the first and second pairs of opposed articulation cables (114) are offset about 90 degrees relative to one another (fig. 6; ¶ 00159).
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 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz in view of Cowley et al. (WO 2021/202035 A1).
Regarding claim 8, as discussed above, Blumenkranz discloses the surgical instrument, as set forth in claim 1. Blumenkranz does not disclose wherein the end effector assembly includes: a body; an ultrasonic transducer housed within the body; and an ultrasonic blade extending distally from the body and configured to treat tissue with ultrasonic energy produced by the ultrasonic transducer.
However, Cowley, in the same field of endeavor, teaches a similar surgical instrument (10) comprising an end effector assembly (200) including: a body (transducer housing 282); an ultrasonic transducer (272) housed within the body 282); and an ultrasonic blade (286) extending distally from the body (282) and configured to treat tissue with ultrasonic energy produced by the ultrasonic transducer (figs. 3 and 4; ¶ 0053).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the end effector assembly of Blumenkranz to include a body; an ultrasonic transducer housed within the body; and an ultrasonic blade extending distally from the body and configured to treat tissue with ultrasonic energy produced by the ultrasonic transducer, as taught by Cowley, for the purpose of treating tissue (Cowley: ¶ 0053).
Regarding claim 9, as discussed above, it would have been obvious for the surgical instrument of Blumenkranz to include a body, ultrasonic transducer and blade as part of the end effector assembly as recited in claim 8. Blumenkranz further discloses wherein the end effector assembly (100) further includes a jaw member (202) pivotable relative to another jaw member (208) between an open position (fig. 4) and a closed position (fig. 5) for clamping tissue therebetween (¶ 0069, 00100-00103). The end effector assembly was modified to have an ultrasonic blade, as describe in claim 8 above. Therefore, the combined elements would function so that the jaw member would be pivotable relative to the ultrasonic blade.
Regarding claim 10, as discussed above, modified Blumenkranz discloses the surgical instrument, as set forth in claim 9. Blumenkranz further discloses at least one jaw actuation cable (114) routed through the articulating component (124) to the end effector assembly (110) (figs. 3-5; ¶ 00108-00109).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz in view of Parihar et al. (PG Pub US 2014/0088637 A1).
Regarding claims 11 and 12, as discussed above, Blumenkranz discloses the surgical instrument, as set forth in claim 1. Blumenkranz discloses in claim 1 that the distal disk is connected to the end effector assembly. However, Blumenkranz does not disclose that they are connected by a releasable engagement as recited in claim 11; further, the releasable engagement including: a first connector; and a second connector including first and second rails defining a slot therebetween and an engagement tab positioned towards an open end of the slot, wherein the first connector is transversely slidable between the first and second rails and into the slot, and wherein the engagement tab is configured to releasably engage the first connector within the slot upon sufficient transverse sliding of the first connector into the slot as recited in claim 12.
However, Parihar, in the same field of endeavor, teaches a similar surgical instrument (¶ 0017) comprising a shaft assembly (outer tube 23) connected to an end effector assembly (10) by a releasable engagement, wherein the releasable engagement, i.e. locked and unlocked position, includes: a first connector (12+17+16+15+14); and a second connector (21+24+25+27) including first and second rails defining a slot therebetween (see figs. 2 and 7; ¶ 0019; the rails are being interpreted as the plurality of arms of collet 25 and the slot is the space between the arms) and an engagement tab (lip 27) positioned towards an open end of the slot, wherein the first connector (12+17+16+15+14) is transversely slidable between the first and second rails and into the slot, and wherein the engagement tab (27) is configured to releasably engage the first connector (12+17+16+15+14) within the slot upon sufficient transverse sliding of the first connector (12+17+16+15+14) into the slot (see figs. 1-2, 4-5 and 7-8; ¶ 0019-0021).
As discussed above, Blumenkranz already teaches that the shaft assembly has an articulating component with a distal disk.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the surgical instrument of Blumenkranz to have the distal disk be connected to the end effector by a releasable engagement; the releasable engagement including: a first connector; and a second connector including first and second rails defining a slot therebetween and an engagement tab positioned towards an open end of the slot, wherein the first connector is transversely slidable between the first and second rails and into the slot, and wherein the engagement tab is configured to releasably engage the first connector within the slot upon sufficient transverse sliding of the first connector into the slot, as taught by Parihar, for the purpose of providing a means for locking engagement of the shaft assembly and end effector (Parihar ¶ 0006).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz in view of Tapia Espriu et al. (US 2018/0360458 A1) and Seex (US 2019/0321055 A1).
Regarding claims 13 and 14, Blumenkranz discloses an articulating surgical instrument, comprising:
a housing (actuator system 118);
a shaft assembly (tube 112) extending distally from the housing (118) and defining a longitudinal axis (fig. 1), the shaft assembly (118) including a proximal shaft (112) and a distal articulating section (124); and
an end effector assembly (110) coupled to the distal articulating section (20) of the shaft assembly (112).
Blumenkranz does not disclose wherein the end effector assembly is releasably coupled to the distal articulating section of the shaft assembly by a releasable engagement including: a first connector disposed on one of the end effector assembly or the distal articulating section; and a second connector disposed on another of the end effector assembly or the distal articulating section and including first and second rails defining a slot therebetween and an engagement tab positioned towards an open end of the slot, wherein the first connector is slidable along a transverse axis perpendicular to the longitudinal axis such that it is slidable between the first and second rails and into the slot, and wherein the engagement tab is configured to releasably engage the first connector within the slot upon sufficient transverse sliding of the first connector into the slot.
However Tapia Espriu, in the same filed of endeavor, teaches (fig. 1-3 and 8A-8C) an end effector assembly 200 that is releasably coupled to a distal section of a shaft assembly 102 (¶0031 and fig. 3) by a releasable engagement (¶0052 and fig. 8A-8C) including: a first connector 202 disposed on the end effector assembly (fig. 3 and ¶0033); and a second connector 101 disposed the distal section (fig. 3 and ¶0031) and including first and second rails defining a slot therebetween (see annotated fig. 3 below), wherein the first connector 202 is slidable along a transverse axis perpendicular to the longitudinal axis such that it is slidable between the first and second rails and into the slot (fig. 3, 8A-8C and ¶0053).
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Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Blumenkranz to have the end effector assembly is releasably coupled to the distal articulating section of the shaft assembly by a releasable engagement including: a first connector disposed on one of the end effector assembly or the distal articulating section; and a second connector disposed on another of the end effector assembly or the distal articulating section and including first and second rails defining a slot therebetween, wherein the first connector is slidable along a transverse axis perpendicular to the longitudinal axis such that it is slidable between the first and second rails and into the slot as taught by Tapia Espriu, for the purpose of having a releasable connection between the end effector and the shaft (see Tapia Espriu ¶0052) to be able to use different end effectors and/or make cleaning easier.
Blumenkranz as modified is further silent regarding an engagement tab positioned towards an open end of the slot; the engagement tab is configured to releasably engage the first connector within the slot upon sufficient transverse sliding of the first connector into the slot.
However Seex, in the analogous art of detachable connections, teaches (fig. 8) of a first connector 408, a second connector 410 comprising a slot (fig. 8), and an engagement tab 414 positioned towards an open end of the slot (fig. 8); the engagement tab 414 is configured to releasably engage the first connector 408 within the slot upon sufficient transverse sliding of the first connector 408 into the slot (¶0060).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Blumenkranz as modified to have an engagement tab positioned towards an open end of the slot; the engagement tab is configured to releasably engage the first connector within the slot upon sufficient transverse sliding of the first connector into the slot as taught by Seex, for the purpose of being able to lock the first connector into the second connector to prevent unintended release (see Seex ¶0060).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz in view of Tapia Espriu and Seex as applied to claim 13 above, and further in view of Walker et al. (US 6,022,363).
Regarding claim 15, as discussed above, modified Blumenkranz discloses the surgical instrument, as set forth in claim 13. Blumenkranz as modified is further silent regarding the second connector further including includes a living hinge, wherein the engagement tab is disposed at a free end of the living hinge.
However Walker, in the analogous art of detachable connections, teaches (fig. 1-3) a first connector 242 (see col. 33 ln. 53-67), a second connector 70 (see col. 8 ln. 59 – col. 9 ln. 11) including an engagement tab 74, wherein the second connector 70 further including includes a living hinge 75 (75 is a living hinge because it is a narrowed flexible portion of formed of the same material as 70; see fig. 3), wherein the engagement tab 74 is disposed at a free end of the living hinge 75 (see fig. 3 and col. 9 ln. 34-53).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Blumenkranz as modified to have the second connector further including includes a living hinge, wherein the engagement tab is disposed at a free end of the living hinge.as taught by Walker, for the purpose of a user being able to easily release the engagement with a press of their fingers (see Walker and col. 9 ln. 34-53).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz in view of Tapia Espriu and Seex as applied to claim 13 above, and further in view of Cowley.
Regarding claim 16, as discussed above, modified Blumenkranz discloses the surgical instrument, as set forth in claim 13. Blumenkranz teaches having a first and second connector in claim 13. However, modified Blumenkranz does not teach wherein the end effector assembly includes: a body having the first or second connector extending therefrom; an ultrasonic transducer housed within the body; and an ultrasonic blade extending distally from the body and configured to treat tissue with ultrasonic energy produced by the ultrasonic transducer.
However, Cowley, in the same field of endeavor, teaches a similar surgical instrument (10) comprising an end effector assembly (200) including: a body (transducer housing 282); an ultrasonic transducer (272) housed within the body (282); and an ultrasonic blade (286) extending distally from the body (282) and configured to treat tissue with ultrasonic energy produced by the ultrasonic transducer (figs. 3 and 4; ¶ 0053).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the end effector assembly of modified Blumenkranz to have the first connector extend from a body; an ultrasonic transducer housed within the body; and an ultrasonic blade extending distally from the body and configured to treat tissue with ultrasonic energy produced by the ultrasonic transducer, as taught by Cowley, for the purpose of treating tissue (Cowley: ¶ 0053).
Regarding claim 17, as discussed above, it would have been obvious for the surgical instrument of Blumenkranz to include a body, ultrasonic transducer and blade as part of the end effector assembly, as set forth in claim 16. Blumenkranz further discloses wherein the end effector assembly (100) further includes a jaw member (202) pivotable relative to another jaw (208) between an open position (fig. 4) and a closed position (fig. 5) for clamping tissue therebetween (¶ 0069, 00100-00103). The end effector assembly was modified to have an ultrasonic blade, as described in claim 16 above. Therefore, the combined elements would function so that the jaw member would be pivotable relative to the ultrasonic blade.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morley et al. (US 2005/0204851 A1) in view of Lee et al. (US 2019/0142532 A1).
Regarding claim 18, Morley discloses a rotating and articulating surgical instrument (14) (fig. 3), comprising:
a housing (53) (fig. 3; ¶ 0032);
a shaft assembly (14.1) extending distally from the housing (53), the shaft assembly (14.1) including a proximal shaft (portion proximal to 50) and a distal articulating section (wrist-like mechanism 50) (fig. 3; ¶ 0032);
an end effector assembly (58) coupled to the distal articulating section (50) (fig. 5; ¶ 0040), wherein the distal articulating section (50) is configured to articulate the end effector assembly (58) relative to the proximal shaft (shat 14.1) within at least one plane (fig. 12; ¶ 0040 and 0049), the end effector assembly (58) including a proximal head 504 defining an annular track 544/546; fig. 12; ¶ 0052-0053); and
a rotation mechanism including a cable (C3+C4) extending through the distal articulating section (50) of the shaft assembly (14.1) to the end effector assembly (58) (Fig. 11 and 14; ¶ 0053 and 0063), the cable (C3) including a first portion (C3), a second portion (C4), and a partially looped portion (portion that rides over the pulley 544/546), the first portion C3 and the second portion C4 extending at least partially through the shaft assembly (fig. 14), the partially looped portion disposed at least partially within the annular track 544/546 of the proximal head 504 of the end effector assembly (58) (figs. 12; ¶0053),
wherein movement of the first and second portions of the cable (C3, C4) in opposite directions slides the partially looped portion through the annular track 544/546 (the wires move in/with the pulleys thus they slide through the annular track) to generate torque to thereby rotate the end effector assembly (58) relative to the shaft assembly (14.1) (¶ 0052-0053).
Morley is silent regarding the partially looped portion interconnecting the first and second portions.
However Lee, in the same filed of endeavor, teaches (fig. 1B-1E) an end effector assembly 100 including a proximal head 120 defining an annular track 123 (see ¶0064); and a rotation mechanism including a cable 140 extending to the end effector assembly (see fig. 1C), the cable 140 including a first portion 141, a second portion 142, and a partially looped portion (portion round around the shaft member, see fig. 1C and ¶0071) interconnecting the first and second portions (see ¶0070, embodiment where they 141 and 142 are one wire) wherein movement of the first and second portions of the cable in opposite directions slides the partially looped portion through the annular track 123 to generate torque to thereby rotate the end effector assembly relative to the shaft assembly (see ¶0070).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Morley to have the partially looped portion interconnecting the first and second portions as taught by Lee, for the purpose of improving the accuracy of the roll joint member (see ¶0134).
Regarding claim 19, Morely as modified discloses the claimed invention substantially as claimed, as set forth above for claim 18. Morely as modified further teaches wherein movement of the first and second portions of the cable in opposite directions in a first manner slides the partially looped portion through the annular track in a clockwise direction to generate torque to thereby rotate the end effector assembly relative to the shaft assembly in the clockwise direction, and wherein movement of the first and second portions of the cable in opposite directions in a second, opposite manner slides the partially looped portion through the annular track in a counterclockwise direction to generate torque to thereby rotate the end effector assembly relative to the shaft assembly in the counterclockwise direction (see Morely ¶0052-0053 and Lee ¶0070).
Regarding claim 20, Morely as modified discloses the claimed invention substantially as claimed, as set forth above for claim 18. Morely as modified further teaches wherein movement of the first and second portions of the cable in opposite directions slides the partially looped portion through the annular track and, as a result of friction between the partially looped portion of the cable and the annular track, torque is generated to thereby rotate the end effector assembly relative to the shaft assembly (see Morely ¶0052-0053 and Lee ¶0070, 0073).
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 DARWIN P EREZO whose telephone number is (571)272-4695. The examiner can normally be reached M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kiesha Bryant can be reached at 571-272-1844. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DARWIN P. EREZO
Supervisory Patent Examiner
Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771