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 01/30/2026 has been entered. Claims 2-6, 8-13, and 15-23 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the passages". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2-6, 8-13, 15-19, and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuh et al. (US 20200305989 A1).
Regarding claims 2, 15, and 19, Schuh et al. teaches a surgical instrument (200/500), comprising:(a) a shaft (205, 480, claims 9 and 12 and see fig. 32 showing effector 500 coupled to a shaft); (b) an end effector (500 [0128-0129], figs. 30-34) operably coupled with the shaft (fig. 32), the end effector including a pair of jaws (525/560) configured to cooperate to clamp and fasten tissue with a plurality of surgical fasteners (545) wherein the end effector (500) is operable to staple tissue with a plurality of surgical staples ([0128-0129, 0132, 0146-0157], figs. 21-34); (c) an articulation joint (505) that interconnects the end effector (500) with the shaft (205, 480, claims 9 and 12 and see fig. 32 showing effector 500 coupled to a shaft) and is configured to provide articulation of the end effector relative to the shaft in each of a first articulation plane and a second articulation plane (at least two degrees of freedom [0128-0133, 0145, 0155]); the articulation joint including a plurality of joint segments that includes a proximal joint segment, a distal joint segment, and an intermediate joint segment (proximal clevis 510, a distal clevis 515, and a lower jaw connector 520) that are longitudinally spaced apart such that the joint segments do not directly abut one another (503 is seen between 520 and 515/510, fig. 30);
(d) a firing driver (540) actuatable through the end effector to fasten the clamped tissue; and(e) a first flexible firing actuator (push shafts 503) operably coupled with a first portion of the firing driver (540), and a second flexible firing actuator (push shafts 503) operably coupled with a second portion of the firing driver, wherein the first and second flexible firing actuators (push shafts 503) are longitudinally translatable through the shaft and the articulation joint to push the firing driver through the end effector while the end effector is articulated in both the first and second articulation planes concurrently ([0147-0157], figs. 30-34);
a plurality/first and second of articulation actuators/cables (445- two cable segments) that extend through the passages of the articulation joint and are operable to drive articulation of the end effector in the first and second articulation planes ([0119, 0127-0128, 0130-0147], figs. 21-34). Schuh et al. also discloses effector (500) with the two flexible firing actuators (503) engage 535 of driver 540 and pass through an articulation joint (wrist 505) wherein the end effector is operable to staple tissue with a plurality of surgical staples while the end effector is articulated in both the first and second articulation planes concurrently ([0145-0158], figs. 30-34).
Regarding claims 3-5, 9, and 16-17, Schuh et al. discloses the first and second articulation planes are non-coplanar (2-DOF [0119, 0127-0147, figs. 23-30) and a plurality of articulation actuators (445- two cable segments) that are independently drivable to actuate the end effector in respective articulation directions wherein the plurality of articulation actuators (445- two cable segments) includes at least one first articulation actuator drivable to actuate the end effector in the first articulation plane, and at least one second articulation cable drivable to actuate the end effector in the second articulation plane (“cable 445 can include a set of two cable segments, which along with at least one additional cable segment, are configured to articulate the wrist 405 in the pitch direction (e.g., around an axis concentric with proximal pulleys 451 of the distal clevis 415) and in the yaw direction (e.g., around an axis concentric with distal pulleys 453 of the distal clevis 415” [0119, 0127-0128, 0130-0147], figs. 21-34).
Regarding claims 6, 8, 10, and 18, Schuh et al. discloses the at least one first articulation actuator includes a first pair of articulation cables (445- at least two cable segments), and the at least one second articulation actuator includes a second pair of articulation cables (445- at least two cable segments and one cable for the yaw direction) and defining a plurality of passages therethrough, wherein the articulation and firing actuators extend through the passages ([0119, 0127-0128, 0130-0147], figs. 21-34), wherein each of the articulation actuators is diametrically opposed from another of the articulation actuators about a central longitudinal axis of the articulation joint and the articulation joint (405) includes a first plurality of actuator passages configured to receive the first and second flexible firing actuators, and a second plurality of actuator passages configured to receive the articulation actuators (fig. 23A).
Regarding claims 11-12, Schuh et al. discloses the first and second flexible firing actuators are slidable through the first plurality of actuator passages (cables 440/435 slid through the passages, figs. 23-27 and push shafts 503 slide through 505, fig. 30), wherein the first and second flexible firing actuators (cables 440/435 and/or 503) are diametrically opposed about a central longitudinal axis of the articulation joint, wherein each of the articulation actuators is diametrically opposed with another of the articulation actuators about the central longitudinal axis ([0119-0158], figs. 23-34).
Regarding claims 13, Schuh et al. discloses the firing driver (430/431) includes a knife configured to cut the clamped tissue ([0126, 0129, 0149], figs. 21-34). Schuh et al. also discloses retractable blade (630) on a firing driver (600 [0158-0162], fig. 35).
Regarding claims 22-23, Viola et al. discloses the articulation joint further includes a central passage extending along a central longitudinal axis thereof (fig. 33) and each of the proximal joint segment, the distal joint segment, and the intermediate joint segment is annular, the articulation joint including a central passage that extends continuously along the central longitudinal axis from the proximal joint segment to the distal joint segment (proximal clevis 510, a distal clevis 515, and a lower jaw connector 520 are annular, [0145-0158], figs. 30-34).
Claim Rejections - 35 USC § 102/103
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) 2-6, 8-13, and 15-23, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viola et al. (US 20160310134 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Contini et al. (US 20160310134 A1) in view of Shelton, IV et al. (US 20190201034 A1) and further in view of Casasanta et al. (US 20130153633 A1).
Regarding claims 2-3, 15, 19-20, and 22, Viola et al. teaches a surgical instrument (1200), comprising:(a) a shaft (1204 and/or Housing assembly 1206 includes a proximal portion 1210); (b) an end effector (1208) operably coupled with the shaft (1204/1206/1210), the end effector including a pair of jaws (1226/1218) configured to cooperate to clamp and fasten tissue with a plurality of surgical fasteners (fig. 40) wherein the end effector (1208) is operable to staple tissue with the plurality of surgical staples (62, 64 [0102, 0140-0148], figs. 38-41); (c) an articulation joint (1214/506) that interconnects the end effector (1208) with the shaft (1204/1206/1210) and is configured to provide articulation of the end effector relative to the shaft in each of a first articulation plane and a second articulation plane (at least two degrees of freedom, flexible tube and beams bend in at least two different planes [0096-0100, 0140-0148]); the articulation joint including a plurality of joint segments that includes a proximal joint segment, a distal joint segment, and an intermediate joint segment (proximal link 514 and a distal link 560 with intermediate links 518, 520, 522, 524, 526, 528, 530 and 532) that are longitudinally spaced apart such that the joint segments do not directly abut one another (figs. 17 and 19);
(d) a firing driver (642/618, 1270/1256) actuatable through the end effector to fasten the clamped tissue; and (e) a first flexible firing actuator (1234) operably coupled with a first portion of the firing driver (1256), and a second flexible firing actuator (1236) operably coupled with a second portion of the firing driver, wherein the first and second flexible firing actuators (1234/1236) are longitudinally translatable through the shaft and the articulation joint to push the firing driver (1256/642) through the end effector while the end effector is articulated in both the first and second articulation planes concurrently (both 642 and 1256 through the articulation joint, [0096-0100, 0147-0157], figs. 17-19 and 38-41);
a first, second, third, and fourth articulation cables (538, 540, 544 and 546) that extend through a plurality of actuator passages of the articulation joint and are operable to drive articulation of the end effector in the first and second articulation planes ([0097-0108], figs. 17-19) and the articulation joint (1214/506) has a central passage (figs. 17 and 19 show central passage) extending along a central longitudinal axis thereof ([0097-0108], figs. 17-19). Viola et al. also teaches an articulation section (30/32) that includes a proximal articulation shaft 34 and a distal articulation shaft 36 with a universal joint 38 connecting the two shafts (34/36) or having flexible shaft assembly 35 with a proximal portion 35a, a distal portion 35b, and a central portion 35c or having a constant-velocity knuckle joint assembly (37, [0067-0068], figs. 2-5 and 43-44).
In the alternative, if it can be argued that Viola et al. fails to explicitly disclose in one embodiment that the first and second flexible firing actuators are longitudinally translatable through the shaft and the articulation joint to push the firing driver through the end effector while the end effector is articulated in both the first and second articulation planes concurrently and/or it would not be obvious to combine the articulation joint embodiment with the flexible firing driver embodiment -
Schuh et al. teaches a surgical instrument (200/500), comprising:(a) a shaft (205, 480, claims 9 and 12 and see fig. 32 showing effector 500 coupled to a shaft); (b) an end effector (500 [0128-0129], figs. 30-34) operably coupled with the shaft (fig. 32) with a firing driver (540) actuatable through the end effector to fasten the clamped tissue; and a first flexible firing actuator (push shafts 503) operably coupled with a first portion of the firing driver (540), and a second flexible firing actuator (push shafts 503) operably coupled with a second portion of the firing driver, wherein the first and second flexible firing actuators (push shafts 503) are longitudinally translatable through the shaft and the articulation joint to push the firing driver through the end effector while the end effector is articulated in both the first and second articulation planes concurrently to push the firing driver (540) through the end effector ([0147-0158], figs. 30-34).
Shelton et al. also teaches a surgical instrument (10, 2000 figs. 1 and 32), comprising:(a) a shaft (100/cylinder assembly 501); (b) an end effector (12/180) operably coupled with the shaft (figs. 1 and 32) and is operable to staple tissue with the plurality of surgical staples ([0137], figs. 1-4) with a firing driver (500/knife bar assembly 30) actuatable through the end effector to fasten the clamped tissue; and a flexible firing actuator (bellows 910) operably coupled with the firing driver (distal end 902 having protrusion 904 which fastens to aperture 33 of the knife bar 30, [0176], fig. 19), wherein the firing actuator (910) is longitudinally translatable through the shaft (cylinder assembly 501 [0176-0178], figs. 17-21) and an articulation joint (104/2002 with segment 2010, pivot socket 2034 and pivot trunions 519) to push the firing driver (30) through the end effector while the end effector is articulated in both the first and second articulation planes concurrently (trunions 519 pivot in a vertical/angled plane and the segment 2010/pivot socket 2034 in another lateral plane ([0193-0195], figs. 32-35).
Given the teachings of Viola et al. to have first and second flexible firing actuators that are longitudinally translatable through the shaft and a articulation joint to push the firing driver through the end effector and teaches having articulation joints that enable the end effector to be articulated in both the first and second articulation planes concurrently, it 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 to modify the firing driver with having the first and second flexible firing actuators are longitudinally translatable through the shaft and the articulation joint to push the firing driver through the end effector while the end effector is articulated in both the first and second articulation planes concurrently to have precise adjustment of the effector for more precise targeted location of the tool, greater pivoting adjustment, and/or for having more compact design (articulation joint with firing drive together) purposes as taught by Schuh et al. and Shelton et al. Also, it has been held adjustability, where needed, is not a patentable advance, and if an art-recognized need for adjustment the prior art would have been obvious and “substitution of a universal joint for the single pivot of the prior art would have been obvious” In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954).
Regarding claims 4-5, 9, and 16-17, Viola et al. discloses the first and second articulation planes are non-coplanar (horizontal/vertical) and a plurality of articulation actuators that are independently drivable to actuate the end effector in respective articulation directions wherein the plurality of articulation actuators includes at least one first articulation actuator drivable to actuate the end effector in the first articulation plane, and at least one second articulation cable drivable to actuate the end effector in the second articulation plane ([0096-0100], figs. 16-19).
Regarding claims 6, 10, 18, and 21, Viola et al. discloses the at least one first articulation actuator (542) includes a first pair of articulation cables (546 and control wire 538), and the at least one second articulation actuator (540) includes a second pair of articulation cables (544, 548) and defining a plurality of passages therethrough, wherein the articulation and firing actuators extend through the passages (notches 556, 558, 560 and 562 and guide notches 564, 566, 568 and 570), wherein each of the articulation actuators is diametrically opposed from another of the articulation actuators about a central longitudinal axis of the articulation joint, wherein each articulation cable of the first, second, third, and fourth articulation cables (538, 540, 544 and 546) is diametrically opposed from another of the articulation cables about a central longitudinal axis of the articulation joint and the articulation joint (405) includes a first plurality of actuator passages configured to receive the first and second flexible firing actuators, and a second plurality of actuator passages configured to receive the articulation actuators ([0096-0100], figs. 16-19).
Regarding claims 11-12, Viola et al. discloses the first and second flexible firing actuators are slidable through the first plurality of actuator passages, wherein the first and second flexible firing actuators (540/542) are diametrically opposed about a central longitudinal axis of the articulation joint, wherein each of the articulation actuators is diametrically opposed with another of the articulation actuators about the central longitudinal axis ([0096-0100], figs. 16-19).
Regarding claim 13, Viola et al. discloses the firing driver (642/618, 1270/1256) includes a knife (592, 1264) configured to cut the clamped tissue ([0097-0108], [0140-0148], figs. 17-19 and 38-41).
Regarding claim 23, Viola et al. discloses each of the proximal joint segment, the distal joint segment, and the intermediate joint segment is annular, the articulation joint including a central passage that extends continuously along the central longitudinal axis from the proximal joint segment to the distal joint segment (proximal link 514 and a distal link 560 with intermediate links 518, 520, 522, 524, 526, 528, 530 and 532 are annular, ([0096-0100], figs. 16-19). Viola et al. also teaches an articulation section (30/32) that includes a proximal articulation shaft 34 and a distal articulation shaft 36 with a universal joint 38 connecting the two shafts (34/36) or having flexible shaft assembly 35 with a proximal portion 35a, a distal portion 35b, and a central portion 35c or having a constant-velocity knuckle joint assembly (37, [0067-0068], figs. 2-5 and 43-44).
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-6, 8-13, and 15-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Additional prior art considered pertinent: See references cited, form 892.
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 ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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/ROBERT F LONG/Primary Examiner, Art Unit 3731