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 09/22/2026 has been entered. Claims 2-6, 8, 12-13, and 22-33 are pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the terms/phrases “a first flexible driver firing actuator and a second flexible driver firing actuator are not found in the specification and the phrase “the first flexible driver firing actuator and the second flexible driver firing actuator are configured to simultaneously bend in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis” is not clear what members are bending. The specification has numerous articulation/bending members associated with the firing driver and articulation joint. Presumably the first flexible driver firing actuator and the second flexible driver firing actuator are cables 2404, 2504? However, the specification discloses cables 2404, 2504 are used for retraction rather than driving. Also, the specification only recites “actuator” once in – “articulation joint 18200 is operably controlled by a cable control system 18400 that comprises four flexible actuator members in the form of cables 18410, 18420, 18430, and 18440” [0154] which is for articulation. Moreover, the “joint segments” are not clear which articulation embodiment (articulation system 2240, articulation joint 18200 or articulation joint 20500) they belong to since “segment” could belong to any of the embodiments. Presumably articulation system 2240 is the embodiment having the joint segments since the term “joint segment” is only found in the articulation system 2240 section of the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a first and a second “flexible driver actuator” in claims 2, 12, and 28.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: cables 2404 and 2504.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 2-6, 8, 12-13, and 22-33, is/are rejected under 35 U.S.C. 103 as obvious over Viola et al. (US 20100320252 A1) in view of Shelton, IV et al. (US 20080029575 A1) and further in view of Schuh et al. (US 20200305989 A1).
Regarding claims 2-3, 22, and 28-29, 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 (502/1208) 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 that are non-coplanar (at least two degrees of freedom, flexible tube and beams bend in at least two different planes that are non-coplanar [0096-0100, 0140-0148]); the articulation joint (1214/506) has a central passage (figs. 17 and 19 show central passage), the articulation joint defining a central longitudinal axis (through the joint 506 figs. 17-19), the articulation joint including:
(i) a plurality of joint segments (proximal link 514 and a distal link 560 with intermediate links 518, 520, 522, 524, 526, 528, 530 and 532, [0095-100], figs. 16-19), wherein adjacent joint segments are configured to collectively articulate within each of the first articulation plane and the second articulation plane ([0095-0101], figs. 16-19),
(ii) a plurality of articulation actuator passages (notches 556, 558, 560 and 562 in proximal link 514 and a distal link 560, four holes 572, 574, 576 and 578 in intermediate link 526) defined by the joint segments, and
(d) a plurality of articulation actuators (538, 540, 544 and 546) longitudinally translatable through the articulation actuator passages of the articulation joint to drive articulation of the end effector in the first and second articulation planes ([0095-0100]);
(e) a firing driver (590-592/594) actuatable through the end effector to deploy the surgical fasteners and thereby fasten the clamped tissue; and
(f) a first flexible driver firing actuator (flexible drive shaft 642/618 [0105]) operably coupled with a first portion (602) of the firing driver (592), and a second flexible driver firing actuator (630/640) operably coupled with a second portion of the firing driver (proximal end of 590), wherein the first and second flexible driver firing actuators (618/630) push the firing driver (590-592/594) longitudinally through the end effector while the end effector is articulated in both the first and second articulation planes concurrently ([0095-108], figs. 16-19).
Viola et al. fails to teach having (iii) first and second driver actuator passages defined by the joint segments; the first and second flexible driver firing actuators (618/630) are longitudinally translatable through the shaft and the first and second driver actuator passages (figs. 18-19), respectively, of the articulation joint and the first flexible driver actuator and the second flexible driver actuator are configured to simultaneously bend in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis and wherein the first flexible driver actuator and the second flexible driver actuator are each angularly offset from each of the articulation actuators of the plurality of articulation actuators about the central longitudinal axis.
However, Viola et al. does teach having first and second flexible driver firing actuators (flexible upper and lower beam extensions 1234 and 1236) that are longitudinally translatable through a shaft (1214/1206) and a driver actuator passage (1238, figs. 38-40), respectively, of an articulation joint and the flexible upper and lower beam extensions 1234 and 1236 are configured to simultaneously bend in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis (1214 [0140-0146], figs. 38-40). Viola et al. also teaches having first and second flexible driver firing actuators (drive wires 380 and 382 and/or drive shafts 344 and 346 and cam 348) wherein the first and second flexible driver actuators are longitudinally translatable through the shaft and first and second driver actuator passages, respectively, of the articulation joint to push the firing driver longitudinally through the end effector while the end effector is articulated in both the first and second articulation planes concurrently (314/392 [0084-0085]) and a driver actuator passage (348, 406/408/394 and 396, figs. 10-11), respectively, of an articulation joint (314) are configured to simultaneously bend in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis (314 note wires 380 and 382 are capable/configured with bending/flexing at least some degree [0083-0091], figs. 10-15). 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).
Viola et al. fails to explicitly disclose in one embodiment (iii) first and second driver actuator passages defined by the joint segments; the first and second flexible driver firing actuators (618/630) are longitudinally translatable through the shaft and the first and second driver actuator passages (figs. 18-19), respectively, of the articulation joint and the first flexible driver actuator and the second flexible driver actuator are configured to simultaneously bend in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis.
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 and the first flexible driver actuator and the second flexible driver actuator (push shafts 503) are configured to simultaneously bend (configured to bend “compressive strength and lateral flexibility so as to bend along with articulation of the wrist 505 without buckling” [0147]) in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis and wherein the first flexible driver actuator and the second flexible driver actuator are each angularly offset from each of the articulation actuators of the plurality of articulation actuators about the central longitudinal axis (“angularly offset as shown and “angularly” not limited to any specific angle including zero or 180 degrees [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) and wherein the first flexible driver actuator and the second flexible driver actuator are each angularly offset from each of the articulation actuators of the plurality of articulation actuators about the central longitudinal axis (“angularly offset as shown and “angularly” not limited to any specific angle including zero or 180 degrees [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 and the first flexible driver actuator and the second flexible driver actuator are configured to simultaneously bend in each of the first articulation plane and the second articulation plane at a select location along the central longitudinal axis and wherein the first flexible driver actuator and the second flexible driver actuator are each angularly offset from each of the articulation actuators of the plurality of articulation actuators about the central longitudinal axis to have precise adjustment of the effector for more precise targeted location of the tool, greater “compressive strength and lateral flexibility so as to bend along with articulation of the wrist 505 without buckling” (Schuh et al. [0147]), 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 and 30-31 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, 8, and 32-33, 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 claim 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).
Regarding claim 24, Viola et al. teaches the articulation joint includes an elastically deformable body ([0140-0146], figs. 38-40). 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).
Regarding claims 25-26, Viola et al. teaches the joint segments are longitudinally spaced apart such that the joint segments do not directly abut one another (figs. 16-17 show spacing between the joints), wherein the joint segments include a proximal joint segment, a distal joint segment, and an intermediate joint segment that are longitudinally spaced apart and arranged coaxially along a central longitudinal axis of the articulation joint (proximal link 514 and a distal link 560 with intermediate links 518, 520, 522, 524, 526, 528, 530 and 532, [0095-100], figs. 16-19).
Regarding claim 27, Viola et al. teaches each articulation cable of the first and second pairs of articulation cables is independently actuatable [0097-0100].
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-6, 8, 12-13, and 22-33 have been considered but are moot because the new ground of rejection does not rely on new sections used in the prior reference(s) applied in the prior rejection of record and new specification objections and U.S.C. 112 6th paragraph issues for any teaching or matter specifically challenged in the argument.
Conclusion
Additional prior art considered pertinent: US 20070114261 A1 – bendable effector and driver with flexing members 520, 530 with flexing guides 260, 360 and rigidizing elements 250, 350 (figs. 1-4) and 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHELLEY SELF can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
