DETAILED ACTION
This action is in response to preliminary amendments received on 4/18/2025. It is acknowledged that all of the originally filed claims 1-20 have been canceled and new claims 21-40 added. A complete action on the merits of claims 21-40 follows below.
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 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.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Objections
Claims 21 and 34 are objected to because of the following informalities:
“is configured be” in ll. 15 of claim 21 should be amended to recite -is configured to be-.
The “.” In line 17 of claim 28 should be amended to “,”.
“tehe” in line 21 of claim 34 should be amended to recite --the--.
Appropriate correction is required.
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 21 and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Messerly (US Patent No. 6,325,811).
Regarding Claim 21, Messerly teaches a surgical instrument, comprising:(a) a shaft assembly 150 (Figs. 1-3) including:
(i) acoustic waveguide 179 (Col. 5, ll. 61-67), (ii) an outer tube 160 including a distal end (Fig. 3), (ii) an inner tube 170 received within the outer tube (Fig. 3 and 36), the inner tube 170 including a pivot pin bore (the bore 173 created by flange 171 allowing the end-effector to be received therethrough by passing bores 206, Col. 10, ll. 37-46 and Figs. 26, 36), and (b) an end effector 180 distally extending from the shaft assembly (Figs. 1, 3, 23-24 and 36, Col. 9, ll. 50-62), the end effector including:
(i) an ultrasonic blade 88 acoustically coupled with the acoustic waveguide 179 (Col. 17, ll. 46-57), (ii) a clamp arm 202 movable relative to the ultrasonic blade 88 for clamping tissue therebetween (Col. 9, ll. 63-Col. 10, ll. 28 and Fig. 3), (iii) a first proximally extending clevis arm (the wall extending proximally of the clamp arm 202 best seen in Figs. 23-31 and 36 that includes pins 206A and 207A) with a first integral pivot pin (206A “inner tube 170 preferably includes a finger or flange 171 that extends therefrom. The flange 171 has an opening 173A and an opening 173B (not shown) to receive the first post 206A and second post 206B of the clamp arm 202. When the inner tube 170 of the elongated member 150 is moved axially, the flange 171 moves forwardly or rearwardly while engaging the first post 206A and second post 206B of the clamp arm assembly 300 to open and close the clamp arm 202” Col. 10, ll. 38-46) projected inwardly from the first clevis arm (Figs. 23-36), wherein the first integral pivot pin is configured be rotatably received by the pivot pin bore of the inner tube 170 (173 at the area 171 best seen in Figs. 26, 36 where the pin 206A is received), (iv) a second proximally extending clevis arm (the wall extending proximally of the clamp arm 202 best seen in Figs. 23-31 and 36 that includes pins 206B and 207BA) with a second integral pivot pin (206B “inner tube 170 preferably includes a finger or flange 171 that extends therefrom. The flange 171 has an opening 173A and an opening 173B (not shown) to receive the first post 206A and second post 206B of the clamp arm 202. When the inner tube 170 of the elongated member 150 is moved axially, the flange 171 moves forwardly or rearwardly while engaging the first post 206A and second post 206B of the clamp arm assembly 300 to open and close the clamp arm 202” Col. 10, ll. 38-46) projected inwardly from the second clevis arm (Figs. 23-36), wherein the second integral pivot pin is configured be rotatably received by the pivot pin bore of the inner tube (173 at the area 171 best seen in Fig. 26, 36 where the pin 206B is received), and (v) a first clevis finger 207A depending downwardly from the first clevis arm and having a first protrusion rotatably received by a corresponding first opening on the distal end of the outer tube 160 (“Located at the distal end of the tubular member 164 of the outer tube 160 is an end-effector 180 for performing various tasks, such as, for example, grasping tissue, cutting tissue and the like. It is contemplated that the end-effector 180 may be formed in any suitable configuration. End-effector 180 and its components are shown in greater detail in FIGS. 23 through 33. The end-effector 180 generally includes a non-vibrating clamp arm assembly 300 to, for example, grip tissue or compress tissue against the ultrasonic blade 88. The end-effector 180 is illustrated in FIGS. 23 and 26 in a clamp open position, and clamp arm assembly 300 is preferably pivotally attached to the distal end of the outer tube 160. Looking first to FIGS. 23 through 26, the clamp arm assembly 300 preferably includes a clamp arm 202, a jaw aperture 204, a first post 206A, a second post 206B, and a tissue pad 208. The clamp arm 202 is pivotally mounted about a pivot pin 207A and pivot pin 207B to rotate in the direction of arrow 122 in FIG. 3 when thumb loop 142 is moved in the direction indicated by arrow 121 in FIG. 3. By advancing the pivoting handle portion 136 toward the instrument housing 130, the clamp arm 202 is pivoted about the pivot pin 207A and pivot pin 207B into a closed position. Retracting the pivoting handle portion 136 away from the instrument housing 130 pivots the clamp arm 202 into an open position” Col. 9, ll. 50-Col. 10, ll. 8 and Fig. 23-31), (vi) a second clevis finger 207B depending downwardly from the second clevis arm and having a second protrusion rotatably received by a corresponding second opening on the distal end of the outer tube (Col. 9, ll. 50-Col. 10, ll. 8 and Figs. 23-31).
Regarding Claim 23, Messerly teaches wherein each of the first and second integral pivot pins 206A-206B include rounded edges configured to facilitate coupling of the clamp arm to the inner tube 170 (Figs. 23-31).
Regarding Claim 24, Messerly teaches wherein the pivot pin bore (173 going across the inner shaft 170 from one flange 171 to the other, best seen in Fig. 36) has a first opening and an opposite, second opening (see the annotated figure below), wherein the distal end of the inner tube includes a first groove extending into the first opening of the pivot pin bore and a second groove extending into the second opening of the pivot pin bore, and wherein the first and second grooves are configured to respectively guide the first and second integral pivot pins into the pivot pin bore (see the following annotated Fig. 36).
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Regarding Claim 25, Messerly teaches wherein each of the first and second grooves respectively extend transversely into the first and second openings of the pivot pin bore (see te annotated Fig. 36 above).
Regarding Claim 26, Messerly teaches wherein the end effector is configured to accommodate lateral deflection of the ultrasonic blade 88 (as best seen in Fig. 36, there is enough clearance between the blade 88 and the end effector 180 such that it allows the blade to freely vibrate and/or configured to accommodate lateral deflection of the ultrasonic blade 88 to some extent, see Col. 11, ll. 45-Col. 12, ll. 9).
Regarding Claim 27, Messerly teaches wherein a portion of the ultrasonic blade is configured to be received between the first and second integral pivot pins 206A-206B (Figs. 23-24 and 36).
Claim 34 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boudreaux (US Pub. No. 2017/0105754).
Regarding Claim 34, Boudreaux teaches a surgical instrument 100 ([0092], Figs. 1A-1B), comprising: (a) a shaft assembly including: (i) acoustic waveguide 154 ([0098], Fig. 5), (ii) an outer tube 132 including a distal end ([0094] and Figs. 1A-5), (ii) an inner tube 138 received within the outer tube ([0106] and Fig. 5), (b) an end effector 102 distally extending from the shaft assembly 130 ([0094], Figs. 2A-2B), the end effector including: (i) an ultrasonic blade 152 acoustically coupled with the acoustic waveguide 154 ([0098], Fig. 5), (ii) a clamp arm 200 movable relative to the ultrasonic blade 152 for clamping tissue therebetween ([0092]-[0093] and Figs. 2A-2B), the clamp arm including a clamp arm electrode 218 ([0122], Figs. 10-12), (c) an ultrasonic electrical circuit configured to deliver energy to the ultrasonic blade ([0128]); (d) an RF electrical circuit operable to deliver RF energy to the clamp arm electrode 218 and the ultrasonic blade 152 ([0128]), the RF electrical circuit including: (i) an active path configured to deliver RF energy distally from the outer tube to the clamp arm electrode 218 and into tissue positioned between the clamp arm electrode and the ultrasonic blade 152 ([0125]-[0129]), and (ii) a return path configured to return RF energy proximally from tissue through the ultrasonic blade 152 and into tehe acoustic waveguide (“blade (152) provides a return path for the RF energy” [0128]); and (e) an electrically conductive element configured to provide a common return path for both the ultrasonic electrical circuit and the RF electrical circuit (“blade (152) is capable of serving two distinct roles in the present example—one role of applying ultrasonic energy to tissue that is in contact with blade (152) and another role of cooperating with electrode (218) to provide bipolar RF energy to tissue that is captured between clamp pad assembly (210) and blade (152)” [0128], please note that other embodiments throughout the spec also teach a clamp electrode 4218, 5218, 6218, 7218, 8218 and blade 4152, 5152, 6152, 7152, 8152 configured to complete an RF circuit as well, see [0225]-[0227], [0244]-[0246], [0265]-[0267], [0284]-[0286], [0302]-[0304]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 22 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Messerly.
Regarding Claim 22, Messerly teaches wherein the first and second integral pivot pins 206A-206B are configured to provide [a snap-fit] engagement with the pivot pin bore of the inner tube 170 for enabling pivotable coupling of the clamp arm to the inner tube (Fig. 36); however, does not specifically teach the first and second integral pivot pins 206A-206B are configured to provide a snap-fit engagement with the pivot pin bore of the inner tube 170 as claimed. Throughout the disclosure, Messerly teaches snap fitting different components together and specifically shows the first and second posts 206A-206B received in openings 173A and 173B of the inner tube 170 as disclosed in Col. 10, ll. 37-46; thereby either Messerly contemplated snap fitting the posts 206A-B into openings 173A-B in order to engage them together or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to snap fit them together in order to engage them together and hold them in place.
Claims 35-40 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Boudreaux.
Regarding Claim 35, Boudreaux teaches wherein the electrically conductive element passes through the acoustic waveguide (Boudreaux teaches the blade is conductive and configured to act as a return electrode, Fig. 5 shows the blade coupled to the waveguide 154 also see [0314]-[0320], [0337]; therefore, either the waveguide itself acts as the conductor that passes RF energy to the generator or alternatively a conductor passes through the waveguide to electrically couple the blade to the generator). It would have been an obvious matter of design choice to run a conductor through the waveguide to couple the blade to the generator, since applicant has not disclosed that passing the electrically conductive element through the acoustic waveguide solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with having a conductive waveguide electrically coupling the blade to the generator.
Regarding Claim 36, Boudreaux teaches wherein the ultrasonic blade is configured to vibrate at an ultrasonic frequency as the RF electrical circuit applies RF energy to the clamp arm electrode and the ultrasonic blade ([0098]-[0100] and [0128]).
Regarding Claim 37, Boudreaux teaches wherein the outer tube is electrically conductive and configured to transmit RF energy to the clamp arm electrode (“Body (202) generally comprises a structural core (204) with a plastic or rubber overmolded exterior portion (206). As will be described in greater detail below, structural core (204) comprises a generally electrically conducting material that is suitable to transfer RF energy through structural core (204). Core (204) thus provides a path for electrical continuity in addition to providing structural support” [0118]).
Regarding Claim 38, Boudreaux teaches wherein the surgical instrument includes a generator configured to selectively activate the ultrasonic electrical circuit and the RF electrical circuit ([0128]).
Regarding Claim 39, Boudreaux teaches wherein the ultrasonic electrical circuit and the RF electrical circuit are configured to be activated independently or concurrently ([0128]).
Regarding Claim 40, Boudreaux teaches wherein the clamp arm electrode 4218/5218 is configured as an active electrode and the ultrasonic blade 4152/5152 is configured as a return electrode in the RF electrical circuit ([0225] and [0244] and Figs. 37-44).
Claims 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Messerly in view of Beaupre’ (US Pub. No. 2010/0063528).
Regarding Claim 28, Messerly teaches a surgical instrument (Figs. 1 and 3-4), comprising: (a) a shaft assembly 150 including: (i) acoustic waveguide 179 (Col. 5, ll. 61-67), (ii) an outer tube 160 including a distal end (Fig. 3), (ii) an inner tube 170 received within the outer tube 160 (Figs. 3-4 and 36), (b) an end effector 180 distally extending from the shaft assembly (Figs. 1, 3, 23-24 and 36, Col. 9, ll. 50-62), the end effector including:
(i) an ultrasonic blade 88 acoustically coupled with the acoustic waveguide 179 (Col. 17, ll. 46-57), (ii) a clamp arm 202 movable relative to the ultrasonic blade for clamping tissue therebetween (Col. 9, ll. 63-Col. 10, ll. 28 and Fig. 3), and (c) a handle assembly 130 coupled to the shaft assembly 150 (Figs. 1, 3-4), the handle assembly including:
(i) a body having a pistol grip 132a-132b (ii) a trigger 136 pivotably coupled to the body (Col. 6, ll. 41-, (iii) a translating member 255 including a proximal arm and a yoke 280, the proximal arm being pivotably coupled to the trigger 136 (Col. 6, ll. 41-61 and Fig. 2A), (iv) a linkage assembly including a first link 128 pivotably coupled to the trigger 136 (Col. 7, ll. 17-27), (v) a spring stack 155 received over a cylindrical spring retainer 260 (Fig. 2A);
however, does not teach a second link pivotably coupled between the first link and the proximal arm of the translating member and (vi) a compression spring positioned at a proximal end of the proximal arm of the translating member.
In the same field of invention, Beaupre’ teaches coupling the movable handle to the body of the housing by the use of a linkage assembly including a first link 80 pivotably coupled to the trigger 110 and a second link 100 pivotably coupled between the first link 100 and the proximal arm of the translating member (Figs. 4-5, 11A-13B and 16) and (vi) a compression spring 130 positioned at a proximal end of the proximal arm of the translating member ([0052], [0063]-[0064]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to couple the movable trigger handle to the body through at least two linkage members and a compression spring in order to control the amount of force applied to tissue grasped between the clamp and the blade as Beaupre’ teaches that by careful selection of the point of farthest travel by the said actuating tube and the preload of the said force-limiting spring 130, the tissue can be compressed and transected with a clamping force within a desirable range.
Regarding Claim 29, Messerly teaches wherein the trigger 136 is configured to be movable toward and away from the pistol grip (Fig. 3 vs. Fig. 4).
Regarding Claim 30, Messerly in view of Beaupre’ teaches wherein the yoke 250 is at least partially encircling and operatively coupling with a proximal end of the outer tube 160 (Messerly teaches the support member 282 of the yoke has a semi-circular shape with pawls 286 that engage tubular collar 260, Col. 7, ll. 28-38; furthermore, Beaupre’ shows the yoke 90 is at least partially encircling and operatively coupling with a proximal end of the outer tube 230 in Figs. 4-5, 11B, 12B, 13B).
Regarding Claim 31, Messerly in view of Beaupre’ teaches wherein the first and second links are configured to translate the translating member in response to actuation of the trigger (linkage 80 and 100 in response to actuation of thumb lever 110 of Beaupre’ as disclosed in [0052] and [0061]-[0064]).
Regarding Claim 32, Messerly teaches wherein the spring stack 155 is restrained proximally by a retaining nut and distally by the yoke of the translating member (retained between the yoke 280 and indexing mechanism 255 including tubular collar 260, see Fig. 2A of Messerly).
Regarding Claim 33, Messerly in view of Beaupre’ teaches wherein the compression spring is configured to bias the translating member distally to return the clamp arm to an open position when the trigger is released (spring 130 of Beaupre’ compresses as thumb lever 110 is squeezed and thus it is configured to bias the translating member distally to return the clamp arm to an open position when the trigger is released, see [0052] and [0063]-[0064] and Figs. 11A-13B of Beaupre’).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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