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 action is in response to the amendment filed on 6/22/2026. In the amendment, claims 1, 3, 5, & 20 have been amended, claims 2 & 16-19 have been cancelled, and claims 21-25 have been added.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-6, 13-15, 20, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulte et al. (US Pub. No. 2015/0080925 A1).
Regarding claim 1, Schulte et al. disclose a surgical instrument 50 (Fig. 30-31B), comprising: (a) an end effector 40 (Fig. 30-31B), the end effector 40 comprising: (i) an ultrasonic blade 42 (Fig. 30-31B), and (ii) a clamp arm 54 (Fig. 30-31B) configured to pivot relative to the ultrasonic blade 42 between an open position and a closed position, wherein the clamp arm 54 comprises an elongated coupling body (proximal portion of 54 that couples to shank 51 - Fig. 30-31B); (b) a shaft assembly 30 (Fig. 30-31B), the shaft assembly 30 comprising: (i) an outer sheath 30 (Fig. 30-31B), and (ii) an ultrasonic waveguide 80 (not shown in Fig. 30-31B, discussed in paragraph [0084]) secured relative to outer sheath 30 (paragraph [0084]), wherein the ultrasonic waveguide 80 is at least partially housed within the outer sheath 30 (paragraph [0084]); (c) a shank 51 (Fig. 30-31B) attached to the clamp arm 54, wherein the shank 51 is configured to pivot relative to the shaft assembly 30 in order to drive the clamp arm 54 between the open position and the closed position (Figs. 30-31B), wherein the shank 51 comprises a clamp arm support 56 (distal recess 56 of shank 51 - described in paragraph [0079] as receiving the proximal portion of clamp arm 54 therein and secured therein with pin 58; Fig. 30-31B) configured (to) receive the elongated coupling body (proximal portion of 54) of the clamp arm 54 in order to assist attachment of the clamp arm 54 to the shank 51 (paragraph [0079]); and (d) a clamp arm alignment structure 602,604 (Fig. 30-31B) configured to promote alignment of the clamp arm 54 relative to the ultrasonic blade 42 in the closed position (alignment structure 602,604 is pivotably connected to the clamp arm 54 but fixes the clamp arm to prevent movement laterally and longitudinally relative to the blade when closed; also discussed in paragraph [0120]); wherein the clamp arm alignment structure 602,604 comprises: (a) a pivotal coupling body 602,604 located on the outer sheath 30 (Fig. 30-31B), (b) a through hole (through which pin 36 is received - Fig. 30-31B) defined by the elongated coupling body (proximal portion of clamp arm 54 - that with the pin extending therethrough) of the clamp arm 54, and (c) a pin 36 (Fig. 30-31B) configured to directly pivotally couple the clamp arm 54 with the outer sheath 30 via the pivotal coupling body 602,604 of the outer sheath 30 and the through hole defined by the elongated coupling body (through which pin 36 extends - Fig. 30-31B).
Regarding claim 3, Schulte et al. further disclose wherein the shank 51 extends away from the end effector 40 proximally along a first side of the outer sheath 30 (Figs. 30-31B), wherein the pivotal coupling body 602,604 is located on a second side of the outer sheath 30 (second portion 604 of the body 602,604 extends on the second side of the outer sheath 30).
Regarding claim 4, Schulte et al. further disclose wherein the first side and the second side face away from each other (shank 51 is on a side facing away from the side that portion 604 of body 602,604 extends- Figs. 30-31B).
Regarding claim 5, Schulte et al. further disclose wherein the shank 51 is attached to the clamp arm 54 via a second pin 58 (Figs. 30-31B) extending through a second through hole defined by the elongated coupling body to the clamp arm 54 and through a side wall of the shank 51 (described in paragraph [0079] as receiving the proximal portion of clamp arm 54 therein and secured therein with pin 58, which inherently has a through hole to fit through in the clamp arm proximal extension to provide securement; Fig. 30-31B)
Regarding claim 6, Schulte et al. further disclose wherein the end effector 40 further comprises a clamp pad 55 coupled to the clamp arm 54 (shown best in Fig. 6).
Regarding claim 13, Schulte et al. further disclose a handle assembly 20 (shown in Fig. 1), wherein the shaft assembly 30 extends distally from the handle assembly 20 (shown in Fig. 1).
Regarding claim 14, Schulte et al. further disclose wherein the handle assembly 20 comprises a transducer assembly 12 (shown in Fig. 1; paragraph [0083]).
Regarding claim 15, Schulte et al. further disclose wherein the handle assembly 20 comprises a button 26 (paragraph [0086]; shown in Fig. 1) configured to activate the transducer 12 (paragraph [0068]).
Regarding claim 20, Schulte et al. disclose a surgical instrument 10 (Figs. 1 & 30-31B), comprising: (a) a shaft assembly 30 (Fig. 30-31B), the shaft assembly 30 comprising: (i) an outer sheath 30 (Fig. 30-31B), and (ii) an ultrasonic waveguide 80 (not shown in Fig. 30-31B, discussed in paragraph [0084]) secured relative to outer sheath 30 (paragraph [0084]), wherein the ultrasonic waveguide is at least partially housed within the outer sheath 30 (paragraph [0084]); (b) an end effector 40 (Fig. 30-31B), the end effector 40 comprising: (i) an ultrasonic blade 42 (Figs. 30-31B) attached to and extending distally from the ultrasonic waveguide 80, and (ii) a clamp arm 54 (Figs. 30-31B) configured to pivot relative to the ultrasonic blade 42 between an open position and a closed position, wherein the clamp arm 54 comprises an elongated coupling body (proximal portion of clamp arm 54 - defining a shank coupling through hole (distal recess 56 of shank 51 - described in paragraph [0079] as receiving the proximal portion of clamp arm 54 therein and secured therein with pin 58 - there would have to be a through hole in the coupling body of the clamp arm in order to receive the pin to achieve securement to the shank as described; Fig. 30-31B); (c) a shank 51 (Figs. 30-31B) comprising a clamp arm support 56 (distal recess 56 of shank 51 - described in paragraph [0079] as receiving the proximal portion of clamp arm 54 therein and secured therein with pin 58; Fig. 30-31B) dimensioned to receive the elongated coupling body of the clamp arm 54 to assist attachment of the clamp arm 54 to the shank 51 (paragraph [0079]), wherein the shank 51 defining a clamp arm coupling through hole (through which pin 58 is received; paragraph [0079]; Figs. 30-31B) and includes a pair of laterally opposed sidewalls defining a cavity dimensioned to house a portion of the outer sheath 30 (602, 604 portion of outer sheath – Fig. 30-31B), wherein at least one of the laterally opposed sidewalls defines a pivot through hole (through which 36 extends – Fig. 31A); (d) a first coupling pin 58 (Figs. 30-31B) extending through the shank 51 coupling through hole of the clamp arm 54 and the clamp arm coupling through hole of the shank 51 (there would have to be a through hole in the coupling body of the clamp arm in order to receive the pin to achieve securement to the shank as described in paragraph [0079]), wherein the shank 51 and the first coupling pin 58 are configured to pivot relative to the shaft assembly 30 in order to drive the clamp arm 54 between the open position and the closed position (Figs. 31A-B); and (e) a clamp arm alignment structure 602,604 (Figs. 30-31B) configured to promote alignment of the clamp arm 54 relative to the ultrasonic blade 42 in the closed position, wherein the clamp arm alignment structure 602,604 comprises: (i) a pivotal coupling body 602,604 located on the outer sheath 30 (Figs. 30-31B), wherein the pivotal coupling body 602,604 extends away from the outer sheath 30 in a direction facing away from the shank 51 (portion 604 of the coupling body 602,604 extends in a direction opposite of the shank 51 relative to the sheath body 30), (ii) a shaft coupling through hole defined by the elongated coupling body of the clamp arm 54 (through which pin 36 is received - Fig. 30-31B), and (ii) a second coupling pin 36 (Figs. 30-31B) configured to directly pivotally couple the clamp arm 54 with the outer sheath 30 via the pivotal coupling body 602,604 of the outer sheath 30 and the shaft coupling through hole defined by the elongated coupling body (Figs. 30-31B), wherein the second coupling pin 36 extends through the pivot through hole (Fig. 31A).
Regarding claim 21, Schulte et al. further disclose wherein the shank 51 is formed of a first material and the clamp arm 54 is formed of a second material different from the first material (paragraph [0144] – different materials with the shank/clamp arm are discussed here).
Allowable Subject Matter
Claims 22-25 are allowed.
The following is an examiner’s statement of reasons for allowance: claim 22 is previously objected form of claim 7 rewritten in independent form (see Reasons for Indicating Allowable Subject Matter in Non-Final Rejection mailed on 3/23/2023).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 7-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 7, it is known in the art to have a clamp pad stop (‘lock’) associated with a clamp jaw/arm to prevent the clamp pad from moving (i.e. US Pub. No. 2006/0079879 A1 - Fig. 3A - clamp pad stop 51; paragraph [0085]). However, the claim requires the clamp pad lock to be associated with the shank ) (‘wherein the shank further comprises a clamp pad lock configured to inhibit the clamp pad from actuating relative to the clamp arm in a proximal direction when the clamp arm is attached to the shank’). In the claims, the shank is coupled to the clamp arm via a clamp arm support configured to receive an elongated coupling body of the clamp arm. Modifying Schulte et al. to include the art known clamp pad stops/locks would not result in the clamp pad lock being associated with the shank, rather, the clamp arm itself. There is no motivation to provide the shank with the clamp pad lock and doing so would not have resulted in prevention of the clamp pad from moving since the shank in Schulte et al.’s device is not positioned adjacent to or remotely near the clamp pad.
Regarding claim 8, Schulte et al. fail to further disclose, teach, or suggest wherein the clamp arm alignment structure comprises a welding plate associated with the clamp arm support of the shank. The previously cited prior art used to reject claim 8 no longer reads on claim 1 as amended, and no longer discloses the combination of newly amended claim 1 and claim 8.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive. Applicant argues that Schulte et al. fails to disclose ‘a pin configured to directly pivotally couple the clamp arm with the outer sheath via the pivotal coupling body of the outer sheath and the through hole defined by the elongated coupling body’, however, examiner finds this ‘argument’ not persuasive since this limitation was in now cancelled claim 2 which was rejected under Schulte et al. and has been updated in the above rejection to be in the rejection of claim 1. See Rejection of Claim 1 for support in Schulte et al. for this specific limitation.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 September 13, 2026
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