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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15 & 20) in the reply filed on 12/9/2025 is acknowledged.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/9/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: line 15 - examiner suggests amending ‘configured receive’ to --configured to receive--. Appropriate correction is required.
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: ‘clamp arm alignment structure’ in claims 1 & 13-15.
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 § 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 1-6, 13-15, and 20 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]).
Regarding claim 2, Schulte et al. further disclose 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); (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).
Claims 1 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawaguchi et al. (US Pub. No. 2013/0303949 A1).
Regarding claim 1, Kawaguchi et al. disclose a surgical instrument (Figs. 8-13), comprising: (a) an end effector 52 (Figs. 8-13), the end effector 52 comprising: (i) an ultrasonic blade 52 (Figs. 8-13), and (ii) a clamp arm 61 (Figs. 8-13) configured to pivot relative to the ultrasonic blade 52 between an open position and a closed position, wherein the clamp arm 61 comprises an elongated coupling body (bottom portion of 61 that couples to clamp arm support 59/60 of shank 21 - Figs. 8-13); (b) a shaft assembly 20 (Figs. 8-13), the shaft assembly 20 comprising: (i) an outer sheath 26 (Figs. 8-13), and (ii) an ultrasonic waveguide 51 (shown in Fig. 3), wherein the ultrasonic waveguide 51 is at least partially housed within the outer sheath 26 (shown in Fig. 3); (c) a shank 21 (best viewed in Fig. 3) attached to the clamp arm 61, wherein the shank 21 is configured to pivot relative to the shaft assembly 20 in order to drive the clamp arm 61 between the open position and the closed position (Figs. 8-13), wherein the shank 21 comprises a clamp arm support 59/60 (distal portion of shank 21; Figs. 8-13) configured (to) receive the elongated coupling body (bottom portion of 61) of the clamp arm 61 in order to assist attachment of the clamp arm 61 to the shank 21 (Figs. 8-13); and (d) a clamp arm alignment structure 60 (Figs. 8-13) configured to promote alignment of the clamp arm 61 relative to the ultrasonic blade 52 in the closed position (alignment structure 60 maintains the position of clamp arm 61 therein to avoid movement laterally or longitudinally relative to the ultrasonic blade 52 - Figs. 8-13).
Regarding claim 8, Kawaguchi et al. further disclose wherein the clamp arm alignment structure 60 comprises a welding plate associated with the clamp arm support 59/60 of the shank 21 (alignment structure 60 comprises a base/recess which receives the clamp arm coupling element and is formed from metal which is considered to be capable of acting as a welding plate - paragraph [0050] ‘base 60 is …formed from a conductive metal’; Fig. 13; since there is no further claiming of an actual ‘weld’ or ‘welding process’, the claimed ‘welding plate’ can be any structure capable of acting as a welding plate - this is also applicable to claims 9-12).
Regarding claim 9, Kawaguchi et al. further disclose wherein the welding plate 60 is configured to receive the elongated coupling body of the clamp arm 61 (proximal bottom portion shown being received within the recess of 60 - Figs. 12 & 13).
Regarding claim 10, Kawaguchi et al. further disclose wherein the welding plate 60 defines a welding window (recess that receives the bottom portion/elongated coupling body of the clamp arm 61 - Figs. 12 & 13) such that the elongated coupling body of the clamp arm is configured to be secured to the welding plate 60 after being initially inserted into the clamp arm support 59/60 (paragraphs [0050]-[0051
Regarding claim 11, Kawaguchi et al. further disclose wherein the elongated coupling body (proximal bottom portion of 61) is configured to be adjusted relative to the welding plate 60 prior to being secured to the welding plate (when the clamp arm 61 is not secured to 60, it is free to be adjusted relative to the welding plate 60 since there is no attachment thereto).
Regarding claim 12, Kawaguchi et al. further disclose wherein the welding plate 60 is directly pivotally coupled to the outer sheath 26 via a pin (since welding plate 60 is unitary with 59, it is considered to be directly pivotally couple to the outer sheath 26 via pin 22 -Figs. 8-13).
Allowable Subject Matter
Claim 7 is 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.
Conclusion
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 March 17, 2026