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 .
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 recites “a slider into receiving” in line 7 which should read “a slider receiving” for grammatical purposes. 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: an engagement portion in claim 18.
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.
Claim(s) 1-3, 6-8, 10-11, 15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Price et al. (US 2012/0116396 A1).
Regarding claim 1, Price discloses a treatment tool (including blade assembly 500, handle assembly 600, and end effector 700; Figs. 5-9C), comprising: a first jaw (distal blade 570); a second jaw (clamp arm 750) configured to open and close relative to the first jaw (Fig. 9C; [0063]); a shaft (waveguide 560 and/or inner tubular actuation member 670 and/or outer sheath 660; Fig. 9C) extending along a longitudinal axis (longitudinal axis through center of 560, 670, 660; Fig. 9C); a first handle (handle portion of casing 610; Fig. 9A) located proximally relative to the shaft (Fig. 9C); a second handle (pivotable trigger 620) pivotally supported about a first axis (see annotated Fig. 9C below) relative to the first handle ([0059]), wherein the second handle includes a connector (see annotated Fig. 9C below) extending from the first axis toward a distal end of the shaft (as the second axis is distal to the first axis and the connector curves towards the distal end of the shaft; Fig. 9C); a transmitter (actuation assembly 622) configured to move along the longitudinal axis (as the actuation assembly 622 moves the outer sheath 660 distally along the longitudinal axis; [0062]) and configured to transmit force generated by moving the second handle (as outer sheath 660 is configured to actuate distally via actuation assembly 622 when trigger 620 is pivoted to the closed position; [0062]); and a link (see annotated Fig. 9C below) pivotally supported about a second axis (see annotated Fig. 9C) relative to the connector and pivotally supported about a third axis (see annotated Fig. 9C) relative to the transmitter ([0062]), wherein when the second handle moves toward the first handle, the link is configured to move the transmitter along the longitudinal axis toward the distal end of the shaft (when the trigger 620 is pivoted to the closed position, actuation assembly 622 moves the outer sheath 660 distally to close the clamp arm 750 via the link therebetween; Fig. 9C; [0062]-[0063]).
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Regarding claim 2, Price discloses a housing (casing 610) connected to a proximal end of the shaft (560, 670, and/or 660) and including the first handle (handle portion of 610; Fig. 9C), wherein the link is arranged between a central axis along the longitudinal axis in the housing and the first axis (see annotated Fig. 9C above).
Regarding claim 3, Price discloses a housing (casing 610) connected to a proximal end of the shaft (560, 670, and/or 660) and including the first handle (handle portion of 610; Fig. 9C), wherein the first axis is fixed relatively to the housing (as the link requires movement of the second and third axes, not the first; Fig. 9C).
Regarding claim 6, Price discloses wherein the shaft (670) is an inner pipe (inner tubular actuation member 670 is considered a pipe as it is hollow and positioned inwards of outer sheath 660; Fig. 9C).
Regarding claim 7, Price discloses wherein the second jaw (750) is configured to grip body tissue between the first jaw and the second jaw (clamp arm 750 is configured to compress tissue against blade 570 when pivoted via trigger 620; [0068]).
Regarding claim 8, Price discloses wherein the treatment tool is configured to apply ultrasound energy to body tissue to treat the body tissue (as the blade 570 oscillates at ultrasonic frequency to simultaneously cut and coagulate tissue; [0056]).
Regarding claim 10, Price discloses wherein the connector comprises a hole (a hole through which a pin resides) defining the second axis (see annotated Fig. 9C above).
Regarding claim 11, Price discloses a pin (pin through second axis) inserted into a first hole (hole in connector at the second axis) of the connector and a second hole (hole through the third axis) of the link (see annotated Fig. 9C above).
Regarding claim 15, Price discloses a treatment system (including blade assembly 500, handle assembly 600, and end effector 700; Figs. 5-9C), comprising: an elongate shaft (outer sheath 660; Fig. 9C) extending along a longitudinal axis (longitudinal axis through center of 660; Fig. 9C); a first jaw member (distal blade 570) and a second jaw member (clamp arm 750) at a distal end of the elongate shaft (Fig. 9C), wherein at least one of the first and second jaw members is movable relative to the other to grasp tissue therebetween (as clamp arm 750 is configured to compress tissue against blade 570 when pivoted via trigger 620; [0068]); a handle assembly (casing 610 and trigger 620) at a proximal end of the elongate shaft (Fig. 9C), the handle assembly including: a stationary handle (handle portion of 610); a movable handle (trigger 620) pivotally coupled to the stationary handle about a first pivot axis (see annotated Fig. 9C below; [0059]); and a connector (see annotated Fig. 9C) extending distally from the movable handle; a drive assembly (including at least outer sheath portion 710, insertable portion 712 and end portion 720; Fig. 7) extending through the elongate shaft (as insertable portion 712 extends through outer sheath 660; Fig. 9C) and operably coupled to at least one of the first and second jaw members (750; Figs. 7, 9C); a transmitter (actuation assembly 622) movable along the longitudinal axis and operably coupled to the drive assembly (via outer sheath 660); and a link (see annotated Fig. 9C below) having a first end pivotally coupled to the connector about a second pivot axis (see annotated Fig. 9C) and a second end pivotally coupled to the transmitter (622) about a third pivot axis (see annotated Fig. 9C), wherein pivotal movement of the movable handle (620) toward the stationary handle causes the link to move the transmitter (622) distally along the longitudinal axis to actuate the drive assembly and move the at least one of the first and second jaw members relative to the other (as movement of the trigger 620 causes distal movement of the actuation assembly 622 and outer sheath 660 which causes second pivot pin 738 to slide proximally within slot 724 i.e. the drive assembly moves relative to the clamp arm 750 to close the clamp arm 750; [0066]-[0068]).
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Regarding claim 17, Price discloses one or more switches (toggle buttons 630) configured to receive treatment operation input from an operator (as toggle buttons selectively activate transducer 510 at different operational levels; [0059]).
Regarding claim 18, Price discloses wherein the transmitter (622) includes an engagement portion (interpreted under 112(f) as a tab or link connected to a slider and 622 includes a tab or link that extends vertically and is connected to circumferential groove 664; Fig. 9A) configured to engage with a slider (circumferential groove 664) of the drive assembly (including at least outer sheath portion 710, insertable portion 712 and end portion 720; Fig. 7; and circumferential groove 664; Fig. 9A).
Regarding claim 19, Price discloses wherein the link is arranged between a central axis along the longitudinal axis in the handle assembly and the first pivot axis (see annotated Fig. 9C above).
Regarding claim 20, Price discloses an ultrasound transducer (transducer 510) configured to generate ultrasound vibration ([0056]), wherein at least one of the first jaw member (570) and the second jaw member is configured to transmit the ultrasound vibration to tissue grasped therebetween ([0056]).
Claim Rejections - 35 USC § 103
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 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) 4-5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (US 2012/0116396 A1) in view of Inui et al. (US 2023/0073915).
Regarding claim 4, Price discloses a slider (circumferential groove 664; Fig. 9A), wherein the transmitter (622) is engaged with the slider (Fig. 9A; [0062]) but fails to explicitly disclose a holder configured to hold the shaft; a slider receiving body receiving the holder and configured to move relative to the holder along a central axis along the longitudinal axis; and the slider receiving the slider receiving body and configured to move relative to the slider receiving body. Price discloses a rotation knob (rotation knob 650) configured to rotate the second jaw member (750) about the longitudinal axis (as the rotation knob 650 rotates the inner tubular actuation member 670 which is attached to the clamp arm 750; [0061]) but fails to disclose the rotation knob is configured to rotate the first jaw member about the longitudinal axis.
However, Inui teaches a treatment tool (ultrasonic treatment instrument 2) comprising a holder (holding portion 112; Fig. 3) configured to hold a shaft (vibration transmission member 13 equivalent to waveguide 560 of Price); a slider receiving body (slider receiver 113; Fig. 3) receiving the holder (112) and configured to move relative to the holder along a central axis along the longitudinal axis (Fig. 3; [0064]); and a slider (slider 114) receiving the slider receiving body (113; Fig. 3) and configured to move relative to the slider receiving body ([0067]), wherein a transmitter (pair of engaging portions in the moveable handle 7; [0067]) is engaged with the slider (Fig. 3; [0067]) in order to effectively hold the shaft so that the shaft (i.e. waveguide of Price) is effectively connected to the rotary knob to rotate a first (distal end of transmission member 13; Fig. 1) and second jaw (jaw 12) about the longitudinal axis ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slider of Price to further include a holder and slider receiving body as claimed as taught by Inui in order to allow both the waveguide i.e. the first jaw and the second jaw to rotate when the rotation knob is turned.
Regarding claim 5, Price modified discloses the invention as claimed above and Price further discloses wherein the transmitter (622) couples the link and the slider (664; Fig. 9A), the link and the slider are located distally relative to the first axis (see annotated Fig. 9C above).
Regarding claim 16, Price discloses a rotation knob (rotation knob 650) configured to rotate the second jaw member (750) about the longitudinal axis (as the rotation knob 650 rotates the inner tubular actuation member 670 which is attached to the clamp arm 750; [0061]) but fails to disclose the rotation knob is configured to rotate the first jaw member about the longitudinal axis.
However, Inui teaches a treatment tool (ultrasonic treatment instrument 2) comprising a holder (holding portion 112; Fig. 3) configured to hold a shaft (vibration transmission member 13 equivalent to waveguide 560 of Price); a slider receiving body (slider receiver 113; Fig. 3) receiving the holder (112) and configured to move relative to the holder along a central axis along the longitudinal axis (Fig. 3; [0064]); and a slider (slider 114) receiving the slider receiving body (113; Fig. 3) and configured to move relative to the slider receiving body ([0067]), wherein a transmitter (pair of engaging portions in the moveable handle 7; [0067]) is engaged with the slider (Fig. 3; [0067]) in order to effectively hold the shaft so that the shaft (i.e. waveguide of Price) is effectively connected to the rotary knob (9) to rotate a first (distal end of transmission member 13; Fig. 1) and second jaw (jaw 12) about the longitudinal axis ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rotation knob and slider of Price to further include a holder and slider receiving body connected to the rotation knob as taught by Inui in order to allow both the waveguide i.e. the first jaw and the second jaw to rotate when the rotation knob is turned.
Claim(s) 9 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (US 2012/0116396 A1) in view of Rupp et al. (US 2013/0090575 A1).
Regarding claim 9, Price fails to explicitly disclose wherein the connector comprises two branches extending toward the distal end of the shaft.
However, Rupp teaches a treatment tool (surgical instrument 50; Fig. 1) comprising a first jaw (blade 82); a second jaw (clamp arm 84) configured to open and close relative to the first jaw (Fig. 1); a shaft (outer sheath 72) extending along a longitudinal axis (Fig. 1); a first handle (lower portion 64) located proximally relative to the shaft (Fig. 1); a second handle (trigger 68) pivotally supported and including a connector (trigger arm 154; Fig. 2), the connector comprises two branches (branches surrounding and holding pin in fig. 2) with holes therein and a pin within each hole connecting a pivotal link (link 156), the link pivotably connected to a transmitter (actuation arm 158; Fig. 2) such that when the second handle (68) moves toward the first handle (64), the link is configured to move the transmitter (158) along the longitudinal axis to close the second jaw ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Price to comprise two branches as taught by Rupp, which would then extend toward the distal end of the shaft of Price in order to improve the securement of the pin within the connector as it would be fit within two branches rather than a single branch.
Regarding claim 12, Price modified discloses the invention as claimed above, and Price further discloses wherein the link comprises: a first hole defining the second axis (hole through which pin is inserted in the second axis; see annotated Fig. 9C above); and a second hole defining the third axis (hole through which pin is inserted in the third axis; see annotated Fig. 9C above).
Regarding claim 13, Price modified discloses the invention as claimed above, and Price further discloses wherein a first distance between the link and the longitudinal axis is smaller than a second distance between the first axis and the longitudinal axis (see annotated Fig. 9C above).
Regarding claim 14, Price modified discloses the invention as claimed above, and Price further discloses wherein the link is located distally relative to the first axis and located between the shaft and the first axis (see annotated Fig. 9C above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Butler (US 2019/0175256 A1) is noted for teaching a connector extending from the first axis toward a distal end of the shaft. Riestenberg et al. (US 2017/0181765 A1) is noted for a similar drive assembly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771