DETAILED ACTION
A complete action on the merits of claims 1-20 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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1072 in Figs. 10A-10B, 1164 in Figs. 11A-11B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 6, 8, 10, 12 and 13 are objected to because of the following informalities:
“first and second side surfaces” and “first and second concave notches” in claim 1 should be amended to recite “a first side surface and a second side surface”, “a first concave notch and a second concave notch”.
“the first and second concave notches” and “the first and second side surfaces” in claim 6 should be amended to recite “the first concave notch and the second concave notch” and “the first side surface and the second side surface”.
“first and second side surfaces” in claim 8 should be amended to recite “a first side surface and a second side surface”.
“first and second relatively broad side surfaces” in claim 10 should be amended to recite “a first relatively broad side surface and a second relatively broad side surface”.
“the first and second side surfaces” in claim 12 should be amended to recite “the first side surface and the second side surface”.
“first and second side surfaces” in claim 13 should be amended to recite “a first side surface and a second side surface”.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balek (US Pub. No. 2013/0116717).
Regarding Claim 1, Balek teaches an ultrasonic blade configured for use with an ultrasonic surgical instrument (Figs. 5, 13), the ultrasonic blade comprising:
a body portion 79 defining a top surface (see the annotated figures below), a bottom surface (see the annotated figures below), first and second side surfaces (the top and bottom sections shown in Fig. 5 extending between the surfaces interpreted to be “top surface” and “bottom surface” are here interpreted to be the first and second side surfaces that include concave portions 510 and 530, also see the following annotated figure 13), and a distal face (520, 1020), wherein first and second concave notches (510, 530 “surface 510 and 530 have nearly identical dimensions and are concave in shape” [0055] and 1010, 1030 [0062]) are defined in the body portion to form a ridge extending along a portion of a length of the bottom surface (see the following annotated figures).
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Regarding Claim 2, Balek teaches wherein the first concave notch 510, 1010 is defined at an intersection of the first side surface and the bottom surface, and wherein the second concave notch 530, 1030 is defined at an intersection of the second side surface and the bottom surface (Figs. 5, 13 and [0055], [0062]).
Regarding Claim 3, Balek teaches wherein the first concave notch 510, 1010 is defined at an intersection of the distal face, the first side surface, and the bottom surface, and wherein the second concave notch 530, 1030 is defined at an intersection of the distal face, the second side surface, and the bottom surface (see the annotated figures above).
Regarding Claim 4, Balek teaches wherein the ridge extends to a distal end of the body portion (Figs. 5 and 13 show the ridge section extending distally to a point here interpreted to be “a distal end” of the blade).
Regarding Claim 5, Balek teaches wherein the ridge is proximally-spaced from a distal end of the body portion (for the purpose of this claim, “a distal end” is interpreted to be the most distal end where Figs. 5 and 13 show the ridge section spaced proximally from the most distal end of the blade, section 1310 in Fig. 13, [0066]).
Regarding Claim 6, Balek teaches wherein the first and second concave notches 510,530/ 1010,1030 are symmetric with one another and wherein the ridge is centered relative to the first and second side surfaces of the body portion (Figs. 5, 13, [0055] and [0062]).
Regarding Claim 7, Balek teaches wherein the ridge is exposed to define a monopolar electrode or coated with an electrically conductive material to define a monopolar electrode (please note that since no power generator has been claimed and/or any energy or treatment to tissue, examiner takes the position that given the broadest reasonable interpretation since the blade is made of a conductive material “titanium alloy (i.e., Ti-6Al-4V), aluminum alloys, sapphire, stainless steel or any other acoustically compatible material” [0049] that it is interpreted to be an electrode and thus defining a monopolar electrode).
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stulen (US Pub. No. 2017/0000516).
Regarding Claim 1, Stulen teaches an ultrasonic blade configured for use with an ultrasonic surgical instrument (Fig. 14), the ultrasonic blade comprising:
a body portion 704 defining a top surface, a bottom surface, first and second side surfaces (see the annotated figure below), and a distal face (the most distal end of the blade is here interpreted to be the distal face), wherein first and second concave notches are defined in the body portion to form a ridge extending along a portion of a length of the bottom surface (see the following annotated figure).
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Regarding Claim 2, Stulen teaches wherein the first concave notch is defined at an intersection of the first side surface and the bottom surface, and wherein the second concave notch is defined at an intersection of the second side surface and the bottom surface (see the annotated figure above).
Regarding Claim 3, Stulen teaches wherein the first concave notch is defined at an intersection of the distal face, the first side surface, and the bottom surface, and wherein the second concave notch is defined at an intersection of the distal face, the second side surface, and the bottom surface (see the annotated figure above).
Regarding Claim 4, Stulen teaches wherein the ridge extends to a distal end of the body portion (Fig. 14 shows the bottom surface extending the whole length of the ultrasonic blade and therefore since the ridge is interpreted to be the very bottom of the bottom surface, it too extends the whole length to a distal end of the body portion).
Regarding Claim 6, Stulen teaches wherein the first and second concave notches are symmetric with one another and wherein the ridge is centered relative to the first and second side surfaces of the body portion (Fig. 14).
Regarding Claim 7, Stulen teaches wherein the ridge is exposed to define a monopolar electrode or coated with an electrically conductive material to define a monopolar electrode (please note that since no power generator has been claimed and/or any energy or treatment to tissue, examiner takes the position that given the broadest reasonable interpretation as long as the blade is made of a conductive material that it is interpreted to be an electrode; therefore since Stulen teaches “The end effector 124 comprises electrodes in the clamp arms 143 and return through the ultrasonic blade 149. The electrodes are coupled to and energized by a bipolar energy source within the generator 102” [0080] the blade is made of an electrically conductive material thereby examiner takes the position that it is interpreted to be an electrode and thus defining a monopolar electrode).
Claims 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meiser (US Pub. No. 2019/0216491).
Regarding Claim 8, Meiser teaches an ultrasonic blade configured for use with an ultrasonic surgical instrument (abstract), the ultrasonic blade comprising:
a body portion (Figs. 3A-4B) defining a top surface, a bottom surface, first and second side surfaces, and a distal face (see the annotated figures below), wherein at least one protrusion protrudes from the bottom surface (324 in Figs. 3A-B or section 920 in Fig. 4B), each protrusion of the at least one protrusion defining an elongated configuration extending in a length-wise direction along a portion of the bottom surface (Figs. 3A-4B).
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Regarding Claim 9, Meiser teaches wherein the at least one protrusion includes a plurality of protrusions spaced apart along a portion of a length of the bottom surface (given the broadest reasonable interpretation taking “a length” to be in a direction from right to left in Fig. 3B, the plurality of protrusions are spaced apart along a portion of a length of the bottom surface).
Regarding Claim 10, Meiser teaches wherein each protrusion of the at least one protrusion includes first and second relatively broad side surfaces and a relatively narrow bottom surface (Figs. 3A-B).
Regarding Claim 11, Meiser teaches wherein the relatively narrow bottom surface is exposed to define a monopolar electrode or coated with an electrically conductive material to define a monopolar electrode (“Wings 324 are recessed relative to ultrasonic blade body 322 and are electrically coupled to generator 110” [0049]).
Regarding Claim 12, Meiser teaches wherein each protrusion of the at least one protrusion 920 is centered relative to the first and second side surfaces of the body portion (Fig. 4B).
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.
Claims 13 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Beaupre (US Pub. No. 2018/0242997) in view of Meiser.
Regarding Claim 13, Beaupre teaches an ultrasonic blade configured for use with an ultrasonic surgical instrument (abstract), the ultrasonic blade comprising:
a body portion defining a top surface 528, a bottom surface (the opposite surface of 528 marked on the annotated figure below), first and second side surfaces (534, 536), and a distal face (the most distal face of the blade shown in Fig. 15), wherein the bottom surface includes an angled distal section (the section opposite to 528c in Fig. 15) that is angled towards the top surface in a proximal-to-distal direction such that a distal portion of the body portion tapers in height in the proximal-to-distal direction (see Fig. 15); however, does not teach wherein a ridge protrudes from the angled distal section of the bottom surface and extends along at least a portion of a length of the bottom surface.
In the same field of invention Meiser teaches providing an opposite jaw member 920 defining opposed electrically conductive surface configured to conduct electrical energy between jaw 910 and 920 to treat tissue therebetween (see Fig. 4B and [0050]-[0051]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a conductive jaw member protruding from the bottom surface of the ultrasonic blade in order to allow treatment of tissue by conducting energy through the jaws as Meiser teaches.
Regarding Claim 17, Beaupre in view of Meiser teaches wherein the ridge does not extend beyond the angled distal section of the bottom surface (“Ultrasonic blade body 930 extends distally from waveguide 92, which is operably coupled to actuator 80 via, for example, direct connection, a drive member, and/or other suitable structure (not shown) such that actuation of actuator 80, e.g., translation of actuator 80 relative to housing 20, translates ultrasonic blade body 930 between a retracted position (FIG. 4A), wherein ultrasonic blade body 930 is proximal of jaw members 910, 920, and an extended position (FIG. 4B)” [0051] of Meiser; thereby the ridge is configured to be in a position that does not extend beyond the angled distal section of the bottom surface).
Regarding Claim 18, Beaupre in view of Meiser teaches wherein the ridge extends the length of the bottom surface (Fig. 4B and [0050]-[0051] of Meiser).
Regarding Claim 19, Beaupre in view of Meiser teaches wherein the ridge is exposed to define a monopolar electrode or coated with an electrically conductive material to define a monopolar electrode (Fig. 4B and [0050]-[0051] of Meiser).
Regarding Claim 20, Beaupre teaches wherein at least a portion of the top surface is exposed to define one electrode of a bipolar configuration or coated with an electrically conductive material to define the one electrode of the bipolar configuration (“ultrasonic surgical device comprising waveguide (12) and blade (24) can be made from any of a variety of materials, particularly various medically and surgically acceptable metals such as titanium, titanium alloy (e.g., Ti6Al4V), aluminum, aluminum alloy, or stainless steel” [0041] teaches the blade is made of a conductive material, since no power source and/or bipolar treatment/ other electrodes coupled to the power source to create a bipolar treatment is claimed, examiner takes the position that the conductive material enables the blade to act as an electrode thus by providing energy to the conductive blade and a separate electrode a bipolar electrode configuration is configured to be created).
Allowable Subject Matter
Claims 14-16 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.
Beaupre in view of Meiser teaches the invention as applied above, but neither alone or in combination teach wherein the ridge defines a variable height along a length thereof, the ridge defines an increasing height in a distal-to-proximal direction along at least a portion of a length of the ridge and wherein a slope of the ridge height increase is substantially complementary to a slope of the angled distal section of the bottom surface.
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