DETAILED ACTION
A complete action on the merits of pending claims 1-20 appears 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 8-13, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura US 20080208108.
Regarding claim 1, Kimura teaches clamping tissue between an ultrasonic blade (Fig. 17 probe 61) and a jaw member (Fig. 17 grasping unit 63); simultaneously: transmitting ultrasonic energy to the ultrasonic blade to vibrate the ultrasonic blade at a first blade velocity (par. [0087] simultaneous activation of both high-frequency and ultrasonic energy), thereby heating the clamped tissue; and supplying electrosurgical energy, at a constant voltage (par. [0049] voltage is changed with output change so if output is unchanged the voltage is constant), to the jaw member and the ultrasonic blade at different potentials such that the electrosurgical energy is conducted therebetween and through the clamped tissue to heat the clamped tissue (par. [0095] bipolar treatment between grasping unit 63 and probe 63); monitoring an impedance of the clamped tissue during the simultaneous transmission of ultrasonic energy and supply of electrosurgical energy (par. [0087]); and at least one of: terminating the simultaneous transmission of ultrasonic energy and supply of electrosurgical energy when the clamped tissue is sealed, as indicated by the impedance of the clamped tissue being equal to or greater than a threshold impedance (par. [0074] high electrical impedance makes the HF energy go down and ultrasonic energy go up, par. [0070] off of HF energy and max ultrasonic energy based on different conditions); or outputting a notification when the clamped tissue is sealed, as indicated by the impedance of the clamped tissue being equal to or greater than the threshold impedance (par. [0050] displaying settings and operation on panel).
Regarding claim 8, Kimura teaches further comprising, after terminating the simultaneous transmission of ultrasonic energy and supply of electrosurgical energy or outputting the notification: transmitting ultrasonic energy to the ultrasonic blade to vibrate the ultrasonic blade at a second blade velocity greater than the first blade velocity (par. [0074] high electrical impedance makes the HF energy go down and ultrasonic energy go up) to transect the sealed tissue (par. [0058] increasing ultrasonic output based on impedance).
Regarding claim 9, Kimura teaches wherein the second blade velocity is from about 7.0 m/s to about 10.0 m/s (par. [0055] selection of 7.4-22m/s selection).
Regarding claim 10, Kimura teaches wherein the second blade velocity is from about 7.5 m/s to about 8.5 m/s (par. [0055] selection of 7.4-22m/s selection).
Regarding claim 11, Kimura teaches wherein the second blade velocity is about 8.0 m/s (par. [0055] selection of 7.4-22m/s selection).
Regarding claim 12, Kimura teaches further comprising terminating the transmission of ultrasonic energy to vibrate the ultrasonic blade at the second blade velocity when it is determined that transection of the sealed tissue is complete (par. [0064]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura view of Shibata US 20100145332.
Regarding claims 2-4, Kimura does not explicitly teach wherein the first blade velocity is about 3.6 m/s.
Shibata, in an analogous device, teaches an ultrasonic device that vibrates 2.3 to 5 m/s (par. [0069]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Kimura to have a vibration speed of about 3.6 m/s, as in Shibata. This is seen as a known velocity to coagulate tissue (Shibata par. [0067]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura view of McFarland US 20170042604.
Regarding claims 5-7, Kimura does not explicitly teach wherein the constant voltage is an applied voltage of from about 30 Vrms to about 35 Vrms.
McFarland, in an analogous device, teaches RF energy that is delivered between 20 to 50 Vrms (par. [0109]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Kimura to output a voltage of 30 to 35 Vrms or any desired Vrms, as in McFarland. The desired Vrms depends on the tissue and the parameters changing during the procedure such as phase angle, tissue temperature, and water between the jaws (McFarland par. [0112]).
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura in view of Weiler US 10130414.
Regarding claims 13-16 and 20, Kimura does not explicitly teach wherein the jaw member includes a body defining first and second radiused surfaces and a jaw liner defining a tissue contacting surface disposed between the first and second radiused surfaces, wherein the tissue contacting surface opposes the ultrasonic blade when clamping tissue therebetween, and wherein supplying the electrosurgical energy includes conducting the electrosurgical energy between the ultrasonic blade and the first and second radiused surfaces, wherein the first and second radiused surfaces define radii of curvature of about 0.008 inches, and wherein the ultrasonic blade defines a tissue contacting surface having first and second angled or arcuate surface portions meeting at an apex configured to oppose the jaw member when clamping tissue therebetween.
Weiler, in an analogous device, teaches where each side of both jaws have radiused surfaces (Fig. 3). The first and second radiused surfaces define radii of curvature of about 0.008 inches (col 3 lines 35-43 0.1 to 0.3 mm radii). The cutting element 32 has two angled surfaces 33 that come to the apex of 32 (Fig. 3). The cutting element 32 comes in contact with counter 42 in the other jaw (Fig. 3).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Kimura to have a jaw body with radii of curvature, as in Weiler. This presents the advantage of tissue receptacles allowing for a good fit between the device and the desired tissue (Weiler col 3 lines 4-13).
Regarding claims 17-19, Kimura does not explicitly teach wherein a first plane is tangential to the first and second radiused surfaces and the tissue contacting surface defines a second plane, the second plane recessed relative to the first plane a distance of about 0.003 inches.
Weiler, in an analogous device, teaches wherein a first plane is tangential to the first and second radiused surfaces and the tissue contacting surface defines a second plane, the second plane recessed relative to the first plane a distance of about 0.003 inches (col 8 line 24-56).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Kimura to have a jaw body with distance between the curved surfaces and tissue contacting surface, as in Weiler. This presents the advantage of tissue receptacles allowing for a good fit between the device and the desired tissue (Weiler col 3 lines 4-13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN T. CLARK whose telephone number is (408)918-7606. The examiner can normally be reached Monday-Friday 7AM-3PM MT.
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/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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