DETAILED ACTION
A complete action on the merits of pending claims 25-44 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 Objections
Claim 25 and 35 are objected to because of the following informalities:
Claims 25 and 35 recite “the touch sensor configured to sense tissue contact at at least one touch location”. One of the ats should be deleted.
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.
(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 25-29, 31, 32, 34-41, 43, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Houser US 20120116266.
Regarding claims 25, 35, and 39, Wiener teaches comprising: an electrosurgical generator configured to output electrosurgical energy; an electrosurgical instrument configured to deliver the electrosurgical energy to tissue, the electrosurgical instrument comprising: an end effector assembly, comprising: a first jaw member with a first surface; and a second jaw member with a second surface, with at least one of the first jaw member or the second jaw member movable about a pivot for grasping the tissue between the first surface and the second surface (Figs. 21 and 22); a touch sensor disposed on one of the first jaw member or the second jaw member, the touch sensor configured to sense tissue contact at least one touch location (par. [0182] and Fig. 22 pressure sensor to determine the tissue location along the jaws); and an angle sensor configured to sense an angle about the pivot between the first surface and the second surface (par. [0222] aperture defined by pivot angle sensed by a potentiometer, a Hall effect sensor, an optical encoder, an optical IR sensor, or an inductance sensor); and a controller communicatively coupled to the touch sensor and the angle sensor and having a processor and a memory, with the controller configured to: estimate a size property of the grasped tissue based on the at least one touch location and the angle (par. [0220] using tissue size to determine energy modalities); and controllably operate the electrosurgical generator to deliver the electrosurgical energy based on the size property (par. [0149] control the device based on sensed parameters).
Regarding claim 26, Wiener teaches wherein the size property comprises at least one of a thickness of the grasped tissue, a cross-sectional area of the grasped tissue, or a mass of the grasped tissue (par. [0186] sensing tissue thickness and density).
Regarding claims 27 and 44, Wiener teaches wherein the controller is further configured to estimate a change in the size property during delivery of electrosurgical energy to the grasped tissue, and to controllably operate the electrosurgical generator based on the change in the size property (par. [0233] comparing aperture values to determine if the tissue has shrunk and apply ultrasonic or RF energy based upon the size).
Regarding claims 28, 36, and 40, Wiener teaches wherein the at least one touch location comprises a proximal touch location and a distal touch location, with the proximal touch location and the distal touch location defining a span region of the grasped tissue along the corresponding one of the first surface or the second surface (Fig. 22 regions 1-5 determining where the tissue is within the jaw).
Regarding claims 29, 37, and 41, Weiner teaches wherein the controller is further configured to: determine a first distance between the pivot and the proximal touch location; determine a second distance between the pivot and the distal touch location (par. [0181] location of the tissue within the jaws based upon the segments); and estimate the size property based on the first distance, the second distance, and the angle (par. [0182] thickens of tissue in the segment locations).
Regarding claims 31, 38, and 43, Weiner teaches wherein the controller is further configured to output at least one feedback indicative of at least one of: the size property of the grasped tissue, the grasped tissue being suitable for tissue sealing, or the grasped tissue being unsuitable for tissue sealing (par. [0233] comparing aperture values for tissue size to determine if RF energy can be applied).
Regarding claim 32, wherein the at least one feedback comprises at least one of an illuminated light source or an audio alert (par. [0149] audio and visual feedback for the user).
Regarding claim 34, Wiener teaches wherein the controller is located within the electrosurgical generator (par. [0113] input unit and processing happen on/in the generator).
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 30 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Weiner in view of Rupp US 20120136354.
Regarding claims 30 and 42, Wiener does not explicitly teach wherein the controller is further configured to: estimate a cross-sectional area of the grasped tissue based on the first distance, the second distance, and the angle; and estimate a mass of the grasped tissue by multiplying the cross-sectional area, a width of the first or second jaw member, and a density of the grasped tissue. However, Wiener teaches determining the tissue thickness and density (par. [0186]).
Rupp, in an analogous device, teaches where the mass of the tissue is predicted for the procedure (par. [0046]).
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 Weiner to determine the mass of the tissue, as in Rupp. Determining the mass allows for a better estimation of total energy needed to complete an ablation procedure (par. [0046]). Multiplying the cross-sectional area, a width of the first or second jaw member, and a density of the grasped tissue is the mathematical equation for determining mass: mass=volume*density.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Weiner in view of Houser US 20120116266.
Regarding claim 33, Wiener teaches wherein the controller is located within the electrosurgical instrument.
Houser, in an analogous device, teaches the controller can be within the housing of the instrument (par. [0046]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the location of the controller of Weiner in the generator with the location in the handle, as in Houser. It is seen to perform equally as well and would yield the predictable result of controlling the energy of the device.
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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