DETAILED ACTION
A complete action on the merits of pending claims 16-35 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.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto US 8425510.
Regarding claim 16, Yamamoto teaches a shaft (Fig. 1 sheath 18) including a conductive element (Fig. 1 wire 20) ; an end cap coupled to a distal end of the shaft (Fig. 1 collar 28), wherein the end cap is at least partially insulating (col 5 lines 27-36) and includes an opening (Fig. 1 where 24 comes out of); and an electrode coupled to the distal end of the shaft and passing through the opening in the end cap (Fig. 1 12), wherein the electrode includes an electrode shaft (Fig. 1 24) and a distal tip (Fig. 1 12/34), wherein the electrode is electrically connected to the conductive element (Fig. 1), and wherein the end cap includes a visualization feature (Fig. 1 taper).
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 17-20, 23-25, 31 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto.
Regarding claims 17-20, 31, 34, 35, Yamamoto teaches the distal tip of the electrode is extended approximately 1 mm to approximately 3 mm from a distal end face of the end cap (Fig. 5 and col 10 lines 24-29 12 and 24 extending into the mucosa layers) wherein the visualization feature is formed by a tapered portion of the end cap, wherein the tapered portion of the end cap includes a straight taper (Fig. 1 taper of 28).
Yamamoto does not explicitly teach wherein the straight taper forms a blind angle of approximately 25 degrees or less.
However, Yamamoto does teach visualization of the tissue through the taper angle (Fig. 12).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have a blind angle of 25, 11, or any degree, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Yamamoto discusses how the angles are arbitrary and can be changed (col 12 lines 1-4). To that end, the applicant has not demonstrated any criticality to the claimed angles. A person of ordinary skill in the art could change the angles of the trapper, thus changing the blind angle, based on optimal visualization or insertion for a certain procedure.
Regarding claims 23 and 33, Yamamoto teaches wherein the tapered portion of the end cap includes one or more tapered side portions (Fig. 1 28 taper toward 24), and one or more partially cylindrical portions (Fig. 1 small portion coming off of sheath 18).
Regarding claim 24, Yamamoto teaches wherein the one or more tapered side portions of the end cap forms a blind angle of approximately 25 degrees on at least one side of the end cap (See rejection of claim 17 above).
Regarding claim 25, Yamamoto teaches wherein the tapered portion of the end cap spans approximately 80% of a length of the end cap (Fig. 1 approximately 20% to 80% and rejection of claim 17).
Claims 21-22, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto in view of Hancock US 20120378738.
Regarding claims 21 and 32, Yamamoto does not explicitly teach wherein the tapered portion of the end cap includes a rounded taper.
Hancock, in an analogous device, teaches the collar of the shaft going into the electrode can be rounded (Fig. 2a 228).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have a rounded taper as in Hancock. It is seen as an obvious matter of design choice that would offer an atraumatic shape with the rounded corners.
Regarding claim 22, Yamamoto and Hancock teach wherein the rounded taper forms a blind angle of approximately 25 degrees of less (See rejection of claim 17).
Claims 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto in view of Greep US 20180333193.
Regarding claim 26, Yamamoto does not explicitly teach wherein the end cap is at least partially transparent.
Greep, in an analogous device, teaches where the distal end of the shaft is transparent or semi-transparent (par. [0038]).
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 Yamamoto with the transparent area of Greep. It presents the advantage of improving the visual field (Greep par. [0038]).
Regarding claim 27, Yamamoto teaches wherein the end cap comprises a ceramic material (col 3 lines 7-10).
Regarding claims 28-30, Yamamoto and Greep teach wherein a distal portion of the shaft is at least partially transparent (Greep par. [0038]), and wherein the end cap and the distal portion of the shaft form the visualization feature (Yamamoto Fig. 1 taper) wherein the distal portion of the shaft is approximately 5 mm to approximately 15 mm in length (Fig. 5 and col 10 lines 24-29 12 and 24 extending into the mucosa layers).
Yamamoto does not explicitly teach wherein the visualization feature forms a blind angle of approximately 21/11 degrees.
However, Yamamoto does teach visualization of the tissue through the taper angle (Fig. 12).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have a blind angle of 25, 11, or any degree, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Yamamoto discusses how the angles are arbitrary and can be changed (col 12 lines 1-4). To that end, the applicant has not demonstrated any criticality to the claimed angles. A person of ordinary skill in the art could change the angles of the trapper, thus changing the blind angle, based on optimal visualization or insertion for a certain procedure.
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 on Monday-Friday 7AM-3PM MT.
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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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