DETAILED ACTION
Claims 16-19, 21, 23, 24, 28-30, 33, and 34 are amended. 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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claim 16-20, 23-25, 31 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto US 8425510 in view of Bonnet US 6447509.
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 tapered portion (Fig. 1 taper of 28).
Yamamoto does not explicitly teach wherein the tapered portion includes one or more tapered side portions and one or more partially cylindrical portions, and wherein the one or more tapered side portions are positioned circumferentially adjacent to the one or more partially cylindrical portions.
Bonnet, in an analogous device, teaches two truncated cone bodies the proximal one 4 and the distal one 3 with electrode circle 2 (Fig. 1). The truncated cone 4 has arced portions 5 and two flattened portions 6, where the arced and flattened portions alternate round the truncated cone (Fig. 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the tapered cap of Yamamoto to have flattened, sides as in Bonnet. The truncated cone with flattened sides allows for a better field of view of the operation site, while still being atraumatic (Bonnet col 1 lines 53-62).
Regarding claims 17-20, 31, 34, 35, the combination of Yamamoto and Bonnet 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 (Yamamoto Fig. 5 and col 10 lines 24-29 12 and 24 extending into the mucosa layers), the tapered portion of the end cap includes two or more tapered side portions (Bonnet Fig. 2 flattened portions 6) and two or more partially cylindrical portions (Bonnet Fig. 2 arced portions 5), wherein one of the partially cylindrical portions is positioned circumferentially between two of the tapered side portions (Bonnet Fig. 2).
Yamamoto and Bonnet do 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 at will (Yamamoto 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, Bonnet teaches wherein the tapered side portions form opposite sides of the end cap, and wherein each of the partially cylindrical portions is positioned between and connecting two of the tapered side portions (Fig. 2 flattened portions 6 and arced portions 5 alternating).
Regarding claim 24, the combination of Yamamoto and Bonnet 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 (Yamamoto optimization rationale in rejection of claim 17 above).
Regarding claim 25, the combination of Yamamoto and Bonnet 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 Yamamoto optimization rationale in rejection of claim 17).
Claims 21-22, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto and Bonnet as applied to claims 18 and 31 above, and further 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, the combination of Yamamoto, Bonnet, and Hancock teaches wherein the rounded taper forms a blind angle of approximately 25 degrees of less (Yamamoto optimization rationale in rejection of claim 17).
Claims 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto and Bonnet as applied to claim 16 above, and further in view of Greep US 20180333193.
Regarding claim 26, the combination of Yamamoto and Bonnet 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 and Bonnet 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]), wherein the distal portion of the shaft is approximately 5 mm to approximately 15 mm in length (Yamamoto Fig. 5 and col 10 lines 24-29 12 and 24 extending into the mucosa layers).
Yamamoto does not explicitly teach wherein each of the one or more tapered side portions forms a blind angle of approximately 21 degrees.
However, Yamamoto and Bonnet teach visualization of the tissue through the taper angle (Yamamoto Fig. 12) (Bonnet col 1 lines 53-62).
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 (Yamamoto 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.
Response to Arguments
Applicant’s arguments with respect to claims 16 and 34 have been considered but are moot because the new ground of rejection above does not rely upon the same combination of references as the previous rejection.
Regarding claim 31, the applicant argues that criticality of the ranges is found in the specification where it states the taper is to help improve the visualization of the electrode by not blocking the camera. This states what the angle is not why the specific angle provides as an unexpected result. Yamamoto Fig. 12 and Bonnet col 1 lines 53-62 demonstrates that the angle of the cap contributes to the viewing angle. Yamamoto col 12 lines 1-4 shows that the angles can be change as desired.
MPEP 2144.05(III)(A) states that the applicant must show criticality to the claimed ranges. The applicant has not shown that their ranges are critical in any way. This is be demonstrated by applicant’s own specification. Par. [0047] states the angle can be between 20 and 40 degrees, then states the angle can be 25 degrees, and again has a different example has an angle of 12.5 degrees, which does not even fall into the originally stated 20 and 40 degrees. Par. [0061] states the angle can be between 15 and 40 degrees, then states the angle can be between 18 and 25 degrees, and again has a different example has an angle of 10.5 degrees, which does not even fall into the originally stated 15 and 40 degrees. Par. [0066] states the angle can be between 5 and 20 degrees, then states the angle can be between 8 and 15 degrees, then states a different angle of 11 degrees, and again has a different example has an angle of 5.5 degrees. Additionally, par. [0023] states that the values in the disclosure are +/-10%. Thus, the range in the applicant’s specification is about 45 degrees or less. Yamamoto Fig. 12 and col 9 line 54 to col 10 line 3 shows that theta is about 90 degrees. A line perpendicular to camera 45 would split theta into two 45 degree angles. As seen both theta1 and theta2 would fit into the 45 degree section making the blind angle less than 45 degrees. Therefore, the arguments presented by the applicant are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.T.C./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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