DETAILED ACTION
Claims 1, 8, 13, and 15 are currently amended. 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 .
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
Claims 1-10, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim US 6083170 in view of Paul US 20070100332.
Regarding claims 1, 8, 13, and 15, Ben-Haim teaches the catheter comprising: an elongate shaft having a proximal end and a distal end (Fig. 10 20); a distal end portion extending distally from the distal end of the shaft (portion shown in Fig. 9A), the distal end portion defining a longitudinal axis extending therethrough and comprising: a proximal segment (Fig. 9A where proximal portion of 30 is); a distal segment located distally of the proximal segment (Fig. 9A where distal portion of 30 is); and a force sensing mechanism comprising: a proximal housing fixed within the proximal segment (Fig. 9A proximal portion of 130), the proximal housing having a lower surface and an upper surface (Fig. 9A); a plurality of piezoelectric sensors mounted to and circumferentially spaced from one another about the proximal housing (Fig. 9B stacks 106, 108, 110, and 12 arranged in a circle), each piezoelectric sensor having a first portion fixedly secured to the proximal housing (Fig. 9A 114 attached to 116 which is attached to the proximal end of 30), and a second portion that is not fixedly secured to the proximal housing (Fig. 9A top part of 114); wherein the second portion is deflectable relative to the first portion upon application of the axial force by the respective projection (Fig. 9C) ; and a distal housing fixed within the distal segment and including a plurality of projections (Fig. 9A 116 on top of 114), each of the projections contacting the second portion of a respective one the piezoelectric sensors and being is configured to apply an axial force to the second portion of the respective piezoelectric sensor (Fig. 9C) upon application of an external force to the distal segment, wherein each of the plurality of piezoelectric sensors is configured to generate an output indicative of an amount of the axial force applied to the second portion thereof in response to the external force applied to the distal segment (col 3 lines 9-14).
Ben-Haim does not explicitly teach wherein the second portion of each piezoelectric sensor is cantilevered over a cavity in the proximal housing.
Paul, in an analogous device, teaches a piezoelectric sensor 220 that shits in an airspace 226 (Fig. 6a). The piezoelectric sensor is not directly connected to the distal end housing (par. [0067]). The other piezoelectric configurations can be longitudinal extending arms (Fig. 2), wires extending into the electrode (Fig. 7c), a sensor held between two plates (Fig. 8a), a basket (Fig. 9a), or a ball joint (Fig. 10).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the piezoelectric sensor between two plates in Ben-Haim with the cantilever configuration of Paul. It is seen to preform equally as well and would yield the predictable result of providing electrical feedback indicative of catheter bending.
Regarding claims 2, 9, 14, and 16, Ben-Haim teaches wherein the proximal housing comprises a plurality of cavities extending from the lower surface through the upper surface, each of the cavities being aligned with a respective one of the piezoelectric sensors, wherein the second portion of each of the piezoelectric sensors extends at least partially across a respective one of the cavities (Fig. 9A proximal 30 and a cut out in the top of 30 making a cavity).
Regarding clams 3, 10, and 17, Ben-Haim teaches wherein the proximal housing comprises a compressible backing material disposed within each of the cavities and contacting the second portion of the piezoelectric sensor positioned thereover opposite the respective projection on the distal housing, wherein the backing material resists deformation of the second portion of the piezoelectric sensor when the external force is applied to the distal segment (Fig. 9A locations of 116 and col 13 lines 9-14 116s are made of resilient steel spring).
Regarding claims 4 and 18, Ben-Haim teaches wherein the piezoelectric sensor has an arcuate or rectangular profile when viewed from a direction parallel to the longitudinal axis (Figs. 9A and B).
Regarding claims 5 and 6 wherein piezoelectric sensor has an annular shape when viewed from a direction parallel to the longitudinal axis, and wherein the first portion is an outer circumferential portion of the piezoelectric sensor, and the second portion is located radially inward of the first portion of the piezoelectric sensor and wherein the piezoelectric sensor is a generally circular disk, and wherein the second portion of each piezoelectric sensor extends across the respective cavity (Fig. 9B the stacks 106, 108, 110, and 112 make a generally circular shape in 30).
Regarding claim 7, Ben-Haim teaches further comprising a pre-load mechanism operatively coupled to the proximal housing and configured to allow a user to selectively pre-load the piezoelectric sensor (col 4 lines 51-57 straight alignment mechanism).
Claims 11, 12, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim in view of Paul as applied to claims 8 and 15 above, and further in view of Bonutti US 20170209717.
Regarding claims 11, 12, 19, and 20, Ben-Haim and Paul do not explicitly teach wherein each piezoelectric sensor has an annular shape when viewed from a direction parallel to the longitudinal axis, and wherein the first portion is an outer circumferential portion of the piezoelectric sensor, and the second portion is located radially inward of the first portion of the piezoelectric sensor and wherein each piezoelectric sensor is a generally circular disk, and wherein the second portion of each piezoelectric sensor extends across the respective cavity.
However, Ben-Haim teaches rectangular shaped piezoelectric elements in a cavity (Fig. 9A 114 in 30).
Bonutti, in an analogous device, teaches where the piezoelectric crystals can have a square, round, circular, oval, or rectangular shape (par. [0057]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the shape of piezoelectric element in Ben-Haim and Paul to be circular, as in Bonutti. It is seen to be an obvious matter of design choice to have any shape. There does not seem to be any criticality of one shape over the other presented in the instant specification and it is seen to preform equally as well.
Response to Arguments
Applicant’s arguments with respect to claims 1, 8, and15have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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