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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claim 13 recites a first and second portion for the piezoelectric elements but claim 8 already recites those portions. It will be interpreted as the portions in 13 are the same as in claim 8. Claim 14 is rejected as being dependent on claim 13. Claims 13 and 14 are included in the rejection of claim 8 since three piezoelectric elements are recited instead of a plurality. Ben-Haim teaches having four stacks of with piezoelectric elements (Fig. 9B), thus meeting the limitation of three.
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 1-10, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben-Haim US 6083170.
Regarding claims 1, 8, and 13-15, 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); 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).
Regarding claims 2, 9, 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).
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 11, 12, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim in view of Bonutti US 20170209717.
Regarding claims 11, 12, 19, and 20, Ben-Haim does 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 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.
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794