DETAILED ACTION
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-3, 5-14, and 16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tegg (US 2018/0092688), herein after “Tegg”.
Regarding claim 1, Tegg teaches “An ablation catheter tip (p.[0004]) comprising a conductive tip shell comprising a distal end and a cylindrical body (Fig. 32, distal end 48 and cylindrical shell 50), the conductive tip shell configured to conduct ablation therapy (p.[0115]); a plurality of thermal sensors placed in thermal communication with the conductive tip shell (Fig. 32, thermal sensors 68/68'); and at least three microelectrodes electrically insulated from the conductive tip shell and configured to sense electrophysiology characteristics of contacted tissue (Fig. 32, spot electrodes 328, p.[0111, 0129], p.[0135] wherein a plurality can be at least three electrodes); wherein the at least three microelectrodes are coupled to a distal face of a tip insert (Fig. 30-31, tip insert 58, p.[0127]) and extend through the distal end of the conductive tip shell (Fig. 32, spot electrodes 328, p.[0111,0129]); wherein the conductive tip shell further comprises an inner surface (Fig. 32); wherein the plurality of thermal sensors are in thermal communication with the inner surface of the conductive tip shell (Fig. 32).”
Regarding claim 2, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the at least three microelectrodes are equally spaced about a circumference of the conductive tip shell (Fig. 35)”.
Regarding claim 3, the limitations of claim 1 are taught as described above. Tegg teaches “the conductive tip shell further comprising a plurality of irrigation ports (Fig. 8, Fig. 32, irrigation holes 46)”.
Regarding claim 5, the limitations of claim 3 are taught as described above. Tegg teaches “wherein one or more of the plurality of irrigation ports are located on the distal end of the conductive tip shell (Fig. 32 with irrigation holes 46)”.
Regarding claim 6, the limitations of claim 3 are taught as described above. Tegg teaches “wherein one or more of the plurality of irrigation ports are circular apertures (Fig. 32, irrigation holes 42)”.
Regarding claim 7, the limitations of claim 1 are taught as described above. Tegg teaches “further comprising an electronic circuit (p.[0010,0048], Fig. 32, flexible circuit 290)”.
Regarding claim 8, the limitations of claim 7 are taught as described above. Tegg teaches “the electronic circuit comprising a wired or wireless communication pathway at least partially disposed on the electronic circuit, the electronic circuit communicatively coupled to the plurality of thermal sensors and the at least three microelectrodes (Fig. 32, p.[0128])”.
Regarding claim 9, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the plurality of thermal sensors are configured to sense regional temperatures of the conductive tip shell (p.[0008], "directional temperature feedback" of "the plurality of thermal sensors in thermal communication with the conductive shell")”.
Regarding claim 10, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the conductive tip shell comprises a distal surface (Fig. 32, distal end 48), and wherein a sensing surface of each of the at least three microelectrodes is positioned flush with the distal surface of the conductive tip shell (Fig. 32, 328 is relatively flush with the distal surface of the conductive tip shell 48)”.
Regarding claim 11, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the at least three microelectrodes mounted on the distal face of the ablation tip insert are circumferentially distributed about the conductive tip shell (Fig. 32 with 328)”.
Regarding claim 12, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the at least three microelectrodes are electrically insulated from the conductive tip shell by an insulative layer that extends between each of the at least three microelectrodes and the conductive tip shell (p.[0129])”.
Regarding claim 13, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the plurality of thermal sensors comprise at least one thermal sensor placed in thermal communication with a distal tip of the conductive tip shell (p.[0008], "The plurality of thermal sensors are in thermal communication with the conductive shell and provide directional temperature feedback")”.
Regarding claim 14, the limitations of claim 1 are taught as described above. Tegg teaches “wherein the conductive tip shell surrounds at least a portion of the tip insert (Fig. 30-32, p.[0127])”.
Regarding claim 16, the limitations of claim 14 are taught as described above. Tegg teaches “wherein the conductive tip shell further comprises a plurality of irrigation ports (irrigation holes 46), the conductive tip shell surrounds at least a portion of the tip insert (Fig. 30-32, tip insert 58), and the tip insert comprises a plurality of irrigant channels (irrigation channels 70 as shown in Fig. 31) which deliver an irrigant to the plurality of irrigation ports (p.[0127])”.
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 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Hillukka (US 2018/0092689), herein after “Hillukka”.
Regarding claim 4, the limitations of claim 3 are taught as described above. Tegg does not teach "wherein the plurality of irrigation ports distributed both longitudinally and circumferentially about the conductive tip shell", but Hillukka does in an analogous catheter tip device. Hillukka teaches "wherein the plurality of irrigation ports distributed both longitudinally and circumferentially about the conductive tip shell (Fig. 28B, irrigation ports 46/46')". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Hillukka in Tegg. It is known in the art to use irrigation ports for cooling the ablation device and produces predictable results of providing cooling and irrigation for the device.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Schultz (US 2016/0143690), herein after “Schultz”.
Regarding claim 15, the limitations of claim 14 are taught as described above. Tegg does not teach "wherein the tip insert comprises a plurality of pedestals positioned on the distal face of the tip insert, the plurality of pedestals are configured to position a sensing surface of each of the at least three microelectrodes flush with a distal surface of the conductive tip shell", but Schultz does in an analogous catheter device. Schultz teaches "wherein the tip insert (Fig. 3, p.[0022], insert 28) comprises a plurality of pedestals (protrusions 30) positioned on the distal face of the tip insert (Fig. 3), the plurality of pedestals are configured to position a sensing surface of each of the at least three microelectrodes (sensor 52, p.[0041]) flush with a distal surface of the conductive tip shell (Fig. 3)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tip insert of Schultz in Tegg. As stated in Schultz p.[0041], the use of the protrusions of Schultz allows for "more accurate measurement of tissue and environmental temperature may be obtained" and produces predictable results of producing more accurate tissue characteristic measurements.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tegg.
Regarding claim 17, Tegg teaches “a conductive tip shell (Fig. 8, conductive shell 44) comprising a distal end (shell distal end portion 48), a cylindrical body (Fig. 8, cylindrical body 50), and a crown (Fig. 8, crown 56) extending between the distal end and the cylindrical body (p.[0080]), the conductive tip shell configured to conduct ablation therapy (p.[0080]); at least three microelectrodes extending through apertures in the crown (Fig. 32, spot electrodes 328); and a plurality of thermal sensors placed in thermal communication with the conductive tip shell (Fig. 32, thermal sensors 68).”
Tegg does not teach the use of a crown and microelectrodes in the same embodiment (Fig. 8 versus Fig. 32). The embodiment of Fig. 8 teaches the use of the crown, whereas the embodiment of Fig. 32 teaches the use of microelectrodes and thermal sensors placed in the thermal communication with the conductive tip shell. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the embodiment of Fig. 8 in the embodiment of Fig. 32 as taught in Tegg. Tegg p.[0142] states that " Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation"
Regarding claim 18, the limitations of claim 17 are taught as described above. Tegg teaches “wherein the at least three microelectrodes are electrically insulated from the conductive tip shell and configured to sense electrophysiology characteristics of contacted tissue (Fig. 32, p.[0128-0129])”.
Regarding claim 19, the limitations of claim 17 are taught as described above. Tegg teaches “wherein the at least three microelectrodes are equally spaced about a circumference of the conductive tip shell (Fig. 32, electrodes 328, p.[0135] wherein a plurality can be at least three electrodes)”.
Regarding claim 20, the limitations of claim 17 are taught as described above. Tegg teaches “ the conductive tip shell further comprising a plurality of irrigation ports (Fig. 32, irrigation holes 46)”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794
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