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 .
A complete action on the merits of pending claims 1-18 appears herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,497,550 in view of Paul (US 2012/0059255 A1). The claims of the present application comprise overlapping subject matter with minor grammatical differences with the claims of U.S. Patent No. 11,497,550, except that the claims of U.S. Patent No. 11,497,550 are silent regarding the determination of contact between electrodes and a target tissue and using said determination in the electrode activation/selection.
Paul, in a similar field of endeavor, teaches detecting, using a contact sensing system, a set of electrodes of the plurality of electrodes that are in contact with a target tissue; (Par. [0031]) and selectively energizing electrodes identified as being in contact with a target tissue. (Par. [0031])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the claims of U.S. Patent No. 11,497,550, to incorporate the teachings of Paul, and include the contact sensing system of Paul, such that the electrodes of U.S. Patent No. 11,497,550 that are in contact with the target tissue are identified and to use said identification in the electrode selection process. Doing so would more effectively direct the therapy to just the target tissue, as suggested in Paul. (Par. [0031])
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,786,301 in view of Paul (US 2012/0059255 A1). The claims of the present application comprise overlapping subject matter with minor grammatical differences with the claims of U.S. Patent No. 11,786,301, except that the claims of U.S. Patent No. 11,786,301 are silent regarding the determination of contact between electrodes and a target tissue and using said determination in the electrode activation/selection.
Paul, in a similar field of endeavor, teaches detecting, using a contact sensing system, a set of electrodes of the plurality of electrodes that are in contact with a target tissue; (Par. [0031]) and selectively energizing electrodes identified as being in contact with a target tissue. (Par. [0031])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the claims of U.S. Patent No. 11,786,301, to incorporate the teachings of Paul, and include the contact sensing system of Paul, such that the electrodes of U.S. Patent No. 11,786,301 that are in contact with the target tissue are identified and to use said identification in the electrode selection process. Doing so would more effectively direct the therapy to just the target tissue, as suggested in Paul. (Par. [0031])
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,171,489 in view of Paul (US 2012/0059255 A1). The claims of the present application comprise overlapping subject matter with minor grammatical differences with the claims of U.S. Patent No. 12,171,489, except that the claims of U.S. Patent No. 12,171,489 are silent regarding the determination of contact between electrodes and a target tissue and using said determination in the electrode activation/selection.
Paul, in a similar field of endeavor, teaches detecting, using a contact sensing system, a set of electrodes of the plurality of electrodes that are in contact with a target tissue; (Par. [0031]) and selectively energizing electrodes identified as being in contact with a target tissue. (Par. [0031])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the claims of U.S. Patent No. 12,171,489, to incorporate the teachings of Paul, and include the contact sensing system of Paul, such that the electrodes of U.S. Patent No. 12,171,489 that are in contact with the target tissue are identified and to use said identification in the electrode selection process. Doing so would more effectively direct the therapy to just the target tissue, as suggested in Paul. (Par. [0031])
Claim Rejections - 35 USC § 103
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.
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(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 2016/0331459 A1) in view of Paul (US 2012/0059255 A1).
Regarding claim 1, Townley teaches a catheter (Fig. 2 and 4, Char. 200 and 402; Par. [0066]) comprising:
a distal section configured to be positioned within a body; (Fig. 4) and
an electrode assembly coupled to the distal section, (Fig. 1, Char. 412: therapeutic assembly) the electrode assembly comprising:
a plurality of electrodes, (Fig. 4, Char. 444: electrodes) each electrode of the plurality of electrodes configured to be selectively energized, (Par. [0072]) wherein a subset of the plurality of electrodes that forms a circumferential ring is configured to be selected by a computing system coupled to the catheter (Par. [0072]: Each electrode can be individually activated/controlled by an operator or a control algorithm executed by the controller (218); Par. [0086]: Electrodes are selectively controlled to apply RF energy in a circular pattern) by:
identifying, electrodes of the plurality of electrodes that form a closed path and that are in contact with the target tissue; (Par. [0078] and Par. [0086]: As part of the electrode selection process, the electrodes that form the circular ablation pattern would have to be identified.) and
selecting, for energization, the identified electrodes that form a closed path. (Par. [0086])
Townley, as applied to claim 1 above, is silent regarding detecting, using a contact sensing system, a set of electrodes of the plurality of electrodes that are in contact with a target tissue; wherein the identified electrodes are from the detected set of electrodes in contact with the target tissue; and wherein the selected electrodes are those that both form a closed path and are in contact with the target tissue.
Paul, in a similar field of endeavor, teaches detecting, using a contact sensing system, a set of electrodes of the plurality of electrodes that are in contact with a target tissue; (Par. [0031]) and selectively energizing electrodes identified as being in contact with a target tissue. (Par. [0031])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Townley, as applied to claim 1 above, to incorporate the teachings of Paul, and include the contact sensing system of Paul, such that the electrodes (444) of Townley that are in contact with the target tissue are identified and to use said identification in the electrode selection process. Doing so would more effectively direct the therapy to just the target tissue, as suggested in Paul. (Par. [0031])
Regarding claim 2, the combination of Townley/Paul, as applied to claim 1 above, teaches the contact sensing system is configured to detect the set of electrodes that are in contact with a target tissue using at least one of imaging, electrogram amplitude, impedance measuring, contact force sensing, ultrasound-based distance measurement, and temperature-based contact sensing. (Paul: Par. [0031]: Impedance is used to indicate contact with the target tissue – it is implicit that this feature be present in the Townley/Paul combination based on the rejection to claim 1 above.)
Regarding claim 3, the combination of Townley/Paul, as applied to claim 1 above, teaches the electrode assembly further comprises a balloon around which the plurality of electrodes are distributed. (Townley: Par. [0070]: The therapeutic assembly (412) can be mechanically expanded via a balloon)
Regarding claim 4, the combination of Townley/Paul, as applied to claim 1 above, teaches a basket having a plurality of splines along which the plurality of electrodes is distributed. (Townley: Fig. 4: The basket formed by struts (440))
Regarding claim 5, the combination of Townley/Paul, as applied to claim 1 above, teaches the plurality of splines define first and second poles at which the plurality of splines join, (Townley: Fig. 4) and wherein the plurality of electrodes are concentrated away from the first and second poles. (Townley: Fig. 4: there are no electrodes at the point where struts (440) meet/converge)
Regarding claim 6, the combination of Townley/Paul, as applied to claim 1 above, is silent regarding the circumferential ring of energized electrodes being non-circular.
However, given that Townley teaches selectively activating a plurality of electrodes in a desired arrangement (Par. [0078]) and that the number of electrodes on each strut can vary (Par. [0071]) it is expected that said electrodes may be activated in such a way as to form non-circular loops. (e.g. oval shaped) Therefore, absent a statement of criticality AND unexpected results, Townley’s selective electrode activation is interpreted as reading on this claim limitation as there is no structural difference from the combination of Townley/Paul, as applied to claim 1 above, created by the claimed circumferential ring of energized electrodes being non-circular.
Claim(s) 7, 8, 12-14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Paul (US 2012/0059255 A1) in view of Townley (US 2016/0331459 A1).
Regarding claim 7, Paul teaches system (Fig. 1) comprising:
a catheter (Fig. 1, Char. 14: catheter) comprising an electrode assembly (Fig. 14, Char. 12e: electrode assemblies) configured to be positioned in a body, (Fig. 1) the electrode assembly comprising:
a plurality of electrodes, (Fig. 14, Char. 92: electrode elements) each electrode of the plurality of electrodes configured to be individually energized; (Par. [0031])
an energy source coupled to the catheter (Fig. 1, Char. 26: electroporation generator) and configured to selectively energize a subset of electrodes of the plurality of electrodes; (Par. [0031]) and
a computing system coupled to the catheter and the energy source, (Fig. 1, Char. 50: electronic control unit) the computing system configured to:
detecting, using a contact sensing system, a set of electrodes of the plurality of electrodes that are in contact with a target tissue; (Par. [0031])
selecting, for energization, the electrodes that are in contact with the target tissue. (Par. [0031])
Paul, as applied to claim 7 above, is silent regarding the computing system being configured to detect respective positions of the plurality of electrodes, and select the subset of electrodes to form a circumferential ring of energized electrodes by: identifying, from the detected set of electrodes in contact with the target tissue, electrodes of the plurality of electrodes that form a closed path and that are in contact with the target tissue; and selecting, for energization, the identified electrodes that form a closed path and that are in contact with the target tissue.
Townley, in a similar field of endeavor, teaches a computing system (Par. [0072]: controller (218)) configured to detect respective positions of the plurality of electrodes, (Par. [0072]) and select the subset of electrodes to form a circumferential ring of energized electrodes by: detecting, using a proximity sensing system, a set of electrodes of the plurality of electrodes that are adjacent with a target tissue; (Par. [0072]) identifying, from the detected set of electrodes adjacent with the target tissue, electrodes of the plurality of electrodes that form a closed path and that are adjacent with the target tissue; (Par. [0078]) and selecting, for energization, the identified electrodes that form a closed path and that are in contact with the target tissue. (Par. [0078])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Paul, as applied to claim 7 above, to incorporate the teachings of Townley, and configure the electronic control unit (50) of Paul to determine which of the electrodes in contact with the target tissue form the desired ablation pattern (e.g. a circular pattern) and selectively activate the electrodes that are both in contact with the target tissue and form said pattern. Doing so would provide greater control over the ablation pattern able to be created by the device of Paul.
Regarding method claim 13, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 7, since operation of the prior art relied on to reject apparatus claim 7 would naturally result in the step of method claim 13 being satisfied.
Regarding claim 8, the combination of Paul/Townley, as applied to claim 7 above, teaches the contact sensing system is configured to detect the set of electrodes that are in contact with a target tissue using at least one of imaging, electrogram amplitude, impedance measuring, contact force sensing, ultrasound based distance measurement, and temperature based contact sensing. (Paul: Par. [0031]: Impedance is used to indicate contact with the target tissue)
Regarding method claim 14, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 8, since operation of the prior art relied on to reject apparatus claim 8 would naturally result in the step of method claim 14 being satisfied.
Regarding claim 12, the combination of Paul/Townley, as applied to claim 7 above, teaches the target tissue is a vein. (Par. [0037])
Regarding claim 16, the combination of Paul/Townley, as applied to claims 7 and 13 above, teaches the catheter comprises a basket catheter, (Paul: Fig. 14 and 16) the method further comprising expanding the basket catheter after positioning the distal section. (Paul: Par. [0086])
Regarding claim 17, the combination of Paul/Townley, as applied to claims 7 and 13 above, teaches energizing the subset of electrodes comprises: generating a direct current (DC) signal; (Par. [0047]) conducting the DC signal through the catheter to the subset of electrodes; (Par. [0047]) and de-energizing remaining electrodes of the plurality of electrodes. (Par. [0031])
Claim(s) 9-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Paul (US 2012/0059255 A1) in view of Townley (US 2016/0331459 A1), as applied to claim 7 above, and further in view of Desai (US 5,433,198).
Regarding claims 9 and 10, the combination of Paul/Townley, as applied to claim 7 above, is silent regarding the computing system further comprises a visualization system configured to display the respective positions of the plurality of electrodes; and wherein the visualization system is further configured to render a three-dimensional display.
Desai, in a similar field of endeavor, teaches a display system configured to display the respective positions of a plurality of electrodes in a target tissue via a three-dimensional display. (Col. 4, Lines 44-47)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Paul/Townley, as applied to claim 7 above, to incorporate the teachings of Desai, and include the display system of Desai, such that the position of the electrode array of Paul is shown within the treatment zone via a three-dimensional display. Doing so would allow a user to easily view the treatment zone and would allow for the electrodes of Paul to be easily placed relative to the target tissue.
Regarding method claim 15, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claims 9 and 10, since operation of the prior art relied on to reject apparatus claims 9 and 10 would naturally result in the step of method claim 15 being satisfied.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Paul (US 2012/0059255 A1) in view of Townley (US 2016/0331459 A1) in view of Desai (US 5,433,198), as applied to claim 9 above, and further in view of Stewart (US 10,271,893 B2).
Regarding claim 11, the combination of Paul/Townley/Desai, as applied to claim 9 above, is silent regarding the computing system further comprises a user interface configured to enable user selection of the subset of electrodes.
Stewart, in a similar field of endeavor, teaches a user interface configured to enable user selection of a subset of electrodes. (Col. 7, Lines 23-27)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Paul/Townley/Desai, as applied to claim 9 above, to incorporate the teachings of Stewart and configure the computing system to comprise the user interface of Stewart, such that a user can individually select the electrodes for activation. Doing so would grant a user greater control over energy delivery and the ablation pattern.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Paul (US 2012/0059255 A1) in view of Townley (US 2016/0331459 A1), as applied to claims 7 and 13 above, and further in view of Salahieh (US 2012/0071870 A1).
Regarding claim 18, the combination of Paul/Townley, as applied to claims 7 and 13 above, is silent regarding the catheter comprises a balloon catheter, the method further comprising expanding the balloon catheter after positioning the distal section.
Salahieh, in a similar field of endeavor, teaches a balloon catheter comprising a plurality of electrodes (Fig. 18A-H) configured to treat cardiac tissue; (Par. [0205]) wherein the balloon is expanded after positioning said balloon within the treatment zone. (The balloon would be inflated after positioning relative to the target tissue due to the smaller size of the deflated state being easier for navigation purposes.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Paul/Townley, as applied to claims 7 and 13 above, to incorporate the teachings of Salahieh, and dispose the electrodes (92) of Paul on a balloon instead of on a basket structure. Doing so would be a simple substitution of one expandable structure for another for the predictable result of moving the electrodes into contact/proximity with the target tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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