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 .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/01/2024 was filed before the mailing date of the First Office Action on the Merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pate (U.S. Pre Grant Pub. No. 2017/0202616 A1).
Regarding claim 1, Pate teaches: A system for forming a fistula between two vessels (see for example para. [0072] and Fig. 20A-21E) comprising:
a first catheter (see first catheter 2006 at least in Figs. 20A-D and para. [0124]) comprising a first body (see at least Figs. 20A-D), an electrode mounted to the first body (see electrode 2008 at least in Figs. 20A-D and para. [0124]), and a first array of magnets mounted to the first body (see at least para. [0137]; in Fig. 20D, the magnets are the rectangular boxes); and
a second catheter (see second catheter 2000 at least in Figs. 20A-D and para. [0124]) comprising a second body (see at least Figs. 20A-D), a second array of magnets mounted to the second body (see at least para. [0137]; in Fig. 20D, the magnets are the rectangular boxes), and a flexible (as broadly recited, because the catheter comprising the backstop is introduced through blood vessels and being bent in the process, the backstop is at least flexible insofar as to bend with the blood vessels) backstop extending longitudinally along the second array of magnets (see electrically conductive portion 2002 in Figs. 20A-D and para. [0124]).
Regarding claim 2, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein a portion of the first array of magnets extends along the electrode in longitudinal direction of the first catheter (see for example Fig. 20D).
Regarding claim 3, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein the flexible backstop comprises a metallic sheet (see at least para. [0125]).
Regarding claim 4, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein the flexible backstop defines a compression region configured to receive the electrode such that tissue is compressed between the flexible backstop and the electrode when the first and second catheters are positioned such that the first and second array of magnets attract each other (see for example para. [0007 and 0015]).
Regarding claim 6, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein the first array of magnets is configured to conform to a shape of the first catheter when acted upon by a bending force (see for example Fig. 20D; since the first array of magnets are attached to the first catheter 2006, the first array of magnets are configured to conform to a shape of the first catheter when acted upon by a bending force, such as, for example, by being introduced through a tortuous blood vessel) and/or the second array of magnets is configured to conform to a shape of the second catheter when acted upon by a bending force (see for example Fig. 20D; since the second array of magnets are attached to the second catheter 2000, the second array of magnets are configured to conform to a shape of the second catheter when acted upon by a bending force, such as, for example, by being introduced through a tortuous blood vessel).
Regarding claim 7, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein the flexible backstop is configured to conform to a shape of the second catheter when acted upon by a bending force (see for example Fig. 20D; since the backstop 2002 is attached to the second catheter 2000, the backstop is configured to conform to a shape of the second catheter when acted upon by a bending force, such as, for example, by being introduced through a tortuous blood vessel).
Regarding claim 8, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein the flexible backstop has a rectangular shaped surface (see for example Fig. 20D).
Regarding claim 9, Pate teaches the invention as discussed above in claim 1. Additionally, Pate teaches wherein the flexible backstop comprises a varying width along a length of the flexible backstop (para. [0100] and Fig. 8 teaches an electrode 800 which varies in width along its length; while para. [0124] teaches an electrically conductive portion 2002 that receives the electrode and serves as an extension of the electrode; therefore, the electrically conductive portion 2002 necessarily has a corresponding varying width as the electrode at least in order to receive the electrode as discussed in para. [0124]), the varying width comprising one or more narrow portions and one or more wide portions which are wider than the one or more narrow portions in a lateral direction (as discussed above, since the electrically conductive portion 2002 must necessarily have a substantially corresponding varying width as the electrode, if an electrode such as the one in Fig. 8 is used, the electrically conductive portion will necessarily have one or more narrow portions and one or more wide portions).
Regarding claim 10, Pate teaches the invention as discussed above in claim 9. Additionally, Pate teaches wherein the one or more narrow portions of the flexible backstop are aligned with one or more magnet interfaces between individual magnets in the second array of magnets (as broadly recited, and as shown in Fig. 20D, the flexible backstop 2002 is aligned with one or more magnet interfaces between individual magnets in the second array of magnets at least because the backstop 2002 is arranged longitudinally in between the array of magnets on either side of the backstop 2002; therefore, the one or more narrow portions will also necessarily align with the one or more magnet interfaces).
Regarding claim 11, Pate teaches: A method of forming a fistula between two vessels (see at least Abstract) comprising:
advancing a first catheter (see first catheter 2006 at least in Figs. 20A-D and para. [0124]) into a first blood vessel (see at least para. [0016]), wherein the first catheter comprises a first treatment portion comprising an electrode (see electrode 2008 at least in Figs. 20A-D and para. [0124]) and a first array of magnets (see at least para. [0137]; in Fig. 20D, the magnets are the rectangular boxes);
advancing a second catheter (see second catheter 2000 at least in Figs. 20A-D and para. [0124]) into a second blood vessel (see at least para. [0016]), the second catheter comprising a second body (see at least Figs. 20A-D), a second array of magnets mounted to the second body (see at least para. [0137]; in Fig. 20D, the magnets are the rectangular boxes), and a flexible (as broadly recited, because the catheter comprising the backstop is introduced through blood vessels and being bent in the process, the backstop is at least flexible insofar as to bend with the blood vessels) backstop extending longitudinally along the second array of magnets (see electrically conductive portion 2002 in Figs. 20A-D and para. [0124]);
aligning the electrode with the flexible backstop (see at least para. [0020-0021]); and
ablating tissue with the electrode thereby forming a fistula between the first blood vessel and the second blood vessel (see at least para. [0016-0017]).
Regarding claim 12, Pate teaches the method as discussed above in claim 11. Additionally, Pate teaches wherein the flexible backstop is configured to conform to a shape of the second catheter when acted upon by a bending force (see for example Fig. 20D; since the backstop 2002 is attached to the second catheter 2000, the backstop is configured to conform to a shape of the second catheter when acted upon by a bending force, such as, for example, by being introduced through a tortuous blood vessel).
Regarding claim 13, Pate teaches the method as discussed above in claim 12. Additionally, Pate teaches wherein magnetic attraction forces between the first array of magnets and the second array of magnets compress tissue between the flexible backstop and the electrode at the compression region (see for example para. [0007 and 0015]).
Regarding claim 14, Pate teaches: A catheter (see second catheter 2000 at least in Figs. 20A-D and para. [0124]) comprising:
a body (see at least Figs. 20A-D);
an array of magnets mounted to the body (see at least para. [0137]; in Fig. 20D, the magnets are the rectangular boxes); and
a flexible (as broadly recited, because the catheter comprising the backstop is introduced through blood vessels and being bent in the process, the backstop is at least flexible insofar as to bend with the blood vessels) backstop mounted to and extending longitudinally alongside the array of magnets (see electrically conductive portion 2002 in Figs. 20A-D and para. [0124]), the flexible backstop defining a treatment region for receiving an electrode (see at least para. [0124]).
Regarding claim 15, Pate teaches the invention as discussed above in claim 14. Additionally, Pate teaches wherein the array of magnets is configured to conform to a shape of the catheter when acted upon by a bending force (see for example Fig. 20D; since the second array of magnets are attached to the second catheter 2000, the second array of magnets are configured to conform to a shape of the second catheter when acted upon by a bending force, such as, for example, by being introduced through a tortuous blood vessel).
Regarding claim 16, Pate teaches the invention as discussed above in claim 14. Additionally, Pate teaches wherein the flexible backstop comprises a metallic sheet (see at least para. [0125]).
Regarding claim 17, Pate teaches the invention as discussed above in claim 16. Additionally, Pate teaches wherein the body extends over a portion of the metallic sheet and defines an opening exposing the treatment region (see for example Figs. 20C showing catheter 2000 extending over a portion of the electrically conductive portion 2002 and showing an opening forming that exposes the treatment region between electrode 2008 and electrically conductive portion 2002).
Regarding claim 18, Pate teaches the invention as discussed above in claim 16. Additionally, Pate teaches wherein the flexible backstop is configured to conform to a shape of the catheter when acted upon by a bending force (see for example Fig. 20D; since the backstop 2002 is attached to the second catheter 2000, the backstop is configured to conform to a shape of the second catheter when acted upon by a bending force, such as, for example, by being introduced through a tortuous blood vessel).
Regarding claim 19, Pate teaches the invention as discussed above in claim 16. Additionally, Pate teaches wherein the metallic sheet has a rectangular shaped surface (see for example Fig. 20D).
Regarding claim 20, Pate teaches the invention as discussed above in claim 16. Additionally, Pate teaches wherein:
the metallic sheet comprises a varying width along a length of the flexible backstop (para. [0100] and Fig. 8 teaches an electrode 800 which varies in width along its length; while para. [0124] teaches an electrically conductive portion 2002 that receives the electrode and serves as an extension of the electrode; therefore, the electrically conductive portion 2002 necessarily has a corresponding varying width as the electrode at least in order to receive the electrode as discussed in para. [0124]), the varying width comprising one or more narrow portions and one or more wide portions which are wider than the one or more narrow portions in a lateral direction (as discussed above, since the electrically conductive portion 2002 must necessarily have a substantially corresponding varying width as the electrode, if an electrode such as the one in Fig. 8 is used, the electrically conductive portion will necessarily have one or more narrow portions and one or more wide portions); and
the one or more narrow portions of the metallic sheet are aligned with one or more magnet interfaces between individual magnets in the array of magnets (as broadly recited, and as shown in Fig. 20D, the flexible backstop 2002 is aligned with one or more magnet interfaces between individual magnets in the second array of magnets at least because the backstop 2002 is arranged longitudinally in between the array of magnets on either side of the backstop 2002; therefore, the one or more narrow portions will also necessarily align with the one or more magnet interfaces).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pate (U.S. Pre Grant Pub. No. 2017/0202616 A1).
Regarding claim 5, Pate teaches the invention as discussed above in claim 4. However, while in the embodiment of Figs. 20A-D, Pate fails to explicitly teach wherein the second catheter further comprises an insulative layer disposed between the flexible backstop and the second array of magnets, as required by the claim, Pate teaches, with respect to the embodiment of Fig. 1A, that the housing 102 of the catheter 100 may comprise one or more insulating materials which may shield or otherwise protect the catheter 100 and its components from heat generated by the electrode 106 during use (see para. [0069]).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Pate by combining components from various embodiments such that the second catheter further comprises an insulative layer disposed between the flexible backstop and the second array of magnets at least because Pate teaches that the components and characteristics of the devices described herein may be used in any combination, and the methods described herein may comprise all or a portion of the elements described herein. The description of certain elements or characteristics with respect to a specific figure are not intended to be limiting or nor should they be interpreted to suggest that the element cannot be used in combination with any of the other described elements (see para. [0237]). Therefore, a combination of the various structures disclosed in Pate is contemplated by the inventor(s). Additionally, one of ordinary skill in the art would have been reasonably motivated to include on the second catheter an insulative layer disposed between the flexible backstop and the second array of magnets at least in order to shield or otherwise protect the catheter and its components from heat generated by the electrode during use, as taught by Pate (see para. [0069]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Narayan (U.S. Pre Grant Pub. No. 2020/0238058 A1) - MAGNETIC PUNCTURE ACCESS AND DELIVERY SYSTEMS AND METHODS
Berman (U.S. Pre Grant Pub. No. 2020/0178970 A1) - METHODS FOR TREATING HYPERTENSION AND REDUCING BLOOD PRESSURE WITH FORMATION OF FISTULA
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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