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 Objections
Claim 6 objected to because of the following informalities: “any of claim 5” should be amended to --claim 5--. Appropriate correction is required.
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 1-9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bloom (US 2013/0158536).
Regarding claim 1, Bloom discloses a system for forming a fistula between two vessels (see Figs. 1-4, considered capable of forming a fistula via the extended electrode configuration shown in Fig. 3), the system comprising a first catheter (see Figs. 1-4), the first catheter comprising: a housing having a proximal section (see bolt circle 120, exterior shaft 170, [0055]; or the tubular interior shaft 110) and a distal section (see bolt circle 150, [0055]); an electrode disposed at least partially within the housing (see one of the electrodes 140 disposed partially within the housing sections; [0064] and [0092], Figs. 1-4), the electrode comprising a distal portion connected to the distal section of the housing (see distal end fixed to distal bolt circle 150, [0064]), a proximal portion connected to the proximal section of the housing (see proximal end of 140 connected to proximal bolt circle 120, [0092]) and an intermediate portion therebetween for contacting a vessel wall and forming the fistula (see portion of 140 between bolt circles 120 and 150); wherein the proximal housing section and the distal housing section are longitudinally moveable with respect to each other to move the electrode between a contracted configuration and an expanded configuration (see [0092], Figs. 2 and 3).
Regarding claim 2, Bloom further discloses wherein the proximal housing section and the distal housing section are connected via at least one flexible connection element (see electrodes 140 acting as flexible connection elements, [0065]).
Regarding claim 3, Bloom further discloses wherein the at least one flexible connection element comprises a catheter sleeve (when the device 100 is passed through catheter sheath 170 as described in [0055], the proximal and distal portions are considered connected via the sleeve since the sleeve would cover and connect both sections).
Regarding claim 4, Bloom further discloses wherein the catheter sleeve is disposed around at least the proximal and distal sections of the housing (see sheath 170 disposed around both sections as they are passed through the catheter sleeve, [0055]).
Regarding claim 5, Bloom further discloses herein the at least one flexible connection element comprises a ribbon, wire or microspring (see electrodes 140 as ribbons of spring-like wire, [0066], Fig. 13).
Regarding claim 6, Bloom further discloses wherein the ribbon, wire or microspring is insulated (see [0096]).
Regarding claim 7, Bloom further discloses wherein the ribbon, wire or microspring is fixed to one of the housing sections and longitudinally moveable with respect to the other housing section (see electrodes being fixed to the distal bolt ring 150, however slidable relative to the inner tubular member 110, [0092]).
Regarding claim 8, Bloom further discloses wherein the ribbon, wire or microspring is fixed to the proximal housing section and longitudinally moveable with respect to the distal housing section (see proximal ends fixed to slidable ring 120 and longitudinally movable with respect to ring 150 when the slidable ring 120 slides, [0092]).
Regarding claim 9, Bloom further discloses wherein the ribbon, wire or microspring is in contact with the inner walls of the distal housing section (see distal end in contact with inner bore of 150, [0064]).
Regarding claim 11, Bloom further discloses wherein the proximal housing section and the distal housing section are not in contact in the contracted configuration (see rings 120 and 150 not being in contact with each other in the contracted configuration as shown in Fig. 3).
Regarding claim 12, Bloom further discloses wherein the electrode is a leaf spring (see Fig. 13, [0065]-[0066]).
Regarding claim 13, Bloom further discloses wherein the electrode has a convex portion (see convex bend as shown in Fig. 3).
Regarding claim 14, Bloom further discloses wherein the electrode is a ribbon wire (as shown in Fig. 13, [0065]-[0066]).
Regarding claim 15, Bloom further discloses wherein a distal end of the electrode is fixed to the distal section of the housing (see [0064]).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bloom in view of Sharkey et al. (US 6,447,508).
Regarding claim 10, Bloom discloses the limitations of claim 1, however fails to further disclose wherein a pull wire is connected to the distal housing section to allow the distal housing section to be moved longitudinally with respect to the proximal housing section.
Sharkey teaches a catheter having deformable electrode segments (see Figs. 2 and 3) wherein the distal section moved longitudinally to collapse and extend the electrode segments using a pull cable connected to the distal housing section (see pull cable 84; col. 6, line 56 - col. 7, line 10, Figs. 2-3). Therefore, 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 actuation mechanism for moving the housing sections as disclosed by Bloom to be a pull wire is connected to the distal housing section to allow the distal housing section to be moved longitudinally with respect to the proximal housing section in light of Sharkey, since the modification would have been a matter of simple substitution of one actuation mechanism for another for the predictable result of moving the housing sections relative to one another to expand and contract electrode segments.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bloom in view of Miller et al. (US 2012/0302935).
Regarding claim 16, Bloom discloses the limitations of claim 1, however Bloom fails to further disclose wherein the housing is at least partially made from a ceramic material.
Miller teaches a device for forming a fistula having a protruding electrode (see Fig. 4) and further including a nesting material as part of the housing for the electrode, wherein the nesting material comprises a ceramic (see [0054]-[0055]). Therefore, 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 housing as disclosed by Bloom to be at least partially made from a ceramic material as nesting material for the electrode in light of Miller, the motivation being to effectively hold the electrode in place while moving through blood vessels and provide beneficial thermal and electrical insulation (see Miller [0055]).
Claims 17-18, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bloom in view of Pate et al. (US 2017/0202616).
Regarding claim 17, Bloom discloses the limitations of claim 1, however fails to further disclose a second catheter comprising a second housing and a backstop for the electrode.
Pate teaches a catheter system for creating a fistula (see Figs. 15A-15B and 16) comprising a first catheter (see 1504, Fig. 15A-15B or 1604 in Fig. 16) and a second catheter comprising a housing and a backstop for the electrode of the first catheter (see 1500 having a housing and backstop 1502 for electrode 1506; [0111], Figs. 15A-15B; or 1600 and 1602 in Fig. 16). Therefore, 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 system as disclosed by Bloom to further include a second catheter comprising a second housing and a backstop for the electrode in light of Pate, the motivation being to provide the additional benefit of properly aligning the catheters and providing tissue compression to better achieve a fistula between two vessels (see Pate [0111] and [0113]).
Regarding claim 18, Pate further teaches wherein the first catheter and the second catheter comprise one or more sets of magnets positioned to align the electrode with the backstop (see [0180]-[0181]) and would have been further obvious to include in the system of Bloom for the same rationale as set forth above (alignment).
Regarding claim 23, Pate further teaches herein the backstop is a recessed backstop which has a portion shaped complementary to the electrode (see recessed portion that is shaped complementary to the electrode that the electrode fits within as shown in Fig. 16).
Regarding claim 25, Pate further teaches wherein the backstop is non-conductive (see [0108]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Farley et al. (US 6,014,589) discloses an expandable electrode configuration where the proximal ends of the electrodes are attached proximally and free on their distal ends (see Figs. 1 and 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794