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 .
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.
Claims 1-10 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by MILLER et al. (US 2015/0080886).
Regarding claim 1, MILLER discloses a catheter (fig.1C; catheter 100) for endovascular treatment of a blood vessel, the catheter comprising: a treatment portion, a proximal magnetic array (proximal anchoring magnet 116) positioned proximal to the treatment portion, and a distal magnetic array (distal anchoring magnet 118) positioned distal to the treatment portion (fig.1C), wherein each of the proximal magnetic array and the distal magnetic array comprise: a first magnetic segment having a first polarity; and a second magnetic segment having a second polarity opposite to the first polarity, wherein the second magnetic segment is disposed adjacent to the treatment portion ([0101]: “ the magnets of an array may have alternating polarity (e.g., each magnet will have the opposite polarity as any adjacent magnets)).
Regarding claim 2, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein a length of the first magnetic segment is different from a length of the second magnetic segment [0101].
Regarding claim 3, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein the first magnetic segment comprises a length that is longer than a length of the second magnetic segment [0101].
Regarding claim 4, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein the second magnetic segment comprises at least two magnetic elements (fig.1C, see also [0101]).
Regarding claim 5, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein magnetic elements of the first and the second magnetic segments have substantially a same shape (fig.1C, see also [0101]).
Regarding claim 6, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein magnetic elements of the first and the second magnetic segments have equal magnetic strengths (fig.1C, see also [0101]).
Regarding claim 7, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein the second magnetic segment is disposed directly adjacent to the treatment portion so as to be positioned between the first magnetic segment and the treatment portion (fig.1C).
Regarding claim 8, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein the treatment portion comprises an electrode (fig.1C; electrode 102).
Regarding claim 9, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 8, further comprising a housing in which the electrode is disposed (fig.1C).
Regarding claim 10, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, further comprising a rotational indicator configured to indicate a rotational alignment of the catheter [006].
Regarding claim 11, MILLER discloses the catheter for endovascular treatment of a blood vessel of claim 1, wherein the second magnetic segment of the proximal magnetic array has a same polarity as the second magnetic segment of the distal magnetic array [0101].
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.
Claims 12-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over PATE et al. (US 20140276335).
Regarding claim 12 and 17-18,Pate discloses a system for endovascular treatment of a blood vessel (fig.1), the system comprising: a first catheter (fig.1; first catheter 101) and a second catheter (fig.1; second catheter 103), each of the first catheter and the second catheter comprising a treatment portion (fistula-forming element 109); a proximal magnetic element (fig.1; proximal magnetic elements 107) positioned proximal to the treatment portion (fig.1), and a distal magnetic element positioned distal to the treatment portion (the distal of magnetic elements 107). In this embodiment (fig.1), Pate does not disclose the magnetic elements being magnetic arrays, wherein each proximal magnetic array and each distal magnetic array comprises: a first magnetic segment having a first polarity; and a second magnetic segment having a second polarity opposite to the first polarity of the first magnetic segment, the second magnetic segment is disposed adjacent to the treatment portion, wherein the second polarity of second magnetic segment of the first catheter has a same polarity orientation as the second magnetic segment of the second catheter when the first catheter and the second catheter are aligned for endovascular treatment.
In another embodiment (fig.2B), Pate teaches each of the magnetic arrays (fig.2B; 221/223) and (fig.2B; 203) are divided into a plurality of regions (fig.2B; see also [0040]), wherein each region has a magnetic polarity (fig.2B). The direction of the polarities of the regions may change from one region to the next according to a magnetization pattern (fig.2A; see also [0037]). Pate teaches wherein each proximal magnetic array and each distal magnetic array comprises: a first magnetic segment having a first polarity (227); and a second magnetic segment (225/229) having a second polarity opposite to the first polarity of the first magnetic segment, the second magnetic segment is disposed adjacent to the treatment portion (the proximal and distal end of the 221/223 may positioned adjacent to the treatment position when placed alone the catheter), wherein the second polarity of second magnetic segment of the first catheter has a same polarity orientation as the second magnetic segment of the second catheter when the first catheter and the second catheter are aligned for endovascular treatment. Pate clearly discloses that wherein each proximal magnetic array and each distal magnetic array comprises: a first magnetic segment having a first polarity; and a second magnetic segment having a second polarity opposite to the first polarity of the first magnetic segment, the second magnetic segment is disposed adjacent to the treatment portion, wherein the second polarity of second magnetic segment of the first catheter has a same polarity orientation as the second magnetic segment of the second catheter when the first catheter and the second catheter are aligned for endovascular treatment (fig.2B, see also [0041]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the first embodiment (fig.1) with plurality of magnetic segments configured to have polarities of the regions within a magnetization pattern may be positioned at any suitable angle as taught by the second embodiment (fig.2B) for the purpose of having the desired magnetic force between the two catheters.
Regarding claim 13, Pate discloses the system for endovascular treatment of a blood vessel of claim 12, wherein each of the second magnetic segments of the first catheter and the second catheter has substantially a same length (fig.1 or fig.2A).
Regarding claim 14, Pate discloses the system for endovascular treatment of a blood vessel of claim 12, wherein each of the second magnetic segments of the first catheter and the second catheter has substantially a same magnetic strength. The combination embodiment teaches that Pate contemplates magnetization pattern may be positioned at any suitable angle which includes at the angle that may provide the same magnetic strength [0041].
Regarding claim 15, Pate discloses the system for endovascular treatment of a blood vessel of claim 12, wherein the second magnetic segments of the first catheter attract the second magnetic segments of the second catheter when the second magnetic segments of the first catheter are aligned with the second magnetic segments of the second catheter (fig.2B).
Regarding claim 19, Pate teaches the method of claim 18, wherein modifying the first blood vessel at the treatment location comprises forming a fistula between the first blood vessel and the second blood vessel with the treatment portions of the first and second catheters [0027].
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over PATE et al. (US 20140276335) in view of Herlinger (US 2021/0022758).
Regarding claim 16 and 20, Pate does not teach the system for endovascular treatment of a blood vessel, wherein alignment of the treatment portions of the first and second catheters generates tactile feedback to a user.
Herlinger teaches an endovascular apparatus comprising magnetic coupler 41 is configured to generate a passive magnetic bond between the first and second device. The system is also configured to provide a tactile response to the user that they are at the pre-specified, e.g., zero, position [0042]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device of Pate with a catheter system that is configure to generate tactile feedback to a user as taught by Herlinger for the purpose of accurate and safe treatment.
Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794