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
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.
Claim(s) 1-11, 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fabro (Pub. No.: US 2013/0023758).
Regarding claim 1, Fabro discloses an adaptive guiding device, comprising:
a hollow flexible catheter, which is pre-shaped and has a bend in a natural state [see 0284];
wherein a distal part of the flexible catheter comprises a distal section [see 0203],
the distal section comprises a transition segment and a straight segment (distal tip 452) [see fig 4, 40A],
the transition segment is bendable so as to change an orientation of the straight segment (distal tip) [see fig 40A],
a bending force application point is adjacent to a connection of the transition segment with the straight segment [see 0417, 0223].
Regarding claim 2, Fabro discloses wherein the straight segment has a length I, where 0
< < 80 mm [see 0399].
Regarding claim 3, Fabro discloses wherein the length of the straight segment is in a
range of 40 to 80 mm [see 0399].
Regarding claim 4, Fabro discloses wherein the transition segment is pre-shaped into an
arc shape [see figs 37A-G].
Regarding claim 5, Fabro discloses wherein the transition segment has a central angle a5,
and an arc bend of the transition segment has a radius R5, where 15° ≤ a5 ≤ 70°, and 25 mm
≤ R5 ≤ 45 mm [see 0399].
Regarding claim 6, Fabro discloses wherein the flexible catheter comprises a main
section,
a trans-aortic arch section and the distal section connected in sequence from proximal
to distal and communicated with each other [see fig 12],
wherein the trans-aortic arch section has a curved structure simulating an aortic arch shape [see fig 12]
two ends of the transition segment are respectively tangent to the straight segment and the trans-aortic arch section [see fig 12].
Regarding claim 7, Fabro discloses wherein the flexible catheter in the natural state is
bent multiple times along its central axis toward different planes [see figs 37A-G, 14].
Regarding claim 8, Fabro discloses wherein the flexible catheter is bent at least five times [see figs 37A-G, 14].
Regarding claim 9, Fabro discloses wherein angles between planes of at least four
consecutive bends are less than 90° [see figs 37A-G, 14].
Regarding claim 10, Fabro discloses wherein an angle between two planes of one bend
closest to a distal end is greater than 90° [see figs 37A-G, 14].
Regarding claim 11, Fabro discloses wherein the trans-aortic arch section comprises:
a first arc segment, a second arc segment, a third arc segment and a fourth arc segment that are
sequentially connected and tangent one after another, the first arc segment, the second arc
segment, the third arc segment and the fourth arc segment are distributed on different planes [see fig 14],
wherein the first arc segment is connected and communicated with the main section, and
the fourth arc segment is connected and communicated with the distal section [see fig 14].
Regarding claim 15, Fabro discloses an operating handle, and the operating handle is connected to the main section and is configured to drive the flexible catheter to move axially and circumferentially [see fig 14, 0223].
Regarding claim 16, Fabro discloses wherein the adaptive guiding device further
comprises a pull assembly [see 0219],
wherein the pull assembly comprises a pull wire, a guiding passageway and an anchor ring, the guiding passageway is defined in a wall of the flexible catheter for the pull wire to pass through [see 0219],
the anchor ring is fixedly connected to the transition segment of the distal section, and the pull wire is connected to the anchor ring and the operating handle respectively [see 0219].
Regarding claim 17, Fabro discloses wherein the anchor ring is adjacent to the
connection of the transition segment with the straight segment [see 0219].
Regarding claim 18, Fabro discloses wherein a start point of the guiding passageway at
the distal section is A, point B is deflected by 90° relative to the point A in a circumferential
direction of the flexible catheter, and a transitional guiding section is formed between point A
and point B, wherein the transitional guiding section extends along a part or an entire of the
trans-aortic arch section, or a part or an entire the main section [see fig 14].
Regarding claim 19, Fabro discloses a treatment device movably received in the flexible catheter,
wherein the flexible catheter functions to establish a path from outside a human body to inside the human body [see fig 16A],
treatment device is configured to pass through an aortic arch via the flexible catheter [see 0156].
Regarding claim 20, Fabro discloses wherein the treatment device is selected
from at least one of a myocardial injection device, a myocardial ablation device, a valve repair
device, or a valve replacement device [see 0156].
Allowable Subject Matter
Claim 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: No prior arts of record alone or in combination discloses the following:
Claim 13
“wherein the first arc segment has an angle a1, an
arc bend of the first arc segment has a radius R1;
the second arc segment has an angle a2, an arc bend of the second arc segment has a radius R2;
the third arc segment has an angle a3, the arc bend of the third arc segment has a radius R3; and the fourth arc segment has an angle a4, and an arc bend of the fourth arc segment has a radius R4;
where 4.5° ≤ a1 ≤ 30°, 90 mm ≤ R1 ≤ 450 mm; 25° ≤ a2 ≤ 80°, 10 mm ≤ R2 ≤ 60 mm; 20° ≤ a3 ≤
70°, 25 mm ≤ R3 ≤ 50 mm; 20° ≤ a4 ≤ 110 °, 20 mm ≤ R4 ≤ 50 mm”
Claim 14
“wherein angles between a central axis of a projection of the straight segment on a first plane, a second plane, and a third plane,
respectively, and a central axis of a projection of the main section are α, ß, and Y respectively, wherein the first plane is a vertical plane, the second plane is perpendicular plane perpendicular to the vertical plane, and the third plane is a horizontal plane perpendicular to both the vertical plane and the perpendicular plane, where 35° ≤ a ≤ 85°, 25° ≤ ß ≤ 80°, and 20° ≤ Y ≤ 75°”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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