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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I directed towards an implant delivery system and species 1 directed towards the embodiment of figures 1-2 in the reply filed on 8/25/2026 is acknowledged.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
In regard to claims 1, the preamble states “characterized in comprising”. “Characterized in” should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 5 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “near” in claim 5 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant disclosure does not provide any further definition for the scope of near.
Since claims 6-10 depend from claim 5, claims 6-10 are also rejected under 112b.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marchand (2021/0030540).
In regard to claim 1, Marchand discloses an implant delivery system 10 adapted to deliver a cardiovascular prosthetic implant 12, characterized in comprising:
an outer sheath (108);
a balloon 28 and a balloon tube 16, the balloon 28 being connected to a distal end of the balloon tube 16 [0061];
and a nose cone 32 and a guidewire tube 18, the nose cone 32 being connected to a distal end of the guidewire tube 18 [0062];
wherein the balloon tube 16 and the guidewire tube 18 are disposed within the outer sheath (108 or 122) in a longitudinal extension manner and are configured to be operable to pass through a distal end of the outer sheath. [0060-0061; fig 1, 7A]
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.
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (2021/0030540) in view of Klausen (2020/0230371A1).
In regard to claim 2, Marchand meets the claim limitations as discussed in the rejection of claim 1, and further teaches that, the guidewire tube is disposed to partially extend through the balloon tube. (nose catheter 18 extends through balloon catheter 16; 0060, fig 1)
However, Marchand does not teach the guidewire tube includes a free segment and a bound segment as claimed.
Kausen teaches the guidewire 28 includes a free segment (segment of guidewire 28 outside the balloon catheter 12 in fig 7) and a bound segment (segment of 28 through balloon catheter 12 in fig 7) adjacent to the free segment (fig 7),
the bound segment is defined by a length of the guidewire extending longitudinally through the balloon tube (fig 7),
the free segment is defined by a length of the guidewire 28 located outside of the balloon tube and extending longitudinally in parallel with the balloon tube (fig 7, capable of being placed in a parallel manner depending how the guidewire is pulled since it is flexible).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery system of Marchand to include the guide wire configuration to include the free and mount segments of the guidewire of Klausen in order to facilitate independent manipulation of the guide wire and balloon tube and control positioning of the balloon.
In regard to claim 3, Marchand meets the claim limitations as discussed in the rejection of claim 2, and further teaches the guidewire tube 18 is configured to be longitudinally movable relative to the balloon tube 16. [0060; fig 1; nose catheter 18 slides longitudinally relative to balloon catheter 16]
In regard to claim 4, Marchand meets the claim limitations as discussed in the rejection of claim 3, but does not teach the balloon tube includes a proximal segment tube, a middle segment tube and a distal segment tube as claimed.
Klausen teaches the balloon tube 12 includes a proximal segment tube 18, a middle segment tube (middle segment of 12 as shown in figures 8-9 with stiffening features) and a distal segment tube 44,
the middle segment tube (middle portion of 12) is located between the proximal segment tube 18 and the distal segment tube 44 (fig 8-9)
and the bound segment of the guidewire tube 28 extends longitudinally through the distal segment tube 44 (see fig 3);
wherein the outer diameter of the middle segment tube (middle portion of 12) is smaller than that of the proximal segment tube 18. (see figure 2)
[0004: designed to increase rigidity along its length towards the proximal end]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the catheter of Marchand to include the proximal middle and distal segment tubes of Klausen (of varying stiffness) in the balloon tube in order to facilitate the bending and steering of the balloon catheter. [0004]
In regard to claim 5, Marchand meets the claim limitations as discussed in the rejection of claim 4, but does not teach a side wall opening as claimed.
Klausen further teaches a side wall opening 50 is provided near the proximal end of the distal segment tube 44 (fig 4), and the bound segment of the guidewire tube 28 extends longitudinally through the distal segment tube 44 via the side wall opening 50 (fig 4).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery system of Marchand to include the side wall opening and bound segment of the guidewire as taught by Klausen to facilitate independent manipulation of the guidewire.
In regard to claim 6, Marchand meets the claim limitations as discussed in the rejection of claim 5, but does not teach the distal segment tube is a double lumen tube.
Klausen further teaches the distal segment tube 44 is a double-lumen tube (at least two lumens as shown in the end in figures 3-4, 10, because the claim uses comprising may be more than two lumens; [0170: 4 lumens]), the double-lumen tube 44 has a first lumen 102 communicating with the balloon [0170: inflation lumen that leads to balloon 40] and a second lumen 100 isolated from the balloon (fig 10), the first lumen 102 is in communication with the lumen of the middle segment tube; (see fig 3-4)
and the bound segment of the guidewire tube 28 extends longitudinally through the second lumen 100 (guidewire lumen). (fig 7, 10)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery system of Marchand to include modify the distal segment tube to be a double lumen tube as taught by Klausen in order to allow for the use of a guidewire and inflation of the balloon without getting tangled or interfering with each other.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (2021/0030540) in view of Klausen (2020/0230371A1) and further in view of McCann (2016/0045311) and further in view of Hartley (7892275).
In regard to claim 9, Marchand meets the claim limitations as discussed in the rejection of claim 2, but does not teach a plurality of positioning wires and an inner sheath as claimed or that the proximal ends of the inner sheath, guidewire tube and balloon tube are non-nested with each other.
McCann teaches the delivery system further comprises a plurality of positioning wires 916 [0130: configured to function as a control wire]
and an inner sheath 904 adapted to accommodate the plurality of the positioning wires, (fig 6, 8a)
the plurality of the positioning wires 916 being configured such that distal ends thereof are connected to an implant; [0130: control wire for positioning the implant 800]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the inner sheath and positioning wires of McCann in the delivery system of Marchand because this will facilitate angular adjustment and positioning of the implant. [0130: allows angular adjustment of the implant]
Hartley teaches proximal ends of the sheath 112, guidewire tube 146 and a proximal end of the balloon tube 126 are configured to extend longitudinally through the outer sheath 106 in parallel and laterally non-nested with each other. (as shown in figure 3, all elements are non-nested a the proximal ends; Col 2, lines 25-40: inner sheath 112 which extends proximal and to a forward most position of 108 and within the outer sheath; access port 116 is for first access sheath 118; see proximal end of 112 in the left of figure 3)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the proximal end of the inner sheath of McCann, the proximal ends of the guidewire tube of Marchand and the balloon tube of Marchand within the outer sheath in parallel and laterally non-nested with each other via a manifold 114 as taught by Hartley because this prevents the tubes from interfering with each other.
In regard to claim 10, Marchand meets the claim limitations as discussed in the rejection of claim 9, and further teaches the delivery system 10 further comprises a handle 20 to which the proximal end of the outer sheath is connected (proximal end of 108 of shaft 22 is connected to handle 20 in figs 1, 7a);
the handle 20 is configured to drive the drive the outer sheath (108 of 22) to move proximally to release the implant 12. [0067-0068; figs 1, 7a]
Allowable Subject Matter
Claim(s) 7- 8 would be objected to as being dependent upon a rejected base claim if the 112b issue was corrected without significantly changing the claim scope.
In regard to claim 7, Marchand (2021/0030540) in view of Klausen (2020/0230371A1) meets all of the claimed limitations except teaches “an inner tube isolated from the inner cavity of the balloon is arranged inside the balloon; the second lumen is in communication with the inner tube from the proximal end of the inner tube; and the bound segment of the guidewire tube extends longitudinally through the inner tube” in combination with the other claimed limitations.
It is noted that the international search report seems to have interpreted both the inner tube and the guidewire tube as element 28.
In regard to claim 8, Marchand (2021/0030540) in view of Klausen (2020/0230371A1) meets all of the claimed limitations except “the cross section of the cavity of the first lumen of the distal segment tube is quasi crescent- shaped” in combination with the other claimed limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
