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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2026.
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.
Claim(s) 1-4, 7-10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. WO 2006026912 A1, herein referred to as Wang, in view of Hosny et al. US 6676691 B1, herein referred to as Hosny.
Regarding claim 1, Wang discloses a transcatheter heart valve implant apparatus (Fig 28, 9)
comprising: an annular valve prosthesis (see annotated Fig 29 below) extending along a longitudinal axis (defined by center of the prosthesis) between an inflow end of the valve prosthesis (defined by the axis along the centers of stent) and an outflow end of the valve prosthesis (inflow and outflow defined by the top and bottom of the annotated annular valve shown below in Fig 29);
an inner shaft member (Fig 28, conveying pipe 91) extending along a shaft axis through the valve prosthesis between a proximal shaft end (opposite end of shaft) and a distal shaft end (end near tip 97), the inner shaft member comprising:
a first guidewire (Fig 28, guidewire 94 exiting 9112) extending through […] and the first exit opening (9112), wherein a first end (proximal portion wire 43) of the first guidewire is configured to be positioned at a first anchoring location ([0131] “Each of the guide wires 94 and the locking wire 92 protrudes from the front end of the conveying pipe through the conveying pipe, and the wire fixing bolt 95 can be screwed on the nozzle of the wire drawing pipe for fixing the wire,” anchored by fixing plot 95);
wherein a second end (proximal portion wire 43) of the second guidewire is configured to be positioned at a second anchoring location simultaneously with the first guidewire positioned at the first anchoring location ([0131] “Each of the guide wires 94 and the locking wire 92 protrudes from the front end of the conveying pipe through the conveying pipe, and the wire fixing bolt 95 can be screwed on the nozzle of the wire drawing pipe for fixing the wire,” anchored by fixing plot 95; Wang teaches using one fixing wire throughout the system, therefore, anchoring would anchor all guidewire simultaneously. Wang is silent regarding independent anchoring).
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Wang does not disclose a first lumen extending between the proximal shaft end and a first exit opening at the distal shaft end; and a second lumen extending adjacent to the first lumen between the proximal shaft end and a second exit opening spaced a distance from the distal shaft end, a shaft wall positioned between the first lumen and the second lumen; and a second guidewire extending through the second lumen and the second exit opening.
However, Hosny discloses a similar transcatheter prosthesis delivery apparatus ([0005]).
Hosny teaches an inner shaft (Fig 3, 40) and a first guidewire (guidewire 36), a first lumen (lumen 48) extending between the proximal shaft end (left end) and a first exit opening (opening 52) at the distal shaft end (end near tip 42);
and a second lumen (lumen 50) extending adjacent to the first lumen between the proximal shaft end and a second exit opening (opening 54) spaced a distance from the distal shaft end (Fig 3), a shaft wall positioned between the first lumen and the second lumen (see annotated Fig 3 below); and a second guidewire (guidewire 38) extending through the second lumen and the second exit opening.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the inner shaft and tip of wang to incorporate a first lumen extending between the proximal shaft end and a first exit opening at the distal shaft end; and a second lumen extending adjacent to the first lumen between the proximal shaft end and a second exit opening spaced a distance from the distal shaft end, a shaft wall positioned between the first lumen and the second lumen; and a second guidewire extending through the second lumen and the second exit opening, as taught and suggested by Hosny to allow each opening to operate with different pressure changes (Hosny [0011]).
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Regarding claim 2, the combination as made of Wang and Hosny, specifically Hosny teaches further comprising a tip (narrowed end of shaft 42) on the distal shaft end (distal end defined as end opposite to the proximal), the tip comprising a tip lumen (portion of lumen 48 near narrowing of 42) that is aligned with the first lumen such that the first guidewire extends through the tip lumen (Hosny Fig 3).
Since Hosny teaches further comprising a tip on the distal shaft end, the tip comprising a tip lumen that is aligned with the first lumen such that the first guidewire extends through the tip lumen, which would be incorporated in the inner shaft when the modification is made.
However, Hosny does not explicitly disclose wherein a tip attached to the distal shaft end.
Moreover, Wang teaches where in the tip is attached to the distal shaft (Fig 28, 94).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention the tip of Hosny to be attached to the distal shaft end, as taught and suggested by Wang in order to allow the tip to be made of softer material (Wang [131]).
Regarding claim 3, the combination as made of Wang and Hosny, specifically Hosny teaches wherein the second exit opening is spaced apart from the tip (Hosny Fig 3).
Since Hosny teaches wherein the second exit opening is spaced apart from the tip, which would be incorporated in the inner shaft when the modification is made.
Regarding claim 4, the combination as made of Wang and Hosny, specifically Wang teaches wherein the first anchoring location comprises a first pulmonary artery branch ([0067] ([0159] [0116], [0126]]; teaching artery branch locations 021 and 022 in Fig 24, valve 7; openings 9112 shown in Figs 28-29 allows to artery branch locations for anchoring as guidewires 94 exit the valve frame), but does not explicitly disclose wherein the second anchoring location comprises a second pulmonary artery branch.
However, in another embodiment, Hosny the second anchoring location comprises a second artery branch (Fig 6, 14; wire in second branch).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the position and configuration of Wang to incorporate wherein the second anchoring location comprises a second pulmonary artery branch, as taught and suggested by Hosny in order to treat bifurcated vessel or arteries (Hosny [0005]).
Regarding claim 7, the combination as made of Wang and Hosny teaches, specifically Wang wherein the first lumen comprises a first diameter that is within a range from about 0.5 millimeters to about 1.5 millimeters, and the second lumen comprises a second diameter that is within a range from about 0.5 millimeters to about 1.5 millimeters (see para [0131], guidewire diameters taught to be 0.36-0.89 mm; While Wang does not teach the specific range, the claimed ranges are within the ranges taught by Wang, see MPEP 2144.05 I).
It would have been obvious to house Wang’s guidewires sized between 0.36-0.89 mm in similarly sized lumens. In the case, where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541
F.2d 257, 191 USPQ 90 (CCPA 1976). The courts have found that the overlapping endpoint of
the prior art and claimed range was sufficient to support an obviousness rejection, particularly
when there was no showing of criticality of the claimed range, also refer to In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
Regarding claim 8, the combination as made of Wang and Hosny teaches, specifically Hosny teaches wherein the first lumen is substantially parallel to the second lumen (Fig 3).
Since Hosny teaches wherein the first lumen is substantially parallel to the second lumen, which would be incorporated in the inner shaft when the modification is made.
Regarding claim 9, Wang disclose a transcatheter heart valve implant apparatus (Fig 28, 9) comprising: an annular valve prosthesis (see annotated Fig 29 below) extending along a longitudinal axis (defined by center of the prosthesis) between an inflow end of the valve prosthesis (defined by the axis along the centers of stent) and an outflow end of the valve prosthesis (inflow and outflow defined by the top and bottom of the annotated annular valve shown below in Fig 29);
an inner shaft member (Fig 28, conveying pipe 91) extending along a shaft axis through the valve prosthesis between a proximal shaft end (opposite end of shaft) and a distal shaft end (end near tip 97), the inner shaft member comprising:
a first guidewire (Fig 28, guidewire 94 exiting 9112) extending through […] and the first exit opening (9112),
wherein a first end (proximal portion wire 43) of the first guidewire is configured to be positioned at in a first pulmonary artery branch ([0131] “Each of the guide wires 94 and the locking wire 92 protrudes from the front end of the conveying pipe through the conveying pipe, and the wire fixing bolt 95 can be screwed on the nozzle of the wire drawing pipe for fixing the wire,” anchored by fixing plot 95);
wherein a second end (proximal portion wire 43) of the second guidewire is configured to be positioned in a second anchoring location simultaneously with the first guidewire positioned in the first pulmonary artery branch ([0131] “Each of the guide wires 94 and the locking wire 92 protrudes from the front end of the conveying pipe through the conveying pipe, and the wire fixing bolt 95 can be screwed on the nozzle of the wire drawing pipe for fixing the wire,” anchored by fixing plot 95; Wang teaches using one fixing wire throughout the system, therefore, anchoring would anchor all guidewire simultaneously. Wang is silent regarding independent anchoring).
Wang does not disclose a first lumen extending between a first entry opening at the proximal shaft end and a first exit opening at the distal shaft end; and a second lumen extending adjacent to the first lumen between a second entry opening at the proximal shaft end and a second exit opening spaced a distance from the distal shaft end, a shaft wall positioned between the first lumen and the second lumen; a first guidewire extending through the first entry opening, the first lumen, and the first exit opening; and wherein a second guidewire extending through the second entry opening, the second lumen, and the second exit opening, wherein a second end of the second guidewire is configured to be positioned in a second pulmonary artery branch simultaneously with the first guidewire positioned in the first pulmonary artery branch.
However, Hosny discloses a similar transcatheter prosthesis delivery apparatus ([0005]).
Hosny teaches an inner shaft (Fig 3, 40) and a first guidewire (guidewire 36), a first lumen (lumen 48) extending between a first entry opening (see annotated Fig 3 II below) at the proximal shaft end (left end) and a first exit opening (opening 52) at the distal shaft end (end near tip 42);
and a second lumen (lumen 50) extending adjacent to the first lumen between a second entry opening (see annotated Fig 3 II below) at the proximal shaft end and a second exit opening (opening 54) spaced a distance from the distal shaft end (Fig 3), a shaft wall positioned between the first lumen and the second lumen (see annotated Fig 3 below); and a second guidewire (guidewire 38) extending through the second lumen and the second exit opening (Fig 3);
and wherein a first end (distal end of 36) of the first guidewire is configured to be positioned in a first […] artery branch (Fig 6, 16); and the second guidewire extending through the second entry opening, the second lumen, and the second exit opening, wherein a second end (distal end of 38) of the second guidewire is configured to be positioned in a second artery branch (Fig 6, 14) simultaneously with the first guidewire positioned in the first pulmonary artery branch (Fig 14).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the inner shaft and tip of wang to incorporate a first lumen extending between a first entry opening at the proximal shaft end and a first exit opening at the distal shaft end; and a second lumen extending adjacent to the first lumen between a second entry opening at the proximal shaft end and a second exit opening spaced a distance from the distal shaft end, a shaft wall positioned between the first lumen and the second lumen; a first guidewire extending through the first entry opening, the first lumen, and the first exit opening; and wherein a second guidewire extending through the second entry opening, the second lumen, and the second exit opening, wherein a second end of the second guidewire is configured to be positioned in a second pulmonary artery branch simultaneously with the first guidewire positioned in the first pulmonary artery branch., as taught and suggested by Hosny to allow each opening to operate with different pressure changes (Hosny [0011]).
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Regarding claim 10, the combination as made of Wang and Hosny, specifical Wang teaches further comprising a guide member (Fig 28, fixation plug 96) attached to the proximal shaft end of the inner shaft member.
Regarding claim 13, the combination as made of Wang and Hosny, specifically Hosny teaches further comprising a tip (narrowed end of shaft 42) on the distal shaft end (distal end defined as end opposite to the proximal), the tip comprising a tip lumen (portion of lumen 48 near narrowing of 42) that is aligned with the first lumen such that the first guidewire extends through the tip lumen (Hosny Fig 3).
Since Hosny teaches further comprising a tip on the distal shaft end, the tip comprising a tip lumen that is aligned with the first lumen such that the first guidewire extends through the tip lumen, which would be incorporated in the inner shaft when the modification is made.
However, Hosny does not explicitly disclose wherein a tip attached to the distal shaft end.
Moreover, Wang teaches where in the tip is attached to the distal shaft (Fig 28, 94).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention the tip of Hosny to be attached to the distal shaft end, as taught and suggested by Wang in order to allow the tip to made of softer material (Wang [0131]).
Regarding claim 14, the combination as made of Wang and Hosny, specifically Hosny teaches wherein the second exit opening is spaced apart from the tip (Hosny Fig 3).
Since Hosny teaches wherein the second exit opening is spaced apart from the tip, which would be incorporated in the inner shaft when the modification is made.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Hosny, and further in view of Foster et al. US 20180140323 A1, herein referred to as Foster.
Regarding claim 5, the combination as made of Wang and Hosny does not disclose further comprising an outer sheath circumferentially surrounding the valve prosthesis and the inner shaft member, the outer sheath movable relative to the inner shaft member such that in a first delivery position, the second exit opening is within a sheath chamber of the outer sheath, and in a second delivery position, the second exit opening is outside of the sheath chamber.
Foster discloses a similar transcatheter heart valve implant apparatus (Fig 1, 10). Foster teaches further comprising an outer sheath (12) circumferentially surrounding the valve prosthesis and the inner shaft member (Fig 1, 32), the outer sheath movable relative to the inner shaft member such that in a first delivery position [0013], the second exit opening is within a sheath chamber of the outer sheath [0013], and in a second delivery position, the second exit opening is outside of the sheath chamber [0021].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the inner shaft and add a sheath to the assembly of Wang as modified by Hosny to incorporate further comprising an outer sheath circumferentially surrounding the valve prosthesis and the inner shaft member, the outer sheath movable relative to the inner shaft member such that in a first delivery position, the second exit opening is within a sheath chamber of the outer sheath, and in a second delivery position, the second exit opening is outside of the sheath chamber, as taught and suggested by Foster in order to give the device a low profile (Foster [0047]).
Regarding claim 6, the combination of Wang, Hosny and Foster, specifically Foster teaches wherein the inner shaft member is configured to be rotatable relative to the outer sheath such that in a first rotational position ([0062] and [0064]), the second exit opening faces a first location of the outer sheath, and in a second rotational
position, the second exit opening faces a second location of the outer sheath ([0062] and
[0064]).
Since Foster teaches wherein the inner shaft member is configured to be rotatable relative to the outer sheath such that in a first rotational position, the second exit opening faces a first location of the outer sheath, and in a second rotational position, the second exit opening faces a second location of the outer sheath, which would be incorporated in the inner shaft when the modification is made.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Hosny, and Wilson et al. US 6221090 B1, herein referred to as Wilson.
Regarding claim 11, the combination as made of Wang and Hosny, does not disclose wherein the guide member comprises: a first passageway that is aligned with the first entry opening of the first lumen such that the first guidewire extends through the first passageway, the first entry opening, and the first lumen, the first passageway extending along a first guide axis; and a second passageway that is aligned with the second entry opening of the second lumen such that the second guidewire extends through the second passageway, the second entry opening, and the second lumen, the second passageway extending along a second guide axis.
However, in the same field of endeavor, Wilson discloses similar prosthesis implant delivery apparatus. Wilson teaches wherein the guide member (Fig 47, port 140a) comprises: a first passageway (125) that is aligned with the first entry opening (see annotated Fig 47 below) of the first lumen such that the first guidewire (151) extends through the first passageway (Fig 7), the first entry opening, and the first lumen (140), the first passageway extending along a first guide axis (defined by tube); and a second passageway that is aligned with the second entry opening (see annotated Fig 47 below) of the second lumen such that the second guidewire extends through the second passageway, the second entry opening, and the second lumen, the second passageway extending along a second guide axis (Fig 47; axis defined by the second guide wire center).
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Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the guide member and internal structure of the inner member of Wang as modified by Hosny to incorporate wherein the guide member comprises: a first passageway that is aligned with the first entry opening of the first lumen such that the first guidewire extends through the first passageway, the first entry opening, and the first lumen, the first passageway extending along a first guide axis; and a second passageway that is aligned with the second entry opening of the second lumen such that the second guidewire extends through the second passageway, the second entry opening, and the second lumen, the second passageway extending along a second guide axis, as taught and suggested by Wilson in order to provide torque to the guidewires as needed [0063].
Regarding claim 12, the combination as made of Wang, Hosny, and Wilson, specifically Hosny teaches wherein an angle between the first guide axis and the second guide axis is within a range from about 20 degrees to about 60 degrees ([0039] Hosny teaching bifurcating in an acute angle, angle below 90 degrees. Therefore, making the angle between the first guide axis and the second guide axis within a range from about 20 to about 60 degrees would have been obvious because the prior art teachings having the passageways and lumens at acute angles, thus making it an obvious modification to have the angle axis within the claimed ranged; since Hosny teaches wherein an angle between the first guide axis and the second guide axis is within a range from about 20 degrees to about 60 degrees, which would be incorporated in inner member when the modification is made.)
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
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