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
Claims 11 and 12 are objected to because of the following informalities:
Regarding Claim 11, "Vascular prosthesis according to claim 6" should read as "The vascular prosthesis of claim 6" to provide consistency throughout all of the claims. Appropriate correction is required.
Regarding Claim 12, "Implantation device comprising a vascular prosthesis according to claim 1" should read as "An implantation device comprising" to provide consistency throughout all of the claims. 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.
Claims 1-3 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6033435 A (hereafter --Penn--).
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Regarding Claim 1, Penn discloses a vascular prosthesis configured to be implanted in a vessel, having substantially a T-shape (see annotated vascular prosthesis 100 in Figures 16 below), comprising a proximal tubular part forming the base of the "T" and a distal tubular part forming the head of the "T" (see annotated proximal tubular and distal tubular parts in Figure 16 below), wherein: the proximal tubular part has a first lumen, the distal tubular part has a second lumen and the first and second lumens are fluidly connected to form a common lumen (see annotated first and second lumens in Figure 16 below);
the distal tubular part comprises a first end portion, a second end portion, and an intermediate portion extending axially between the first and second end portions the intermediate portion being provided with a lateral window from which the proximal tubular part extends (see annotated lateral window in Figure 15 below, in which the claim doesn’t state a direction of “extends”, the lateral window being surrounded by a peripheral frame (see annotated first end portion, second end portion, intermediate portion, lateral window, and peripheral frame in Figure 15 below); the first end portion and the intermediate portion are radially expandable (see Abstract);
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the flap being opposed to a circumferential indentation of the second end portion in the unfolded position (see annotated circumferential indentation in Figures 15 and 16 below, the indentation being the top point of the annotated structure, the point directed towards the opposite direction that the flap extends from the second portion to, the limitation “indentation” being interpreted broadly, as meaning “an angular cut (such as a notch) or something resembling such a cut in an edge” (see Merriam Webster definition 2a), the point in the red circle in Figure 16 below being the “indentation”); the flap has a structural frame comprising an arched segment (see arched segment in Figures 15 and 16 below); and the arched segment is connected at its ends to the intermediate portion (see annotated intermediate portion and end in Figure 15 below, the other end being on the other side of the flap that is not visible in the Figure), on each side of the peripheral frame (see end connected to side of peripheral frame that is visible in the figure in Figure 16 below, the other side not visible the figure being the other of the “each side” of the peripheral frame), and surrounds a portion of the peripheral frame in the unfolded position (see end connected to side of peripheral frame that is visible in the figure in Figure 16 below, the other side not visible the figure being the other of the “each side” of the peripheral frame, the ends “surrounding” the portions of the peripheral frame that it is connected to).
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The limitation “the second end portion is formed by a flap movable between a folded position in which the flap is folded inside the second lumen and an unfolded position in which the flap is axially deployed” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the specification disclosing that the flaps can be bent and that the stent is expandable (see Abstract, see column 4, lines 9-12 denoting that the stent can be expanded, see also column 12, lines 66- column 13 line 2 denoting that the flaps can be bent), the flaps are capable of being movable between a folded position in which the flap is folded inside the second lumen and an unfolded position in which the flap is axially deployed.
The limitation “the arched segment being bendable so as to form a joint for the folding/unfolding movement of the flap” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the specification disclosing that the flaps can be bent and that the stent is expandable, and the flaps being able to be bent at the arched segment (see annotated arched augment in Figure 15 below, see also Abstract, see column 4, lines 9-12 denoting that the stent can be expanded, see also column 12, lines 66- column 13 line 2 denoting that the flaps can be bent), the arched segment of the flaps are capable of being bendable so as to form a joint for the folding/unfolding movement of the flap.
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Regarding Claim 2, Penn discloses the vascular prosthesis of claim 1.
The limitation “wherein the arched segment is elastically bendable between an unstable bent position corresponding to the folded position of the flap and a stable unbent position corresponding to the unfolded position of the flap” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the specification disclosing that the flaps can be bent and that the stent is expandable (see annotated arched augment in Figure 15 above, see also Abstract, see column 4, lines 9-12 denoting that the stent can be expanded, see also column 12, lines 66- column 13 line 2 denoting that the flaps can be bent), and the flaps being able to be bent at the arched segment (see annotated arched augment in Figure 15 above being bent and arched), the arched segment of the flaps are capable of being elastically bendable between an unstable bent position corresponding to the folded position of the flap and a stable unbent position corresponding to the unfolded position of the flap.
Regarding Claim 3, Penn discloses the vascular prosthesis of claim 1, wherein in the deployed position, the circumferential width of the flap decreases with the distance from the intermediate portion (see annotated flap in Figure 18 below, the flap including the last two undulations of the frame 110 as part of the “flap,” hence the flap tapers to the part 111, with its width decreasing with the distance from the intermediate portion of the frame).
Regarding Claim 5, Penn discloses the vascular prosthesis of claim 1, wherein in the unfolded position, the flap is outwardly offset with respect to the axial direction of the distal tubular part (see annotated unfolded position and axis of the distal tubular part in Figure 18 below).
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Regarding Claim 6, Penn discloses the vascular prosthesis of claim 1, wherein the structural frame of the flap further comprises at least one finger connected to the arched segment (see annotated finger in Figure 15 above, the finger connected to the arched portion as it is all interconnected).
Regarding Claim 7, Penn discloses the vascular prosthesis of claim 6, wherein the at least one finger extends from the middle of the arched segment (see annotated finger in Figure 15 above, the “middle” being the center along the long axis of the flap 111).
Regarding Claim 8, Penn discloses the vascular prosthesis of claim 6, wherein the at least one finger extends perpendicularly from the arched segment (see annotated finger in Figure 15 below, the finger indirectly extending from the middle of the arched portion as it is all interconnected, the finger being perpendicular to the arched segment).
Regarding Claim 9, Penn discloses the vascular prosthesis of claim 6, wherein the at least one finger has a distal end with a hole (see annotated distal end and hole in Figure 20 below, see also column 13, lines 28-35).
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Regarding Claim 10, Penn discloses the vascular prosthesis of claim 6, wherein the at least one finger has a distal end with a widening (see annotated finger in Figure 20 above). The limitation “widening” is being given its broadest reasonable interpretation, meaning “to increase the width, scope, or extent of”. Since the annotated distal end of the finger has a hole towards the inside end then is full and complete towards the outside end, it has widened as it has increased the extent of and scope of the material of the finger. Alternatively, the “distal end” of the finger would be the edge farthest from the flap (111/112). Since the claim doesn’t state what the “widening” is compared to, the long distal edge of the finger (117/118 as a whole) is wider than the short sides (see annotated short sides and “distal end” in Figure 20 below).
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Regarding Claim 11, Penn discloses the vascular prosthesis of claim 6, wherein the at least one finger comprises at least one fold, so that, in the deployed position, the finger extends outwardly from the central axis of the distal tubular part (see annotated fold being the corner in the annotated box in Figure 20, see also finger in Figures 15 and 16 above extending outward from the center of the distal tubular part).
Regarding Claim 12, Penn discloses an implantation device comprising a vascular prosthesis according to claim 1 with the flap in the folded position (see column 4, line 61 to column 5, line 4 denoting the stent is in a contracted position), a sheath and a link between the sheath and the vascular prosthesis (see annotated sheath and implantation device in Figure 12 below, see also column 11, lines 18-25 denoting that sheaths have balloons within them that fill with air and press up against the inside of the vascular prosthesis, thereby “linking” the sheath and the prosthesis together since the balloon is attached to both components, see also column 11 line 65 to column 12 lines 1-2).
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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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 6033435 A (hereafter --Penn--).
Regarding Claim 4, Penn discloses the vascular prosthesis of claim 1, in which the width of the flap in comparison to the lumen is clearly a small fraction of the second lumen circumference, as shown in Figures 15, 16, and 18 above).
Penn fails to disclose the specific size of the flaps in comparison with the size of the second lumen, specifically wherein the circumferential distance along the flap between the ends of the arched segment (see annotated ends of the arched segment) is comprised between 10% and 50% of the total circumference of the second lumen.
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However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150250626 A1: This reference discloses vascular prosthesis configured to be implanted in a vessel, having substantially a T-shape (see annotated vascular prosthesis 10 in Figure 2A below), comprising a proximal tubular part forming the base of the "T" and a distal tubular part forming the head of the "T" (see annotated proximal tubular and distal tubular parts in Figure 2A below), wherein: the proximal tubular part has a first lumen, the distal tubular part has a second lumen and the first and second lumens are fluidly connected to form a common lumen (see annotated first and second lumens in Figure 2A below); the distal tubular part comprises a
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774