DETAILED ACTION
This action is in response to applicant's amendments filed 12/16/25.
The examiner acknowledges the amendments to the claims.
Claims 21-40 are pending in this application.
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 .
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection set forth in this office action.
Claim Objections
Applicant is advised that should claim 25 be found allowable, claim 35 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dwork (U.S. Pub. No. 2011/0257733).
Regarding claim 21, Dwork discloses a delivery device configured for transcatheter delivery of a collapsed and loaded prosthetic heart valve through a vasculature of a patient (see abstract) comprising:
a handle assembly 48 (Figures 3-4);
an inner shaft 44/80;
a sheath 46 slidably disposed over a distal portion of the inner shaft ([0050]), the sheath comprising:
an outer tubular layer 116 (Figures 6A-6B) extending along an elongated axis comprising a proximal portion, an intermediate portion, and a distal portion; and
a plurality of apertures 118 circumferentially positioned around the outer tubular layer (Id. and [0044]; cuts 118 are formed in a pattern about a circumference of tube 46), wherein each aperture of the plurality of apertures radially extends at least from an inner radial surface of the outer tubular layer to an outer peripheral surface of the outer tubular layer (Id.; cuts 118 are formed through a thickness of the tubular wall 116),
wherein the sheath is configured to selectively cover a prosthetic heart valve that is collapsed and loaded about the distal portion of the inner shaft during delivery (as in Figure 8A and 11B), as well as facilitate recapture of a partially expanded prosthetic heart valve ([0056]; cuts 118 at the distal end of the tube 46 facilitate expansion when distally advanced).
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.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Zhou et al., hereinafter “Zhou” (U.S. Pub. No. 2016/0296730).
Regarding claim 22, Dwork discloses the claimed invention, as discussed above including the plurality of apertures 118 comprises a first plurality of apertures circumferentially positioned around the distal portion of the outer tubular layer (Figure 6A; see row of distalmost cuts 118 of tube 46), and wherein each aperture of the first plurality of apertures further extends for a length in a proximal direction of the elongated axis from a first end to a second end of the aperture at the distal portion of the outer tubular layer (Id.; the cuts have a length that extends proximally).
However, Dwork does not teach that the first end of the aperture is configured to be open at a distal end of the outer tubular layer.
In the same field of art, namely delivery devices, Zhou teaches in Figures 32-33 and [0097] a sheath having a tubular layer 42 having a first plurality of apertures (first and second notches 90) in a distal portion, wherein each aperture extends for a length in a proximal direction of an elongated axis of the sheath from a first end of the aperture configured to be open at a distal end of the tubular layer to a second end of the aperture at the distal portion of the tubular layer (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the plurality of apertures in Dwork to have the first end of the aperture configured to be open as claimed, as taught by Zhou, since the open distal end apertures facilitate tip expansion and retrieval of an implant (Id.).
Regarding claim 23, Dwork as modified teaches the sheath further comprises a second plurality of apertures (Figure 6A, Dwork; see row of cuts 118 in middle portion of tube 46 that are rotationally offset from the distalmost row of cuts) circumferentially positioned around the intermediate portion of the outer tubular layer ([0044] cuts 118 are formed in a pattern about a circumference of sheath 46), wherein each aperture of the second plurality of apertures comprises an elongated aperture that extends for a length in the intermediate portion along the elongated axis (Id.).
Regarding claim 24, Dwork as modified teaches the first plurality of apertures are rotationally offset from the second plurality of apertures (Id.), but does not expressly teach being offset by approximately 90 degrees. Dwork teaches in [0044] that apertures 118 are formed in a pattern about a circumference of sheath 46, and in Figure 6A shows that rows along the length of the sheath are generally rotationally offset. It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified such that the first and second plurality of apertures are rotationally offset by approximately 90 degrees, in order to distribute the apertures in different portions of the sheath for even rotational expansion along the circumference and length. In addition, it appears that Dwork as modified would operate equally well with the apertures rotationally offset by approximately 90 degrees, and applicant has not disclosed that approximately 90 degrees solves any stated problem or is for any particular purpose ([0072] of present invention publication merely states that distal windows 310a, 310b are rotationally offset from the intermediate windows 312a, 312b by approximately ninety degrees).
Claims 25-26, 29-31, 35, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Forde et al., hereinafter “Forde” (U.S. Pub. No. 2008/0082083).
Regarding claims 25-26, 35, Dwork discloses the claimed invention, as discussed above, except for the sheath further comprises a covering layer circumferentially covering each aperture of the plurality of apertures, wherein an elasticity of the covering layer is greater than an elasticity of the outer tubular layer.
In the same field of art, namely delivery devices, Forde teaches a sheath 10 having apertures 22/68/66/64/69 (Figures 1 and 5) which may have a covering layer (outer elastomeric layer; [0036]) covering each aperture of the plurality of apertures (Id.; the elastomeric layer may be flush with the distal end of the sheath, therein covering the plurality of apertures), wherein an elasticity of the covering layer is greater than an elasticity of the outer tubular layer ([0036]-[0037] the sheath can include a wall formed of braided “high-stiffness material” and the covering layer includes an elastomeric layer which may provide a “less stiff” or “softer” distal tip of the sheath).
It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified with a covering layer as claimed, as taught by Forde, to help with controlled and consistent expansion of the sheath, and protect against snags ([0038]; Forde).
Regarding claim 29, Dwork as modified teaches the claimed invention, as discussed above, except for the sheath further comprises an inner tubular layer extending along the elongated axis, wherein the outer tubular layer is circumferentially positioned around the inner tubular layer
In the same field of art, namely delivery devices, in [0007], [0036] Forde teaches multiple layers of a sheath, wherein an innermost layer is an inner tubular layer.
It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified to include an inner tubular layer as claimed, as taught by Forde, in order to provide additional structural integrity to the sheath (Id.).
Regarding claims 30-31, Dwork as modified teaches the claimed invention, as discussed above, except for wherein the plurality of apertures is further circumferentially positioned around the inner tubular layer, wherein each aperture of the
plurality of apertures further radially extends at least from an inner radial surface of the inner tubular layer to an outer peripheral surface of the inner tubular layer, wherein each aperture of the plurality of apertures of the inner tubular layer is aligned with a corresponding aperture of the plurality of apertures of the outer tubular layer.
Forde teaches further teaches in [0007] that the plurality of apertures may be circumferentially positioned around the inner tubular layer (the apertures may “extend through the thickness of one or more layers of the sheath”, and therefore extends through both the outer tubular layer and the inner tubular layer), wherein each aperture of the plurality of apertures further radially extends at least from an inner radial surface of the inner tubular layer to an outer peripheral surface of the inner tubular layer (Id.), wherein each aperture of the plurality of apertures of the inner tubular layer is aligned (overlaps) with a corresponding aperture of the plurality of apertures of the outer tubular layer (Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified to include the plurality of apertures in the inner tubular layer as claimed, in order to still allow for further expansion of the sheath while providing additional structural integrity to the sheath.
Regarding claim 40, Dwork discloses a delivery device configured for transcatheter delivery of a collapsed and loaded prosthetic heart valve through a vasculature of a patient (see abstract) comprising:
a handle assembly 48 (Figures 3-4);
an inner shaft 44/80;
a sheath 46 slidably disposed over a distal portion of the inner shaft ([0050]), the sheath comprising:
an outer tubular layer 116 (Figures 6A-6B) extending along an elongated axis comprising a proximal portion, an intermediate portion, and a distal portion;
a plurality of apertures 118 circumferentially positioned around the intermediate portion of the outer tubular layer (Id. and [0044]; cuts 118 are formed in a pattern about a circumference of a middle portion of the tube 46), wherein each aperture of the plurality of apertures radially extends at least from an inner radial surface of the outer tubular layer to an outer peripheral surface of the outer tubular layer (Id.; cuts 118 are formed through a thickness of the tubular wall 116), and wherein each aperture of the plurality of apertures comprises an elongated aperture that extends for a length in the intermediate portion along the elongated axis (Id.),
wherein the sheath is configured to selectively cover a prosthetic heart valve that is collapsed and loaded about the distal portion of the inner shaft during delivery (as in Figure 8A and 11B), as well as facilitate recapture of a partially expanded prosthetic heart valve ([0056]; cuts 118 of the tube 46 facilitate expansion when distally advanced).
However, Dwork does not disclose an inner tubular layer extending along the elongated axis, wherein the outer tubular layer is circumferentially positioned around the inner tubular layer.
In the same field of art, namely delivery devices, in [0007], [0036] Forde teaches multiple layers of a sheath, wherein an innermost layer is an inner tubular layer.
It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified to include an inner tubular layer as claimed, as taught by Forde, in order to provide additional structural integrity to the sheath (Id.).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Thai et al., hereinafter “Thai” (U.S. Pub. No. 2010/0016832).
Regarding claim 27, Dwork as modified teaches the claimed invention, as discussed above, except for the outer tubular layer comprises a material comprising Nylon 12, although Dwork teaches that the outer tubular layer 116 may be made of nylon.
Thai teaches in paragraph [0027] an outer sheath being made of Nylon 12 that possesses sufficient stiffness and elasticity without reinforcement.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer tubular body to comprise a material including Nylon 12, as taught by Thai, in order to impart sufficient stiffness and elasticity and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Kick et al., hereinafter “Kick” (U.S. Pub. No. 2006/0135962).
Regarding claim 28, Dwork as modified teaches the claimed invention, as discussed above, except for the covering layer comprises polyether-urethane although Dwork teaches that the outer tubular layer 116 may be made of a biocompatible polymer material.
Kick teaches in paragraph [0030] an outer sheath being made of polyether polyurethane as an alternative to silicone material.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the covering layer to include polyether-urethane, as taught by Kick, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Forde (U.S. Pub. No. 2008/0082083).as applied to claim 30 above, and further in view of Zhou (U.S. Pub. No. 2016/0296730).
Regarding claim 32, Dwork as modified teaches the claimed invention, as discussed above, including the plurality of apertures comprises a first plurality of apertures (Figure 6A, Dwork; see row of distalmost cuts 118 of tube 46) circumferentially positioned around the distal portion of the outer tubular layer ([0044]; cuts 118 are formed in a pattern about a circumference of sheath 46) and the inner tubular layer, and wherein each aperture of the first plurality of apertures further extends for a length in a proximal direction of the elongated axis from a first end of the aperture of the corresponding outer tubular layer and inner tubular layer to a second end of the aperture at the distal portion of the corresponding outer tubular layer and inner tubular layer (as discussed above regarding claim 30; see apertures 118 Figure 6A of Dwork and the apertures may “extend through the thickness of one or more layers of the sheath” in [0007] of Forde).
However, Dwork does not teach that the first end of the aperture is configured to be open at a distal end of the outer tubular layer and inner tubular layer.
In the same field of art, namely delivery devices, Zhou teaches in Figures 32-33 and [0097] a sheath having a tubular layer 42 having a first plurality of apertures (first and second notches 90) in a distal portion, wherein each aperture extends for a length in a proximal direction of an elongated axis of the sheath from a first end of the aperture configured to be open at a distal end of the tubular layer to a second end of the aperture at the distal portion of the tubular layer (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the plurality of apertures in Dwork to have the first end of the aperture configured to be open as claimed, as taught by Zhou, since the open distal end apertures facilitate tip expansion and retrieval of an implant (Id.).
Regarding claim 33, Dwork as modified teaches the claimed invention, as discussed above, including the sheath further comprises a second plurality of apertures (Figure 6A, Dwork; see row of cuts 118 in middle portion of tube 46 that are rotationally offset from the distalmost row of cuts) circumferentially positioned around the intermediate portion of the outer tubular layer and the inner tubular layer ([0044]; cuts 118 are formed in a pattern about a circumference of sheath 46), wherein each aperture of the second plurality of apertures comprises an elongated aperture that extends for a length in the intermediate portion of the corresponding outer tubular layer and inner tubular layer along the elongated axis (apertures may “extend through the thickness of one or more layers of the sheath” in [0007] of Forde).
Regarding claim 34, Dwork as modified teaches the first plurality of apertures are rotationally offset from the second plurality of apertures (Dwork; Figure 6A), but does not expressly teach being offset by approximately 90 degrees. Dwork teaches in [0044] that apertures 118 are formed in a pattern about a circumference of sheath 46, and in Figure 6A shows that rows along the length of the sheath are generally rotationally offset. It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified such that the first and second plurality of apertures are rotationally offset by approximately 90 degrees, in order to distribute the apertures in different portions of the sheath for even rotational expansion along the circumference and length. In addition, it appears that Dwork as modified would operate equally well with the apertures rotationally offset by approximately 90 degrees, and applicant has not disclosed that approximately 90 degrees solves any stated problem or is for any particular purpose ([0072] of present invention publication merely states that distal windows 310a, 310b are rotationally offset from the intermediate windows 312a, 312b by approximately ninety degrees).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Forde (U.S. Pub. No. 2008/0082083), as applied to claim 30 above, and further in view of Nguyen et al., hereinafter “Nguyen” (U.S. Pub. No. 2010/0094392).
Regarding claim 36, Dwork as modified teaches the claimed invention, as discussed above, except for the inner tubular layer comprises a material comprising PTFE.
Nguyen teaches in [0103] a sheath with an inner tubular layer material can include PTFE, which advantageously has a low coefficient of friction that would facilitate passage of a device through the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the inner tubular layer with a material comprising PTFE, as taught by Nguyen, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use, and in order to facilitate passage of a device within and through the sheath (Id.).
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork (U.S. Pub. No. 2011/0257733) in view of Nguyen (U.S. Pub. No. 2010/0094392), Zhou (U.S. Pub. No. 2016/0296730), and Forde (U.S. Pub. No. 2008/0082083).
Regarding claim 37, Dwork discloses a delivery device configured for transcatheter delivery of a collapsed and loaded prosthetic heart valve through a vasculature of a patient (see abstract) comprising:
a handle assembly 48 (Figures 3-4);
an inner shaft 44/80;
a sheath 46 slidably disposed over a distal portion of the inner shaft ([0050]), the sheath comprising:
an outer tubular layer 116 (Figures 6A-6B) extending along an elongated axis comprising a proximal portion, an intermediate portion, and a distal portion;
a first plurality of apertures (Id.; see row of distalmost cuts 118 of tube 46) circumferentially positioned around the distal portion of the outer tubular layer ([0044]; cuts 118 are formed in a pattern about a circumference of tube 46), wherein each aperture of the first plurality of apertures radially extends at least from an inner radial surface of the outer tubular layer to an outer peripheral surface of the outer tubular layer (Id.; cuts 118 are formed through a thickness of the tubular wall 116), and wherein each aperture of the first plurality of apertures further extends for a length in a proximal direction of the elongated axis from a first end of the aperture of the outer tubular layer to a second end of the aperture at the distal portion of the outer tubular layer (Id.; the cuts have a length that extends proximally); and
wherein the sheath is configured to selectively cover a prosthetic heart valve that is collapsed and loaded about the distal portion of the inner shaft during delivery (as in Figure 8A and 11B), as well as facilitate recapture of a partially expanded prosthetic heart valve ([0056]; cuts 118 at the distal end of the tube 46 facilitate expansion when distally advanced).
However, Dwork does not disclose an inner tubular layer extending along the elongated axis, wherein the outer tubular layer is circumferentially positioned around the inner tubular layer, or that the first end of the aperture is configured to be open at a distal end of the outer tubular layer, or a covering layer circumferentially covering each aperture of the first plurality of apertures.
In the same field of art, namely delivery devices, Nguyen teaches in Figure 2D a sheath including an inner tubular layer 24 or 28 extending along an elongated axis, wherein an outer tubular layer 26 is circumferentially positioned around the inner tubular layer.
It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork with an inner tubular layer as claimed, as taught by Nguyen, in order to add structural integrity and additional beneficial properties to the sheath (Nguyen; [0010]-[0015]).
In the same field of art, namely delivery devices, Zhou teaches in Figures 32-33 and [0097] a sheath having a tubular layer 42 having a first plurality of apertures (first and second notches 90) in a distal portion, wherein each aperture extends for a length in a proximal direction of an elongated axis of the sheath from a first end of the aperture configured to be open at a distal end of the tubular layer to a second end of the aperture at the distal portion of the tubular layer (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the plurality of apertures in Dwork to have the first end of the aperture configured to be open as claimed, as taught by Zhou, since the open distal end apertures facilitate tip expansion and retrieval of an implant (Id.).
In the same field of art, namely delivery devices, Forde teaches a sheath 10 having apertures 22/68/66/64/69 (Figures 1 and 5) which may have a covering layer (outer elastomeric layer; [0036]) covering each aperture of the plurality of apertures (Id.; the elastomeric layer may be flush with the distal end of the sheath, therein covering the plurality of apertures).
It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork with a covering layer as claimed, as taught by Forde, to help with controlled and consistent expansion of the sheath, and protect against snags ([0038]; Forde).
Regarding claim 38, Dwork as modified teaches the sheath further comprises a second plurality of apertures (Figure 6A, Dwork; see row of cuts 118 in middle portion of tube 46 that are rotationally offset from the distalmost row of cuts) circumferentially positioned around the intermediate portion of the outer tubular layer ([0044] cuts 118 are formed in a pattern about a circumference of sheath 46), wherein each aperture of the second plurality of apertures comprises an elongated aperture that extends for a length in the intermediate portion along the elongated axis (Figure 6A).
Regarding claim 39, Dwork as modified teaches the first plurality of apertures are rotationally offset from the second plurality of apertures (Id.), but does not expressly teach being offset by approximately 90 degrees. Dwork teaches in [0044] that apertures 118 are formed in a pattern about a circumference of sheath 46, and in Figure 6A shows that rows along the length of the sheath are generally rotationally offset. It would have been obvious to one of ordinary skill before the effective filing date to modify Dwork as modified such that the first and second plurality of apertures are rotationally offset by approximately 90 degrees, in order to distribute the apertures in different portions of the sheath for even rotational expansion along the circumference and length. In addition, it appears that Dwork as modified would operate equally well with the apertures rotationally offset by approximately 90 degrees, and applicant has not disclosed that approximately 90 degrees solves any stated problem or is for any particular purpose ([0072] of present invention publication merely states that distal windows 310a, 310b are rotationally offset from the intermediate windows 312a, 312b by approximately ninety degrees).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cahill (U.S. Pub. No. 2008/0249558) discloses a recovery sheath having a plurality of apertures 132 to permit further expansion.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771