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 § 103
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 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) 1, 4-5, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Melissano (WO 2016075615 A2) “Melissano”.
Regarding Claim 1, the first embodiment of Melissano teaches an aortic arch repair device (device 200, par. [0164], Fig. 13), comprising: a base member (distal component 201, par. [0164], Fig. 13) having a first end portion (bottom end of component 201, Fig. 13) and a second end portion (top end of component 201, Fig. 13), the base member comprising—
and the second end portion of the base member defines a second fluid opening for the primary lumen and a third fluid opening for the secondary lumen (Fig. 13);
and a leg member (proximal component 230, par. [0164], Fig. 13) defining a leg lumen configured to be fluidly coupled to the secondary lumen (Figs. 14I-J), the leg member comprising—
a coupling portion (distal portion 211, par. [0169], Fig. 13) configured to be received within the secondary lumen between the septum and the cover (Figs. 13, 14I-J),
and a leg portion (portion 212, par. [0169], Fig. 13) coupled to the coupling portion and configured to extend through the third fluid opening and outwardly from the second end portion of the base member, the leg portion having a leg end portion defining a fourth fluid opening for the secondary lumen (Figs. 13, 14I-J), but does not disclose a plurality of first and second stents and a septum.
However, another embodiment of Melissano teaches a plurality of first stents (stents on body 210, Fig. 13), a plurality of second stents (stents on part 220, Fig. 13), and a cover (body 210 and part 220, par. [0167], Fig. 13) coupled to the plurality of first stents and the plurality of second stents, the cover defining a fluid conduit through the base member (Fig. 13),
wherein the first end portion of the base member defines a first fluid opening, and at least a portion of the cover is positioned between the plurality of first stents and the plurality of second stents (Fig. 13);
a septum (branch 231, par. [0167], Fig. 13) coupled to the plurality of second stents and extending through the base member from the second end portion of the base member toward the first end portion of the base member (Fig. 13),
wherein— the septum divides the fluid conduit into a primary lumen having a first cross-sectional area (mooring branch 232, par. [0171], Fig. 13) and a secondary lumen having a second cross-sectional area less than the first cross-sectional area (mooring branch 231, par. [0171], Fig. 13). 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 structure disclosed by the first embodiment of Melissano to include a plurality of first and second stents and a septum, as taught by another embodiment of Melissano, in order to control blood flow within the desired aortic branches (pars. [0020] and [0059]).
Regarding Claim 4, the first embodiment of Melissano does not teach at least partially defined first and third fluid openings. However, another embodiment of Melissano teaches the aortic arch repair device of claim 1 wherein at least one of the plurality of first stents at least partially defines the first fluid opening and wherein at least one of the plurality of second stents at least partially defines the third fluid opening (Fig. 13). 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 structure disclosed by the first embodiment of Melissano to include at least partially defined first and third fluid openings, as taught by another embodiment of Melissano, in order to control blood flow within the desired aortic branches (pars. [0020] and [0059]).
Regarding Claim 5, the first embodiment of Melissano does not teach a leg member cover and a plurality of third and fourth stents. However, another embodiment of Melissano teaches the aortic arch repair device of claim 1 wherein the leg member comprises:
a leg member cover (par. [0167], Fig. 13, body 210 will cover leg member through stages of device deployment) having an outer surface and an inner surface,
a plurality of third stents positioned within the coupling portion (stents on portion 211, Fig. 13), wherein individual ones of the plurality of third stents are coupled to the inner surface or the outer surface of the leg member cover (par. [0172], stents on the leg member will overlap the branches inside the cover, therefore causing the third stents to be placed on the inner surface of the leg member cover 210),
and a plurality of fourth stents positioned within the leg portion (stents on portion 212, Fig. 13), wherein individual ones of the plurality of fourth stents are coupled to the inner surface or the outer surface of the leg member cover (par. [0172], stents on the leg member will overlap the branches inside the cover, therefore causing the third stents to be placed on the inner surface of the leg member cover 210). 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 structure disclosed by the first embodiment of Melissano to include a leg member cover and a plurality of third and fourth stents, as taught by another embodiment of Melissano, in order to control blood flow within the desired aortic branches (pars. [0020] and [0059]).
Regarding Claim 11, the first embodiment of Melissano does not teach none of the plurality of first stents attached to the septum. However, another embodiment of Melissano teaches the aortic arch repair device of claim 1 wherein none of the plurality of first stents are attached to or extend along the septum (Fig. 13, the plurality of first stents are only attached to body 210 and not part 220). 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 structure disclosed by the first embodiment of Melissano to include none of the plurality of first stents attached to the septum, as taught by another embodiment of Melissano, in order to control blood flow within the desired aortic branches (pars. [0020] and [0059]).
Regarding Claim 12, the first embodiment of Melissano further teaches the aortic arch repair device of claim 1 wherein the coupling portion of the leg member has a first cross-sectional shape and wherein the leg portion of the leg member has a second cross-sectional shape different than the first cross-sectional shape (Fig. 13).
Claim(s) 2-3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Melissano (WO 2016075615 A2) “Melissano” in view of Perkins et al (US 11083605 B2) “Perkins”.
Regarding Claim 2, Melissano does not teach the plurality of first stents being abluminal and the plurality of second stents being intraluminal. However, Perkins, in the same field of art, teaches a modular stent device that is deployed into the ascending aorta via femoral access (Abstract), wherein the plurality of first stents (stents 134 and 140, pars. (27) and (32) Description, Fig. 1) comprise a plurality of abluminal stents (pars. (28) and (33) Description, stents 134 and 140 are coupled to an outside surface of graft material 132 and 138) and wherein the plurality of second stents (circumferential stents 128, par. (21) Description, Fig. 1) comprise a plurality of intraluminal stents (par. (22) Description, stents 128 may be coupled to an inside surface of graft material 126). 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 structure disclosed by Melissano to include the plurality of first stents being abluminal and the plurality of second stents being intraluminal, as taught by Perkins, in order to help with device stability (Perkins, par. (21) Description).
Regarding Claim 3, Melissano does not teach the cover with a graft material having an outer and inner surface. However, Perkins, in the same field of art, teaches a modular stent device that is deployed into the ascending aorta via femoral access (Abstract), wherein: the cover comprises a graft material having an outer surface and an inner surface (graft materials 126, 132, and 138, par. (37) Description, Fig. 1);
the plurality of first stents are coupled to the outer surface (pars. (28) and (33) Description, stents 134 and 140 are coupled to an outside surface of graft material 132 and 138) and extend circumferentially about the outer surface (pars. (28) and (33) Description, Fig. 1), and
the plurality of second stents are coupled to the inner surface (par. (22) Description, stents 128 may be coupled to an inside surface of graft material 126) and the septum (division between bypass gate 104 and artery leg 106, par. (16) Description, Fig. 1) and extend circumferentially about the secondary lumen. 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 structure disclosed by Melissano to include the cover with a graft material having an outer and inner surface, as taught by Perkins, in order to help with device stability (Perkins, par. (21) Description).
Regarding Claim 6, Melissano does not teach the plurality of third stents expanding. However, Perkins, in the same field of art, teaches a modular stent device that is deployed into the ascending aorta via femoral access (Abstract), wherein one or more of the plurality of third stents (stents 134, par. (30) Description, Fig. 1) are configured to be expanded when the coupling portion (bypass gate 104, par. (29) Description, Fig. 1) is received within the secondary lumen. 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 structure disclosed by Melissano to include the plurality of third stents expanding, as taught by Perkins, in order to help the device components interact effectively (Perkins, par. (30) Description).
Claim(s) 7-10, 13-14, 16-17, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Melissano (WO 2016075615 A2) “Melissano” in view of Shahriari (US 20160361153 A1) “Shahriari”.
Regarding Claim 7, Melissano does not teach the plurality of second and third stents having flat and curved portions. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein: the plurality of second stents (stents on shorter tube 1606, par. [0160], Fig. 24) have a first cross-sectional shape comprising a first flat portion and a first curved portion (flat portion facing septum 1602, par. [0160], Fig. 25), the plurality of third stents (longer tube 1604, par. [0160], Fig. 24) have a second cross-sectional shape comprising a second flat portion and a second curved portion, the second flat portion is configured to sealingly engage the first flat portion, and the second curved portion is configured to sealingly engage the first curved portion (Figs. 24 and 25). 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 structure disclosed by Melissano to include the plurality of second and third stents having flat and curved portions, as taught by Shahriari, in order to create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Regarding Claim 8, Melissano does not teach first and second markers positioned at the intersection of the flat and curved portions. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), further comprising: a pair of first markers (marker 1120, pars. [0150] and [0164], Figs. 19 and 30), each of the pair of first markers positioned at a respective first intersection of the first flat portion and the first curved portion;
and a pair of second markers (marker 1120, pars. [0150] and [0164], Figs. 19 and 30), each of the pair of second markers positioned at a respective second intersection of the second flat portion and the second curved portion, wherein the pair of first markers are configured to be aligned with the pair of second markers to rotationally align the base member and the leg member. 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 structure disclosed by Melissano to include first and second markers positioned at the intersection of the flat and curved portions, as taught by Shahriari, in order to monitor the positioning and deployment of the stent assembly (Shahriari, par. [0149]).
Regarding Claim 9, Melissano does not teach two pairs of radiopaque markers. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein the pair of first markers are a pair of first radiopaque markers (marker 1120, pars. [0150] and [0164], Figs. 19 and 30) and wherein the pair of second markers are a pair of second radiopaque markers (marker 1120, pars. [0150] and [0164], Figs. 19 and 30). 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 structure disclosed by Melissano to include first and second markers positioned at the intersection of the flat and curved portions, as taught by Shahriari, in order to monitor the positioning and deployment of the stent assembly (Shahriari, par. [0149]).
Regarding Claim 10, Melissano further teaches the aortic arch repair device of claim 7, further comprising: a first radiopaque marker at a proximal end of the leg member (par. [0174]);
and a second radiopaque marker positioned along the septum of the base member (par. [0174]).
Regarding Claim 13, Melissano does not teach D-shaped and circular shaped cross-sections. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein the first cross-sectional shape is D-shaped (cross-section of tube 1604 that extends past tube 1606, Fig. 24) and the second cross-sectional shape is circular (cross-section of tubes 1604 and 1606 when they are the same length, Figs. 24 and 25). 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 structure disclosed by Melissano to include D-shaped and circular shaped cross-sections, as taught by Shahriari, in order to help create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Regarding Claim 14, Melissano does not teach D-shaped and circular shaped cross-sections. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein: the coupling portion of the leg member comprises a substantially D-shaped cross-section (cross-section of tube 1604 that extends past tube 1606, Fig. 24);
the leg portion of the leg member comprises a circular cross-sectional shape (cross-section of tubes 1604 and 1606 when they are the same length, Figs. 24 and 25), and the leg member comprises transition section comprises stents that change from the substantially D-shaped cross-section to the circular cross-section shape (limb stent 1608 may be circular when connected to shorter tube 1606, par. [0160], Figs. 25, 27-28). 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 structure disclosed by Melissano to include D-shaped and circular shaped cross-sections, as taught by Shahriari, in order to help create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Regarding Claim 16, Melissano does not teach at least one of the plurality of first stents with a keyhole configuration. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein: at least one of the plurality of first stents (support rings 102, 202, 302, par. [0109], Fig. 3) has a keyhole configuration in which linear first segments (outer prongs 122, par. [0107], Fig. 3) extend between second segments (tips 124, par. [0107], Fig. 3) at apex portions of the individual first stent, the second segments forming nonzero angles relative to adjacent first segments. 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 structure disclosed by Melissano to include at least one of the plurality of first stents with a keyhole configuration, as taught by Shahriari, in order to allow for secure placement of parallel covered stents while reducing the likelihood of an endoleak along the stents, and reducing the risk of kinking and compression of the stents (Shahriari, par. [0106]).
Regarding Claim 17, Melissano teaches an aortic arch repair device (device 200, par. [0164], Fig. 13), comprising: a base member (distal component 201, par. [0164], Fig. 13) having a first end portion (bottom end of component 201, Fig. 13) and a second end portion (top end of component 201, Fig. 13),
the base member comprising a plurality of stents (stents on body 210 and part 220, Fig. 13) and a cover (body 210 and part 220, par. [0167], Fig. 13) coupled to the plurality of stents to define a fluid conduit through the base member, wherein the first end portion of the base member defines a first fluid opening (Fig. 13);
wherein— the septum (branch 231, par. [0167], Fig. 13) divides the fluid conduit into a primary lumen having a first cross-sectional area (mooring branch 232, par. [0171], Fig. 13) and a secondary lumen having a second cross-sectional area (mooring branch 231, par. [0171], Fig. 13) less than the first cross-sectional area,
and the second end portion of the base member defines a second fluid opening for the primary lumen and a third fluid opening for the secondary lumen (Fig. 13);
and a leg member (proximal component 230, par. [0164], Fig. 13) defining a leg lumen configured to be fluidly coupled to the secondary lumen (Figs. 14I-J), the leg member comprising—
a coupling portion (distal portion 211, par. [0169], Fig. 13) configured to be received within the secondary lumen, but does not teach a septum extending through the base member, a secondary lumen with a flat portion, the coupling portion having a curved and flat surface, and a leg portion coupled to the coupling portion.
However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), comprising a septum (septum 1602, par. [0160], Fig. 24) coupled to the cover (graft tube 1610, par. [0161], Fig. 26) and extending through the base member (tube 1604, par. [0160], Fig. 24) from the second end portion of the base member toward the first end portion of the base member (Fig. 24),
the secondary lumen (lumen of shorter tube 1606, par. [0160], Figs. 24 and 25) comprises a generally flat portion adjacent the septum and a curved portion adjacent the cover, the generally flat portion being less curved than the curved portion (Figs. 24 and 25),
a curved surface configured to be aligned with and sealingly engage the curved portion of the secondary lumen (Figs. 24 and 25),
and a generally flat surface configured to be aligned with and sealingly engage the generally flat portion of the secondary lumen, the generally flat surface being less curved than the curved surface (Figs. 24 and 25);
and a leg portion coupled to the coupling portion and configured to extend through the third fluid opening and outwardly from the second end portion of the base member, the leg portion having a leg end portion defining a fourth fluid opening for the secondary lumen (second iliac limb stent 1608 connecting to tube 1606, par. [0160], Figs. 28 and 30). 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 structure disclosed by Melissano to include a septum extending through the base member, a secondary lumen with a flat portion, the coupling portion having a curved and flat surface, and a leg portion coupled to the coupling portion, as taught by Shahriari, in order to help create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Regarding Claim 21, Melissano does not teach the coupling portion expanding when in the secondary lumen. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein the coupling portion is configured to be expanded when positioned within the secondary lumen (par. [0129]), and wherein the expansion of the coupling portion creates the sealing engagement between the generally flat surface and the generally flat portion and the curved surface and the curved portion (par. [0129]). 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 structure disclosed by Melissano to include the coupling portion expanding when in the secondary lumen, as taught by Shahriari, in order to help support the stent assembly while urging it to conform to the new anatomical dimensions (Shahriari, par. [0129]).
Regarding Claim 22, Melissano does not teach the base member and leg member extending along non-parallel axes. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein the base member extends along a first axis and the leg member extends along a second axis non-parallel to the first axis (Figs. 29 and 30). 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 structure disclosed by Melissano to include the base member and leg member extending along non-parallel axes, as taught by Shahriari, in order to help create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Regarding Claim 23, Melissano further teaches the aortic arch repair device of claim 17 wherein the base member is configured to be positioned in an ascending portion of a thoracic aorta of a patient such that the first fluid opening receives blood flow from the ascending portion of the thoracic aorta and the second fluid opening discharges the blood flow into the thoracic aorta, and wherein at least a portion of the leg member is configured to be positioned within a branch vessel branching from the thoracic aorta (par. [0027], Figs. 14H-K).
Regarding Claim 24, Melissano further teaches the aortic arch repair device of claim 17 wherein the base member is configured to be positioned in a descending portion of a thoracic aorta of a patient such that the second fluid opening receives blood flow from the thoracic aorta and the first fluid opening discharges the blood flow into the descending portion of the thoracic aorta, and wherein at least a portion of the leg member is configured to be positioned within a branch vessel branching from the thoracic aorta (par. [0119], Figs. 14H-K).
Claim(s) 15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Melissano (WO 2016075615 A2) “Melissano” in view of Shahriari (US 20160361153 A1) “Shahriari” in further view of Perkins et al (US 11083605 B2) “Perkins”.
Regarding Claim 15, Melissano in view of Shahriari does not teach the coupling portion with a larger cross-sectional dimension than the leg portion. However, Perkins, in the same field of art, teaches a modular stent device that is deployed into the ascending aorta via femoral access (Abstract), wherein the coupling portion (bypass gate 104, par. (29) Description, Fig. 1) has a larger cross-sectional dimension than the leg portion (artery leg 106, Fig. 1). 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 structure disclosed by Melissano in view of Shahriari to include the coupling portion with a larger cross-sectional dimension than the leg portion, as taught by Perkins, in order to help the device components interact effectively (Perkins, par. (30) Description).
Regarding Claim 18, Melissano in view of Shahriari does not teach a plurality of stents coupled to the inner and outer surface of the graft material. However, Perkins, in the same field of art, teaches a modular stent device that is deployed into the ascending aorta via femoral access (Abstract), wherein the cover comprises a graft material having an outer surface and an inner surface (graft materials 126, 132, and 138, par. (37) Description, Fig. 1), and wherein the plurality of stents comprise a plurality of first stents coupled to the outer surface of the graft material (pars. (28) and (33) Description, stents 134 and 140 are coupled to an outside surface of graft material 132 and 138) and a plurality of second stents coupled to the inner surface of the graft material (par. (22) Description, stents 128 may be coupled to an inside surface of graft material 126). 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 structure disclosed by Melissano in view of Shahriari to include a plurality of stents coupled to the inner and outer surface of the graft material, as taught by Perkins, in order to help the device components interact effectively (Perkins, par. (30) Description).
Regarding Claim 19, Melissano does not teach the plurality of first and second stents having different shaped cross-sections. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein the plurality of first stents have a first cross-sectional shape (circular cross-section of tubes 1604 and 1606 when they are the same length, Figs. 24 and 25) and wherein the plurality of second stents have a second cross-sectional shape different than the first cross-sectional shape (D-shaped cross-section of tube 1604 that extends past tube 1606, Fig. 24). 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 structure disclosed by Melissano to the plurality of first and second stents having different shaped cross-sections, as taught by Shahriari, in order to help create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Regarding Claim 20, Melissano does not teach the plurality of second stents having a curved section and flat section. However, Shahriari, in the same field of art, teaches a prosthetic device for treating aortic aneurysm (Abstract, par. [0002]), wherein the plurality of second stents at least partially define the secondary lumen (Fig. 24) and individual ones of the plurality of second stents comprise:
a curved section defining the curved portion of the secondary lumen (portion opposite the septum 1602, Figs. 24 and 25), and
a generally flat section defining the generally flat portion of the secondary lumen (section facing septum 1602, Figs. 24 and 25), the generally flat section being less curved than the curved section. 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 structure disclosed by Melissano to the plurality of second stents having a curved section and flat section, as taught by Shahriari, in order to help create a bifurcation that accesses the desired arterial branches (Shahriari, pars. [0161] and [0162]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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