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 Objections
Claims 2, 6, 14, 18 and 20 are objected to because of the following informalities: currently reads the sheathing portion is longitudinally "displaced way from" instead of "displaced away from". Appropriate correction is required.
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.
Claims 1-13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0167456 A1 (hereinafter, "Collins") and US 12,508,404 B2 (hereinafter, “Cresswell”), and further in view of US 2013/0184805 A1 (hereinafter, "Sawada").
In regards to claim 1, Collins discloses an endograft delivery device assembly (Fig. 1, endovascular delivery device, 10, para 0087) comprising:
a proximal end (Fig. 1, proximal end, 12, para 0087);
a distal end (Fig. 1, distal end, 10, para 0087);
a prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070);
a tip at the proximal end (Fig. 1B, tip, 105, para 0088)
a handle assembly (Fig. 1, handle assembly, 200, para 0087)
at the distal end (see below, annotated Fig. 1, handle, 200 in combination with directional markers, para 0088);
a guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092)
extending distally from the tip to the handle assembly (see below, annotated Fig. 1, directional markers in combination with tip, 105, and handle assembly, 200, para 0087),
the guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092)
configured to slidably receive a guide wire (Fig. 20A, wire, 117, in combination with guide wire catheter, 40, para 0131);
a positioner (Fig. 5A, pusher catheter, 300, para 0111-0112) disposed around the guide wire cannula,
the positioner extending from the handle assembly towards the tip (see below, annotated Fig. 5A, pusher catheter, 300, in combination with directional markers, para 0111-0112);
a sheath (Fig. 1, sheath, 510, para 0107) extending from the handle assembly over the positioner towards the tip,
the sheath having an inner surface (Fig. 2, sheath, 510, para 007, discloses that the sheath has an outer portion therefore inherently also having an inner surface);
However, Collins does not disclose wherein the endograft device has a sheath splitter assembly within the handle, the sheath splitting assembly including: a splitter body attached to the positioner and disposed within the sheath, the splitter body defining a through-hole through which the guide wire cannula passes; and at least one splitter arm, the at least one splitter arm extending laterally, from the splitter body though a slit though the sheath to a support within the handle assembly, wherein the splitter body includes a circumferential sealing surface extending towards the tip, the sealing surface and the inner surface of the sheath dimensioned such that the sheath is circumferentially stretched over the sealing surface thereby forming a seal.
Cresswell teaches a sheath splitting apparatus, used for medical device delivery systems (Abs).
a sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) within the handle assembly,
the sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) including:
a splitter body (Fig. 1, body, 3, col. 3 lines 59-66) attached to the positioner and disposed within the sheath,
the splitter body defining a through-hole (Fig. 4A-4C, opposing side, 4 and 5, col. 3 lines 59-66) through which the guide wire cannula passes (Fig. 8b, guidewire 31, in combination with device, 6, col. 5 lines 19-27);
and at least one splitter arm (Fig. 9, arm member, 10, col. 4 lines 1-6), the at least one splitter arm extending laterally (Fig. 2A-B and Fig. 9, points, 22, or hinges, 30, col. 4 lines 19-32, teaches points at which the arm member, 10, can bend to be in a lateral configuration from the splitter body)
from the splitter body though a slit though the sheath (Fig. 1, guide slot, 12 in combination with the singular handle, 32, col. 5 line 62- col. 6 lines 3) to a support within the handle assembly,
wherein the splitter body includes a circumferential sealing surface (Fig. 5a-5b, clamp element, 15, in combination with access branch 27, col. 4 lines 60-67) extending towards the tip.
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft device of Collins with the sheath splitting apparatus of Creswell since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
However, modified Collins does not explicitly disclose the sheath splitting assembly has a sealing surface and the inner surface of the sheath dimensioned such that the sheath is circumferentially stretched over the sealing surface thereby forming a seal.
Sawada teaches an endograft delivery device (Fig. 1, blood vessel treatment instrument placement device, 10, para 0033) where the sealing surface (Fig. 4, ring-shaped seal member, 54 in combination with sheath body, 18, para 0047)
and the inner surface of the sheath dimensioned such that the sheath is circumferentially stretched over the sealing surface thereby forming a seal (para 0048).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft device of Collins as modified by Creswell to incorporate the sealing surface and seal of Sawada since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
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In regards to claim 2, modified Collins further discloses wherein the sheath (Fig. 1, sheath, 510, para 0107) includes a prosthesis sheathing portion (see below, annotated Fig. 1, PSP, para 0033-0034), the prosthesis sheathing portion moveable (see below, annotated Fig. 1 and Fig. 2, PSP, in covered and retracted positions, para 0033-0036) from a covering position in which it covers the prosthesis receiving zone and a retracted position (Fig. 2A, sheath, 510 in combination with endograft delivery device, 10, para 0036 ) in which the prosthesis sheathing portion is longitudinally displaced way (see below, annotated Fig. 2, directional markers, para 0037) from the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070).
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In regards to claim 3, modified Collins further discloses the sheath (Fig. 1, sheath, 510, para 0107) as it is pulled distally away (Fig. 5B/C, proximal end of sheath, 512, para 0062 and para 0111) from the tip and into the handle assembly (Fig. 1, handle assembly, 200, para 0087).
Collins does not explicitly teach wherein the splitter body includes a ramp portion configured to provide, in use, a gradual stretching of the sheath. Sawada further discloses wherein the splitter body (Fig. 2, hub, para 0036) includes a ramp portion (Fig. 4, distal-side opening, para 0057) configured to provide, in use, a gradual stretching (Fig. 8, para 0084, teaches tension exerted on the linear members, 122 and 124, in combination with sheath body, 18, as it is drawn in the hub).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Sawada since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
In regards to claim 4, modified Collins discloses the endograft delivery device assembly (Fig. 1, endovascular delivery device, 10, para 0087) of claim 2. However, it does not disclose wherein the ramp portion includes a pair of projections.
Sawada further discloses wherein the ramp portion (Fig. 4, distal-side opening, 45 para 0057) includes a pair of projections (see below, annotated Fig. 3, PP1 and PP2, para 0058) extending toward the tip. Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins as modified to include the ramp portion of Sawada since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
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In regards to claim 5, modified Collins discloses the endograft delivery device (Fig. 1, endovascular delivery device, 10, para 0087) of claim 1, with a handle assembly (Fig. 1, handle assembly, 200, para 0087). However, it does not disclose wherein the at least one splitter arm comprises a pair of arms, each arm of the pair of arms supported by the support within the handle assembly.
Creswell further teaches wherein the at least one splitter arm (Fig. 9, arm member, 10, col. 4 lines 1-6) comprises a pair of arms (Fig. 9, arm member, 10, in combination with sides 4 and 5, col. 4 lines 1-6), each arm of the pair of arms supported by the support (see below, annotated Fig. 2B, AS1 and AS2, col. 4 lines 6-12). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the splitter arms and support of Cresswell to connect the splitter to the handle and cause tension on the sheath material while joined to the handle (to remove the sheath material from medical devices during deployment (Abs.).
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In regards to claim 6, modified Collins further discloses a follower (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085) attached to the sheath (Fig. 1, sheath, 510, para 0107), the follower drivable (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085, teaches a slidably drivable actuator), wherein movement of the follower in a direction away from the proximal end of the delivery device assembly (Fig. 1, endovascular delivery device, 10, para 0087) and pulls the prosthesis sheathing portion (see below, annotated Fig. 1, PSP, para 0033-0034) of the sheath from the covering position in which it covers the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070); to the retracted position (Fig. 2A, sheath, 510 in combination with endograft delivery device, 10, para 0036) in which the prosthesis sheathing portion is longitudinally displaced way (see below, annotated Fig. 2, directional markers, para 0037) from the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070).
However, Collins does not explicitly disclose that the follower is driveable to the sheath splitter in a direction away from the proximal end of the delivery device, wherein movement of the follower slides the sheath over the sealing surface. Cresswell further discloses the sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) moving in a direction away from the proximal end of the delivery device assembly (Fig. 8B, directional arrow, 25, col. 5 lines 19-27).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the sheath splitter body of Cresswell to allow for the sheath to be accessed and pulled rearwardly to deploy the device through the handle (col. 5 lines 19-44).
However, modified Collins does not explicitly disclose that the sheath slides over the sealing surface. Sawada further discloses that the sheath slides over the sealing surface (Fig. 4, ring-shaped seal member, 54 in combination with sheath body, 18, para 0047-0048). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the sealing surface and seal of Sawada since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
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In regards to claim 7, modified Collins further discloses wherein the follower (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085) is operatively attached to the sheath (Fig. 1, sheath, 510, para 0107) at a sheath distal end (para 0069, references sheath proximal end, 512, therefore a sheath distal end is inherent), and wherein the follower (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085).
However, Collins does not explicitly disclose the follower is sandwiched between a pair of spaced apart sheath portions. Cresswell further teaches a pair of spaced apart sheath portions (see below, annotated Fig. 1, ASP). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the spaced apart sheath portions of Cresswell as courts have found it obvious to apply a known technique to a known method ready for improvement to yield predictable results (MPEP 2143).
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In regards to claim 8, modified Collins further discloses comprising a stiffener (Fig. 10, connector, 14, para 0081-0082) disposed around the guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092).
However, Collins does not explicitly disclose the splitter body. Cresswell further teaches the splitter body (Fig. 1, body, 3, col. 3 lines 59-66). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stiffener of Collins with the splitter body of Cresswell in order to transmit or convey a force during deployment (Collins, para 0082).
In regards to claim 9, modified Collins further discloses wherein the stiffener (Fig. 10, connector, 14, para 0081-0082) is supported at a distal end (Fig. 10, distal portion, 115, para 0080-0081) thereof by the handle assembly (Fig. 1, handle assembly, 200, para 0087).
In regards to claim 10, modified Collins discloses the endograft delivery device (Fig. 1, endovascular delivery device, 10, para 0087) of claim 1. However, it does not explicitly disclose wherein the at least one splitter arm includes a side access passage into the through-hole of the splitter body.
Creswell further discloses wherein the at least one splitter arm (Fig. 9, arm member, 10, in combination with sides 4 and 5, col. 4 lines 1-6) with a through-hole of the splitter body (Fig. 4A-4C, opposing side, 4 and 5, col. 3 lines 59-66). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the splitter arms of Cresswell in order to connect the splitter to the handle and cause tension on the sheath material while joined to the handle (col. 6, lines 8-13).
However, modified Collins does not explicitly teach a side access passage into the through-hole of the splitter body. Sawada further teaches a side access passage (Fig. 4, distal-side opening, 46, para 0057) into the through-hole of the splitter body (Fig. 4, through holes, 76 and 78, in combination with hub body, 31, para 0048, and 0058).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the splitter body and side access passage of Sawada to allow for insertion and fixation of the cutting blades to allow for the length extension of the sheath body to be shortened (Abs.).
In regards to claim 13, modified Collins discloses the endograft delivery device assembly (Fig. 1, endovascular delivery device, 10, para 0087) with the positioner (Fig. 5A, pusher catheter, 300, para 0111-0112) and sheath (Fig. 1, sheath, 510, para 0107).
However, Collins does not discloses the endograft delivery device assembly has at least one splitter arm, presents an angled edge with respect to a plane orthogonal to the positioner. Cresswell further discloses the at least one splitter arm (Fig. 9, arm member, 10, in combination with sides 4 and 5, col. 4 lines 1-6)
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the splitter arms of Cresswell in order to control the force of the sheath as it splits (col. 5 lines 49-56).
However, modified Collins does not disclose that the splitter am presents an angled edge is orthogonal with respect to the positioner. Sawada further discloses wherein the at least one splitter arm, presents an angled edge (Fig. 4, take up shaft, 30 and 32, in combination with the tubular guide member, 68, para 0042 and 0051), with respect to a plane orthogonal (Fig. 2, para 0059 teaches that through holes 74 and 76 are orthogonal to the axis of side opening). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of modified Collins to include the angled splitter arms of Sawada in order to remove the separated terminal pieces (para 0061).
In regards to claim 20, An endograft delivery device assembly (Fig. 1, endovascular delivery device, 10, para 0087) comprising:
a proximal end (Fig. 1, proximal end, 12, para 0087);
a distal end (Fig. 1, distal end, 10, para 0087);
a prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070);
a tip at the proximal end Fig. 1B, tip, 105, para 0088);
a handle assembly (Fig. 1, handle assembly, 200, para 0087) at the distal end (see below, annotated Fig. 1, handle, 200 in combination with directional markers, para 0088);
a guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092)
extending distally from the tip to the handle assembly (see below, annotated Fig. 1, direction markers, tip, 105, in combination with handle assembly, 200, para 0087),
the guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092)
configured to slidably receive a guide wire (Fig. 20A, wire, 117, in combination with guide wire catheter, 40, para 0131);
a positioner (Fig. 5A, pusher catheter, 300, para 0111-0112)
disposed around the guide wire cannula (Fig. 7, guide wire catheter, 40, in combination with pusher catheter, 300, para 0067),
the positioner extending from the handle assembly towards the tip (Fig. 1A, pusher catheter, 300, in combination with handle, 200, para 0111-0112);
a sheath (Fig. 1, sheath, 510, para 0107)
extending from the handle assembly over the positioner towards the tip (Fig. 1, sheath, 500, in combination with pusher catheter, 300, and tip assembly, 100, para),
the sheath having an inner surface (Fig. 2, sheath, 510, para 007, discloses that the sheath has an outer portion therefore inherently also having an inner surface ),
wherein the sheath includes a prosthesis sheathing portion (see below, annotated Fig. 1, PSP, para 0033-0034),
the prosthesis sheathing portion moveable from a covering position (see below, annotated Fig. 1 and Fig.2, PSP, in covered and retracted positions, para 0033-0036)
in which it covers the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070);
and a retracted position (Fig. 2A, sheath, 510 in combination with endograft delivery device, 10, para 0036)
in which the prosthesis sheathing portion is longitudinally displaced (see below, annotated Fig. 2, directional markers, para 0037) way from the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070);
the handle assembly (see below, annotated Fig. 1, direction markers, proximal tip, 20 in combination with main handle, 10, para 0071),
attached to the positioner (Fig. 5A, pusher catheter, 300, para 0111-0112)
and disposed within the sheath (Fig. 1, sheath, 510, para 0107),
through which the guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092) passes;
extending towards the tip (Fig. 1B, tip, 105, para 0088),
and the inner surface of the sheath (Fig. 2, sheath, 510, para 007, discloses that the sheath has an outer portion therefore inherently also having an inner surface)
loss through the positioner (Fig. 5A, pusher catheter, 300, para 0111-0112).
However, Collins does not disclose wherein the endograft device has a sheath splitter assembly within the handle assembly, the sheath splitting assembly including: a splitter body attached to the positioner and disposed within the sheath, the splitter body defining a through-hole through which the guide wire cannula passes; and at least one splitter arm, the at least one splitter arm extending from the splitter body though a slit though the sheath to a support within the handle assembly, wherein the splitter body includes a circumferential sealing surface extending towards the tip, the sealing surface and the inner surface of the sheath dimensioned such that the sheath is circumferentially stretched over the sealing surface thereby forming a seal.
Cresswell teaches a sheath splitting apparatus, used for medical device delivery systems (Abs).
a sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) within the handle assembly,
the sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) including:
a splitter body (Fig. 1, body, 3, col. 3 lines 59-66) attached to the positioner and disposed within the sheath,
the splitter body defining a through-hole (Fig. 4A-4C, opposing side, 4 and 5, col. 3 lines 59-66) through which the guide wire cannula passes (Fig. 8b, guidewire 31, in combination with device, 6, col. 5 lines 19-27);
and at least one splitter arm (Fig. 9, arm member, 10, col. 4 lines 1-6), the at least one splitter arm extending (Fig. 2A-B and Fig. 9, points, 22, or hinges, 30, col. 4 lines 19-32)
from the splitter body though a slit though the sheath (Fig. 1, guide slot, 12 in combination with the singular handle, 32, col. 5 line 62- col. 6 lines 3) to a support within the handle assembly,
wherein the splitter body includes a circumferential sealing surface (Fig. 5a-5b, clamp element, 15, in combination with access branch 27, col. 4 lines 60-67) extending towards the tip,
the sealing surface and the inner of the sheath dimensioned such that the sheath is circumferentially stretched over the sealing surface thereby forming a seal (col. 3 lines 1-10).
However, modified Collins does not disclose wherein the at least one splitter arm comprises a side seal disposed within the at least one splitter arm, the side seal configured to prevent blood loss through the positioner, and wherein the sheath is configured to be pulled past the side access passage without breaking the hemostatic seal.
Sawada teaches an endograft delivery device (Fig. 1, blood vessel treatment instrument placement device, 10, para 0033) where the positioner (Fig. 1, inner tube, 16, para 0035) having a side access passage (Fig. 4, distal-side opening, 46, para 0057) wherein the splitter arm includes a circumferential sealing surface (Fig. 4, ring-shaped seal member, 54 in combination with sheath body, 18, para 0047) dimensioned such that the sheath is circumferentially (para 0048)
stretched over the sealing surface thereby forming a seal (para 0048); comprises a side seal (Fig. 3, col. 7 lines 1-12)
the side seal (Fig. 4, ring-shaped member, 54 in combination with sheath body, 18, para 0048)
configured to prevent blood (Fig. 4, check valve, 70 in combination with hub, 20, para 0053)
wherein the sheath is configured to be pulled past the side access passage (Fig. 4, proximal side opening, 48, in combination with check valve, 70 and 70a, para 0052)
without breaking a hemostatic seal (para 0052). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of modified Collins to include the angled splitter arms and sealing surface of Sawada in order to create a liquid tight seal (para 0063-0064).
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Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Collins, Creswell and Sawada as applied to claim 1-10 above, and further in view of US 2016/0310303 A1 ("hereinafter, Thapliyal") .
In regards to claim 11, modified Collins further discloses a side passage(s) (see below, annotated, Fig. 15, valve body, 540, in combination with SAP). However, modified Collins does not explicitly disclose wherein the side passage includes a side seal and the side seal is configured to sealably receive a cannula.
Thapliyal teaches an endograft delivery system (Fig. 35A/B, delivery catheter system (DC), para 0209) wherein the side access passage(s) (Fig. 35B, side arm, 88, para 0213) includes a side seal (Fig. 35B, fluid-tight seal, 82, para 0213), the side seal configured to sealably receive a cannula (Fig. 35B, TB adapter, 90, para 0213).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the side access passage(s) and side seal of Thapliyal to provide an effective method of preventing side branch endoleaks during device deployment (para 0010).
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In regards to claim 12, modified Collins further discloses wherein the handle assembly (Fig. 1, handle assembly, 200, para 0087) comprises a main grip portion (see below, annotated Fig. 4A, MGP) and the side access passage(s) (see above, annotated, Fig. 15, valve body, 540, in combination with SAP) extend out through the main grip portion of the handle assembly (Fig. 1, handle assembly, 200, para 0087), within an endograft (Fig. 1, endovascular delivery device, 10, para 0087).
However, modified Collins does not disclose the side access passage(s), thereby allowing cannulation of side fenestrations. Thapliyal further discloses an endograft delivery system (Fig. 35A/B, delivery catheter system (DC), para 0209) with side access passage(s) (Fig. 35B, side arm, 88, para 0213), thereby allowing cannulation of side fenestrations (Fig. 35B, side arm, 88, in combination with TB adapter, 90 and fluid seal, 92, para 0213). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the side access passage of Thapliyal since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
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Claims 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0167456 A1 (hereinafter, "Collins") and US 12,508,404 B2 (hereinafter, “Cresswell”) and US 2013/0184805 A1 (hereinafter, "Sawada"), and further in view of US 2019/0159915 A1 (hereinafter, "Roeder").
In regards to claim 14, Collins discloses an endograft delivery device assembly (Fig. 1, endovascular delivery device, 10, para 0087) comprising:
a proximal end (Fig. 1, proximal end, 12, para 0087);
a distal end (Fig. 1, distal end, 10, para 0087);
a prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070);
a tip at the proximal end (Fig. 1B, tip, 105, para 0088);
a handle assembly (Fig. 1, handle assembly, 200, para 0087) at the distal end;
a guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092)
extending distally from the tip to the handle assembly (see below, annotated Fig. 1, direction markers, tip, 105, in combination with handle assembly, 200, para 0087),
the guide wire cannula (Fig. 1, guide wire catheter, 40, para 0092) configured to slidably receive a guide wire (Fig. 20A, wire, 117, in combination with guide wire catheter, 40, para 0131);
a positioner disposed around the guide wire cannula (Fig. 7, guide wire catheter, 40, in combination with pusher catheter, 300, para 0067),
the positioner (Fig. 3, positioner, 30, para 0072) extending from the handle assembly (Fig. 1, handle assembly, 200, para 0087)
towards the tip (Fig. 1B, tip, 105, para 0088),
wherein the handle assembly (Fig. 1, handle assembly, 200, para 0087) is configured to accommodate the positioner (Fig. 5A, pusher catheter, 300, para 0111-0112)
a sheath (Fig. 1, sheath, 510, para 0107)
extending from the handle assembly (Fig. 1, handle assembly, 200, para 0087, see also directional markers)
over the positioner (Fig. 5A, pusher catheter, 300, para 0111-0112)
towards the tip (Fig. 1B, tip, 105, para 0088),
the sheath (Fig. 1, sheath, 510, para 0107)
having an inner surface (Fig. 2, sheath, 510, para 007, discloses that the sheath has an outer portion therefore inherently also having an inner surface),
wherein the sheath (Fig. 1, sheath, 510, para 0107)
includes a prosthesis sheathing portion (see below, annotated Fig. 1, PSP, para 0033-0034),
the prosthesis sheathing portion moveable from a covering position in which it covers the prosthesis receiving zone (see below, annotated Fig. 2, directional markers);
and a retracted position in which the prosthesis sheathing portion is longitudinally displaced way (see below, annotated Fig. 2, directional markers, para 0037) from the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070);
Collins does not explicitly teach a multi lumen positioner. Roeder teaches a stent graft delivery device (Fig. 4, novel delivery device, 200, para 0040) that can accommodate a multi lumen positioner (Fig. 6, pusher catheter, 212, para 0012, see also para 0052) extending from the handle assembly (Fig. 4, handle assembly, 230, para 0043). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the multi lumen positioner of Roeder since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
Modified Collins does not explicitly teach the specifics of the sheath splitter device. Cresswell teaches a sheath splitting apparatus, used for medical device delivery systems (Abs). Cresswell discloses a sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) within the handle assembly (Fig. 8A, handle, 32, col. 5, lines 19-26), the sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) including:
a splitter body (Fig. 1, body, 3, col. 3 lines 59-66), attached to the positioner and disposed within the sheath (Fig. 1, sheath, 8, col. 3 lines 61-65),
the splitter body defining a through-hole (Fig. 4A-4C, opposing side, 4 and 5, col. 3 lines 59-66) through which the guide wire cannula passes (Fig. 8b, guidewire 31, in combination with device, 6, col. 5 lines 19-27);
and at least one splitter arm (Fig. 9, arm member, 10, col. 4 lines 1-6), wherein the splitter body (Fig. 1, body, 3, col. 3 lines 59-66) extends towards the tip the sealing surface (Fig. 5a-5b, clamp element, 15, in combination with access branch 27, col. 4 lines 60-67)
and the inner surface of the sheath dimensioned such that the sheath is circumferentially stretched over the sealing surface thereby forming a seal (col. 3 lines 1-10). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the sheath splitter assembly of Cresswell in order to in order to control the force of the sheath as it splits (col. 5 lines 49-56).
However, modified Collins does not explicitly disclose the sheath extending from the splitter body through a slit or that the splitter arms are presents an angled edge with respect to the orthogonal plane, including a circumferential sealing surface.
Sawada teaches an endograft delivery device (Fig. 1, blood vessel treatment instrument placement device, 10, para 0033) where the positioner (Fig. 1, inner tube, 16, para 0035) is disposed within the sheath (Fig. 1, introducer sheath, 14, para 0036) extending from the splitter body though a slit though the sheath (Fig. 2, sheath body, 18, para 0042) wherein the splitter arm presents an angled edge (Fig. 4, take up shaft, 30 and 32, in combination with the tubular guide member, 68, para 0042 and 0051), with respect to a plane orthogonal (Fig. 2, para 0059 teaches that through holes 74 and 76 are orthogonal to the axis of side opening) and where the splitter body includes a circumferential sealing surface (Fig. 4, ring-shaped seal member, 54 in combination with sheath body, 18, para 0047) extending towards the tip. Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of modified Collins to include the angled splitter arms and sealing surface of Sawada in order to create a liquid tight seal (para 0063-0064).
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In regards to claim 15, modified Collins discloses the endograft delivery assembly (Fig. 1, endovascular delivery device, 10, para 0087) of claim 14.
However, Collins does not disclose the splitter wherein the splitter edges are configured to assist in splitting. Sawada further discloses wherein the splitter edges (Fig. 5, cutting blades, 72 and 74, para 0056) are configured to assist in splitting (Fig. 4, terminal pieces 28a and 28, para 0067) the sheath (Fig. 1, sheath body, 18, para 0067).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the sheath splitter of Sawada since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
In regards to claim 16, modified Collins further discloses the endograft delivery assembly (Fig. 1, endovascular delivery device, 10, para 0087) of claim 14 with a handle assembly (Fig. 1, handle assembly, 200, para 0087). However, Collins does not disclose the splitter arm mounts holding the at least one splitter am in position. Cresswell further discloses the splitter arm mounts (col. 1 line 65-67, teaches arm members are hingeably mounted) holding the at least one splitter arm (Fig. 9, arm member, 10, col. 4 lines 1-6) in position relative to the handle assembly (Fig. 8A, handle, 32, col. 5, lines 19-26).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the splitter arm mounts of Cresswell in order to allow for deployment with the sheath pathways along the sheath pull handle (col. 5 lines 23-27).
In regards to claim 17, modified Collins further discloses positioner (Fig. 5A, pusher catheter, 300, para 0111-0112). However, Collins does not disclose wherein the at least one splitter arm comprises a side seal disposed within the at least one splitter arms the side seal configured to prevent blood loss through the positioner.
Cresswell further discloses the at least one splitter arm (Fig. 9, arm member, 10, col. 4 lines 1-6). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the splitter arm of Cresswell since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
However, modified Collins does not disclose comprises a side seal disposed within the at least one splitter arms the side seal configured to prevent blood loss.
Sawada further discloses the side seal (Fig. 6, seal members 58 and 60 in combination with take up shafts 30 and 32, para 0064) configured to prevent blood loss (para 0020) through the positioner.
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the side seal of Sawada to prevent blood from leaking to the exterior hub (para 0019).
In regards to claim 18, modified Collins further discloses further comprising a follower (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085) attached to the sheath (Fig. 1, sheath, 510, para 0107), the follower drivable (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085, teaches a slidably drivable actuator) in a direction away from the proximal end (see below, annotated Fig. 2, directional markers) of the delivery device assembly, and pulls the prosthesis sheathing portion (see below, annotated Fig. 1, PSP, para 0033-0034) of the sheath from the covering position in which it covers the prosthesis receiving zone (Fig. 2B, receiving portion, 50, para 0070); to the retracted position (Fig. 2A, sheath, 510 in combination with endograft delivery device, 10, para 0036 ) in which the prosthesis sheathing portion is longitudinally displaced (see below, annotated Fig. 2, directional markers) way from the prosthesis receiving zone.
However, Collins does not explicitly disclose that the follower is driveable to the sheath splitter in a direction away from the proximal end of the delivery device, wherein movement of the follower slides the sheath over the sealing surface. Cresswell further discloses the sheath splitter assembly (Fig. 1, sheath splitting apparatus, col. 3, lines 56-58) moving in a direction away from the proximal end of the delivery device assembly (Fig. 8B, directional arrow, 25, col. 5 lines 19-27).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the sheath splitter assembly of Cresswell since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
Modified Collins does not explicitly disclose a sealing surface. Sawada further discloses the delivery device assembly slides the sheath over the sealing surface sealing surface (Fig. 4, ring-shaped seal member, 54 in combination with sheath body, 18, para 0047). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins to include the sealing surface of Sawada in order to create a liquid tight seal between the sheath body and the hub (para 0049).
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In regards to claim 19, modified Collins further discloses wherein the follower (Fig. 8A/B, actuator, 182, in combinations with actuator receiving portion, 184, para 0085) is operatively attached to the sheath (Fig. 1, sheath, 510, para 0107) at a sheath distal end (para 0069, references sheath proximal end, 512, therefore a sheath distal end is inherent).
However, Collins does not explicitly disclose the follower is sandwiched between a pair of spaced apart sheath portions. Cresswell further teaches a pair of spaced apart sheath portions (see below, annotated Fig. 1, ASP). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the endograft delivery device of Collins with the spaced apart sheath portions of Cresswell as courts have found it obvious to apply a known technique to a known method ready for improvement to yield predictable results (MPEP 2143).
Conclusion
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/J.M.S./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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