DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/03/2025 has been entered.
Response to Amendment
The amendment filed 12/03/2025 has been entered. Claims 185-191, 193-195, 197-200, 202-203, and 205-207 remain pending in the application. Claim 196 remains withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claims 185 and 200 have been considered but are moot because the new ground of rejection (US 20160317301 A1 (hereafter --Quadri--), in further view of US 20030130712 A1 (hereafter --Smits--) does not rely on any reference that had matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 185 and 188 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 185, Claim 185 recites the limitation "the third deflectable bend portion" in line 28. There is insufficient antecedent basis for this limitation in the claim, as there is no third deflectable bend portion introduced in the claim. Additionally, it is unclear if the limitation “third portion of the elongate shaft” is the same portion as the “third deflectable bend portion”. For purposes of expedited prosecution, the examiner is considering the “third portion of the elongate shaft” to mean the “third deflectable bend portion”.
Regarding Claim 188, it is unclear how the third tether is connected to both third deflectable bend portion (as stated in claim 185) and the sheath (as stated in claim 188). Further clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 185-187, 193-194, 197-198, 200, 202, and 206-207 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160317301 A1 (hereafter --Quadri--), in further view of US 20030130712 A1 (hereafter --Smits--).
Regarding Claim 185, Quadri discloses a delivery system for replacing the function of a native heart valve, the delivery system (see annotated delivery system 10 in Figure 1 below) comprising: a prosthetic heart valve implant (70); an elongate shaft (see annotated elongated shaft 12 (comprising of subassemblies inner shaft assembly 18, midshaft 20 assembly, outer sheath 22, and nose cone assembly 31) in Figure 1 below, see also paragraph [0116] describing the elongate shaft) having: a distal end portion (see annotated distal end portion 13 in Figure 1 below), an implant retention area for retaining the prosthetic heart valve implant in a compressed configuration (see annotated implant retention area 16 and prosthetic heart valve 70 in Figure 2 below).
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Quadri fails to disclose a first deflectable bend portion located proximal to the implant retention area and configured to deflect the implant retention area and the distal end portion in a first direction and a second deflectable bend portion located proximal to the first deflectable bend portion and configured to deflect the implant retention area and the distal end portion in a second direction, wherein deflection in the second direction is in a different plane than the deflection in the first direction, and a first pull tether that is: connected to the first deflectable bend portion and configured, via the connection to the first deflectable bend portion, to actuate the first deflectable bend portion to deflect the implant retention area and the distal end portion in the first direction; a second pull tether that is: connected to the second deflectable bend portion; and configured, via the connection to the second deflectable bend portion, to actuate the second deflectable bend portion to deflect the implant retention area and the distal end portion in the second direction; and a third pull tether that is: connected to a third portion of the elongate shaft that is proximal to both the first and second deflectable bend portions: and configured, via the connection to the third deflectable bend portion, to actuate the third portion to deflect in a third direction that is opposed to the first direction.
Smits discloses a delivery device (see Abstract) comprising of an elongate shaft (10’). Smits teaches a first deflectable bend portion (66) located proximal to the distal end (see annotated distal end 28 and first deflectable bend portion 66 in Figure 6 below) and a first pull tether that is: connected to the first deflectable bend portion and configured, via the connection to the first deflectable bend portion (see paragraph [0058] denoting that there can be multiple pull wires that can extend through the lumen to selectively induce curves in the portions 62, 64, and 66), to deflect the distal end portion (24’) in a first direction (see annotated first direction and first deflectable bend portion in Figure 6 below), and a second deflectable bend portion (64) located proximal to the first deflectable bend portion (see annotated first and second portions in Figure 6 below), and a second pull tether that is: connected to the second deflectable bend portion and configured, via the connection to the second deflectable bend portion, to deflect the distal end portion in a second direction (see paragraph [0058] denoting that there can be multiple pull wires that can extend through the lumen to selectively induce curves in the portions 62, 64, and 66), wherein deflection in the second direction is in a different plane than the deflection in the first direction (see annotated first and second directions in Figure 6 below), and a third deflectable bend portion (66) and a third pull tether that is: connected to the third deflectable bend portion, in which the portion is proximal to both the first and second deflectable bend portions (see annotated first, second, and third deflectable bend portions in Figure 6 below) and configured, via the connection to the third deflectable bend portion (see paragraph [0058] denoting that there can be multiple pull wires that can extend through the lumen to selectively induce curves in the portions 62, 64, and 66), to actuate the third portion to deflect in a third direction that is opposed to the first direction (see annotated first and third direction in Figure 6 below).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri to have a first deflectable bend portion located proximal to the implant retention area and configured to deflect the implant retention area and the distal end portion in a first direction and a second deflectable bend portion located proximal to the first deflectable bend portion and configured to deflect the implant retention area and the distal end portion in a second direction, the bend portions having a first pull tether that is: connected to the first deflectable bend portion and configured, via the connection to the first deflectable bend portion, to actuate the first deflectable bend portion to deflect the implant retention area and the distal end portion in the first direction; a second pull tether that is: connected to the second deflectable bend portion; and configured, via the connection to the second deflectable bend portion, to actuate the second deflectable bend portion to deflect the implant retention area and the distal end portion in the second direction; a third pull tether that is: connected to the third deflectable bend portion, in which the portion is proximal to both the first and second deflectable bend portions, and configured, via the connection to the third deflectable bend portion, to actuate the third portion to deflect in a third direction that is opposed to the first direction, as by doing so would allow the pull wires to selectively induce the bends in each bend portion, as taught by Smits (see paragraph [0058]).
Regarding Claim 186, Quadri as modified discloses the delivery system of claim 185.
The limitation “wherein the third direction is coplanar with the first direction” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The sheath is and has bending portions (see annotated bending portions Figure 6) that would deflect the elongate shaft inside of it in three different directions, (the third in which is coplanar with the first, see annotated directions in Figure 6 above). Due to the sheath having the structural features to do so, the sheath is capable of bending or deflecting in any direction, including in a direction that is coplanar with the first direction.
Regarding Claim 187, Quadri as modified discloses the delivery system of claim 185, wherein the second direction is perpendicular to the first direction (see annotated first and second directions in Figure 6 above, see also paragraph [0056] of Smits).
Regarding Claim 193, Quadri as modified discloses the delivery system of claim 185, wherein the elongate shaft is sized for transfemoral advancement into a patient's body (see paragraphs [0114] and [0169]).
Regarding Claim 194, Quadri as modified discloses the delivery system of claim 185, wherein the elongate shaft has an axial dimension and includes a port for the prosthetic heart valve implant to be deployed from the implant retention area (see annotated axial dimension and port in Figure 11 below) in a direction transverse to the axial dimension (see paragraph [0180], see also annotation in Figure 11 below).
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Regarding Claim 197, Quadri as modified discloses the delivery system of claim 185, further comprising a port positioned on the prosthetic heart valve implant (see annotated port in Figure above, as the outer sheath surrounds the entire heart valve, and the port is the most distal end on the outer sheath, every portion of the outer sheath, the port included, also positioned on the prosthetic heart valve).
The limitation “configured to receive a diagnostic or therapeutic device” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Since the “port” is the aperture/edge of a flexible tube, it has the structural features to “receive” a diagnostic or therapeutic device by coming in contact with a device of sorts that has the physical characteristics to interact with such a system.
Regarding Claim 198, Quadri as modified discloses the delivery system of claim 185, wherein the prosthetic heart valve implant comprises a replacement tricuspid heart valve (see paragraph [0255]).
Regarding Claim 200, Quadri discloses delivery system for replacing the function of a native heart valve, the delivery system comprising: a prosthetic heart valve implant (see annotated delivery system 10 in Figure 1 above); an elongate shaft having ((see annotated elongated shaft 12 (comprising of subassemblies inner shaft assembly 18, midshaft assembly 20, outer sheath 22, and nose cone assembly 31) in Figure 1 above, see also paragraph [0116] describing the elongate shaft)): a distal end portion (see annotated distal end portion 13 in Figure 1 above), an implant retention area for retaining the prosthetic heart valve implant in a compressed configuration (see annotated implant retention area 16 and prosthetic heart valve 70 in Figure 2 above).
Quadri fails to disclose a first deflectable bend portion located proximal to the implant retention area and configured to deflect the implant retention area and the distal end portion in a first direction and a second deflectable bend portion located proximal to the first deflectable bend portion and configured to deflect the implant retention area and the distal end portion in a second direction, wherein deflection in the second direction is in a different plane than the deflection in the first direction, and a third deflectable bend portion located proximal to both the first and second deflectable bend portions and configured to deflect in a third direction that is opposed to the first direction; a first pull tether configured to actuate the first deflectable bend portion to deflect the implant retention area and the distal end portion in the first direction; a second pull tether configured to actuate the second deflectable bend portion to deflect the implant retention area and the distal end portion in the second direction; and a third pull tether configured to actuate the third deflectable bend portion to deflect in the third direction, as well as a first pull tether that is: connected to the first deflectable bend portion; a second pull tether that is: connected to the second deflectable bend portion; and a third pull tether that is: connected to a third portion of the elongate shaft that is proximal to both the first and second deflectable bend portions. Quadri does however teach multiple bend portions that can bend in different directions and planes (see paragraphs [0174], [0178], and [0179]).
Smits discloses a delivery device (see Abstract) comprising of an elongate shaft (10’). Smits teaches a first deflectable bend portion (66) located proximal to the distal end (see annotated distal end 28 and first deflectable bend portion 66 in Figure 6 below) configured to deflect the distal end (28’) portion in a first direction (see annotated first direction in Figure 6 below), a second deflectable bend portion (64) located proximal to the first deflectable bend portion (see annotated first and second deflectable bend portion) and configured to deflect the implant retention area and the distal end portion in a second direction (see annotated second direction in Figure 6 below), wherein deflection in the second direction is in a different plane than the deflection in the first direction (see annotated first and second directions in Figure 6 below, one being on the X axis, one being on the Z axis); a third deflectable bend portion (62) located proximal to both the first and second deflectable bend portions (see annotated first, second, and third deflectable bend portions in Figure 6 below) and configured to deflect in a third direction that is opposed to the first direction (see annotated first and third directions in Figure 6 below); a first pull tether that is: connected to the first deflectable bend portion ; and configured to actuate the first deflectable bend portion to deflect the implant retention area and the distal end portion in the first direction (see paragraph [0058] denoting that there can be multiple pull wires that can extend through the lumen to selectively induce curves in the portions 62, 64, and 66); a second pull tether that is: connected to the second deflectable bend portion; and configured to actuate the second deflectable bend portion to deflect the implant retention area and the distal end portion in the second direction (see paragraph [0058] denoting that there can be multiple pull wires that can extend through the lumen to selectively induce curves in the portions 62, 64, and 66); and a third pull tether that is: connected to the third deflectable bend portion; and configured to actuate the third deflectable bend portion to deflect in the third direction (see paragraph [0058] denoting that there can be multiple pull wires that can extend through the lumen to selectively induce curves in the portions 62, 64, and 66, see also annotated first and third direction in Figure 6 below).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri to have a first deflectable bend portion located proximal to the implant retention area and configured to deflect the implant retention area and the distal end portion in a first direction and a second deflectable bend portion located proximal to the first deflectable bend portion and configured to deflect the implant retention area and the distal end portion in a second direction, wherein deflection in the second direction is in a different plane than the deflection in the first direction; a third deflectable bend portion located proximal to both the first and second deflectable bend portions and configured to deflect in a third direction that is opposed to the first direction; a first pull tether that is: connected to the first deflectable bend portion; and configured to actuate the first deflectable bend portion to deflect the implant retention area and the distal end portion in the first direction; a second pull tether that is: connected to the second deflectable bend portion; and configured to actuate the second deflectable bend portion to deflect the implant retention area and the distal end portion in the second direction; and a third pull tether that is: connected to the third deflectable bend portion; and configured to actuate the third deflectable bend portion to deflect in the third direction, as by doing so would allow the pull wires to selectively induce the bends in each bend portion, as taught by Smits (see paragraph [0058]).
Regarding Claim 202, Quadri as modified discloses the delivery system of claim 200, wherein the third pull tether includes a distal end coupled to the elongate shaft proximal of the second deflectable bend portion (see claim 200 rejection above).
Regarding Claim 206, Quadri as modified discloses the delivery system of claim 200.
The limitation “wherein the third direction is coplanar with the first direction” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The sheath is and has bending portions (see annotated bending portions Figure 6) that would deflect the elongate shaft inside of it in three different directions, (the third in which is coplanar with the first, see annotated directions in Figure 6 above). Due to the sheath having the structural features to do so, the sheath is capable of bending or deflecting in any direction, including in a direction that is coplanar with the first direction.
Regarding Claim 207, Quadri as modified discloses the delivery system of claim 200, wherein the second direction is perpendicular to the first direction (see annotated first and second directions in Figure 6 above, see also paragraph [0056] of Smits).
Claim 195 is rejected under 35 U.S.C. 103 as being unpatentable over US 20160317301 A1 (hereafter --Quadri--), in view of US 20030130712 A1 (hereafter --Smits--), as applied to claim 185 above, in even further view of US 20050070844 A1 (hereafter --Chow-).
Regarding Claim 195, Quadri as modified discloses the delivery system of claim 185.
Quadri as modified fails to disclose wherein the elongate shaft is configured to bend more than 180 degrees to form a loop.
Chow discloses a delivery device (100) comprising of an elongate shaft (101) comprising of: an outer sheath (120), mid shaft (122), and an inner shaft (138) (see annotated components in Figures 1 and 2 below, see paragraph [0071]). Chow teaches wherein the elongate shaft is configured to bend more than 180 degrees to form a loop (see paragraph [0236]).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri as modified to have the elongate shaft is configured to bend more than 180 degrees to form a loop, as by doing so would eliminate the need to turn the catheter shaft during stent delivery, as well as would provide a catheter assembly that is easy to use and is capable of reaching all target locations within a 3D cavity with precise therapy dosing (see paragraph [0236]).
Claim 199 is rejected under 35 U.S.C. 103 as being unpatentable over US 20160317301 A1 (hereafter --Quadri--), in view of US 20030130712 A1 (hereafter --Smits--), in even further view of US 5509900 A (hereafter --Kirkman--).
Regarding Claim 199, Quadri as modified discloses the delivery system of claim 185.
Quadri as modified fails to disclose further comprising multiple support bodies extendable radially outward from the shaft to contact tissue of the heart in a manner that resists deflection of the shaft.
Kirkman discloses a delivery catheter with a shaft (see Abstract, see also annotated shaft in Figure 7 below). Kirkman teaches multiple support bodies extendable radially outward from the shaft to contact tissue of the heart in a manner that resists deflection of the shaft (see annotated shaft and support bodies in Figure 7 below).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri further comprising of multiple support bodies extendable radially outward from the shaft to contact tissue of the heart in a manner that resists deflection of the shaft, as by doing so would center the tip of the delivery system in the vessel so that there is no contact with the vessel wall (see column 11, lines 8-11) while also ensuring that there is no penetration on the vessel wall (see column 11, lines 6-8).
Claims 188-190 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160317301 A1 (hereafter --Quadri--), in view of US 20030130712 A1 (hereafter --Smits--), as applied to claim 185 above, in further view of US 20050070844 A1 (hereafter --Chow-), in even further view of US 20140243877 A9 (hereafter --Lee--).
Regarding Claim 188, Quadri as modified discloses the delivery system of claim 185.
Quadri fails to disclose a sheath positioned over the elongate shaft. Quadri however does disclose a steerable catheter may be used instead of the externalized guidewire to position the delivery device (see paragraph [0172]).
Chow teaches a sheath (194) positioned over the elongate shaft (101) (see paragraph [0118], see also annotated sheath 194 in Figures 14A-14C below), in which the sheath (194) has a flexible distal portion (198) that is able to bend and deflect to give the catheter assembly additional direction (see paragraphs [0120] and [0122]).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri to have a sheath with a deflectable bend portion positioned over the elongate shaft, as by doing so would facilitate the introduction of the delivery device into a patient by creating a pathway into the left ventricle through which the device can be inserted into as taught by Chow (see paragraphs [0118] and [0122]).
Quadri as modified further fails to disclose wherein the third pull tether is coupled to the sheath.
Lee discloses a catheter delivery assembly comprising of a shaft, sheath, and pull tether for deflecting the system (see annotated sheath, shaft, and pull tether in Figure 7A-7C below). Lee teaches wherein the pull tether is coupled to the sheath (see paragraph [0071]).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the third pull tether of Quadri as modified to be coupled to the sheath, as by doing so would provide a sheath that could perform rotation, steering, and axial translation, as all three degrees of independent motion provide important clinical advantages able to navigate the tightly acute/close together nature of a subject’s brachiocephalic trunk and left carotid artery as taught by Lee (see paragraph [0081]).
The limitation “wherein the sheath is configured to deflect the portion of the elongate shaft in the third direction to increase height of the distal end portion from a deployment site of the prosthetic heart valve implant” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The sheath is flexible and has bending portions (see paragraphs [0120] and [0122] of Crow, see also Figures 14A-C above of Crow) that would deflect the elongate shaft inside of it in three different directions (see annotated directions in Figure 6 above, see also Figures 14A-C above of Crow). Due to the sheath having the structural features to do so, the outer sheath is capable of bending or deflecting in any direction, including in a “third” direction that would increase the height of the distal end portion from the deployment site, as the third direction as annotated in the Figure above is the most proximal direction and would be able to pull the distal end in that direction, increasing the distance of the distal end from the deployment site.
Regarding Claim 189, Quadri as modified discloses the delivery system of claim 188.
The limitation “wherein the sheath is configured to rotate around the elongate shaft to vary a plane of the third direction” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The sheath is flexible and is able to be inserted into in a sliding manner (see paragraphs [0118] and [0122]) and therefore also able to be pulled back from surrounding the elongate shaft, (therefore is not attached in a way that would keep it from being able to rotate around the shaft), the sheath is able to rotate around the elongate shaft to vary a plane of the third direction.
Regarding Claim 190, Quadri as modified discloses the delivery system of claim 189, wherein: the first deflectable bend portion is configured to defect the implant retention area and the distal end portion in a first plane (see annotated first deflectable bend portion in Figure 6 above), the second deflectable bend portion is configured to deflect the implant retention area and the distal end portion in a second plane that is different than the first plane (see annotated second deflectable bend portion in Figure 6 above).
The limitation “the sheath is configured to deflect the portion of the elongate shaft that is proximal to both the first and second deflectable bend portions in a third plane that is different than the first plane and the second plane” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The sheath is flexible and has bending portions ((see paragraphs [0120] and [0122] of Crow, see also Figures 14A-C above of Crow) that would deflect the elongate shaft inside of it in three different directions (see annotated directions in Figure 6 above, see also Figures 14A-C above of Crow). Due to the sheath having the structural features to do so, the, the sheath is capable of bending or deflecting in any direction based on placement of inserts, including in a “third” direction that is different from the first and second directions.
Claims 191, 203, and 205 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160317301 A1 (hereafter --Quadri--), in view of US 20030130712 A1 (hereafter --Smits--), as applied to claims 185 and 200 above, in further view of US 8500733 B2 (hereafter --Watson--).
Regarding Claim 191, Quadri as modified discloses the delivery system of claim 185, wherein the elongate shaft (12) includes: an inner shaft (18), a mid-shaft (20) extending over the inner shaft (see annotated inner and mid shaft in Figure 2 below), see also paragraph [0117] describing subassembly components of elongate shaft 12 (comprising of subassemblies inner shaft assembly 18, midshaft assembly 20, outer sheath 22, and nose cone assembly 31), see also paragraph [0116] describing the elongate shaft), including the first and second deflectable bend portions (as modified by Chow), and an outer sheath surrounding the mid shaft and the first and second deflectable bend portions (see annotated outer sheath 22 and first/second deflectable bend portions in Figure 2 below, see also paragraph [0200], see also annotated inner shaft assembly 18, mid shaft assembly 20, and outer sheath 22 of the elongate shaft 12 in Figure below).
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Quadri fails to disclose the elongate shaft having a rail shaft surrounding the inner shaft.
Watson discloses a delivery system with an elongate shaft assembly comprising an inner shaft, a middle shaft, and an outer sheath, the delivery system having two deflectable bend portions (see annotated inner shaft, middle shaft outer sheath, and deflectable bend portions). Watson teaches wherein the middle shaft is a rail shaft (see annotated rail shaft in Figure below, see also column 8, lines 15-35).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri to have the mid-shaft that is over the inner shaft and under the outer sheath (22) be a rail shaft, as by doing so would facilitate bi-directional asymmetric deflection of the elongated shaft, in that the notches can be configured to achieve any desired curve circumference, shape, and fulcrum point position as taught by Watson (see also column 8, lines 15-35).
The limitation “the outer sheath configured to slide relative to the rail shaft to vary a distance of the implant retention area from the rail shaft” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Since the outer sheath is flexible and is able to be protracted and retracted or pulled back from surrounding the shaft (see paragraphs [0020], [0150], [0181], [0186], and [0189]), the sheath 22 able to slide relative to a rail shaft to vary a distance of the implant retention area from the rail shaft.
Regarding Claim 203, Quadri discloses the delivery system of claim 200, wherein the elongate shaft (12) includes: an inner shaft assembly (18), a mid-shaft assembly (20) (see paragraph [0117] describing subassembly components of elongate shaft 12 (comprising of subassemblies inner shaft 18, midshaft 20, outer sheath 22, and nose cone assembly 31), see also paragraph [0116] describing the elongate shaft), first and second deflectable bend portions (as modified by Chow), and an outer sheath surrounding the mid shaft and the first and second deflectable bend portions (see annotated outer sheath 22 and first/second deflectable bend portions in Figure 2 above, see also paragraph [0200], see also annotated inner shaft 18, mid shaft 20, and outer sheath 22 of the elongate shaft 12 in Figure above).
Quadri fails to disclose the device wherein the elongate shaft includes: a rail shaft extending over the inner shaft and having one or more cuts thereon.
Watson teaches wherein the elongate shaft includes: a rail shaft extending over the inner shaft and having one or more cuts thereon (see rail shaft and cuts in Figure 3A below).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the delivery system of Quadri to have the mid-shaft that is over the inner shaft and under the outer sheath (22) of Quadri be a rail shaft with over the inner fast that has multiple cuts as by doing so would facilitate bi-directional asymmetric deflection of the elongated shaft, in that the notches can be configured to achieve any desired curve circumference, shape, and fulcrum point position as taught by Watson (see also column 8, lines 15-35).
Regarding Claim 205, Quadri as modified discloses the delivery system of claim 203, wherein the inner shaft is configured to slide relative to the rail shaft to vary a distance of the implant retention area from the rail shaft (see paragraph [0131] denoting that the inner and mid shafts slide relative to each other, the mid shaft being the rail shaft as modified by Watson in claim 203 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20080139999 A1: This reference discloses a delivery device with multiple bending areas and pull wires.
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/PARIS MARIE BLASS/
Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774