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 Objections
Claim 107 is objected to because of the following informalities: line 19- “the first end of tubular body” should be amended to - - the first end of the tubular body - - to correct an apparent typographical error. Appropriate correction is required.
Claims 108- 121 are objected to because they depend off claim 107.
Claims 114 is objected to because of the following informalities: line 1- “the tensioners” should be amended to - - the plurality of tensioners - - to maintain consistent claim terminology. Appropriate correction 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.
Claim(s) 107, 110, 112- 115 and 118- 121 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US Pub. No. 2017/0035445 A1) in view of Brady et al. (US Pub. No. 2013/0184739 A1) (hereinafter “Brady ‘739”).
Regarding claims 107, 112 and 115, Nguyen discloses a capture system comprising:
a tubular body (8) (Figs. 16A-D, 17A-D), comprising a first end (800) (Figs. 16A-D, 17A-D), a second end (88) (Figs. 16A-D, 17A-D), and an axial length therebetween, the first end (800) defining an opening (802) (Fig. 16A)
an inner shaft (6) (Figs. 16C, 17D) coupled to the tubular body (8);
an outer shaft (12) (Figs. 16A) defining a lumen configured to receive the inner shaft (6) and the tubular body (8);
a plurality of tensioners (10) (Figs. 16B- 16D) including at least a first tensioner (10) and a second tensioner (10 - - same reference number for all capture pull wires) (P. [0076] - - As illustrated in FIGS. 5-9 for example, a thrombus capture guide 11 can attach to a portion, such as an open end of the ALTC Device 8 and one, two, or more capture pull wires 10 where the capture pull wires are positioned inside the side lumen of the suction catheter 2 or outside of the lumen in other embodiments, and extends proximally; it is noted that the Nguyen reference discloses a plurality of tensioners),
wherein the tubular body (8) has a first configuration (Fig. 12) in which the first end (800) is expanded while the second end (88) and a portion of the tubular body (81) remain compressed, the tubular body (8) having a first expanded axial length (L12A) (Fig. 12) in the first configuration (Fig. 12) (P. [0088] - - As illustrated in FIG. 12, some or most of the axial length of the ALTC device, e.g., the tubular mesh structure 8 remains radially compressed as part of the reserve segment between the outer diameter of the guidewire catheter 6 and the inner diameter of the shaft 12 of the capture catheter (distance between of which is length L12B), with the radially expanded portion of the tubular mesh structure 8 being defined along the axial length between proximal end 800 with proximal-facing opening 802 and the dynamic fold point 88 (distance between of which is length L12A)),
wherein the tubular body (8) is transformable to a second configuration (Fig. 6) in which the tubular body (8) has a second expanded axial length (See Fig. 6) greater than the first expanded axial length (L12A) (P. [0078] - - As shown, for example, in FIG. 6, it can also be possible to lengthen the ALTC Device 8 in an appropriate direction, such as distally, by pushing the capture catheter 12 relative to the guidewire shaft 6, thereby allowing additional reserve radially compressed length of the tubular mesh 8 to radially expand out of the confines of the lumen of the capture catheter 12 to axially lengthen the Thrombus Capture Device 8 and maintain its constant or substantially constant diameter through a working range), and wherein:
a proximal end of the first tensioner (10) is attached to the outer shaft (12) at a shaft attachment point, and
a proximal end of the second tensioner (10 - - same reference number for all capture pull wires) is attached to the outer shaft (12) at the shaft attachment point (P. [0095] - - a sleeve 30 (FIGS. 16A-D and 17A-D) can be used to couple, such as permanently, the Capture Pull Wire 10 to a portion of the Capture Catheter shaft 12 to enable both components to operate together. Coupling the Capture Pull Wire 10 and the Capture Catheter shaft 12 can allow the user to manage the capture device more efficiently and easily. In another embodiment, the capture guide 11 takes the form of a loop and can attach to the Sleeve 30, which is coupled to the Capture Catheter Shaft 12).
Nguyen does not explicitly disclose
(claim 107) the plurality of tensioners, when activated, being configured to limit or prevent deflection of the first end of the tubular body relative to when each of the plurality of tensioners are deactivated as claimed;
(claim 107) a distal end of the first tensioner is attached to the first end of tubular body at a first attachment point,
a distal end of the second tensioner is attached to the first end of the tubular body at a second attachment point, the second attachment point spaced apart from the first attachment point.
(claim 112) wherein each of the plurality of tensioners are non-rigid when deactivated;
(claim 115) further comprising a control handle, wherein the outer shaft is mechanically coupled to the control handle, and wherein the control handle is configured to control a tension of the plurality of tensioners by at least controlling axial movement of the outer shaft relative to the inner shaft.
However, Brady ‘739 teaches a device for removal of clot obstructing the flow of blood in the same field of endeavor (Abstract)
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(claim 107) a plurality of tensioners (T1, T2) including at least a first tensioner (T1) and a second tensioner (T2) (See Annotated Fig. 37a), the plurality of tensioners (T1, T2), when activated, being configured to limit or prevent deflection of the first end of the tubular body (F1) (See Annotated Fig. 37a) relative to when each of the plurality of tensioners (T1, T2) are deactivated (Ps. [0004], [0005], [0007] - - neurovascular vessels are more fragile than similarly sized vessels in other parts of the body and are in a soft tissue bed. This issue is compounded by the fact that in many instances the clot is firmly wedged in the vessel … All three of these mechanisms play a role in strongly adhering the clot to the vessel wall. Breaking these bonds without damaging these fragile vessels is a significant challenge. The high aspect ratio of the device and the vessel tortuousity make it difficult to transmit forces to the clot and for the user to feel reaction forces from the clot; These and other problems are solved by the present invention; the basket further comprising a cable extending through the lumen of the elongate member, the cable attached to the first ring member, the cable comprising an activated state and a deactivated state, in the activated state the cable transmitting a force from the user to the frame, said force causing the deployed frame to assume the expanded state).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the plurality of tensioners associated with Nguyen such that the plurality of tensioners, when activated, are configured to limit or prevent deflection of the first end of the tubular body associated with Nguyen relative when each of the plurality of polymeric tensioners are deactivated according to the teachings of Brady ‘739 because it would allow force to be transmitted from the user to the frame, causing the deployed frame to assume the expanded state, thereby transmitting the force to the clot firmly adhered to the vessel walls to facilitate clot removal (Brady ‘739 - - [0004], [0005], [0007]).
Modified Nguyen does not disclose
(claim 107) a distal end of the first tensioner is attached to the first end of tubular body at a first attachment point,
a distal end of the second tensioner is attached to the first end of the tubular body at a second attachment point, the second attachment point spaced apart from the first attachment point.
(claim 112) wherein each of the plurality of tensioners are non-rigid when deactivated;
(claim 115) further comprising a control handle, wherein the outer shaft is mechanically coupled to the control handle, and wherein the control handle is configured to control a tension of the plurality of tensioners by at least controlling axial movement of the outer shaft relative to the inner shaft.
However, Brady ‘739 teaches a device for removal of clot obstructing the flow of blood in the same field of endeavor (Abstract)
(claim 107) a distal end of the first tensioner (T1) is attached to the first end of tubular body (F1) at a first attachment point (AP1),
a distal end of the second tensioner (T2) is attached to the first end of the tubular body (F1) at a second attachment point (AP2), the second attachment point (AP2) spaced apart from the first attachment point (AP1) (See Annotated Fig. 37a) (P. [0537] - - The pull cable extends from attachment point(s) 880 through the exit port 879 through the lumen of the g support member 877 to the handle 883. In one embodiment the cable is interfaced with a slider 884 such that activation of the slider 884 causes the cable 878 to undergo tension and deactivation of the slider 884 reduces or removes tension from the cable 878. Tensioning the pull cables 878 causes the frame 875 to articulate about a region adjacent the junction 881. FIG. 37b and FIG. 37c show a top and side view respectively of the basket 871 with pull cable 878 in the untensioned state. FIG. 37d shows a top view of the basket 871 constrained in a vessel with pull cable 878 in the untensioned state; it is noted that Fig. 37a is similar to applicant’s Fig. 1A showing tethers which have the same reference number of 120);
(claim 112) wherein each of the plurality of tensioners (T1, T2) are non-rigid when deactivated (Figs. 37b- 37d) (P. [0537] - - FIG. 37b and FIG. 37c show a top and side view respectively of the basket 871 with pull cable 878 in the untensioned state. FIG. 37d shows a top view of the basket 871 constrained in a vessel with pull cable 878 in the untensioned state; it is noted that untensioned is interpreted as non-rigid as shown in the collapsed/ delivery configurations of Figs. 37b- 37d for navigating through tortuous anatomy);
(claim 115) further comprising a control handle (883) (Fig. 37a), wherein the outer shaft (877) (Figs. 37a- 37e) is mechanically coupled to the control handle (883), and wherein the control handle (883) is configured to control a tension of the plurality of polymeric tensioners (878) (Figs. 37a- 37b, 37d) (P. [0537] - - The pull cable extends from attachment point(s) 880 through the exit port 879 through the lumen of the support member 877 to the handle 883. In one embodiment the cable is interfaced with a slider 884 such that activation of the slider 884 causes the cable 878 to undergo tension and deactivation of the slider 884 reduces or removes tension from the cable 878. Tensioning the pull cables 878 causes the frame 875 to articulate about a region adjacent the junction 881).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the tensioners associated with Nguyen such that they comprise first and second tensioners attached at first and second attachment points of the first end of the tubular body and are mechanically coupled to a control handle according to the teachings of Brady ‘739 such that the control handle controls the axial movement of the outer shaft (12) relative to the inner shaft (6) associated with Nguyen because it would allow a user to articulate a frame from a flat, non-rigid collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]).
Regarding claim 110, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen further disclosing wherein the shaft attachment point where the proximal end of the first tensioner (10) and the proximal end of the second tensioner (10 - - same reference number for all capture pull wires) are attached to the outer shaft (12) is located between a proximal and a distal end of the outer shaft (12) (See Figs. 16A-D and 17A-D).
Regarding claim 113, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen further disclosing wherein each of the plurality of tensioners (10) are configured to be pulled proximally independent of the inner shaft (6) (See Figs. 16A- 16D) (P. [0094] - - As such, when the guidewire shaft 6 with distal nose tip 7 is maintained in a constant position, axial elongation of the expanded tubular mesh 8 results in an increase in the axial distance D between the distal nose tip 7 and the dynamic fold point 88, so distance D3 is greater than D2, which is in turn greater than D1).
Regarding claim 114, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen further disclosing wherein the tensioners (10) are not attached to the inner shaft (6) (See Figs. 16A- 16D) (P. [0093] - - The capture guide 11 and associated terminal wires 10 are operably coupled to the sleeve 30, and the sleeve 30 is coupled to the outer wall of the capture catheter shaft 12; it is noted that as shaft 12 is retracted, inner shaft (6) is stationary as shown in Figs. 16B- 16D).
Regarding claim 118, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen further disclosing further comprising a capture guide (11) (Figs. 15B, 17A), attached to the first end of the tubular body (800), the capture guide (11) including a nitinol loop, and wherein each of the first tensioner (10) and the second tensioner (10 - - same reference number for all capture pull wires) are mechanically coupled to the nitinol loop of the capture guide (11) via a tied knot of a suture (Ps. [0076] - - the capture pullwire 10 and the capture guide 11 can be made into a single component such as a Loop. In some other embodiments, the capture guide and the proximal end of the ALTC device is sutured in place using silk or polymeric filaments such as Ultra-High Molecular Weight polyethylene, Nylon, PET, PTFE … the thrombus capture guide 11 can include a loop configuration and be formed from nitinol shape memory wire; it is noted that suturing in place is broadly interpreted as including a tied knot of suture).
Regarding claims 119- 121, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen does not disclose
(claim 119) wherein the second attachment point is spaced apart from the first attachment point by at least 60 degrees around the first end of the tubular body;
(claim 120) wherein when the tubular body is in the first configuration: the first attachment point is spaced apart from the inner shaft by at least 90 degrees around the first end of the tubular body, and the second attachment point is spaced apart from the inner shaft by at least 90 degrees around the first end of the tubular body;
(claim 121) wherein when the tubular body is in the first configuration, the first attachment point, the second attachment point, and the inner shaft are spaced apart from each other around the first end of the tubular body by at least 60 degrees.
However, Brady ‘739 teaches a device for removal of clot obstructing the flow of blood in the same field of endeavor (Abstract)
(claims 119- 121) wherein when the tubular body (F1) is in the first configuration (Fig. 37a), the first attachment point (AP1), the second attachment point (AP2), and the inner shaft are spaced apart from each other around the first end of the tubular body (F1) by at least a non-zero angle (See Annotated Fig. 37a) (P. [0537] - - The pull cable extends from attachment point(s) 880 through the exit port 879 through the lumen of the g support member 877 to the handle 883. In one embodiment the cable is interfaced with a slider 884 such that activation of the slider 884 causes the cable 878 to undergo tension and deactivation of the slider 884 reduces or removes tension from the cable 878. Tensioning the pull cables 878 causes the frame 875 to articulate about a region adjacent the junction 881. FIG. 37b and FIG. 37c show a top and side view respectively of the basket 871 with pull cable 878 in the untensioned state. FIG. 37d shows a top view of the basket 871 constrained in a vessel with pull cable 878 in the untensioned state; it is noted that Fig. 37a is similar to applicant’s Fig. 1A showing tethers which have the same reference number of 120);
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the tensioners associated with Nguyen such that the first attachment point, the second attachment point, and the inner shaft are spaced apart from each other around the first end of the tubular body by at least a non-zero angle according to the teachings of Brady ‘739 such that the control handle controls the axial movement of the outer shaft (12) relative to the inner shaft (6) associated with Nguyen because it would allow a user to articulate a frame from a flat collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]).
(claims 119- 121) Modified Nguyen Smith et al. discloses the invention essentially as claimed as discussed above.
However, modified Nguyen does not explicitly disclose
(claim 119) wherein the second attachment point is spaced apart from the first attachment point by at least 60 degrees around the first end of the tubular body.
(claim 119) It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of modified Nguyen to have a 60 degree angle between first and second attachment points, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Nguyen would not operate differently with the claimed angle(s) and since the angle(s) between attachment points is intended to articulate a frame from a flat collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]), the device would function appropriately having the claimed angle(s). Further, applicant places no criticality on the range claimed, indicating simply that “The two tensioners 120 can be separated by 30 degree, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, or any range of the foregoing values” (applicant’s Specification, P. [0092]).
Modified Nguyen does not explicitly disclose
(claim 120) wherein when the tubular body is in the first configuration: the first attachment point is spaced apart from the inner shaft by at least 90 degrees around the first end of the tubular body, and the second attachment point is spaced apart from the inner shaft by at least 90 degrees around the first end of the tubular body;
(claim 121) wherein when the tubular body is in the first configuration, the first attachment point, the second attachment point, and the inner shaft are spaced apart from each other around the first end of the tubular body by at least 60 degrees.
(claim 120 and claim 121) It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of modified Nguyen to have a 90 degree angle between the first attachment point and the inner shaft, a 90 degree angle between the second attachment point and the inner shaft and the first attachment point, the second attachment point, and the inner shaft spaced apart from each other around the first end of the tubular body by at least 60 degrees, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Nguyen would not operate differently with the claimed angle(s) and since the angle(s) between attachment points and inner shaft is intended to articulate a frame from a flat collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]), the device would function appropriately having the claimed angle(s). Further, applicant places no criticality on the range claimed, indicating simply that “the two tensioners 120 and the second member 106 can be separated by 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, or any range of the foregoing values” (applicant’s Specification, P. [0093]).
Claim(s) 108- 110 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US Pub. No. 2017/0035445 A1) in view of Brady et al. (US Pub. No. 2013/0184739 A1) (hereinafter “Brady ‘739”) as applied to claim 107 above, and further in view of Walzman (US Pub. No. 2019/0029791 A1).
Regarding claim 108, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen further disclosing wherein a portion of each of the first polymeric tensioner and the second polymeric tensioner extend on the outer surface of the outer shaft (See Figs. 16B- 16D) (P. [0093] - - The capture guide 11 and associated terminal wires 10 are operably coupled to the sleeve 30, and the sleeve 30 is coupled to the outer wall of the capture catheter shaft 12), but Nguyen does not disclose
(claim 108) wherein a portion of each of the first polymeric tensioner and the second polymeric tensioner extend within the lumen of the outer shaft;
(claim 109) wherein the portion of each of the first polymeric tensioner and the second polymeric tensioner that extends within the lumen of the outer shaft includes the proximal end of the first polymeric tensioner and the proximal end of the second polymeric tensioner.
However, Walzman teaches a device for removing clot in a blood vessel in the same field of endeavor (Abstract)
(claim 108 and claim 109) Walzman teaches a sleeve (1091) that couples a filter 1030 on the outside of an outer shaft (1020) (Figs. 13A, 13B) and also teaches a sleeve (1090) that couples a filter 1030 on the inside of an outer shaft (1020) (Figs. 11A, 11B) (P. [0341] - - According to some embodiments, as depicted in FIGS. 11A and 11B, and 13A and 13B, a semi-permeable membrane can be expanded or collapsed into a folded shape via movement of a rigid ring structure 1091 that extends from the aspiration catheter. According to some embodiments, the filter 1030 is attached to the inside of the aspirating end of the aspiration catheter 1020 and the rigid ring structure 1091 abuts the aspirating end of the aspirating catheter, acting as an extension of the aspirating catheter. According to some embodiments, the rigid ring structure can be advanced over the filter 1030 by being pushed by one or more stiff wires 1100. According to some embodiments, the rigid ring 1091 does not reduce the cross sectional area through which aspiration occurs).
Thus, Walzman teaches that a sleeve for operably coupling an extension to an outer surface of a catheter is a functionally equivalent structure as a sleeve for operably coupling an extension to an inside surface of the distal end of the catheter.
As such, the sleeve disposed inside the outer catheter taught by Walzman performs the same function of operably coupling an extension to an outer catheter as the sleeve disposed outside the outer catheter associated with Nguyen (Walzman - - Figs. 11A, 11B, 13A, 13B, P. [0341]; Nguyen - - Figs. 16B- 16D) (P. [0093]))). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (sleeve disposed inside the outer catheter) for another (a sleeve disposed outside the outer catheter) such that the proximal end portions of the tensioners associated with Nguyen extend within the lumen of the outer shaft according to the teachings of Walzman, since the substitution would have yielded predictable results, namely, operably coupling an extension to an outer catheter. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim(s) 111, 116, 117 and 122- 126 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US Pub. No. 2017/0035445 A1) in view of Brady et al. (US Pub. No. 2013/0184739 A1) (hereinafter “Brady ‘739”) as applied to claim 107 and claim 122, and further in view of Marks et al. (US Pub. No. 2015/0250497 A1).
Regarding claims 111, 116 and 117, Nguyen in view of Brady ‘739 discloses the apparatus of claim 107, Nguyen further disclosing a metallic tensioner (10) (P. [0076] - - In some embodiments, the capture pullwire 10 and the capture guide 11 can be made into a single component such as a Loop … The Thrombus Capture Guide 11 can be formed, for example, from metallic, shape memory, or other appropriate materials. In some embodiment, the thrombus capture guide 11 can include a loop configuration and be formed from nitinol shape memory wire of various geometries such as round, oval, elliptical, flat, and the like).
Modified Nguyen does not disclose
(claim 111) wherein each of the plurality of tensioners are flexible when deactivated;
(claim 116) wherein the first tensioner and the second tensioner are formed from a polymeric material;
(claim 117) wherein the polymeric material is PTFE.
However, Marks teaches a device for removing a clot from a blood vessel in the same field of endeavor (Abstract) having a tensioner (190) that, when activated (Fig. 1A), is configured to limit or prevent movement of the engaging elements (65, 67, 90) relative to when it is deactivated (Fig. 1B) (Ps. [0133] - - Also, all the multiple engaging elements can be associated with the connection wire (190). In some embodiments, the flexible connection wire (190) can link proximal ends of all engaging elements at pre-set or equal space there between. In such embodiments, the engaging elements are fixed at their respective positions on the connection wire and maintain that distance with certain maneuvers)
(claim 111) wherein each of the plurality of tensioners (190) are flexible when deactivated (Ps. [0113], [0133] - - The connection wire can be flexible, or floppy, which allows the space between engaging elements to be shortened when it is desired to bring the engaging elements closer together. In these circumstances the connection wire may be stretch resistant under tension so that the maximum distance between the engaging elements is also limited by the connection wire; Because the connection wire may be flexible, but is generally not stretchable, it allows the engaging elements to move closer to each other when it is slack, but prevents the engaging elements from being separated more than a preset distance when it is under tension).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the plurality of tensioners associated with Nguyen in view of Brady ‘739 such that they are flexible when deactivated according to the teachings of Marks because flexibility in the untensioned state would allow the first end of the tubular body to move without stretching, thereby preventing the deployed first end from moving more than a preset distance when under tension (Marks - - Ps. [0113], [0133]).
Modified Nguyen does not disclose
(claim 116) wherein the first tensioner and the second tensioner are formed from a polymeric material;
(claim 117) wherein the polymeric material is PTFE.
However, Marks teaches a device for removing a clot from a blood vessel in the same field of endeavor (Abstract) having a tensioner (190) that, when activated (Fig. 1A), is configured to limit or prevent movement of the engaging elements (65, 67, 90) relative to when it is deactivated (Fig. 1B) (Ps. [0133] - - Also, all the multiple engaging elements can be associated with the connection wire (190). In some embodiments, the flexible connection wire (190) can link proximal ends of all engaging elements at pre-set or equal space there between. In such embodiments, the engaging elements are fixed at their respective positions on the connection wire and maintain that distance with certain maneuvers)
(claim 116) wherein the tensioner (109) (Figs 1A, 1B, 2C- 7C) is polymeric (P. [0116] - - A connection wire and/or a spacing wire can be in the form of a round or flat wire, cable, or have a braid structure. The connection wire, in some embodiments, is flexible yet stretch-resistant. Some non-limiting examples of metal materials for the connection wire may comprise nickel, titanium, stainless steel, cobalt, chrome and any alloys of the foregoing such as Nitinol (NiTi), Titanium alloys, or Cobalt Chromium alloys. In addition, any polymers or plastics which have desired properties of being the connection wire can be used for production of the same. Polymers include, but not limited to, Polyimide, PEEK (Polyether ether ketone), Nylon, PTFE (polytetrafluoroethylene), PET (Polyethylene terephthalate), Polypropylene, etc. Polymer coated metal including but not limited to, PTFE coated Stainless Steel, or PTFE coated NiTi can also be used as a connection wire. Also a hydrophilic coating can be applied );
(claim 117) wherein the polymeric material is PTFE (P. [0116] - - Polymers include, but not limited to, Polyimide, PEEK (Polyether ether ketone), Nylon, PTFE (polytetrafluoroethylene), PET (Polyethylene terephthalate), Polypropylene, etc.).
(claim 116 and claim 117) A polymeric tensioner performs the same function of applying tension to wires connected to clot engaging element(s), thereby maintaining a pre-set position of the clot engaging element(s) during certain maneuvers (Marks - - Ps. [0116], [0133]) as the metallic tensioner associated with Nguyen (Nguyen - - Figs. 16A- 16D, P. [0094]). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (polymeric tensioner) for another (metallic tensioner) since the substitution would have yielded predictable results, namely, applying tension to wires connected to clot engaging element(s), thereby maintaining a pre-set position of the clot engaging element(s) during certain maneuvers. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 122 and claim 125, Nguyen discloses a medical device comprising:
a tubular body (8) (Figs. 16A-D, 17A-D), comprising a first end (800) (Figs. 16A-D, 17A-D), a second end (88) (Figs. 16A-D, 17A-D), and an axial length therebetween, the first end (800) defining an opening (802) (Fig. 16A)
an inner shaft (6) (Figs. 16C, 17D) coupled to the tubular body (8);
an outer shaft (12) (Figs. 16A) defining a lumen configured to receive the inner shaft (6) and the tubular body (8);
a plurality of tensioners (10) (Figs. 16B- 16D) including at least a first tensioner (10) and a second tensioner (10 - - same reference number for all capture pull wires) (P. [0076] - - As illustrated in FIGS. 5-9 for example, a thrombus capture guide 11 can attach to a portion, such as an open end of the ALTC Device 8 and one, two, or more capture pull wires 10 where the capture pull wires are positioned inside the side lumen of the suction catheter 2 or outside of the lumen in other embodiments, and extends proximally; it is noted that the Nguyen reference discloses a plurality of tensioners),
wherein the tubular body (8) has a first configuration (Fig. 12) in which the first end (800) is expanded while the second end (88) and a portion of the tubular body (81) remain compressed, the tubular body (8) having a first expanded axial length (L12A) (Fig. 12) in the first configuration (Fig. 12) (P. [0088] - - As illustrated in FIG. 12, some or most of the axial length of the ALTC device, e.g., the tubular mesh structure 8 remains radially compressed as part of the reserve segment between the outer diameter of the guidewire catheter 6 and the inner diameter of the shaft 12 of the capture catheter (distance between of which is length L12B), with the radially expanded portion of the tubular mesh structure 8 being defined along the axial length between proximal end 800 with proximal-facing opening 802 and the dynamic fold point 88 (distance between of which is length L12A)),
wherein the tubular body (8) is transformable to a second configuration (Fig. 6) in which the tubular body (8) has a second expanded axial length (See Fig. 6) greater than the first expanded axial length (L12A) (Col. 13, l. 8- 16 - - As shown, for example, in FIG. 6, it can also be possible to lengthen the ALTC Device 8 in an appropriate direction, such as distally, by pushing the capture catheter 12 relative to the guidewire shaft 6, thereby allowing additional reserve radially compressed length of the tubular mesh 8 to radially expand out of the confines of the lumen of the capture catheter 12 to axially lengthen the Thrombus Capture Device 8 and maintain its constant or substantially constant diameter through a working range),
and
wherein:
a proximal end of the first tensioner (10) is attached to the outer shaft (12) at a shaft attachment point, and
a proximal end of the second tensioner (10 - - same reference number for all capture pull wires) is attached to the outer shaft (12) at the shaft attachment point (P. [0095] - - a sleeve 30 (FIGS. 16A-D and 17A-D) can be used to couple, such as permanently, the Capture Pull Wire 10 to a portion of the Capture Catheter shaft 12 to enable both components to operate together. Coupling the Capture Pull Wire 10 and the Capture Catheter shaft 12 can allow the user to manage the capture device more efficiently and easily. In another embodiment, the capture guide 11 takes the form of a loop and can attach to the Sleeve 30, which is coupled to the Capture Catheter Shaft 12).
Nguyen further disclosing a metallic tensioner (10) (P. [0076] - - In some embodiments, the capture pullwire 10 and the capture guide 11 can be made into a single component such as a Loop … The Thrombus Capture Guide 11 can be formed, for example, from metallic, shape memory, or other appropriate materials. In some embodiment, the thrombus capture guide 11 can include a loop configuration and be formed from nitinol shape memory wire of various geometries such as round, oval, elliptical, flat, and the like).
Nguyen does not disclose:
(claim 122) the plurality of tensioners, when activated, being configured to limit or prevent deflection of the first end of the tubular body relative to when each of the plurality of tensioners are deactivated;
(claim 122) a distal end of the first tensioner is attached to the first end of tubular body at a first attachment point, a distal end of the second tensioner is attached to the first end of the tubular body at a second attachment point, the second attachment point spaced apart from the first attachment point;
(claim 125) further comprising a control handle, wherein the outer shaft is mechanically coupled to the control handle, and wherein the control handle is configured to control a tension of the plurality of polymeric tensioners by at least controlling axial movement of the outer shaft relative to the inner shaft.
(claim 122) polymetric tensioners as claimed;
(claim 122) wherein each of the plurality of polymeric tensioners are flexible when deactivated.
However, Brady ‘739 teaches a device for removal of clot obstructing the flow of blood in the same field of endeavor (Abstract)
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(claim 122) a plurality of tensioners (T1, T2) including at least a first tensioner (T1) and a second tensioner (T2) (See Annotated Fig. 37a), the plurality of tensioners (T1, T2), when activated, being configured to limit or prevent deflection of the first end of the tubular body (F1) (See Annotated Fig. 37a) relative to when each of the plurality of tensioners (T1, T2) are deactivated (Ps. [0004], [0005], [0007] - - neurovascular vessels are more fragile than similarly sized vessels in other parts of the body and are in a soft tissue bed. This issue is compounded by the fact that in many instances the clot is firmly wedged in the vessel … All three of these mechanisms play a role in strongly adhering the clot to the vessel wall. Breaking these bonds without damaging these fragile vessels is a significant challenge. The high aspect ratio of the device and the vessel tortuousity make it difficult to transmit forces to the clot and for the user to feel reaction forces from the clot; These and other problems are solved by the present invention; the basket further comprising a cable extending through the lumen of the elongate member, the cable attached to the first ring member, the cable comprising an activated state and a deactivated state, in the activated state the cable transmitting a force from the user to the frame, said force causing the deployed frame to assume the expanded state).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the plurality of tensioners associated with Nguyen such that the plurality of tensioners, when activated, are configured to limit or prevent deflection of the first end of the tubular body associated with Nguyen relative when each of the plurality of polymeric tensioners are deactivated according to the teachings of Brady ‘739 because it would allow force to be transmitted from the user to the frame, causing the deployed frame to assume the expanded state, thereby transmitting the force to the clot firmly adhered to the vessel walls to facilitate clot removal (Brady ‘739 - - [0004], [0005], [0007]).
Modified Nguyen does not disclose
(claim 122) a distal end of the first tensioner is attached to the first end of tubular body at a first attachment point, a distal end of the second tensioner is attached to the first end of the tubular body at a second attachment point, the second attachment point spaced apart from the first attachment point;
(claim 125) further comprising a control handle, wherein the outer shaft is mechanically coupled to the control handle, and wherein the control handle is configured to control a tension of the plurality of polymeric tensioners by at least controlling axial movement of the outer shaft relative to the inner shaft.
(claim 122) polymetric tensioners as claimed;
(claim 122) wherein each of the plurality of polymeric tensioners are flexible when deactivated;
However, Brady ‘739 teaches a device for removal of clot obstructing the flow of blood in the same field of endeavor (Abstract)
(claim 122) a distal end of the first tensioner (T1) is attached to the first end of tubular body (F1) at a first attachment point (AP1),
a distal end of the second tensioner (T2) is attached to the first end of the tubular body (F1) at a second attachment point (AP2), the second attachment point (AP2) spaced apart from the first attachment point (AP1) (See Annotated Fig. 37a) (P. [0537] - - The pull cable extends from attachment point(s) 880 through the exit port 879 through the lumen of the g support member 877 to the handle 883. In one embodiment the cable is interfaced with a slider 884 such that activation of the slider 884 causes the cable 878 to undergo tension and deactivation of the slider 884 reduces or removes tension from the cable 878. Tensioning the pull cables 878 causes the frame 875 to articulate about a region adjacent the junction 881. FIG. 37b and FIG. 37c show a top and side view respectively of the basket 871 with pull cable 878 in the untensioned state. FIG. 37d shows a top view of the basket 871 constrained in a vessel with pull cable 878 in the untensioned state; it is noted that Fig. 37a is similar to applicant’s Fig. 1A showing tethers which have the same reference number of 120);
(claim 125) further comprising a control handle (883) (Fig. 37a), wherein the outer shaft (877) (Figs. 37a- 37e) is mechanically coupled to the control handle (883), and wherein the control handle (883) is configured to control a tension of the plurality of polymeric tensioners (878) (Figs. 37a- 37b, 37d) (P. [0537] - - The pull cable extends from attachment point(s) 880 through the exit port 879 through the lumen of the support member 877 to the handle 883. In one embodiment the cable is interfaced with a slider 884 such that activation of the slider 884 causes the cable 878 to undergo tension and deactivation of the slider 884 reduces or removes tension from the cable 878. Tensioning the pull cables 878 causes the frame 875 to articulate about a region adjacent the junction 881).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the tensioners associated with Nguyen such that they comprise first and second tensioners attached at first and second attachment points of the first end of the tubular body and are mechanically coupled to a control handle according to the teachings of Brady ‘739 such that the control handle controls the axial movement of the outer shaft (12) relative to the inner shaft (6) associated with Nguyen because it would allow a user to articulate a frame from a flat collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]).
Modified Nguyen does not disclose
(claim 122) polymetric tensioners as claimed;
(claim 122) wherein each of the plurality of polymeric tensioners are flexible when deactivated.
However, Marks teaches a device for removing a clot from a blood vessel in the same field of endeavor (Abstract) having a tensioner (190) that, when activated (Fig. 1A), is configured to limit or prevent movement of the engaging elements (65, 67, 90) relative to when it is deactivated (Fig. 1B) (Ps. [0133] - - Also, all the multiple engaging elements can be associated with the connection wire (190). In some embodiments, the flexible connection wire (190) can link proximal ends of all engaging elements at pre-set or equal space there between. In such embodiments, the engaging elements are fixed at their respective positions on the connection wire and maintain that distance with certain maneuvers;
(claim 122) wherein the tensioner (109) (Figs 1A, 1B, 2C- 7C) is polymeric (P. [0116] - - A connection wire and/or a spacing wire can be in the form of a round or flat wire, cable, or have a braid structure. The connection wire, in some embodiments, is flexible yet stretch-resistant. Some non-limiting examples of metal materials for the connection wire may comprise nickel, titanium, stainless steel, cobalt, chrome and any alloys of the foregoing such as Nitinol (NiTi), Titanium alloys, or Cobalt Chromium alloys. In addition, any polymers or plastics which have desired properties of being the connection wire can be used for production of the same. Polymers include, but not limited to, Polyimide, PEEK (Polyether ether ketone), Nylon, PTFE (polytetrafluoroethylene), PET (Polyethylene terephthalate), Polypropylene, etc. Polymer coated metal including but not limited to, PTFE coated Stainless Steel, or PTFE coated NiTi can also be used as a connection wire. Also a hydrophilic coating can be applied ).
A polymeric tensioner performs the same function of applying tension to wires connected to clot engaging element(s), thereby maintaining a pre-set position of the clot engaging element(s) during certain maneuvers (Marks - - Ps. [0116], [0133]) as the metallic tensioner associated with Nguyen (Nguyen - - Figs. 16A- 16D, P. [0094]). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (polymeric tensioner) for another (metallic tensioner) since the substitution would have yielded predictable results, namely, applying tension to wires connected to clot engaging element(s), thereby maintaining a pre-set position of the clot engaging element(s) during certain maneuvers. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Modified Nguyen does not disclose
(claim 122) wherein each of the plurality of polymeric tensioners are flexible when deactivated;
However, Marks teaches a device for removing a clot from a blood vessel in the same field of endeavor (Abstract)
(claim 122) wherein each of the plurality of polymeric tensioners (190) are flexible when deactivated (Ps. [0113], [0133] - - The connection wire can be flexible, or floppy, which allows the space between engaging elements to be shortened when it is desired to bring the engaging elements closer together. In these circumstances the connection wire may be stretch resistant under tension so that the maximum distance between the engaging elements is also limited by the connection wire; Because the connection wire may be flexible, but is generally not stretchable, it allows the engaging elements to move closer to each other when it is slack, but prevents the engaging elements from being separated more than a preset distance when it is under tension).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the plurality of polymeric tensioners associated with Nguyen in view of Brady ‘739 such that they are flexible when deactivated according to the teachings of Marks because flexibility in the untensioned state would allow the first end of the tubular body to move without stretching, thereby preventing the deployed first end from moving more than a preset distance when under tension (Marks - - Ps. [0113], [0133]).
Regarding claim 126, Nguyen in view of Brady ‘739 and Marks discloses the apparatus of claim 122, Nguyen does not disclose
(claim 126) wherein when the tubular body is in the first configuration, the first attachment point, the second attachment point, and the inner shaft are spaced apart from each other around the first end of the tubular body by at least 60 degrees.
However, Brady ‘739 teaches a device for removal of clot obstructing the flow of blood in the same field of endeavor (Abstract)
(claim 126) wherein when the tubular body (F1) is in the first configuration (Fig. 37a), the first attachment point (AP1), the second attachment point (AP2), and the inner shaft are spaced apart from each other around the first end of the tubular body (F1) by at least a non-zero angle (See Annotated Fig. 37a) (P. [0537] - - The pull cable extends from attachment point(s) 880 through the exit port 879 through the lumen of the g support member 877 to the handle 883. In one embodiment the cable is interfaced with a slider 884 such that activation of the slider 884 causes the cable 878 to undergo tension and deactivation of the slider 884 reduces or removes tension from the cable 878. Tensioning the pull cables 878 causes the frame 875 to articulate about a region adjacent the junction 881. FIG. 37b and FIG. 37c show a top and side view respectively of the basket 871 with pull cable 878 in the untensioned state. FIG. 37d shows a top view of the basket 871 constrained in a vessel with pull cable 878 in the untensioned state; it is noted that Fig. 37a is similar to applicant’s Fig. 1A showing tethers which have the same reference number of 120);
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the tensioners associated with Nguyen such that the first attachment point, the second attachment point, and the inner shaft are spaced apart from each other around the first end of the tubular body by at least a non-zero angle according to the teachings of Brady ‘739 such that the control handle controls the axial movement of the outer shaft (12) relative to the inner shaft (6) associated with Nguyen because it would allow a user to articulate a frame from a flat collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]).
(claim 126) Modified Nguyen Smith et al. discloses the invention essentially as claimed as discussed above.
However, modified Nguyen does not expressly disclose wherein when the tubular body is in the first configuration, the first attachment point, the second attachment point, and the inner shaft are spaced apart from each other around the first end of the tubular body by at least 60 degrees.
(claim 126) It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of modified Nguyen to have the first attachment point, the second attachment point, and the inner shaft spaced apart from each other around the first end of the tubular body by at least 60 degrees, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Nguyen would not operate differently with the claimed angle(s) and since the angle(s) between attachment points and inner shaft is intended to articulate a frame from a flat collapsed delivery untensioned configuration into an angled frame into tensioned-reinforced contact with clot adhered to the vessel walls for engagement with the clot and for disengaging the clot from the vessel wall (Brady ‘739 - - Ps. [0004], [0007], [0537]), the device would function appropriately having the claimed angle(s). Further, applicant places no criticality on the range claimed, indicating simply that “the two tensioners 120 and the second member 106 can be separated by 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, or any range of the foregoing values” (applicant’s Specification, P. [0093]).
Claim(s) 123- 124 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US Pub. No. 2017/0035445 A1) in view of Brady et al. (US Pub. No. 2013/0184739 A1) (hereinafter “Brady ‘739”) and Marks et al. (US Pub. No. 2015/0250497 A1) as applied to claim 122 above, and further in view of Walzman (US Pub. No. 2019/0029791 A1).
Regarding claim 123 and claim 24, Nguyen in view of Brady ‘739 and Marks discloses the apparatus of claim 122, Nguyen further disclosing wherein a portion of each of the first polymeric tensioner and the second polymeric tensioner extend on the outer surface of the outer shaft (See Figs. 16B- 16D) (P. [0093] - - The capture guide 11 and associated terminal wires 10 are operably coupled to the sleeve 30, and the sleeve 30 is coupled to the outer wall of the capture catheter shaft 12), but Nguyen does not disclose
(claim 123) wherein a portion of each of the first polymeric tensioner and the second polymeric tensioner extend within the lumen of the outer shaft;
(claim 124) wherein the portion of each of the first polymeric tensioner and the second polymeric tensioner that extends within the lumen of the outer shaft includes the proximal end of the first polymeric tensioner and the proximal end of the second polymeric tensioner.
However, Walzman teaches a device for removing clot in a blood vessel in the same field of endeavor (Abstract)
(claim 123, claim 124) Walzman teaches a sleeve (1091) that couples a filter 1030 on the outside of an outer shaft (1020) (Figs. 13A, 13B) and also teaches a sleeve (1090) that couples a filter 1030 on the inside of an outer shaft (1020) (Figs. 11A, 11B) (P. [0341] - - According to some embodiments, as depicted in FIGS. 11A and 11B, and 13A and 13B, a semi-permeable membrane can be expanded or collapsed into a folded shape via movement of a rigid ring structure 1091 that extends from the aspiration catheter. According to some embodiments, the filter 1030 is attached to the inside of the aspirating end of the aspiration catheter 1020 and the rigid ring structure 1091 abuts the aspirating end of the aspirating catheter, acting as an extension of the aspirating catheter. According to some embodiments, the rigid ring structure can be advanced over the filter 1030 by being pushed by one or more stiff wires 1100. According to some embodiments, the rigid ring 1091 does not reduce the cross sectional area through which aspiration occurs).
Thus, Walzman teaches that a sleeve for operably coupling an extension to an outer surface of a catheter is a functionally equivalent structure as a sleeve for operably coupling an extension to an inside surface of the distal end of the catheter.
As such, the sleeve disposed inside the outer catheter taught by Walzman performs the same function of operably coupling an extension to an outer catheter as the sleeve disposed outside the outer catheter associated with Nguyen (Walzman - - Figs. 11A, 11B, 13A, 13B, P. [0341]; Nguyen - - Figs. 16B- 16D) (P. [0093]))). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (sleeve disposed inside the outer catheter) for another (a sleeve disposed outside the outer catheter) such that the proximal end portions of the tensioners associated with Nguyen extend within the lumen of the outer shaft according to the teachings of Walzman, since the substitution would have yielded predictable results, namely, operably coupling an extension to an outer catheter. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Conclusion
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771
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