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 .
Response to Arguments
Applicant’s arguments filed 7/10/26 with respect to the rejection(s) of claim(s) 14-30 and 32 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kohler et al. US 2003/0036698 and new ground(s) of rejection is made in view of Chou et al. US 2011/0034986 in view of Schaer US 2004/0082859 as further discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 discloses the stagnation device comprising an inflatable balloon. However, claims 14 and 21 disclose “retracting the sheath to cause expansion of the stagnation device” on line 6. The specification further discloses the inflatable and/or expandable balloon is inflated or expanded by inflating or using air and/or fluid to form an expanded shape (paragraphs 0082, 0084), the stagnation device comprising a variety of forms including a network of wires or umbrella, inflatable balloons, and/or an extendable tube/sheath (paragraph 0103), the balloon being inflatable (paragraphs 0113, 0121, 0143, 0168, 0182). The specification does not explicitly disclose wherein retracting the sheath causes expansion of the stagnation device, wherein the stagnation device is a balloon. But instead, it appears that retracting the sheath only causes expansion in the alternative embodiments including, for example, the network of wires or umbrella or tubes.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kohler et al. US 2003/0036698.
Regarding claim 14, Kohler et al. discloses a method comprising: delivering a stagnation device 102 and a medical implants 30 to a blood flow pathway of a heart via a sheath 108 (figure 10); delivering the medical implant beyond the sheath and proximate to a tissue wall of the heart (paragraph 0042, figure 9, heart wall 32); retracting the sheath to cause expansion of the stagnation device (paragraphs 0014, 0035, sheath is retracted and self-expanding device 102 permitted to expand) and at least partial inhibition of blood flow within the blood flow pathway (will at least partially inhibit blood flow when placed within the pathway); injecting a contrast solution into the blood flow pathway (paragraph 0039, radio-opaque contrast fluid to enable imaging of the heart and blood flow); and extending the sheath to compress the stagnation device (paragraph 0046, catheter 14 is advanced so that sheath 108 causes basket 102 to collapse reverting back to the collapsed basket).
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) 15, 16, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohler et al. US 2003/0036698 in view of Taft et al. US 2017/0106176.
Regarding claims 15, 16, 21 and 22 Kohler et al. discloses a method comprising: delivering a stagnation device 102 and one or more medical implants 30 to a blood flow pathway of a heart via a sheath 108 (figure 10); delivering the medical implant beyond the sheath and proximate to and at least partially through an opening in a tissue wall of the heart (paragraph 0042, figure 9, heart wall 32);
retracting the sheath to cause expansion of the stagnation device (paragraphs 0014, 0035, sheath is retracted and self-expanding device 102 permitted to expand) and at least partial inhibition of blood flow within the blood flow pathway (will at least partially inhibit blood flow when placed within the pathway); injecting a contrast solution into the blood flow pathway (paragraph 0039, radio-opaque contrast fluid to enable imaging of the heart and blood flow); and extending the sheath to compress the stagnation device (paragraph 0046, catheter 14 is advanced so that sheath 108 causes basket 102 to collapse reverting back to the collapsed basket), but fails to disclose anchoring the medical implant to a distal side of the tissue wall; extending an actuating rod detachably coupled to an arm of the medical implant to anchor the arm of the medical implant to a proximal side of the tissue wall and maintain contact with the medical implant following anchoring of the medical implant; wherein the actuating rod is attached to the medical implant while the contrast solution is injected into the blood flow pathway, further comprising detaching the actuating rod from the medical implant following injection of the contrast solution.
Taft et al. teaches a method for positioning a medical implant 150, comprising anchoring the medical implant to a distal side of the tissue wall (distal flange 152, figure 3O, 3P); extending an actuating rod 162a detachably coupled to an arm of the medical implant to anchor the arm of the medical implant to a proximal side of the tissue wall (proximal flange 154) and maintain contact with the medical implant (figure 3R) following anchoring of the medical implant (flanges 152, 154 clamp tissue therebetween, paragraph 0067), extending an actuating rod 162a to attach the medical implant 150 to the tissue wall (figure 3R), wherein the actuating rod is attached to the medical implant while the contrast solution is injected into the blood flow pathway (paragraph 0066, contrast injection made once implant flange is believed to be positioned but prior to release) and further comprising detaching the actuating rod from the medical implant following injection of the contrast solution (figures 3S-3U, paragraph 0067, implant or shunt is released)
Therefore, it would have been obvious to one having ordinary skill in the art to provide a medical implant being positioned with an actuating rod for holding the implant and anchoring in position by clamping between a proximal and distal side of the tissue during injection of the contrast solution, as taught by Taft et al., to ensure proper positioning or repositioning and further control of the implant prior to being released at the target location by the actuating rod.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohler et al. US 2003/0036698 in view of Besselink et al. US 2005/0113862.
Regarding claim 17, Kohler et al. discloses wherein the stagnation device comprises a basket of elastic or super-elastic material such as nickel-titanium alloy (basket 102, figure 6) but fails to explicitly disclose the basket being made of a network of wires.
Besselink et al. discloses an endoluminal device comprising a collapsible and expandable basket made of Nitinol or related shape memory materials, the basket may be a wire mesh basket to provide a shape memory material being configured as a collapsible basket (paragraph 0013).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Kohler et al. with the basket being made of a network of wires, as taught by Besselink et al., as known in the art to provide a basket being formed of a network of nitinol wires to allow for sufficient expandability or collapsibility and a resilient of the basket when placed unconstrained in the target location.
Claim(s) 14, 17, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. US 2011/0034986 in view of Schaer US 2004/0082859.
Regarding claims 14, 17, 18 and 20, Chou et al. discloses a method comprising: delivering a stagnation device (occlusion element 129, such as a balloon or other element, paragraph 0132) and a medical implant (paragraph 0136-0138) to a blood flow pathway of a heart via a sheath (figures 3A, 3B; paragraph 0136, 0137); delivering the medical implant beyond the sheath and proximate to a tissue wall of the heart (stent deployed in the vasculature proximate the heart, paragraph 0128; Examiner notes the implant is not required to be within the heart, but only proximate; being defined as close or very near); injecting a contrast solution into the blood flow pathway (contrast fluid injected through flush line 22 during a procedure, paragraph 0129, 0188).
Chou et al. fails to disclose retracting the sheath to cause expansion of the stagnation device and at least partial inhibition of blood flow within the blood flow pathway and extending the sheath to compress the stagnation device, the stagnation device comprising a network of wires and a covering extending between the wires.
Schaer teaches a method comprising: delivering a stagnation device (paragraph 0164; may be a balloon or other self-expanding disk or foam material, or wire cage covered in a polymer, or any combination thereof) via a sheath 108 (paragraph 0164, expanded and compressed when deployed out and back in a sheath); retracting the sheath to cause expansion of the stagnation device (paragraph 0164, expanded and compressed when deployed out and back in a sheath); and extending the sheath to compress the stagnation device (paragraph 0164, expanded and compressed when deployed out and back in a sheath), the stagnation device comprising a network of wires comprising a covering extending between the wires (wire cage covered in a polymer or covering between the wires, paragraph 0164).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Chou et al. with retracting a sheath to cause expansion of the stagnation device and at least partial inhibition of blood flow within the blood flow pathway, and extending the sheath to compress the stagnation device, as taught by Schaer., as known in the art to provide a balloon and/or self-expanding device that may be deployed or expanded for occlusion and compressed with a sheath to be housed when being removed from the target location.
Claim(s) 15, 16, 21-24, 26, 27, 28, 30, 32, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. US 2011/0034986 in view of Schaer US 2004/0082859 and further in view of Taft et al. US 2017/0106176.
Regarding claims 15, 16, 21-24, 26, 27, 28, 30, 32 and 33, Chou et al. discloses a method comprising: delivering a stagnation device (occlusion element 129, such as a balloon or other element, paragraph 0132) attached or extending from an outer surface of an inner sheath 110 (figure 3A); and one or more medical implants (paragraph 0136-0138) to a blood flow pathway via a sheath or outer sheath (figures 3A, 3B; paragraph 0136, 0137); delivering the medical implant beyond the sheath and proximate to a tissue wall of the heart (stent deployed in the vasculature proximate the heart, paragraph 0128); injecting a contrast solution into the blood flow pathway (contrast fluid injected through flush line 22 during a procedure, paragraph 0129, 0188).
Chou et al. fails to disclose a retracting the outer sheath to cause expansion of the stagnation device and at least partial inhibition of blood flow within the blood flow pathway and extending an inner sheath and an outer sheath to compress the stagnation device, or anchoring the medical implant to a distal side of the tissue wall of a heart; extending an actuating rod from the inner sheath to attach the medical implant to the tissue wall, the actuating rod detachably coupled to an arm of the medical implant to anchor the arm of the medical implant to a proximal side of the tissue wall of a heart and maintain contact with the medical implant following anchoring of the medical implant; wherein the actuating rod is attached to the medical implant while the contrast solution is injected into the blood flow pathway, further comprising detaching the actuating rod from the medical implant following injection of the contrast solution, the stagnation device comprising a network of wires and a covering extending between the wires.
Schaer teaches a method comprising: delivering a stagnation device (paragraph 0164; may be a balloon or other self-expanding disk or foam material, or wire cage covered in a polymer, or any combination thereof) via a outer sheath (paragraph 0164, expanded and compressed when deployed out and back in a sheath); retracting the sheath to expose the stagnation device to cause expansion of the stagnation device (paragraph 0164, expanded and compressed when deployed out and back in a sheath); and extending the sheath to compress the stagnation device (paragraph 0164, expanded and compressed when deployed out and back in a sheath), the stagnation device comprising a network of wires comprising a covering extending between the wires (wire cage covered in a polymer or covering between the wires, paragraph 0164).
Taft et al. teaches a method for positioning a medical implant 150, comprising an inner and outer sheath (paragraph 0015, inner and outer sheath surrounding and maintaining the implant) anchoring the medical implant to a distal side of the tissue wall of the heart (distal flange 152, figure 3O, 3R, 3P, 3U; tissue wall 30 between coronary sinus and left atrium); extending an actuating rod 162a extending from the inner sheath (paragraph 0015, actuating rod extends from the handle distally through the inner sheath) detachably coupled to an arm of the medical implant to anchor the arm of the medical implant to a proximal side of the tissue wall (proximal flange 154) and maintain contact with the medical implant (figure 3R) following anchoring of the medical implant (flanges 152, 154 clamp tissue therebetween, paragraph 0067), extending an actuating rod 162a to attach the medical implant 150 to the tissue wall (figure 3R), wherein the actuating rod is attached to the medical implant while the contrast solution is injected into the blood flow pathway (paragraph 0066, contrast injection made once implant flange is believed to be positioned but prior to release) and further comprising detaching the actuating rod from the medical implant following injection of the contrast solution (figures 3S-3U, paragraph 0067, implant or shunt is released), an inner sheath within the outer sheath maintaining the implant 150
Therefore, it would have been obvious to one having ordinary skill in the art to provide a medical implant being positioned with an actuating rod for holding the implant and anchoring in position by clamping between a proximal and distal side of the tissue during injection of the contrast solution, as taught by Taft et al., to ensure proper positioning or repositioning and further control of the implant prior to being released at the target location by the actuating rod, and with retracting a sheath to cause expansion of the stagnation device and at least partial inhibition of blood flow within the blood flow pathway, and extending the sheath to compress the stagnation device, as taught by Schaer., as known in the art to provide a balloon and/or self-expanding device that may be deployed or expanded for occlusion and compressed with a sheath to be housed when being removed from the target location.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. US 2011/0034986 in view of Schaer US 2004/0082859 and further in view of Gilson et al. US 2002/0002384.
Regarding claim 19, Chou et al. in combination discloses the method essentially as claimed above including the stagnation device being a porous balloon including an open cell foam (Schaer, paragraph 0161) or a covering over a network of wires (foam over wires cage or ribs, paragraph 0164) but fails to explicitly disclose the covering is porous.
Gilson et al. teaches a method for occluding a blood flow pathway comprising a stagnation device that may be expanded from a delivery sheath for deployment into a target vessel, the stagnation device comprising a network of wires 30 (figures 11-15), wherein the stagnation device comprises a covering 31 extending between the wires (figures 11-15), wherein the covering is porous (paragraph 0141, covering may be a porous fabric or mesh).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Chou et al. with a stagnation device comprising a network of wires and a porous covering to be delivered and expanded from within a sheath, as taught by Gilson et al, as a known substitute in the art to provide a collapsable and expandable arrangement to form an occluding screen allowing for controlled porosity.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kohler et al. US 2003/0036698 in view of Taft et al. US 2017/0106176 in view of Besselink et al. US 2005/0113862.
Regarding claim 23, Kohler et al. discloses wherein the stagnation device comprises a basket of elastic or super-elastic material such as nickel-titanium alloy (basket 102, figure 6) but fails to explicitly disclose the basket being made of a network of wires.
Besselink et al. discloses an endoluminal device comprising a collapsible and expandable basket made of Nitinol or related shape memory materials, the basket may be a wire mesh basket to provide a shape memory material being configured as a collapsible basket (paragraph 0013).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Kohler et al. with the basket being made of a network of wires, as taught by Besselink et al., as known in the art to provide a basket being formed of a network of nitinol wires to allow for sufficient expandability or collapsibility and a resilient of the basket when placed unconstrained in the target location.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. US 2011/0034986 in view of Schaer US 2004/0082859 in view of Taft et al. US 2017/0106176 and further in view of Gilson et al. US 2002/0002384.
Regarding claim 25, Chou et al. in combination discloses the method essentially as claimed above including the stagnation device being a porous balloon including an open cell foam (Schaer, paragraph 0161) or a covering over a network of wires (foam over wires cage or ribs, paragraph 0164) but fails to explicitly disclose the covering is porous.
Gilson et al. teaches a method for occluding a blood flow pathway comprising a stagnation device that may be expanded from a delivery sheath for deployment into a target vessel, the stagnation device comprising a network of wires 30 (figures 11-15), wherein the stagnation device comprises a covering 31 extending between the wires (figures 11-15), wherein the covering is porous (paragraph 0141, covering may be a porous fabric or mesh).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Chou et al. with a stagnation device comprising a network of wires and a porous covering to be delivered and expanded from within a sheath, as taught by Gilson et al, as a known substitute in the art to provide a collapsable and expandable arrangement to form an occluding screen allowing for controlled porosity.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. US 2011/0034986 in view of Schaer US 2004/0082859 in view of Taft et al. US 2017/0106176 and further in view of Hart et al. US 6183492.
Regarding claim 29, Chou et al. in combination discloses a method essentially as claimed including the stagnation being a variety of occluding members (paragraph 0164), but fails to explicitly disclose the stagnation device being a tubular sheath having one or more expandable petals at and end portion of the tubular sheath.
Hart et al. teaches a stagnation device comprising a tubular sheath having one or more expandable petals at and end portion of the tubular sheath (figure 19, tubular sheath or sleeve 511 comprising a plurality of fingers or petals 525 at an end portion of the tubular sheath) to move from a low profile to an expanded profile (figures 18, 19, column 6, lines 26-43).
Therefore, it would have been an obvious matter of design choice to modify the Chou et al. to have a stagnation device comprising a tubular sheath having one or more expandable petals at and end portion of the tubular sheath, as taught by Hart et al. since applicant has not disclosed that having this shape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs that have a collapsed or expanded configuration to be deployed with a sheath.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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