DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Claims 2-20 are pending in the application. Claim 1 has been canceled. Claims 2-20 are new.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/16/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4-11, and 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flaherty et al. (US 6,726,677 B1) (“Flaherty”) in view of Kim et al. (US 2004/0088042 A1) (“Kim”).
Regarding claim 2, Flaherty discloses (Figures 5A-5C, 6A-8C) a system capable of placing a stent graft between a femoral artery and a femoral vein, said system comprising: a penetration catheter (136 in Figures 5A-5C; 156 in Figures 6A-8C) which carries a penetration tool (134 in Figures 5A-5C; 164 in Figures 6A-8C) proximal to a distal end of the penetration catheter (Figures 5A-5C, 7A); wherein said penetration tool comprises a penetration guidewire lumen (Column 11, lines 54-56) extending along a length of the penetration tool (Figures 5C and 6D), wherein the penetration tool is configured to move from a retracted position (Figure 6B) to an advanced position (Figures 6C, 6D), wherein in the advanced position, the penetration tool is extended to a length to form a proximal penetration between a peripheral artery and a peripheral vein, and wherein in the advanced position, the penetration guidewire is slidably extendable through the penetration guidewire lumen from the peripheral artery to the peripheral vein (Figures 6B-6D, 7A, 7B). Flaherty fails to disclose a guidewire capture and stabilization catheter comprising a portion configured to expand and contract to capture the penetration guidewire advanced by the penetration catheter from the peripheral artery to the peripheral vein.
In the same field of endeavor, Kim teaches (Figures 10a-10j) a system capable of placing a stent graft between a femoral artery (A) and a femoral vein (V). Kim teaches the system comprises a guidewire capture and stabilization catheter (100) comprising a portion (102) configured to expand and contract (snare) to capture a penetration guidewire (GW) advanced from the peripheral artery to the peripheral vein.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system disclosed by Flaherty to include a guidewire capture and stabilization catheter comprising a portion configured to expand and contract to capture the penetration guidewire advanced by the penetration catheter from the peripheral artery to the peripheral vein, as taught by Kim. This modification would provide a catheter within the vein that can capture the guidewire near its distal end and pull the guidewire distally of the penetration to a desired location in the vein (Kim, paragraph 0103).
Regarding claim 4, Flaherty as modified by Kim teaches (Flaherty, Figure 8C) a stent placement catheter capable of extending across the peripheral vein to transverse the peripheral artery to place at least one stent graft (194) extending from a first opening in the peripheral artery to a second opening in the peripheral artery (Flaherty, Column 13, lines 41-51).
Regarding claim 5, Flaherty as modified by Kim teaches (Flaherty, Figures 5C, 6A-8C) that the penetration catheter comprises a shaft having a proximal end, a distal end, and a penetration guidewire lumen (Column 9, lines 51-61).
Regarding claim 6, Flaherty as modified by Kim teaches (Flaherty, Figure 6D) that in the advanced position of the penetration tool (164), the penetration guidewire extends through the catheter, the penetration tool, and the proximal penetration (Column 11, lines 54-63).
Regarding claim 7, Flaherty as modified by Kim teaches (Flaherty, Figures 5A-5C) that the penetration catheter comprises a penetration tool port (142) opening towards a portion of a wall of the peripheral artery when the penetration catheter is at a target artery position.
Regarding claim 8, Flaherty as modified by Kim teaches (Flaherty, Figures 5A-5C) that the penetration tool comprises a hollow tube portion (134) extendable through the penetration tool port (142).
Regarding claim 9, Flaherty as modified by Kim teaches (Flaherty, Figures 5A-5C, 6D) that the penetration tool comprises a hollow needle portion extendable through the penetration tool port (142).
Regarding claim 10, Flaherty as modified by Kim teaches (Flaherty, Figure 6B) in the retracted position of the penetration tool, the needle is fully retracted within the distal end of the catheter.
Regarding claim 11, Flaherty as modified by Kim teaches (Flaherty, Figures 5A-5C, 6D) the penetration guidewire is dimensioned to advance through the penetration tool port.
Regarding claim 17, Flaherty as modified by Kim teaches (Flaherty, Figure 8C) the stent placement catheter is capable of extending from across the femoral vein to traverse the femoral artery over a stent placement guidewire (192; Flaherty, Column 13, lines 41-51).
Regarding claim 18, Flaherty as modified by Kim teaches (Flaherty, Figure 8C) a stent graft (194) capable of being placed across the proximal penetration.
Regarding claim 19, Flaherty as modified by Kim teaches (Flaherty, Figure 8C) a diameter of the stent graft (194) in a fully expanded configuration is smaller than an inner diameter of a wall of the peripheral vein (at CS).
Regarding claim 20, the stent placement catheter taught by Flaherty as modified by Kim (Flaherty, Column 13, lines 41-51) is capable of placing a plurality of stent grafts extending from a first opening of the peripheral artery to a second opening in the peripheral artery. NOTE: the plurality of stent grafts is not positively recited.
Claims 3, 13, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flaherty et al. (US 6,726,677 B1) (“Flaherty”) in view of Kim et al. (US 2004/0088042 A1) (“Kim”) as applied to claim 2 above, and further in view of Heuser (US 6,464,665 B1).
Regarding claims 3, 13, and 14, Flaherty in view of Kim teaches the invention substantially as claimed. However, the combined teaching fails to teach the guidewire capture and stabilization catheter comprises a stabilizing element adapted to align the penetration catheter within the peripheral vein while the penetration tool penetrates and advances a guidewire into the peripheral vein, wherein the stabilizing element comprises a balloon, an expandable braid, or a malecot, and wherein the stabilizing element comprises expansible portions.
In the same field of endeavor, Heuser teaches (Figures 16-19) a venous catheter (44) that comprises two stabilizing elements (124, 126) in the form of two expandable balloons that are adapted to align a penetrator catheter within the peripheral vein while a penetration tool penetrates and advances a guidewire into the peripheral vein (Column 9, line 50 – Column 10, line 13).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the guidewire capture and stabilization catheter to comprise a balloon stabilizing element with two expansile balloon portions that are adapted to align the penetration catheter within the peripheral vein while the penetration tool penetrates and advances a guidewire into the peripheral vein, as taught by Heuser. This modification would allow a physician to check the positioning of the guidewire capturing and stabilization catheter before, during, and after inflation of balloons via radiographically observing the contrast inflation fluid that fills the balloon (Heuser, Column 9, line 50 – Column 10, line 13).
Claims 15 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flaherty et al. (US 6,726,677 B1) (“Flaherty”) in view of Kim et al. (US 2004/0088042 A1) (“Kim”) as applied to claim 7 above, and further in view of Webler, Jr. (US 2010/0057050 A1) (“Webler”).
Regarding claims 15 and 16, Flaherty in view of Kim teaches the invention substantially as claimed. However, the combined teaching fails to teach that the penetration catheter comprises an expandable cage structure located proximal to the distal end of the penetration catheter and the penetration tool port is located between the expandable cage structure and a distal end of the penetration catheter.
Webler teaches (Figures 1-6) a penetration catheter (10) which carries a penetration tool (13) proximal to a distal end of the penetration catheter; wherein the penetration tool is capable of moving from a retracted position to an advanced position, wherein in the advanced position, the penetration tool is capable of being extending to a length to form a proximal penetration between a peripheral artery and a peripheral vein. Webler teaches (Figure 1) that the penetration catheter comprises a penetration tool port opening (18) towards a portion of a wall of the peripheral artery when the penetration catheter is at a target artery position. Webler teaches (Figure 1) that the penetration catheter comprises an expandable cage structure (14) located proximal to the distal end of the penetration catheter (paragraph 0022) and the penetration tool port (18) is located between the expandable cage structure (14) and a distal end of the penetration catheter. Webler teaches that the expandable cage structure (14) is configured to expand against the inner surface of the patient's body lumen (30), to thereby temporarily center and stabilize the location of the penetration catheter in the body lumen (paragraph 0021).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the configuration of the penetration catheter taught by Webler (an expandable cage structure located proximal to the distal end of the penetration catheter and the penetration tool port is located between the expandable cage structure and a distal end of the penetration catheter) for the configuration taught by Flaherty in view of Kim. Substitution of one known element (an expandable cage with a distal port) for another element providing the same function to yield predictable results (stabilizing the penetration catheter) would have been obvious to one of ordinary skill in the art at the time of the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Heuser et al. (US 2007/0203515 A1; Figures 1-21) disclose a system for placing a stent graft between an artery and a vein.
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/C.D.K/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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