DETAILED ACTION
The following is a non-final office action is response to communications received on 06/22/2023. Claims 7-26 are currently pending and addressed below. Claims 1-6 are cancelled.
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrig et al. (US 8,079,973) in view of Sithian (US 9,517,124).
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Regarding Claim 7, Herrig discloses the invention substantially as claimed. Herrig teaches a vascular access system (10), comprising:
a first conduit (26) extending between a first end (shown at 18) and a second end (shown), the first end fully capable of being disposed within the vena cava of a patient (Col 5: lines 3-6); and
a second conduit (22) extending between a first end (shown) and a second end (shown at 14), the second conduit capable of being anastomosed directly to the vasculature of the patient (Col 5: lines 3-6);
wherein the second end of the first conduit comprises an expandable stent (35); wherein the expandable stent comprises a fluid tight conduit (20).
However, Herrig does not disclose wherein the expandable stent (35) is configured to be deployed within the second conduit.
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Sithian teaches a grafting method in the same field of endeavor. Said method axially joins two lumen components for passage of blood flow. The method comprises Placing a stented end (27) of a first conduit (12) within an opening (22b) of a second conduit (10), and expanding the stented first component (Figs 9-10) to define a fluid-tight passage for bloodflow (Col 2: lines 40-41).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the stent, as taught by Herrig, on the inside of the second conduit, as taught by Sithian, in order to create an alternative fluid tight passageway between first and second conduits for bloodflow.
Regarding Claim 8, the combination teaches wherein the expandable stent comprises a self-expanding stent (Herrig Col 11: lines 4-9 teaches Nitinol).
Regarding Claim 9, the combination teaches wherein the expandable stent comprises a balloon expandable stent (Herrig Col 11: lines 4-9 teaches stainless steel or titanium).
Regarding Claim 10, the combination teaches wherein the first conduit or the second conduit comprises a fibrous polymer (Herrig Col 6: lines 28-39).
Regarding Claim 11, the combination teaches wherein one or both of the first conduit and the second conduit are fully capable of being puncturable and self-sealing wall material (Herrig Col 6: lines 28-39) such that the wall material may be punctured by insertion of a needle and then reseal upon withdrawal of the needle.
Regarding Claim 12, the combination teaches wherein the vascular access system, when implanted and assembled, is fully capable of being a fully subcutaneous implant (Herrig Col 4: lines 59-61).
Regarding Claim 13, the combination teaches wherein the length of the expandable stent is sufficient to maintain the position of the expandable stent when deployed in the second conduit (in order to function properly).
Regarding Claim 14, the combination teaches wherein the expandable stent (35) is formed with the first conduit during the manufacturing process (Fig 1).
Regarding Claim 15, the combination teaches wherein the expandable stent (35) is fully capable of being coupled to the first conduit by a practitioner during use.
Regarding Claim 16, the combination teaches wherein the expandable stent (35) is integrally coupled to the first conduit (Fig 1).
Regarding Claim 17, the combination teaches wherein the assembled vascular access system resists kinking and pinching of the first conduit and/or the second conduit (Herrig teaches the structural limitations and materials disclosed supra that would resist kinking ion order to maintain bloodflow through the lumen) .
Claim(s) 18-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrig et al. (US 8,079,973) in view of Sithian (US 9,517,124) and in further view of Alanis (US 2002/0049403).
Regarding Claims 18-20, the combination of Herrig in view of Sithian, as set forth in Claims 7-17, discloses the invention substantially as claimed. Further the combination teaches coupling the second conduit (22) to a first vascular segment (Herrig Col 5: lines 3-6), and coupling the first conduit (26) to a second vascular segment (Herrig (Col 6: lines 45-52); positioning a segment of a reinforced portion (i.e., first conduit) outside the vasculature of the patient (i.e., the length of the device that does not reside within the vasculature); and expanding a second end of the reinforced portion (at the stent) within the graft portion (i.e., second conduit) to couple the reinforced portion to the graft portion.
However, the combination does not specifically disclose wherein the method for implanting comprises: coupling a graft portion (i.e., second conduit) of an access system to the vasculature in the arm of a patient; inserting the first end of a reinforced portion (i.e., first conduit) of the access system into a vena cava of the patient.
Alanis teaches a vascular access method [0023] for hemodialysis (Fig 2) in the same field of endeavor. Said method comprising coupling a graft portion (42) of an access system (10) to the vasculature in the arm (12) of a patient; and inserting the other end of the graft portion (44) of the access system into a vena cava (26) of the patient, in order to establish a permanent or semi-permanent vascular access system [0002] for hemodialysis [0003] by creating a pathway between the patient’s arterial and venous systems.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the vascular access system, as taught by the combination, in the manner as taught by Alanis in order to establish a permanent or semi-permanent vascular access system [0002] for hemodialysis [0003] by creating a pathway between the patient’s arterial and venous systems.
Regarding Claim 21, the combination teaches wherein the graft portion (second conduit) and the reinforced portion (first conduit) are positioned to form a continuous lumen (Herrig Fig 1).
Regarding Claim 22, the combination teaches wherein the method further comprises subcutaneously tunneling a portion of the graft portion (Alanis Fig 2).
Regarding Claims 23-26, the combination teaches the device as set forth in the rejections of claims 18-22.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774