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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 12, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on May 12, 2026. As directed by the amendment: claims 1, 4, 7, and 16 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-28 are presently pending in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 8, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks, filed May 12, 2026, with respect to the rejection(s) of claim(s) independent claims 1 and 16 under 35 U.S.C. 103 have been fully considered and are persuasive. Neither of Byrne or Buyda disclose the amended limitation of a planar flange protruding radially away from and extending continuously around the tubular body. Therefore, the rejections of claims 1 and 16 have been withdrawn. Due to their dependency on claims 1 or 16, the rejections of claims 2-15 and 17-28 have been withdrawn for similar reasons. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
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.
Claims 1-7, 11-18, and 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over Stephan (US 20200238052), in view of Buyda et al. (US 20180271557), hereinafter Buyda, and Byrne et al. (US 6074380), hereinafter Byrne.
Regarding claim 1, Stephan discloses an antimicrobial medical device (Fig. 1, port 2), comprising: a tubular body (Fig. 1-2, tubular body of port 2, including outer tube 10 and inner tube 6) defining a lumen extending between a proximal end and a distal end (Fig. 2, lumen formed by tubular body, extends from proximal end (end of outer tube 10) to distal end (end of inner tube 6)), the lumen configured to receive a catheter therethrough during an intravascular procedure (Fig. 2, lumen receives catheter 16); a planar flange protruding radially away from and extending continuously around the tubular body (Fig. 1-2, planar flange member 4 continuously extends radially away from tubular body); and wherein the tubular body is configured for insertion into a vascular access pathway extending through a skin layer of a patient so that, in use, a wall of the tubular body defines a barrier between the skin layer and the catheter (Fig. 2 and 10 and [0102, 0109], inner tube 6 portion of tubular body is configured for insertion into access pathway for a vein through the skin layer 36, such that the wall of tube 6 defines a barrier between skin layer 36 and catheter 16).
Stephan fails to disclose wherein a circumferential wall of the tubular body is configured to conform to a shape of the catheter. However, Buyda discloses wherein a circumferential wall of the tubular body is configured to conform to a shape of the catheter (Fig. 5-7 and [0049], sleeve 16 of the fluid port 38 is made of a elastomeric materials and secures around the cannula 14 via an interference fit, therefore sleeve 16 conforms to the shape of the cannula 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan to incorporate the disclosures of Buyda and modify the tubular body to have a circumferential wall configured to conform to a shape of the catheter. Doing so would provide a tubular body which is secured to the cannula/catheter which may fix movement relative of the components relative to one another and serve as sealing between the components (Buyda [0041, 0049]).
Stephan, in view of Buyda, fails to disclose an antimicrobial material coupled with the tubular body, wherein the wall of the tubular body defines a microbial barrier. However, Byrne discloses an antimicrobial material coupled with the tubular body (Col. 6:17-30, transcutaneous distal portion 11 may be coated in a lubricant coating containing an antimicrobial agent), wherein the wall of the tubular body defines a microbial barrier (Fig. 1 and Col. 6:17-30, in operation, the transcutaneous distal portion 11, with its antimicrobial agent coating, forms a microbial barrier between the skin tissue of the incision wound 20 and the catheter 51 inserted into shield device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda, to incorporate the disclosures of Byrne and modify the tubular body to have an antimicrobial material coupled with the tubular body, wherein the wall of the tubular body defines a microbial barrier. Doing so would inhibit growth of infectious bacteria in the wound area or in the surrounding tissue (Byrne, Col. 6:23-26).
Regarding claim 2, Stephan, in view of Buyda and Byrne, discloses the antimicrobial medical device of claim 1, as explained above. As noted above, Stephan fails to disclose the antimicrobial material, and is thus silent to wherein the antimicrobial material is a coating applied to the tubular body. However, Byrne further discloses wherein the antimicrobial material is a coating applied to the tubular body (Col. 6:17-30, antimicrobial material is a lubricant coating containing an antimicrobial agent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the antimicrobial material to be a coating applied to the tubular body. Doing so would inhibit growth of infectious bacteria in the wound area or in the surrounding tissue (Byrne, Col. 6:23-26).
Regarding claim 3, Stephan, in view of Buyda and Byrne, discloses the antimicrobial medical device of claim 1, as explained above. As noted above, Stephan fails to disclose the antimicrobial material, and is thus silent to wherein the antimicrobial material is impregnated into a body material of the tubular body. However, Byrne further discloses wherein the antimicrobial material is impregnated into a body material of the tubular body (Col. 6:17-30, shield device is a one-piece construction and its material may be impregnated with an antimicrobial agent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the antimicrobial material to be impregnated into a body material of the tubular body. Doing so would inhibit growth of infectious bacteria in the wound area or in the surrounding tissue (Byrne, Col. 6:23-26).
Regarding claim 4 and Stephan, in view of Buyda and Byrne, Stephan further discloses the antimicrobial medical device of claim 1, wherein the planar flange is configured to extend along a surface of the skin (Fig. 2, planar flange member 4 extends along surface of skin 34).
Regarding claim 5 and Stephan, in view of Buyda and Byrne, Stephan further discloses the antimicrobial medical device of claim 4, wherein the flange is configured for attachment to the surface of the skin (Fig. 2 and [0104], flange member 4 comprises cushion layer 28 which has an adhesive coating that attaches to skin surface 34).
Regarding claim 6 and Stephan, in view of Buyda and Byrne, Stephan further discloses the antimicrobial medical device of claim 4, wherein the flange includes an adhesive applied to an underside thereof (Fig. 2 and [0104], adhesive coating is applied to underside of cushion 28 of flange member 4).
Regarding claim 7 and Stephan, in view of Buyda and Byrne, Stephan further discloses the antimicrobial medical device of claim 4, wherein the planar flange is oriented to form an angle other than 90 degrees with respect to a longitudinal axis of the tubular body (Fig. 7-9 and [0103, 0108-0109], outer tube 10 comprises a flexing region 8 such that, based on the angle of the inserted catheter 16, the outer tube 10 may bend therefore the longitudinal axis of the outer tube 10 is at an angle other than 90 degrees with respect to the planar flange member 4).
Regarding claim 11 and Stephan, in view of Buyda and Byrne, Stephan further discloses the antimicrobial medical device of claim 1, wherein the catheter is a central line catheter (Fig. 10-11 and [0109], catheter may be a peripherally inserted central catheter (PICC)).
Regarding claim 12 and Stephan, in view of Buyda and Byrne, Stephan further discloses an intravascular catheter assembly (Fig. 7, assembly 22), comprising: a catheter (Fig. 7, catheter 16); and the antimicrobial medical device of claim 1 (Fig. 7, port 2) coupled with the catheter so that the antimicrobial medical device annularly covers at least a portion of the catheter (Fig. 7 and 9, port 2 is coupled to catheter 16 such that the port 2 annularly covers a portion of catheter 16).
Regarding claim 13 and Stephan, in view of Buyda and Byrne, Stephan further discloses the intravascular catheter assembly of claim 12, wherein the antimicrobial medical device covers a distal tip of the catheter (Fig. 10 and 16-18 and [0110], when the catheter 16 is first inserted into the body, the port 2 covers the entire catheter, including the distal tip of catheter, to ensure no portion of the catheter touches the patient's skin).
Regarding claim 14, Stephan, in view of Buyda and Byrne, discloses the antimicrobial medical device of claim 1, as explained above. Stephan is silent to a catheter introducer assembly, comprising: a catheter introducer; and the antimicrobial medical device coupled with the catheter introducer so that the antimicrobial medical device annularly covers at least a portion of the catheter introducer. However, Byrne further discloses a catheter introducer assembly (assembly of Fig. 1), comprising: a catheter introducer (Col 6:31-40, shield device 10 can be used with an introducer); and the antimicrobial medical device coupled with the catheter introducer so that the antimicrobial medical device annularly covers at least a portion of the catheter introducer (Col 6:31-40, shield device 10 can be disposed on a distal portion of an introducer, therefore the shield device covers the distal portion of the introducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the antimicrobial medical device to be used in a catheter introducer assembly, comprising: a catheter introducer; and the antimicrobial medical device coupled with the catheter introducer so that the antimicrobial medical device annularly covers at least a portion of the catheter introducer. Doing so would allow for attachment of the device to the skin with the introducer, then allowing subsequent introduction of further instrumentation through the antimicrobial medical device (Byrne, Col. 6:31-40).
Regarding claim 15, Stephan, in view of Buyda and Byrne, discloses the catheter introducer assembly of claim 14, as explained above. As noted above, Stephan fails to disclose the introducer and is thus silent to wherein the antimicrobial medical device covers a distal tip of the catheter introducer. However, Byrne further discloses wherein the antimicrobial medical device covers a distal tip of the catheter introducer (Col 6:31-40, shield device 10 is disposed on the distal portion of the introducer, and therefore would cover its distal tip).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the antimicrobial medical device to cover a distal tip of the catheter introducer. Doing so would allow for attachment of the device to the skin with the introducer, then allowing subsequent introduction of further instrumentation through the antimicrobial medical device (Byrne, Col. 6:31-40).
Regarding claim 16, Stephan discloses a method of placing a catheter within a patient (Figs. 12-19 and [0110], method of administering a catheter), comprising: providing an isolator (Fig. 1, port 2) comprising: a tubular body (Fig. 1-2, tubular body of port 2, including outer tube 10 and inner tube 6) defining a lumen extending between a proximal end and a distal end (Fig. 2, lumen formed by tubular body, extends from proximal end (end of outer tube 10) to distal end (end of inner tube 6)), the lumen configured to receive the catheter therethrough during an intravascular procedure (Fig. 2 and 16-19, lumen receives catheter 16); a planar flange protruding radially away from and extending continuously around the tubular body (Fig. 1-2, planar flange member 4 continuously extends radially away from tubular body); inserting the isolator into a vascular access pathway of the patient (Fig. 16-17 and [0110], inserting/seating the port 2 onto the skin and inner tube 6 is in an access pathway for a vein); inserting the catheter through the lumen of the isolator (Fig. 10 and [0109], catheter 16 is inserted through lumen of port 2); and advancing the catheter along a blood vessel of the patient ([0109-0110], catheter is advanced along the vein to target region).
Stephan fails to disclose coupling the isolator with the catheter during manufacture of the catheter. However, Buyda discloses coupling the isolator with the catheter during manufacture of the catheter (Fig. 6 and [0041, 0049], fluid port 38/outer sleeve 16 are coaxially mounted to the cannula 14 via interference fit or use of adhesives/welding during manufacture/assembly of cannula assembly 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan to incorporate the disclosures of Buyda and modify the method to include coupling the isolator with the catheter during manufacture of the catheter. Doing so would provide a tubular body of the isolator which is secured to the cannula/catheter which may serve as sealing between the components (Buyda [0041, 0049]).
Stephan, in view of Buyda, fails to disclose an antimicrobial material coupled with the tubular body. However, Byrne discloses an antimicrobial material coupled with the tubular body (Col. 6:17-30, transcutaneous distal portion 11 may be coated in a lubricant coating containing an antimicrobial agent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda, to incorporate the disclosures of Byrne and modify the tubular body to have an antimicrobial material coupled with the tubular body. Doing so would inhibit growth of infectious bacteria in the wound area or in the surrounding tissue (Byrne, Col. 6:23-26).
Regarding claim 17, Stephan, in view of Buyda and Byrne, discloses the method of claim 16, as explained above. Stephan is silent to wherein: a tubular wall of the tubular body is stretchable to facilitate an interference fit with the catheter, the interference fit defining a friction force between the tubular wall and the catheter, and inserting the catheter through the lumen of the isolator forms a fluid seal between the catheter and the isolator. However, Buyda further discloses wherein: a tubular wall of the tubular body is stretchable to facilitate an interference fit with the catheter, the interference fit defining a friction force between the tubular wall and the catheter (Fig. 5-7 and [0049], sleeve 16 has interference fit with cannula 14 such that a frictional sealing is formed between the components), and inserting the catheter through the lumen of the isolator forms a fluid seal between the catheter and the isolator (Fig. 6 and [0049], the cannula 14 being inserted through the sleeve 16 serves as a fluid seal between the cannula 14 and the sleeve 16 of the isolator).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Buyda and modify the method to include wherein: a tubular wall of the tubular body is stretchable to facilitate an interference fit with the catheter, the interference fit defining a friction force between the tubular wall and the catheter, and inserting the catheter through the lumen of the isolator forms a fluid seal between the catheter and the isolator. Doing so would provide a tubular body which is secured to the cannula/catheter that may fix movement relative of the components relative to one another and serve as sealing between the components (Buyda [0041, 0049]).
Regarding claim 18, Stephan, in view of Buyda and Byrne, discloses the method of claim 16, as explained above. As noted above, Stephan fails to disclose an antimicrobial material, and is thus silent to wherein the isolator defines a microbial barrier between a skin layer of the patient and the catheter. However, Byrne further discloses wherein the isolator defines a microbial barrier between a skin layer of the patient and the catheter. (Fig. 1 and Col. 6:17-30, in operation, the transcutaneous distal portion 11, with its antimicrobial agent coating, forms a microbial barrier between the skin tissue of the incision wound 20 and the catheter 51 inserted into shield device ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the method to include wherein the isolator defines a microbial barrier between a skin layer of the patient and the catheter. Doing so would inhibit growth of infectious bacteria in the wound area or in the surrounding tissue (Byrne, Col. 6:23-26).
Regarding claim 20 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 16, further comprising inserting the catheter through the lumen of the isolator after inserting the isolator into the vascular access pathway (Fig. 10 and [0109], catheter 16 is inserted into lumen of port 2 after the inner tube 6 of port 2 is inserted into the access pathway for vein).
Regarding claim 21 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 16, further comprising inserting the isolator into the vascular access pathway so that a flange of the isolator is disposed adjacent a skin surface of the patient (Fig. 2 and [0104], port 2 is inserted into patient such that flange member 4 is disposed adjacent skin surface 34).
Regarding claim 22 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 21, further comprising attaching the flange of the isolator to the skin surface (Fig. 2 and [0104], flange member 4 comprises cushion 28 which has an adhesive layer for attaching flange member 4 to skin surface 34).
Regarding claim 23 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 16, further comprising attaching the isolator to the catheter (Fig. 7 and [0108], catheter 16 is attached to port 2 by inserting the catheter 16 into the lumen of port 2).
Stephan is silent to the attachment inhibiting longitudinal displacement of the catheter with respect to the isolator. However, Buyda further discloses the attachment inhibiting longitudinal displacement of the catheter with respect to the isolator (Fig. 6 and [0049], the insertion of the cannula 14 into the sleeve 16 allows the interference fit between the components to fix longitudinal movement between the components).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Buyda and modify the method to include the attachment inhibiting longitudinal displacement of the catheter with respect to the isolator. Doing so would provide a tubular body which is secured to the cannula/catheter that may fix movement relative of the components relative to one another and serve as sealing between the components (Buyda [0041, 0049]).
Regarding claim 24 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 16, further comprising inserting the catheter into the lumen of the isolator so that a distal end of the catheter is disposed proximal the distal end of the tubular body prior to inserting the isolator into the vascular access pathway (Fig. 16-17 and [0110], catheter 16 is inserted into lumen of catheter access port 2, such that the catheter is inserted into the patient with the catheter access port).
Regarding claim 25 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 24, wherein inserting the isolator into the vascular access pathway comprises manually applying a distally oriented force to the catheter, wherein the distally oriented force is transferred to the isolator via the catheter (Fig. 16-17 and [0110], catheter 16 is pushed into insertion site which in turn pushes catheter access port 2 into insertion site).
Regarding claim 26, Stephan, in view of Buyda and Byrne, discloses the method of claim 16, as explained above. Stephan is silent to the method further comprising inserting a catheter introducer into the isolator. However, Byrne further discloses inserting a catheter introducer into the isolator (Col 6:31-40, a distal portion of an introducer can be inserted into shield device 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the method to include inserting a catheter introducer into the isolator. Doing so would allow for attachment of the device to the skin with the introducer, then allowing subsequent introduction of further instrumentation through the antimicrobial medical device (Byrne, Col. 6:31-40).
Regarding claim 27, Stephan, in view of Buyda and Byrne, discloses the method of claim 26, as explained above. As noted above, Stephan fails to disclose a catheter introducer and is thus silent to the method further comprising inserting the catheter introducer into the vascular access pathway after inserting the catheter introducer into the isolator. However, Byrne further discloses inserting the catheter introducer into the vascular access pathway after inserting the catheter introducer into the isolator (Col 6:31-40, shield device 10 can be disposed on a distal portion of an introducer, then the introducer and shield device may be inserted into the vascular access pathway).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to further incorporate the disclosures of Byrne and modify the method to include inserting the catheter introducer into the vascular access pathway after inserting the catheter introducer into the isolator. Doing so would allow for attachment of the device to the skin with the introducer, then allowing subsequent introduction of further instrumentation through the antimicrobial medical device (Byrne, Col. 6:31-40).
Regarding claim 28 and Stephan, in view of Buyda and Byrne, Stephan further discloses the method of claim 16, wherein the catheter is a central line catheter (Fig. 10-11 and [0109], catheter may be a peripherally inserted central catheter (PICC)).
Claims 8-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stephan (US 20200238052), in view of Buyda (US 20180271557) and Byrne (US 6074380), as applied to claims 1 and 16 above, and further in view of Kratoska et al. (US 6090072), hereinafter Kratoska.
Regarding claim 8, Stephan, in view of Buyda and Byrne, discloses ---the antimicrobial medical device of claim 1.
Stephan, in view of Buyda and Byrne, fails to disclose wherein the tubular body is configured to form a seal with the catheter to prevent egress of body fluid between the tubular body and the catheter. However, Kratoska discloses wherein the tubular body is configured to form a seal with the catheter to prevent egress of body fluid between the tubular body and the catheter (Fig. 2B-2C and Col. 2:52-57, the entry hub of sheath 50 includes a hemostasis valve, which is configured to for a seal with the intravascular catheters to prevent flow of blood out of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to incorporate the disclosures of Kratoska and modify the tubular body to form a seal with the catheter to prevent egress of body fluid between the tubular body and the catheter. Doing so would prevent the flow of blood out of the patient or air into the patient (Kratoska, Col. 2:52-57).
Regarding claim 9, Stephan, in view of Buyda, Byrne, and Kratoska, discloses ---the antimicrobial medical device of claim 8, as explained above. As noted above Stephan, in view of Buyda and Byrne, fails to disclose the seal, and is thus silent to wherein the tubular body includes an inward annular protrusion configured to form the seal. However, Kratoska further discloses wherein the tubular body includes an inward annular protrusion configured to form the seal (Figs. 2B-2C, hemostasis valve 59 protrudes inwardly into lumen from an annular surface of the hub for sheath 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda, Byrne, and Kratoska, to further incorporate the disclosures of Kratoska and modify the seal to be an inward annular protrusion. Doing so would prevent the flow of blood out of the patient or air into the patient (Kratoska, Col. 2:52-57).
Regarding claim 10, Stephan, in view of Buyda and Byrne, discloses ---the antimicrobial medical device of claim 1.
Stephan, in view of Buyda and Byrne, fails to disclose wherein the tubular body is sized so that, in use, the distal end of the tubular body is disposed within a blood vessel. However, Kratoska discloses wherein the tubular body is sized so that, in use, the distal end of the tubular body is disposed within a blood vessel (Fig. 2D, tubular portion of sheath 50 is inserted such that distal end 58 is disposed within vessel 56)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to incorporate the disclosures of Kratoska and modify the tubular body to be sized so that, in use, the distal end of the tubular body is disposed within a blood vessel. Doing so would allow for the sheath to provide the catheter inserted within the device to have access directly into the vessel (Kratoska, Col 12:9-23).
Regarding claim 19, Stephan, in view of Buyda and Byrne, discloses ---the method of claim 16.
Stephan, in view of Buyda and Byrne, fails to disclose inserting the isolator into the vascular access pathway so that the distal end of the tubular body is disposed within the blood vessel. However, Kratoska discloses inserting the isolator into the vascular access pathway so that the distal end of the tubular body is disposed within the blood vessel (Fig. 2D, tubular portion of sheath 50 is inserted such that distal end 58 is disposed within vessel 56)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stephan, in view of Buyda and Byrne, to incorporate the disclosures of Kratoska and modify the method to include inserting the isolator into the vascular access pathway so that the distal end of the tubular body is disposed within the blood vessel. Doing so would allow for the sheath to provide the catheter inserted within the device to have access directly into the vessel (Kratoska, Col 12:9-23).
Conclusion
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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