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 Amendment
This office action is responsive to the amendment filed on November 26, 2025. As directed by the amendment: claims 1, 7, 16-17, and 23 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-28 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed November 26, 2025, with respect to the rejection(s) of claim(s) 1 and 16 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. With regards to claim 1, Byrne does not disclose the added limitation wherein a circumferential wall of the tubular body is configured to conform to a shape of the catheter. Therefore, the rejection has been withdrawn, and the rejections of claims 2-15 have similarly been withdrawn due to their dependence on claim 1. With regards to claim 16, Byrne does not disclose the added limitation coupling the isolator with the catheter during manufacture of the catheter. Therefore, the rejection has been withdrawn, and the rejections of claims 17-28 have similarly been withdrawn due to their dependence on claim 16. 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 1-6, 11-18, 20-23, 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Byrne (US 6074380), in view of Buyda (US 20180271557).
Regarding claim 1, Byrne discloses an antimicrobial medical device (Fig. 1, shield device 10), comprising: a tubular body (Fig. 1, transcutaneous distal portion 11) defining a lumen (Fig. 1, transcutaneous distal portion 11 has an internal lumen) extending between a proximal end (Fig. 1, transcutaneous distal portion 11 proximal end is end which abuts access port 12) and a distal end (Fig. 1, transcutaneous distal portion 11 distal end is end which is inserted into patient), the lumen configured to receive a catheter therethrough during an intravascular procedure (Fig. 1 and Col. 4:61-65, lumen of transcutaneous distal portion 11 is configured to receive catheter 51 therethrough during a procedure); and 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 tubular body is configured for insertion into a vascular access pathway extending through a skin layer of a patient (Fig. 1 and Col. 4:36-49, transcutaneous distal portion 11 is configured for insertion through incision wound 20 in patient's skin 21 such that it is inserted in a pathway for access to vessel 22) so that, in use, a wall of the tubular body defines a microbial barrier between the skin layer 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 ).
Byrne 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 an elastomeric material 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 Byrne 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]).
Regarding claim 2 and Byrne, in view of Buyda, Byrne further discloses the antimicrobial medical device of claim 1, 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).
Regarding claim 3 and Byrne, in view of Buyda, Byrne further discloses the antimicrobial medical device of claim 1, 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).
Regarding claim 4 and Byrne, in view of Buyda, Byrne further discloses the antimicrobial medical device of claim 1, wherein the tubular body includes a flange (Fig. 1, proximal portion 13) protruding radially away from the tubular body (Fig. 1, proximal portion 13 extends radially from the proximal end of distal portion 11), the flange configured to extend along a surface of the skin (Fig. 1 and Col. 4:57-60, proximal portion 13 lies substantially against surface of patient's skin).
Regarding claim 5 and Byrne, in view of Buyda, Byrne further discloses the antimicrobial medical device of claim 4, wherein the flange is configured for attachment to the surface of the skin (Col. 4:57-60 and Col. 5: 43-49, proximal portion 13, which is configured to lay substantially against the skin, may be configured for temporary adhesion to the skin)
Regarding claim 6 and Byrne, in view of Buyda, Byrne further discloses the antimicrobial medical device of claim 4, wherein the flange includes an adhesive applied to an underside thereof (Col. 4:57-60 and Col. 5: 43-49, proximal portion 13, which is configured to lay substantially against the skin, may be comprise one or more adhesive strips provided on the distal surface (underside) for temporary adhesion to skin).
Regarding claim 11 and Byrne, in view of Buyda, Byrne further discloses the antimicrobial medical device of claim 1, wherein the catheter is a central line catheter (Fig. 1 and Col. 4:61-65, catheter 51 is a central venous catheter).
Regarding claim 12 and Byrne, in view of Buyda, Byrne further discloses an intravascular catheter assembly (assembly of Fig. 1), comprising: a catheter (Fig. 1, catheter 51); and the antimicrobial medical device of claim 1 (Fig. 1, shield device 10 as explained in claim 1 rejection above) coupled with the catheter so that the antimicrobial medical device annularly covers at least a portion of the catheter (Fig. 1 and Col. 4:46-65, when catheter 51 is inserted into the access port 12, the transcutaneous distal portion 11 annularly covers a portion of catheter 51).
Regarding claim 13 and Byrne, in view of Buyda, Byrne further discloses the intravascular catheter assembly of claim 12, wherein the antimicrobial medical device covers a distal tip of the catheter (Fig. 1 and Col. 4:46-65, when catheter 51 is being inserted into the access port 12, the transcutaneous distal portion 11 may cover the distal tip of catheter 51).
Regarding claim 14 and Byrne, in view of Buyda, 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 of claim 1 (Fig. 1, shield device 10 as explained in claim 1 rejection above) 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).
Regarding claim 15 and Byrne, in view of Buyda, Byrne further discloses catheter introducer assembly of claim 14, 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).
Regarding claim 16, Byrne discloses a method of placing a catheter within a patient (method of placing catheter in patient as seen in Fig. 1), comprising: providing an isolator (Fig. 1, shield device 10) comprising: a tubular body (Fig. 1, transcutaneous distal portion 11) defining a lumen (Fig. 1, transcutaneous distal portion 11 has an internal lumen) extending between a proximal end (Fig. 1, transcutaneous distal portion 11 proximal end is end which abuts access port 12) and a distal end (Fig. 1, transcutaneous distal portion 11 distal end is end which is inserted into patient), the lumen configured to receive a catheter therethrough during an intravascular procedure (Fig. 1 and Col. 4:61-65, lumen of transcutaneous distal portion 11 is configured to receive catheter 51 therethrough during a procedure); and 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); inserting the isolator into a vascular access pathway of the patient (Fig. 1 and Col. 4:36-49, transcutaneous distal portion 11 is inserted through incision wound 20 in patient's skin 21 such that it is inserted in a pathway for access to vessel 22); inserting the catheter through the lumen of the isolator (Fig. 1 and Col. 4:61-65, catheter 51 is inserted into the lumen of transcutaneous distal portion 11); and advancing the catheter along a blood vessel of the patient (Fig. 1 and Col. 4:61-65, catheter 51 is further advanced into the blood vessel of the patient).
Byrne 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 Byrne 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]).
Regarding claim 17, Byrne, in view of Buyda, discloses the method of claim 16, as explained above. Byrne 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 Byrne, in view of Buyda, 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 and Byrne, in view of Buyda, Byrne further discloses the method of claim 16, 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 ).
Regarding claim 20 and Byrne, in view of Buyda, Byrne 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. 1 and Col. 4:36-49, 61-65, the catheter 51 is inserted into the lumen of the transcutaneous distal portion 11 after the transcutaneous distal portion 11 is inserted into the vascular access pathway).
Regarding claim 21 and Byrne, in view of Buyda, Byrne further discloses the method of claim 16, further comprising inserting the isolator into the vascular access pathway so that a flange (Fig. 1, proximal portion 13 of shield device 10) of the isolator is disposed adjacent a skin surface of the patient (Fig. 1 and Col. 4:57-60, proximal portion 13 lies substantially against surface of patient's skin when shield device is inserted into the vascular access pathway).
Regarding claim 22 and Byrne, in view of Buyda, Byrne further discloses the method of claim 21, further comprising attaching the flange of the isolator to the skin surface (Col. 4:57-60 and Col. 5: 43-49, proximal portion 13, which is configured to lay substantially against the skin, may be configured for temporary adhesion to the skin).
Regarding claim 23 and Byrne, in view of Buyda, Byrne further discloses the method of claim 16, further comprising attaching the isolator to the catheter (Fig. 1 and Col. 4:61-65, catheter 51 is attached to shield device 10 by inserting the catheter 51 into the lumen of transcutaneous distal portion 11).
Byrne 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 Byrne, in view of Buyda, 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 26 and Byrne, in view of Buyda, Byrne further discloses the method of claim 16, further comprising inserting a catheter introducer into the isolator (Col 6:31-40, shield device 10 can be disposed on a distal portion of an introducer).
Regarding claim 27 and Byrne, in view of Buyda, Byrne further discloses the method of claim 26, further comprising 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).
Regarding claim 28 and Byrne, in view of Buyda, Byrne further discloses the method of claim 16, wherein the catheter is a central line catheter (Fig. 1 and Col. 4:61-65, catheter 51 is a central venous catheter).
Claims 7-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Byrne (US 6074380), in view of Buyda (US 20180271557), as applied to claims 1 and 16 above, and further in view of Kratoska (US 6090072).
Regarding claim 7, Byrne, in view of Buyda, discloses ---the antimicrobial medical device of claim 1.
Byrne, in view of Buyda, fails to disclose wherein the flange is oriented to form an angle other than 90 degrees with respect to a longitudinal axis of the tubular body. However, Kratoska discloses wherein the flange is oriented to form an angle other than 90 degrees with respect to a longitudinal axis of the tubular body (Fig. 4C and Col. 18:43-64, hub 138 is formed with a tapered region 136 leading from the entrance of hub 138 to the sheath 130, thus the walls of the hub extend at an angle other than 90 degrees with respect to a longitudinal axis of the tubular body).
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 Byrne, in view of Buyda, to incorporate the disclosures of Kratoska and modify the flange such that the flange is oriented to form an angle other than 90 degrees with respect to a longitudinal axis of the tubular body. Doing so would shape the hub/flange in a way that facilitates the insertion and/or withdrawal of intravascular devices of varying sizes via the sheath (Kratoska, Col. 2:43-65; Col. 18:43-64).
Regarding claim 8, Byrne, in view of Buyda, discloses ---the antimicrobial medical device of claim 1.
Byrne, in view of Buyda, 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 Byrne, in view of Buyda, 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, Byrne, in view of Buyda and Kratoska, discloses ---the antimicrobial medical device of claim 8, as explained above. As noted above Byrne, in view of Buyda, 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 Byrne, in view of Buyda 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, Byrne, in view of Buyda, discloses ---the antimicrobial medical device of claim 1.
Byrne, in view of Buyda, 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 Byrne, in view of Buyda, 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, Byrne, in view of Buyda, discloses ---the method of claim 16.
Byrne, in view of Buyda, 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 Byrne, in view of Buyda, 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).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Byrne (US 6074380), in view of Buyda (US 20180271557), as applied to claim 16 above, and further in view of Stephan (US 20200238052).
Regarding claim 24, Byrne, in view of Buyda, discloses ---the method of claim 16.
Byrne, in view of Buyda, fails to disclose 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. However, Stephan discloses 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)
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 Byrne, in view of Buyda, to incorporate the disclosures of Stephan and modify the method to include 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. Doing so would provide an installation method of the catheter and catheter port which ensures no portion of the catheter will contact the patient’s epidermis, thus reducing the opportunity for infection (Stephan, [0110]).
Regarding claim 25, Byrne, in view of Buyda and Stephan, discloses ---the method of claim 24, as explained above. As noted above Byrne, in view of Buyda, fails to disclose inserting the catheter into the lumen of the isolator prior to inserting the isolator into the vascular access pathway, and is thus silent to 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. However, Stephan further discloses 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).
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 Byrne, in view of Buyda and Stephan, to further incorporate the disclosures of Stephan and modify the method to include 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. Doing so would provide an installation method of the catheter and catheter port which ensures no portion of the catheter will contact the patient’s epidermis, thus reducing the opportunity for infection (Stephan, [0110]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783