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 May 7, 2026. As directed by the amendment: claims 1-2 and 10-11 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-21 are presently pending in this application, with claims 20-21 previously withdrawn. Applicant’s amendments are sufficient to overcome the §112(b) rejections of the previous action.
Response to Arguments
Applicant’s arguments, see Remarks, filed May 7, 2026, with respect to the rejections of newly amended independent claims 1 and 10 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Burkholz et al. (Burkholz) US 2019/0321599 A1, wherein the claimed body is mapped to include additional structure proximal to the connector 30 of Burkholz.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (Burkholz) US 2019/0321599 A1 in view of Burkholz et al. (Burkholz 906’) US 2008/0287906 A1.
Regarding claim 1, Burkholz discloses a catheter extension set (catheter system 10, P0039 and shown in Figs. 1A-C), comprising a body (connector 30, extension tube 24 and connector 34, P0040-0041) defining a channel (channel, see annotated Fig. 1B below) to direct a biological fluid therethrough; a connection port (connection port, see annotated Fig. 1A below) defined in the body, in which an extension tube (extension tube 44, P0044) is fluidly coupled with the connection port; and a distal access port (distal access port, see annotated Fig. 1A below) defined in the body, and an adapter (adapter 12, P0039) extending from a proximal end of the body, the adapter configured to engage with a non-integrated catheter (catheter 20, P0039).
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Burkholz does not teach a vented access port.
However, Burkholz 906’ teaches an extravascular system venting having a vented access port (ventable end cap 28 and removable vent plug 30, P0073 and shown in Figs. 13-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter extension set taper connection 46 of Burkholz with the vented access port of Burkholz 906’ for the purpose of venting the blood sample as taught by Burkholz 906’ P0063, wherein the vented access port of the modified catheter extension set is in fluid communication with the extension tube of Burkholz, the vented access port spaced apart from the connection port of Burkholz, wherein an initial biological fluid volume directed through the body is directed into the vented access port via the extension tube because that is the open fluid pathway when the distal access port is closed off by septum 38 as shown in Fig. 1B of Burkholz.
Regarding claim 2, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising the non-integrated catheter (Burkholz, catheter adapter 12, P0041, which includes catheter 20) removably couplable with the body (Burkholz, connector 34 may selectively couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12, P0041).
Regarding claim 3, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a stabilization platform (Burkholz, stabilization platform, see annotated Fig. 1A above) operatively connected to the body (Burkholz, Fig. 1A) to stabilize the catheter extension set on a desired surface (Burkholz, P0056).
Regarding claim 4, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a luer adaptor (Burkholz, luer adapter 46, P0047), wherein the vented access port is integrated with the luer adaptor (Burkholz 906’ Figs. 13-15).
Regarding claims 5, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 4, further comprising a vent plug (Burkholz 906’, air permeable material 44, P0066) integrated with at least one of the luer adapter and the vented access port (Burkholz 906’, Figs. 13-15).
Regarding claim 6, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a vent plug (Burkholz 906’, air permeable material 44, P0066) operatively connected to the vented access port (Burkholz 906’, Figs. 13-15) at an end of the extension tube opposite the connection port (Burkholz 906’, Fig. 1).
Regarding claim 7, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a clamping member (Burkholz, clamp 39, P0045) disposed about a portion of the extension tube (Burkholz, Figs. 1A-B), wherein in a clamping position the clamping member is configured to occlude at least a portion of the extension tube (Burkholz, in a clamping position wherein the clamping member is clamped together, the clamping member is fully capable of occluding at least a portion of the extension tube).
Regarding claim 8, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, further comprising a luer lock access device (Burkholz, connector 30 may include a luer adapter, P0040) fluidically connected to the distal access port (Burkholz, Figs. 1A-C).
Regarding claim 9, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 1, wherein the vented access port comprises a dual port luer adaptor (Burkholz 906’, y adapter 18, P0061) operatively connected to an end of the extension tube opposite the connection port.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the luer adapter 46 of Burkholz with a dual port luer adapter as taught by Burkholz 906’ for the purpose of providing for both an access port and vent, Burkholz 906’ P0061.
Regarding claim 10, Burkholz discloses a catheter extension set (catheter system 10, P0039 and shown in Figs. 1A-C), comprising: a body (connector 30, extension tube 24 and connector 34, P0040-0041) defining a channel (channel, see annotated Fig. 1B below) to direct a biological fluid therethrough; a connection port (connection port, see annotated Fig. 1A below) defined in the body, in which an extension tube (extension tube 44, P0044) is fluidly coupled to the connection port; a non-integrated catheter (catheter 20, P0039) removably connectable with the body (connector 34 may selectively couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12, P0041) to direct a biological fluid into the body; an adapter (adapter 12, P0039) extending from a proximal end of the body, the adapter configured to engage with the non-integrated catheter (Fig. 1B); and a distal access port (distal access port, see annotated Fig. 1A below) defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container (blood collection tube, P0050 and shown in Fig. 1C).
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Burkholz does not teach a vented access port.
However, Burkholz 906’ teaches an extravascular system venting having a vented access port (ventable end cap 28 and removable vent plug 30, P0073 and shown in Figs. 13-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the catheter extension set taper connection 46 of Burkholz with the vented access port of Burkholz 906’ for the purpose of venting the blood sample as taught by Burkholz 906’ P0063, wherein the vented access port of the modified catheter extension set is in fluid communication with the extension tube of Burkholz, the vented access port spaced apart from the connection port of Burkholz, wherein an initial biological fluid volume directed through the body of Burkholz is directed into the extension tube of Burkholz via the connection port of Burkholz and into the vented access port of the modified catheter extension set because that is the open fluid pathway when the distal access port is closed off by septum 38, as shown in Fig. 1B of Burkholz.
Regarding claim 11, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, wherein the catheter extension set is configured to direct a portion of the biological fluid into the removable sample collection container after the initial blood volume is directed into the vented access port (the catheter extension set is fully capable of directing a portion of the biological fluid into the removable sample collection container after the initial blood volume is directed into the vented access port by using clamp 39 to direct flow toward the removable sample collection container).
Regarding claim 12, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising the removable sample collection container (Burkholz, blood collection tube, P0050 and shown in Fig. 1C) in fluid communication with the distal access port (Burkholz, Fig. 1C).
Regarding claim 13, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 12, wherein the removable sample collection container is a blood culture sample collection tube (Burkholz, blood collection tube, P0050 and shown in Fig. 1C).
Regarding claim 14, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a stabilization platform (Burkholz, stabilization platform, see annotated Fig. 1A above) operatively connected to the body (Burkholz, Fig. 1A) to stabilize the catheter extension set on a desired surface (Burkholz, P0056).
Regarding claim 15, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a luer adaptor (Burkholz, luer adapter 46, P0047), wherein the vented access port is integrated with the luer adaptor (Burkholz 906’ Figs. 13-15).
Regarding claim 16, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 15, further comprising a vent plug (Burkholz 906’, air permeable material 44, P0066) integrated with at least one of the luer adapter and the vented access port (Burkholz 906’, Figs. 13-15).
Regarding claim 17, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a clamping member (Burkholz, clamp 39, P0045) disposed about a portion of the extension tube, wherein in a clamping position the clamping member is configured to occlude at least a portion of the extension tube (in a clamping position wherein the clamping member is clamped together, the clamping member is fully capable of occluding at least a portion of the extension tube).
Regarding claim 18, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, further comprising a luer lock access device (Burkholz, connector 30 may include a luer adapter, P0040) fluidically connected to the distal access port (Burkholz, Figs. 1A-C).
Regarding claim 19, Burkholz in view of Burkholz 906’ teaches the catheter extension set of claim 10, wherein the vented access port comprises a dual port luer adaptor (Burkholz 906’, y adapter 18, P0061) operatively connected to an end of the extension tube opposite the connection port.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the luer adapter 46 of Burkholz with a dual port luer adapter as taught by Burkholz 906’ for the purpose of providing for both an access port and vent, Burkholz 906’ P0061.
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.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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