DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 18 August 2026. The Examiner acknowledges the amendments to claims 1-21. Claims 1-22 are pending.
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 Objections
Claim(s) 21 is/are objected to because of the following informalities:
Claim 21 should read “the integrated catheter[[ ]];” [line 10, wherein the Examiner notes that there appears to be a space after “catheter”].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-6, 8, 10-14, 16-17, 19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langdell (US-20190374144-A1, previously presented) in view of Burkholz (US-20200046948-A1), hereinafter Burkholz ‘948.
Regarding claim 1, Langdell teaches
An integrated catheter assembly, comprising:
a body defining a channel to direct a biological fluid therethrough [a body member 102 having an interior wall 104 defining a generally “Y” shaped fluid conduit 106 (Langdell ¶0038, Figs. 1A-C)];
a connection port defined in a distal end of the body [The fluid conduit 106 can include… a first proximal portion 110 (Langdell ¶0038, Figs. 1A-C), wherein the Examiner notes that “distal” and “proximal” are considered relative and non-limiting in terms of structure; see also Annotated Fig. 1], in which an extension tube is fluidly coupled with the connection port [an extension tube 130, which can be operably coupled to the distal end of the first proximal portion, (as depicted in FIG. 1C) (Langdell ¶0043, Fig. 1C)];
a distal access port defined in the body [The fluid conduit 106 can include… a second proximal portion 112 (Langdell ¶0038, Figs. 1A-C), wherein the Examiner notes that “distal” and “proximal” are considered relative and non-limiting in terms of structure];
a vented access port in fluid communication with the extension tube, the vented access port spaced apart from the connection port [the vent path 126 can be sealed at one end by a plug 128. The plug 128 can be made out of an air permeable, hydrophilic material that enables the passage of air, but inhibits the passage of liquid (Langdell ¶0042, Figs. 1A-C); the plug 128 can be operably coupled to an extension tube 130, which can be operably coupled to the distal end of the first proximal portion, (as depicted in FIG. 1C) (Langdell ¶0043, Fig. 1C), wherein the portion of the extension tube 130 connected to the plug 128 is considered to define a vented access port],
wherein an initial biological fluid volume of the biological fluid directed through the body is directed into the vented access port via the extension tube [Langdell ¶¶0042-0043]; and
an integrated catheter operatively connected to the body [The fluid conduit 106 can include a distal portion 108 (Langdell ¶0038, Fig. 1A); The distal portion 108 can include an inlet port 114 configured to be fluidly coupled to vasculature of a patient. For example, in one embodiment, the inlet port 114 can be in fluid communication with a catheter assembly 116. The catheter assembly 116 can include a catheter hub 118 and a catheter tube 120 (Langdell ¶0039, Fig. 1A)], wherein the connection port is positioned between the integrated catheter and the distal access port [see Annotated Fig. 2].
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Annotated Figure 1. The Examiner has annotated Fig. 1A [but notes that similar annotations are applicable to each of Figs. 1B-C of Langdell] to identify how the body 102, which is defined as comprising an inlet port 114 at “distal” portion 108, a vent path 126 at first “proximal” portion 110, and an outlet port 132 at second “proximal” portion 112. The Examiner notes that while Langdell refers to certain portions of body 102 using “distal” and “proximal”, the use of “distal” and “proximal” are considered to be relative and non-limiting in terms of structure. As identified in the Examiner’s annotation of Fig. 1A, the highlighted portion of the body 102 may be considered “distal” relative to a user of the device [based on the location of wing assembly 122, which is configured to be gripped by a user of the device (see Langdell ¶0040)], and the highlighted portion of the body 102 may be considered “proximal” relative to the user of the device.
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Annotated Figure 2. The Examiner has annotated Fig. 1A of Langdell to clearly depict how the first proximal portion 110 [connection port] branches out from a location that is between the integrated catheter [catheter assembly 116] and the distal access port [second proximal portion 112].
However, Langdell fails to explicitly disclose the distal access port being positioned in-line with the body.
Burkholz ‘948 discloses an integrated catheter assembly comprising an integrated catheter operatively connected to a body for blood sampling [See catheter system 10 of Burkholz ‘948 Fig. 1B, which includes catheter adapter 12 and catheter 14 (integrated catheter) and Y-adapter 24 (body)], wherein the body comprises a connection port defined in a distal end of the body [a second connector 42 coupled to the second arm 30 (Burkholz ‘948 ¶0038, Fig. 1B)], a distal access port defined in the body, the distal access port being positioned in-line with the body [a first connector 40 coupled to the first arm 28 (Burkholz ‘948 ¶0038, Fig. 1B)], and a vented access port in fluid communication with the connection port to allow for venting of the integrated catheter assembly prior to blood collection [the catheter system 10 may further include a vent cap 44, which may be coupled to the second arm 30 (Burkholz ‘948 ¶0039, Fig. 1B); when collection of one or more blood samples is desired using the catheter system 10, the catheter system 10 may not be primed or connected to the IV line 46. In these and other embodiments, the vent cap 44 may be actuated to allow blood to fill the unprimed catheter system 10 by venting the second arm 30 to which the vent cap 44 may be attached. In some embodiments, after the catheter 14 is inserted into the vein and blood fills the extension tubing, the vent cap 44 may be removed, and a blood collection device (such as, for example, a vacuum tube holder, syringe, or another device) may be attached to the first arm 28 or second arm 30 to collect the blood samples via the blood collection device (Burkholz ‘948 ¶0048)]. Burkholz ‘948 further discloses that the first arm 28 and the second arm 30 may refer to either/or of the central arm and the side arm of the Y-adapter [In some embodiments, the first arm 28 may correspond to a central arm of the Y-adapter 24, as illustrated in FIG. 1A. In these embodiments, the second arm 30 may correspond to a side arm of the Y-adapter 24, as illustrated in FIG. 1A. Conversely, in some embodiments, the first arm 28 may correspond to the side arm of the Y-adapter 24 and the second arm 30 may correspond to the central arm of the Y-adapter 24 (Burkholz ¶¶0034)].
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 the integrated catheter assembly of Langdell to employ the distal access port being positioned in-line with the body, as this modification would amount to mere application of a known technique to a known device (method, or product ready for improvement to yield predictable results [use of the port of the “side”/angled arm of a Y-adapter for venting and use of the port of the “central”/in-line arm of the Y-adapter for blood collection] [MPEP § 2143(I)(D)]. The Examiner notes that the modification of Langdell in view of Burkholz ‘948 is still considered to teach the limitation “wherein the connection port is positioned between the integrated catheter and the distal access port” based on Burkholz ‘948 Fig. 1B depicting the second/side arm 30 being disposed between the first/central arm 28 and the distal end 26 [Burkholz ‘948 Fig. 1B].
Regarding claim 2, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 1, further comprising a catheter adapter, wherein the integrated catheter is operatively connected to the body via the catheter adapter [Langdell ¶0039].
Regarding claim 4, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 1, further comprising a luer adaptor, wherein the vented access port is integrated with the luer adaptor [In one embodiment, the plug 128 can be inserted into the vent path 126 (as depicted in FIG. 1A). For example, in one embodiment, the vent path 126 can define a Luer connector configured to accept a portion of the plug 128 (Langdell ¶0043, Fig. 1A)].
Regarding claim 5, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 4, further comprising a vent plug integrated with at least one of the luer adapter and the vented access port [Langdell ¶¶0042-0043].
Regarding claim 6, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 1, further comprising a vent plug operatively connected to the vented access port at an end of the extension tube opposite the connection port [Langdell ¶¶0042-0043].
Regarding claim 8, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 1, further comprising a luer lock access device fluidically connected to the distal access port [See § 103 modification of claim 1 above; [The second proximal portion 112 can define a fluid path and an outlet port 132 configured to be fluidly coupled to a blood collection device 134. For example, in one embodiment, the outlet port 132 can define a Luer connector configured to accept a portion of the blood collection device 134 (Langdell ¶0046, Fig. 1A)]].
Regarding claim 10, Langdell teaches
An integrated catheter assembly, comprising:
a body defining a channel to direct a biological fluid therethrough [a body member 102 having an interior wall 104 defining a generally “Y” shaped fluid conduit 106 (Langdell ¶0038, Figs. 1A-C)];
a connection port defined in a distal end of the body [The fluid conduit 106 can include… a first proximal portion 110 (Langdell ¶0038, Figs. 1A-C), wherein the Examiner notes that “distal” and “proximal” are considered relative and non-limiting in terms of structure; see also Annotated Fig. 1], in which an extension tube is fluidly coupled to the connection port [an extension tube 130, which can be operably coupled to the distal end of the first proximal portion, (as depicted in FIG. 1C) (Langdell ¶0043, Fig. 1C)];
a vented access port in fluid communication with the extension tube, the vented access port spaced apart from the connection port [the vent path 126 can be sealed at one end by a plug 128. The plug 128 can be made out of an air permeable, hydrophilic material that enables the passage of air, but inhibits the passage of liquid (Langdell ¶0042, Figs. 1A-C); the plug 128 can be operably coupled to an extension tube 130, which can be operably coupled to the distal end of the first proximal portion, (as depicted in FIG. 1C) (Langdell ¶0043, Fig. 1C), wherein the portion of the extension tube 130 connected to the plug 128 is considered to define a vented access port];
an integrated catheter operatively connected to the body to direct a biological fluid into the body [The fluid conduit 106 can include a distal portion 108 (Langdell ¶0038, Fig. 1A); The distal portion 108 can include an inlet port 114 configured to be fluidly coupled to vasculature of a patient. For example, in one embodiment, the inlet port 114 can be in fluid communication with a catheter assembly 116. The catheter assembly 116 can include a catheter hub 118 and a catheter tube 120 (Langdell ¶0039, Fig. 1A)]; and
a distal access port defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container [The fluid conduit 106 can include… a second proximal portion 112 (Langdell ¶0038, Figs. 1A-C), wherein the Examiner notes that “distal” and “proximal” are considered relative and non-limiting in terms of structure; The second proximal portion 112 can define a fluid path and an outlet port 132 configured to be fluidly coupled to a blood collection device 134 (Langdell ¶0046, Fig. 1A)], wherein the connection port is positioned between the integrated catheter and the distal access port [See Annotated Fig. 2];
wherein an initial biological fluid volume of the biological fluid directed through the body is directed into the extension tube via the connection port and into the vented access port [The first proximal portion 110 can define a sequestration chamber 124 configured to isolate an initial quantity of blood during the collection of a blood sample for blood culture analysis. For example, in one embodiment, blood from the vasculature of the patient under normal pressure can flow into and fill the sequestration chamber 124, thereby displacing a quantity of gas initially trapped within the sequestration chamber 124 (Langdell ¶0041)].
However, Langdell fails to explicitly disclose the distal access port being positioned in-line with the body.
Burkholz ‘948 discloses an integrated catheter assembly comprising an integrated catheter operatively connected to a body for blood sampling [See catheter system 10 of Burkholz ‘948 Fig. 1B, which includes catheter adapter 12 and catheter 14 (integrated catheter) and Y-adapter 24 (body)], wherein the body comprises a connection port defined in a distal end of the body [a second connector 42 coupled to the second arm 30 (Burkholz ‘948 ¶0038, Fig. 1B)], a distal access port defined in the body, the distal access port being positioned in-line with the body [a first connector 40 coupled to the first arm 28 (Burkholz ‘948 ¶0038, Fig. 1B)], and a vented access port in fluid communication with the connection port to allow for venting of the integrated catheter assembly prior to blood collection [the catheter system 10 may further include a vent cap 44, which may be coupled to the second arm 30 (Burkholz ‘948 ¶0039, Fig. 1B); when collection of one or more blood samples is desired using the catheter system 10, the catheter system 10 may not be primed or connected to the IV line 46. In these and other embodiments, the vent cap 44 may be actuated to allow blood to fill the unprimed catheter system 10 by venting the second arm 30 to which the vent cap 44 may be attached. In some embodiments, after the catheter 14 is inserted into the vein and blood fills the extension tubing, the vent cap 44 may be removed, and a blood collection device (such as, for example, a vacuum tube holder, syringe, or another device) may be attached to the first arm 28 or second arm 30 to collect the blood samples via the blood collection device (Burkholz ‘948 ¶0048)]. Burkholz ‘948 further discloses that the first arm 28 and the second arm 30 may refer to either/or of the central arm and the side arm of the Y-adapter [In some embodiments, the first arm 28 may correspond to a central arm of the Y-adapter 24, as illustrated in FIG. 1A. In these embodiments, the second arm 30 may correspond to a side arm of the Y-adapter 24, as illustrated in FIG. 1A. Conversely, in some embodiments, the first arm 28 may correspond to the side arm of the Y-adapter 24 and the second arm 30 may correspond to the central arm of the Y-adapter 24 (Burkholz ¶¶0034)].
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 the integrated catheter assembly of Langdell to employ the distal access port being positioned in-line with the body, as this modification would amount to mere application of a known technique to a known device (method, or product ready for improvement to yield predictable results [use of the port of the “side”/angled arm of a Y-adapter for venting and use of the port of the “central”/in-line arm of the Y-adapter for blood collection] [MPEP § 2143(I)(D)]. The Examiner notes that the modification of Langdell in view of Burkholz ‘948 is still considered to teach the limitation “wherein the connection port is positioned between the integrated catheter and the distal access port” based on Burkholz ‘948 Fig. 1B depicting the second/side arm 30 being disposed between the first/central arm 28 and the distal end 26 [Burkholz ‘948 Fig. 1B].
Regarding claim 11, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10, wherein a portion of the biological fluid is directed into the removable sample collection container after the initial biological fluid volume is directed into the vented access port [a smooth flow of blood past an opening into the sequestration chamber 124 and into the second proximal portion 112, once the sequestration chamber 124 has been filled with the initial quantity of blood for isolation (Langdell ¶0048)].
Regarding claim 12, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10, further comprising the removable sample collection container in fluid communication with the distal access port [Langdell ¶0046, Fig. 1A].
Regarding claim 13, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 12, wherein the removable sample collection container is a blood culture sample collection tube [Langdell ¶0046, Fig. 1A].
Regarding claim 14, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10, further comprising a catheter adapter, wherein the integrated catheter is operatively connected to the body via the catheter adapter [Langdell ¶0039].
Regarding claim 16, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10, further comprising a luer adaptor, wherein the vented access port is integrated with the luer adaptor [Langdell ¶0043, Fig. 1A].
Regarding claim 17, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 16, further comprising a vent plug integrated with at least one of the luer adapter and the vented access port [Langdell ¶0043, Fig. 1A].
Regarding claim 19, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10, further comprising a luer lock access device fluidically connected to the distal access port [Langdell ¶0046, Fig. 1A].
Regarding claim 21, Langdell teaches
A method of collecting a biological fluid sample, the method comprising:
providing an integrated catheter connected to a body defining a channel to direct a biological fluid therethrough [a body member 102 having an interior wall 104 defining a generally “Y” shaped fluid conduit 106 (Langdell ¶0038, Figs. 1A-C)], a connection port defined in a distal end of the body [The fluid conduit 106 can include… a first proximal portion 110 (Langdell ¶0038, Figs. 1A-C), wherein the Examiner notes that “distal” and “proximal” are considered relative and non-limiting in terms of structure], in which an extension tube is fluidly coupled to the connection port [an extension tube 130, which can be operably coupled to the distal end of the first proximal portion, (as depicted in FIG. 1C) (Langdell ¶0043, Fig. 1C)], a vented access port in fluid communication with the extension tube, the vented access port spaced apart from the connection port [the vent path 126 can be sealed at one end by a plug 128. The plug 128 can be made out of an air permeable, hydrophilic material that enables the passage of air, but inhibits the passage of liquid (Langdell ¶0042, Figs. 1A-C); the plug 128 can be operably coupled to an extension tube 130, which can be operably coupled to the distal end of the first proximal portion, (as depicted in FIG. 1C) (Langdell ¶0043, Fig. 1C), wherein the portion of the extension tube 130 connected to the plug 128 is considered to define a vented access port], and a distal access port defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container [The fluid conduit 106 can include… a second proximal portion 112 (Langdell ¶0038, Figs. 1A-C), wherein the Examiner notes that “distal” and “proximal” are considered relative and non-limiting in terms of structure; The second proximal portion 112 can define a fluid path and an outlet port 132 configured to be fluidly coupled to a blood collection device 134 (Langdell ¶0046, Fig. 1A)], wherein the connection port is positioned between the integrated catheter and the distal access port [See Annotated Fig. 2];
receiving an initial volume of the biological fluid in the integrated catheter [The first proximal portion 110 can define a sequestration chamber 124 configured to isolate an initial quantity of blood during the collection of a blood sample for blood culture analysis. For example, in one embodiment, blood from the vasculature of the patient under normal pressure can flow into and fill the sequestration chamber 124, thereby displacing a quantity of gas initially trapped within the sequestration chamber 124 (Langdell ¶0041)];
directing the initial volume of the biological fluid through the connection port and into the extension tube fluidly connected to the connection port [the oblique angle of the second proximal portion 110 can enable a smooth flow of blood past an opening into the sequestration chamber 124 and into the second proximal portion 112, once the sequestration chamber 124 has been filled with the initial quantity of blood for isolation (Langdell ¶0048)];
venting air from the initial volume of the biological fluid through vented access port operatively connected to the extension tube [Langdell ¶0041];
and occluding the extension tube [wherein the sequestration chamber 124 structurally being defined by the extension tube 130 (see Langdell ¶0043) being filled with blood is considered to “occlude” the extension tube from further blood flow through the extension tube, based on the broadest reasonable interpretation of “occlude” meaning “to block off” (see https://www.merriam-webster.com/dictionary/occlude)].
However, Langdell fails to explicitly disclose the distal access port being positioned in-line with the body.
Burkholz ‘948 discloses an integrated catheter assembly comprising an integrated catheter operatively connected to a body for blood sampling [See catheter system 10 of Burkholz ‘948 Fig. 1B, which includes catheter adapter 12 and catheter 14 (integrated catheter) and Y-adapter 24 (body)], wherein the body comprises a connection port defined in a distal end of the body [a second connector 42 coupled to the second arm 30 (Burkholz ‘948 ¶0038, Fig. 1B)], a distal access port defined in the body, the distal access port being positioned in-line with the body [a first connector 40 coupled to the first arm 28 (Burkholz ‘948 ¶0038, Fig. 1B)], and a vented access port in fluid communication with the connection port to allow for venting of the integrated catheter assembly prior to blood collection [the catheter system 10 may further include a vent cap 44, which may be coupled to the second arm 30 (Burkholz ‘948 ¶0039, Fig. 1B); when collection of one or more blood samples is desired using the catheter system 10, the catheter system 10 may not be primed or connected to the IV line 46. In these and other embodiments, the vent cap 44 may be actuated to allow blood to fill the unprimed catheter system 10 by venting the second arm 30 to which the vent cap 44 may be attached. In some embodiments, after the catheter 14 is inserted into the vein and blood fills the extension tubing, the vent cap 44 may be removed, and a blood collection device (such as, for example, a vacuum tube holder, syringe, or another device) may be attached to the first arm 28 or second arm 30 to collect the blood samples via the blood collection device (Burkholz ‘948 ¶0048)]. Burkholz ‘948 further discloses that the first arm 28 and the second arm 30 may refer to either/or of the central arm and the side arm of the Y-adapter [In some embodiments, the first arm 28 may correspond to a central arm of the Y-adapter 24, as illustrated in FIG. 1A. In these embodiments, the second arm 30 may correspond to a side arm of the Y-adapter 24, as illustrated in FIG. 1A. Conversely, in some embodiments, the first arm 28 may correspond to the side arm of the Y-adapter 24 and the second arm 30 may correspond to the central arm of the Y-adapter 24 (Burkholz ¶¶0034)].
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 the integrated catheter provided in the method of Langdell to employ the distal access port being positioned in-line with the body, as this modification would amount to mere application of a known technique to a known device (method, or product ready for improvement to yield predictable results [use of the port of the “side”/angled arm of a Y-adapter for venting and use of the port of the “central”/in-line arm of the Y-adapter for blood collection] [MPEP § 2143(I)(D)]. The Examiner notes that the modification of Langdell in view of Burkholz ‘948 is still considered to teach the limitation “wherein the connection port is positioned between the integrated catheter and the distal access port” based on Burkholz ‘948 Fig. 1B depicting the second/side arm 30 being disposed between the first/central arm 28 and the distal end 26 [Burkholz ‘948 Fig. 1B].
Regarding claim 22, Langdell in view of Burkholz ‘948 teaches
The method of claim 21, further comprising collecting a subsequent volume of biological fluid from the catheter extension set and into a blood culture sample collection tube [Langdell ¶0048].
Claim(s) 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langdell, as applied to claims 2 and 14 above, in view of Burkholz (US-20180161543-A1, previously presented), hereinafter Burkholz ‘543 [previously referred to as “Burkholz”].
Regarding claim 3, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 2.
However, Langdell in view of Burkholz ‘948 fails to explicitly disclose further comprising a stabilization platform operatively connected to the catheter adapter to stabilize the integrated catheter on a desired surface.
Burkholz ‘543 discloses catheter systems for withdrawing fluids from a patient, wherein Burkholz ‘543 discloses a stabilization platform operatively connected to a catheter adapter to stabilize an integrated catheter on a desired surface [a catheter securement dressing 1 is shown. The catheter securement dressing 1 can comprise a first dressing layer 10. The first dressing layer 10 can comprise a first overlap portion 12 at a first end. The first dressing layer 10 can also comprise an access window 14 configured to permit access to a catheter insertion site. The first dressing layer 10 can include an adhesive layer 16 on a bottom contact side of the first dressing layer 10 for contact and adhesion with a skin surface of a patient (Burkholz ‘543 ¶0022, Figs. 1-3); The first dressing layer 10 can then be pressed onto the skin of the patient so that adhesive layer 16 attaches the bottom portion of the first dressing layer 10 to the skin of the patient 3 to secure the catheter 2 to the patient 3 (Burkholz ‘543 ¶0034)].
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 the integrated catheter assembly of Langdell in view of Burkholz ‘948 to employ a stabilization platform operatively connected to the catheter adapter to stabilize the integrated catheter on a desired surface, so as to secure the integrated catheter to a patient and prevent unintentional dislodging of the catheter [More specifically, this disclosure discusses methods and systems for securing a catheter at a catheter insertion site to permit a clinician to apply skin adhesive to the catheter insertion site while reducing the risk of dislodging the catheter during application, allowing for efficient application of the skin adhesive, and reducing the use of excess adhesive (Burkholz ‘543 ¶0004)].
Regarding claim 15, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 14.
However, Langdell in view of Burkholz ‘948 fails to explicitly disclose further comprising a stabilization platform operatively connected to the catheter adapter to stabilize the integrated catheter on a desired surface.
Burkholz ‘543 discloses catheter systems for withdrawing fluids from a patient, wherein Burkholz discloses a stabilization platform operatively connected to a catheter adapter to stabilize an integrated catheter on a desired surface [Burkholz ‘543 ¶¶0022, 0034, Figs. 1-3].
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 the integrated catheter of Langdell in view of Burkholz ‘948 to employ a stabilization platform operatively connected to the catheter adapter to stabilize the integrated catheter on a desired surface, so as to secure the integrated catheter to a patient and prevent unintentional dislodging of the catheter [Burkholz ‘543 ¶0004].
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langdell in view of Burkholz ‘948, as applied to claims 1 and 10 above, in further view of Bischof (US-6126618-A, previously presented).
Regarding claim 7, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 1.
However, while Langdell does disclose the use of a clamping member to occlude a portion of a tube downstream from a fluid flow path [the blood collection device 134 can include a clamp 140 configured to occlude the extension tube 138 and/or inhibit the venting of an initial quantity of gas present in the second proximal portion 112 and portions of the blood collection device 134, such that a natural pressure of the trapped gas within the second proximal portion 112 inhibits a flow of blood into the second proximal portion 112 (Langdell ¶0047, Fig. 1A)], Langdell in view of Burkholz ‘948 fails to explicitly disclose further comprising a clamping member 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.
Bischof discloses systems for withdrawing fluids from a patient, wherein Bischof discloses the use of a clamping member to occlude a first fluid path to divert blood flow into a second fluid path [The illustrated disposable set 10 may include a needle such as venipuncture needle 12, and a length of plastic tubing 14 extending from needle 12 to a collection container such as a flexible plastic bag 16 (Bischof Col 4:3-6, Fig. 1); Referring first to FIG. 3, sampling vial 20 is inserted into the interior 42 of receptacle 40 so that cap 48 of vial 20 is pierced by the second piercing end 38 of piercing member 34, as shown in FIG. 4. Next, the entire vial with receptacle is moved forward by adjusting the length of sleeve 32. As shown, for example, in FIGS. 4 and 5, vial 20 with receptacle 40 is moved forward by compressing length adjustable sleeve 32. As length adjustable sleeve 32 is compressed, end 36 of piercing member 34 penetrates access site 23 as substantially shown in FIG. 4... In any event, continued translational movement of the vial and receptacle toward the access site 23 causes further penetration of the piercing member through the barrier and into the flow path 22 of the housing 18 (Bischof Col 5:61-6:10, Figs. 3-5); During collection of the blood sample, it may be desirable to clamp off tubing 14 near container 16 and divert the blood as described above (Bischof Col 6:15-17)].
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 the integrated catheter assembly of Langdell in view of Burkholz ‘948 to employ a clamping member 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, so as to facilitate fluid flow into the distal access port [Bischof Col 6:15-17].
Regarding claim 18, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10.
However, while Langdell does disclose the use of a clamping member to occlude a portion of a tube downstream from a fluid flow path [Langdell ¶0047, Fig. 1A], Langdell in view of Burkholz ‘948 fails to explicitly disclose further comprising a clamping member 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.
Bischof discloses systems for withdrawing fluids from a patient, wherein Bischof discloses the use of a clamping member to occlude a first fluid path to divert blood flow into a second fluid path [Bischof Col 4:3-6, Fig. 1; Col 5:61-6:10, Figs. 3-5; Col 6:15-17].
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 the integrated catheter of Langdell in view of Burkholz ‘948 to employ a clamping member 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, so as to facilitate fluid flow into the distal access port [Bischof Col 6:15-17].
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langdell in view of Burkholz ‘948, as applied to claims 1 and 10 above, in view of Burkholz (US-20120016213-A1, previously presented), hereinafter Burkholz ‘213 [previously referred to as “Burkholz II”].
Regarding claim 9, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 1.
However, while Langdell is considered to disclose the use of luer connectors for the vented access port [Langdell ¶0043], Langdell in view of Burkholz ‘948 fails to explicitly disclose wherein the vented access port comprises a dual port luer adaptor operatively connected to an end of the extension tube opposite the connection port.
Burkholz ‘213 discloses catheter systems for withdrawing fluids from a patient, wherein Burkholz ‘213 discloses a vented access port [Luer access port 86 (Burkholz ‘213 Figs. 5-6); the venting device 30 can be inserted into a closed access port having a septum 88 with a slit 90 therein. When inserted through the slit 90 of the septum 88, small channels can remain at least partially open, forming a vent across the septum 88 (Burkholz ‘213 ¶0041, Fig. 7B)] coupled to a connection port of a body [Y adapter 80 having two ports 82 (Burkholz ‘213 ¶0037, Fig. 5)], wherein the vented access port comprises a dual port luer adaptor operatively connected to an end of the connection port [wherein as depicted in Burkholz ‘213 Figs. 5-7B, each side of the Luer access port 86 (considered to be equivalent to the claimed vented access port) comprises a luer-type connector].
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 the integrated catheter assembly of Langdell in view of Burkholz ‘948 to employ wherein the vented access port comprises a dual port luer adaptor operatively connected to an end of the extension tube opposite the connection port, as this modification would amount to merely applying a known technique [luer-type connections] to a known device ready for improvement to yield predictable results [allow for connection with other devices using luer-type connectors] [MPEP § 2143(I)(D)].
Regarding claim 20, Langdell in view of Burkholz ‘948 teaches
The integrated catheter assembly of claim 10.
However, while Langdell is considered to disclose the use of luer connectors for the vented access port [Langdell ¶0043], Langdell in view of Burkholz ‘948 fails to explicitly disclose wherein the vented access port comprises a dual port luer adaptor operatively connected to an end of the extension tube opposite the connection port.
Burkholz ‘213 discloses catheter systems for withdrawing fluids from a patient, wherein Burkholz ‘213 discloses a vented access port [Luer access port 86 (Burkholz ‘213 ¶0041, Figs. 5-6, 7B] coupled to a connection port of a body [Y adapter 80 having two ports 82 (Burkholz ‘213 ¶0037, Fig. 5)], wherein the vented access port comprises a dual port luer adaptor operatively connected to an end of the connection port [wherein as depicted in Burkholz ‘213 Figs. 5-7B, each side of the Luer access port 86 (considered to be equivalent to the claimed vented access port) comprises a luer-type connector].
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 the integrated catheter assembly of Langdell in view of Burkholz ‘948 to employ wherein the vented access port comprises a dual port luer adaptor operatively connected to an end of the extension tube opposite the connection port, as this modification would amount to merely applying a known technique [luer-type connections] to a known device ready for improvement to yield predictable results [allow for connection with other devices using luer-type connectors] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 18 August 2026, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 1, 10, and those dependent therefrom under § 112(b) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-8, with respect to the rejection(s) of claim(s) 1, 10, 21, and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Langdell (US-20190374144-A1, previously presented) in view of Burkholz ‘948 (US-20200046948-A1).
The Applicant asserts that the amended limitation of claims 1, 10, and 21 wherein “the distal access port being positioned in-line with the body” fails to be disclosed or suggested by Langdell, as the Applicant notes that in the previously presented interpretation of Langdell, the second proximal portion 112 (equated to the claimed distal access port) is not positioned in-line with the body member 102 (equated to the claimed body), and instead the second proximal portion 112 extends at an angle relative to the body member 102, and the first proximal portion 110 is positioned in-line with the body member 102. The Applicant further notes that Burkholz, Bischof, Burkholz II, and the cited prior art of record fail to correct the deficiencies of Langdell. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 10, and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 1, 10, and 21 are each rejected under § 103 as being obvious over Langdell (US-20190374144-A1, previously presented) in view of Burkholz ‘948 (US-20200046948-A1), as the Examiner notes that Burkholz ‘948 discloses a distal access port of a body being positioned in-line with the body as claimed [See structural position and functionality of each of the first connector 40 coupled to the first arm 28 and second connector 42 coupled to the second arm 30 (Burkholz ‘948 ¶¶0038-0039, Fig. 1B)].
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
