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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31 March 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 10, and 21 [the Examiner notes that claim 11 was disclosed as having been amended in the Applicant’s Remarks p. 6, filed 31 March 2026, however no amendments are present in claim 11]. Claims 1-22 are pending.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 10, and those dependent therefrom is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “an integrated catheter operatively connected to the body” [line 10], which is considered indefinite, as it is not clear whether the presently recited integrated catheter is meant to refer to the same integrated catheter as recited in the preamble [“An integrated catheter, comprising…” (line 1)], such that the indefinite limitation should read “[[an]] the integrated catheter, wherein the integrated catheter is operatively connected to the body” or whether the preamble is meant to recite “An integrated catheter system” / “An integrated catheter device” / “An integrated catheter assembly” [as the Examiner notes that claim 1 recites additional elements coupled to an integrated catheter, as opposed to elements of an integrated catheter]. For examination purposes, the Examiner has interpreted claim 1 to define an integrated catheter system/device comprising an integrated catheter operatively connected to the body. The Examiner notes that if the preamble of claim 1 is amended to recite “system” / “device” / “assembly”, all claims that are dependent from claim 1 should be amended accordingly. The Examiner notes that claim 10 is considered to recite similarly indefinite subject matter [see claim 10 preamble and line 7].
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6, 8, 10-14, 16-17, 19, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Langdell (US-20190374144-A1, previously presented).
Regarding claim 1, Langdell teaches
An integrated catheter, 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].
Regarding claim 2, Langdell teaches
The integrated catheter 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 teaches
The integrated catheter 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 teaches
The integrated catheter 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 teaches
The integrated catheter 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 teaches
The integrated catheter of claim 1, further comprising a luer lock access device fluidically connected to the distal access port [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, 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)].
Regarding claim 11, Langdell teaches
The integrated catheter 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 [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)].
Regarding claim 12, Langdell teaches
The integrated catheter 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 teaches
The integrated catheter of claim 12, wherein the removable sample collection container is a blood culture sample collection tube [Langdell ¶0046, Fig. 1A].
Regarding claim 14, Langdell teaches
The integrated catheter 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 teaches
The integrated catheter 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 teaches
The integrated catheter 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 teaches
The integrated catheter 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 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], 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;
directing the initial volume of the biological fluid through the connection port and into the extension tube fluidly connected to the connection 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)];
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 [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), 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)].
Regarding claim 22, Langdell 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 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) 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).
Regarding claim 3, Langdell teaches
The integrated catheter of claim 2.
However, Langdell 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 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 [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 ¶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 ¶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 of Langdell 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 ¶0004)].
Regarding claim 15, Langdell teaches
The integrated catheter of claim 14.
However, Langdell 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 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 ¶¶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 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 ¶0004].
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langdell, as applied to claims 1 and 10 above, in view of Bischof (US-6126618-A, previously presented).
Regarding claim 7, Langdell teaches
The integrated catheter 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 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 of Langdell 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 teaches
The integrated catheter 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 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 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, as applied to claims 1 and 10 above, in view of Burkholz (US-20120016213-A1, previously presented), hereinafter Burkholz II.
Regarding claim 9, Langdell teaches
The integrated catheter of claim 1.
However, while Langdell is considered to disclose the use of luer connectors for the vented access port [Langdell ¶0043], Langdell 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 II discloses catheter systems for withdrawing fluids from a patient, wherein Burkholz II discloses a vented access port [Luer access port 86 (Burkholz 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 II ¶0041, Fig. 7B)] coupled to a connection port of a body [Y adapter 80 having two ports 82 (Burkholz II ¶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 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 of Langdell 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 teaches
The integrated catheter of claim 10.
However, while Langdell is considered to disclose the use of luer connectors for the vented access port [Langdell ¶0043], Langdell 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 II discloses catheter systems for withdrawing fluids from a patient, wherein Burkholz II discloses a vented access port [Luer access port 86 (Burkholz Figs. 5-6); Burkholz II ¶0041, Fig. 7)] coupled to a connection port of a body [Y adapter 80 having two ports 82 (Burkholz II ¶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 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 of Langdell 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. 6-8, filed 31 March 2026, have been fully considered but they are not persuasive.
Regarding claims 1, 10, and 21, the Applicant asserts that Langdell fails to disclose a connection port positioned between an integrated catheter and a distal access port, wherein the Applicant notes that the previously presented interpretation of Langdell teaches a distal access port [second proximal portion 112] positioned between an integrated catheter [catheter assembly 116] and a connection port [first proximal portion 110], which the Applicant further notes would require clamping the extension tube connected to the second proximal portion 112 to direct an initial biological fluid sample into the first proximal portion 110. However, the Examiner disagrees with the Applicant’s argument, wherein the Examiner presents Annotated Fig. 2 to clearly visualize the Examiner’s interpretation of Langdell, which is considered to anticipate the argued amended subject matter regarding the connection being positioned between the integrated catheter and the distal access port. The Examiner notes that as Langdell defines a “Y” shaped body 102, the first proximal portion 110 is depicted as branching out from a position that is between the integrated catheter [catheter assembly 116] and the distal access port [second proximal portion 112]. The Examiner further notes that in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “without clamping the extension tube connected to the second proximal portion 112”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
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
Prosecution Insights