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
The amendment filed January 15th 2026 has been entered. Claims 1 and 3-18 are pending in the application.
Claim Objections
Claim 8 is objected to because of the following informalities: Regarding claim 8, “a body” should be corrected to “the body” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blanchard (US 20200078564 A1).
Regarding claim 1, Blanchard discloses an integrated intravenous catheter (catheter assembly 30, [0040] & Fig. 2A-2B) comprising: a catheter adapter comprising a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature (catheter adapter 32 comprising catheter 40 and side port 38, abstract and [0040] & Fig. 2A-2B);
a needle-free connector comprising a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port (first connector 48 including a third port 64, which is being interpreted as the first port, a second port 52, and a first port 50, which is being interpreted as the side port, [0046]-[0047] & Fig. 2A-2B and 6A), the second port comprising a valve member (“one or more of the first port 50, the second port 52, and the third port 64 may be coupled to a needleless connector, such as, for example, the Becton Dickinson SMARTSITE™ needle-free valve, or another suitable needleless connector”, [0049] & Fig. 2A-2B),
wherein the needle-free connector comprises a body defining a first flow path extending between the first port and the second port (connector 48 comprises a body defining a fluid pathway between port 64 and port 52 for fluid injections, see [0041] and [0060]-[0061] & Fig. 2A-2B, 4A, and 7A-7B; annotated below in Fig. 7A as “1st Fluid Path”), and wherein the side port defines a second flow path extending from the side port into the body of the needle-free connector (first port 50 defines a second flow path extending from port 50 into the body of connector 48, [0041] and [0044] & Fig. 2A-2B, 4A, and 7A-7B; annotated below in Fig. 7A as “2nd Fluid Path”), wherein a center of the second flow path is offset from a center of the first flow path such that the center of the second flow path does not intersect the center of the first flow path (a center of the second flow path, annotated below in Fig. 7A as “2nd Center” of the “2nd Flow Path”, is illustrated as offset from a center of the first flow path, annotated below in Fig. 7A as “1st Center” of the “1st Flow Path”, such that the center of the second flow path does not intersect the center of the first flow path – the center of the second flow path is distal to the center of the first flow path);
intermediate tubing extending between the inlet of the catheter adapter and the first port of the needle-free connector (first extension tube 42 extending between side port 38 of catheter adapter 32 and port 64 of connector 48, [0041] and [0047] & Fig. 2A-2B and 6A); and extension tubing extending from the side port of the needle-free connector (second extension tube 54 extending from port 50 of connector 48, [0042] & Fig. 2A-2B).
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Regarding claim 3, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter wherein a length of the intermediate tubing is shorter than a length of the extension tubing (“the second extension tube 54 may be longer than the first extension tube 42”, [0042] & Fig. 2A-2B).
Regarding claim 4, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter wherein the intermediate tubing has a length configured to allow a probe of a blood draw device to extend a predetermined length beyond a tip of the catheter (“the first connector 48 and/or the second port 52 may be disposed in proximity to the catheter adapter 32 and the catheter 40 to improve access for an instrument… the instrument may include an additional catheter for fluid infusion or blood draw, a guidewire… a length of the first extension tube 42 may be about 12 millimeters. In some embodiments, the length of the first extension tube 42 may be between about 11 and 13 millimeters… The length of the first extension tube 42 may vary, according to some embodiments.”, [0041] & Fig. 2A-2B; length of tube 42 is configured to allow an instrument 80, which may be a catheter, or probe, configured for blood withdrawal, to extend beyond the tip of catheter 40, [0060] & Fig. 2A-2B, 3A, and 4A; “The devices, systems, and methods of the present disclosure may also be used for blood withdrawal”, [0006]).
Regarding claim 5, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter further comprising a medical component positioned at an end of the extension tubing (second connector 60 coupled to the proximal end 56 of tube 54, [0042] & Fig. 2A-2B).
Regarding claim 6, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter wherein the intermediate tubing is fixedly connected to the inlet of the catheter adapter and the first port of the needle-free connector (connector 48, through port 64, may be permanently coupled to tube 42, [0047] and [0050] & Fig. 2A-2B; “the distal end 46 of the first extension tube 42 may be permanently… coupled to the catheter adapter 32.”, [0054] & Fig. 2A-2B).
Regarding claim 7, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter wherein the first port of the needle-free connector is connected to the intermediate tubing via a line connector (connector 48 may be connected to tube 42 via snap mechanism 102, which is being interpreted as a line connector, [0065] & Fig. 7A-7B; “the first port 50, the second port 52, and the third port 64 of the first connector 48 may include any suitable type of coupling mechanism.”, [0047]).
Regarding claim 8, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter wherein the needle-free connector comprises a body defining a longitudinal axis extending between the first port and the second port (connector 48 comprises a body defining a longitudinal axis between ports 64 and 52, [0042] & Fig. 2A-2B, 4A, and 7A), and wherein the side port extends from the body at an angle of 30-150 degrees relative to the longitudinal axis of the body (“the first port 50 may be disposed at an angle of less than 90° with respect to the second port 52, as illustrated, for example, in FIG. 2A. In further detail, in some embodiments, the first port 50 may be disposed at an angle between 45° and 90° with respect to the second port 52”, [0043]-[0044] & Fig. 2A-2B and 4A).
Regarding claim 10, Blanchard discloses all the limitations of claim 1. Blanchard further discloses the integrated intravenous catheter wherein at least a portion of the needle-free connector is transparent (“the first connector 48… may be transparent,”, [0056]).
Claim(s) 9 and 11 is rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1) as applied to claim 1 above, and further in view of Burkholz (US 20190021640 A1).
Regarding claim 9, Blanchard discloses all the limitations of claim 8. However, Blanchard fails to explicitly disclose the integrated intravenous catheter wherein the body of the needle-free connector comprises a first portion and a second portion connected to the first portion via a luer connector.
However, Burkholz teaches an integrated intravenous catheter (catheter assembly 14, [0040] & Fig. 1A/B) wherein the body of the needle-free connector (the body of adapter 32 and coupling mechanism 30, [0049] & Fig. 1B) comprises a first portion and a second portion connected to the first portion via a luer connector (adapter 32, which is being interpreted as a first portion, is coupled to mechanism 30, which is being interpreted as a second portion, via a luer connection, [0048]-[0049] & Fig. 1A-1C).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the body of the needle-free connector of Blanchard with Burkholz to include a first portion and a second portion connected to the first portion via a luer connector since such a modification would provide structure to facilitate connection to additional medical devices, such as a needle-free blood probe, an additional catheter, or a removable needle-free connector (see [0013], [0041], and [0048]-[0050] of Burkholz).
Regarding claim 11, Blanchard discloses all the limitations of claim 1. However, Blanchard fails to explicitly disclose the integrated intravenous catheter wherein the needle-free connector comprises an anti-reflux valve.
However, Burkholz teaches an integrated intravenous catheter (catheter assembly 14, [0040] & Fig. 1A/B) wherein the needle-free connector (adapter 32 and coupling mechanism 30, [0049] & Fig. 1B) comprises an anti-reflux valve (adapter 32 may include a blood control valve, [0049], this valve is being interpreted as an anti-reflux valve; alternatively, coupling mechanism 30 may include at least one valve which may be interpreted as an anti-reflux valve, [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the needle-free connector of Blanchard with Burkholz to include an anti-reflux valve since such a modification would “facilitate maintenance of the closed system and prevent blood leakage” or prevent fluid from the catheter from entering upstream components of the catheter assembly, like a blood collection device (see [0049]-[0050] of Burkholz).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1) as applied to claim 1 above, and further in view of Bihlmaier (US 20190091462 A1).
Regarding claim 12, Blanchard discloses all the limitations of claim 1. However, Blanchard fails to explicitly disclose the integrated intravenous catheter wherein the needle-free connector comprises internal structure configured to create a vortex when fluid enters the needle-free connector via the side port.
However, Bihlmaier teaches a catheter adapter 201 with a side port 204 that includes an internal flow diverting protrusion 210a that can be curved in a spiral to impart a spiraling pattern to the resulting eddy from fluid flowing through side port 204 (see [0026]-[0030] & Fig. 2B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the internal structure of the needle-free connector of Blanchard with Bihlmaier to include the internal flow diverting protrusion since such a modification would “minimize the amount of residual blood, medicament, or other fluid that may exist within the catheter adapter” and yield predictable results pertaining to flushing efficiency (see [0005] and [0028] of Bihlmaier).
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 20200078564 A1) as applied to claim 1 above, and further in view of Funk (US 20190160275 A1).
Regarding claims 13-15, Blanchard discloses all the limitations of claim 1. However, Blanchard fails to explicitly disclose the integrated intravenous catheter wherein the needle-free connector comprises a stabilization member, wherein the stabilization member is formed either integrally with the needle-free connector or separately, configured to contact a skin surface of a patient during use of the integrated intravenous catheter.
However, Funk teaches an integrated intravenous catheter wherein a needle-free connector (coupler 215 and 220, of stabilizing connector 200, may both be needle free connectors, [0055] & Fig. 2 and 3) comprises a stabilization member, wherein the stabilization member is formed integrally with the needle-free connector (see [0036]), configured to contact a skin surface of a patient (stabilization portion 230 is configured to contact the skin of a patient, see [0056]) during use of the integrated intravenous catheter (stabilizing connector 200 is configured for use with a catheter, (see [0005]-[0006], [0041], and [0056]).
However, the embodiment of Figures 2-3 does not explicitly disclose the stabilization member separately connected to the needle-free connector. However, the embodiment of Figures 16-19 teaches the stabilization portion 430 formed separately from the connector portion 410 (see [0090]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Blanchard with Funk to include the needle-free connector comprising a stabilization member since such a modification would minimize movement of a placed or indwelling catheter and yield predictable results pertaining to device stabilization (see [0006], [0041], and [0054] of Funk).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the stabilization member 230 separately connected to connector 200, as taught in the alternate embodiment of Figures 16-19, since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Further, the Applicant is advised that patentability of a product does not depend on its method of production. If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Response to Arguments
In response to Applicant's arguments that the Examiner did not fully respond to arguments directed toward the new limitation of “…wherein the side port is offset from a center of the flow path such that a center of the side port does not intersect the center of the flow path”, the Examiner finds that the limitation was a new limitation that was rejected with a new teaching, and a new annotated figure, which rendered the arguments directed toward this new limitation moot. The new ground of rejection did not rely on any reference applied in the prior rejection for any teaching specifically challenged in the argument.
Applicant’s arguments with respect to the claims 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Burkholz ‘599 (US 20190321599 A1). Burkholz ‘599 teaches a two-piece needle-free connector 30 with an anti-reflux valve 38 ([0040]-[0042] & Fig. 1A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783