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 .
Claim Objections
Claims 2, 9 and 10 is/are objected to due to the following informalities:
In claim 2, line 4-5 repeats the lines 15-16 from claim 1, and therefore should be removed since it is repetitive.
In claim 9, line 3, “fluid conduit” should be corrected to “the fluid conduit” for claim language consistency.
In claim 10, lines 3-4, “a predetermined separation force” should be corrected to “the predetermined separation force” for claim language consistency.
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) 1-16 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.
In claim 1, lines 8-9 recites the terms “the proximal coupler” and “the distal coupler”, however, claim 1 does not introduce these terms and therefore there is insufficient antecedent basis for these limitations of the claim. It is unclear if the Applicant intended for “the proximal coupler” and “the distal coupler” to refer to the proximal port and distal port previously introduced in claim 1, or introduce new “proximal” and “distal” couplers. For the sake of examination, “the proximal coupler” and “the distal coupler” is being interpreted to refer to the “proximal port” and “distal port” of claim 1. Applicant is therefore suggested to amend claim 1 to overcome rejection.
In claim 1, lines 2-14 set forth that the “fluid conduit” is a part of the “connector”, however lines 16-17 recite that the platform is “spaced from the connector and positioned along the fluid conduit”. If the fluid conduit is a part of the connector as required by lines 2-14, then the platform cannot be “spaced from the connector” as required by lines 16-17 when the platform is “positioned along the fluid conduit” as required by lines 16-17. It is unclear if the fluid conduit is intended to be a part of or separate from the catheter connector. The fluid conduit is being interpreted as being separate from the catheter; thus Applicant is suggested to add the term “and” after line 7, delete the term “and” from line 10, and reduce the indent for line 11 so that it is aligned with the indent of line 2 and line 15. Therefore Applicant is suggested to amend claim 1 to overcome rejection.
Claims 2-16 are rejected by virtue of their dependency on claim 1.
In claim 14, line 1 recites “further comprising a catheter hub and a catheter”. Claim 14 is dependent on claim 1, and claim 1 introduces “a hub of a catheter” in line 3. It is unclear if the Applicant intended for the “catheter hub” and “catheter” of claim 14 to refer to the “hub” and “catheter” of claim 1 or introduce new hub and catheter. For the sake of examination, the “catheter hub” and “catheter” of claim 14 is being interpreted to refer to the hub and catheter of claim 1. Therefore, Applicant is suggested to amend claim 14 to overcome rejection.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 2, 3, 4, 5, 6, 7, 8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20190321599 A1, herein Burkholz) and further in view of Jones et al. (US 20190160262 A1, herein Jones).
Regarding claim 1, Burkholz discloses a non-integrated vascular access system (catheter system 10 in Fig. 1B) comprising:
a connector (connector 34, extension tube 24 and connector 30 in Fig. 1B) having:
a distal port (distal end 26 in Fig. 1B) configured to be coupled to a hub (catheter adapter 12 in Fig. 1B; the distal end 26 of the extension tube 24 may be coupled to the proximal end 16 of the catheter adapter 12 via connector 34 [0041]) of a catheter (catheter 20 in Fig. 1B);
a proximal port (see proximal port in annotated Fig. 1B below);
a first lumen (pathway 41 in Fig. 1B) extending between the distal port and the proximal port (pathway 41 is located between distal end 26 and proximal port in annotated Fig. 1B below), the lumen being in fluid communication with a second lumen (lumen 18 in Fig. 1B; one or more of the following may form a straight pathway 41 for delivery of an instrument into the catheter system 10 and/or the vasculature: the lumen 18, the catheter 20, the connector 30, the extension tube 24, and the connector 34. The straight pathway 41 may be aligned with a longitudinal axis 42 of the catheter assembly 22. The straight pathway 41 may be unobstructed.) defined by the catheter when the distal port is coupled to the hub;
a side port arranged in the connector between the proximal coupler and the distal coupler (side port in connector 30, see annotated Fig. 1B), the side port configured to be in fluid communication with the first lumen (the catheter system 10 may include a second extension tube 44, which may be coupled to the extension tube 24 [0044]; see also fluid communication between pathway 41, sideport and extension tube 24 in annotated Fig. 1B); and
a fluid conduit (extension tube 44 in Fig. 1B) having a proximal end coupled to the side port and a distal end (see proximal and distal end of extension tube 44 in annotated Fig. 1B), the fluid conduit in fluid communication with the side port and configured to extend distally from the connector (extension tube 44 in connection with side port and extend distally from connector in Fig. 1B and 1J);
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Annotated Fig. 1B of Burkholz
However, Burkholz failed to explicitly disclose:
and a stabilization anchor platform spaced from the connector and positioned along the fluid conduit.
However, Jones teaches the tube stabilising device 20 includes a base member 210 and a tube retaining member 220 moveably attached to the base member 210 [0050; see also Fig. 3].
Jones further teaches that the tube stabilizing device 20 is positioned along a cannula 800 in the tube stabilizing assembly 1000 of Fig. 5.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz to include a stabilization anchor platform spaced from the connector and positioned along the fluid conduit as taught by Jones since a modification may enable the device of Burkholz to prevent accidental movement or dislodgement when used on patient [Jones, 0003]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 2, Burkholz as modified by Jones disclosed all limitations of claim 1. Burkholz further discloses further comprising:
a stabilization portion connected to the connector (stabilization features 54a and 54b located near connector 34 in Fig. 1D; the stabilization feature 54 may snap onto the connector 30 and/or the connector 34 [0055]; it can be understood that the stabilization features 54a and 54b are configured to be used with the catheter system 10 of Fig. 1B), the stabilization portion configured to be in contact with a patient (the stabilization feature 54 may include one or more platforms 55, which may be configured to contact the skin of the patient [0052]; the platforms 55 may each include an adhesive layer 56, which may be configured to contact the skin of the patient. In some embodiments, the adhesive layer 56 may be covered by a removable backing layer, which may be removed prior to securing the stabilization feature 54 to the patient [0057]); but failed to explicitly disclose:
and a stabilization anchor platform spaced from the connector and positioned along the fluid conduit.
However, Jones teaches the tube stabilising device 20 includes a base member 210 and a tube retaining member 220 moveably attached to the base member 210 [0050; see also Fig. 3].
Jones further teaches the tube stabilizing device 20 is positioned along a cannula 800 in the tube stabilizing assembly 1000 of Fig. 5. One of ordinary skill in the art may recognize that a stabilizing device positioned along a cannula can be configured to be positioned spaced away from the connector 34 and along the extension tube 44 in the device of Burkholz.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz to include and a stabilization anchor platform spaced from the connector and positioned along the fluid conduit as taught by Jones since such a modification may enable the device of Burkholz to prevent accidental movement or dislodgement when used on patient [Jones, 0003]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 3, Burkholz as modified by Jones disclosed all limitations of claim 1. However, Burkholz failed to explicitly disclose wherein the stabilization anchor platform comprises an attachment member configured to secure the stabilization anchor platform to a skin surface of a patient.
However, Jones teaches the tube stabilising device 20 of FIG. 3 may include an adhesive pad similar to the adhesive pad 350 of the tube stabilising device 30 of FIG. 4 [0064].
Jones further teaches the tube stabilising device may be attached to a patient using any means suitable of fixing the base member of the tube stabilising device relative to the patient. For example, the tube stabilising device may be strapped onto the patient or an adhesive may be applied to the tube stabilising device to attach the tube stabilising device to the patient [0065].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones to include wherein the stabilization anchor platform comprises an attachment member configured to secure the stabilization anchor platform to a skin surface of a patient as taught by Jones since such a modification may enable the device of Burkholz to prevent accidental movement or dislodgement when used on patient [Jones, 0003]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 4, Burkholz as modified by Jones disclosed all limitations of claim 3. Burkholz however failed to explicitly disclose wherein the attachment member comprises an adhesive pad.
However, Jones teaches the tube stabilising device 20 of FIG. 3 may include an adhesive pad similar to the adhesive pad 350 of the tube stabilising device 30 of FIG. 4 [0064].
Jones further teaches the tube stabilising device may be attached to a patient using any means suitable of fixing the base member of the tube stabilising device relative to the patient. For example, the tube stabilising device may be strapped onto the patient or an adhesive may be applied to the tube stabilising device to attach the tube stabilising device to the patient [0065].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones to include wherein the attachment member comprises an adhesive pad as taught by Jones since such a modification may enable the device of Burkholz to prevent accidental movement or dislodgement when used on patient [Jones, 0003]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 7, Burkholz as modified by Jones disclosed all limitations of claim 1. However, Burkholz failed to explicitly disclose wherein the stabilization anchor platform is moveable along the fluid conduit.
However, Jones teaches the tube stabilising device 20 includes a base member 210 and a tube retaining member 220 moveably attached to the base member 210 [0050].
Jones further teaches the tube stabilising assembly being configured such that the tube is moveable within the assembly relative to the patient [0032].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz to include wherein the stabilization anchor platform is moveable along the fluid conduit as taught by Jones since such a modification may enable the device of Burkholz to assist in absorbing of movement and dissipation of unwanted forces on the tubing and catheter during accidental movement [0057]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 8, Burkholz as modified by Jones disclosed all limitations of claim 1. Burkholz further discloses further comprising an access connector (connector 46 in Fig. 1B) positioned at the distal end of the fluid conduit (an end of the second extension tube 44 opposite an end of the second extension tube 44 coupled to the extension tube 24, may include a connector 46 [0047]), wherein the access connector comprises at least one of a luer connector and a needle-free connector (such as a luer adapter or another suitable connector [0047]).
Regarding claim 14, Burkholz as modified by Jones disclosed all limitations of claim 1. Burkholz further discloses further comprising a catheter hub (catheter adapter 12 in Fig. 1B) and a catheter (catheter 20 in Fig. 1B) received by the catheter hub (catheter 20 disclosed from the catheter hub 12 in Fig. 1B), wherein the catheter hub is coupled to the connector (the connector 34 may selectively or fixedly couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12. In some embodiments, the connector 34 may include a luer adapter, such as a male or female luer adapter, or any other suitable connector [0041]; see also Fig. 1B).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599 A1, herein Burkholz) and further in view of Jones et al. (US 20190160262 A1, herein Jones) and Yan (US 20210068732 A1, herein Yan).
Regarding claim 5, Burkholz as modified by Jones disclosed all limitations of claim 1. Burkholz further discloses further comprising a clamp positioned along the fluid conduit (clamp 39 positioned along extension tube 44 in Fig. 1B), but failed to explicitly disclose:
wherein the stabilization anchor platform is positioned between the clamp and the distal end of the fluid conduit.
However, Jones teaches that the tube stabilizing device 20 is positioned along a cannula 800 in the tube stabilizing assembly 1000 of Fig. 5. One of ordinary skill in the art may recognize that a stabilizing device positioned along a cannula can be configured to be positioned between the clamp 39 and the distal end of the extension tube 44 in the device of Burkholz.
Furthermore, Yan teaches positioning a clamp 10 at a far end of a tube 42 (as seen in Fig. 4F), which allows for the tube 42 to be primed [0069]. One of ordinary skill in the art may recognize that the clamp of Burkholz can be placed at the farthest end of Burkholz conduit 44 (near hub 46) which would result in the stabilization anchor platform of Jones being between the clamp (since this is at the furthest end of the conduit 44) and the distal end of the fluid conduit (since the distal end is at the closest end of the conduit 44).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified bv Jones to include wherein the stabilization anchor platform is positioned between the clamp and the distal end of the fluid conduit as taught by Jones and Yan since a modification may enable the device of Burkholz to prevent accidental movement or dislodgement when used on patient [Jones, 0003] and to prime the fluid conduit [Yan, 0069]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 6, Burkholz as modified by Jones disclosed all limitations of claim 5. Burkholz further discloses further comprising a clamp positioned along the fluid conduit (clamp 39 positioned along extension tube 44 in Fig. 1B), but failed to explicitly disclose:
wherein the stabilization anchor platform is positioned between the clamp and the side port of the connector.
However, Jones teaches that the tube stabilizing device 20 is positioned along a cannula 800 in the tube stabilizing assembly 1000 of Fig. 5. One of ordinary skill in the art may recognize that a stabilizing device positioned along a cannula can be configured to be positioned between the clamp 39 and the side port in the device of Burkholz.
Furthermore, Yan teaches positioning a clamp 10 at a far end of a tube 42 (as seen in Fig. 4F), which allows for the tube 42 to be primed [0069]. One of ordinary skill in the art may recognize that the clamp of Burkholz can be placed at the farthest end of Burkholz conduit 44 (near hub 46) which would result in the stabilization anchor platform of Jones being between the clamp (since this is at the furthest end of the conduit 44) and the side port (since the side port is at the closest end of the conduit 44).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones to include wherein the stabilization anchor platform is positioned between the clamp and the side port of the connector as taught by Jones and Yan since a modification may enable the device of Burkholz to prevent accidental movement or dislodgement when used on patient [Jones, 0003] and to prime the fluid conduit [Yan, 0069]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Claim(s) 9, 10, 11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599 A1, herein Burkholz) and further in view of Jones et al. (US 20190160262 A1, herein Jones) and Lopez (US 5688254 A, herein Lopez).
Regarding claim 9, Burkholz as modified by Jones disclosed all limitations of claim 1. Burkholz discloses a connector 53 coupled to the distal end of the conduit 44 in Fig. 1D, but failed to explicitly disclose that the connector 53 is a force controlled release connector having at least a portion of the force controlled release connector is configured to separate from fluid conduit when a predetermined separation force is applied to the force controlled release connector.
However, Lopez teaches further comprising a force controlled release connector (connector 90 in Fig. 7) coupled to the distal end of the fluid conduit (connector 90 coupled to tube 154 in Fig. 20), wherein at least a portion of the force controlled release connector is configured to separate from from fluid conduit when a predetermined separation force is applied to the force controlled release connector (to remove the cap member 92, the handle 96 is depressed, moving it to the position shown in FIG. 10a. With the handle 96 in this position, the cap member 92 is pulled off the port structure 91 [Col. 9, lines 55-58; see also Fig. 10a]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones to include further comprising a force controlled release connector coupled to the distal end of the fluid conduit, wherein at least a portion of the force controlled release connector is configured to separate from fluid conduit when a predetermined separation force is applied to the force controlled release connector as taught by Lopez since such a modification may enable the device of Burkholz to prevent accidental disconnection by axial pulling. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 10, Burkholz as modified by Jones and Lopez disclose all limitations of claim 9. However, Burkholz as modified by Jones failed to explicitly disclose wherein the force controlled release connector comprises a disconnect connector and a release feature, the release feature is engaged with the disconnect connector and configured to be disengaged from the disconnect connector when a predetermined separation force is applied to the disconnect connector.
However, Lopez teaches wherein the force controlled release connector comprises a disconnect connector (port structure 91 in Fig. 7) and a release feature (cap member 92 with handle 96 in Fig. 7), the release feature is engaged with the disconnect connector and configured to be disengaged from the disconnect connector when a predetermined separation force is applied to the disconnect connector ((to remove the cap member 92, the handle 96 is depressed, moving it to the position shown in FIG. 10a. With the handle 96 in this position, the cap member 92 is pulled off the port structure 91 [Col. 9, lines 55-58; see also Fig. 10a]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones to include wherein the force controlled release connector comprises a disconnect connector and a release feature, the release feature is engaged with the disconnect connector and configured to be disengaged from the disconnect connector when a predetermined separation force is applied to the disconnect connector as taught by Lopez since such a modification may enable the device of Burkholz to prevent accidental disconnection by axial pulling. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 11, Burkholz as modified by Jones and Lopez disclosed all limitations of claim 10. Burkholz as modified Jones however failed to explicitly disclose wherein the disconnect connector comprises a valve member.
However, Lopez teaches a standard latex rubber seal 36 at inlet port 38 to seal [Col 4, 62-63]. One of ordinary skill in the art may interpret this rubber seal as a septum, which is a type of valve.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention, to modify the the non-integrated vascular access system of Burkholz as modified by Jones to include wherein the disconnect connector comprises a valve member as taught by Lopez since such a modification may enable the disconnect connector to prevent entry of bacteria [Lopez, Col 4, lines 63-64]. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 15, Burkholz as modified by Jones and Lopez disclosed all limitations of claim 10. However, Burkholz as modified by Jones failed to explicitly disclose wherein the disconnect connector may be re-connected with the release feature after the release feature and the disconnect connector are disconnected.
However, Lopez teaches the two component hinge 100 does not break due to fatigue. Thus, in accordance with one feature of connector 90, the handle 96 may be moved between a locked position (FIG. 10) and unlocked position (FIG. 8) as often as one wishes without breaking [Col. 9, lines 7-11]. One of ordinary skill in the art may interpret that since handle 96 can switch between locked and unlocked position repeatedly without mechanical failure, port structure 91 and cap member 92 can be re-coupled after disconnection.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention, to modify the the non-integrated vascular access system of Burkholz as modified by Jones to include wherein the disconnect connector may be re-connected with the release feature after the release feature and the disconnect connector are disconnected as taught by Lopez since such a modification may enable the disconnect connector and release feature to be re-used and thus eliminating a need for replacement. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599 A1, herein Burkholz) and further in view of Jones et al. (US 20190160262 A1, herein Jones), Lopez (US 5688254 A, herein Lopez) and Blackman et al. (US 20190184134 A1, herein Blackman).
Regarding claim 12, Burkholz as modified by Jones and Lopez disclosed all limitations of claim 10. However, Burkholz as modified by Jones failed to explicitly disclose wherein the disconnect connector comprises a first line extending from the disconnect connector and a second line extending from the disconnect connector, and wherein the first line comprises a first port and the second line comprises a second port.
Lopez teaches a first line extending from the disconnect connector (tube 152 in Fig. 20) and wherein the first line comprises a first port (female luer component 148 in Fig. 20) but fails to teach a second line extending from the disconnect connector and second port.
However, Blackman teaches hub 850 includes a second coupler 820 that is mateable with first coupler 810. In at least some examples, first coupler 810 may be a female connector and second coupler 820 may be a male connector that mates with the female coupler [0047; see also Fig. 8A].
Blackman further teaches two tubes 855 branch out from second coupler 820, each terminating in conventional end couplers 860 having mating elements 862 [0048]. One of ordinary skill in the art may recognize that the second coupler 820 of Blackman can be configured to be substituted in for luer 150 of Lopez, and configured to be coupled to the luer component 148 of Lopez to perform the functions as required by claim 12.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones and Lopez to include further comprising wherein the disconnect connector comprises a first line extending from the disconnect connector and a second line extending from the disconnect connector, and wherein the first line comprises a first port and the second line comprises a second port as taught by Blackman since such a modification may enable the device of Burkholz to provide co-infusion therapy from multiple fluid sources. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Regarding claim 13, Burkholz as modified by Jones, Lopez and Blackman disclosed all limitations of claim 12. However, Burkholz as modified by Jones and Lopez failed to explicitly disclose wherein the first and second ports each comprises a needle-free connector.
However, Blackman teaches two tubes 855 branch out from second coupler 820, each terminating in conventional end couplers 860 having mating elements 862. End couplers 860 may include a Luer Taper/Lock mechanism [0048]. One of ordinary skill in the art may interpret that Luer taper connectors are needle free connectors.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones and Lopez to include wherein the first and second ports each comprises a needle-free connector as taught by Blackman since such a modification may enable the device of Burkholz to provide co-infusion therapy from multiple fluid sources. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599 A1, herein Burkholz) and further in view of Jones et al. (US 20190160262 A1, herein Jones), Lopez (US 5688254 A, herein Lopez) and Lazzara et al. (US 20220032029 A1, herein Lazzara).
Regarding claim 16, Burkholz as modified by Jones and Lopez disclosed all limitations of claim 10. However, Burkholz as modified by Jones and Lopez failed to explicitly disclose wherein the disconnect connector is prevented from being reconnected with the release feature after the release feature and the disconnect connector are disconnected.
However, Lazzara teaches the assembly 10 also includes at least one guard member 34 connected to the tubular housing 16 of the single-use connector 12. The at least one guard member 34 can be configured to transition between a pre-use or open position (shown in FIG. 1A) in which the single-use connector 12 can be connected to the reusable connector 14, an in-use or connected position (shown in FIG. 1B), and a post-use or closed position (shown in FIG. 1C) in which the guard member 34 prevents the single-use connector 12 from being re-connected to the reusable connector 14. In order to prevent reuse of the single-use connector 12, removing or disconnecting the single-use connector 12 from the reusable connector 14 causes the at least one guard member 34 to transition to the closed position [0073]. One of ordinary skill in the art may recognize that the guard of Lazzara can be configured to be used in conjunction with the connector of Blackman to perform the function of preventing the connection between the disconnect connector and release feature.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the non-integrated vascular access system of Burkholz as modified by Jones and Lopez to include wherein the disconnect connector is prevented from being reconnected with the release feature after the release feature and the disconnect connector are disconnected as taught by Lazzara since such a modification may enable the device of Burkholz to prevent reconnection of connectors intended for single use. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2143.I.D).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Dalle et al. (US 20050225082 A1, herein Dalle) is considered relavant prior art with regards to a fluid connector comprising two respectively male and female hubs. The male hub can be disconnected from the female by applying pressure on pressure zones.
Hellstrom et al. (US 20230147836 A1, herein Hellstrom) is considered relavant prior art with regards to a catheter assembly with catheter hub, coupling element and extension tube.
Ofek et al. (US 20210205530 A1, herein Ofek) is considered relevant prior art with regards to stabilization device with adhesive pad to anchor vascular access device to an insertion site.
Chelak et al. (US 20190275312 A1, herein Chelak) is considered relevant prior art with regards to a vascular access site management system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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