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 .
Election/Restrictions
Applicant’s election without traverse of Species II Subspecies D drawn to the manifold of Fig. 7 with the multi-lumen tubing of Fig. 2, in the reply filed on June 12, 2026 is acknowledged.
Claim 8 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 12, 2026.
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 –
Claims 1-7, 9-10, 13-14, and 17-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jense et al. (US 2022/0001103 A1).
Regarding claim 1, Jense et al. discloses a multi-lumen intravenous tubing system (Fig. 1 treatment delivery apparatus 100), comprising: a multi-lumen tubing (Fig. 6A multi-lumen catheter 600) comprising a primary lumen (Fig. 6B major lumen 610) and a secondary lumen (Fig. 6B minor lumen 608), the primary lumen (Fig. 6B major lumen 610) and the secondary lumen (Fig. 6B minor lumen 608) each extending (see such extending in Fig. 6A) from a first end (Fig. 6A upstream end 604) of the multi-lumen tubing (Fig. 6A multi-lumen catheter 600) to a second end (Fig. 6A downstream end 606) of the multi-lumen tubing (Fig. 6A multi-lumen catheter 600), and the secondary lumen (Fig. 6B minor lumen 608) is fluidly separated (see fluidly separated as described in p. 7, col 1, [0071], lines 6-13, each of the minor lumens 608 is configured to fluidically connect with one of the independent fluidic channels of the treatment administration device, and to maintain isolation of that fluidic channel along at least part of the length of the multi-lumen catheter 600) from the primary lumen (Fig. 6B major lumen 610); and a manifold (Fig. 4A and Fig. 4B manifold 400) comprising a first fluid flow path (see ‘Modified Fig. 4A’ below, first fluid flow path), a second fluid flow path (see ‘Modified Fig. 4 A' below, second fluid flow path), a first inlet (Fig. 4B auxiliary medication entry port 410), a second inlet (see ‘Modified Fig. 4A’ below, second inlet), and an outlet (see ‘Modified Fig. 4A’ below, outlet), the first fluid flow path (see ‘Modified Fig. 4A’ below, first fluid flow path) extending from the first inlet (410) to the outlet (see ‘Modified Fig. 4A’ below, outlet), and the second fluid flow path (see ‘Modified Fig. 4 A' below, second fluid flow path) extending from the second inlet (see ‘Modified Fig. 4A’ below, second inlet) to the outlet (see ‘Modified Fig. 4A’ below, outlet), wherein the first fluid flow path (see ‘Modified Fig. 4A’ below, first fluid flow path) is fluidly separated (see fluidly separated as described in p. 5, col 2, [0061], lines 11-14, each of the manifold medication entry ports 402 fluidically connects via an isolated fluidic flow path to one of the manifold medication exit ports 404) from the second fluid flow path (see ‘Modified Fig. 4 A' below, second fluid flow path); wherein the first end (604) of the multi-lumen tubing (600) is coupled (see “is coupled” as described in p. 6, col, [0063], lines 2-7, catheter adaptor 500 (hereinafter “adaptor”), which is similar to the adaptor 210 of FIG. 2. The adaptor 500 is configured for reversible coupling to a treatment administration device (e.g., treatment administration device 200 of FIG. 2) via a downstream portion of a manifold (e.g., manifold 400) to the outlet (see ‘Modified Fig. 4A’ below, outlet) of the manifold (Fig. 4A and Fig. 4B manifold 400) with the first fluid flow path (see ‘Modified Fig. 4A’ below, first fluid flow path) fluidly coupled (see fluidly coupled as described in p. 6-7, col 2-1, [0071], lines 1-13, the tubing body 602 includes a plurality of minor lumens 608 formed integrally therein that run along a major lumen 610, which is also integrally formed with the tubing body 602. The minor lumens 608 and the major lumen 610 may each run substantially along the length of the multi-lumen catheter 600. Each of the minor lumens 608 is configured to fluidically connect with one of the independent fluidic channels of the treatment administration device, and to maintain isolation of that fluidic channel along at least part of the length of the multi-lumen catheter 600. Thus, each of the minor lumens 608 is configured to fluidically connect to a pump and to a cartridge-pump interface of the treatment administration device) to the primary lumen (610), and the second fluid flow path (see ‘Modified Fig. 4 A' below, second fluid flow path) fluidly coupled (see fluidly coupled as described in p. 6-7, col 2-1, [0071], lines 1-13) to the secondary lumen (608).
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Regarding claim 2, Jense discloses the primary lumen (610) forms a primary lumen cross-sectional profile (see ‘Modified Fig. 6A’ below, primary lumen cross-sectional profile) that is transverse (see ‘Modified Fig. 6A’ below, transverse) to a longitudinal primary axis (see ‘Modified Fig. 6A’ below, longitudinal primary axis) of the primary lumen (610), and the secondary lumen (608) forms a secondary lumen cross- sectional profile (see ‘Modified Fig. 6A’ below, secondary lumen cross-sectional profile) that is transverse (see ‘Modified Fig. 6A’ below, transverse) to a longitudinal secondary axis (see ‘Modified Fig. 6A’ below, longitudinal secondary axis) of the secondary lumen (608), and wherein an area (see area of primary lumen cross-sectional profile as described in p. 7, col 1, [0074], lines 1-14, each of the minor lumens 608 and the major lumen 610 may be sized and shaped to improve delivery dynamics. In some embodiments, the major lumen 610 has a largest cross-sectional dimension of about 1 mm to about 5 mm, and none of the minor lumens 608 has a largest cross-sectional dimension that equals or exceeds the largest cross sectional dimension of the major lumen 610. In some embodiments, the relatively small cross-sectional area of the minor lumens 608 effectively prevents backflow of medication into the treatment administration device, thereby improving safety. In some embodiments, at least one of the minor lumens has a different largest cross-sectional dimension that differs from at least one other of the minor lumens and/or the major lumen) of the primary lumen cross-sectional profile (see ‘Modified Fig. 6A’ below, primary lumen cross-sectional profile) is greater (see greater as described in p. 7, col 1, [0074], lines 1-14) than an area (see area of secondary lumen cross-sectional profile as described in p. 7, col, [0074], lines 1-14) of the secondary lumen cross-sectional profile (see ‘Modified Fig. 6A’ below, secondary lumen cross-sectional profile).
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Regarding claim 3, Jense discloses the primary lumen (610) forms a first volume (seeing that the primary lumen extends between the first end and the second end of the multi-lumen tubing, the cross-sectional dimension of the primary lumen necessarily provides an internal first volume as described in p. 7, col 1, [0074], lines 1-14) between the first end (604) and the second end (606) of the multi-lumen tubing (600), and the secondary lumen (608) forms a second volume (seeing that the secondary lumen extends between the first end and the second end of the multi-lumen tubing, the cross-sectional dimension of the secondary lumen necessarily provides an internal second volume as described in p. 7, col 1, [0074], lines 1-14) between the first end (604) and the second end (606) of the multi-lumen tubing (600), and wherein the first volume (p. 7, col 1, [0074], lines 1-14) is greater (seeing that the primary lumen extends between the first end and the second end of the multi-lumen tubing, and each secondary lumen extends between the first and second ends, the larger cross-sectional dimension of the primary lumen necessarily provides a greater internal volume than each secondary lumen over the same longitudinal extent as described in p. 7, col 1, [0074], lines 1-14) than the second volume (p. 7, col 1, [0074], lines 1-14).
Regarding claim 4, Jense discloses the primary lumen (610) defines a longitudinal primary axis (see ‘Modified Fig. 6A’ above, longitudinal primary axis), and the secondary lumen (608) defines a longitudinal secondary axis (see ‘Modified Fig. 6A’ above, longitudinal primary axis), and wherein the longitudinal primary axis (see ‘Modified Fig. 6A’ above, longitudinal primary axis) is parallel (see ‘Modified Fig. 6A’ above, parallel) with the longitudinal secondary axis (see ‘Modified Fig. 6A’ above, longitudinal primary axis).
Regarding claim 5, Jense discloses the secondary lumen (608) comprises a first secondary lumen (see ‘Modified Fig. 6B’ below, first secondary lumen) and a second secondary lumen (see ‘Modified Fig. 6B’ below, second secondary lumen).
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Regarding claim 6, Jense discloses each of the first secondary lumen (see ‘Modified Fig. 6B’ above, first secondary lumen) and the second secondary lumen (see ‘Modified Fig. 6B’ above, second secondary lumen) are positioned concentrically (see such concentric positioning with how the first and second secondary lumen are in relation to the primary lumen in ‘Modified Fig. 6B’) around the primary lumen (610).
Regarding claim 7, Jense discloses each of the first secondary lumen (see ‘Modified Fig. 6B’ above, first secondary lumen) and the second secondary lumen (see ‘Modified Fig. 6B’ above, second secondary lumen) define a longitudinal secondary axis (see ‘Modified Fig. 6B’ above, first longitudinal secondary axis and second longitudinal secondary axis) that is parallel (see such parallel positioning with how the longitudinal secondary axis of the first secondary lumen and the second secondary lumen are in relation to the longitudinal primary axis in ‘Modified Fig. 6B’) to a longitudinal primary axis (see ‘Modified Fig. 6B’ above, longitudinal primary axis) of the primary lumen (610).
Regarding claim 9, Jense discloses a length (see ‘Modified Fig. 6A’ above, primary lumen length) of the primary lumen (610), from the first end (604) to the second end (606) of the multi-lumen tubing (600), is equal (see such equal length as described in p. 6-7, col 2-1, [0071], lines 1-13, the tubing body 602 includes a plurality of minor lumens 608 formed integrally therein that run along a major lumen 610, which is also integrally formed with the tubing body 602. The minor lumens 608 and the major lumen 610 may each run substantially along the length of the multi-lumen catheter 600. Each of the minor lumens 608 is configured to fluidically connect with one of the independent fluidic channels of the treatment administration device, and to maintain isolation of that fluidic channel along at least part of the length of the multi-lumen catheter 600. Thus, each of the minor lumens 608 is configured to fluidically connect to a pump and to a cartridge-pump interface of the treatment administration device) to a length (see ‘Modified Fig. 6A’ above, secondary lumen length) of the secondary lumen (608), from the first end (604) to the second end (606) of the multi-lumen tubing (600).
Regarding claim 10, Jense discloses the multi-lumen tubing (600) comprises an outer surface forming a cross-sectional profile of multi-lumen tubing (see ‘Modified Fig. 6A’ above, outer surface forming a cross-sectional profile of multi-lumen tubing), and wherein the cross-sectional profile of multi-lumen tubing (see ‘Modified Fig. 6A’ above, outer surface forming a cross-sectional profile of multi-lumen tubing) is circular (see such circular shape of the cross-sectional profile present in ‘Modified Fig. 6A’ above).
Regarding claim 13, Jense discloses a multi-lumen intravenous tubing system (Fig. 1 treatment delivery apparatus 100) comprising: a medicament source (p. 4, col 1, [0047], line 4, medication bags (e.g., saline bag 112 and IV bag 114)); a manifold (Fig. 4A and Fig. 4B manifold 400) comprising a first fluid flow path (see ‘Modified Fig. 4A’ above, first fluid flow path) that extends from a first inlet (Fig. 4B auxiliary medication entry port 410) to an outlet (see ‘Modified Fig. 4A’ above, outlet) of the manifold (Fig. 4A and Fig. 4B manifold 400), a second fluid flow path (see ‘Modified Fig. 4 A' above, second fluid flow path) that extends from a second inlet (see ‘Modified Fig. 4A’ above, second inlet) to the outlet (see ‘Modified Fig. 4A’ above, outlet), wherein the first inlet (Fig. 4B auxiliary medication entry port 410) is fluidly coupled (see fluidly coupled in Fig. 1 as described in p. 4, col 1, [0047], lines 4-5, medication bags (e.g., saline bag 112 and IV bag 114) coupled with the treatment administration device 102 ) to the medicament source (p. 4, col 1, [0047], line 4, medication bags (e.g., saline bag 112 and IV bag 114)); and a multi-lumen tubing (Fig. 1 multi-lumen catheter 104) comprising a first end (Fig. 6A upstream end 604), a second end (Fig. 6A downstream end 606), a primary lumen (Fig. 6B major lumen 610), and a secondary lumen (Fig. 6B minor lumen 608), the first end (Fig. 6A upstream end 604) coupled (see coupled as described in p. 6, col 1, [0063], lines 2-7, catheter adaptor 500 (hereinafter “adaptor”), which is similar to the adaptor 210 of FIG. 2. The adaptor 500 is configured for reversible coupling to a treatment administration device (e.g., treatment administration device 200 of FIG. 2) via a downstream portion of a manifold (e.g., manifold 400) to the outlet (see ‘Modified Fig. 4A’ above, outlet) of the manifold (Fig. 4A and Fig. 4B manifold 400), the second end (Fig. 6A downstream end 606) coupled (p. 6, col 2, [70], lines 12-16, the downstream end 606 is configured to couple with a patient's IV (i.e., a hypodermic needle), with a reservoir, and/or with one or more hardware elements (e.g., a connector, a flow regulator, or a Luer lock) located upstream of the patient's IV) to the fluid connector (p. 6, col 2, [70], line 15, connector), and each of the primary lumen (610) and the secondary lumen (608) extending from a first end (604) to the second end (606) of the multi-lumen tubing (600); wherein a first fluid (p. 7, col 1, [0072], line 3, liquid medication) can move (p. 7, col 1, [0072], lines 2-3, the major lumen 610 is configured to carry at least one liquid medication) from the medicament source (p. 4, col 1, [0047], line 4, medication bags (e.g., saline bag 112 and IV bag 114)), through the first fluid flow path (see ‘Modified Fig. 4A’ above, first fluid flow path) of the manifold (600) and the primary lumen (610), to the fluid connector (p. 6, col 2, [70], line 15, connector), and wherein a second fluid (p. 7, col 1, [0072], line 2, liquid medication) can move (p. 7, col 1, [0072], lines 1-2, the minor lumens 608 are each configured to carry a liquid medication) from the second fluid flow path (see ‘Modified Fig. 4 A' above, second fluid flow path), through the second fluid flow path (see ‘Modified Fig. 4 A' above, second fluid flow path), and the secondary lumen (608), to the fluid connector (p. 6, col 2, [70], line 15, connector).
Regarding claim 14, Jense discloses the secondary lumen (608) is fluidly separated (see fluidly separated as described in p. 7, col 1, [0071], lines 6-13, each of the minor lumens 608 is configured to fluidically connect with one of the independent fluidic channels of the treatment administration device, and to maintain isolation of that fluidic channel along at least part of the length of the multi-lumen catheter 600) from the primary lumen (610).
Regarding claim 17, Jense discloses the primary lumen (610) forms a first volume (seeing that the primary lumen extends between the first end and the second end of the multi-lumen tubing, the cross-sectional dimension of the primary lumen necessarily provides an internal first volume as described in p. 7, col 1, [0074], lines 1-14) between the first end (604) and the second end (606) of the multi-lumen tubing (600), and the secondary lumen (608) forms a second volume (seeing that the secondary lumen extends between the first end and the second end of the multi-lumen tubing, the cross-sectional dimension of the secondary lumen necessarily provides an internal second volume as described in p. 7, col 1, [0074], lines 1-14) between the first end (604) and the second end (606) of the multi-lumen tubing (600), and wherein the first volume (p. 7, col 1, [0074], lines 1-14) is greater (seeing that the primary lumen extends between the first end and the second end of the multi-lumen tubing, and each secondary lumen extends between the first and second ends, the larger cross-sectional dimension of the primary lumen necessarily provides a greater internal volume than each secondary lumen over the same longitudinal extent as described in p. 7, col 1, [0074], lines 1-14) than the second volume (p. 7, col 1, [0074], lines 1-14).
Regarding claim 18, Jense discloses a method (p. 11, col 1, [0105], lines 1-3, methodologies) for providing a multi-lumen intravenous tubing system (Fig. 1 treatment delivery apparatus 100), the method (p. 11, col 1, [0105], lines 1-3, methodologies) comprising: providing a manifold (Fig. 4A and Fig. 4B manifold 400) comprising a first fluid flow path (see ‘Modified Fig. 4A’ above, first fluid flow path) that extends from a first inlet (Fig. 4B auxiliary medication entry port 410) to an outlet (see ‘Modified Fig. 4A’ above, outlet) of the manifold (400), a second fluid flow path (see ‘Modified Fig. 4 A' above, second fluid flow path) that extends from a second inlet (see ‘Modified Fig. 4A’ above, second inlet) to the outlet (see ‘Modified Fig. 4A’ above, outlet) of the manifold (400); and providing a multi-lumen tubing (Fig. 6A multi-lumen catheter 600) comprising a first end (Fig. 6A upstream end 604) coupled (see coupled as described in p. 6, col 1, [0063], lines 2-7, catheter adaptor 500 (hereinafter “adaptor”), which is similar to the adaptor 210 of FIG. 2. The adaptor 500 is configured for reversible coupling to a treatment administration device (e.g., treatment administration device 200 of FIG. 2) via a downstream portion of a manifold (e.g., manifold 400) to the outlet (see ‘Modified Fig. 4A’ above, outlet) of the manifold (400) such that a primary lumen (Fig. 6B major lumen 610) of the multi-lumen tubing (104) is fluidly coupled (see fluidly coupled as described in p. 6-7, col 2-1, [0071], lines 1-13, the tubing body 602 includes a plurality of minor lumens 608 formed integrally therein that run along a major lumen 610, which is also integrally formed with the tubing body 602. The minor lumens 608 and the major lumen 610 may each run substantially along the length of the multi-lumen catheter 600. Each of the minor lumens 608 is configured to fluidically connect with one of the independent fluidic channels of the treatment administration device, and to maintain isolation of that fluidic channel along at least part of the length of the multi-lumen catheter 600. Thus, each of the minor lumens 608 is configured to fluidically connect to a pump and to a cartridge-pump interface of the treatment administration device) with only the first fluid flow path (see ‘Modified Fig. 4A’ above, first fluid flow path), and a secondary lumen (Fig. 6B minor lumen 608) of the multi-lumen tubing (600) is fluidly coupled (see fluidly coupled as described in p. 6-7, col 2-1, [0071], lines 1-13) with only the second fluid flow path (see ‘Modified Fig. 4 A' above, second fluid flow path).
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.
Claims 11-12, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jense et al. (US 2022/0001103 A1) in view of Underwood et al. (US 2022/0313898 A1).
Regarding claim 11, the device of Fig. 1 of Jense et al. in view of the embodiment of Fig. 6A and Fig. 6B of Jense et al. further in view of the embodiment of Fig. 4A and Fig. 4B of Jense et al. discloses the manifold (400).
Jense discloses the device substantially as claimed, however, Jense does not explicitly mention comprises a tertiary fluid flow path that extends from the first fluid flow path to the second fluid flow path. However, Underwood et al. teaches a tertiary fluid flow path (see tertiary fluid flow path with drug stream B introduced into the channel carrying infustate stream A and the streams combining to form a combined stream flowing through channel 118 as described in Underwood, p. 2, col 2, [0026], lines 1-8.
It would have been obvious to a person of ordinary skill in the art at the time of the claimed invention to have modified the device of Jense to include a tertiary fluid flow path that extends from the first fluid flow path to the second fluid flow path, as taught by Underwood, as Underwood teaches that “during operation, the fluid manifolds 110 of the fluid manifold array 100 allow for the introduction of a drug stream B or any other stream of medical fluid to be combined with the infusate stream A to be administered to the patient as the combined infusate stream C. In the depicted example, each fluid manifold 110 can allow for a drug stream B to be combined with the infusate stream A flowing therethrough” as described in Underwood, p. 2, col 2, [0026], lines 1-8.
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Regarding claim 12, Jense does not explicitly mention the manifold comprises a valve configured to selectively permit a fluid to move from the first fluid flow path to the second fluid flow path. However, Underwood teaches the manifold comprises a valve (see Underwood, ‘First Modified Fig. 1’ above, valve 130) configured to selectively permit a fluid to move (see selectively permit a fluid to move as described in Underwood, p. 3, col 2, [0036], lines 1-18, as shown in FIG. 3, the valve 130 can be depressed, actuated, or otherwise moved into an actuated or flow position to allow flow from the injection port 120 into the flow channel 118. In the depicted example, the divider body 134 can define a divider port 136 that allows flow therethrough. Therefore, as illustrated, the divider body 134 can be moved to permit flow from the injection port 120 to the flow channel 118 via the divider port 136. In some embodiments, the divider port 136 is aligned to create a flow path between the first injection channel 122, the divider port 136, and the second injection channel 117. As can be appreciated, the divider body 134 can be moved within the divider volume 116 to permit the divider port 136 to be aligned with the first injection channel 122 and the second injection channel 117 in the flow position. Advantageously, the configuration of the divider port 136 within the divider volume 116 minimizes the dead volume of residual drugs within the fluid manifold 110) from the first fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, first fluid flow path) to the second fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, second fluid flow path).
It would have been obvious to a person of ordinary skill in the art at the time of the claimed invention to have modified the device of Jense so the manifold comprises a valve configured to selectively permit a fluid to move from the first fluid flow path to the second fluid flow path, as taught by Underwood, as Jense teaches “each of the medication entry ports 508 and the auxiliary entry port 518 is fitted with an optional check valve 522 to prevent backflow into the manifold and/or treatment administration device” (p. 6, col 1, [0065], lines 11-14).
Regarding claim 15, Jense does not explicitly mention the manifold (400) comprises a tertiary fluid flow path that extends from the first fluid flow path to the second fluid flow path. However, Underwood teaches comprises a tertiary fluid flow path (see tertiary fluid flow path with drug stream B introduced into the channel carrying infustate stream A and the streams combining to form a combined stream flowing through channel 118 as described in Underwood, p. 2, col 2, [0026], lines 1-8, during operation, the fluid manifolds 110 of the fluid manifold array 100 allow for the introduction of a drug stream B or any other stream of medical fluid to be combined with the infusate stream A to be administered to the patient as the combined infusate stream C. In the depicted example, each fluid manifold 110 can allow for a drug stream B to be combined with the infusate stream A flowing therethrough) that extends (see Underwood, ‘First Modified Fig. 1’ above, extent of tertiary fluid flow path from the first fluid flow path to the second fluid flow path) from the first fluid flow path (see first fluid flow path corresponding to infustate stream A flowing through channel 118 as described in Underwood, p. 2, col 2, [0028], lines 1-7, the injection port 120 can include a sealing member 150 disposed within the injection port lumen 121. The sealing member 150 can seal against the injection port lumen 121 to reduce the exposure of the flow channel 118 and the infusate stream A to the environment, reducing the chance of contamination and/or blood stream infections through the infusate stream C) to the second fluid flow path (see a second fluid path corresponding to drug stream B introduced through injection port 120 and injection port lumen 121 flowing through channel 118 with sealing member 150 sealing against the first fluid path as described in Underwood, p. 3, col 1, [0029], lines 1-8, during operation, the sealing member 150 can permit the introduction of a syringe or other fluid source into the injection port 120. The sealing member 150 can define a split septum 152 to permit the syringe or other fluid source to be inserted past the sealing member 150. The split septum 152 can seal against the syringe or other fluid source to minimize exposure of the infusate stream A to the environment).
It would have been obvious to a person of ordinary skill in the art at the time of the claimed invention to have modified the device of Jense to include comprises a tertiary fluid flow path that extends from the first fluid flow path to the second fluid flow path, as taught by Underwood, as Underwood teaches that “during operation, the fluid manifolds 110 of the fluid manifold array 100 allow for the introduction of a drug stream B or any other stream of medical fluid to be combined with the infusate stream A to be administered to the patient as the combined infusate stream C. In the depicted example, each fluid manifold 110 can allow for a drug stream B to be combined with the infusate stream A flowing therethrough” as described in Underwood, p. 2, col 2, [0026], lines 1-8.
Regarding claim 16, Jense does not explicitly mention the manifold comprises a valve configured to selectively permit at least a portion of the first fluid to move from the first fluid flow path to the second fluid flow path. However, Underwood teaches the manifold comprises a valve (see Underwood, ‘First Modified Fig. 1’ above, valve 130) configured to selectively permit at least a portion of the first fluid to move (see selectively permit at least a portion of the first fluid to move as described in Underwood, p. 3, col 2, [0036], lines 1-18, as shown in FIG. 3, the valve 130 can be depressed, actuated, or otherwise moved into an actuated or flow position to allow flow from the injection port 120 into the flow channel 118. In the depicted example, the divider body 134 can define a divider port 136 that allows flow therethrough. Therefore, as illustrated, the divider body 134 can be moved to permit flow from the injection port 120 to the flow channel 118 via the divider port 136. In some embodiments, the divider port 136 is aligned to create a flow path between the first injection channel 122, the divider port 136, and the second injection channel 117. As can be appreciated, the divider body 134 can be moved within the divider volume 116 to permit the divider port 136 to be aligned with the first injection channel 122 and the second injection channel 117 in the flow position. Advantageously, the configuration of the divider port 136 within the divider volume 116 minimizes the dead volume of residual drugs within the fluid manifold 110) from the first fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, first fluid flow path) to the second fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, second fluid flow path).
It would have been obvious to a person of ordinary skill in the art at the time of the claimed invention to have modified the device of Jense so the manifold comprises a valve configured to selectively permit a fluid to move from the first fluid flow path to the second fluid flow path, as taught by Underwood, as Jense teaches “each of the medication entry ports 508 and the auxiliary entry port 518 is fitted with an optional check valve 522 to prevent backflow into the manifold and/or treatment administration device” (p. 6, col 1, [0065], lines 11-14).
Regarding claim 19, Jense discloses providing a manifold (400). Jense does not explicitly mention further comprises providing a tertiary fluid flow path between the first fluid flow path to the second fluid flow path, such that at least a portion of a fluid can move from the first fluid flow path to the second fluid flow path. However, Underwood teaches further comprises providing a tertiary fluid flow path (see tertiary fluid flow path with drug stream B introduced into the channel carrying infustate stream A and the streams combining to form a combined stream flowing through channel 118 as described in Underwood, p. 2, col 2, [0026], lines 1-8, during operation, the fluid manifolds 110 of the fluid manifold array 100 allow for the introduction of a drug stream B or any other stream of medical fluid to be combined with the infusate stream A to be administered to the patient as the combined infusate stream C. In the depicted example, each fluid manifold 110 can allow for a drug stream B to be combined with the infusate stream A flowing therethrough) between the first fluid flow path (see first fluid flow path corresponding to infustate stream A flowing through channel 118 as described in Underwood, p. 2, col 2, [0028], lines 1-7, the injection port 120 can include a sealing member 150 disposed within the injection port lumen 121. The sealing member 150 can seal against the injection port lumen 121 to reduce the exposure of the flow channel 118 and the infusate stream A to the environment, reducing the chance of contamination and/or blood stream infections through the infusate stream C) to the second fluid flow path (see a second fluid path corresponding to drug stream B introduced through injection port 120 and injection port lumen 121 flowing through channel 118 with sealing member 150 sealing against the first fluid path as described in Underwood, p. 3, col 1, [0029], lines 1-8, during operation, the sealing member 150 can permit the introduction of a syringe or other fluid source into the injection port 120. The sealing member 150 can define a split septum 152 to permit the syringe or other fluid source to be inserted past the sealing member 150. The split septum 152 can seal against the syringe or other fluid source to minimize exposure of the infusate stream A to the environment), such that at least a portion of a fluid can move (see at least a portion of a fluid can move as described in Underwood, p. 3, col 2, [0036], lines 1-18, as shown in FIG. 3, the valve 130 can be depressed, actuated, or otherwise moved into an actuated or flow position to allow flow from the injection port 120 into the flow channel 118. In the depicted example, the divider body 134 can define a divider port 136 that allows flow therethrough. Therefore, as illustrated, the divider body 134 can be moved to permit flow from the injection port 120 to the flow channel 118 via the divider port 136. In some embodiments, the divider port 136 is aligned to create a flow path between the first injection channel 122, the divider port 136, and the second injection channel 117. As can be appreciated, the divider body 134 can be moved within the divider volume 116 to permit the divider port 136 to be aligned with the first injection channel 122 and the second injection channel 117 in the flow position. Advantageously, the configuration of the divider port 136 within the divider volume 116 minimizes the dead volume of residual drugs within the fluid manifold 110) from the first fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, first fluid flow path) to the second fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, second fluid flow path).
It would have been obvious to a person of ordinary skill in the art at the time of the claimed invention to have modified the device of Jense to include further comprises providing a tertiary fluid flow path between the first fluid flow path to the second fluid flow path, such that at least a portion of a fluid can move from the first fluid flow path to the second fluid flow path, as taught by Underwood, as Underwood teaches that “during operation, the fluid manifolds 110 of the fluid manifold array 100 allow for the introduction of a drug stream B or any other stream of medical fluid to be combined with the infusate stream A to be administered to the patient as the combined infusate stream C. In the depicted example, each fluid manifold 110 can allow for a drug stream B to be combined with the infusate stream A flowing therethrough” as described in Underwood, p. 2, col 2, [0026], lines 1-8.
Regarding claim 20, Jense in view of Underwood discloses further comprising providing a valve (see Underwood, ‘First Modified Fig. 1’ above, valve 130) along the tertiary fluid flow path to selectively permit or resist movement of the fluid (see selectively permit or resist movement of the fluid as described in Underwood, p. 3, col 2, [0036], lines 1-18, as shown in FIG. 3, the valve 130 can be depressed, actuated, or otherwise moved into an actuated or flow position to allow flow from the injection port 120 into the flow channel 118. In the depicted example, the divider body 134 can define a divider port 136 that allows flow therethrough. Therefore, as illustrated, the divider body 134 can be moved to permit flow from the injection port 120 to the flow channel 118 via the divider port 136. In some embodiments, the divider port 136 is aligned to create a flow path between the first injection channel 122, the divider port 136, and the second injection channel 117. As can be appreciated, the divider body 134 can be moved within the divider volume 116 to permit the divider port 136 to be aligned with the first injection channel 122 and the second injection channel 117 in the flow position. Advantageously, the configuration of the divider port 136 within the divider volume 116 minimizes the dead volume of residual drugs within the fluid manifold 110) between the first fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, first fluid flow path) and the second fluid flow path (see Underwood, ‘First Modified Fig. 1’ above, second fluid flow path).
Conclusion
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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