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 the (I) dual lumen IV admin set as shown in (B) figs. 2-4, having check valve 208 and roller clamp 202, and the (II) injection port cap as shown in (A) fig. 7a with a nipple 702A and slit 704, in the reply filed on 11/07/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) 10/31/2025 has been considered by the Examiner.
The information disclosure statement filed 12/22/2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered if lined through.
The information disclosure statement filed 12/22/2022 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered if lined through.
Specifically, no copy or explanation of relevance was provided for any Foreign Patent or Non-Patent Literature Document listed in the IDS of 12/22/2022. Foreign Patent Documents 1 and 2 (CN-109045387-A and DE-102008052752-A1) and Non-Patent Literature Documents 1 and 2 (“English Translation of CN109045387A” and “Copy of Extended European Search Report mailed December 05, 2022 for European Patent Application No. 20802427.3, 8 pages”) were thus not considered.
Status of the Claims
Claims 21-38 are currently pending. Claims 21-38 are currently rejected.
Claim Objections
Claim 31 is objected to because of the following informalities:
Claim 31 reads “when a patient needs” on line 8. This should read “when [[a]]the patient needs” since “a patient” is noted in the first line of claim 31.
Appropriate correction is required.
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.
Claims 26-27 and 34-35 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.
Claims 26-27 and 34-35, recite the limitation of an “injection port that intersects the second lumen after the flush pump and prior to the flow merger”. Independent claims 21 and 31 recite a flush pump associated with a first lumen. From the claim limitations it is unclear whether the flush pump is meant to be located along the first lumen, in which case it is unclear how the injection port is “intersecting” the second lumen, or along the second lumen, in which case it is unclear how the flush pump could draw fluid into the first lumen. For purposes of examination, this limitation has been interpreted to refer to the point on the second lumen which is analogous to the point on the first lumen where the flush pump is located.
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.
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) 21-27, 29, 31-35, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Fink (US-4219021-A; hereafter Fink) in view of Faden (US-20190070406-A1; hereafter Faden).
Regarding claim 21, Fink discloses a method of administering an IV to a patient, the method comprising steps of:
connecting a dual lumen IV set (IV set, Fig. 14, col. 7 ln. 63-col. 8 ln. 19) to the patient, the dual lumen IV set including a first lumen (lumen extending through tubings 146, 150, 156; fig. 14; col. 8 In. 5-14) having an inner diameter of a first value (see fig. 14, note that fluid flows through the noted tubings and thus they must have an inner diameter of a value), and a second lumen (second lumen extending through tubings 146', 150', 156'; fig. 14; col. 8, In 5-14) having an inner diameter of a second value (see fig. 14, note that fluid flows through the noted tubings and thus they must have an inner diameter of a value);
establishing an IV flow through the first lumen (liquid medication 142, fig. 14, col. 7 ln. 63-col. 8 ln. 19);
inputting a drug into the second lumen of the dual lumen IV set (liquid medication 142’, fig. 14, col. 7 ln. 63-col. 8 ln. 19); and
merging, into a merged flow (flow through flexible tubing section 80, fig. 14, col. 8 ln. 14-17), the IV flow in the first lumen and the drug in the second lumen, the merged flow being merged prior to entering the patient (see fig. 14; col. 7 ln. 64-69, “…two medications may be delivered individually or simultaneously to a patient through the same needle.”).
Fink is silent to the relative inner diameters of the first and second lumens and the step of actuating a flush pump to draw IV fluid into the first lumen to regulate a volume of the IV flow.
Faden, directed to an apparatus and method for dispensing fluid intravenously, teaches actuating a flush pump (reservoir pump 260, fig. 14b, [0091] and [0083]) to draw IV fluid into the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) to regulate a volume of the IV flow ([0063] reservoir pump 260 dispenses a predetermined amount of IV fluid into tubing 256 and pressure-operated valve 270 when operated).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the IV set of Fink to include the flush pump taught by Faden since both references deal with IV fluid delivery systems. One would have been motivated to make the modification because the flush pump of Faden allows for user-controlled bolus delivery, instead of just continuous flow. Therefore, the fluid delivery can be better controlled by the user.
Fink modified by Faden discloses all limitations of the claim invention except for wherein the second value is greater than the first value. This limitation represents only a change in size/proportion (MPEP 2144.04(IV)(A)). Altering the relative diameters of the first and second lumina would not adversely affect the fluid delivery system of Fink modified by Faden. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation. Additionally, while Fink modified by Faden fails to specifically teach the second value that is greater than the first value, Fink teaches the ports of valve body 14 of valve 10 having a first diameter and a second diameter, the second diameter greater than the first (Fig. 6), and tubes 26, 28, 30 coupled to the ports (Fig. 1, Fig. 6, col. 3, In 57-60). It would have been obvious to one of ordinary skill in the art that the set of Fink could have been modified as claimed, through routine experimentation, for secure attachment of the tubes to the valve ports.
Regarding claim 22, Fink modified by Faden discloses the method according to claim 21, as described above.
Fink is silent to splitting the IV flow via a flow splitter.
Faden further teaches further comprising splitting the IV flow via a flow splitter (Y-split 280, fig. 14b, [0105]) to split input from a single flow input line ([0105] respective upper or proximal ends of tubing 252 and tubing 254 are configured to operate in fluid communication with the same IV fluid source (e.g. IV fluid bag 210) via a Y-split of tubing (e.g. Y-split 280)) into: a first flow into the first lumen (lumen of upstream tubing 254, see fig. 14b), and a second flow into the second lumen (lumen of upstream tubing 252, see fig. 14b).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink as already modified by Faden to include a flow splitter as taught by Faden since both references deal with IV delivery systems. One would have been motivated to make the modification because having a Y-split allows the same base fluid to be present in both tubing sections while still providing tubing lengths for each section which can accept additional fluids. Having the same base fluid helps to ensure appropriate mixing of the fluids when joined via the merging step.
Regarding claim 23, Fink modified by Faden discloses the method according to claim 22, as described above. Fink further discloses wherein the step of merging includes merging a flow output via a flow merger (valve 10, fig. 14) to combine the first flow that is output from a distal end of the first lumen (lumen extending through tubings 146, 150, 156; fig. 14) and the second flow that is output from a distal end of the second lumen (lumen extending through tubings 146', 150', 156'; fig. 14) to form the merged flow in an exit lumen (line 70, fig. 14) (valve 10 couples to distal ends of tubes 156, 156' and coupled at an outlet end to line 70, fig. 14; col. 8 In. 10-14; col. 3 In. 1-5).
Regarding claim 24, Fink modified by Faden discloses the method according to claim 23, as described above.
Fink further discloses further comprising providing an injection port (Y-injection fitting 152, fig. 14, col. 8 ln. 5-10 “Y-injection fitting 152 which permits the coupling of additional IV sets, or the injection of other medication at a Y-stem 154”) that intersects the first lumen (see fig. 14).
Fink is silent to the injection port intersecting the first lumen after the flush pump and prior to the flow merger.
Faden further discloses further comprising providing an injection port (port connector 275, fig. 14b, [0082]) that intersects the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) after the flush pump (260, fig. 14b) and prior to the flow merger (valve 270, fig. 14b, [0082]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink to have the injection port located after the flush pump and before the flow merger as taught by Faden. One would have been motivated to make the modification because with the injection port located after the flush pump, a user could inject an additional fluid continuously into the flow merger and bypass the pump, allowing for optional continuous deliver of two fluids simultaneously. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Regarding claim 25, Fink modified by Faden discloses the method according to claim 23, as described above.
Fink further discloses further comprising providing an injection port (Y-injection fitting 152, fig. 14, col. 8 ln. 5-10 “Y-injection fitting 152 which permits the coupling of additional IV sets, or the injection of other medication at a Y-stem 154”) that intersects the first lumen (see fig. 14).
Fink is silent to the injection port intersecting the first lumen after the flush pump and prior to the flow merger.
Faden further discloses further comprising providing an injection port (port connector 275, fig. 14b, [0082]) that intersects the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) after the flush pump (260, fig. 14b) and prior to the flow merger (valve 270, fig. 14b, [0082]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink to have the injection port located after the flush pump and before the flow merger as taught by Faden. One would have been motivated to make the modification because with the injection port located after the flush pump, a user could inject an additional fluid continuously into the flow merger and bypass the pump, allowing for optional continuous deliver of two fluids simultaneously. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Fink modified by Faden teaches the claimed invention except the injection port intersecting the second lumen instead of the first lumen. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the injection port on the second IV line instead of the first IV line, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement.
Regarding claim 26, Fink modified by Faden discloses the method according to claim 23, as described above.
Fink further discloses further comprising providing an injection port (Y-injection fitting 152, fig. 14, col. 8 ln. 5-10 “Y-injection fitting 152 which permits the coupling of additional IV sets, or the injection of other medication at a Y-stem 154”) that intersects the first lumen (see fig. 14).
Fink is silent to the injection port intersecting the first lumen after the flush pump and prior to the flow merger.
Faden further discloses further comprising providing an injection port (port connector 275, fig. 14b, [0082]) that intersects the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) after the flush pump (260, fig. 14b) and prior to the flow merger (valve 270, fig. 14b, [0082]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink to have the injection port located after the flush pump and before the flow merger as taught by Faden. One would have been motivated to make the modification because with the injection port located after the flush pump, a user could inject an additional fluid continuously into the flow merger and bypass the pump, allowing for optional continuous deliver of two fluids simultaneously. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Fink modified by Faden teaches the claimed invention except a second injection port intersecting the second lumen after the flush pump (see 112b interpretation above) and prior to the flow merger. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange a second injection port on the second IV line in the similarly claimed and taught position as that of the port on the first IV line, since it has been held that duplication of parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-B). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement, and would allow an additional access point for delivering additional fluid types as necessary, improving the flexibility of the modified device.
Regarding claim 27, Fink modified by Faden discloses the method according to claim 23, as described above.
Fink further discloses further comprising providing an injection port (Y-injection fitting 152, fig. 14, col. 8 ln. 5-10 “Y-injection fitting 152 which permits the coupling of additional IV sets, or the injection of other medication at a Y-stem 154”) that intersects the first lumen (see fig. 14).
Fink is silent to the injection port intersecting the first lumen after the flush pump and prior to the flow merger.
Faden further discloses further comprising providing an injection port (port connector 275, fig. 14b, [0082]) that intersects the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) after the flush pump (260, fig. 14b) and prior to the flow merger (valve 270, fig. 14b, [0082]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink to have the injection port located after the flush pump and before the flow merger as taught by Faden. One would have been motivated to make the modification because with the injection port located after the flush pump, a user could inject an additional fluid continuously into the flow merger and bypass the pump, allowing for optional continuous deliver of two fluids simultaneously. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Fink modified by Faden teaches the claimed invention except a second injection port intersecting the second lumen after the flush pump (see 112b interpretation above) and prior to the flow merger. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange a second injection port on the second IV line in the similarly claimed and taught position as that of the port on the first IV line, since it has been held that duplication of parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-B). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement, and would allow an additional access point for delivering additional fluid types as necessary, improving the flexibility of the modified device.
Fink as modified by Faden is silent to a third injection port that intersects the second lumen above the flush pump on the first lumen and before a lumen clamp on the second lumen.
A second embodiment of Faden, see fig. 14a, teaches an injection port (port connector 275, fig. 14b, [0082]) that intersects the second lumen above the flush pump (260, fig. 14b) on the first lumen (lumen of second upstream tubing 254, fig. 14a, [0061]) (see fig. 14a, note that the port connector 275 is relatively farther upstream from the connection point 270 than the pump 260 as shown) and [before] a lumen clamp (clamp 230, fig. 14a, [0058] a roller clamp such as, for example, thumb wheel regulator (TWR) 230) on the second lumen (lumen of first upstream tubing 252, fig. 14a, [0061]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink with other embodiments of Faden since the noted embodiments of Faden are similar. One would have been motivated to make the modification because incorporating an additional injection port would allow for even further fluids to be injected/attached as necessary for easy access.
Fink modified by Faden teaches the claimed invention except the third injection port intersecting the second lumen above the flush pump on the first lumen and before a lumen clamp on the second lumen. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the third injection port on the second IV line to be above/before both noted structures, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement. Additionally, the new arrangement would be beneficial because having the roller clamp located after the port connector allows for priming of the line to be checked prior to allowing full flow through the second lumen, therefore allowing a clinician to better control delivery of fluid through the port connector 275.
Regarding claim 29, Fink modified by Faden discloses the method according to claim 21, as described above. Fink further discloses further comprising providing the first lumen as coupled longitudinally at least in part to the second lumen between respective outer surfaces thereof (coupled in a parallel relative orientation, Fig. 14).
Regarding claim 31, Fink discloses a method of administering an IV to a patient, the method comprising steps of:
connecting a dual lumen IV set (IV set, Fig. 14, col. 7 ln. 63-col. 8 ln. 19) to the patient, the dual lumen IV set including a first lumen (lumen extending through tubings 146, 150, 156; fig. 14; col. 8 In. 5-14) having an inner diameter of a first value (see fig. 14, note that fluid flows through the noted tubings and thus they must have an inner diameter of a value), and a second lumen (second lumen extending through tubings 146', 150', 156'; fig. 14; col. 8, In 5-14) having an inner diameter of a second value (see fig. 14, note that fluid flows through the noted tubings and thus they must have an inner diameter of a value);
establishing a first IV flow through the first lumen (liquid medication 142, fig. 14, col. 7 ln. 63-col. 8 ln. 19);
establishing a second IV flow through the second lumen (liquid medication 142’, fig. 14, col. 7 ln. 63-col. 8 ln. 19); and
merging, into a merged flow (flow through flexible tubing section 80, fig. 14, col. 8 ln. 14-17), the first IV flow in the first lumen and the second IV flow in the second lumen, the merged flow being merged prior to entering the patient (see fig. 14; col. 7 ln. 64-69, “…two medications may be delivered individually or simultaneously to a patient through the same needle.”).
Fink is silent to the relative inner diameters of the first and second lumens, actuating a flush pump to draw IV fluid into the first lumen to regulate a volume of the IV flow, and providing an injection port in the second lumen.
Faden, directed to an apparatus and method for dispensing fluid intravenously, teaches:
providing an injection port (port connector 275, fig. 14a, [0082]) in the second lumen (lumen of second upstream tubing 252, fig. 14a, [0061]) for when a patient needs a drug injected ([0082] port connector 275 may be used to introduce an IV fluid, such as a medicament); and
actuating a flush pump (reservoir pump 260, fig. 14a, [0091] and [0083]) to draw IV fluid into the first lumen (lumen of second upstream tubing 254, fig. 14a, [0061]) to regulate a volume of the first IV flow ([0063] reservoir pump 260 dispenses a predetermined amount of IV fluid into tubing 256 and pressure-operated valve 270 when operated).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the IV set of Fink to include the injection port and the flush pump taught by Faden since both references deal with IV fluid delivery systems. One would have been motivated to make the modification because the flush pump of Faden allows for user-controlled bolus delivery, instead of just continuous flow. Therefore, the fluid delivery can be better controlled by the user. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Fink modified by Faden discloses all limitations of the claim invention except for wherein the second value is greater than the first value. This limitation represents only a change in size/proportion (MPEP 2144.04(IV)(A)). Altering the relative diameters of the first and second lumina would not adversely affect the fluid delivery system of Fink modified by Faden. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation. Additionally, while Fink modified by Faden fails to specifically teach the second value that is greater than the first value, Fink teaches the ports of valve body 14 of valve 10 having a first diameter and a second diameter, the second diameter greater than the first (Fig. 6), and tubes 26, 28, 30 coupled to the ports (Fig. 1, Fig. 6, col. 3, In 57-60). It would have been obvious to one of ordinary skill in the art that the set of Fink could have been modified as claimed, through routine experimentation, for secure attachment of the tubes to the valve ports.
Regarding claim 32, Fink modified by Faden discloses the method according to claim 31, as described above. Fink further discloses wherein the step of merging includes merging a flow output via a flow merger (valve 10, fig. 14) to combine the first IV flow that is output from a distal end of the first lumen (lumen extending through tubings 146, 150, 156; fig. 14) and the second IV flow that is output from a distal end of the second lumen (lumen extending through tubings 146', 150', 156'; fig. 14) to form the merged flow in an exit lumen (line 70, fig. 14) (valve 10 couples to distal ends of tubes 156, 156' and coupled at an outlet end to line 70, fig. 14; col. 8 In. 10-14; col. 3 In. 1-5).
Regarding claim 33, Fink modified by Faden discloses the method according to claim 31, as described above.
Fink and Faden are silent to wherein the injection port is a first injection port, and wherein the method further comprises providing a second injection port that intersects the first lumen after the flush pump and prior to the flow merger.
An additional embodiment of Faden, see fig. 14b, teaches further comprising providing an injection port (port connector 275, fig. 14b, [0082]) that intersects the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) after the flush pump (260, fig. 14b) and prior to the flow merger (valve 270, fig. 14b, [0082]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink to have an additional injection port located after the flush pump and before the flow merger as taught by Faden fig. 14b. One would have been motivated to make the modification because with the injection port located after the flush pump, a user could inject an additional fluid continuously into the flow merger and bypass the pump, allowing for optional continuous deliver of two fluids simultaneously. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Regarding claim 34, Fink modified by Faden discloses the method according to claim 31, including wherein the injection port (Faden: port connector 275, fig. 14a) is a [first] injection port that intersects the second lumen before the flush pump (see fig. 14a, note that the port connector 275 is relatively farther upstream from the connection point 270 than the pump 260 as shown).
Fink modified by Faden teaches the claimed invention except a second injection port that intersects the second lumen after the flush pump (see 112b interpretation above) and prior to the flow merger. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange a second injection port on the second IV line after the flush pump, since it has been held that duplication of parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-B). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement, and would allow an additional access point for delivering additional fluid types as necessary, improving the flexibility of the modified device. Additionally, it would have been obvious to place the second IV line after the flush pump since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement. Note that no criticality is provided for the claimed arrangement.
Regarding claim 35, Fink modified by Faden discloses the method according to claim 31, wherein the injection port (Faden: port connector 275, fig. 14a) is a [first] injection port that intersects the second lumen before the flush pump (see fig. 14a, note that the port connector 275 is relatively farther upstream from the connection point 270 than the pump 260 as shown).
Fink and Faden are silent to wherein the method further comprises:
a second injection port that intersects the first lumen after the flush pump and prior to the flow merger, and
a third injection port that intersects the second lumen after the flush pump and prior to the flow merger.
An additional embodiment of Faden, see fig. 14b, teaches further comprising providing an injection port (port connector 275, fig. 14b, [0082]) that intersects the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) after the flush pump (260, fig. 14b) and prior to the flow merger (valve 270, fig. 14b, [0082]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Fink to have an additional injection port located after the flush pump and before the flow merger as taught by Faden fig. 14b. One would have been motivated to make the modification because with the injection port located after the flush pump, a user could inject an additional fluid continuously into the flow merger and bypass the pump, allowing for optional continuous deliver of two fluids simultaneously. Additionally, including the injection port of Faden allows for additional drugs to be delivered as necessary during treatment without connecting a new IV line, thus reducing harm to the patient.
Fink modified by Faden teaches the claimed invention except a second injection port that intersects the second lumen after the flush pump (see 112b interpretation above) and prior to the flow merger. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange a second injection port on the second IV line after the flush pump, since it has been held that duplication of parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-B). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement, and would allow an additional access point for delivering additional fluid types as necessary, improving the flexibility of the modified device. Additionally, it would have been obvious to place the second IV line after the flush pump since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of supplying additional fluids to a patient with the described arrangement. Note that no criticality is provided for the claimed arrangement.
Regarding claim 37, Fink modified by Faden discloses the method according to claim 31, as described above. Fink further discloses further comprising providing the first lumen as coupled longitudinally at least in part to the second lumen between respective outer surfaces thereof (coupled in a parallel relative orientation, Fig. 14).
Claim(s) 28, 30, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Fink modified by Faden and further in view of Hart et al (US 20020077597 A1; hereafter Hart).
Regarding claim 28, Fink modified by Faden discloses the method according to claim 22, as described above, including wherein the flush pump (Faden: 260, fig. 14b) is disposed inline with the first lumen (Faden: lumen of upstream tubing 254, fig. 14b) after the flow splitter (Faden: 280, fig. 14b) (Faden: see inline arrangement shown in fig. 14b), the flush pump (260) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to regulate the volume of the IV flow (Faden: [0063] reservoir pump 260 dispenses a predetermined amount of IV fluid into tubing 256 and pressure-operated valve 270 when operated).
Fink and Faden are silent to regulating the volume of the IV flow via actuation of a valve disposed at a flow input end of the flush pump.
Hart, directed to a fluid injection device, teaches a flush pump (compressible reservoir pump 132, fig. 1, [0021]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to regulate the volume of IV fluid flow via actuation of a valve (one-way valve 136, fig. 1, [0021]) disposed at a flow input ([0021] describes fluid going through fluid inlet conduit 130 through pump 132 to outlet tube 134) end of the flush pump (see fig. 1 which shows valve 136 at the flow input end connected to inlet conduit 130; note [0021] one-way valve 136 allows fluid to flow only in the distal direction, as indicated by the arrow on the valve 136).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Fink modified by Faden to include the valve at the flow input end of the flush pump as taught by Hart since all three deal with delivering fluid to a patient’s vasculature. One would have been motivated to make the modification because doing so prevents fluid from flowing backward when the pump is actuated, as noted in [0021] of Hart.
Regarding claim 30, Fink modified by Faden discloses the method according to claim 21, as described above.
Fink and Faden are silent to wherein the step of actuating the flush pump includes manually squeezing the flush pump via hand.
Hart teaches wherein the step of actuating the flush pump includes manually squeezing the flush pump via hand ([0006] “The present invention reduces the hand injection of contrast to one simple step, the squeeze of a small pump located on or near the manifold”; [0025] [0025] Upon compression by the physician, fluid in the reservoir 230, such as contrast media, is forced through one-way valve 234).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Fink modified by Faden to include a manually actuated flush pump as taught by Hart since all three deal with delivering fluid to a patient’s vasculature. One would have been motivated to make the modification because having the flush pump be actuated manually allows the user to have fine control over the delivery and quickly alter the delivery rate as necessary.
Regarding claim 36, Fink modified by Faden discloses the method according to claim 31, as described above including wherein the flush pump (Faden: 260, fig. 14b) is disposed inline with the first lumen (Faden: lumen of upstream tubing 254, fig. 14b) after the flow splitter (Faden: 280, fig. 14b) (Faden: see inline arrangement shown in fig. 14b), the flush pump (260) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to regulate the volume of the IV flow (Faden: [0063] reservoir pump 260 dispenses a predetermined amount of IV fluid into tubing 256 and pressure-operated valve 270 when operated).
Fink and Faden are silent to regulating the volume of the IV flow via actuation of a valve disposed at a flow input end of the flush pump.
Hart, directed to a fluid injection device, teaches a flush pump (compressible reservoir pump 132, fig. 1, [0021]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to regulate the volume of IV fluid flow via actuation of a valve (one-way valve 136, fig. 1, [0021]) disposed at a flow input ([0021] describes fluid going through fluid inlet conduit 130 through pump 132 to outlet tube 134) end of the flush pump (see fig. 1 which shows valve 136 at the flow input end connected to inlet conduit 130; note [0021] one-way valve 136 allows fluid to flow only in the distal direction, as indicated by the arrow on the valve 136).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Fink modified by Faden to include the valve at the flow input end of the flush pump as taught by Hart since all three deal with delivering fluid to a patient’s vasculature. One would have been motivated to make the modification because doing so prevents fluid from flowing backward when the pump is actuated, as noted in [0021] of Hart.
Regarding claim 38, Fink modified by Faden discloses the method according to claim 31, wherein the step of actuating the flush pump includes manually squeezing the flush pump via hand.
Fink and Faden are silent to wherein the step of actuating the flush pump includes manually squeezing the flush pump via hand.
Hart teaches wherein the step of actuating the flush pump includes manually squeezing the flush pump via hand ([0006] “The present invention reduces the hand injection of contrast to one simple step, the squeeze of a small pump located on or near the manifold”; [0025] [0025] Upon compression by the physician, fluid in the reservoir 230, such as contrast media, is forced through one-way valve 234).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Fink modified by Faden to include a manually actuated flush pump as taught by Hart since all three deal with delivering fluid to a patient’s vasculature. One would have been motivated to make the modification because having the flush pump be actuated manually allows the user to have fine control over the delivery and quickly alter the delivery rate as necessary.
Claim(s) 29 and 37 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Fink modified by Faden and further in view of O’Neil (US 5364377 A; hereafter O’Neil).
Alternatively, regarding claim 29, Fink modified by Faden discloses the method according to claim 21, as described above.
Fink and Faden are silent to coupling between respective outer surfaces thereof.
O’Neil, directed to a fluid coupling, teaches further comprising providing the first lumen (lumen of tube 44, see figs. 4-6) as coupled longitudinally at least in part to the second lumen (lumen of tube 46, see figs. 4-6) between respective outer surfaces thereof (see figs. 4-6, col. 4 ln. 56-60, tubes 44, 46 and 48 are embedded within the lumen of a connector by an adhesive or resin 58; col. 4 ln. 35-41, tubing grip 56 can be slid along the tubes 44, 46 and 48 to selectively vary the length of tubing up to the connector 42 that is clustered as a compact group).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the lumina of Fink modified by Faden to include contact between the exterior of the tubes forming the lumina as taught by O’Neil since all references deal with tubing for use in injection. One would have been motivated to make the modification because clustering the tubes allows for a sort of “V-set” connection at the tubing outlets which, as noted by O’Neil col. 5 ln. 18-35, is safer for patients because it mitigates fluid flow inconsistencies which may arise when using a “Y-set”.
Alternatively, regarding claim 37, Fink modified by Faden discloses the method according to claim 31, as described above.
Fink and Faden are silent to coupling between respective outer surfaces thereof.
O’Neil, directed to a fluid coupling, teaches further comprising providing the first lumen (lumen of tube 44, see figs. 4-6) as coupled longitudinally at least in part to the second lumen (lumen of tube 46, see figs. 4-6) between respective outer surfaces thereof (see figs. 4-6, col. 4 ln. 56-60, tubes 44, 46 and 48 are embedded within the lumen of a connector by an adhesive or resin 58; col. 4 ln. 35-41, tubing grip 56 can be slid along the tubes 44, 46 and 48 to selectively vary the length of tubing up to the connector 42 that is clustered as a compact group).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the lumina of Fink modified by Faden to include contact between the exterior of the tubes forming the lumina as taught by O’Neil since all references deal with tubing for use in injection. One would have been motivated to make the modification because clustering the tubes allows for a sort of “V-set” connection at the tubing outlets which, as noted by O’Neil col. 5 ln. 18-35, is safer for patients because it mitigates fluid flow inconsistencies which may arise when using a “Y-set”.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/22/2026