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 .
Status of the Claims
Claims 21-38 are currently pending. Claims 31-38 are currently rejected. Claims 21 and 31 are currently amended.
Information Disclosure Statement
The information disclosure statement(s) (IDS) 12/22/2022 has been considered by the Examiner. The previously lined through documents were included with the parent application, and all documents have thus been considered. An updated signed IDS is included with this Office Action.
Response to Arguments
Applicant’s arguments filed 04/27/2026 with respect to claim(s) 21 and 31 as amended have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the amendments to claims 21 and 31 overcome the previous 112(b) rejections. Examiner disagrees, please see 112(b) rejections below.
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 25-26 and 34-35, recite the limitation of an “injection port that intersects the second lumen (after/before) the flush pump”. Independent claims 21 and 31 recite a flush pump associated with a first lumen. The amendment to claims 21 and 31 of the flush pump being “disposed inline with the first lumen” fail to clarify the issues in the dependent claims, because the phrase “injection port that intersects the second lumen after the flush pump and prior to the flow merger” may be interpreted as “injection port that intersects the second lumen after the flush pump (intersects the second lumen) and prior to the flow merger (intersecting the second lumen)”. From the claim limitations it is unclear whether an additional flush pump is meant to be located along the second lumen, in which case such the claim language should be altered to clarify the difference between the two flush pumps, or whether the location of the injection port is made with reference to a point along the first lumen, in which case that limitation should be included clearly in the claim language. For purposes of examination, any of the interpretations noted above is interpreted to meet the claim limitation.
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 is rejected under 35 U.S.C. 102 as being anticipated by Vaillancourt (US 4585435 A; hereafter Vaillancourt), or alternatively under 35 U.S.C. 103 as being unpatentable over Vaillancourt in view of Faden (US-20190070406-A1; hereafter Faden)
Regarding claim 21, Vaillancourt discloses a method of administering an IV to a patient, the method comprising steps of:
connecting a dual lumen IV set (extension set 50, fig. 5, col. 6 ln. 20-24, “the extension set 50 is constructed so that the means defining a pair of lumen is in the form of a pair of elongated flexible tubes 51, 52 which are disposed substantially one within the other”; col. 6 ln. 61-68, “the micro-tube 51 may be made as part of the wall of a double tube extrusion”) to the patient (col. 7 ln. 12-14, fluid flows through needle 65 into vein of the patient), the dual lumen IV set including a first lumen (micro-bore tube 51, figs. 7 and 8) having an inner diameter of a first value (see figs. 7-8), and a second lumen (tube 52, figs. 7 and 8) having an inner diameter of a second value (see figs. 7-8) that is greater than the first value (col. 6 ln. 50-52, “the inner tube 51 is of smaller size than the outer tube 52”);
establishing an IV flow through the first lumen (col. 6 ln. 53-55, “col. 7 ln. 12-14, fluid flows through needle 65 into vein of the patient”; also see col. 2 ln. 62-65);
inputting a drug into the second lumen (col. 2 ln. 62-65, “each of the lumen of the set may be respectively connected to a means for delivering an intravenous fluid or a means for delivering a drug”) of the dual lumen IV set (col. 6 ln. 29-35, fluid is delivered from administration set 15 by pump 58 into outer tube 52, see fig. 5); and
actuating a flush pump (syringe pump 17, fig. 5, col. 6 ln. 41-45) disposed inline with the first lumen (micro-bore tube 51, figs. 7 and 8) to draw IV fluid into the first lumen to regulate a volume of the IV flow (syringe pump 17, fig. 5, “As indicated, a well 60 is disposed within the rubber diaphragm 59 and is reduced in section until terminating in a small opening which receives the inner tube 51. In addition, a syringe 61 having a needle 62 is utilized to pierce the rubber diaphragm 59 so as to deliver a drug thereto, for example from a suitable syringe pump 17 via a supply line 63 as indicated in FIG. 5.”); and
merging, into a merged flow (see fig. 6 which shows the flows of tubes 51 and 52 merging in the connector 54 prior to entering the catheter needle 65; col. 6 ln. 25-29), the IV flow in the first lumen and the drug in the second lumen, the merged flow being merged prior to entering the patient (col. 7 ln. 12-14, fluid flows through needle 65 into vein of the patient) (col. 6 ln. 25-29, “As illustrated in FIG. 6, the outermost tube 52 has a terminal end which is secured within a socket 53 of a luer slip connector 54 whereas the inner tube 51 extends through the socket 53 into a tapered male part 55 of the connector 54.”).
Alternatively, Vaillancourt is silent to the flush pump drawing IV fluid into the first lumen. Examiner notes that pump 58 in fig. 5 does appear to draw fluid into the second lumen (see fig. 5 and col. 6 ln. 20-35).
Faden, directed to an apparatus and method for dispensing fluid intravenously, teaches a flush pump (reservoir pump 260, fig. 14b, [0091] and [0083]) disposed inline with the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) to draw IV fluid into the first lumen (see fig. 14b which shows reservoir pump 260 inline with upstream tubing 254) 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 syringe pump of Vaillancourt to be a reservoir pump which draws fluid into the lumen, as taught by Faden, since both references deal with delivering multiple fluids intravenously. Additionally, as noted above, Vaillancourt fig. 5 shows pump 58 in line with the second lumen and appearing to draw fluid into the second lumen (see fig. 5 and col. 6 ln. 20-35). One would have been motivated to make the modification because having the flush pump disposed such that it draws fluid from a reservoir and dispenses a dose through a valve would facilitate repeatable bolus delivery and ensure that not too much fluid passes through the pump at one time.
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt, or alternatively over Vaillancourt in view of Faden.
Regarding claim 31 ,Vaillancourt discloses a method of administering an IV to a patient, the method comprising steps of:
connecting a dual lumen IV set (extension set 50, fig. 5, col. 6 ln. 20-24, “the extension set 50 is constructed so that the means defining a pair of lumen is in the form of a pair of elongated flexible tubes 51, 52 which are disposed substantially one within the other”; col. 6 ln. 61-68, “the micro-tube 51 may be made as part of the wall of a double tube extrusion”) to the patient (col. 7 ln. 12-14, fluid flows through needle 65 into vein of the patient), the dual lumen IV set including a first lumen (micro-bore tube 51, figs. 7 and 8) having an inner diameter of a first value (see figs. 7-8), and a second lumen (tube 52, figs. 7 and 8) having an inner diameter of a second value (see figs. 7-8) that is greater than the first value (col. 6 ln. 50-52, “the inner tube 51 is of smaller size than the outer tube 52”);
establishing a firth IV flow through the first lumen (col. 6 ln. 53-55, “col. 7 ln. 12-14, fluid flows through needle 65 into vein of the patient”; also see col. 2 ln. 62-65);
establishing a second IV flow through the second lumen (col. 2 ln. 62-65, “each of the lumen of the set may be respectively connected to a means for delivering an intravenous fluid or a means for delivering a drug”);
actuating a flush pump (syringe pump 17, fig. 5, col. 6 ln. 41-45) disposed inline with the first lumen (micro-bore tube 51, figs. 7 and 8) to draw IV fluid into the first lumen to regulate a volume of the IV flow (syringe pump 17, fig. 5, “As indicated, a well 60 is disposed within the rubber diaphragm 59 and is reduced in section until terminating in a small opening which receives the inner tube 51. In addition, a syringe 61 having a needle 62 is utilized to pierce the rubber diaphragm 59 so as to deliver a drug thereto, for example from a suitable syringe pump 17 via a supply line 63 as indicated in FIG. 5.”); and
merging, into a merged flow (see fig. 6 which shows the flows of tubes 51 and 52 merging in the connector 54 prior to entering the catheter needle 65; col. 6 ln. 25-29), 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 (col. 7 ln. 12-14, fluid flows through needle 65 into vein of the patient) (col. 6 ln. 25-29, “As illustrated in FIG. 6, the outermost tube 52 has a terminal end which is secured within a socket 53 of a luer slip connector 54 whereas the inner tube 51 extends through the socket 53 into a tapered male part 55 of the connector 54.”).
Vaillancourt figs. 5-8 are silent to providing an injection port in the second lumen for when the patient needs a drug injected.
Vaillancourt fig. 10, in a similar embodiment, teaches providing an injection port (Y-connector 80, fig. 10, col. 7 ln. 19-30) in the second lumen for when the patient needs a drug injected (Examiner nots that “for when the patient needs a drug injected” is a functional limitation which the provided injection port 80 meets).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Vaillancourt of figs. 5-8 to include an injection port in the second lumen, as taught by Vaillancourt fig. 10, since both embodiments are similar and deal with injection multiple fluids intravenously into a patient. One would have been motivated to make the modification because the injection port allows an additional fluid to be injected, and because the injection port would allow for an emptied fluid bag to be switched out for a full fluid bag without interrupting delivery of the intravenous fluid.
Alternatively, Vaillancourt is silent to the flush pump drawing IV fluid into the first lumen and an injection port in the second lumen for when the patient needs a drug injected. Examiner notes that pump 58 in fig. 5 does appear to draw fluid into the second lumen (see fig. 5 and col. 6 ln. 20-35), and that Vaillancourt fig. 10 shows an additional 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
a flush pump (reservoir pump 260, fig. 14b, [0091] and [0083]) disposed inline with the first lumen (lumen of second upstream tubing 254, fig. 14b, [0061]) to draw IV fluid into the first lumen (see fig. 14b which shows reservoir pump 260 inline with upstream tubing 254) 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 syringe pump of Vaillancourt to be a reservoir pump which draws fluid into the lumen, as taught by Faden, since both references deal with delivering multiple fluids intravenously. Additionally, as noted above, Vaillancourt fig. 5 shows pump 58 in line with the second lumen and appearing to draw fluid into the second lumen (see fig. 5 and col. 6 ln. 20-35). One would have been motivated to make the modification because having the flush pump disposed such that it draws fluid from a reservoir and dispenses a dose through a valve would facilitate repeatable bolus delivery and ensure that not too much fluid passes through the pump at one time. 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. It would have been further obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the IV set of Vaillancourt to include the injection port and the flush pump taught by Faden since both references deal with IV fluid delivery systems. Additionally, one would have been motivated to make the modification because 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.
Claim(s) 22-27, 29, 32-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt in view of Faden.
Regarding claim 22, Vaillancourt, or Vaillancourt modified by Faden, discloses the method according to claim 21, as described above.
Vaillancourt is silent to splitting the IV flow via a flow splitter.
Faden, directed to an apparatus and method for dispensing fluid intravenously, 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 modify Vaillancourt in view of 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, Vaillancourt modified by Faden discloses the method according to claim 22, as described above. Vaillancourt further discloses wherein the step of merging includes merging a flow output via a flow merger (luer slip connector 54, fig. 6, col. 6 ln. 25-29) to combine the first flow that is output from a distal end of the first lumen (lumen of micro-bore tube 51, as shown in fig. 7-8) and the second flow that is output from a distal end of the second lumen (lumen of tube 52, as shown in fig. 7-8) to form the merged flow in an exit lumen (lumen of catheter needle 65, fig. 6) (see fig. 6 which shows the flows of tubes 51 and 52 merging in the connector 54 prior to entering the catheter needle 65; col. 6 ln. 25-29).
Regarding claim 24, Vaillancourt modified by Faden discloses the method according to claim 23, as described above.
Faden further 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 Vaillancourt 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, Vaillancourt modified by Faden discloses the method according to claim 23, as described above.
Vaillancourt is silent to an 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 Vaillancourt to have an 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.
Vaillancourt 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, Vaillancourt modified by Faden discloses the method according to claim 23, as described above.
Vaillancourt is silent to a first injection port intersecting the first lumen after the flush pump and prior to the flow merger.
Faden further 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 Vaillancourt 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.
Vaillancourt 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 one would be motivated to make the modification because a second injection port would allow an additional access point for delivering additional fluid types as necessary, improving the flexibility of the modified device.
Regarding claim 27, Vaillancourt modified by Faden discloses the method according to claim 23, as described above.
Vaillancourt is silent to a first injection port intersecting the first lumen after the flush pump and prior to the flow merger.
Faden further 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 Vaillancourt to have an 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 an 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.
Vaillancourt 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 one would be motivated to make the modification because an additional injection port would allow an additional access point for delivering additional fluid types as necessary, improving the flexibility of the modified device.
Vaillancourt 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 Vaillancourt with other embodiments of Faden since the noted embodiments of Faden are similar, and again, Vaillancourt and Faden both deal with intravenous delivery of multiple fluids through a single needle. 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.
Vaillancourt 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, Vaillancourt modified by Faden discloses the method according to claim 21, as described above. Vaillancourt further discloses further comprising providing the first lumen as coupled longitudinally at least in part to the second lumen between respective outer surfaces thereof (see figs. 7-8 which show the first and second lumen coupled along respective outer surfaces along a longitudinal direction; col. 6 ln. 61-68).
Regarding claim 32, Vaillancourt modified by Faden discloses the method according to claim 31, as described above. Vaillancourt further discloses wherein the step of merging includes merging a flow output via a flow merger (luer slip connector 54, fig. 6, col. 6 ln. 25-29) to combine the first IV flow that is output from a distal end of the first lumen (lumen of micro-bore tube 51, as shown in fig. 7-8) and the second IV flow that is output from a distal end of the second lumen (lumen of tube 52, as shown in fig. 7-8) to form the merged flow in an exit lumen (lumen of catheter needle 65, fig. 6) (see fig. 6 which shows the flows of tubes 51 and 52 merging in the connector 54 prior to entering the catheter needle 65; col. 6 ln. 25-29).
Regarding claim 33, Vaillancourt modified by Faden discloses the method according to claim 31, as described above.
Vaillancourt 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 Vaillancourt 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, Vaillancourt 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).
Vaillancourt 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, Vaillancourt 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).
Vaillancourt 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 Vaillancourt 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.
Vaillancourt 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, Vaillancourt modified by Faden discloses the method according to claim 31, as described above. Vaillancourt further discloses further comprising providing the first lumen as coupled longitudinally at least in part to the second lumen between respective outer surfaces thereof (see figs. 7-8 which show the first and second lumen coupled along respective outer surfaces along a longitudinal direction; col. 6 ln. 61-68).
Claim(s) 28, 30, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt modified by Faden and further in view of Hart et al (US 20020077597 A1; hereafter Hart).
Regarding claim 28, Vaillancourt 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).
Vaillancourt 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 Vaillancourt 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, thus ensuring that the full dose delivered through the flush pump is pushed down the lumen toward the patient.
Regarding claim 30, Vaillancourt modified by Faden discloses the method according to claim 21, as described above.
Vaillancourt 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 Vaillancourt 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, Vaillancourt 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).
Vaillancourt 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 Vaillancourt 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, Vaillancourt 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.
Vaillancourt 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 Vaillancourt 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hadzic et al (US 5910135 A) - intravenous infusion system, fig. 1, flow is split from one source into a macro lumen and a micro lumen which are then rejoined.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/23/2026
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