DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment on 01/12/2026. As directed by the amendment: claims 1-13 have been amended, no claims have been cancelled, and claims 19-21 have been added. Thus, claims 1-21 are presently pending in this application, with claims 14-18 being withdrawn from consideration. Applicant’s amendments to the claims, specification, and drawings have overcome each and every objection and 112 rejection as set forth in the Non-Final Office Action mailed on 12/16/2025.
Claim Objections
Claims 1, 11-12, and 19-21 are objected to because of the following informalities:
Regarding claim 1, the phrase “bubble forming gas” in line 12 should read “bubble-forming gas” to add a hyphen for consistency,
Regarding claim 11, the phrase “wherein the distal ends of the at least two IV tubes” in line 2 should read “the distal ends of each of the at least two IV tubes” for clarity,
Regarding claim 12, the phrase “to control flow through the each of the at least two IV tubes” in line 3 should read “to control flow through each of the at least two IV tubes” to remove an extra “the”,
Regarding claims 19-21, the phrase “The intravascular fluid delivery system of claim 1” should read “The intravascular fluid delivery system of claim,” to add a comma for proper grammar,
Regarding claim 21, the phrase “out let” in line 2 should read “outlet” to correct a typo,
Regarding claim 21, the phrase “a user” in line 3 should read “the user” for proper antecedent basis,
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 6-10 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.
Claim 6 recites the limitation "the drip spout" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 6-10, the phrase “the enclosed volume of the drip chamber provided an enclosed chamber volume” in lines 3-4 of claim 6 and the subsequent iterations of “the enclosed volume” and “the enclosed chamber volume” renders the claim indefinite because it is unclear. It is unclear whether the enclosed volume of the drip chamber and the enclosed chamber volume of the drip chamber are the same structure or different. From the claims, they are referenced as separate structures. However, the specification nor drawings provide any clarity on the difference between the two. Examiner is interpreting them as the same structure denoted by “an enclosed drip chamber volume 50” as shown in Fig. 2. Examiner suggests applicant amend to converge the two separate limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-4, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar et al. (U.S Patent Pub. No. 20080004574 A1, “Dyar”) in view of Theeuwes (U.S Patent No. 4540403) in view of Sasahara et al. (U.S Patent Pub. No. 20190388674 A1, “Sasahara”) in view of Kolbel (U.S Patent Pub. No. 20170367861 A1).
Regarding claim 1, Dyar discloses the limitations of (Claim 1) an intravascular fluid delivery system (10 in Fig. 1-3 and para. 0009) comprising:
a medicament container (12 in Fig. 1) providing a container volume (volume of 12, see Fig. 1 and para. 0009 for volume of container 12),
a set of at least two IV tubes (36, 40 in Fig. 1, see para. 0010 – tubing 36 and 40 are used in IV infusion set 10 and thus are considered IV tubes),
a manifold (44 in Fig. 1-2) communicating between the volume (volume of 12) and the set of at least two IV tubes (36, 40) fixedly attached to the manifold (44) at their proximal ends for the delivery of medicament intravascularly from the container volume (volume of 12) through distal ends of the at least two IV tubes (36, 38, see Fig. 1-2 and para. 0010 – IV tubing 36 and 40 are fixedly attached to manifold 44 at their proximal ends through drip chambers 30 and 32 which thus communicates them with the volume of container 12).
While Dyar discloses a Y-connector (22 in Fig. 1) for connecting the distal ends of the two IV tubes (36 and 40) to additional tubing (18) which is sealed with a cap (16, see para. 0009), Dyar fails to disclose (Claim 1) at least one cap releasably sealing the distal ends of the at least two IV tubes to define a system volume being the inter-communicating volumes of the medicament container, the at least two IV tubes, and the manifold sealed against outside air; and a degassed saline solution free of bubble forming gas filling the system volume to an exclusion of bubble-forming gas, and a medicament container providing a container volume of at least 100 ml.
Theeuwes discloses an intravenous delivery system (10 in Fig. 1) for administering an agent (12) such as saline from a container volume (11 in Fig.1, see Col.2, lines 21-27 and Col.6, line 1), wherein Theeuwes teaches (Claim 1) the medicament container (11 in Fig. 1) providing a container volume of at least 100 ml (see Col.6, lines 7-15 – examiner notes 1 cc is equivalent to 1 ml, thus the container volume may be about 100 ml -350 ml or 250 ml to 1000 ml).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container volume taught by Dyar to be at least 100 ml as taught by Theeuwes as Theeuwes provides motivation that the volume of the container should be selected to provide a volume sufficient for performing a preselected therapeutic program (see Col.6, lines 4-15).
Sasahara discloses a Y-connector (in Fig. 1, 5, and 12) with a cap (6) that is capable of coupling two tubes to a single, distal tube (see para. 0041), wherein Sasahara teaches (Claim 1) at least one cap (“medical connector” para. 0041 and in Fig. 1, 5, and 10) releasably sealing the distal ends of two tubes (see Fig. 1, 5, and 12 and para. 0047 – upon coupling the connectors Ca1 and Ca2 to distal ends of two tubes, the distal ends of the two tubes would be releasably sealed by the cap 6 of the Y-connector).
Since modified Dyar discloses the at least two IV tubes (36, 40) connected at their distal ends to a Y-connector (22) for coupling to line (18) ending with cap (16, see Fig. 1), and Sasahara discloses a Y-connector (Fig. 1) which can be releasably capped by cap (6), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the Y-connector of modified Dyar with the Y-connector of Sasahara. In combination, the Y-connector (Fig. 1) of Sasahara would replace the Y-connector (22) of Dyar such that the distal ends of the IV tubes (36, 40) can be releasably sealed when cap (6) closes the Y-connector (Fig. 1) of Sasahara or be coupled to the line (18) of Dyar thus allowing the user to reuse and dispose of certain parts of the system by being able to prime them separately. Such that when, cap (6) is closed on the Y-connector (Fig. 1) of Sasahara, modified Dyar would define (Claim 1) a system volume being the inter-communicating volumes of the medicament container (12), the at least two IV tubes (36, 40), and the manifold (44) sealed against outside air. Sasahara provides motivation for using the Y-connector construction as it allows for sealing off any desired connector of the Y-connector for desired priming of attached components while also providing a ventilation option (see para. 0009 and 0020).
Kolbel discloses a vascular stent and graft delivery system that is flushed with degassed saline solution before use (see para. 0039), wherein Kolbel teaches (Claim 1) a degassed saline solution free of bubble forming gas filling the system volume to an exclusion of bubble-forming gas (see para. 0039 and 0044 – a degassed saline solution which has been degassed by vacuum degasification or other suitable methods is used to flush the delivery device 8 and thus fill its volume).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified system taught by modified Dyar to incorporate a degassed saline solution to fill the system volume as taught by Kolbel as Kolbel teaches uses degassed solutions rather than standard solutions increases their ability to take up target gases during flushing and prevents bubble formation during storage (see para. 0039). In combination, modified Dyar having the Y-connector and cap of Sasahara would be filled with the degassed saline solution excluding any bubble-forming gas as taught by Kolbel.
Regarding claim 3, modified Dyar discloses the intravascular fluid delivery system of claim 1, as discussed above. In modified Dyar, Sasahara discloses (Claim 3) wherein the at least one cap (“medical-connector” in para. 0041 and Fig. 1) is a capping manifold joining the distal ends of each of the at least two tubes to a common manifold chamber (“R” in para. 0042) sealed against outside air (see Fig. 5 and 12 and para. 0042 and 0047 - Y-connector of Fig. 1 as shown in Fig. 5 and 10 defines a common manifold chamber “R” which are sealed against outside air when connectors Ca2 and Ca1 are connected to the distal ends of tubes and cap 6 is sealed over connector Cb).
Regarding claim 4, modified Dyar discloses the intravascular fluid delivery system of claim 3, as discussed above. In modified Dyar, Sasahara discloses (Claim 4) wherein the capping manifold includes an irreversibly sealable manifold outlet (“Cb” in para. 0047-0048, examiner notes the instant application provides a definition for the limitation “irreversibly sealable” in para. 0046 stating "irreversibly sealable" herein, meaning that they can be readily sealed when open but resist undetectable and inadvertent unsealing by a user after first being closed,” see Fig. 12 and para. 0047-0048 – port Cb may be readily sealed when open by cap 6 and resists inadvertent unsealing by a user after being closed unless a user intentionally removes the cap 6).
In modified Dyar, the Y-connector (Fig. 1) of Sasahara replaces the Y-connector (22) of Dyar such that the distal ends of the IV tubes (36, 40) are connected to Y-connector (Fig. 1 of Sasahara) with an irreversibly sealable manifold outlet (“Cb”) which is capable of being adapted for flushing the at least two IV tubes (36, 40) during manufacture (examiner notes when cap 6 is intentionally removed by the user from the Y-connector in Fig. 1 of Sasahara, the IV tubes 36 and 40 of Dyar would be capable of being flushed during manufacture).
Regarding claim 20, modified Dyar discloses the system of claim 1, as discussed above. In modified Dyar, Dyar discloses (Claim 20) wherein the medicament container (12), set of at least two IV tubes (36, 40) and manifold (44) are interconnected to prevent ready decoupling by the user (examiner notes ready decoupling by the user is being interpreted as the user cannot easily separate the connections during normal use, see para. 0010 and 0012 – all the connections within the system are bonded connections such as UV bonded such that they cannot be easily separated by the user during normal use).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Sardari et al. (U.S Patent Pub. No. 20180264225 A1, “Sardari”).
Regarding claim 2, modified Dyar discloses the intravascular fluid delivery system of claim 1, as discussed above.
In modified Dyar, Kolbel discloses (Claim 2) the degassed saline solution (see para. 0039).
However, modified Dyar fails to disclose the degassed saline solution includes heparin.
Sardari discloses a flushing system for intravascular or percutaneous catheter systems (see para. 0084), wherein Sardari teaches (Claim 2) the saline solution includes heparin (see para. 0136 – the saline solution may be heparinized).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the degassed saline solution taught by modified Dyar to include heparin as taught by Sardari as Sardari teaches incorporating heparin into saline solution enhances its anticoagulant properties (see para. 0136).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Thompson et al. (U.S Patent Pub. No. 20230031533 A1, “Thompson”).
Regarding claim 5, modifier Dyar discloses the intravascular fluid delivery system of claim 1, as discussed above. However, modified Dyar fails to disclose (Claim 5) wherein the medicament container further provides a sealable flush channel positioned, in opposition to a communication between the container volume and the manifold, at a top end of the medicament container as defined by normal operation of the intravascular fluid delivery system.
Thompson discloses a container (1 in Fig. 1) for holding a volume of enteral feeding solution (see Fig. 1 and para. 0149), wherein the container (1) comprises a delivery outlet (6) interfacing with tubing (10 in Fig. 16) for delivery of the solution and an inlet (5) for refilling the container (1, see para. 0149). Thompson teaches (Claim 5) wherein the container (1 in Fig. 1) further provides a sealable flush channel (5 in Fig. 1) positioned, in opposition to a communication (6 in Fig. 1) between the container volume and the manifold (19 in Fig. 1), at a top end of the medicament container (1, examiner notes a sealable flush channel is being interpreted as a channel that can be is sealable and configured for flushing, see Fig. 1 and para. 0149 and 0153 – inlet 5 is a channel that is sealable by cap 20 and is capable of being configured for flushing, inlet 5 is positioned in opposite to the outlet 6).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication container taught by modified Dyar to incorporate an inlet as taught by Thompson. In combination, the medication container (12 in Fig. 1) of modified Dyar would be modified to comprise an inlet (5) as taught by Thompson placed in opposite to the outlet (60) of the medication container (12) of Dyar such that the inlet (5) would be positioned at a top end of the container (12) as defined by normal operation of the intravascular fluid delivery system (10, examiner notes normal operation of the system 10 of Dyar would have the orientation of the medication container 12 seen in Fig. 1 placing the inlet 5 at its proximal end in opposition to the distal outlet 60). Thompson provides motivation for this modification as the inlet allows for refilling and venting of the container (see para. 0149 and 0153), and would further provide opening for flushing of the container if desired.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Davis et al. (U.S Patent Pub. No. 20110275988 A1, “Davis”).
Regarding claim 6, modified Dyar discloses the intravascular fluid delivery system of claim 1, as discussed above. In modified Dyar, Dyar discloses the limitations of (Claim 6) further including a drip chamber (30, 32 in Fig. 1-2 and 5) positioned along each of the at least two IV tubes (36, 40 in Fig. 1, see para. 0010-0011), the enclosed volume of the drip chamber (30, 32 in Fig. 5) providing an enclosed chamber volume (see Fig. 5) communicating with a drip spout inlet (64, 66 in Fig. 5) receiving medicament into the drip spout (64, 66) extending into the enclosed chamber volume (see Fig. 5) to form drips of medicament that may fall through gas in the enclosed chamber volume (examiner is interpreting the enclosed volume and the enclosed chamber volume as the same interior volume of the drip chamber, see Fig. 5 and para. 0011 – each drip chamber 30 and 32 comprises a drip spout inlet 64 and 66, respectively, which extend into the volumes defined by each chamber and receives the medicament to form drips that fall through each chamber); a drip chamber outlet (34, 38 in Fig. 5) collecting the drips of medicament to conduct them to a corresponding IV tube (36, 40, see Fig. 2 and 5 and para. 0011).
However, modified Dyar fails to disclose (Claim 6) wherein the drip chamber comprises a chamber flush inlet for receiving a flushing medium for scavenging gas from the drip chamber.
Davis discloses an intravenous delivery system (10 in Fig. 3) comprising a drip chamber (40 in Fig. 3) having a drip spout inlet (46 in Fig. 3) and drip chamber outlet (48 in Fig. 3, see para. 0030 and 0035), wherein Davis teaches (Claim 6) wherein the drip chamber (40 in Fig. 3) comprises a chamber flush inlet (44 in Fig. 3) for receiving a flushing medium for scavenging gas from the drip chamber (40 in Fig. 3, see para. 0032).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drip chamber taught by modified Dyar to incorporate an a chamber flush inlet as taught by Davis. Davis teaches that providing a priming/flushing port in the drip chamber allows a priming or flushing solution to be delivered directly to the drip chamber and downstream components to remove air from the system (see para. 0032-0033).
Regarding claim 7, modified Dyar discloses the intravascular fluid delivery system of claim 6, as discussed above. In modified Dyar, Davis discloses (Claim 7) wherein the chamber flush inlet (44 in Fig. 3) provides for a greater flow rate at a given pressure than the drip spout inlet (46, see Fig. 2-3 and para. 0063 – chamber flush inlet 44 has a larger, inner diameter than inner diameter of the drip spout inlet 46 at point 64 which proves a greater flow rate at a given pressure due to the increased diameter).
Regarding claim 8, modified Dyar discloses the intravascular fluid delivery system of claim 6, as discussed above. In modified Dyar, Davis discloses (Claim 8) wherein the chamber flush inlet (44 in Fig. 3) joins with the enclosed volume (volume of 40) of the drip chamber (40) at an uppermost end of the enclosed volume (volume of 40) of the drip chamber (40) as defined by normal operation of the drip chamber (40, see Fig. 3-4 and para. 0032 – chamber flush inlet 44 joins with the interior volume of drip chamber 40 an uppermost, proximal end of the drip chamber 40 as defined by normal operation of the system 10 seen in the orientation illustrated in Fig. 3).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel in view of Davis as applied to claim 6 above, and further in view of Bormann et al. (U.S Patent Pub. No. 20020029021 A1, “Bormann”).
Regarding claim 9, modified Dyar discloses the intravascular fluid delivery system of claim 6, as discussed above.
However, modified Dyar fails to disclose (Claim 9) wherein the enclosed chamber volume of the drip chamber further communicates with a vent opening closed by a resealable cap to allow venting of air into the drip chamber during use.
Davis teaches the limitations of (Claim 9) wherein the enclosed chamber volume (volume of 40) of the drip chamber (40 in Fig. 3) further communicates with a vent opening (74 in Fig. 3) to allow venting of air into the drip chamber (40) during use (see para. 0045 and 0052).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drip chamber taught by modified Dyar to incorporate a vent opening as taught by Davis to allow negative pressure within the drip chamber to permit automatic flow out of the outlet of the drip chamber (see para. 0045).
However, modified Dyar fails to disclose (Claim 9) a vent opening closed by a resealable cap.
Bormann discloses a drip chamber (100 in Fig. 1) for use in intravenous systems (see para. 0004), wherein Bormann teaches (Claim 9) a vent opening (3 in Fig. 1) closed by a resealable cap (see para. 0062 and 0084 – vent 3 may be sealed by a cap that can be placed on vent 3 and removed from vent 3 by the user indicating it is resealable).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drip chamber having the vent opening taught by modified Dyar to incorporate resealable cap for the vent opening as taught by Bormann. Bormann teaches that the providing resealable cap for the vent opening allows for the selective entry and exit of gas from the drip chamber (see para. 0062).
Regarding claim 10, modified Dyar discloses the intravascular fluid delivery system of claim 9, as discussed above. In modified Dyar, Davis discloses (Claim 10) wherein the vent opening (74 in Fig. 3) includes a filter (see para. 0052).
However, modified Dyar fails to explicitly disclose the filter sized to prevent an introduction of bacteria into the enclosed volume of the drip chamber.
Bormann teaches (Claim 10) wherein the vent opening (3 in Fig. 1) further includes a filter (10 in Fig. 1) sized to prevent an introduction of bacteria into the enclosed volume (15, 20) of the drip chamber (100, see Fig. 1 and para. 0051 – porous medium 10 acts as a filter for the vent 3 and has a pore structure sized to block bacteria from entering the drip chamber interior of combined chambers 15 and 20).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filter of the vent opening taught by modified Dyar to incorporate a pore structure sized to prevent introduction of bacteria as taught by Bormann. Bormann teaches that the providing the porous medium with this pore structure precludes bacteria from entering the system (see para. 0051).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Brugger et al. (U.S Patent No. 5776091, “Brugger”).
Regarding claim 11, modified Dyar discloses the intravascular fluid delivery system of claim 1, as discussed above. In modified Dyar, Sasahara discloses (Claim 11) the distal ends of the at least two tubes are provided with connectors for engaging the connectors (Ca2 and Ca1) of the at least one cap (see Fig. 1 and para. 0043 – examiner notes that the connectors Ca1 and Ca2 are configured for mating with complementary connectors at the distal ends of the tubes).
However, modified Dyar fails to disclose the connectors as explicitly luer locks.
Brugger discloses a Y-connector (102 in Fig. 8) adapted for connecting the distal ends of two lines (66, 38) to a common line (104, see Fig. 8 and Col.7, lines 42-45), wherein the Y-connector comprises male luer connectors (116, 118) for connection to corresponding connectors on the distal ends of the two lines (66, 38, see Fig. 8 and Col.8, lines 7-10 – examiner notes that luer connectors are standardized connectors making the connectors on the distal ends of the two lines female luer connectors).
Since the Y-connector (see Fig. 1) of Sasahara in modified Dyar comprises two male connectors (Ca1 and Ca2, see Fig. 1), and Brugger discloses a Y-connector comprising two male luer connectors (116, 118), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified distal ends of the at least two IV tubes and male connectors of the Y-connector taught by modified Dyar to be luer connectors as taught by Brugger according to known methods to yield predictable results. Both connectors are Y-connectors comprising two male connectors for connection to tubing, and thus one of ordinary skill in the art would have recognized that the combination would yield results of standardized luer connections that are predictable. Further, Brugger discloses that using luer connections is preferable than other connection types (see Col.8, lines 7-10). In combination, the Y-connector (see Fig. 1) of Sasahara in modified Dyar coupled to the distal ends of the IV tubes (36, 40) of Dyar is being modified to have two male luer connectors corresponding to two female luer connectors on the IV tubes (36, 40) of Dyar as taught by Brugger, and the provided luer connectors on the IV tubes (36, 40) would be capable of being configured for subsequent attachment to intravascular catheters upon disconnection from the Y-connector.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Li et al. (U.S Patent Pub. No. 20210085949 A1, “Li”).
Regarding claim 12, modified Dyar discloses the intravascular fluid delivery system of claim 1, as discussed above.
While Dyar discloses that a pinch clamp (42) may be clamped on one of the IV tubes (40, see Fig. 1), modified Dyar fails to disclose (Claim 12) at least one metering clamp on each of the at least two IV tubes operative to control flow through the each of the at least two IV tubes.
Li discloses a multi-tubing intravenous extension set (10 in Fig. 1) comprising at least two IV tubes (18, 19, 21, 22), wherein Li teaches (Claim 12) at least one metering clamp (27 in Fig. 1) on each of the at least two IV tubes (18, 19, 21, 22) operative to control flow through the each of the at least two IV tubes (18, 19, 21, 22, see Fig. 1 and para. 0025).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Dyar to incorporate at least one metering clamp on each IV tube as taught by Li since Li teaches that clamps provided on each IV tube allows the selective flow blocking for each IV tube especially during priming (see para. 0025).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel in view of Li as applied to claim 12 above, and further in view of Urquhart et al. (U.S Patent No. 4583981, “Urquhart”).
Regarding claim 13, modified Dyar discloses the intravascular fluid delivery system of claim 12, as discussed above.
However, modified Dyar fails to disclose (Claim 13) further including at least two metering clamps on each of the at least two IV tubes.
Urquhart discloses an intravenous fluid delivery system (10 in Fig. 1) comprising at least two IV tubes (21, 35 in Fig. 1), wherein Urquhart teaches (Claim 13) at least two metering clamps (33, 40 in Fig. 1) on an IV tube (35, see Fig. 1 and Col.5, lines 43-47 and Col.6, lines 3-10 – IV tube 35 may comprise two metering clamps 33 and 40).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Dyar to incorporate at least two metering clamps on each IV tube as taught by Urquhart since Urquhart teaches that providing two metering clamps on a single IV tube allows for more fine-tuned control of flow rate along the length of a single IV tube (see Col.6, lines 3-10). In combination, each IV tube of modified Dyar comprises at least one metering clamp as taught by Li and would further be modified to incorporate at least two metering clamps as taught by Urquhart for more fine-tuned control of flow rate along the lengths of each IV tube.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Burg et al. (W.O Patent Pub. No. 2008003045 A2, “Burg”).
Regarding claim 19, modified Dyar discloses the system of claim 1, as discussed above. In modified Dyar, Dyar discloses (Claim 19) wherein the medicament container (12 in Fig. 1) is an IV bag (see para. 0009).
However, Dyar does not explicitly disclose the IV bag is constructed of a flexible medical grade plastic.
Burg discloses fluid containers for holding medical fluids for intravenous administration (see para. 01), wherein Burg teaches (Claim 19) wherein the medicament container is an IV bag (12 in Fig. 1-2) constructed of a flexible medical grade plastic (see para. 01 – the bag 12 is constructed of a flexible medical grade polyolefin film).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IV bag taught by modified Dyar to be constructed of a flexible medical grade plastic as taught by Burg. Burg teaches that utilizing a flexible medical grade polyolefin film to construct the IV bag provides an improved IV bag with a longer shelf life, lower moisture vapor transmission rate, and can be terminally sterilized using high temperature treatment (see para. 01).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar in view of Theeuwes in view of Sasahara in view of Kolbel as applied to claim 1 above, and further in view of Richmond (U.S Patent No. 6068617).
Regarding claim 21, modified Dyar discloses the system of claim 1, as discussed above. In modified Dyar, Dyar discloses (Claim 21) wherein the manifold (44) provides at least one out let port (see annotated Dyar drawing 1 below for at least one outlet port).
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However, modified Dyar fails to disclose wherein the at least one outlet port is irreversibly sealed to resist undetectable and inadvertent unsealing by a user after first being closed.
Richmond discloses an IV system (in Fig. 1) having a valve manifold (346 in Fig. 10) disposed between the IV bag (350 in Fig. 10) and drip chamber (20 in Fig. 1), wherein Richmond teaches (Claim 21) wherein the manifold (346 in Fig. 10) provides at least one out let port (ports of 352, 354) that is irreversibly sealed to resist undetectable inadvertent unsealing by a user after being closed (examiner notes the instant application provides a definition for the limitation “irreversibly sealable” in para. 0046 stating "irreversibly sealable" herein, meaning that they can be readily sealed when open but resist undetectable and inadvertent unsealing by a user after first being closed, see Fig. 10 and Col.9, lines 8-20 – valve manifold 346 has outlet ports of valves 352 and 354 which may be irreversibly sealed by tamper-resistant caps 356 and 358 which readily seal the outlets port but provide detectable tampering after first being closed).
Since Dyar discloses a valve manifold (44) having two outlet ports, and Richmond discloses a valve manifold (346) having two outlet ports with tamper-resistant caps (356, 358), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet ports taught by modified Dyar to have tamper-resistant caps before use as taught by Richmond. Richmond provides caps on the outlet ports that are tamper-resistant and thus having plastic ratchet threads that strip during removal to prevent tampering before use (see Col.9, lines 8-20).
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783