DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-2, 4-6, 8-13, 15, and 17 are objected to because of the following informalities:
-Claim 1, line 5: please correct “thereto” to “to the body of the patient”
-Claim 1, line 8: please correct “thereof” to “of the fluid conveyance assembly”
-Claim 1, line 11: please correct “fluid” to “the fluid”
-Claim 1, line 11: please correct “thereof” to “of the first and second fluidic lines”
-Claim 1, line 11: please correct “therebetween” to “between the opposite ends of the first and second fluidic lines”
-Claim 1, line 15: please correct “inner ones” to “inner ends”
-Claim 2, line 3: please correct “the corresponding one” to “a corresponding one”
-Claim 4, line 3: please correct “the corresponding one” to “a corresponding one”
-Claim 4, line 4: please delete “thereto”
-Claim 5, line 3: please correct “the corresponding one” to “a corresponding one”
-Claim 6, line 2: please correct “the flexible tubing” to “the flexible tubing of the corresponding one of the first and second fluidic lines”
-Claim 8, line 3: please correct “the event” to “an event”
-Claim 9, line 4: please correct “thereof” to “of the enclosure”
-Claim 10, line 6: please correct “thereto” to “to the fixed-length linearly-extending member”
-Claim 10, lines 6-7: please correct “the attachment members” to “the first and second attachment members”
-Claim 11, lines 2-3: please correct “said movable one of the attachment members” to “said another one of the first and second attachment members”
-Claim 11, line 4: please correct “the movable attachment member” to “the another one of the first and second attachment members”
-Claim 11, lines 4-5: please correct “said fixed one of the attachment members” to “said one of the first and second attachment members”
-Claim 12, line 6: please correct “thereof” to “of the fluid conveyance assembly”
-Claim 13, line 2: please correct “a bridging device” to “the bridging device”
-Claim 15, line 3: please correct “a bridging device” to “the bridging device”
-Claim 17, line 5: please correct “a bridging device” to “the bridging device”
-Claim 17, line 6: please correct “the attachment members” to “the opposite attachment members”
-Claim 17, line 7: please correct “therebetween” to “between the opposite attachment members”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Filz (US 2017/0065808 A1).
Regarding claim 1, Filz discloses a fluid transfer system for a patient (see Figs. 1-8, par. [0013], [0019], [0039], [0041], [0045]), comprising:
a reservoir supported in generally fixed location externally of a body of the patient and configured to receive a fluid (see par. [0013], [0041], [0045], the intravenous tubing of Fig. 3 is connected at one end to a fluid source to allow delivery of intravenous fluids to a patient);
a fluid exchange catheter configured for insertion into the body of the patient so as to be fixed in relation thereto and configured for transferring the fluid between the patient and the reservoir (see par. [0013], [0041], [0045], the intravenous tubing of Fig. 3 is connected at the other end to an IV needle/catheter to allow delivery of intravenous fluids to a patient);
a fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) configured to convey the fluid between opposite ends thereof (see Fig. 3, par. [0041] and [0045], fluid is deliverable through the IV tubing) and fluidically interconnecting the reservoir and the fluid exchange catheter (see Fig. 3, par. [0013]), wherein the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) includes first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)) in fluidic intercommunication (see Fig. 3, par. [0041] and [0045]), wherein each of the first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)) is configured to transfer fluid between opposite ends thereof (see Fig. 3, par. [0041] and [0045]) and includes flexible tubing therebetween such that the opposite ends of the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]), which are respectively connected to the reservoir and the fluid exchange catheter (see Fig. 3, par. [0013]), are movable relative to one another, such that the fluid conveyance assembly is tensionable (see Fig. 3, par. [0013]-[0014], [0016], [0041] and [0045], intravenous tubing is flexible such that it can bend from connection to a fluid source/bag/pump and into the patient on the bed);
wherein inner ones of the opposite ends of the first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)), which are proximal to each other and in fluidic intercommunication (see Fig. 3), form a joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) which is free of external support (see Fig. 3, par. [0041] and [0045]); and
a joint reinforcement device (apparatus of Figs. 1-2) configured to reinforce the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) in the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]), wherein the joint reinforcement device (apparatus of Figs. 1-2) comprises first and second attachment members (channels and grooves 24) attached in fixed relation to the first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)) to be positioned on either side of the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) (see Figs. 2-3, par. [0041], the intravenous tubing is inserted and clipped into a fixed position in the channels and grooves 24) and a bridging member (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) interconnecting the first and second attachment members (channels and grooves 24) and which is rigid (see par. [0041]), such that the joint reinforcement device (apparatus of Figs. 1-2) forms an auxiliary path around the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) for transmission of tensile forces along the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) (see Figs. 1-3, par. [0041] and [0045], the manifold/port(s) are clipped into the apparatus of Figs. 1-2 and thus forms an enclosure/path around the manifold/port(s) which would allow transmission of tensile forces along the intravenous tubing).
Regarding claim 2, Filz discloses the fluid transfer system of claim 1, wherein at least one of the first and second attachment members (channels and grooves 24) of the joint reinforcement device (apparatus of Figs. 1-2) is configured to attach to the flexible tubing (intravenous tubing, see Fig. 3, par. [0041]) of the corresponding one of the first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)) (see Fig. 3, par. [0041]).
Regarding claim 3, Filz discloses the fluid transfer system of claim 1, wherein, when at least one of the inner ends of the first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)) is in the form of a rigid connector (port(s), see par. [0019], [0041], [0045]), a corresponding one of the first and second attachment members (channels and grooves 24) of the joint reinforcement device (apparatus of Figs. 1-2) is configured to attach to the rigid connector (port(s), see par. [0019], [0041], [0045]) (see Fig. 3, par. [0041]).
Regarding claim 4, Filz discloses the fluid transfer system of claim 1, wherein at least one of the first and second attachment members (channels and grooves 24) of the joint reinforcement device (apparatus of Figs. 1-2) is in the form of a clip configured to at least partially surround the corresponding one of the first and second fluidic lines (see Fig. 3, par. [0045], the intravenous tubing has a first fluidic line connected to one side of the manifold/port(s) and a second fluidic line connected to the other side of the manifold/port(s)) at an attachment location thereto (see Fig. 3, par. [0041]).
Regarding claim 7, Filz discloses the fluid transfer system of claim 1, wherein the bridging member (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) comprises an enclosure (body 20) configured to surround the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) (see Figs. 3-4, par. [0041]).
Regarding claim 9, Filz discloses the fluid transfer system of claim 7, wherein the enclosure (body 20) comprises first and second portions (halves of body 20) which are interconnected and movable relative to one another between an open position (see Fig. 3) in which an interior of the enclosure (body 20) is accessible from an exterior thereof and a closed position (see Fig. 4) in which the interior is closed, wherein the enclosure (body 20) further includes a lock (latching mechanism or inter-lock device, see par. [0041]) for maintaining the first and second portions (halves of body 20) in the closed position (see Fig. 4) (see Figs. 3-4, par. [0039] and [0041]).
Regarding claim 12, Filz discloses a method (see Figs. 1-8, par. [0039], [0041], [0045]) for transferring fluid between an external reservoir and a patient using a catheter inserted in a body of the patient (see par. [0013], [0041], [0045], the intravenous tubing of Fig. 3 is connected at one end to a fluid source and at the other end to an IV needle/catheter to allow delivery of intravenous fluids to a patient), the method comprising:
fluidically interconnecting the reservoir and the catheter using a fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) which is flexible such that opposite ends of the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) are movable relative to one another (see Fig. 3, par. [0013]-[0014], [0016], [0041] and [0045], intravenous tubing is flexible such that it can bend from connection to a fluid source/bag/pump and into the patient on the bed), wherein the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) includes a joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) intermediate the opposite ends thereof so as to be free of support, wherein the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) is formed between different parts of the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) and is fluidically sealed (see Fig. 3, par. [0041] and [0045]); and
attaching a bridging device (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) to reinforce the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint), wherein the bridging device (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) is attached to said different parts (see Fig. 3, par. [0045], the intravenous tubing has one part connected to one side of the manifold/port(s) and another part connected to the other side of the manifold/port(s)) in fluidic intercommunication (see Fig. 3, par. [0041] and [0045]) of the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) on either side of the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint), so as to locate the bridging device (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) in coincident relation with the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) to provide an auxiliary path for tensile forces transmitted along the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) (see Figs. 1-3, par. [0041] and [0045], the manifold/port(s) are clipped into the apparatus of Figs. 1-2 and thus forms an enclosure/path around the manifold/port(s) which would allow transmission of tensile forces along the intravenous tubing).
Regarding claim 13, Filz discloses the method of claim 12 wherein, when the bridging device (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) includes an enclosure (body 20), attaching a bridging device (see Fig. 2, the lower half of the body 20 interconnects the channels and grooves 24) to reinforce the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) includes enclosing the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) (see Figs. 3-4, par. [0041]).
Regarding claim 14, Filz discloses the method of claim 13 wherein enclosing the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) includes locking the enclosure (body 20) in a closed position (see Fig. 4, par. [0041]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Filz (US 2017/0065808 A1), as applied to claims 1 and 12 above, in view of Hupps (US 10,413,713 B1).
Regarding claim 5, Filz discloses the fluid transfer system of claim 1. However, Filz fails to state wherein at least one of the first and second attachment members is in the form of a spool configured to windingly receive the flexible tubing of the corresponding one of the first and second fluidic lines.
Hupps teaches a fluid transfer system (see Figs. 1-4, col. 4 line 59-col. 5 line 3) comprising an attachment member (spool 150) in the form of a spool configured to windingly receive the flexible tubing of the fluidic line (fluid supply tube 112) (see Figs. 1-4, col. 5 lines 51-59, col. 6 lines 43-58).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify at least one of the first and second attachment members of the fluid transfer system of Filz to be in the form of a spool configured to windingly receive the flexible tubing of the corresponding one of the first and second fluidic lines, as suggested by Hupps, in order to allow the system to automatically retract the first and second fluidic lines into the joint reinforcement device in a simple and economical manner in order to manage any excess length of the first and second fluidic lines when the full, overall length of the first and second fluidic lines is not needed to reach the patient (see Hupps col. 4 lines 52-58).
Regarding claim 6, modified Filz teaches the fluid transfer system of claim 5 substantially as claimed. Modified Filz further teaches wherein the spool (Hupps, spool 150) includes a pair of diametrically opposite slots (see Hupps Fig. 7, col. 8 lines 1-10, each of plates 154 and 156 has a slot which allows the tubing to be held within the spool 150) for releasably securing the flexible tubing to the spool (Hupps, spool 150) (see previous modifications in rejection of claim 5 above to cause at least one of the first and second attachment members 24 of Filz to be a spool as taught by Hupps; see Hupps Fig. 7, col. 8 lines 1-10, each of plates 154 and 156 has a slot which allows the tubing to be held within the spool 150).
Regarding claim 15, Filz discloses the method of claim 12 wherein, when the fluid conveyance assembly (intravenous tubing, see Fig. 3, par. [0041]) includes flexible tubing proximal to the joint (see Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) (see Fig. 3, par. [0013]-[0014], [0016], [0041] and [0045], intravenous tubing is flexible such that it can bend from connection to a fluid source/bag/pump and into the patient on the bed).
However, Filz fails to state wherein when the bridging device comprises a spool, attaching a bridging device to reinforce the joint includes wrapping a length of the flexible tubing around the spool.
Hupps teaches a method (see Figs. 1-4, col. 4 line 59-col. 5 line 3) wherein when the bridging device (housing half 122) comprises a spool (spool 150), attaching a bridging device (housing half 122) to reinforce the flexible tubing (fluid supply tube 112) includes wrapping a length of the flexible tubing (fluid supply tube 112) around the spool (spool 150) (see Figs. 1-4, col. 5 lines 51-59, col. 6 lines 43-58).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the bridging device of the method of Filz to be a spool such that attaching the bridging device to reinforce the joint includes wrapping a length of the flexible tubing around the spool, as suggested by Hupps, in order to allow the method to automatically retract the flexible tubing into the bridging device in a simple and economical manner in order to manage any excess length of the flexible tubing when the full, overall length of the flexible tubing is not needed to reach the patient (see Hupps col. 4 lines 52-58).
Regarding claim 16, modified Filz teaches the method of claim 15 substantially as claimed. Modified Filz further teaches wherein the length of the flexible tubing (Filz intravenous tubing, see Fig. 3, par. [0041]) is wrapped around the spool (Hupps spool 150) to leave an untensioned end portion of the flexible tubing (Filz intravenous tubing, see Fig. 3, par. [0041]) between the joint (see Filz Fig. 3, par. [0041] and [0045], the manifold/port(s) is a joint) and the spool (Hupps, spool 150) (see previous modifications in rejection of claim 15 above to cause the bridging device of Filz to include a spool as taught by Hupps; since the joint and the spool are both held within the bridging device, an untensioned end of the flexible tubing would be between the joint and the spool).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Filz (US 2017/0065808 A1), as applied to claim 7 above, in view of Balsiger et al. (US 2023/0074512 A1).
Regarding claim 8, Filz discloses the fluid transfer system of claim 7. However, Filz fails to state wherein the joint reinforcement device further includes a visual indicator inside the enclosure and configured to change colour in response to contact with the fluid in the event of a leak.
Balsiger teaches a fluid transfer system (see Figs. 3A-B, par. [0026]) wherein the joint reinforcement device (chamber 12) further includes a visual indicator (coating, see par. [0030], [0039]) inside the enclosure (halves 18) and configured to change colour in response to contact with the fluid in the event of a leak (see Figs. 3A-B, par. [0030], [0039]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid transfer system of Filz to include wherein the joint reinforcement device further includes a visual indicator inside the enclosure and configured to change colour in response to contact with the fluid in the event of a leak, as taught by Balsiger, in order to allow the user to monitor the joint reinforcement device and its contents for contamination (see Balsiger par. [0039]).
Claims 10-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Filz (US 2017/0065808 A1), as applied to claims 1 and 12 above, in view of Schweikert (US 7,614,123 B2).
Regarding claim 10, Filz discloses the fluid transfer system of claim 1. However, Filz fails to state wherein the bridging member comprises a fixed-length linearly-extending member and one of the first and second attachment members is supported in fixed relation to the fixed-length linearly-extending member and another one of the first and second attachment members is movably supported on the fixed-length linearly-extending member and configured to be releasably secured in fixed position thereto, so as to adjust spacing between the attachment members.
Schweikert teaches a fluid transfer system (see Figs. 8-10, col. 1 lines 13-17) wherein the bridging member (luer clip 300) comprises a fixed-length linearly-extending member (proximal portion 310) and one of the first and second attachment members (clip formed by legs 322/324 and opening 326) is supported in fixed relation to the fixed-length linearly-extending member (proximal portion 310) and another one of the first and second attachment members (clip formed by legs 342/344 and opening 346) is movably supported on the fixed-length linearly-extending member (proximal portion 310) and configured to be releasably secured in fixed position thereto, so as to adjust spacing between the attachment members (clip formed by legs 322/324 and opening 326 and clip formed by legs 342/344 and opening 346) (see Figs. 8-10, col. 6 line 4-col. 7 line 10).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Filz such that the bridging member comprises a fixed-length linearly-extending member and one of the first and second attachment members is supported in fixed relation to the fixed-length linearly-extending member and another one of the first and second attachment members is movably supported on the fixed-length linearly-extending member and configured to be releasably secured in fixed position thereto, so as to adjust spacing between the attachment members, as taught by Schweikert, in order to securely connect and lock the first and second fluidic lines with the joint (see Schweikert col. 6 line 4-col. 7 line 10).
Regarding claim 11, modified Filz teaches fluid transfer system of claim 10 substantially as claimed. Modified Filz further teaches wherein the joint reinforcement device (Filz, apparatus of Figs. 1-2) includes a ratchet mechanism (Schweikert, beveled tab 334 and locking slots 320) operatively interconnecting said movable one of the attachment members (Schweikert, clip formed by legs 342/344 and opening 346) to the fixed-length linearly-extending member (Schweikert, proximal portion 310) and configured to resist movement of the movable attachment member (Schweikert, clip formed by legs 342/344 and opening 346) away from said fixed one of the attachment members (Schweikert, clip formed by legs 322/324 and opening 326) (see previous modifications in rejection of claim 10 above to cause the bridging member of Filz to include the fixed length-linearly extending member of Schweikert which has the movable and fixed first and second attachment members; see Schweikert col. 6 line 4-col. 7 line 10).
Regarding claim 17, Filz discloses the method of claim 12. However, Filz fails to state wherein, when the bridging device has adjustable length between opposite attachment members and comprises a ratchet mechanism operatively interconnecting the opposite attachment members for maintaining the opposite attachment members at a fixed distance, attaching a bridging device to reinforce the joint comprises attaching the opposite attachment members in spaced relation to each other on the joint and ratcheting the attachment members towards each other to relieve tension in the fluid conveyance assembly therebetween.
Schweikert teaches a method (see Figs. 8-10, col. 1 lines 13-17) wherein, when the bridging device (luer clip 300) has adjustable length between opposite attachment members (clip formed by legs 322/324 and opening 326 and clip formed by legs 342/344 and opening 346) and comprises a ratchet mechanism (beveled tab 334 and locking slots 320) operatively interconnecting the opposite attachment members (clip formed by legs 322/324 and opening 326 and clip formed by legs 342/344 and opening 346) for maintaining the opposite attachment members (clip formed by legs 322/324 and opening 326 and clip formed by legs 342/344 and opening 346) at a fixed distance, attaching a bridging device (luer clip 300) to reinforce the joint (female luer 220 and male luer 240) comprises attaching the opposite attachment members (clip formed by legs 322/324 and opening 326 and clip formed by legs 342/344 and opening 346) in spaced relation to each other on the joint (female luer 220 and male luer 240) and ratcheting the attachment members (clip formed by legs 322/324 and opening 326 and clip formed by legs 342/344 and opening 346) towards each other to relieve tension in the fluid conveyance assembly (tubes 210 and 230) therebetween (see Figs. 8-10, col. 6 line 4-col. 7 line 10).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Filz to include wherein, when the bridging device has adjustable length between opposite attachment members and comprises a ratchet mechanism operatively interconnecting the opposite attachment members for maintaining the opposite attachment members at a fixed distance, attaching a bridging device to reinforce the joint comprises attaching the opposite attachment members in spaced relation to each other on the joint and ratcheting the attachment members towards each other to relieve tension in the fluid conveyance assembly therebetween, as taught by Schweikert, in order to securely connect and lock the fluid conveyance assembly with the joint (see Schweikert col. 6 line 4-col. 7 line 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783