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
The examiner acknowledges the amendments set forth by the applicant on 07/15/2026 for claims 1-4, 9, and 13.
Response to Arguments
Applicant’s amendments, with respect to the prior 112(b) rejections over claims 1-13 regarding indefinite phrases, have been accepted and overcome the 112(b) rejections, thus the 112(b) rejections have been withdrawn.
Applicant’s arguments with respect to the prior 103 rejection over claims 1-4 and 8-12 regarding wherein none of the prior art references whether considered alone or in combination, teaches or suggests the specific series connection arrangement recited in claim, have been fully considered but are not found persuasive. While it is true that Vincent teaches a Y-shaped, parallel-like configuration, and similarly true to that Klewinghaus does not cure this deficiency, the examiner utilized reference Lo, to cure this deficiency in the nonfinal OC, wherein on Page 8 the examiner states Lo [0057] re. a series configuration, also including the motivation to do so. In accordance to the continued arguments regarding how Lo does not cure this deficiency, the examiner disagrees as Lo was used to show that series connectivity within dialysis supply lines are known in the art, and as stated in the nonfinal rejection, the adapters from Klewinghaus and the system of Vincent make the modified invention compatible with the disclosed series-type style of Lo. Although Lo may use this series-type connection system in an earlier portion of the dialysis process for the delivery and/or storage of unmodified dialysate, Lo still teaches a dialysis supply system, thus existing in a small field of endeavor, similar to the invention of Vincent, allowing one of reasonable skill in the art prior to the effective filing date to modify Vincent with the series connectivity of Lo to allow for long-term storage of dialysate prior to the application of the dialysate with a patient. {Lo, [0117]}
Applicant’s arguments with respect to the 103 rejection over claims 1-4 and 8-12 pertaining to the removable first and second sections through the first and second connectors (in view of Klewinghaus) 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’s argument with respect to the prior 103 rejection over claim(s) 2-13 rely on their arguments for independent claim 1, thus, for the reasons set forth above, are not found persuasive.
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 1-2, 4, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vincent (WO2019150058A2) in view of Lo (US20140316332A1). Vincent is directed to the attached, machine-translated, English version.
Regarding claim 1, Vincent teaches a dialysis machine for treating a body fluid, the dialysis machine comprising: {Page 3 middle, "dialysis machine … plasma"}
a dialyzer comprising an enclosure {Page 3 middle, "dialyzer comprising an enclosure"} which includes a body fluid passage zone {Page 3 middle, "body fluid passage zone"} which has a body fluid inlet {Page 3 middle, "body fluid inlet"} and a body fluid outlet, {Page 3 middle, "body fluid outlet"} and a dialysate passage zone {Page 3 bottom, "dialysate passage zone"} which has a dialysate inlet {Page 3 bottom, "dialysate inlet"} and a dialysate outlet, {Page 3 bottom, "dialysate outlet"} and a membrane system between the body fluid passage zone and the dialysate passage zone; {Page 3 bottom, "membrane system … passage zone;"}
a dialysate delivery system, {Page 3 bottom, "dialysate delivery system"}
a connection system for connecting a dialysate supply source to the dialysate delivery system, {Page 4 top, "A connection system comprising: … connectable to the dialysate delivery system."}
the connection system comprising: a first section, {Page 4 top, "first branch"} which comprises a conduit {Page 4 top, "first conduit"} provided at one end with a first connection device {Page 4 top, "having and end capable of being connected"} which is connectable to a connector of a first dialysate supply source, {Page 4 top, "connected to a first dialysate supply source"} and which is disconnectable from said connector of the first dialysate supply source, {Page 4 bottom, "first branch is disconnected … supply"}
and provided at the other end with a second connection device, {Page 4 top, "a portion … first and second branch"} said conduit being a flexible conduit of constant cross section in the uncrushed state of said conduit, {Page 4 top, " a first conduit called a first branch"; Page 18 middle, "a first pipe, called the first branch"; Page 19 top, "The pipes of the connection system … flexible hoses"}
and a second section, which comprises a conduit {Page 4 top, "second conduit, called a second branch"} which has one end connected to a dialysate delivery system {Page 4 top, "connected to a second dialysate supply source"} and which is provided at an opposite end with a connection device which is connected, in a disconnectable manner, to the second connection device of the first section, {Page 18 bottom re. quick coupling or Luer lock connections for the first and second branches. Note how the quick couplings or Luer Locks, may be connected and disconnected repeatedly}
while allowing said first section to be disconnected from the second section, {Page 18 bottom re. quick coupling or Luer lock connections for the first and second branches"} said conduit of the second section being a flexible conduit of constant cross section in the uncrushed state of said conduit, {Page 4 top, " a second conduit, called a second branch"; Page 18 bottom, "a second pipe, called the second branch"; Page 19 top, "The pipes of the connection system … flexible hoses"}
so that, in the state with the first section disconnected and removed from the second section, said connection device of the second section is connectable to a connector of a second dialysate supply source {Page 18 bottom re. quick coupling or Luer lock connections for the first and second branches wherein either branch can be connected to the dialysate supply source} and disconnectable from said connector of the second dialysate supply source. {Page 18 bottom re. quick coupling or Luer lock connections for the first and second branches. Note how the quick couplings or Luer Locks, may be connected and disconnected repeatedly}
Vincent fails to teach a series connection of the first section and the second section.
Lo, drawn to a dialysate supply system {Lo, [0097]} teaches a series connection of the first section and the second section. {[0057], "another aspect … in series"}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify Vincent with Lo’s teachings of a series connection of the first section and the second section, as Lo, similar to Vincent, teaches a system for the delivery of biological fluid, specifically dialysate. {Lo, [0097]} Doing so provides a safe and stable environment for the delivery of dialysate, as dialysate often requires additives, separation, and/or sterilization before entering the patient. {Lo, [0117]}
Regarding claim 2, Vincent teaches wherein the connection system comprises a closing element {Page 4 top, "clamping system for opening / closing the first branch."} which, in the closed state, prevents liquid from circulating inside the conduit of the first section. {Page 11 top, "closing/opening downstream member … in the open state, allows the flow of dialysate … closed state, prevents the flow of dialysate."}
Regarding claim 4, Vincent teaches wherein the second section comprises an activatable and deactivatable opening and closing element {Page 4 top, "clamping system for opening / closing the second branch."} configured to allow or prevent the circulation of liquid through the conduit of the second section. {Page 11 top, "closing/opening downstream member … in the open state, allows the flow of dialysate … closed state, prevents the flow of dialysate."}
Regarding claim 8, Vincent teaches wherein the machine comprises: a dialysate feed line {Page 3 bottom, "dialysate feed line"} which is connectable to an inlet of a dialysate passage zone of the dialyzer, {Page 3 bottom, "dialysate feed line … passage zone"}
and a dialysate discharge line which is connectable to an outlet of the dialysate passage zone of the dialyzer. {Page 6 middle, "connection of the discharge … of the dialyzer"}
Regarding claim 9, Vincent teaches wherein the discharge line comprises a conduit {Page 6 middle, "connection duct, lines of the cassette"} for connection to a discharge device. {Page 12 bottom, "Said opening / closing … pockets 60 or 60'."}
Regarding claim 10, Vincent teaches wherein the machine comprises at least one flexible bag, called a ventricle bag, intended to contain dialysate and forming part of said delivery system. {Page 3 bottom, "dialysate delivery system … containing dialysate"}
Regarding claim 11, Vincent teaches wherein said at least one bag is included in a device, called a cassette, {Page 4 middle, "dialysate cassette … belong."} which is insertable into and removable from a corresponding housing provided in the dialysis machine. {Page 4 bottom, "called a cassette … machine"}
Regarding claim 12, Vincent teaches wherein the machine comprises a frame {Page 14 bottom, "relative to … machine"} and said device, called a cassette, is removable from the frame of the machine. {Page 14 bottom, "The cassette 9 … said frame"}
Regarding claim 13, Vincent teaches a method for successively connecting dialysate supply sources to a connection system of the machine as claimed in claim 1, the method comprising the following steps: {Page 4 top, "A connection system comprising: … connectable to the dialysate delivery system."}
providing the connection system {Page 4 top, "A connection system comprising: … connectable to the dialysate delivery system."} in a configuration in which the first section is connected to the second section, {Page 19 top, "Each branch 451… by its end 456"} the second section being connected by its other end to the dialysate delivery system; {Page 4 top, "a second conduit … supply source"}
providing a first dialysate supply source {Page 4 top, "first dialysate supply source"} having a connector not connected to the connection system; {Page 4 bottom, "while the first branch is disconnected … dialysate supply"}
when a stopper closes the end of the first section opposite the end connected to the second section, removing said stopper; {Page 4 middle, "the first branch is connected … being in the open position"}
connecting the first connection device of the first section to the first dialysate supply source, {Page 6 top, "connection by the user … first branch … dialysate delivery system"} and, after use of the first dialysate supply source:- preferably closing off the first section, {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}
preferably removing the first dialysate supply source and closing the connection device of the first section with the aid of a stopper; {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}
removing the first section from the second section of the device so that the second section has a free connection device; {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}
providing a second dialysate supply source having a connector not connected to the connection system; {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}
connecting the connector of the second dialysate supply source to the free connection device of said second section. {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Vincent (WO2019150058A2) modified by Lo (US20140316332A1), as applied to the claims above, in view of Klewinghaus (US20130237903A1). Vincent is directed to the attached, machine-translated, English version.
Regarding claim 3, modified Vincent fails to teach wherein the closing element is of the tamper-evident type so that, in the closed state, the closing element locks and/or damages the conduit of the first section in order to prevent reuse of the conduit after the closing element has been closed.
Klewinghaus, drawn to a connection device for a dialysis system {Klewinghaus, title}, teaches wherein the closing element is of the tamper-evident type so that, in the closed state, the closing element locks and/or damages the conduit of the first section in order to prevent reuse of the conduit after the closing element has been closed. {[0007] re. locking mechanism of tubing adapter & [0043] re. tubing adapter being released only in a destructive manner. Which would prevent the reuse of the conduit}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify modified Vincent with Klewinghaus’ teachings wherein the closing element is of the tamper-evident type so that, in the closed state, the closing element locks and/or damages the conduit of the first section in order to prevent reuse of the conduit after the closing element has been closed as Klewinghaus, similar to modified Vincent, teaches an apparatus for the delivery of biological fluid in dialysis. Doing so creates a system that minimizes pressure loss between components utilizing adapters or connectors between sections of the system. {Klewinghaus, [0005]}
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Vincent (WO2019150058A2) modified by Lo (US20140316332A1), as applied to the claims above, in view of Tsai (US20170036008A1). Vincent is directed to the attached, machine-translated, English version.
Regarding claim 5 and 7, Vincent teaches wherein the first connection device of the first section comprises: a tubular element {Page 18 bottom re. Luer Lock type connection for 451 (first branch)} capable of being engaged in an opening of the corresponding connector of the first dialysate supply source in order to allow liquid communication inside said tubular element. {Page 18 bottom re. wherein the tubing comprises an end (453, and one side of Luer Lock) that is capable of being connected to the quick connector (other side Luer Lock)}
Modified Vincent fails to teach a peripheral wall which extends around and at a distance from the tubular element in order to define an annular space for insertion of a peripheral wall of said connector of the first dialysate supply source; (Claim 5) and wherein the second connection device of the first section comprises a peripheral wall provided with a thread able to cooperate with an internal thread formed in the peripheral wall of the connection device of the second section. (Claim 7)
Tsai, drawn to a specific type of Luer connection {Tsai, title}, teaches a peripheral wall {[0031] middle, "The first member 20 has … to define a chamber therein."} which extends around and at a distance from the tubular element in order to define an annular space {[0031] middle, "The first member 20 has … to define a chamber therein."} for insertion of a peripheral wall of said connector of the first dialysate supply source; (Claim 5) {[0031] middle, "closed male luer … fluid transfusion tubing"} and wherein the second connection device of the first section comprises a peripheral wall {[0031] middle, "The first member 20 … to define a chamber therein."} provided with a thread {[0031] middle, "male-connection head 221 … threads."} able to cooperate with an internal thread formed in the peripheral wall of the connection device of the second section. (Claim 7) {[0031] bottom, "second member 30 can serve … needlefree connector"}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify modified Vincent with Tsai’s teachings of a peripheral wall which extends around and at a distance from the tubular element in order to define an annular space for insertion of a peripheral wall of said connector of the first dialysate supply source; (Claim 5) and wherein the second connection device of the first section comprises a peripheral wall provided with a thread able to cooperate with an internal thread formed in the peripheral wall of the connection device of the second section (Claim 7) as Tsai, similar to modified Vincent, teaches an improvement upon the disclosed connection type of Vincent. Doing so allows for complete 360 degree rotation of the connection pieces, which facilities a smooth transition and prevents disengagement from the second connector. {Tsai, [0007]}
Regarding claim 6, Vincent teaches wherein the connection device of the second section comprises: a tubular element {Page 18 bottom re. Luer Lock type connection for 452 (second branch)} which is capable of being engaged in an opening of the second connection device of the first section in order to allow liquid communication inside said tubular element, and which, in the withdrawn state of the first section, is capable of being engaged in an opening of the connector of the second dialysate supply source in order to allow liquid communication inside said tubular member. {Page 18 bottom re. wherein the tubing comprises an end (454, and one side of Luer Lock) that is capable of being connected to the quick connector (other side Luer Lock)}
Vincent is silent to the connection of the second connector to the first section and the compatibility of the connectors to one another, however modified Vincent teaches a series connection, as described in rejection of claim 1, and given the Luer Lock connectors are taught on both ends of the branches as well as the dialysate sources, it is clear that the Luer Lock connectors would allow Vincent to be compatible to connect to any of the sections and/or supply sources of modified Vincent. One of reasonable skill in the art prior to the effective filing date of the claimed invention would be motivated to make this modification, as the Luer-Lock connections provide quick installation and removal of the components connected to them. {Page 18 bottom re. quick coupling}
Vincent fails to teach a peripheral wall which extends around and at a distance from the tubular element in order to define an annular space for insertion of a peripheral wall of said second connection device of the first section or, in the withdrawn state of the first section, to define an annular space for insertion of a peripheral wall of the connector of the second dialysate supply source.
Tsai teaches a peripheral wall which extends around and at a distance from the tubular element in order to define an annular space {[0031] middle, "The first member 20 … define a chamber 23 therein."} for insertion of a peripheral wall of said second connection device of the first section {[0031] bottom, "Note that the second member … needlefree connector"} or, in the withdrawn state of the first section, to define an annular space for insertion of a peripheral wall of the connector of the second dialysate supply source. {[0031] middle, "The first member 20 … to define a chamber therein."}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify modified Vincent with Tsai’s teachings of a peripheral wall which extends around and at a distance from the tubular element in order to define an annular space for insertion of a peripheral wall of said second connection device of the first section or, in the withdrawn state of the first section, to define an annular space for insertion of a peripheral wall of the connector of the second dialysate supply source as Tsai, similar to modified Vincent, teaches an improvement upon the disclosed connection type of Vincent. Doing so allows for complete 360 degree rotation of the connection pieces, which facilities a smooth transition and prevents disengagement from the second connector. {Tsai, [0007]}
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kamen (US20090101549A1), drawn to a general independent claim 1 containing locking mechanisms, dialysate supply, inlets and outlets, flexible conduits, and connecting/disconnecting components.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR J ROTONDI whose telephone number is (571)272-2058. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571)272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CONNOR J ROTONDI/ Examiner, Art Unit 1773
/BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773
