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 .
Priority
Acknowledgment is made of the applicant's priority to the French applications FR2105337 and FR2105339. The priority dates for all of the claims within this application are as follows:
05/21/2021: Claims 1-13
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/13/2023 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The amendment to the specification filed on 11/13/2023 disclosed an incorrect patent application when referring to priority. Application number 2105337 was listed twice, opposed to both 2105337 and 2105339 being listed as the priority documents. Appropriate correction is required.
Claim Objections
Claims 1-11 and 13 are objected to because they include reference characters which do not follow the guidelines in which they should be enclosed within parentheses. They are currently written as, “Connector [[(#)]]”, however, they should be formatted as, “Connector (#)”. Appropriate action 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 1, 2, 4, 9, and 13 and any of their dependent claims 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.
Regarding claims 1 and 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 2 and 4, the phrase “makes or making it possible" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 13, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Interpretation
To promote clarity and efficiency in the examination process (compact prosecution), the following phrase from claim 3 will be interpreted, but not limited to, the following:
Original Language: “so that, in the closed state, the closing element [[(C541)]] is locked and/or damages the conduit…”.
Interpreted (non-limiting) Language: “so that, in the closed state, the closing element [[(C451)]] locks and/or damages the conduit…”.
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.
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.
Claims 1-4 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vincent (WO2019150058A2) in view of Lo (US20140316332A1), in further view Klewinghaus (US20130237903A1). *Note the teachings and mappings of Vincent are from a machine translated, English version; attached within the office correspondence file.
In regards to claim 1, Vincent teaches a dialysis machine for treating a body fluid, such as blood or plasma, 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 [[(12)]] {Page 3 middle, "body fluid passage zone"} which has a body fluid inlet [[(201)]] {Page 3 middle, "body fluid inlet"} and a body fluid outlet [[(202)]] {Page 3 middle, "body fluid outlet"}, and a dialysate passage zone [[(14)]] {Page 3 bottom, "dialysate passage zone"} which has a dialysate inlet [[(401)]] {Page 3 bottom, "dialysate inlet"} and a dialysate outlet [[(402)]] {Page 3 bottom, "dialysate outlet"}, and a membrane system [[(3)]] between the body fluid passage zone and the dialysate passage zone [[(14)]] {Page 3 bottom, "membrane system … passage zone;"}; a dialysate delivery system [[(51)]] {Page 3 bottom, "dialysate delivery system"}, a connection system [[(450)]] for connecting a dialysate supply source [[(40)]] to the dialysate delivery system [[(51)]] {Page 4 top, "A connection system comprising: … connectable to the dialysate delivery system."}, the connection system [[(450)]] comprising: a first section [[(451)]] {Page 4 top, "first branch"}, which comprises a conduit [[(4510)]] {Page 4 top, "first conduit"} provided at one end with a first connection device [[(4511)]] {Page 4 top, "having and end capable of being connected"} which is connectable to a connector [[(415)]] of a first dialysate supply source [[(40)]] {Page 4 top, "connected to a first dialysate supply source"}, and which is disconnectable from said connector [[(415)]] of the first dialysate supply source [[(40)]] {Page 4 bottom, "first branch is disconnected … supply"}, and provided at the other end with a second connection device [[(4512)]] {Page 4 top, "a portion … first and second branch"}, said conduit [[(4510)]] being a flexible conduit of constant cross section in the uncrushed state of said conduit [[(4510)]] {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 [[(452)]], which comprises a conduit [[(4520)]] {Page 4 top, "second conduit, called a second branch"} which has one end connected to a dialysate delivery system [[(51)]] {Page 4 top, "connected to a second dialysate supply source"}. Vincent further teaches in regards to claim 1 the conduit of the second section being a flexible conduit of constant cross section in the uncrushed state of said conduit [[(4520)]] {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"}.
In regards to claim 2, Vincent teaches wherein the connection system comprises a closing element [[(C451)]] {Page 4 top, "clamping system for opening / closing the first branch."} which, in the closed state, makes it possible to prevent liquid from circulating inside the conduit [[(4510)]] of the first section [[(451)]] {Page 11 top, "closing/opening downstream member … in the open state, allows the flow of dialysate … closed state, prevents the flow of dialysate."}.
In regards to claim 4, Vincent teaches wherein the second section [[(452)]] comprises an activatable and deactivatable opening and closing element [[(C452)]] {Page 4 top, "clamping system for opening / closing the second branch."} making it possible to allow or prevent the circulation of liquid through the conduit of the second section [[(452)]] {Page 11 top, "closing/opening downstream member … in the open state, allows the flow of dialysate … closed state, prevents the flow of dialysate."}.
In regards to claim 8, Vincent teaches wherein the machine comprises: a dialysate feed line [[(52)]] {Page 3 bottom, "dialysate feed line"} which is connectable to an inlet [[(401)]] of a dialysate passage zone [[(14)]] of the dialyzer [[(100)]] {Page 3 bottom, "dialysate feed line … passage zone"}, and a dialysate discharge line [[(62)]] which is connectable to an outlet [[(402)]] of the dialysate passage zone [[(14)]] of the dialyzer [[(100)]] {Page 6 middle, "connection of the discharge … of the dialyzer"}.
In regards to claim 9, Vincent teaches the discharge line [[(62)]] comprises a conduit [[(6100)]] {Page 6 middle, "connection duct, lines of the cassette"} for connection to a discharge device such as a drainage system [[(Egt)]] and/or a spent dialysate recovery system {Page 12 bottom, "Said opening / closing … pockets 60 or 60'."}.
In regards to claim 10, Vincent teaches wherein the machine comprises at least one flexible bag [[(50)]], called a ventricle bag, intended to contain dialysate and forming part of said delivery system [[(51)]] {Page 3 bottom, "dialysate delivery system … containing dialysate"}.
In regards to claim 11, Vincent teaches wherein said at least one bag is included in a device, called a cassette [[(9)]] {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"}.
In regards to 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"}.
Vincent does not teach that the conduit of the section connects at an opposite end with a connection device [[(4521)]] which is connected, in a disconnectable manner, to the second connection device [[(4512)]] of the first section [[(451)]], in order to provide a series connection of the first section [[(451)]] and the second section [[(452)]], while allowing said first section [[(451)]] to be disconnected from the second section [[(452)]], so that, in the state with the first section [[(451)]] disconnected and removed from the second section [[(452)]], said connection device [[(4521)]] of the second section [[(452)]] is connectable to a connector [[(415')]] of a second dialysate supply source [[(40')]] and disconnectable from said connector [[(415')]] of the second dialysate supply source [[(40')]]. Vincent does not teach wherein the closing element [[(C451)]] is of the tamper-evident type so that, in the closed state, the closing element [[(C451)]] is locked and/or damages the conduit [[(4510)]] of the first section [[(451)]] in order to prevent reuse of the conduit after the closing element [[(C451)]] has been closed.
However, Klewinghaus and Lo teach the missing limitations in claims 1-4 and 8-12 that Vincent does not teach.
In regards to claim 1, Klewinghaus and Lo teach that the conduit of the section connects at an opposite end with a connection device [[(4521)]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."} which is connected, in a disconnectable manner, to the second connection device [[(4512)]] of the first section [[(451)]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."}, in order to provide a series connection of the first section [[(451)]] and the second section [[(452)]] {Lo ¶ 57, "another aspect … in series"}, while allowing said first section [[(451)]] to be disconnected from the second section [[(452)]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."}, so that, in the state with the first section [[(451)]] disconnected and removed from the second section [[(452)]], said connection device [[(4521)]] of the second section [[(452)]] is connectable to a connector [[(415')]] of a second dialysate supply source [[(40')]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."} and disconnectable from said connector [[(415')]] of the second dialysate supply source [[(40')]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."}.
In regards to claim 3, Klewinghaus and Lo teach wherein the closing element [[(C451)]] is of the tamper-evident type {¶ 7, "The tubing adapter … flow-through lumen of the tubing adapter"} so that, in the closed state, the closing element [[(C451)]] is locked and/or damages the conduit [[(4510)]] of the first section [[(451)]] in order to prevent reuse of the conduit after the closing element [[(C451)]] has been closed {¶ 7, "The tubing adapter … flow-through lumen of the tubing adapter"}.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the invention of Vincent with the connection capabilities of Klewinghaus and Lo because all three of these inventions appear within the same field of endeavor; specifically, tubing and connection components of dialysis systems. One of ordinary skill in the art prior to the effective filing date of the claimed invention would be motivated to combine the connection capabilities of Klewinghaus to Vincent because the invention of Klewinghaus usese a tubing adapter and method to avoid issues with pressure within the fluid tubing that can sometimes occur during treatment {Klewinghuas ¶ 5, “Moreover … pressure.”}. One of ordinary skill in the art prior to the effective filing date of the claimed invention would be motivated to combine the connection system of Lo to the, now combined, invention of Vincent and Klewinghaus because Lo’s system and apparatus allows for long-term storage of dialysate in its unmixed form, allowing for later mixing of the separated parts to constitute a final product and/or for further addition of additives {Lo ¶ 0117 bottom, “The apparatus … additives.”}.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Vincent (WO2019150058A2), Lo (US20140316332A1), and Klewinghaus (US20130237903A1); in further view of Tsai (US20170036008A1). *Note the teachings and mappings of Vincent are from a machine translated, English version; attached within the office correspondence file.
The combination of Vincent, Lo, and Klewinghaus teach all of the limitations of claims 1-4, and 8-12 in the prior rejection.
In regards to claim 5, these inventions further teach wherein the first connection device [[(4511)]] of the first section [[(451)]] comprises: a tubular element [[(4511a)]] {Klewinghaus ¶ 6, "The tubing adapter"} capable of being engaged in an opening of the corresponding connector [[(415)]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."} of the first dialysate supply source [[(40)]] in order to allow liquid communication inside said tubular element [[(4511a)]] {Klewinghaus ¶ 15, "Therefore … as the tubing section"}. In regards to claim 6, they also teach that the second connection device is capable of being engaged in an opening of the second connection device [[(4512)]] of the first section [[(451)]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."} and which, in the withdrawn state of the first section [[(451)]], is capable of being engaged in an opening of the connector [[(415')]] of the second dialysate supply source [[(40')]] {Klewinghaus ¶ 6, "Alternatively, the tubing adapter … to be used and adapted accordingly."}.
They do not teach a peripheral wall [[(4511b)]] which extends around and at a distance from the tubular element [[(4511a)]] in order to define an annular space for insertion of a peripheral wall of said connector of the first dialysate supply source. They do not teach wherein the connection device [[(4521)]] of the second section [[(452)]] comprises: a tubular element [[(4521a)]] in order to allow liquid communication inside said tubular element [[(4521a)]] and a peripheral wall [[(4521b)]] which extends around and at a distance from the tubular element [[(4521a)]] in order to define an annular space for insertion of a peripheral wall of said second connection device [[(4512)]] of the first section [[(4521)]] or, in the withdrawn state of the first section [[(451)]], to define an annular space for insertion of a peripheral wall of the connector [[(415')]] of the second dialysate supply source [[(40')]]. They do not teach wherein the second connection device [[(4512)]] of the first section [[(451)]] comprises a peripheral wall provided with a thread [[(4512a)]] able to cooperate with an internal thread formed in the peripheral wall [[(4521b)]] of the connection device [[(4521)]] of the second section [[(452)]].
However, Tsai teaches all of the missing limitations of claims 5-7 that the combination of Vincent, Klewinghaus, and Lo do not teach.
In regards to claim 5, Tsai teaches a peripheral wall [[(4511b)]] {¶ 31 middle, "The first member 20 has … to define a chamber therein."} which extends around and at a distance from the tubular element [[(4511a)]] in order to define an annular space {¶ 31 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 {¶ 31 middle, "closed male luer … fluid transfusion tubing"}.
In regards to claim 6, Tsai teaches wherein the connection device [[(4521)]] of the second section [[(452)]] comprises: a tubular element [[(4521a)]] {¶ 31 middle, "interconnecting … second member 30"} in order to allow liquid communication inside said tubular element [[(4521a)]] {¶ 31 middle, "fluid transmission tubing"} and a peripheral wall [[(4521b)]] which extends around and at a distance from the tubular element [[(4521a)]] {¶ 31 middle, "The first member 20 … define a chamber 23 therein."} in order to define an annular space {¶ 31 middle, "The first member 20 … define a chamber 23 therein."} for insertion of a peripheral wall of said second connection device [[(4512)]] of the first section [[(4521)]] {¶ 31 bottom, "Note that the second member … needlefree connector"} or, in the withdrawn state of the first section [[(451)]], to define an annular space for insertion of a peripheral wall of the connector [[(415')]] of the second dialysate supply source [[(40')]] {¶ 31 middle, "The first member 20 … to define a chamber therein."}.
In regards to claim 7, Tsai teaches wherein the second connection device [[(4512)]] of the first section [[(451)]] comprises a peripheral wall {¶ 31 middle, "The first member 20 … to define a chamber therein."} provided with a thread [[(4512a)]] {¶ 31 middle, "male-connection head 221 … threads."} able to cooperate with an internal thread formed in the peripheral wall [[(4521b)]] of the connection device [[(4521)]] of the second section [[(452)]] {¶ 31 bottom, "second member 30 can serve … needlefree connector"}.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the already-combined invnention of Vincent, Klewinghaus, and Lo with the physical connection properties of Tsai, because all of the inventions appear within the same field of endeavor; specifically, dialysis connection and tubing systems. One of ordinary skill in the art prior to the effective filing date of the claimed invention would be motivated to combine these inventions because the connector of Tsai allows a 360-degree rotation of the second connector to the first which facilitates a smooth transition and prevents disengagement of thee second connector {Tsai ¶ 7, “second connector can rotate … second member.”}.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Vincent (WO2019150058A2), Lo (US20140316332A1), Klewinghaus (US20130237903A1), and Tsai (US20170036008A1); in further view of Vincent (WO2019150058A2). *Note the teachings and mappings of Vincent are from a machine translated, English version; attached within the office correspondence file. ** Secondly, note that because claim 13 depends on all of claims 1–12, it requires a separate rejection for clarity of the record.
The combination of Vincent, Lo, Klewinghaus, and Tsai teach all of the limitations of claims 1-12 in prior rejections.
In regards to claim 13, they further teach a method for successively connecting dialysate supply sources (40, 40') to a connection system [[(450)]] of the machine as claimed in claim[[s]] 1 [[to 12]], the method comprising the following steps {Page 4 top, "A connection system comprising: … connectable to the dialysate delivery system."}: providing the connection system [[(450)]] {Page 4 top, "A connection system comprising: … connectable to the dialysate delivery system."} in a configuration in which the first section [[(451)]] is connected to the second section [[(452)]] {Page 19 top, "Each branch 451… by its end 456"}, the second section being connected by its other end to the dialysate [[(5)]] delivery system [[(51)]] {Page 4 top, "a second conduit … supply source"}; providing a first dialysate supply source [[(40)]] {Page 4 top, "first dialysate supply source"} having a connector [[(415)]] not connected to the connection system [[(450)]] {Page 4 bottom, "while the first branch is disconnected … dialysate supply"}; when a stopper [[(4519)]] closes the end of the first section [[(451)]] opposite the end connected to the second section [[(452)]], removing said stopper [[(4519)]] {Page 4 middle, "the first branch is connected … being in the open position"}; connecting the first connection device [[(4511)]] of the first section [[(451)]] to the first dialysate supply source [[(40)]] {Page 6 top, "connection by the user … first branch … dialysate delivery system"}, and, after use of the first dialysate supply source [[(40)]]: preferably closing off the first section [[(451)]], for example by closure of a clamp system [[(C451)]] on 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 [[(40)]] and closing the connection device [[(4511)]] of the first section [[(451)]] with the aid of a stopper [[(4519)]] {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}; removing the first section [[(451)]] from the second section [[(452)]] of the device so that the second section [[(452)]] has a free connection device [[(4521)]] {}; providing a second dialysate supply source [[(40')]] having a connector [[(415')]] not connected to the connection system [[(450)]] {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}; connecting the connector [[(415')]] of the second dialysate supply source [[(40')]] to the free connection device [[(4521)]] of said second section [[(452)]] {Page 6 middle, "after the first dialysis session … which is connected to the dialysate delivery system"}.
There are no remaining limitations within this invention that the combined invention of Vincent, Lo, Klewinghaus, and Tsai have not already taught. The motivation and obviousness arguments for the combination of these inventions have already been addressed in prior rejections.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CONNOR J ROTONDI/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779