DETAILED ACTION
Applicant’s request for continued examination filed December 8, 2025 is acknowledged. Claims 1 and 18 are amended. Claims 1-20 are pending and further considered on the merits.
Response to Amendment
In light of applicant’s amendment, the examiner modifies the grounds of rejection set forth in the office action filed September 8, 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a dialysis system comprising a dialysis machine having a controller, and a dialysis fluid source having a controller, where the controller of the dialysis fluid source is configured to receive a sensed fluid pressure from a pressure transducer and control a flow rate such that the flow rate of dialysis fluid matches the draw rate of a pump of the dialysis machine. However, applicant’s originally filed disclosure does not support a dialysis fluid source controller configured as recited in claim 1. For reference, applicant’s stated support appears below.
[0044] In another embodiment, a system uses a fluid connection to convey information from the dialysis machine 30 to the fluid source 10. When the dialysis machine 30 draws fluid at the high rate, the fluid source 10 experiences a reduced pressure on an outlet line. A pressure transducer may be used to detect this pressure drop and increase the fluid generation rate accordingly. When the dialysis machine 30 reduces the draw rate, the pressure on the outlet line of the fluid source 10 will increase, which can be detected with the same pressure sensor, leading to a reduction in flow rate. This embodiment provides another means of conveying flow rate information.
As seen above, a pressure transducer on the outlet line detects a change in pressure indicating either an increase or decrease in demand by the dialysis machine whereby a fluid generation rate (of the dialysis fluid source) is modified. In the subsequent paragraph of applicant’s disclosure, a “data connection allows the flow rate of the fluid from the source 10 to be synchronized with the draw rate of the dialysis device 30”. The data connection is defined by applicant in paragraph 0043 as a “connection between the dialysis machine 30 and the fluid source…provided by any type of data communication link, including wired, radio, infrared, Bluetooth, and the like”. Lastly, paragraph 0042 recites “the data connection provides a signal from the dialysis machine 30 to the fluid source 10 to adjust the flow setting of fluid from the fluid source 10”.
Taking the relevant passages recited above as a whole, it is clear the dialysis machine controller provides the signal to synchronize the flow rate of the dialysis fluid source with the draw rate of the dialysis machine. Therefore, applicant’s recitation of a dialysis fluid source controller and said controller being configured as recited in claim 1 are considered to be new matter not present in the originally filed disclosure. Claim 18 recites the same dialysis fluid source controller configuration and is similarly rejected as presenting new matter not present in the originally filed disclosure.
Response to Arguments
Applicant’s arguments, filed December 8, 2025 are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIRK R BASS whose telephone number is (571) 270-7370. The examiner can normally be reached 8-4:30 EST Monday-Friday.
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DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/Primary Examiner, Art Unit 1779