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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0262526 to Wyeth et al. (“Wyeth”) in view of U.S. Patent No. 5,591,344 to Kenley et al. (“Kenley”).
Regarding claim 14, Wyeth teaches a method of generating a custom mini batch of dialysate with a proportioning system (Figs. 20A-G), the method comprising attaching a disposable component (all the embodiments including those of Figs. 20A-G have disposable components as mentioned in at least [0302] & [0303]) to the proportioning system, generating purified water with a water purification system (850), first adding a first quantity of the purified water to a mixing container (1.0, Fig. 15E) that is pre-attached to the disposable component (mixing container 855 is part of disposable component), after the first adding, conveying a second quantity of a first concentrated medicament (852) through a sterilizing filter (824, Fig. 20F) and to the mixing container (2.0, Fig. 15E), after the conveying the second quantity, first mixing contents of the mixing container (3.0, Fig. 15E), after the first mixing, determining a concentration of the contents of the mixing container (4.0, Fig. 15E) by flowing (down arrow, Fig. 20F) at least a portion of the contents of the mixing container past at least one fluid quality sensor (859, Fig. 20F), after the determining the concentration, conveying a third quantity of a second concentrated medicament (853) through the sterilizing filter (824) and to the mixing container (5.0, Fig. 15E), after the conveying the third quantity, second mixing the contents of the mixing container (6.0, Fig. 15E), after the second mixing, confirming a final concentration of the contents of the mixing container (12.0, Fig. 15E) by flowing (down arrow, Fig. 20F) at least a portion of the contents of the mixing container past the at least one fluid quality sensor (859), after the confirming the final concentration, testing integrity of the sterilizing filter ([0076]), and if the testing indicates that the sterilizing filter is acceptable, providing the contents of the mixing container to a medicament user (12.0, Fig. 15E), and otherwise indicating an error condition ([0189], test failure), and although Wyeth has shown flowing (down arrow, Fig. 20F) past a sensor (859) as well as an indication (and structure 857) of flowing (up arrow, Fig. 20F) back to the mixing container, Wyeth does not explicitly state that the flowing of the contents of the mixing container back into the mixing container via 857 are necessarily part of the determining the concentration using the sensor.
Kenly has been cited as a teaching for showing that the contents flowed past a fluid quality sensor can be circulated back into the mixing container (column 43, lines 14-16) to determine fluid quality in a similar type of dialysate preparation system. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have circulated the contents during the determining the concentration of the contents and confirming a final concentration of the contents in the method of Wyeth as taught by Kenly, for the predictable result of determining or confirming the contents of the mixing container as well as conserving content volume as circulation would eliminate waste. It is noted that Wyeth already teaches the determining and the confirming; Kenly is merely being relied upon as an example of using a circulating loop to determine/confirm concentration. Additionally, since the sensor of Wyeth is already located adjacent to the mixing container and has a parallel return line, the function of Wyeth would not be altered.
Regarding claim 15, Wyeth and Kenly teach the method according to claim 14 as shown above, Kenly further teaching the determining of the concentration of the contents of the mixing container includes continuously recirculating at least a portion of the contents of the mixing container past the at least one fluid quality sensor until a value output by the at least one fluid quality sensor reaches a steady state (column 43, lines 17-19).
Regarding claim 16, Wyeth and Kenly teach the method according to claim 14 as shown above, Wyeth further comprising conveying a variable quantity of the purified water to the mixing container after the first mixing, wherein the variable quantity is determined based on the determined concentration of the contents of the mixing container (10.1.2, Fig. 15E).
Regarding claim 17, Wyeth and Kenly teach the method according to claim 16 as shown above, Wyeth further teaching the variable quantity of the purified water is less than a difference between the first quantity of the purified water and an estimated total quantity of the purified water required in the custom mini batch of dialysate (10.1.2, Fig. 15E).
Regarding claim 19, Wyeth and Kenly teach the method according to claim 14 as shown above, Wyeth further teaching the testing of the integrity of the sterilizing filter is performed after the second mixing of the contents of the mixing container (Fig. 15E) and the testing of the integrity of the sterilizing filter includes performing a pressurized air test on a membrane of the sterilizing filter ([0076], pressure testing).
Regarding claim 20, Wyeth and Kenly teach the method according to claim 14 as shown above, Wyeth further teaching the conveying of the third quantity of the second concentrated medicament through the sterilizing filter and to the mixing container comprises conveying the third quantity of the second concentrated medicament through the sterilizing filter and to the mixing container in response to the determining of the concentration of the contents indicating that there is no gross error in a measurement of the concentration of the contents ([0189], any failure at any filter leads to termination of the batch, therefore, the contents must be indicated as having no gross error in order to move to the next step of operation).
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
The specification amendments were received on 01/14/2026. The specification amendments are acceptable.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant's arguments and amendments regarding art rejections have been fully considered but they are not persuasive. Applicant argues that Wyeth does not teaching conveying the both the first and second concentrated medicament through the same filter. Examiner respectfully disagrees. Although the original embodiment of Wyeth cited in the office action appears to have separate filters, Wyeth is replete with alternative filter configurations which are interchangeable between embodiments as demonstrated in Figs. 1B-1H and Figs. 20A-G, many of which include a single filter configuration. In order to better clarify the record, a new rejection has been issued based on the embodiment of Fig. 20F.
Applicant also argues there is no teaching, suggestion, or motivation to combine the references. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Applicant appears to assume an embodiment in Wyeth where the sensor is located in a drain, Examiner notes that the Office Action did not assume such an embodiment. Furthermore, Examiner notes that Wyeth is not limited to having a sensor only located in the drain. Examiner notes Figs. 20F where the concentration sensor (859) is located adjacent the mixing container (855) as well as available structure which would allow output through the sensor via outflow line (858) and a return via inflow line (857), which would make the combination with Kenly proper since such a modification would not change the principal operation or make the system of Wyeth unsatisfactory for its intended use. Applicant also appears to assume that the sensor located on the drain of Wyeth has additional functions such as testing used dialysate, although such a use does not appear to be in the paragraph cited by Applicant. In any case, as previously stated, Wyeth is not limited to the sensor being located in the drain and is operable in embodiments where the sensor is located adjacent the mixing container as discussed above.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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