DETAILED ACTION
Applicant’s response filed November 3, 2025 is acknowledged. Claims 1-20 are pending and further considered on the merits.
Response to Amendment
In light of applicant’s amendment, the examiner maintains the grounds of rejection set forth in the office action filed August 1, 2025.
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.
Claim 1-8, 10-13, and 15-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Favre, US 2005/0082210 (Favre, IDS) in view of Hamada et al., US 2007/0061045 (Hamada).
Regarding claim 1, Favre discloses a system enabling both peritoneal dialysis and extracorporeal dialysis (abstract, figs. 1-3) comprising:
A blood treatment unit (fig. 1) configured to perform at least one extracorporeal blood treatment on a patient, the blood treatment unit including:
A blood pump (REF 2) configured to pump blood from a patient (REF P) and back to the patient;
A controller (REF 15a) for controlling the blood pump (Claim 1); and
A user interface (¶ 0036) operable with the controller; and
A base unit (fig. 2) operable with the blood treatment unit, the base unit including a base unit controller (REF 15) and a fluid container (REF 13), the base unit controller programmed to:
Receive information indicative whether a peritoneal dialysis treatment or extracorporeal treatment is to be performed (¶ 0035); and
Operate first software instructions when the base unit uses a first fluid stored in the fluid container when peritoneal dialysis treatment is selected (via REF 15b, ¶ 0038) or operate second software instructions when the base unit uses a second different fluid from an online source when extracorporeal blood treatment is selected (via REF 15a, ¶ 0038).
Regarding claim 1, it is apparent that the base unit is configured to utilize a variety of fluids for their respective treatment modalities (see “exchange solution”, means of continuous generation”, ¶ 0033, and “evacuated solution”, ¶ 0043). Furthermore, recitations or limitations drawn to materials worked upon by the system do not impart patentable weight to the claim since those materials are not structurally recited as part of the system (MPEP 2115).
Favre does not disclose a system comprising a calendar of days in which an extracorporeal blood treatment is scheduled or second days in which a peritoneal dialysis treatment is scheduled or a user interface for receiving a selection input indicating the extracorporeal blood treatment is to be performed for a next treatment. However, Hamada discloses a system for operating peritoneal and extracorporeal dialysis systems for hybrid treatment (abstract, fig. 1, Claims 9-16) including a user interface (REF 10) operable with a controller (¶ 0056) for displaying a calendar of days in which an extracorporeal blood treatment is scheduled to be performed (fig. 12, ¶ 0070) and receiving a selection input indicating the extracorporeal blood treatment is to be performed for a next treatment (fig. 12, ¶ 0030, 0070).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the system of Favre to include the display means and capabilities described in Hamada in order to visually organize and indicate a treatment modality to an operator and/or user.
Regarding claim 2, Hamada further discloses the calendar includes indications of past treatments performed including whether the past treatment was a peritoneal dialysis treatment or extracorporeal blood treatment (see “PD”, “HD”, fig. 12).
Regarding claim 3, Hamada further discloses the calendar schedule is received in a controller of the blood treatment unit (via “output unit”, ¶ 0084, Claims 9-13). Functional elements drawn to who provides the instructions are not considered to provide patentable weight to the claim since there is no structurally linking feature of said functional element to the claimed system.
Regarding claim 4, Favre (in view of Hamada) does not disclose the base unit controller being separate from the controller of the blood treatment unit. However, it would have been obvious to one having ordinary skill in the art to provide separate controllers for individual treatment parameters, since it has been held that constructing a formerly integral structure (i.e. single control unit) into various elements involves only routine skill in the art (MPEP 2144.04, Section V-C).
Regarding claim 5, recitations or limitations drawn to materials worked upon by the system do not impart patentable weight to the claim since those materials are not structurally recited as part of the system (MPEP 2115).
Regarding claim 6, Favre (in view of Hamada) discloses a system wherein the base unit is configured to prepare dialysis fluid for the at least one extracorporeal blood treatment using fluid from an online source (¶ 0033).
Regarding claim 7, Favre (in view of Hamada) discloses a system wherein the controller of the blood treatment unit is programmed to control the operational speed of the blood pump (see communicating line between REF 15 and REF 2, fig. 1).
Regarding claim 8, Favre (in view of Hamada) discloses a system further comprising a blood filter (REF 4, fig. 1) that receives a second fluid from a base unit (via REF 6) for use in an extracorporeal blood treatment.
Regarding claim 10, while Favre (in view of Hamada) does not disclose the base unit controller being separate from the controller of the blood treatment unit and sharing data via a wired or wireless connection, it would have been obvious to one having ordinary skill in the art to provide separate and communicating controllers for individual treatment parameters, since it has been held that constructing a formerly integral structure (i.e. single control unit) into various elements involves only routine skill in the art (MPEP 2144.04, Section V-C).
Regarding claim 11, Favre (in view of Hamada) discloses a system wherein the user interface controls both the base unit and the blood treatment unit (¶ 0036).
Regarding claim 12, Favre discloses a system enabling both peritoneal dialysis and extracorporeal dialysis (abstract, figs. 1-3) comprising:
A peritoneal dialysis unit (fig. 2) configured to perform at least one peritoneal dialysis treatment on a patient, the peritoneal dialysis unit including:
A dialysis fluid pump (REF 6, 8) configured to pump fluid through a patient line (REF 5-7) to a peritoneal cavity of the patient (REF P) and to remove fluid from the patient;
A control unit (REF 15b) for controlling the dialysis fluid pump (Claim 1); and
A user interface (¶ 0036) operable with the controller; and
A base unit (fig. 2) operable with the peritoneal dialysis unit, the base unit including a base unit controller (REF 15) and a fluid container (REF 13), the base unit controller programmed to:
Receive information indicative whether a peritoneal dialysis treatment or extracorporeal treatment is to be performed (¶ 0035); and
Operate first software instructions when the base unit uses a first fluid stored in the fluid container when peritoneal dialysis treatment is selected (via REF 15b, ¶ 0038) or operate second software instructions when the base unit uses a second different fluid from an online source when extracorporeal blood treatment is selected (via REF 15a, ¶ 0038).
Regarding claim 12, it is apparent that the base unit is configured to utilize a variety of fluids for their respective treatment modalities (see “exchange solution”, means of continuous generation”, ¶ 0033, and “evacuated solution”, ¶ 0043). Furthermore, recitations or limitations drawn to materials worked upon by the system do not impart patentable weight to the claim since those materials are not structurally recited as part of the system (MPEP 2115).
Favre does not disclose a system comprising a calendar of days in which an extracorporeal blood treatment is scheduled or second days in which a peritoneal dialysis treatment is scheduled or a user interface for receiving a selection input indicating the extracorporeal blood treatment is to be performed for a next treatment. However, Hamada discloses a system for operating peritoneal and extracorporeal dialysis systems for hybrid treatment (abstract, fig. 1, Claims 9-16) including a user interface (REF 10) operable with a controller (¶ 0056) for displaying a calendar of days in which an extracorporeal blood treatment is scheduled to be performed (fig. 12, ¶ 0070) and receiving a selection input indicating the extracorporeal blood treatment is to be performed for a next treatment (fig. 12, ¶ 0030, 0070).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the system of Favre to include the display means and capabilities described in Hamada in order to visually organize and indicate a treatment modality to an operator and/or user.
Regarding claim 13, Favre (in view of Hamada) discloses a system further comprising a supply fluid line (REF 9) removably coupling the base unit to the peritoneal dialysis unit.
Regarding claim 15, Hamada further discloses the calendar includes indications of past treatments performed including whether the past treatment was a peritoneal dialysis treatment or extracorporeal blood treatment (see “PD”, “HD”, fig. 12).
Regarding claim 16, Hamada further discloses the calendar schedule is received in a controller of the peritoneal dialysis treatment unit (via “output unit”, ¶ 0084, Claims 9-13). Functional elements drawn to who provides the instructions are not considered to provide patentable weight to the claim since there is no structurally linking feature of said functional element to the claimed system.
Regarding claim 17, recitations or limitations drawn to materials worked upon by the system do not impart patentable weight to the claim since those materials are not structurally recited as part of the system (MPEP 2115).
Regarding claims 18-19, Favre (in view of Hamada) discloses a system comprising a control unit (REF 15) programmed to perform different operational modes (¶ 0032, 0039-0040), where it is implicit that the controller confirms whether a peritoneal dialysis or extracorporeal dialysis treatment unit is properly set up. While Favre (in view of Hamada) does not disclose the base unit controller being separate from the controller of the peritoneal dialysis unit and sharing data via a wired or wireless connection for a handshake routine, it would have been obvious to one having ordinary skill in the art to provide separate and communicating controllers for individual treatment parameters, since it has been held that constructing a formerly integral structure (i.e. single control unit) into various elements involves only routine skill in the art (MPEP 2144.04, Section V-C).
Regarding claim 20, Favre (in view of Hamada) discloses a system wherein the user interface controls both the base unit and the peritoneal dialysis unit (¶ 0036).
Claim 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Favre in view of Hamada as relied upon in the rejection of claim 1 set forth above, and in further view of Kelly et al., US 2005/0131332 (Kelly, IDS).
Regarding claim 9, Favre (in view of Hamada) does not disclose a system wherein the base unit controller is programmed to operate with a blood treatment cassette. However, Kelly discloses that it is common to use blood treatment cassettes for extracorporeal blood treatment procedures, where a controller confirms the presence of the cassette and is programmed to operate the unit based on the cassette provided (abstract, ¶ 0007-0008, 0012).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the system of Favre (in view of Hamada) to utilize a cassette-based extracorporeal treatment set-up as described in Kelly in order to provide a convenient and easy means for setting up extracorporeal dialysis treatment which minimizes the chances of cross contamination or improper set-up.
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Favre in view of Hamada as relied upon in the rejection of claim 12 set forth above, and in further view of Childers et al., US 2004/0019312 (Childers, IDS).
Regarding claim 14, Favre (in view of Hamada) does not disclose a system utilizing a peritoneal cassette including a pump chamber and a port for fluid connection to a supply line. However, the use of peritoneal dialysis cassettes is very well known in the prior art as seen in Childers. Childers discloses a peritoneal dialysis system (abstract) which uses a disposable cassette system comprising a pump chamber and port for fluid connection to a supply fluid line (¶ 0044).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the system of Favre (in view of Hamada) to utilize a cassette based peritoneal dialysis treatment set-up as described in Childers in order to provide a convenient and easy means for setting up peritoneal dialysis treatments which minimize the chances of cross-contamination or improper set up.
Response to Arguments
Applicant's arguments filed November 3, 2025 have been fully considered but are not found persuasive.
Applicant argues Hamada does not disclose the feature drawn to a user interface for receiving a selection input indicating a blood treatment is to be performed “instead” of a peritoneal dialysis treatment. Applicant asserts Hamada “merely discloses scheduling for days an allocation of days when not dialysis treatment is performed”. In response, the examiner directs applicant’s attention to the full context of paragraph 0070 of Hamada:
[0070] Based on each of these curves presented on the display 10, the operator sets a condition for each input item of the PD-HD hybrid remedy (PD-HD planning). To be specific, the operator specifies conditions on: a HD and PD dialysis schedule for a fixed period of time (here, on a weekly basis), in which scheduling for days when no dialysis treatment is performed is also incorporated; PD conditions (the osmotic pressure and volume of each dialysis solution, the retention periods, and the number of exchanges); HD conditions (the dialysis duration, water removal volume, urea nitrogen clearance, and creatinine clearance), and inputs these specified conditions from a PD-HD planning input screen (FIG. 12). The PC 1 calculates the initial value of the ratio M/C(0), using the amount of target-solute removal M and the concentration of the target solute in the blood before dialysis C(0) for the dialysis plan based on the input conditions. The ratio M/C(0) is divided by the body fluid volume VB to obtain M/C(0)/V.sub.B, which is displayed as an integrated sum of divisional M/C(0)/V.sub.B planned to be achieved by HD, PD, and RRF (residual renal function), respectively (PD-HD planning output; FIG. 13).
As seen in Hamada, the operator specifies conditions “in which scheduling for days when no dialysis treatment is performed is also incorporated”. Preceding this disclosure is language regarding the selection of either HD or PD treatments on a weekly calendar (seen in fig. 12). In light of Hamada, the examiner maintains that the claimed user interface functionality is clearly disclosed in Hamada as indicated in the previous office action.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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