DETAILED ACTION
This detailed action is in response to the amendments and arguments filed on 04/30/2026, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 1-17 are pending. Claims 1-2 are withdrawn.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
After further consideration, the previous indications of allowable subject matter have been withdrawn.
Claim Rejections - 35 USC § 112
The Applicant argues that the disclosure of “permanently attached” provides support for the claim limitation “integrally connected, without connectors” (pg. 9). This argument is unpersuasive because U.S. Publication US 20240123128 A1, sharing multiple co-inventors with the instant application, teaches permanent attachments utilizing connectors. Thus, the disclosure “permanently attached” does not readily inform one of ordinary skill in the art of the Applicant’s alleged possession of “integrally connected, without connectors”.
Response to Amendment
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 3-6 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.
Claim 3 is directed towards a method of performing a peritoneal dialysis treatment, and lists multiple device components and steps involving using a controller to mix water, a sterile osmotic agent concentrate and a sterile electrolyte concentrate. However, it is unclear which of the multiple device components or which of the aforementioned steps performs the peritoneal dialysis treatment, rendering the claim indefinite.
Dependent claims not recited above require all of the limitations of independent Claim 3, and therefore are rejected for the same reasons set forth above.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3-13 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication US20090182263A1 (‘Burbank’) in view of U.S. Publication US20050209563A1 (‘Hopping’).
The Applicant’s claims are directed towards a method.
Regarding Claims 3-6, Burbank teaches a method of performing a peritoneal dialysis treatment ([0076]), comprising:
connecting a disposable unit (Fig. 19A, [0139-0140], disposable circuit 1303) to a source of water (Fig. 19B, [0140], source line 1364 provides water), said disposable unit including
at least a first container holding a first sterile concentrate containing an osmotic agent (Fig. 19A, [0137] and [0139], containers of medicament concentrate),
a second container holding a second sterile concentrate containing electrolytes (Fig. 19A, [0137] and [0139], containers of medicament concentrate),
an empty sterile mixing container (Fig. 19A, [0139-0140], batch container 1317), and
a tubing set connected to each of the first container, the second container, and the empty sterile mixing container (Fig. 19A, [0140]) and including a pre-attached peritoneal fill/drain line (Fig. 19A, [0140], discharge line 1345) that is configured to connect to a peritoneal access of a patient (Fig. 19A, [0140], connected to treatment machine 1312);
receiving a prescription command by a controller ([0187]), indicating at least a fill volume ([0187], size of batch and [0222-0223]) and a desired final concentration of the osmotic agent to be used for a current fill cycle under said treatment ([0210-0223]);
using the controller, controlling a first pump to pump (Fig. 19B, [0142-0145], pump in operative association with the path selector, pumping and short term filter portion 1315) quantities of sterile osmotic agent concentrate, responsively to the prescription command and to achieve the desired final concentration ([0142-0145] and [0210-0223]), from the first container into the mixing container ([0210]);
using the controller, controlling the first pump to pump the water into the mixing container ([0143], circuit 1315 pumps water);
using the controller, controlling the first pump to pump, a quantity of the sterile electrolyte concentrate from the second container into the mixing container ([0142-0145] and [0210]);
mixing contents of the mixing container ([0125] and [0131]); and
further adding the water or further adding sterile osmotic agent concentrate to the mixing container ([0210-0223], further dilution);
flowing fluid from the mixing container to a patient ([0226], pumping to a patient).
However, Burbank does not teach that the tubing set is permanently connected and that the first pump pumps at a first pump speed.
Hopping also relates to a method of performing a peritoneal dialysis treatment ([0024]), including that the tubing set is permanently connected ([0026]); and
the first pump pumps at a first pump speed ([0105], in the case of admixing, pump from two or more bags simultaneously).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the first pump of Burbank to pump at the first pump speed, as demonstrated by Hopping, to very accurately achieve fluid volumes (Hopping, [0214]).
Additional Disclosures Included:
Claim 4: prior to the pumping a quantity of the sterile osmotic agent concentrate into the mixing chamber, responsively to the prescription command, using the controller, controlling the first pump to pump a volume of water from the source of water into the mixing container (Burbank, [0161], adding the initial quantity of water before the transfer of concentrate).
Claim 5: after the mixing, detecting the concentration of osmotic agent in the mixing container (Burbank, Fig. 15, [0131], contents of container may be mixed and the contents may be checked in S51, such as by checking conductivity).
Claim 6: the controller controls the first pump such that different volumes of the sterile osmotic agent concentrate and the sterile electrolyte concentrate are conveyed into the mixing container (Hopping, [0056] and [0215]).
Regarding Claims 7-13 and 17, Burbank teaches a method of preparing a treatment fluid (abstract), comprising:
activating a flow switch (Fig. 19A, [0139], path selector, pumping, and short term filter portion 1315) to connect a first fluid concentrate to a pump (Fig. 19A, [0139], line 1366 provides connection to containers of medicament concentrate 1310) and flowing the first fluid concentrate through the pump into a batch container at a first pumping rate ([0207]);
activating the flow switch to connect a second fluid concentrate to the pump (Fig. 19A, [0139], line 1366 provides connection to containers of medicament concentrate 1310) and flowing the second fluid concentrate through the pump into a batch container at a second pumping rate ([0207]);
activating the flow switch to connect a diluent fluid source to the pump (Fig. 19A, [0143], line 1370 provides water) and flowing the diluent fluid through the pump into the batch container at a third pumping rate ([0143]).
Burbank does not teach controlling a pumping rate of the pump to maintain constant pumping rates wherein the first pumping rate, the second pumping rate, and third pumping rate are identical to each other and held constant during the pumping.
Hopping also relates to a method of preparing a treatment fluid (abstract and [0033]), including controlling a pumping rate of the pump to maintain constant pumping rates wherein the first pumping rate, the second pumping rate, and third pumping rate are identical to each other and held constant during the pumping ([0215]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control the pumping rate of the pump of Burbank to maintain constant pumping rates, as demonstrated by Hopping, to very accurately achieve fluid volumes (Hopping, [0214]).
Additional Disclosures Included:
Claim 8: the flowing the first fluid concentrate and the flowing the second fluid concentrate are such that different overall volumes of the first and second fluid concentrates are conveyed (Hopping, [0056] and [0215-0216]).
Claim 9: the flowing the first fluid concentrate and the flowing the diluent fluid are such that different overall volumes of the first fluid concentrate and the diluent are conveyed (Hopping, [0056] and [0215-0216]).
Claim 10: the flowing the first fluid concentrate, the flowing the second fluid concentrate, and the flowing the diluent fluid are such that respective volumes of the first fluid concentrate, the second fluid concentrate, and the diluent conveyed to the batch container differ from each other (Hopping, [0056] and [0215-0216]).
Claim 11: using the pump to mix fluid in the batch container (Hopping, [0033]).
Claim 12: using the pump to convey mixed fluid from the batch container to a patient (Hopping, [0229]).
Claim 13: the using the pump to mix fluid includes drawing fluid from a first connector of the batch container and flowing fluid back into the batch container through a second connector of the batch container (Burbank, Fig. 29A, [0190], recirculation process may be performed to thoroughly mix the concentrate and drawing fluid from the dangling tube may help to ensure that concentrate is drawn from the container and injected into the container through the other tube).
Claim 17: calibrating the pump prior to generating at least one flow calibration parameter and determining a number of cycles of said pump responsively to said at least one calibration parameter (Burbank, [0182]).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication US20090182263A1 (‘Burbank’) and U.S. Publication US20050209563A1 (‘Hopping’) as applied to claim 13 above, and further in view of U.S. Patent US3847809A (‘Kopf’).
The Applicant’s claim is directed towards a method.
Regarding Claim 14, the combination of Burbank and Hopping teach the method of Claim 13, except that the using the pump to mix fluid includes periodically varying the rate of flow during a mixing operation.
Kopf also relates to a method of preparing a treatment fluid (abstract), including that the using the pump to mix fluid includes periodically varying the rate of flow during a mixing operation (Fig. 2, C5/L16-38, motor 140 increases or decreases the speed of pump 110 to change the rate at which concentrate discharges based on the conductivity of the dialysate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary the rate of flow, as demonstrated by Kopf, in the method of the combination of Burbank and Hopping in order to maintain a desired conductivity where the conductivity can be adjusted to accommodate differences in patients, concentrates and mix proportions (Kopf, C4/L27-43).
Claim 15-16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication US20090182263A1 (‘Burbank’) and U.S. Publication US20050209563A1 (‘Hopping’) as applied to claim 13 above, and further in view of U.S. Publication US20100069817A1 (‘Falkvall’).
The Applicant’s claims are directed towards a method.
Regarding Claims 15-16, the combination of Burbank and Hopping teach the method of Claim 13, except that the using the pump to mix fluid includes periodically halting the rate of flow during a mixing operation and that the using the pump to mix fluid includes periodically reversing the flow during a mixing operation.
Falkvall also relates to a method of preparing a treatment fluid ([0001]), including that the using the pump to mix fluid includes periodically halting the rate of flow during a mixing operation ([0090]) and
that the using the pump to mix fluid includes periodically reversing the flow during a mixing operation (Fig. 6, [0041] and [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the halting and reversing of flow of Falkvall and the method of the combination of Burbank and Hopping because alternating the flow of the pump back and forth is capable of mixing the contents (Falkvall, [0041]) and agitating the water facilitates the dissolution of solute in the water (Falkvall, [0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOI-LIEN THI NGUYEN whose telephone number is (703)756-4613. The examiner can normally be reached Monday to Friday, 8 am to 6 pm.
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/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
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