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 .
Election/Restrictions
Claims 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01JUN2026.
Applicant's election with traverse of Group I, claims 13 to 21 in the reply filed on 01JUN2026 is acknowledged. The traversal is on the ground(s) that the election requirements are improper, because the Office Action did not adequately address the common special technical features of Claims 13 and 22. This is not found persuasive because the two claims are of different claim scope and do not provide the commonality of a special technical feature that makes contribution over the prior art. Claim 22 is interpreted as follows:
Claim 22 (New) A control arrangement [a device] for determining a water permeability status of a forward osmosis (FO-) membrane of a FO-device in a dialysis fluid generation apparatus, […] [the intended use of the device in the preamble; no positively claimed structure], the control arrangement comprising:
a feed pump [pump structure] configured to provide a flow of pure water at the feed side [pump capability/intended use];
a draw pump [pump structure] configured to provide a flow of pure water at the draw side [pump capability/intended use];
one or more valves [valve structure] configured to control flow via one or more of the ports [valve capability/intended use]; and
one or more pressure sensors [sensor structure] configured to sense one or more pressures indicative of a transmembrane pressure (TMP) between the feed side and the draw side [sensor capability/intended use];
wherein the control arrangement is configured to [device capability/intended use]:
stop flow via one of the ports [intended use/operating method of an unclaimed structure],
monitor one or more pressures indicative of the TMP [intended use of the pressure sensor],
control flow to or from the one of the feed side and the draw side that has a stopped flow, based on the one or more pressures, such that the TMP is maintained constant and at a non-zero magnitude [intended use/operating method of an unclaimed structure], and
determine the water permeability status of the FO-membrane based on a property indicative of the controlled flow [no structure is claimed; no control unit is claimed; unclear how the claimed pumps/valves/pressure sensor determine a water permeability status of an unclaimed FO-membrane].
In contrast, the method of claim 13 provides method steps for determining a water permeability status of a forward osmosis (FO-) membrane of a FO-device in a dialysis fluid generation apparatus including the steps of:
providing a flow […];
providing a flow […];
monitoring one or more pressures […];
stopping flow […];
controlling flow […] based on the monitored one or more pressures […]; and
determining the water permeability status of the FO-membrane based on a property indicative of the controlled flow.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Benefit of domestic priority of application 63/172,853 filed on 04/09/2021 under 35 U.S.C. 120, 121, or 119e is acknowledged.
Claim Interpretation
Claim 13 line(s) 1-2 sets forth the limitation “a water permeability status of a forward osmosis (FO-) membrane”, which is interpreted as a water permeability of a FO-membrane that is determined to be either within operable range (“acceptable”) or out of operable range (“error”). See e.g. SPEC. P6/L29-P7/L2.
Double Patenting Analysis
Application or Patent #
Double Patenting
US 12643073
No
18/554,401
No
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.
Claim 20 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 20 line(s) 1-2 sets forth the limitation “performing the method for both controlling flow such that the TMP is maintained positive and such that TMP is maintained negative”. It is unclear how the TMP can be both maintained positive and maintained negative. Perhaps the Applicant intended:
- - further comprising either performing the method for [[both]] controlling flow such that the TMP is maintained positive and or performing the method for controlling flow such that TMP is maintained negative, and wherein the determining further comprises determining the water permeability status of the FO-membrane based on a property indicative of the controlled flow for each case. - -
Allowable Subject Matter
Claims 13-21 have allowable subject matter over the prior art of record. The prior art neither teaches, suggests, nor makes obvious to one having ordinary skill in the art a method for determining a water permeability status of a forward osmosis (FO-) membrane of a FO-device in a dialysis fluid generation apparatus comprising the combination of claimed steps.
AFFLERBAUGH (US 4202764) discloses an ultrafiltration control system (title, Fis.) comprising a dialysis machine and a negative-pressure-type dialyzer, having a semipermeable membrane where on one side flows blood and waste products and a dialysis solution flows on another side. The transmembrane pressure is controlled to establish a desired ultrafiltration rate (abstract; C1/L15-17).
SIMARD (US 5476592) discloses a method and device for injection of a sterile and antipyrogenic fluid (title, Figs.) including a filter having a porous membrane and a secondary filter is provided downstream of the main filter and, in combination with pressure sensors, is used to determine if a rupture exists in the main filter (abstract).
YANG (US 20210055199) discloses system for measuring properties of mass transport behavior in membrane and solutions (title, Figs.) including a method for determining a water permeability status (e.g. mass transfer; abstract) of a forward osmosis (FO-) membrane of a FO-device (“draw solution whose osmotic concentration is higher than that of the feed solution; abstract),
the FO-membrane (Figs. 1-2 #m) separating a feed side (Figs. 1-2 #11) and a draw side (Figs. 1-2 #13) of the FO-device,
the FO-device comprising a feed inlet port (Figs. 2 #11a) and a feed outlet port (Figs. 2 #11b) in fluid communication with the feed side, and
a draw inlet port (near reference sign Figs. 2 #13) and a draw outlet port (near reference sign Figs. 2 #m) in fluid communication with the draw side, the method comprising:
providing a flow of pure water at the feed side (par. [0052,0065]);
providing a flow of draw solution at the draw side (par. [0047,0065]);
monitoring a pressure indicative of a transmembrane pressure (TMP) between the feed side and the draw side (TMP can be measured via pressure gauges #40,80);
stopping flow via one of the ports (par. [0042]);
controlling flow e.g. from the feed side that has a stopped flow based on the monitored pressure, such that the TMP is maintained constant and at a non-zero magnitude (water flows across the membrane at a water flux (WF), which is fixed a constant non-zero level; par. [0042]); and
determining the water flux and mass transfer of the FO-membrane based on a property indicative of the controlled flow (e.g. feed pressures; par. [0060-0061]).
FOLDEN (US 5711883) discloses a method for testing dialyzer integrity prior to use including testing the transmembrane pressure to determine if a leak in the membrane has occurred.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIAM A ROYCE whose telephone number is (571)270-0352. The examiner can normally be reached M-F ~08:00~15:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571)272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LIAM A. ROYCE
Primary Examiner
Art Unit 1777
/Liam Royce/ Primary Examiner, Art Unit 1777
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