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 Objections
Claim 19 objected to because of the following informalities:
The limitation "a second variable quantity" in claim 19, line 2 indicates the presence of “a first variable quantity”. Claim 19 is dependent on claim 13. The limitation “a variable quantity” is disclosed in claim 18 line 1; however, it is not disclosed in claims 13 or 19. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-14, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyeth et al. (US 20190262526 A1).
Regarding claim 13, Wyeth discloses a method of generating a custom mini batch of dialysate with a proportioning system (fluid module 772, Fig 18A; [0242]), the method comprising: attaching a disposable component (disposable unit of circuit 701E, Fig 18A) to the proportioning system (772, Fig 18A; [0241]); generating purified water (Step S548, Fig 18C) with a water purification system (water source 766, Fig 18A); adding a first quantity of the purified water (50% of water; [0270]; S548) to a mixing container (mixing container 732, Fig 18A) that is pre-attached to the disposable component (701E) (S548, Fig. 18C; [0270]); conveying a second quantity (step S552, Fig 18C) of a first concentrated medicament (electrolyte; [0272]) to the mixing container (732) ([0272]); first mixing contents of the mixing container (S554, Fig. 18C; [0273]: controller 739 mixes the mixing container 732 contents); determining a concentration of the contents (concentration is determined based on conductivity values; [0171]) of the mixing container (732) (S556, Fig. 18C; [0274]; [0171]: “In all of the foregoing conductivity measurement operations, the conductivity and the temperature of the fluid may be converted directly to concentration of the electrolytes in water”); conveying a third quantity of a second concentrated medicament (quantity of osmotic agent 738; [0276]) to the mixing container (732) (S560, Fig. 18C; [0276]); second mixing the contents of the mixing container (S562, Fig. 18D: controller 739 mixes contents of container 732); confirming a final concentration of the contents of the mixing container (S570 similar to S556, [0281]; Fig. 18D); and providing the contents of the mixing container to a medicament user (patient 718 connected to the system by patient line 754, Fig 18A) wherein the determining the concentration of the contents of the mixing container includes measuring a conductivity of the contents (Steps S556 and S564 measures the conductivity of the contents of the mixing container 732; concentration is determined based on conductivity values; [0171]), wherein the measuring of the conductivity of the contents (conductivity measurement; [0274]) includes pumping a first quantity of the contents (quantity of contents: water and electrolyte, being pump; step S556, Fig 18C) through a conductivity sensor (conductivity sensors 764; step S556) and first measuring, by the conductivity sensor (764), a conductivity of the first quantity of the contents (conductivity of water + electrolyte); in response to determining that a magnitude of the measured conductivity of the first quantity of the contents (magnitude of conductivity of contents: water +electrolyte; S556) is not greater than a predefined magnitude (highest magnitude of threshold stablished for step S556), pumping a second quantity of the contents (Since any mixing operation may include multiple testing as disclosed in [0350]; a 2nd quantity of contents: water+ electrolyte is pumped as result of failure to meet the threshold criteria for step S556) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the second quantity of the contents(conductivity of a 2nd quantity of contents: water+ electrolyte); in response to determining that the measured conductivity of the second quantity of the contents (magnitude of conductivity of 2nd contents: water + electrolyte; [0350]) differs from the measured conductivity of the first quantity of the contents (first quantity being pump; step S556, Fig 18C) by more than a predefined range (threshold range for step S556), further mixing the contents and subsequently pumping a third quantity of the contents (3rd quantity of content after mix; [0206];[0350]) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the third quantity of the contents (3rd quantity of content; step S556); in response to determining that a magnitude of the measured conductivity of the third quantity of the contents (conductivity of 3rd quantity after compensation; step S558) is not greater than a second predefined magnitude (highest predefined magnitude of second threshold stablished for desired concentration after mixing; S558), pumping a fourth quantity of the contents (Since any mixing operation may include multiple mixing and testing as disclosed in [0350]; If conductivity of 3rd quantity after compensation is below the second predefined magnitude a 4th quantity can be pumped for retest) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the fourth quantity of the contents (conductivity of 4th quantity: (water +electrolyte); [0350]); and in response to determining that the measured conductivity of the fourth quantity of the contents (conductivity of 4th quantity for retest; [0350]) differs from the measured conductivity of the third quantity of the contents (conductivity of 3rd quantity; step S556) by less than a predefined range (second threshold range stablished), outputting a measurement based on either one or both of the measured conductivity of the third quantity of the contents and the measured conductivity of the fourth quantity of the contents (output value within predetermined range is processed and continue to S560).
Regarding claim 14, Wyeth discloses the method according to claim 13, further comprising: connecting a first source (concentrate container 736, Fig 18A) of the first concentrated medicament (electrolyte; [0241]) to the disposable component (701E) with a connector (path 790, 791, 728, 745, 758, 742; [0255];Fig. 18F); and connecting a second source (concentrate container 738, Fig 18A) of the second concentrated medicament (OA: Osmotic agent, Fig 18A) to the disposable component (701E) with a second connector (path 789, 791, 728, 745, 758, 744, Fig 18A)
Regarding claim 18, Wyeth discloses the method according to claim 13, further comprising: conveying a variable quantity (quantity of purified water is variable and dependent on the previous conductivity measure; [0274]) of the purified water to the mixing container (732) after the first mixing (0270];[0272]; step S554: initial mixing of water and electrolytes) wherein the variable quantity is determined based on the determined concentration of the contents ([0274]: “Any difference between the actual and expected conductivity measurements is compared to a threshold and if the threshold is exceeded, at S558, additional water or electrolyte concentrate may be added to provide the target ratio.”); and further determining a concentration of the contents ([0171]: conductivity values of contents can be converted to concentration) at a time after conveying the variable quantity of the purified water to the mixing container (732) and before conveying the third quantity of the second concentrated medicament ([0276]; step S560) to the mixing container (732) (concentration is determined based on conductivity, ([0171]); [0274] after added quantity of water or electrolyte is mixed; [0275]: “This process may be iterative to provide, effectively, a titration until the required ratio of electrolyte to water is achieved”; therefore each addition of water or electrolyte is mixed in the container by recirculating through lines 746 and 750 and a sample is tested for conductivity and concentration is derived from this values).
Regarding claim 19, Wyeth discloses the method according to claim 13, further comprising: conveying a second variable quantity of the purified water to the mixing container (732) after the second mixing, wherein the second variable quantity is determined based on a determined concentration of the contents of the mixing container after the second mixing ([0279]: “At S566, the controller 739 determines and adds the complement of water depending on the initial amount provided at S548... the balance is adjusted based on any additional quantity added to the contents of the mixing container 732”; at S564, controller 379 conducts conductivity test with sensors 764 to determine whether the batch can be passed onto S566; [0278], Fig. 18D)
Regarding claim 20, Wyeth discloses the method according to claim 13, wherein the conveying of the third quantity of the second concentrated medicament (quantity of osmotic agent 738; [0276]) to the mixing container (732) comprises conveying the third quantity of the second concentrated medicament (quantity of osmotic agent 738; [0276]) to the mixing container (732) in response to the determining of the concentration of the contents of the mixing container (732) indicating that there is no gross error in a measurement of the concentration of the contents of the mixing container ([0274]: “Any difference between the actual and expected conductivity measurements is compared to a threshold and if the threshold is exceeded, at S558, additional water or electrolyte concentrate may be added to provide the target ratio.”;[0275]) (Step S560 does not occur until the conductivity test occurs to confirm proportions, [0275]-[0276] & Fig. 18C; the determination of proper proportions is being interpreted as an indication of whether or not there is a gross error in measurement of the concentration of the contents).
Response to Arguments
Applicant’s arguments with respect to claim(s) 10/28/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Grounds of rejection rely on an alternative interpretation of Wyeth et al. (US 20190262526 A1).
Applicant submits that the method steps recited in Claim 13 recite specific conditions ("in response to determining that ...") at multiple stages, which trigger specific actions which include remixing but also adding additional ingredients. This establishes a specific process flow (as shown in Applicants' Fig. 2A), which is not disclosed by Wyeth.
Examiner respectfully disagrees please see relevant portion of Claim 1 below:
(…) determining the concentration of the contents of the mixing container includes measuring a conductivity of the contents (Steps S556 and S564 measures the conductivity of the contents of the mixing container 732; concentration is determined based on conductivity values; [0171]), wherein the measuring of the conductivity of the contents (conductivity measurement; [0274]) includes pumping a first quantity of the contents (quantity of contents: water and electrolyte, being pump; step S556, Fig 18C) through a conductivity sensor (conductivity sensors 764; step S556) and first measuring, by the conductivity sensor (764), a conductivity of the first quantity of the contents (conductivity of water + electrolyte); in response to determining that a magnitude of the measured conductivity of the first quantity of the contents (magnitude of conductivity of contents: water +electrolyte; S556) is not greater than a predefined magnitude (highest magnitude of threshold stablished for step S556), pumping a second quantity of the contents (Since any mixing operation may include multiple testing as disclosed in [0350]; a 2nd quantity of contents: water+ electrolyte is pumped as result of failure to meet the threshold criteria for step S556) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the second quantity of the contents(conductivity of a 2nd quantity of contents: water+ electrolyte); in response to determining that the measured conductivity of the second quantity of the contents (magnitude of conductivity of 2nd contents: water + electrolyte; [0350]) differs from the measured conductivity of the first quantity of the contents (first quantity being pump; step S556, Fig 18C) by more than a predefined range (threshold range for step S556), further mixing the contents and subsequently pumping a third quantity of the contents (3rd quantity of content after mix; [0206];[0350]) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the third quantity of the contents (3rd quantity of content; step S556);
Please note that additional ingredients are added at S558, please see below:
in response to determining that a magnitude of the measured conductivity of the third quantity of the contents (conductivity of 3rd quantity after compensation; step S558) is not greater than a second predefined magnitude (highest predefined magnitude of second threshold stablished for desired concentration after mixing; S558), pumping a fourth quantity of the contents (Since any mixing operation may include multiple mixing and testing as disclosed in [0350]; If conductivity of 3rd quantity after compensation is below the second predefined magnitude a 4th quantity can be pumped for retest) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the fourth quantity of the contents (conductivity of 4th quantity: (water +electrolyte); [0350]); and in response to determining that the measured conductivity of the fourth quantity of the contents (conductivity of 4th quantity for retest; [0350]) differs from the measured conductivity of the third quantity of the contents (conductivity of 3rd quantity; step S556) by less than a predefined range (second threshold range stablished), outputting a measurement based on either one or both of the measured conductivity of the third quantity of the contents and the measured conductivity of the fourth quantity of the contents (output value within predetermined range is processed and continue to S560).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783