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
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13-14, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth et al. (US 20190262526 A1) in view of Kenley et al. (US 5783072 A).
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 (step S556: 1st quantity: water+ electrolyte, 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 1st quantity ; conductivity test of step S556) is not greater than a predefined magnitude (threshold; [0274]), pumping a second quantity of the contents ([0164]: “the controller may be programmed so as to make an adjustment in the concentrate only after a predefined number of mixing/testing reattempts. This will ensure against any concentration bias resulting from incomplete mixing”; 2nd quantity, re-test attempt based on previous failure without modifying concentration to test against concentration bias) 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); further mixing the contents and subsequently pumping a third quantity of the contents (3rd quantity having adjusted concentration based on previous test;[0164]; [0275]: “conditionally pumps further water or electrolyte concentrate responsively to the previous conductivity test done at S556. This process may be iterative to provide, effectively, a titration until the required ratio of electrolyte to water is achieved.”) 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); 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 (threshold; [0274]), pumping a fourth quantity of the contents (4th quantity; [0164]; [0275]) through the conductivity sensor (764) and measuring, by the conductivity sensor (764), a conductivity of the fourth quantity of the contents (conductivity 4th quantity; [0164]); 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).
Note: Wyeth discloses that steps S556 and S558 can be iterative until required ratio is achieved. 1st and 3rd quantity are being compared to threshold in steps S556; [0164] discloses that to prevent concentration bias resulting from incomplete mixing, additional test can be made before adjusting quantities. The 2nd and 4th quantities are drawn for this purpose; however there is not explicit disclosure of a comparison between their conductivities.
Wyeth does not specifically disclose wherein in response to determining that the measured conductivity of the second quantity of the contents differs from the measured conductivity of the first quantity of the contents by more than a predefined range; and in response to determining that the measured conductivity of the fourth quantity of the contents differs from the measured conductivity of the third quantity of the contents by less than a predefined range.
Kenley teaches a method of generating a custom batch of dialysate (Fig 19) wherein in response to determining that the measured conductivity of the second quantity of the contents (2nd sampled quantity) differs from the measured conductivity of the first quantity (1st sampled quantity ) of the contents by more than a predefined range (predefined time range threshold stablished; Col 43, lines 23-40); and in response to determining that the measured conductivity of the fourth quantity (4th sampled quantity) of the contents differs from the measured conductivity of the third quantity (3rd sampled quantity) of the contents by less than a predefined range (Col 43, lines 23-40: conductivity from sampler 210 is being measured by sensor 218; samples are taken to be tested and resulted conductivities are compared to previous measurement until the conductivity of the dialysate remains constant for a sufficient period of time to ensure the components are fully mixed)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Wyeth with a relative comparison of conductivity measurements steps during verification of mixture status as taught by Kenley for the purpose of verifying that the solution is fully mixed, preventing bias in the conductivity reading (Col 43, lines 23-40).
Regarding claim 14, Wyeth/Kenley discloses the method according to claim 13. Wyeth discloses 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/Kenley discloses the method according to claim 13. Wyeth discloses further comprising: conveying a variable quantity (quantity of purified water, S558 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 (third quantity; [0274]) 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 20, Wyeth/Kenley discloses the method according to claim 13. Wyeth discloses 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 claims 13-14, 18 and 20 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.
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
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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