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
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2008/0230450 to Burbank et al. (“Burbank”) in view of U.S. Patent Publication No. 2019/0201607 to Oberg and U.S Patent Publication No. 2019/0262526 to Wyeth et al. (“Wyeth”).
Regarding claim 11, Burbank teaches a method for preparing a ready-to-use medicament for use by a medicament user (abstract) comprising pumping a first quantity of water into a mixing container (S270 & [0153]) in a fluid circuit of a medicament preparation system to form a first mixed fluid, the mixing container being pre-filled with a fixed quantity of concentrated medicament before the pumping of the first quantity of water ([0157], the initial amount of concentrate is interpreted as a fixed quantity, the batch bag is supplied with a concentrate already in it instead of adding it separately), performing a first conductivity measurement on the first mixed fluid (Fig. 21B S274, [0132] & [1428]), in response to a controller of the medicament preparation system determining there is no error in a result of the first conductivity measurement ([0108], batch is utilized if the value is not out of range), pumping the final batch of medicament to the medicament user from the mixing container ([0153], once the completed batch is prepared in the batch container, treatment to the patient is performed using the batch, [0154] & Fig. 21C), but does not explicitly teach adding a second and third quantity of water and performing a second and third conductivity measurement, although Burbank contemplates testing for out of bound conditions at various points of the process ([0153]).
Oberg teaches adding a second quantity of water to the first mixed fluid, the second quantity of water being less than a remaining quantity of water required in the final batch of medicament ([0243], 90-95% of the final fluid volume), mixing the first mixed fluid and the second quantity of water in the mixing container ([0243]) to form a second mixed fluid (diluted second mixed fluid of [0244]) in the mixing container, performing a second conductivity measurement on the second mixed fluid ([0244]), adding a third quantity of water ([0246], additional purified water) to the second mixed fluid in the mixing container and mixing the second mixed fluid and the third quantity of water to form the final batch of medicament in the mixing container ([0246]), performing a third conductivity measurement on the final batch of medicament ([0247]), and in response to the controller determining there is no error in a result of the third conductivity measurement, pumping the final batch of medicament to the medicament user ([0249], patient treatment occurs if the final batch is at the desired concentration, which means the third conductivity measurement was found to be without error), wherein the controller permits the second quantity of water to be added only after determining that the result of the first conductivity measurement satisfies a first predefined criterion ([0234]) and permits the third quantity of water to be added only after determining that the result of the second conductivity measurement satisfies a second predefined criterion ([0238]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Burbank to repeat the addition of water and performing conductivity measurements to yield the predictable result of ensuring the final batch sent to the patient has the proper conductivity and/or concentration which is a necessity to properly treat the patient.
Additionally and/or alternatively, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burbank to add a second and third quantity of water as taught by Oberg, in order to treat a patient according to the treating sessions or required cycles following a procedure, which sometimes requires multiple consecutive cycles using agents having different concentrations ([0249] in each cycle).
Once Burbank is modified by Oberg to add a second and third quantity of water and performing a second a third conductivity measurement, the first quantity of water would necessarily be less than a total quantity of water required in a final batch of medicament, the final batch being the resultant quantity after the third conductivity measurement. However, Oberg does not explicitly teach using circulation to form the mixed fluid and adding of the third quantity of water explicitly occurring in response to the controller determining there is no error in a result of the second conductivity measurement.
Wyeth teaches circulating ([0116]) a mixed fluid (osmotic agent concentrate) and water (water for dilution) in a mixing container (406) to form a second mixed fluid in the mixing container. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have circulated the first mixed fluid and the second quantity of water of Oberg as taught by Wyeth to mix the contents of the mixing container ([0116]).
Furthermore, Wyeth (Fig. 21C & [0312]) teaches adding a third quantity of water (S704) to a second mixed fluid (C2) in response to the controller determining there is no error in a result of the second conductivity measurement (S702). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the third quantity of water after determining there is no error in the result of the second conductivity measurement in the method of Oberg as taught by Wythe to yield the predictable result of ensuring a proper conductivity level in a diluted concentrate used for dialysis. As shown in Fig. 21C of Wythe, batches that do not conform to the proper conductivity are discarded and are not used in subsequent processes.
Regarding claim 13, Burbank, Oberg, and Wyeth teach the method of claim 11 as shown above, Burbank further teaching the fluid circuit (Fig. 22) including a first mixing line (1462) connected to the mixing container (1444), a second mixing line (1460) connected to the mixing container and the first mixing line, a water line (1370) connecting a water source to the first and second mixing lines, a drain conductivity line (1422) connected to the first and second mixing lines, and a supply line (1469) connecting the medicament user to the first and second mixing lines, and wherein the pumping of the first quantity of water into the mixing container includes pumping the first quantity of water into the mixing container through the water line (1370) and the first mixing line (1462) at a pressure below a cracking pressure of a check valve (1472) on the second mixing line while a water line valve (1418) on the water line is open, a drain conductivity line valve (1414) on the drain conductivity line is closed, and a batch release valve (1412) on the supply line is closed (the opening and closing of the various valves is consistent with the pumping water to the mixing container).
Regarding claim 14, Burbank, Oberg, and Wyeth teach the method of claim 11 as shown above, Burbank further teaching the fluid circuit (Fig. 22) including a first mixing line (1460) connected to the mixing container (1444), a second mixing line (1462) connected to the mixing container and the first mixing line, a water line (1370) connecting a water source (1379) to the first and second mixing lines, a drain conductivity line (1422) connected to the first and second mixing lines, and a supply line (1745) connecting the medicament user to the first and second mixing lines, and wherein the pumping of the first quantity of water into the mixing container includes pumping the first quantity of water into the mixing container through the water line (1370) and the first mixing line (1460) while a water line valve (1418) on the water line is open, a mixing valve (1416) leading to the second mixing line is closed, a drain conductivity line valve (1414) on the drain conductivity line is closed, and a batch release valve (1412) on the supply line is closed (the other valves must be closed in order for water to flow to the batch bag).
Regarding claim 15, Burbank, Oberg, and Wyeth teach the method of claim 14 as shown above, Burbank further teaching the performing of the first conductivity measurement includes pumping a portion of the first mixed fluid through a conductivity sensor (1428) in the drain conductivity line (1422) while the drain conductivity line valve is open, and the water line valve, the mixing valve, and the batch release valve are closed (Fig. 22, the other valves must be closed for the first mixed fluid to flow to the conductivity sensor).
Regarding claim 16, Burbank, Oberg, and Wyeth teach the method of claim 14 as shown above, Burbank further teaching the pumping of the final batch of medicament to the medicament user includes pumping the final batch of medicament through the supply line (1469) while the batch release valve (1412) is open, and the water line valve, the mixing valve, and the drain conductivity line valve are closed (the other valves must be closed in order for the final batch to flow to the supply line).
Regarding claim 17, Burbank teaches a method for preparing a ready-to-use medicament for use by a medicament user (abstract) comprising pumping a first quantity of water into a mixing container (S270 & [0153]) in a fluid circuit of a medicament preparation system to form a first mixed fluid, the mixing container being pre-filled with a fixed quantity of concentrated medicament before the pumping of the first quantity of water ([0157], the initial amount of concentrate is interpreted as a fixed quantity, the batch bag is supplied with a concentrate already in it instead of adding it separately), performing a first conductivity measurement on the first mixed fluid (Fig. 21B S274, [0132] & [1428]), in response to a controller of the medicament preparation system determining there is no error in a result of the first conductivity measurement ([0108], batch is utilized if the value is not out of range), pumping the final batch of medicament to the medicament user from the mixing container ([0153], once the completed batch is prepared in the batch container, treatment to the patient is performed using the batch, [0154] & Fig. 21C), wherein the performing of the first conductivity measurement includes pumping a first quantity of the first mixed fluid through a conductivity sensor and measuring, by the conductivity sensor, a conductivity of the first quantity of the first mixed fluid ([0132]), but does not explicitly teach adding a second and third quantity of water, performing a second and third conductivity measurement, although Burbank contemplates testing for out of bound conditions at various points of the process ([0153]), and pumping a second quantity of the first mixed fluid through the conductivity sensor, although Burbank recognizes that verification of conductivity may be necessary ([0092]).
Oberg teaches adding a second quantity of water to the first mixed fluid, the second quantity of water being less than a remaining quantity of water required in the final batch of medicament ([0243], 90-95% of the final fluid volume), mixing the first mixed fluid and the second quantity of water in the mixing container ([0243]) to form a second mixed fluid (diluted second mixed fluid of [0244]) in the mixing container, performing a second conductivity measurement on the second mixed fluid ([0244]), adding a third quantity of water ([0246], additional purified water) to the second mixed fluid in the mixing container and mixing the second mixed fluid and the third quantity of water to form the final batch of medicament in the mixing container ([0246]), performing a third conductivity measurement on the final batch of medicament ([0247]), and in response to the controller determining there is no error in a result of the third conductivity measurement, pumping the final batch of medicament to the medicament user ([0249], patient treatment occurs if the final batch is at the desired concentration, which means the third conductivity measurement was found to be without error). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Burbank to repeat the addition of water and performing conductivity measurements to yield the predictable result of ensuring the final batch sent to the patient has the proper conductivity and/or concentration which is a necessity to properly treat the patient.
Additionally and/or alternatively, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burbank to add a second and third quantity of water as taught by Oberg, in order to treat a patient according to the treating sessions or required cycles following a procedure, which sometimes requires multiple consecutive cycles using agents having different concentrations ([0249] in each cycle).
Once Burbank is modified by Oberg to add a second and third quantity of water and performing a second a third conductivity measurement, the first quantity of water would necessarily be less than a total quantity of water required in a final batch of medicament, the final batch being the resultant quantity after the third conductivity measurement. However, Oberg does not explicitly teach using circulation to form the mixed fluid and adding of the third quantity of water explicitly occurring in response to the controller determining there is no error in a result of the second conductivity measurement.
Wyeth teaches circulating ([0116]) a mixed fluid (osmotic agent concentrate) and water (water for dilution) in a mixing container (406) to form a second mixed fluid in the mixing container. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have circulated the first mixed fluid and the second quantity of water of Oberg as taught by Wyeth to mix the contents of the mixing container ([0116]).
Furthermore, Wyeth (Fig. 21C & [0312]) teaches adding a third quantity of water (S704) to a second mixed fluid (C2) in response to the controller determining there is no error in a result of the second conductivity measurement (S702). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the third quantity of water after determining there is no error in the result of the second conductivity measurement in the method of Oberg as taught by Wythe to yield the predictable result of ensuring a proper conductivity level in a diluted concentrate used for dialysis. As shown in Fig. 21C of Wythe, batches that do not conform to the proper conductivity are discarded and are not used in subsequent processes.
Wyeth also teaches that when conductivity is measured, mixing operations including multiple mixing testing, and remixing trials until a predefined number of retries is reached. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed multiple tests for conductivity for the first mixed fluid of Burbank as taught by Wyeth in order to compensate for numerical deviations. Once modified by Wyeth to perform a second test of conductivity for the first mixed fluid, Wyeth would teach that in response to the controller determining that a magnitude of the measured conductivity of the first quantity of the first mixed fluid is not greater than a predefined magnitude, pumping a second quantity of the first mixed fluid through the conductivity sensor and measuring, by the conductivity sensor, a conductivity of the second quantity of the first mixed fluid (the determining, pumping, and measuring steps are repeats of the conductivity test already performed by Burbank), and in response to the controller determining that the measured conductivity of the second quantity of the first mixed fluid differs from the measured conductivity of the first quantity of the first mixed fluid by less than a predefined range, outputting, by the controller, a measurement based on either one or both of the measured conductivity of the first quantity of the first mixed fluid and the measured conductivity of the second quantity of the first mixed fluid (the outputting is a result of the conductivity reaching the standard conductivity in Burbank as modified by Wyeth).
Regarding claim 18, Burbank teaches a method for preparing a ready-to-use medicament for use by a medicament user (abstract) comprising pumping a first quantity of water into a mixing container (S270 & [0153]) in a fluid circuit of a medicament preparation system to form a first mixed fluid, the mixing container being pre-filled with a fixed quantity of concentrated medicament before the pumping of the first quantity of water ([0157], the initial amount of concentrate is interpreted as a fixed quantity, the batch bag is supplied with a concentrate already in it instead of adding it separately), performing a first conductivity measurement on the first mixed fluid (Fig. 21B S274, [0132] & [1428]), in response to a controller of the medicament preparation system determining there is no error in a result of the first conductivity measurement ([0108], batch is utilized if the value is not out of range), pumping the final batch of medicament to the medicament user from the mixing container ([0153], once the completed batch is prepared in the batch container, treatment to the patient is performed using the batch, [0154] & Fig. 21C), wherein the performing of the first conductivity measurement includes pumping a first quantity of the first mixed fluid through a conductivity sensor and measuring, by the conductivity sensor, a conductivity of the first quantity of the first mixed fluid ([0132]), and performing of the first conductivity measurement including pumping a first quantity of the first mixed fluid through a conductivity sensor and measuring, by the conductivity sensor, a conductivity of the first quantity of the first mixed fluid (S274), but does not explicitly teach adding a second and third quantity of water, performing a second and third conductivity measurement, although Burbank contemplates testing for out of bound conditions at various points of the process ([0153]), pumping a second quantity of the first mixed fluid through the conductivity sensor, although Burbank recognizes that verification of conductivity may be necessary ([0092]), and pumping a second through fourth quantity of the first mixed fluid through the conductivity sensor, although Burbank recognizes that verification of conductivity may be necessary ([0092]).
Oberg teaches adding a second quantity of water to the first mixed fluid, the second quantity of water being less than a remaining quantity of water required in the final batch of medicament ([0243], 90-95% of the final fluid volume), mixing the first mixed fluid and the second quantity of water in the mixing container ([0243]) to form a second mixed fluid (diluted second mixed fluid of [0244]) in the mixing container, performing a second conductivity measurement on the second mixed fluid ([0244]), adding a third quantity of water ([0246], additional purified water) to the second mixed fluid in the mixing container and mixing the second mixed fluid and the third quantity of water to form the final batch of medicament in the mixing container ([0246]), performing a third conductivity measurement on the final batch of medicament ([0247]), and in response to the controller determining there is no error in a result of the third conductivity measurement, pumping the final batch of medicament to the medicament user ([0249], patient treatment occurs if the final batch is at the desired concentration, which means the third conductivity measurement was found to be without error). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Burbank to repeat the addition of water and performing conductivity measurements to yield the predictable result of ensuring the final batch sent to the patient has the proper conductivity and/or concentration which is a necessity to properly treat the patient.
Additionally and/or alternatively, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burbank to add a second and third quantity of water as taught by Oberg, in order to treat a patient according to the treating sessions or required cycles following a procedure, which sometimes requires multiple consecutive cycles using agents having different concentrations ([0249] in each cycle).
Once Burbank is modified by Oberg to add a second and third quantity of water and performing a second a third conductivity measurement, the first quantity of water would necessarily be less than a total quantity of water required in a final batch of medicament, the final batch being the resultant quantity after the third conductivity measurement. However, Oberg does not explicitly teach using circulation to form the mixed fluid and adding of the third quantity of water explicitly occurring in response to the controller determining there is no error in a result of the second conductivity measurement.
Wyeth teaches circulating ([0116]) a mixed fluid (osmotic agent concentrate) and water (water for dilution) in a mixing container (406) to form a second mixed fluid in the mixing container. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have circulated the first mixed fluid and the second quantity of water of Oberg as taught by Wyeth to mix the contents of the mixing container ([0116]).
Furthermore, Wyeth (Fig. 21C & [0312]) teaches adding a third quantity of water (S704) to a second mixed fluid (C2) in response to the controller determining there is no error in a result of the second conductivity measurement (S702). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the third quantity of water after determining there is no error in the result of the second conductivity measurement in the method of Oberg as taught by Wythe to yield the predictable result of ensuring a proper conductivity level in a diluted concentrate used for dialysis. As shown in Fig. 21C of Wythe, batches that do not conform to the proper conductivity are discarded and are not used in subsequent processes.
Wyeth also teaches that when conductivity is measured, mixing operations including multiple mixing testing, and remixing trials until a predefined number of retries is reached. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed multiple tests for conductivity for the first mixed fluid of Burbank as taught by Wyeth in order to compensate for numerical deviations. Once modified by Wyeth to perform multiple tests of conductivity for the first mixed fluid, such as four tests, Wyeth would teach that in response to the controller determining that a magnitude of the measured conductivity of the first quantity of the mixed fluid is not greater than a first predefined magnitude, pumping a second quantity of the first mixed fluid through the conductivity sensor and measuring, by the conductivity sensor, a conductivity of the second quantity of the first mixed fluid, in response to the controller determining that the measured conductivity of the second quantity of the first mixed fluid differs from the measured conductivity of the first quantity of the first mixed fluid by more than a predefined range, further mixing the first mixed fluid through the mixing container and subsequently pumping a third quantity of the first mixed fluid through the conductivity sensor and measuring, by the conductivity sensor, a conductivity of the third quantity of the first mixed fluid, in response the controller determining that a magnitude of the measured conductivity of the third quantity of the further mixed fluid is not greater than a second predefined magnitude, pumping a fourth quantity of the first mixed fluid through the conductivity sensor and measuring, by the conductivity sensor, a conductivity of the fourth quantity of the first mixed fluid, and in response to the controller determining that the measured conductivity of the fourth quantity of the first mixed fluid differs from the measured conductivity of the third quantity of the first mixed fluid by less than a predefined range, outputting, by the controller, a measurement based on either one or both of the measured conductivity of the third quantity of the first mixed fluid and the measured conductivity of the fourth quantity of the first mixed fluid (the determining, pumping, and measuring steps are repeats of the conductivity test already performed by Burbank, and the outputting is a result of the conductivity reaching the standard conductivity in Burbank as modified by Wyeth).
Regarding claim 19, Burbank, Oberg, and Wyeth teach the method of claim 18 as shown above, Burbank further teaching the fluid circuit including a first mixing line (1462) connected to the mixing container (1444), a second mixing line (1460) connected to the mixing container and the first mixing line, a water line (1370) connecting to a water source (1379) to the first and second mixing lines, a drain conductivity line (1422) connected to the first and second mixing lines, and a supply line (1469) connecting the medicament user to the first and second mixing lines, and once modified by Wyeth to including circulating as a form of mixing (as shown above in the rejection of claim 11), the further mixing of the first mixed fluid through the mixing container (1444) includes pumping the fluid in a circular path sequentially through the first mixing line (1462), the second mixing line (1460), and the mixing container (1444) while a water line valve on the water line, a drain conductivity line valve on the drain conductivity line, and a batch release valve on the supply line are closed, (all the valves would be closed in order for the mixed fluid to circulate) such that the first mixed fluid passes through a check valve (1472) on the second mixing line.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burbank, Oberg, and Wyeth as applied to claim 11 above, and further in view of U.S. Patent Publication No. 2018/0326138 to Kalaskar et al. (“Kalaskar”).
Regarding claim 12, Burbank, Oberg, and Wyeth teach the method of claim 11 as shown above, but do not explicitly teach the mixing container to be detachable.
Kalaskar teaches a mixing container is detachably connected to mixing container lines of the fluid circuit by connectors ([0096], ports). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the mixing container of Burbank detachable as taught by Kalaskar to provide a larger mixing chamber when necessary ([0076]) and to yield the predictable result of allowing the user to replace the mixing chamber after prolonged use to prevent contamination.
Response to Arguments
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are not persuasive.
Applicant argues that Burbank does not teach or suggest adding less than a total quantity of water. As similarly stated in the previous Office Action, since Burbank is only being relied upon for the initial dilution, it cannot be compared to the total amount of water after a second and third dilution. However, once modified by Oberg to have a second and third dilution, the initial amount of water will inherently be less than a total quantity of water, since additional water is added a second and a third time. Due to two more dilutions or additions of water, the initial water will be less than the total amount of water.
Applicant also argues that the alleged rationale for modifying Burbank relies on redundant advantage. Examiner respectfully disagrees. First, Examiner notes that in response to Applicant's arguments against the references individually (i.e., Burbank), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Applicant argues that the Office Action does not explain how Burbank alone is lacking in “ensuring the final batch sent to the patient has the proper conductivity and/or concentration” and that Burbank describes at length and detail that the final batch is checked. However, Burbank’s checking method is the conductivity check associated with the single dilution. Burbank cannot teach the final batch sent to the patient has the proper conductivity because the final batch is the last or third batch, and Burbank only has one batch. Since Burbank lacks ensuring a final batch (i.e., third batch) sent to the patient has the proper conductivity and/or concentration, it is not a redundant advantage. In any case, additional or supplemental motivation has been shown by Oberg as shown above.
Rather than being a redundant advantage, the checking of conductivity/concentration is a necessary or ordinary operation. Oberg teaches a second and third dilution. It is both logical and necessary for the conductivity to be checked after each dilution, since any mixed fluid that is no longer viable must be discarded. Therefore, the modification of Burbank by Oberg yields predictable results, since the final batch sent to the patient would need to be checked since proper treatment cannot take place with the correct conductivity.
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 mailing date of this final action.
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/B.K./Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
