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
Applicant's renewed traversal of the Election of Species requirement in the reply filed on 01/02/2026 is acknowledged. The traversal of the species election is on the grounds that the Office Action has not established mutual exclusivity between the alleged species. Without acquiescing to Applicant’s arguments, Examiner has rejoined claims 12 and 14-19 to expedite prosecution. Claim 20 remains withdrawn. Examiner submits that claims 19 and 20 recite mutually exclusive limitations in that the manner in which the mixing operations are performed which involve a sequential circular path. In claim 19, the sequential circular path includes passing through a check valve on the second mixing line, whereas the sequential circular path of claim 20 includes passing through an open mixing valve. All disclosed embodiments either have the check valve or the mixing valve in the circulation path, not both.
Claim 20 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/02/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 concentrated medicament ([0157]), 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). 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. 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, Oberg, and Wyeth teach the method of claim 11 as shown above, Burbank further teaching 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 show pumping a second quantity of the first mixed fluid through the conductivity sensor, although Burbank recognizes that verification of conductivity may be necessary ([0092]).
Wyeth 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, Oberg, and Wyeth teach the method of claim 11 as shown above, Burbank further teaching the 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 show 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]).
Wyeth 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 with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
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. Without acquiescing to Applicant’s arguments, Examiner has issued a new rejection using the same prior art as shown above. While Burbank may not explicitly teach adding less than a total quantity of water initially, once modified by Oberg to have a second and third quantity of water added, the first quantity of water would necessarily be less than the final or total quantity of water.
Applicant also argues that the alleged rationale for modifying Burbank relies on redundant advantage. Examiner respectfully disagrees. Applicant recites paragraph [0091] that states that conductivity is confirmed prior to use. However, the teaching of confirmation does not exclude additional testing. Paragraph [0092] recognizes that there are situations where conductivity may not meet the desired specification, that the results should be verified, and that additional dilution may be necessary. Therefore, the confirmation of conductivity prior to delivery to the patient in Burbank does not exclude additional testing, nor is it limited to a single conductivity test after which no additional testing may be performed, since the confirmation itself can be the result of additional verifications and dilutions in the cases when the batch may not meet the desired conductivity range. The combination is deemed proper.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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