Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
Examiner suggests applicant to update the status of parent U.S. Patent Application No. 18/452,516 as follows:
Under “RELATED APPLICATIONS” in Page 1:
-Line 2: After “2023, ”, add “and issued as U.S. Patent No. 12,064,540, “.
Claim Objections
Claims 14 and 22-23 are objected to because of the following informalities:
-Claim 14, Line 10: Recitation of “(500)” should be deleted.
-Claim 22, Line 2: “pumps” should be changed to “is configured to pump”.
-Claim 23, Line 2: “pumps” should be changed to “is configured to pump”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 14 are rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the drain path" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the second flowpath" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claim 4 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 14 would be allowable if rewritten to overcome the rejection(s) under 35 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 5-13 and 15-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Connell et al (US 2005/0242034 A1) is considered the closest prior art to a hemodialysis system of claim 4.
Connell et al teach a hemodialysis system comprising:
a blood flow path (308, 310) through which blood is drawn from a patient and passed
through a dialyzer (306); and a dialysate flow path (206, 174) through which dialysate flows
from a dialysate supply through the dialyzer (306),
the dialysate flow path comprising:
a balancing fluid circuit (54, 42, 72) which controls the amount of dialysate passing through the dialyzer, a mixing fluid circuit (121, 124, 38, 40, 88, 112) which forms dialysate from dialysate precursor and water, and a directing fluid circuit (82, 86, 24) which passes water from a water supply to the mixing fluid circuit and passes dialysate from the mixing fluid circuit to the
balancing fluid circuit (see figures 1A-1B, 6-7; paragraphs 00170054, 0065, 0111, 0141-0149).
Connell et al. further teaches a dialysate conductivity sensor (60) (see fig. 1B), a conductivity sensor (46) (see fig. 1B), two reciprocating positive displacement pumps (42, 72) (see fig. 1A-1B), a dialysate reservoir (26) (see fig. 1A), acid concentrate (88) (see fig. 1A; paragraph 0022) and bicarbonate concentrate (112) (see fig. 1B; paragraph 0033).
Tracey et al (US 2008/0175719 A1) teach a cassette system (2015) comprising pod pumps (2025)(see figure 22A; paragraphs 0250, 0261, 0346).
Donig et al (US Patent No. 6,743,201) teach a cassette (10) for delivering fluids which have the advantages of partial functions of delivering, metering/balancing, mixing, measuring,
connecting and heating of medical fluids can be combined and performed in one unit to greatly
facilitate operation of the system and make it more fail-safe by minimizing the steps that are
subject to the risk (see figure 1; col. 1, lines 49-57).
However, none of the prior art of record teaches or suggests the hemodialysis system comprising:
the mixing fluid circuit comprising a mixing cassette including a fluid flowpath for mixing water with bicarbonate solution to form water and bicarbonate mixture, and for mixing water and bicarbonate mixture with acid solution to form dialysate;
the mixing cassette configured to:
send a volume of bicarbonate and water mixture to an external sensor cassette, and receive the volume of bicarbonate and water mixture from the sensor cassette;
mix the volume of bicarbonate and water mixture with acid solution to form a volume of dialysate if the volume of bicarbonate and water mixture meets a first conductivity threshold or parameter in the sensor cassette;
send the volume of dialysate to the sensor cassette, and receive the volume of dialysate from the sensor cassette;
send the volume of dialysate to a drain path if the volume of dialysate does not meet a second conductivity threshold or parameter measured in the sensor cassette; and
send the volume of dialysate to an external dialysate reservoir if the volume of dialysate meets a second conductivity threshold or parameter in the sensor cassette.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1772
JK
9/24/26
