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 .
Information Disclosure Statement
The information disclosure statements filed on 7/10/2024 and 9/26/2023 do not fully comply with the requirements of 37 CFR 1.98(b) because some of the non-patent literature citations on each of the IDSs are missing a publication date (see Examiner’s strikethrough annotations on citations 1, 21, and 39 on the IDS of 7/10/2024 and on citation D12** of the IDS of 9/26/2023). See 37 CFR 1.98(b)(5). Since the submissions appear to be bona fide, applicant is given ONE (1) MONTH from the date of this notice to supply the above mentioned omissions or corrections in the information disclosure statements. NO EXTENSION OF THIS TIME LIMIT MAY BE GRANTED UNDER EITHER 37 CFR 1.136(a) OR (b). Failure to timely comply with this notice will result in the above mentioned information disclosure statement being placed in the application file with the noncomplying information not being considered. See 37 CFR 1.97(i).
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0001] should be amended to include application 16/863,824 and its associated filing date.
Appropriate correction is required.
Claim Objections
Claims 23, 30-31, and 33-35 are objected to because of the following informalities:
-Claim 23, line 2: please correct “a diuretic” to “the diuretic”
-Claim 30, line 8: please correct “fluid” to “the fluid”
-Claim 30, line 10: please correct “fluid” to “the fluid”
-Claim 30, lines 10-11: please correct “the measured urine output rate” to “the urine output rate”
-Claim 31, line 3: please correct “fluid” to “the fluid”
-Claim 31, line 4: please correct “administer fluid” to “administer the fluid”
-Claim 33, line 2: please correct “fluid” to “the fluid”
-Claim 34, line 2: please correct “the start” to “a start”
-Claim 35, line 2: please correct “the measured urine output rate” to “the urine output rate”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claim 34 is rejected under 35 U.S.C. 112(b) or 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 34 recites the limitation “wherein the controller is configured to control the fluid administration device to automatically administer a diuretic at the start of therapy”. It is unclear what is meant by “therapy”. Should “therapy” be considered one of “the first therapy period” or “the second therapy period”? Or would the diuretic be automatically administered at the start of any therapeutic steps performed by the system, such that “the start of therapy” could be considered “the start of receiving a urine output rate of the patient…”? For examination purposes, the Examiner interprets “the start of therapy” in claim 34 as “a start of the first therapy period”.
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.
Claims 30-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Da Silva et al. (US 2008/0221512 A1).
Regarding claim 30, Da Silva discloses a fluid therapy system (see Fig. 1) comprising:
a urine output measurement device (urine output measurement subsystem, see par. [0050]) configured to measure a urine output of a patient (see par. [0050]);
a fluid administration device (infusion subsystem, see par. [0050]) configured to administer fluid to the patient (see par. [0050]); and
a controller (controller, see par. [0050]) configured to
receive a urine output rate of the patient based on the measured urine output from the urine output measurement device (urine output measurement subsystem, see par. [0050]) (see par. [0060], [0063]),
control the fluid administration device (infusion subsystem, see par. [0050]) to administer, during a first therapy period, fluid to the patient at one or more first rates (see par. [0063], [0072], fluid is delivered in a first interval at a percentage such as 100% of the urine output), and
control the fluid administration device (infusion subsystem, see par. [0050]) to administer, during a second therapy period, fluid to the patient at one or more second rates less than the measured urine output rate to induce a net fluid loss from the patient (see par. [0054], [0063], [0069], [0071]-[0072], fluid is delivered in a second interval at a percentage of the urine output less than in the first interval such as less than 100% of the urine output to induce a net fluid loss).
Regarding claim 31, Da Silva discloses the fluid therapy system of claim 30 wherein the controller (see par. [0050]) is configured to receive an input for setting a total fluid loss goal (see par. [0052] and [0054]-[0055]), and wherein controlling the fluid administration device (infusion subsystem, see par. [0050]) to administer fluid to the patient at the one or more second rates includes controlling the fluid administration device (infusion subsystem, see par. [0050]) to administer fluid to the patient at the one or more second rates at least until the net fluid loss from the patient reaches the total fluid loss goal (see par. [0052], [0054]-[0055], [0063], [0069], [0071]-[0072], fluid is delivered in a second interval at a percentage of the urine output less than in the first interval such as less than 100% of the urine output to induce a total net fluid loss as set by the user).
Regarding claim 32, Da Silva discloses the fluid therapy system of claim 30 wherein the urine output measurement device (urine output measurement subsystem, see par. [0050]) includes one or more devices (weight scale(s) including an electronic strain gauge or other means, see par. [0050]) configured to weigh a urine collection bag (urine collection bag 52) (see par. [0050]).
Regarding claim 33, Da Silva discloses the fluid therapy system of claim 30 wherein the fluid administration device (infusion subsystem, see par. [0050]) is configured to administer both fluid and a diuretic (see par. [0050], [0063]).
Regarding claim 34, Da Silva discloses the fluid therapy system of claim 30 wherein the controller (see par. [0050]) is configured to control the fluid administration device (infusion subsystem, see par. [0050]) to automatically administer a diuretic at the start of therapy (see par. [0050], [0063]).
Regarding claim 35, Da Silva discloses the fluid therapy system of claim 30 wherein the one or more first rates are equal to or approximately equal to the measured urine output rate (see par. [0063], [0072], fluid is delivered in a first interval at a percentage such as 100% of the urine output).
Regarding claim 36, Da Silva discloses the fluid therapy system of claim 30 wherein the controller (see par. [0050]) is configured to control the fluid administration device (infusion subsystem, see par. [0050]) to administer the fluid to the patient at the one or more first rates such that, during the first therapy period, the patient has little to no net fluid loss (see par. [0063], [0072], fluid is delivered in a first interval at a percentage such as 100% of the urine output which would induce no net fluid loss).
Regarding claim 37, Da Silva discloses the fluid therapy system of claim 30 wherein the controller (see par. [0050]) is configured to control the fluid administration device (infusion subsystem, see par. [0050]) to administer the fluid to the patient at the one or more first rates to increase the urine output rate of the patient (see par. [0052], [0054]-[0055], [0063], [0069], [0071]-[0072], fluid is delivered in a first interval at a percentage of the urine output which can increase the urine output rate).
Regarding claim 38, Da Silva discloses the fluid therapy system of claim 30 wherein the one or more second rates are less than the one or more first rates (see par. [0054], [0063], [0069], [0071]-[0072]; fluid is delivered in a first interval at a percentage such as 100% of the urine output; then fluid is delivered in a second interval at a percentage of the urine output less than in the first interval such as less than 100% of the urine output).
Allowable Subject Matter
Claims 20-29 are allowable.
Claim 39 is 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:
In regards to independent claim 20, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the fluid therapy system as claimed, specifically including the combination of the claimed features with the controller configured to control the infusion of the fluid during a first therapy period while (i) the patient is receiving a diuretic and/or (ii) the measured urine output of the patient is below a threshold urine output level; and after the measured urine output exceeds the threshold urine output level, adjust the infusion of the fluid to achieve a negative fluid balance during a second therapy period following the first therapy period.
The closest prior art of record is Da Silva et al. (US 2008/0221512 A1).
Da Silva discloses a fluid therapy system (see Fig. 1) comprising: a urine output measurement device (urine output measurement subsystem, see par. [0050]) configured to measure a urine output of a patient (see par. [0050]); a fluid administration device (infusion subsystem, see par. [0050]) configured to infuse a fluid to the patient (see par. [0050]); and a controller (controller, see par. [0050]) configured to receive a urine output of the patient based at least partially on the measured urine output (see par. [0050], [0060], [0063]), and control the infusion of the fluid (see par. [0054], [0063], [0069], [0071]-[0072]).
However, Da Silva fails to state the combination of these features with the aforementioned allowable limitations of claim 20.
Dependent claims 21-29 are allowable by virtue of their dependency on allowable claim 20.
In regards to dependent claim 39, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the fluid therapy system as claimed, specifically including the combination of the claimed features with wherein the controller is configured to receive an input for setting a urine output rate desired threshold, and wherein the controller is configured to control the fluid administration device to administer the fluid at the one or more second rates after the urine output rate of the patient reaches the urine output rate desired threshold.
The closest prior art of record is Da Silva et al. (US 2008/0221512 A1).
Da Silva discloses the fluid therapy system of claim 30 (see rejection of claim 30 under 35 U.S.C. 102(a)(1) above).
However, Da Silva fails to state the combination of these features with the aforementioned allowable limitations of claim 39.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783