DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The abstract of the disclosure is objected to because it exceeds 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: Para [0001] refers to U.S. Patent Application No. 17/359,280. Since this application was issued as U.S Patent No. 11,992,332 on 5/28/2024, para [0001] should be updated to indicate this. 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.
Claims 26, 30, 38 and 40 are 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 26 recites that the second urine output rate is “at least 100 mL/hour” and the second infusion rate is “at least 200 mL/hour”. However, claim 21 recites that “the second infusion rate is less than a second urine output rate”. Since claim 26 allows the “second urine output rate” to be as low as 100 mL/hour but only allows the “second infusion rate” to be as low at 200 mL/hour, claim 26 allows for a situation where the second infusion rate is greater than the second urine output rate, contradicting the requirement of claim 21. Because claim 26 allows for a situation that contradicts the requirement of claim 21, claim 26 is indefinite. In order to overcome this rejection, claim 26 needs to require the minimum second infusion rate to be less than the minimum second urine output rate.
Claim 30 recites “wherein – causing the hydration fluid to be infused to the patient includes […]”. Since claim 21 recites “causing a hydration fluid to be infused to the patient via a pump at a first infusion rate” and “causing the hydration fluid to be infused to the patient via the pump at a second infusion rate”, it is unclear if the limitation of claim 30 refers to the step of infusing at the first infusion rate, to the step of infusing at the second infusion rate, or to both the steps of infusing at the first infusion rate and at the second infusion rate. Because of this, claim 30 lacks proper antecedent basis and is indefinite. For the sake of examination, the limitation of claim 30 is interpreted as referring to both the steps of infusing at the first infusion rate and at the second infusion rate.
Claim 30 recites “a pump of the fluid therapy system”. Since claim 21 already introduces “a pump” and the specification does not appear to describe using two pumps to cause the hydration fluid to be infused, it is unclear if the “pump of the fluid therapy system” of claim 30 is truly intended to be an additional pump (as written) or if the “pump of the fluid therapy system” of claim 30 is intended to be the same as the “pump” of claim 21. Because of this, claim 30 is indefinite. For the sake of examination, the “pump” of claim 30 is interpreted as being the same as the “pump” of claim 21.
Claim 30 recites “wherein […] obtaining the first urine output rate includes obtaining via the processor and/or a urine measurement device of the fluid therapy system, the first urine output rate”. Since claim 21 already introduces “a urine measurement device” and the specification does not appear to describe using two urine output devices to obtain the first urine output rate, it is unclear if the “urine output device of the fluid therapy system” of claim 30 is truly intended to be an additional urine output device (as written) or if the “urine output device of the fluid therapy system” of claim 30 is intended to be the same as the “urine output device” of claim 21. Because of this, claim 30 is indefinite. For the sake of examination, the “urine output device” of claim 30 is interpreted as being the same as the “urine output device” of claim 21.
Claim 30 recites “wherein […] obtaining the first urine output rate includes obtaining via the processor and/or a urine measurement device of the fluid therapy system, the first urine output rate”. This limitation allows for the first urine output rate to be obtained via the processor alone, the urine measurement device alone, or both of the processor and the urine measurement device. However, claim 21 recites that the first urine output rate is obtained “via a urine measurement device”. Since claim 30 allows for this output rate to be obtained by only the processor, claim 30 allows for a situation that contradicts the requirement of claim 21. Because claim 30 allows for a situation that contracts the requirement of claim 21, claim 30 is indefinite.
In order to overcome these rejections, it is suggested to amend claim 40 to recite “wherein – the pump and the urine measurement device are components of a fluid therapy system; causing the hydration fluid to be infused to the patient via the pump at the first infusion rate and at the second infusion rate includes causing, via a processor of [[a]] the fluid therapy system, the hydration fluid to be infused to the patient by [[a]] the pump of the fluid therapy system; obtaining the first urine output rate includes obtaining, via the processor and the urine measurement device of the fluid therapy system, the first urine output rate; and obtaining the actual fluid balance includes obtaining, via the processor, the actual fluid balance of the patient”.
Claim 38 recites that the second urine output rate is “at least 100 mL/hour” and the second infusion rate is “at least 200 mL/hour”. However, claim 31 recites that “the second infusion rate is less than a second urine output rate”. Since claim 38 allows the “second urine output rate” to be as low as 100 mL/hour but only allows the “second infusion rate” to be as low at 200 mL/hour, claim 38 allows for a situation where the second infusion rate is greater than the second urine output rate, contradicting the requirement of claim 31. Because claim 38 allows for a situation that contradicts the requirement of claim 31, claim 38 is indefinite. In order to overcome this rejection, claim 38 needs to require the minimum second infusion rate to be less than the minimum second urine output rate.
Claim 40 recites “wherein causing the hydration fluid to be infused to the patient includes […]”. Since claim 31 recites “causing a hydration fluid to be infused to the patient at a first infusion rate” and “causing the hydration fluid to be infused to the patient at a second infusion rate”, it is unclear if the limitation of claim 40 refers to the step of infusing at the first infusion rate, to the step of infusing at the second infusion rate, or to both the steps of infusing at the first infusion rate and at the second infusion rate. Because of this, claim 40 lacks proper antecedent basis and is indefinite. For the sake of examination, the limitation of claim 40 is interpreted as referring to both the steps of infusing at the first infusion rate and at the second infusion rate. In order to overcome this rejection, it is suggested to amend claim 40 to recite “wherein causing the hydration fluid to be infused to the patient at the first infusion rate and at the second infusion rate includes […]”.
Allowable Subject Matter
Claims 21-25, 27-29, 31-37 and 39 are allowed. Claims 26, 30, 38 and 40 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office Action.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the independent claims could not be found nor was suggested in the prior art of record.
Independent claims 21 and 31 each require a method for managing fluid levels of a patient comprising the steps of (1) causing a hydration fluid to be infused to the patient at a first infusion rate that is less than a first urine output rate of the patient by a first predetermined threshold and (2) causing the hydration fluid to be infused to the patient at a second infusion rate that is less than a second urine output rate by a second predetermined threshold, wherein (a) the second predetermined threshold is greater than the first predetermined threshold and (b) the second urine output rate is greater than the first urine output rate. Claim 21 further requires both infusions to be performed by a pump, the first urine output to be obtained by a urine measurement device, an actual fluid balance to be obtained based at least in part on the first urine output rate, and the second infusion rate being infused based at least in part on the actual fluid balance; claim 31 further requires the infusion at the first infusion rate to be at a first time and the infusion at the second infusion rate to be at a second time after the first time.
The method steps that are shared by claims 21 and 31 could not be found nor were suggested in the prior art of record. The closest prior art of record is PG PUB 2006/0052764 to Gelfand et al. which discloses a method for managing fluid levels of a patient by changing a infusion rate of hydration fluid based on a urine output rate, wherein the infusion rate can be less than the urine output rate and wherein a latter urine output rate can be greater than a former urine output rate (“A control system or hydration balance means 34 detects the amount of urine output by a patient and automatically adjusts the infusion rate of infusion pump 22 to achieve, as necessary, a zero, positive or negative net fluid balance in the patient”, Para 48). Gelfand is silent as to the operations requiring the first infusion rates to be less than the first urine output rate by a first predetermined threshold, the second infusion rate to be less than the second urine output rate by a second predetermined threshold that is greater than the first predetermined threshold, and the second urine output rate to be greater than the first urine output rate. Additionally, a fluid therapy system that is configured to cause fluid to be infused to the patient based on these features could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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