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 (IDS) submitted on 12/26/24, 12/05/24, and 01/10/23 have been considered by the examiner.
Response to Arguments
Upon further consideration, Examiner has re-opened the USC 101 rejection raised in the previous non-final office action. Examiner notes that the addition of the limitation “wherein providing the output comprises (i) adjusting the diuretic dosage rate of the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient”, doesn’t explicitly state that the output is provided by the pump associated with the fluid therapy system. The output could be provided by the user or some other means. Please see corresponding heading below
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were considered. While the arguments regarding claims 10-14, 16 and 17 were persuasive, they do not pertain to new claim 45, as claim 45 does not comprise the limitations “a urine measurement device configured to repeatedly measure urine output from a patient at predetermined intervals”, “a pump configured to provide a diuretic to the patient at a diuretic dosage rate”, “obtaining (i) a first input corresponding to a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid, and/or (ii) a second input corresponding to an estimated amount of excess fluid remaining”, and “and based on (i) the urine output rate being below the predetermined urine output threshold for the first time period, (ii) the diuretic dosage rate being equal to or above a predetermined diuretic threshold for the second time period, and (iii) the first input and/or the second input, providing an output associated with adjusting fluid therapy provided to the patient, wherein providing the output comprises (i) adjusting the diuretic dosage rate of the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient”. As such, Examiner has rejected claim 45. Please see corresponding heading below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10-14, 16, 17 and 45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 10 follows.
Regarding claim 10, the claim recites a fluid therapy system for adjusting fluid therapy. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“determining that (i) the urine output rate over a first time period of at least one hour is below a predetermined urine output threshold and (ii) the diuretic dosage rate over a second time period of at least one hour is equal to or above a predetermined diuretic threshold of at least 5 milligrams/hour; obtaining (i) a first input corresponding to a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid, and/or (ii) a second input corresponding to an estimated amount of excess fluid remaining”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a urine measurement device; a pump; one or more processors; non-transitory computer-readable media; receiving an estimated amount of excess fluid for the patient; obtaining a urine output rate of the patient; obtaining a diuretic dosage rate of the patient; and providing an output associated with adjusting fluid therapy provided to the patient, wherein providing the output comprises (i) adjusting the diuretic dosage rate of the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient ”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity e.g., mere generic means of gathering and outputting data.
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art.
Dependent claims 11-14, 16 and 17 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Regarding claim 45, the claim recites a fluid therapy system for adjusting fluid therapy. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“determining that (i) the urine output rate over a first time period of at least one hour is below a predetermined urine output threshold and (ii) the diuretic dosage rate over a second time period of at least one hour is equal to or above a predetermined diuretic threshold of at least 5 milligrams/hour;”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a fluid therapy system, comprising: tangible, non-transitory computer-readable media; one or more processors; receiving an estimated amount of excess fluid for the patient; obtaining a urine output rate of the patient; obtaining a diuretic dosage rate of the patient; providing an output associated with adjusting fluid therapy provided to the patient, wherein providing the output comprises (i) adjusting the diuretic dosage rate of the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity e.g., mere generic means of gathering and outputting data.
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art.
Therefore, claims 10-14, 16, 17 and 45 are not patent eligible under 35 USC 101.
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 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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Engelman (WO 2019222485 A2) and in further view of Halpert (U.S. Patent Application Publication 2019/0046723 A1), Felker (Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol 2020; 75:1178-1195) and Bhattacharya (U.S. Patent Application Publication 2021/0024536 A1)
Engelman, Halpert, Felker and Bhattacharya were applied in the previous office action
Regarding claim 45, Engelman teaches a fluid therapy system, comprising: tangible, non-transitory computer-readable media having instructions that, when executed by the one or more processors, cause the fluid therapy system to perform operations comprising receiving an estimated amount of excess fluid for the patient [par. 14, 37, 61, 64]; obtaining a urine output rate of the patient [par. 14]; obtaining a diuretic dosage rate of the patient [par. 61];
However, Engelman does not teach determining that (i) the urine output rate over a first time period of at least one hour is below a predetermined urine output threshold and (ii) the diuretic dosage rate over a second time period of at least one hour is equal to or above a predetermined diuretic threshold of at least 5 milligrams/hour; based on the urine output rate being below the predetermined urine output threshold for the first time period and the diuretic dosage rate being equal to or above a predetermined diuretic threshold for the second time period input, providing an output associated with adjusting fluid therapy provided to the patient, wherein providing the output comprises (i) adjusting the diuretic dosage rate of the the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient.
Halpert teaches determining that (i) the urine output rate over a first time period is below a predetermined urine output threshold [par. 18] and (ii) the diuretic dosage rate over a second time period is equal to or above a predetermined diuretic threshold [par. 18 “the urine output rate of the patient is driven to a higher level by automatically controlling an infusion pump to infuse fluid into the patient at rates which match or closely match the monitored patient's urine output rates”; Examiner notes that the infusion rate must be measured after the urine output rate to determine if the infusion rate must be adjusted]; and based on the urine output rate being below the predetermined urine output threshold for the first time period, and the diuretic dosage rate being equal to or above a predetermined diuretic threshold for the second time period, providing an output associated with adjusting fluid therapy provided to the patient [par. 18, 39; Examiner notes urine output rate, infusion rate and fluid loss are all used to determine fluid therapy].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Engelman, to incorporate determining that (i) the urine output rate over a first time period is below a predetermined urine output threshold and (ii) the diuretic dosage rate over a second time period is equal to or above a predetermined diuretic threshold; and based on the urine output rate being below the predetermined urine output threshold for the first time period, and the diuretic dosage rate being equal to or above a predetermined diuretic threshold for the second time period, providing an output associated with adjusting fluid therapy provided to the patient, as these are necessary steps to achieve the desired fluid loss of the patient, as evidence by Halpert [par. 18].
Felker teaches determining (i) the urine output rate over a first time period of at least one hour is below a predetermined urine output threshold and (ii) the diuretic dosage rate over a second time period of at least one hour is equal to or above a predetermined diuretic threshold, and wherein providing the output comprises (i) adjusting the diuretic dosage rate of the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient [pg. 2, par. 3 “Subsequent doses of loop diuretic agents should be guided by clinical response to initial doses. For a sufficient dose of loop diuretic agent, urine output should measurably increase within 2 hours. If there is not an adequate response to initial dose, there is no need to wait until the next scheduled dose to increase dosing. Because the dose-response curve to loop diuretic agents is logarithmic, substantial increases in dose (i.e., doubling) are usually required for improved diuretic response”, Examiner notes it is inherent if the urine output is too low with a specific diuretic dosage rate, this increase in dosage rate is due to the diuretic dosage rate being too low]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Engelman, to incorporate determining (i) the urine output rate over a first time period of at least one hour is below a predetermined urine output threshold and (ii) the diuretic dosage rate over a second time period of at least one hour is equal to or above a predetermined diuretic threshold, and wherein providing the output comprises (i) adjusting the diuretic dosage rate of the diuretic, (ii) infusing a hydration fluid to the patient, and/or (iii) administering a different diuretic to the patient, for improved diuretic response, as evidence by Felker [pg. 2, par. 3].
Additionally, Bhattacharya teaches (ii) the diuretic dosage rate over a second time period is equal to or above a predetermined diuretic threshold of at least 5 milligrams/hour [par. 154, 183, 187 “a single bolus may be administered, several divided doses may be administered over time or the dose may be proportionally reduced or increased as indicated by the exigencies of the therapeutic situation”]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791