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 election without traverse of species C, claims 1-13 and 16-20, in the reply filed on 7/29/2026 is acknowledged.
Claims 14 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species A, B, D and E, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/19/2024, 10/24/2024 and 7/16/2025 was received and placed in the record on file. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-13, 16, 17, 19 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claims 1-13, 16, 17, 19 and 20; using the two-part test for subject matter eligibility, independent claims 1, 19 and 20 are the exemplary claims, they are directed to a product (claims 1), process (claim 19) and machine (claim 20) (Step 1: Yes), and is directed to a judicial exception regarding and abstract idea (Step 2A, Prong 1: Yes). The claims are recreated below and the abstract idea is bolded and italicized:
Claim 1:
A non-transitory computer-readable medium storing a computer program that causes a computer to execute a process comprising:
acquiring urine information including urinary oxygen tension;
calculating a renal status index on the basis of the urine information; and
outputting the renal status index.
Claim 19:
An information processing method, comprising:
acquiring urine information including urinary oxygen tension;
calculating a renal status index on the basis of the urine information; and
outputting the renal status index.
Claim 20:
An information processing apparatus comprising a control unit, wherein the control unit is configured to:
acquire urine information including urinary oxygen tension;
calculate a renal status index on the basis of the urine information; and
output the renal status index.
The independent claims encompass an abstract idea drawn to a mental process that can be performed in the human mind and/or by hand using a pen and paper. In this case, the acquiring urine information including urinary oxygen tension (observing information and/or data), calculating a renal status index on the basis of the urine information (using your brain to perform a calculation), and output the renal status index (with regards to claim 19, saying the value from the brains calculation) are all mental processes. In other words, the mental process includes observation, evaluation, judgement and opinion.
Further, the claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2: No). The claims fail to recite additional element or combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes meaningful limitation on the judicial exception. In the instant claims, the identified additional elements include:
A non-transitory computer-readable medium storing a computer program that causes a computer to execute a process (claim 1)
outputting the renal status index (claims 1 and 20)
An information processing apparatus comprising a control unit (claim 20)
These additional elements do not integrate the judicial exception into a practical application. Instead, the additional elements amount to merely applying the judicial exception by including the instruction to implement on a computer as a program, or merely using a computer as a tool to perform the abstract idea (Claim 1: the abstract idea stored as a program on a CPU readable medium that causes a computer to execute the abstract idea; Claim 20: the information processing apparatus and control unit as computers configured to execute the abstract idea); generally linking the use of the judicial exception to a particular technological environment (Claims 1 and 20: tying to a CPU readable medium, or an apparatus and control unit for executing carrying out the abstract idea); and adding insignificant extra-solution activity to the judicial exception (in this case, the post solution activity of causing a computer or apparatus to output the calculated renal status index, which is merely displaying the result of a calculation which is insignificant extra solution activity, see MPEP 2106.05(g)). Further, the additional elements, considered individually and as a whole, along with the abstract idea: do not result in an improvement in the functioning of a computer, or an improvement to other technology or technical field; use the judicial exception to effect a particular treatment or prophylaxis for a disease or condition; implement the judicial exception on a particular machine or manufacture that is integral to the claim; effect a transformation or reduction of a particular article to a different state or thing; or apply the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Finally, the claims, as a whole, do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: No). The additional elements as identified above, do not amount to or contribute to the inventive concept recited in the abstract idea. The additional elements, considered individually and as a whole, amount to merely implementing the abstract idea on a computer by reciting implementation of the abstract idea on a general purpose computer comprising a processor and memory (in this case, the CPU readable medium storing a computer program that causes a generic computer to execute a process for claim 1 and an information processing apparatus comprising a control unit for claim 20) which are recited at a high level of generality and do not attempt to meaningfully limit the abstract idea. Further, the outputting of the renal status index is mere extra-solution activity (mere data gathering and outputting via a computer). Thus, when considered as a whole, claims 1, 19 and 20 do not amount to more than the abstract idea.
Accordingly, claims 1, 19 and 20 are rejected as non-statutory as being directed to a judicial exception (abstract idea: mental process) without significantly more.
Furthermore, dependent claims 2-13, 16 and 17 do not recite any additioanl elements that implement the abstract idea into a practical application or amount to significantly more than the abstract idea as they merely further specify the details of the abstract idea or recite further steps to the abstract idea wherein eligibility cannot be furnished by the unpatentable abstract idea itself (MPEP 2106.04, II, A, 2; referring to claims 2-13, 16 and 17); or recite additional elements (claim 12: outputting the urine information, the circulatory dynamics information, and vital sign data together with the renal status index; claim 13: outputting a newly calculated renal status index by using a relative value with past calculated renal status index; claims 16 and 17: outputting a treatment guideline on the basis of the renal status index) that amount to mere extra-solution activity (in this case outputting a determination/calculation from the computer or instructing the computer to output the determination/calculation). Therefore, the dependent claims 2-13, 16 and 20 are also rejected as non-statutory as being directed to a judicial exception (abstract idea: mental process) without significantly more.
Examiner’s Note: It should be noted that claim 18 is not rejected under 35 USC 101 as non-statutory because it recites that additional elements of causing a drug administration device to administer a drug on the basis of the treatment guideline and repeatedly changing the amount of a drug the drug administration device administers based on the renal status index amount, thus providing a prophylaxis that incorporates the abstract idea into a practical application and/or amounts to significantly more than the abstract idea.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 12, 13, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silverton et al (US 2020/0205718 A1).
Regarding claims 1-4; Silverton discloses a non-transitory computer-readable medium storing a computer program that causes a computer to execute a process (paragraph [0110]; figure 3a) comprising:
acquiring urine information including urinary oxygen tension (element 318; paragraphs [0071]-[0104]; figure 3a);
calculating a renal status index on the basis of the urine information (element 322; paragraphs [0071]-[0104]; figures 3a); and
outputting the renal status index (via user interface; paragraph [0062]; figure 1).
Further regarding claim 2; Silverton discloses the urine information includes at least one or more of a urinary output, a urine flow rate, urinary color, urine absorbance, a urinary sodium amount, and a urinary creatinine amount, in addition to the urinary oxygen tension (element 312; paragraphs [0071]-[104]; figure 3a).
Further regarding claim 3; Silverton discloses the renal status index is an index related to an estimated value of renal artery blood flow (wherein the regional blood flow rate and medullary oxygenation is related to the renal status index [e.g. risk of acute kidney injury, medullary oxygenation of patient or both] element 322; paragraph [0095];); the urine information includes at least one or more of the urinary oxygen tension (element 318) and a urine flow rate (element 312); and calculating the renal status index on the basis of the urinary oxygen tension and the urine flow rate, by using a predetermined algorithm (paragraphs [0074]-[104]; figure 3a).
Further regarding claim 4; Silverton discloses the renal status index is an index related to an estimated value of renal tissue oxygen tension (wherein mean medullary oxygen tension is equivalent to renal tissue oxygen tension; paragraph [0080]); the urine information includes at least one or more of the urinary oxygen tension (element 318) and a urine flow rate (element 312); and calculating the renal status index on the basis of the urinary oxygen tension and the urine flow rate, by using a predetermined algorithm (element 322; paragraphs [0071]-[0104]; figure 3a).
Further regarding claim 5; Silverton discloses that the renal status index is an index related to an estimated value of a glomerular filtration rate (wherein the examiner notes that the calculated risk of acute kidney injury, medullary oxygenation of the patient, or both in step 322 is related to glomerular filtration rate as kidney status is inherently related to glomerular filtration rate, thus meeting the BRI of the instant claim which does not require any calculation or determination of the GFR; paragraphs [0071]-[104]; figure 3a); the urine information includes at least one or more of urinary oxygen tension (element 318) and a urine flow rate (element 312); and calculating the renal status index (element 322) on the basis of the urinary oxygen tension and urine flow rate, by using a predetermined algorithm (paragraphs [0071]-[0104]; figure 3a)
Further regarding claim 6; Silverton discloses outputting urine information and vital sign data together with the renal status index (paragraph [0062], [0099], [0101]; figure 1).
Further regarding claim 7; Silverton discloses acquiring circulatory dynamics information (paragraph [0095]); and calculating the renal status index on the basis of the urine information and the circulatory dynamics information (wherein it discloses that step 322 for determining risk of kidney injury, medullary oxygenation of the patient or both can include one or more properties of blood such as arterial blood oxygenation, venous blood oxygenation, hemoglobin oxygenation, global and regional blood flowrate, blood pressure; paragraphs [0071]-[0104], specifically [0095]).
Further regarding claim 8; Silverton discloses the circulatory dynamics information includes at least one or more of a mean blood pressure, a pulse pressure, a heart rate, blood oxygen saturation, and tissue oxygen saturation (discloses using cardiac output, blood pressure, blood oxygen saturation and tissue oxygen saturation; paragraph [0095]).
Further regarding claim 12; Silverton discloses outputting urine information, circulatory dynamics, and vital sign data together with the renal status index (wherein the user interface is configured to display any of the measured parameters for viewing as desired by user; paragraph [0062]-[0104], specifically [0062], [0099], [0101]; figure 1)
Further regarding claim 13; Silverton discloses repeatedly calculating the renal status index in time series; and outputting a newly calculated renal status index by using a relative value with a past calculated renal status index (paragraphs [0071]-[0104], specifically [0101]-[0103]; figure 3a).
Regarding claim 19; Silverton discloses an information processing method, comprising:
acquiring urine information including urinary oxygen tension (element 318; paragraphs [0071]-[0104]; figure 3a);
calculating a renal status index on the basis of the urine information (element 322; wherein risk of acute kidney injury, medullary oxygenation of the patient or both is calculating a renal status index of the patient; paragraphs [0071]-[0104]; figure 3a); and
outputting the renal status index (via user interface; paragraph [0062]; figure 1).
Regarding claim 20; Silverton discloses an information processing apparatus (element 100; figure 1) comprising a control unit (element 106; figure 1), wherein the control unit is configured to:
acquire urine information including urinary oxygen tension (element 318; paragraphs [0071]-[0104]; figure 3a);
calculate a renal status index on the basis of the urine information element 322; wherein risk of acute kidney injury, medullary oxygenation of the patient or both is calculating a renal status index of the patient; paragraphs [0071]-[0104]; figure 3a); and
output the renal status index (via user interface; paragraph [0062]; figure 1).
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 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Silverton as applied to claims 1 and 7 above, and further in view of Burnes et al (US 2014/0031787 A1).
Silverton is described in the rejection of claims 1 and 7 above; Silverton further discloses that in addition to the urinary information of urinary oxygen tension and urine flow rate, a plurality of other physiological parameters can be used in calculating and determining the renal status index including on or more properties of blood (i.e. global and regional blood flowrate, blood pressure, arterial blood oxygenation, venous blood oxygenation, hemoglobin oxygenation), cardiac output parameters, inspiratory oxygen concentration and patient demographic information (paragraphs [0095]-[0100]).
However, Silverton does not explicitly disclose that using circulatory dynamics information which includes mean blood pressure, pulse pressure and heart rate in calculating the renal status index.
Burnes teaches a system for monitoring cardiac and kidney function in order to control fluid volume and regulation in the body wherein the system additionally monitors circulatory dynamics in addition to urinary information to determine kidney and cardiac function indexes which provide feedback for control of treatment to the patient wherein cardiac function parameters which were used for feedback in determining kidney and cardiac function include mean blood pressure, pulse pressure and heart rate (paragraphs [0121]-[0142]; table 1).
Regarding claims 9-11; Both Silverton and Burnes are related as system for monitoring parameters within the body for determining renal function. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Silverton’s algorithm for determining the renal status index of the patient to further monitor and consider circulatory dynamics including mean blood pressure, pulse pressure and heart rate as taught by Burnes for determining/calculating the renal status index in order to provide a more comprehensive monitor of kidney function.
Further regarding claim 9; the renal status index as determined/calculated in the Silverton/Burnes combination as described above is related to an estimated value of renal artery blood flow as Silverton discloses the renal status index includes local blood flow which would include the renal artery (as the renal artery is local to the kidney and affects renal function).
Further regarding claim 10; the renal status index as determined/calculated in the Silverton/Burnes combination as described above is related to an estimated value of renal tissue oxygen tension as Silverton discloses the determined renal status index (determined risk of acute kidney injury, medullary oxygenation, or both) is related to an estimated value of renal tissue oxygen tension (wherein medullary oxygen tension is a specific type of renal tissue oxygenation; paragraphs [0071]-[0104]; specifically [0080]).
Further regarding claim 11; it would have been obvious to one of ordinary skill in the art at the time of filing to modify the renal status index as determined/calculated in the Silverton/Burnes combination to be further related to the glomerular filtration rate (GFR) as Burnes teaches measuring/determining the GFR when determining/calculating kidney function (Burnes paragraph [0122]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Silverton as applied to claim 1 above, and further in view of Honda et al (provided WO 2021/192971 A1, wherein examiner will cite corresponding US application US 2023/0015588 A1 for English translation).
Silverton is described in the rejection of claim 1 above; however Silverton does not explicitly disclose outputting a treatment guideline on the basis of the renal status index (claim 16); that the treatment guideline is a treatment guideline intended to bring a relation between a urine flow rate and urinary oxygen tension into a predetermined status; or the treatment guideline is a treatment guideline intended to bring the renal status index to a predetermined value (claim 17); or causing a drug administration device to administer a drug on the basis of the treatment guideline, repeatedly calculating the renal status index in time series, and changing an amount of a drug that the drug administration device is caused to administer on the basis of a change in the renal status index after the drug administration device administers the drug; acquiring, in a case where the renal status index and the treatment guideline are input, a predicted value of a renal status index after drug administration based on the treatment guideline is executed, by using a trained model that outputs the renal status index after drug administration based on the treatment guideline is executed, calculating a difference between the predicted value and an actual renal status index after drug administration based on the treatment guideline is executed, and performing retraining of the trained model on the basis of the difference; and acquiring, in a case where the renal status index and the treatment guideline are input, a predicted value of the renal status index after drug administration based on the treatment guideline is executed, by using a trained model that outputs the renal status index after drug administration based on the treatment guideline is executed, calculating a difference between the predicted value and the actual renal status index after drug administration based on the treatment guideline is executed, and adjusting output data of the trained model on the basis of the difference (claim 18).
Honda teaches a system for estimating the biological function of the kidney (i.e. renal function) using urinary information and other parameters and outputting a treatment guidelines on the basis of the renal function evaluation (wherein it outputs treatment guidelines as instructions to administer a drug via a pump; paragraphs [0070]-[0145]; figures 3-10); wherein the treatment guideline is intended to bring the renal status index (evaluated renal function) to a predetermined value (goes through algorithm until renal function is in desired level; paragraphs [0070]-[0145], specifically [0088]-[0089]; figures 3-10); and causing a drug administration device to administer a drug on the basis of the treatment guideline, repeatedly calculating the renal status index in time series, and changing an amount of a drug that the drug administration device is caused to administer on the basis of a change in the renal status index after the drug administration device administers the drug; acquiring, in a case where the renal status index and the treatment guideline are input, a predicted value of a renal status index after drug administration based on the treatment guideline is executed, by using a trained model that outputs the renal status index after drug administration based on the treatment guideline is executed, calculating a difference between the predicted value and an actual renal status index after drug administration based on the treatment guideline is executed, and performing retraining of the trained model on the basis of the difference; and acquiring, in a case where the renal status index and the treatment guideline are input, a predicted value of the renal status index after drug administration based on the treatment guideline is executed, by using a trained model that outputs the renal status index after drug administration based on the treatment guideline is executed, calculating a difference between the predicted value and the actual renal status index after drug administration based on the treatment guideline is executed, and adjusting output data of the trained model on the basis of the difference (paragraphs [0070]-[0145], specifically [0072]-[0089], [0101]-[0114], [0118]-[0129] and [0132]-[0143]; figures 3-10).
Regarding claims 16-18; Silverton discloses the CPU readable medium storing a CPU program that causes a computer to execute a process as described in claim 1 to continuously determine a renal status index of a patient to determine a risk of kidney injury. Honda teaches a method of using a measure of kidney function to output and control treatment guidelines including administering drugs in order to improve the kidney function as described above. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Silverton to further include the algorithm for providing guidelines for treating the kidney as taught by Honda in order to actively monitor and improve kidney function through drug administration.
Further regarding claims 17; Honda teaches the treatment guideline is a treatment guideline intended to bring a relation between a urine flow rate and urinary oxygen tension into a predetermined status; or the treatment guideline is a treatment guideline intended to bring the renal status index to a predetermined value (repeats algorithm until the difference between the evaluated renal function and the predicted renal function is below a threshold value for the predetermined renal status index (paragraphs [0070]-[0145], specifically [0072]-[0089], [0101]-[0114], [0118]-[0129] and [0132]-[0143]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Silverton/Honda combination to provide the same function for the treatment guidelines.
Further regarding claim 18; Honda teaches the drug administration guidelines and algorithm as claimed (paragraphs [0070]-[0145], specifically [0072]-[0089], [0101]-[0114], [0118]-[0129] and [0132]-[0143]); figures 3-10 as described above). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Silverton/Honda combination to provide the same drug administration algorithm as taught by Honda in order to provide treatment bring the renal status to the desired level.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2019/0035496 A1 to Netzer et al; discloses a system and method for selecting optimal medications for a specific patient.
US 2006/0253064 A1 to Gelfand et al; discloses a patient hydration system with hydration state detection.
US2019/0150801 A1 to Suehara et al; discloses a oxygen measuring device for monitoring parameters regarding urinary information.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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