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 .
Claim Status
Claims 1-16 are pending and are examined on the merits.
Priority
As recorded on the 05/11/2023 filing receipt, the effective filing date of the claimed invention is 04/21/2023. At this point in examination, all claims have been interpreted as being accorded this priority date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/29/2023 and 09/13/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner. A signed copy of the corresponding 1449 form has been included with this Office action.
Drawings
The drawings filed 04/21/2023 are accepted.
Specification
The specification filed 04/21/2023 has been accepted.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claim(s) 1-16 being representative) is directed to a method. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claims 1-16 recite the following steps which fall under the mathematical concepts, mental processes, and/or certain methods of organizing human activity groupings of abstract ideas:
Claim 1 recites determining a probability of a kidney stone in a subject being a uric-acid (UA) stone by using a machine learning algorithm; the limitation determining a probability using a mathematical algorithm is considered mathematical calculation, as claimed in claims 2-5 and 16. As such, said limitation falls into mathematical concepts groupings of abstract ideas.
Claims 2-5 and 16 recite that the prediction model is mathematically expressed as y=1/1+ef(x) (mathematical formula/mathematical concepts).
Claim 14 recites determining the eGFR of the input variable set based on the age, the gender indicator and the creatinine concentration; the limitation determining eGFR is considered a mathematical calculation using a mathematical formula claimed in claim 15, and as such, falls into mathematical concepts groupings of abstract ideas.
Claim 15 recites calculating the eGFR by using the isotope dilution mass spectrometry traceable Modification of Diet in Renal Disease formula that is mathematically expressed as: eGFR [mL/min/1.73m2] =175(Scr)-1.154 (Age)-0.203(0.742)G ; the limitation calculating eGFR using a mathematical formula is considered mathematical calculation, and as such, falls into mathematical concepts groupings of abstract ideas.
Claims 6-13 provide more information about the input data.
Additionally, claims 1-16 recite a correlation between urine PH and composition of kidney stone, and as such, falls into judicial exception of Laws of nature and natural phenomena. See MPEP 2106(b) I.
The identified claims recite a law of nature, a natural phenomenon (product of nature) and/or fall into one of the groups of abstract ideas of mathematical concepts, mental processes, and/or certain methods of organizing human activity for the reasons set forth above. See MPEP 2106.04 (a)(2) III and MPEP 2106.04 (b) I. Therefore, claims are directed to one or more judicial exception(s) and require further analysis in Prong Two. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
The additional elements of claims 1-16 include the following.
Claim 1 recites feeding an input variable set into the prediction model so as to obtain the probability of the kidney stone in the subject being a UA stone (inputting data).
The additional elements of feeding an input variable set into the prediction model (inputting data) amount to necessary data gathering and outputting. The courts have found the limitations that amount to necessary data gathering and outputting are insignificant extra-solution activity that do not integrate a recited judicial exception into a practical application in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968 and O/P Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (see MPEP 2106.05(g)).
Therefore, the additionally recited elements amount to insignificant extra-solution activity and, as such, the claims as a whole do no integrate the abstract idea into practical application.
MPEP 2106.04(d). I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using 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, as discussed in MPEP § 2106.05(e).
In Step 2A, Prong 1 above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, Prong 2, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination, it is not yet the case that any of the Step 2A, Prong 2 considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
In conclusion regarding Prong 2, claims 1-16 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. An inventive concept cannot be furnished by an abstract idea itself. See MPEP § 2106.05.
The additional elements of claims 1-16 include the following.
Claim 1 recites feeding an input variable set into the prediction model so as to obtain the probability of the kidney stone in the subject being a UA stone (inputting data).
The additional elements of feeding an input variable set into the prediction model (inputting data) amount to necessary data gathering and outputting. The courts have found the limitations that amount to necessary data gathering and outputting are insignificant extra-solution activity that do not amount to significantly more (see MPEP 2106.05(g)).
Therefore, the additional element is not sufficient to amount to significantly more than the judicial exception.
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
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 1 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN115205213A; as cited in the IDS form dated 08/29/2023) in view of Patel (Association of Impaired Renal Function with Changes in Urinary Mineral Excretion and Stone Composition, Urology, Volume 141, July 2020, Pages 45-49; as cited in the attached 892 form).
Regarding claim 1, the recited method for determining a probability of a kidney stone in a subject being a uric-acid (UA) stone, is taught as a method of predicting the composition of calculus for early and non-invasive diagnosis of calculi (Wang: abstract).
The recited determining a probability using a machine learning algorithm, is taught as predicting using machine learning model (Wang: pg. 7, last para.).
The recited training data sets that are related to a plurality of patients and includes a value of urine pH, is taught as 119 patient samples data for training the model with clinical features such as gender, age, BMI, blood calcium, blood uric acid, blood glucose, total cholesterol, triglycerides, high density lipoproteins, low density lipoproteins, blood leukocytes, neutrophil percentage, urine ph, urine nitrite test, urine under-lens leukocyte count, urine bacterial count, urine pus cells, urine culture, stone diameter (Wang: pg. 9, para. 4-9).
The recited feeding an input variable set including a value of urine pH of the subject into the prediction model so as to obtain the probability of the kidney stone in the subject being a UA stone, is taught as a calculation module, used for inputting the clinical features, dual-source CT parameter features and radiomics features into a prediction model for calculation to obtain a prediction result of urinary calculi components in vivo (Wang: claim 1).
Further regarding claim 1, Wang does not teach that the training data sets includes an estimated glomerular filtration rate (eGFR), but Patel does teach this limitation.
Patel investigates the effect of kidney function on stone composition and urinary mineral excretion and teaches that uric acid stones are associated with lower eGFR and that patients with lower eGFR also demonstrated a statistically significant association with lower urinary pH (Patel: Abstract Results; see also, section: Results, pg. 46-47).
Regarding claims 8, 9, 10, 11 and 12, the recited input variables BMI (as in claim 8), age (as in claim 9), gender (as in claim 10), Diabetes mellitus indicator (as in claim 11), and a gout indicator and a bacteriuria indicator (as in claim 12) are taught as the clinical features include gender, age, BMI, blood calcium, blood uric acid (for example, a gout indicator), blood sugar (for example, a diabetes mellitus indicator indicator), total cholesterol, triglyceride, high density lipoprotein, low density lipid One or more of protein, blood white blood cells, percentage of neutrophils, urine pH, urine nitrite test, urine microscopic white blood cell count, urine bacterial count (for example, a bacteriuria indicator), urine pus cells, urine culture or stone diameter (Wang: claim 2).
Regarding claim 13, Patel teaches hypertension as one of the demographic factors of chronic kidney disease and nephrolithiasis (pg. 47, col. 2, last para.; Table 1).
Rationale for combining Wang and Patel
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard to Wang and Patel, the examiner concludes that the combination of Fischer and Dash represents the use of known techniques to improve similar methods. Both Wang and Patel are directed to parameters affecting kidney stone composition. Wang only disclosed determining a probability of a kidney stone in a subject being a uric-acid stone by analyzing various parameters such as gender, age, BMI and, urine PH (Wang: pg. 9, para. 4-9). In the same field of research, Patel provided that lower kidney eGFR and lower urine PH are linked to uric acid stones. It would have been prima facie obvious to one ordinary skilled in the art before the effective filling date of invention to include eGFR as one of the parameters for kidney stone composition prediction, since uric acid stones are strongly predicted by lower urinary pH and decreased eGFR, as disclosed by Patel. One ordinary skilled in the art before he effective filing data of the claimed invention would have had a reasonable expectation of success at combining the method of Wang and Patel. This combination of using eGFR parameter of Patel in kidney stone composition prediction model of Wang would have allowed for more accurate predictive results.
Claims 14 nd 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, in view of Patel, as applied to claims 1 and 8-13 above, and further in view of Levey (A New Equation to Estimate Glomerular Filtration Rate, Annals of internal medicine vol. 150,9 (2009): 604-12, pages:1-16; as cited in the IDS form dated 09/13/2013).
The art is applied to claims 1, 8-13 similarly to as described above. The following further applies to claims 14 and 15.
Regarding claims 14 and 15, Wang and Patel do not teach a creatine concentration as one of the input variables and estimated eGFR equation, But Levey teaches these limitations.
Wang and Patel disclose various parameters as input variables for the prediction model such as gender, age, BMI, blood calcium, blood uric acid, blood sugar, total cholesterol, triglyceride, high density lipoprotein, low density lipid One or more of protein, blood white blood cells, percentage of neutrophils, urine pH, urine nitrite test, urine microscopic white blood cell count, urine bacterial count, urine pus cells, urine culture or stone diameter (Wang: claim 2) (pg. 47, col. 2, last para.; Table 1).
Levey teaches determining the eGFR based on age, gender, and creatinine concentration. Levey further teaches that the CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] _ 1.159 [if black], where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κor 1, and max indicates the maximum of Scr/κ or 1. In this table, the multiplication factors for race and sex are incorporated into the intercept, which results in different intercepts for age and sex combinations. (Levey: Table 1).
Levey further teaches that the equation for estimated GFR is = 175 × standardized Scr −1.154 × age−0.203 × 1.212 [if black] × 0.742 [if female], where GFR is expressed as mL/min/1.73 m2 of body surface area41 and Scr is expressed in mg/dL (Levey: pg. 3, para. 3).
Rationale for combining Wang, Patel, and Levey
It would have been prima facie obvious to one ordinary skilled in the art before the effective filling date of invention to include creatinine as one of the parameters for kidney stone composition prediction and estimate eGFR as disclosed by Levey based on the creatinine concentration, age, and gender since uric acid stones are strongly associated with decreased eGFR, as disclosed by Patel. One ordinary skilled in the art before he effective filing data of the claimed invention would have had a reasonable expectation of success at combining the method of Wang and Patel with the eGFR estimation of Levey and this combination would have allowed for more accurate prediction of kidney stone composition.
Citation of pertinent prior art
Simmons (Risk Factors for Common Kidney Stones Are Correlated with Kidney Function Independent of Stone Composition, American Journal of Nephrology, Received: March 22, 2023)
Conclusion
No claims are allowed.
Claims 2-7 and 16 appear to be free from prior art because the art does not teach or fairly suggest the mathematical equation of the prediction model as disclosed in claims 2-5 and 16.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GHAZAL SABOUR whose telephone number is (703)756-1289. The examiner can normally be reached M-F 7:30-5:00.
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/G.S./Examiner, Art Unit 1686
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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