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 81-93 are pending and under examination.
Claims 81-93 are new.
Claims 1-80 are canceled.
Claims 81, 87, and 93 are independent.
Claims 84 and 90 are objected to.
Office Action Outline
3.
Rejections applied
Abbreviations
X
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
X
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
X
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 11/08/2021 filing receipt, his application is a 371 of PCT/US2019/041887 filed 07/15/2019, which claims the benefit of priority to Provisional Application No. 62/858,771 filed 06/07/2019, and to Provisional Application No.62/698,046 filed 07/14/ 2018.
Overview of Withdrawal/Revision of Objections/Rejections
In view of the amendment and remarks received 10/31/2025:
• The previous 101 rejection is withdrawn as claims 1-81 are canceled; a new 101 rejection of claims 81-93 is applied below.
• The previous 103 rejection is withdrawn; a new 103 rejection of claims 81-93 is applied below
Claim Interpretation and note about Soft Classifier
Applicant's 10/31/2025 remarks (p.8, section I, "Status of the Claims") state:
Claims 1-3, 33-35, 42, 55, 62-63, 65, 69, 74, and 79 are canceled. Claims 81-93 are newly added and within the scope of the claims as elected in Group II having a soft classifier that determines the probability score of a feline developing CKD. (Emphasis added.)
New claims 81-93 do not recite a "soft classifier" as in the now-canceled claims of elected Group II. To keep the scope of new claims 81-93 within a "soft classifier", it is suggested to amend independent claims 81, 87, and 93 to recite "soft classifier." It is noted a notice of non-compliance was considered for not reciting "soft classifier," however, because new claims 81-92 recite "classification algorithm to derive a probability score of the feline developing CKD", and for sake of compact prosecution, the claims will be examined with the expectation that Applicant may amend claims 81, 87, and 93 to include "soft classifier" and further amend claim 93 to include "derive a probability score." Additionally, the below interpretations are asserted:
New independent claims 81 and 87 do not recite a "soft classifier", although they do recite a "classification algorithm to derive a probability score of the feline developing CKD." The classification algorithm of claims 81 and 87 is interpreted to be a "soft classifier" in view of Specification paragraphs [0010, 0036, and 0054], which describe the classification algorithm as a soft classifier which determines the probability score.
New claim 93 does not recite a "soft classifier" nor a "classification algorithm to derive a probability score of the feline developing CKD," however, the classification algorithm of claim 93 is interpreted to be a "soft classifier which derives a probability score" to keep in scope of elected Group II.
Specification
Reference to the Specification in this Office Action refers to U.S. Pub. No.
US 2021/0327589 A1, published 10/21/2021.
Claim Objections
Claim 84 and 90 are objected to because of the following informalities:
The end of both claim 84 and claim 90 recites "assigned to the Prediction of Disease" which should be corrected to "assigned to the Prediction of Disease category." 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 84 and 90 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.
In both "testing..." steps of claim 84, the recitation of "from when the input level of one or more biomarkers is measured" is unclear because measuring biomarkers was not recited in a previous step. Claim 90 is rejected similarly.
In the "identifying underlying..." step of claim 84, the recitation of "continuing with International Renal Interest Society (IRIS) staging" is unclear because IRIS staging was not recited in a previous step. Claim 90 is rejected similarly.
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 81-93 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical
relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices
or principles, managing personal behavior or relationships or interactions between
people); and/or
• mental processes (procedures for observing, evaluating, analyzing/ judging and
organizing information).
• laws of nature and natural phenomena are naturally occurring principles/ relations that
are naturally occurring or that do not have markedly different characteristics compared to
what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1:
Claims 81-86 are directed to a 101 machine, here a system. Claims 87-93 are directed to a 101 process, here a method. As such, claims 81-93 are directed to a related system and method, which fall under categories of statutory subject matter. (Step 1: Yes.)
Step 2A, Prong One:
The claims recite judicial exceptions in the form of abstract ideas and a law of nature as follows:
Independent claim 81 recites a system that includes abstract ideas in the form of mental processes and mathematical concepts for:
• analyzing input levels of biomarkers classification algorithm to derive probability score
• accessing training datasets of medical information of felines diagnosed with CKD
• extracting medical information associated with biomarkers
• training predictors using the extracted medical information
• training the classification algorithm based on the predictors
• categorize the feline based on the probability score
• determine a customized recommendation
Independent claim 87 recites a method for performing similar abstract ideas as claim 81.
Independent claim 93 recites a method for performing abstract ideas similar to the abstract ideas of accessing, extracting, training predictors, and training the classification algorithm steps of claim 81.
Claims 82 and 83 further limit the probability scores of claims 81; claims 88 and 89 further limit the probability scores of claim 87.
Claims 84 and 90 recite mental processes and mathematical concepts for:
•identifying underlying commodities
• continue IRIS staging
Claims 81-93 recite a law of nature in the correlation of biomarker levels in a feline with a probability of contracting CKD in the feline.
Step 2A Prong One Summary: Claim 81-93 recite judicial exceptions of abstract ideas (characterized as mental processes and mathematical concepts). Considering the BRI of the claims, the mental processes recited in independent claims 81, 87, and 93 (e.g., analyzing input levels of biomarkers; accessing subset of data; extracting medical information; and training steps, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, because there are no limitations recited which would prevent the analysis and generating of results mentally. Additionally, at least the limitations for training the classification algorithms inherently recite mathematical concepts such as those disclosed in Specification [0185-0199], table 4-12 (p.28-31); and throughout the drawings. Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Finally, the law of nature correlates naturally occurring urine specific gravity, creatinine, urine protein, BUN/urea level, WBC, and/or urine pH, (and, optionally, feline age) in a feline with a probability of contracting CKD in the feline. Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea and law of nature. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) 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).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) 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).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) 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)
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps: Claim 81 and 87 recites receiving (i.e., inputting/gathering) data. Claims 84 and 90 recite testing the feline (interpreted as data gathering by testing biomarker levels). Claims 85 and 91 recite displaying (outputting) data. Claims 86 and 92 recite transmitting data. Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology [see MPEP § 2106.04(d)(I)].
Additional elements of computer components: Claim 81 recites additional elements of a system, a processor, and/or a memory storing code; claim 85 and 91 recite an additional element of a graphical user interface; claim 86 and 92 recite additional elements of a communication device and a remote system. The claims require only generic computer components, which do not improve computer technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two 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. a treatment, 3. a particular machine, or 4. a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement. It is noted Specification [0109] discloses to date, there remains a need for methods of predicting, treating and/or preventing CKD. The present application relates to determining susceptibility of a feline to developing chronic kidney disease (CKD) and methods of preventing and/or reducing a risk of developing CKD for a feline..., however, this is not yet enough to show an improvement. (Step 2A, Prong Two: No).
Step 2B:
Because the additional claim elements do not integrate the judicial exceptions (i.e., the abstract ideas) into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: Regarding the additional elements of receiving (i.e., inputting/gathering) data in claims 81 and 87; testing the feline (interpreted as data gathering by testing biomarker levels) in claims 84 and 90; displaying (outputting) data in claims 85 and 91; and transmitting data in claims 86 and 92; these additional elements do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory; and determining the level of a biomarker in blood by any means [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Thus, the data gathering and outputting steps are shown to be routine, well-understood, and conventional in the art, and do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional elements of computer components: Claim 81 recites additional elements of a system, a processor, and/or a memory storing code; claim 85 and 91 recite an additional element of a graphical user interface; claim 86 and 92 recite additional elements of a communication device and a remote system. These are conventional computer components, and do not provide an inventive concept.
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claims 81, 85, 86, 91 and 92, which are interpreted to recite conventional computer components.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). E.g., in the instant claims, the graphical user interface, remote systems, and communication devices of claim 85, 86, 91, and 92 act only as a tools in the outputting of the data from the data analysis by judicial exception, and do not integrate the judicial exception into a practical application or provide significantly more.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The graphical user interface, remote systems, and communication devices of claim 85, 86, 91, and 92 do not impose meaningful limitations on the claims.
• The courts have recognized "receiving or transmitting data over a network", "performing repetitive calculations", and "storing and retrieving information in memory", as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The determining, receiving, displaying, and transmitting of data in the claims is recited in a generic manner.
All the limitations of claims 81-93 have been analyzed with respect to Step 2B. Considering these elements both alone and in combination, the additional elements do not provide an inventive concept that transforms the judicial exception into a patent eligible application of the exception, and the claims do not amount to significantly more than the judicial exception itself. (Step2B: NO.) Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Response to Applicant Arguments - 35 USC § 101
The Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Regarding Step 2A Prong One and Prong Two arguments:
The Applicant asserts, on p.8, that claims 81-93 are not directed to an abstract idea as follows:
• The instant claims do not recite a relationship between variables, numbers, a numerical formula, an equation, or a calculation... Biomarker data is extracted from these samples to train multiple predictors. The ensemble of these predictors forms the classification model, which outputs a CKD probability score... therefore the claims do not fall within the mathematical concept grouping... (p.9, ¶ 1).
• The claims may also be considered in comparison to the patent-eligible claim(s) discussed in Example 39 of the USPTO Subject Matter Eligibility Examples: Abstract Ideas. (p.9, ¶ 2).
• Applicant submits that the claims include several specific features that are significantly more than the cited judicial exception of mathematical concepts. (p.10, ¶ 2).
• The combination of the steps in claims 81 and 93, for example, operates in a non-conventional and non-generic way to enable prediction of CKD probability scores, ... as in Bascom Global Internet v. AT&T Mobility LLC, the claimed combination of additional elements presents a specific implementation of the abstract idea. (p.10, ¶ 3).
The argument is not persuasive because the data analysis method (identifying susceptibility of a feline to developing chronic kidney disease (CKD), recites abstract ideas – both mental processes and mathematical concepts as detailed in the above 101 rejection.
Regarding Example 39, the fact pattern differs between Example 39 (method for training a neural network for facial detection) and the instant application (a system and a method for determining a recommendation based on a probability score of a feline developing CKD, the score derived using a trained classification algorithm), and further, the judicial exceptions identified at Eligibility Step 2A, Prong One are not yet integrated into a practical application at Eligibility Step 2A, Prong Two.
Specifically, at this point in examination it is not yet the case that any of the Step 2A Prong Two considerations (an improvement, a treatment, a particular machine, or a transformation) clearly demonstrates integration of the identified JE(s) into a practical application. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement. It is noted Specification [0109] discloses "to date, there remains a need for methods of predicting, treating and/or preventing CKD. The present application relates to determining susceptibility of a feline to developing chronic kidney disease (CKD) and methods of preventing and/or reducing a risk of developing CKD for a feline," however, this is not yet enough to show an improvement.
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.
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 81-93 are rejected under 35 U.S.C. 103 as being unpatentable over Paepe (Journal of Feline Medicine and Surgery, vol. 15(l_suppl), p. 15-27 (2013); cited in the 08/23/2024 form PTO-892); in view of Gunarathne (In 2017 IEEE 17th international conference on bioinformatics and bioengineering (BIBE) (pp. 291-296). IEEE. (23 Oct 2017); cited in the 08/23/2024 form PTO-892), in view of Razavian (In Machine learning for healthcare conference (pp. 73-100) PMLR (2016); cited in the attached form PTO-892), in view of Martin (US 2015/0178639, published 25 June 2015, cited in the 12/08/2023 IDS).
Independent claims 81 and 87 respectively recite a system and a method for determining a customized recommendation based on categorizing a feline in one of three different categories according to a probability score of developing chronic kidney disease (CKD); the score is derived from analysis of biomarker levels (and optionally age) by training and using a classification algorithm. Independent claim 93 recites a method for training the classification algorithm as in claim 87.
Note, italic and bold emphasis was used in the 103 rejection below for ease of communication; this emphasis was added by the Examiner and is not recited in the instant claims.
Regarding receiving one or more input levels of one or more respective biomarkers of a feline of claims 81 and 87:
Paepe teaches biomarkers used in diagnosis and staging of feline CKD, with a discussion of serum creatinine, urine specific gravity, and proteinuria (p.16-18).
Regarding deriving a probability score, and the customized recommendation of claims 81 and 87, and categorizing the feline based on probability score of high, medium, and low score (corresponding to Prediction of Disease, Insufficient Certainty to Predict Disease, and No Prediction of Disease categories) of claims 81 and 87, the scores indicating probability of developing kidney disease of claims 82 and 88, the score ranges of claims 83 and 89:
Paepe teaches a score for staging CKD, the IRIS staging assists in prognosis of CKD in cats (p.22, col.2, under "Staging"), teaching "probability scores" by IRIS substaging. Paepe discusses the IRIS classification system used in assisting prognostication of CKD in cats, and shows low, medium, and high substage score classification (i.e., Prediction of Disease, Insufficient Certainty to Predict, and No Prediction of Disease categories), and therefore categorization, of feline biomarkers in staging CKD in felines (p.22, col.2, under "Staging"). Paepe shows UPC (urinary protein: creatinine ratio) substaging in IRIS staging the proteinuric (>0.4 ), non-proteinuric ( <0.2), and borderline proteinuric (02.-0.4) scores; these scores are interpreted to respectively correspond to the high (50-100), low (0-5), and medium (6-50) probability scores.
Regarding the customized recommendation comprises identifying underlying commodities, testing for CKD, or continuing with International Renal Interest Society (IRIS) staging of claim 84 and 90:
Paepe teaches the customized recommendation in continuing with IRIS staging by re-evaluating the felines who are borderline proteinuric (score 0.2-0.4) within 2 months, or repeating the IRIS UPC substaging within 2 weeks with felines who are proteinuric (score > 0.4) (p.22, col.2, under "Staging").
Paepe does not teach analyzing the one or more input levels of the one or more respective biomarkers and age by a classification algorithm to derive a probability score of claims 81 and 87; and accessing reduced trajectories as truncated data, sampled subsets of a training database, extracting medical information, training predictors, and training the classification algorithm of claims 81, 87, and 93. (Taught below by Gunarathne and Razavian .)
Paepe does not teach accuracy of claims 82 and 88. (Taught below by Gunarathne.)
Paepe does not teach the processor and memory of claim 81; the display and graphical user interface of claims 85 and 91; communication devices and remote systems of claims 86 and 92. (Taught below by Martin.)
Regarding analyzing the one or more input levels of the one or more respective biomarkers and age by a classification algorithm to derive a probability score of claims 81 and 87; and accessing sampled subsets of a training database, extracting medical information, training predictors, and training the classification algorithm of claims 81, 87, and 93:
Gunarathne teaches evaluation of machine learning in classification and forecasting models using CKD patient data (p.291, abstract). Gunarathne shows datasets for building the predictive model include attributes of serum creatinine, WBC count, and age (p .292, col.2, table II). Gunarathne shows using a publicly available dataset which includes 400 CKD patient records with 25 attributes. Out of those 25 attributes, a reduced dataset was used with 14 selected attributes to build the predictive model (p.292, col.2). Gunarathne shows filtered data set with the 14 attributes was used in the data mining model. For the testing and training purpose the data set with 400 records was integrated with duplicated data set...70% of records were used to train the model and 30% used for test the trained model (p.293, col.2). Gunarathne shows using multiclass logistic regression algorithm (i.e., a soft classifier) to predict the probability of CKD (p.294, bridging cols.1-2; p.295, Fig.5). Gunarathne shows the logistic regression classification algorithms predicts with high overall accuracy (p.295, Table III).
Regarding a temporally ordered subset of clinical visit records truncated at a point up to two years prior to a CKD diagnosis of claims 81 and 87, Razavian teaches a method for prediction of disease onsets from longitudinal lab test results. Razavian shows their goal is early diagnosis of diseases for people who do not already have the disease (p.2, ¶ 2), and outlines the prediction framework (p.2, fig.1) which includes a 3 month gap between the backward window and the prediction window (showing data truncated up to two years prior). Razavian shows a dataset consisting of lab measurements and diagnosis information for 298,000 individuals; the lab measurements had the resolution of 1 month and a backward window of 36 months was used for each prediction (p.3, ¶ 1). Razavian shows adapting the model to predict onset of end-stage renal disease (ESRD) in patients with advanced CKD (p.7), and including the labs associated with the most common LOINC codes for all of the labs used in the predictive models for kidney failure, and dividing the dataset into training, validation, and test data (p.9, ¶ 2).
Regarding the processor and memory of claim 81; the display and graphical user interface of claims 85 and 91; communication devices and remote systems of claims 86 and 92:
Martin shows systems and methods for generating biomarker signatures [Title, 0021-0024], and shows a processor and memory [0050, 0056, 0057]; communication interface units, protocols, and devices [0049-0052]; a display [0055]; and remote computer [0057].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method for categorization of biomarker levels in feline CKD staging, determining of CKD probability scores, and determining customized recommendations of Paepe, with the classification method using training datasets of biomarkers and ages of subjects with and without CKD for predicting CKD with high accuracy of Gunarathne, with the truncated training sets, backward window, and 3 month gap of Razavian, with the systems for generating biomarker signatures of Martin. This is because Gunarathne shows logistic regression is a well-known statistical method used in predicting probability of an outcome, and is particularly popular for classification tasks (Gunarathne, p.294, col.2), while Razavian discloses the purpose of the 3 month gap was to ensure that the clinical tests taken right before the diagnosis of a disease would not allow the system to cheat in the prediction of that disease (Razavian, p.2, ¶ 2). Martin states the computer systems described ... may achieve improved classification performance in biomarker and other data classification applications (Martin, [0008]). Paepe provides motivation to combine by stating diagnosis of early feline CKD is challenging...(and) practical, inexpensive, accurate methods to detect early feline CKD are urgently needed (Paepe, p.23, col.2). One of ordinary skill in the art would have understood how to and been motivated to combine the related teachings of Paepe, Gunarathne, Razavian, and Martin to come to a system for computational classification of CKD biomarkers to derive probability scores in feline CKD using a classification algorithm, and as such, the combination would have been obvious.
Response to Applicant Arguments – 35 USC 103
The Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Note: The instant 103 rejection utilizes the Paepe, Gunarathne, (new) Razavian, and Martin references, whereas the previous, now-withdrawn 103 rejections (from the 08/13/2025 nonfinal Office action) utilized Paepe, Gunarathne, Liu, Jepson, Roudebush, Larsen, Martin, and Srivastava. In spite of the different combination of references used, every effort was made to respond fully and appropriately to Applicant arguments which pertain to the instant 103.
Applicant asserts (bold emphasis added):
Paepe does not teach the features of a soft classification algorithm or data on samples diagnosed with CKD (p.12, ¶ 2).
The argument is not persuasive. A soft classifier is not recited in claims 81-93, and further Paepe is not relied upon for teaching a classification algorithm. Gunarathne is relied upon for teaching a logistic regression classification algorithm; logistic regression is a well-known soft classification method used in predicting probabilities.
Applicant asserts (bold emphasis added):
Gunarathne fails to disclose, tech, or suggest "accessing a plurality of sampled subsets of a training dataset, the training dataset comprising..." One of the skills in the art would recognize that the training dataset recited in claims 81 and 94 is much more complicated than... Gunarathne... which include multiple sampled subsets. For each feline diagnosed with CKD, a single reduced trajectory-an ordered subset of clinical records truncated up to two years before diagnosis-is randomly selected from multiple such trajectories and used as training data (p.12, ¶ 3).
The argument is not persuasive. Specifically, Razavian has been used to show the truncated training dataset of claims 81, 87, and 93 as follows: Razavian teaches a method for prediction of disease onsets from longitudinal lab test results. Razavian shows their goal is early diagnosis of diseases for people who do not already have the disease (p.2, ¶ 2), and outlines the prediction framework (p.2, fig.1) which includes a gap between the backward window and the prediction window (showing data truncated up to two years prior). Razavian shows a dataset consisting of lab measurements and diagnosis information for 298,000 individuals; the lab measurements had the resolution of 1 month and a backward window of 36 months was used for each prediction (p.3, ¶ 1). Razavian shows adapting the model to predict onset of end-stage renal disease (ESRD) in patients with advanced CKD (p.7), and including the labs associated with the most common LOINC codes for all of the labs used in the predictive models for kidney failure, and dividing the dataset into training, validation, and test data (p.9, ¶ 2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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NSDP- 1 of 2:
Claims 81-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of reference Application Nos.16/963,093 (hereinafter the ‘093 application) in view of Paepe, (Journal of Feline Medicine and Surgery, vol. 15(l_suppl), pages 15-27 (2013); cited on the 08/23/2024 form PTO-892)).
Reference claims of the ‘093 application do not recite categorizing the feline, based on the probability score.
Paepe teaches the IRIS classification system used in assisting prognostication (i.e., prediction) of CKD in cats, and shows low, medium, and high substage score classification by the proteinuric (>0.4), non-proteinuric (<0.2), and borderline proteinuric (02.-0.4) scores are interpreted to respectively correspond to the high (50-100), low (0-5), and medium (6-50) probability scores (p.22, col.2, under "Staging").
It would have been obvious to one of ordinary skill in the art to modify the method of reference claims of the ‘093 application to include the categorizing of the feline based on probability score of Paepe, as Paepe discloses the classification system to stage (dogs and) cats with CKD has been developed by the International Renal Interest Society (IRIS) and adopted by both the American and European Societies of Veterinary Nephrology and Urology (Paepe, p.22, under "Staging"). Accordingly, pending claims 81-93 are not patentably distinct from one or more reference claims of the ‘093 application.
This is a provisional nonstatutory double patenting rejection.
NSDP- 2 of 2:
Claims 81-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of reference Application Nos.18/000,406 (hereinafter the ‘406 application) in view of Paepe, (Journal of Feline Medicine and Surgery, vol. 15(l_suppl), pages 15-27 (2013); cited on the 08/23/2024 form PTO-892)).
Reference claims of the ‘406 application do not recite felines, nor categorizing the feline, based on the probability score.
Paepe teaches a classification system (the IRIS classification system) to stage (dogs and) cats with CKD, and shows low, medium, and high substage score classification by the proteinuric (>0.4), non-proteinuric (<0.2), and borderline proteinuric (02.-0.4) scores are interpreted to respectively correspond to the high (50-100), low (0-5), and medium (6-50) probability scores (p.22, col.2, under "Staging").
It would have been obvious to one of ordinary skill in the art to modify the method of reference claims of the ‘406 application to include the categorizing of cats based on probability score of Paepe, as Paepe discloses the classification system to stage dogs and cats with CKD has been developed by the International Renal Interest Society (IRIS) and adopted by both the American and European Societies of Veterinary Nephrology and Urology (Paepe, p.22, under "Staging"). Accordingly, pending claims 81-93 are not patentably distinct from one or more reference claims of the ‘406 application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686