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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/22/2025 has been entered.
Response to Arguments
Applicant’s argument filed 09/22/2025 have been fully considered but they are not persuasive for the 101 rejections. The amended claims have overcome 103 rejections and the 103 rejections have been withdrawn.
Applicant’s Argument: On page 7-9 of Applicant’s response, applicant states “Starting with prong one of step 2A, the amended claims do not recite a judicial exception, at all, and are therefore patent eligible. MPEP 2106.04 clarifies that a claim may be held to recite a judicial exception only if the office identifies claim limitations that fall within one of three enumerated categories. The Office alleges that the claims recite a “mental process” accomplished using mathematical concepts. Applicant respectfully disagrees, and submits that the present claims, which relate to a structured computer- implemented process for preprocessing clinical data, generating weights, and applying predictive models, do not recite or relate to a mental process.
MPEP 2106.04 explains that claims “[a] claim with limitation(s) that cannot practically be performed in the human mind does not recite a mental process.” This includes, for example, “when the human mind is not equipped to perform the claim limitations.” Id. Simply put, if a claim includes one or more elements that “cannot be practically performed in the human mind,” it is not abstract. ... These operations involve preprocessing medical entries into structured form, structural lookups, numerical aggregations, and predictive modeling over multi-entry medical records. Applicant respectfully submits that these operations are not practically performed in the human mind, even with a pen and paper.”
Examiner’s Response: Applicant’s argument is not persuasive. In Step 2A Prong 1 of the analysis, the steps that recite an abstract idea are identified. The steps of “selecting a first entry” and “generating ... a prediction” as recited in the claims are an abstract idea because those claim elements recite a mental process that can be performed in the human mind. Selection of the first data in a given dataset can be performed in the human mind and “generating ... prediction” is similar to making an educated guess based on historical data. The steps of “generating ... a ratio”, “summing the ratios”, and generating a weight” as recited in the claims are an abstract idea because those claim elements recite a mathematical concept (see MPEP § 2106.04(a)(2)). The newly added claim limitation of preprocessing the plurality of historical records to transform the records into a scaled representation is a mental process that can be performed in the human mind with the aid of pen and paper. This claim limitation discloses the process of identifying the maximum and minimum values of a dataset and scaling the rest of the data to the defined range based on the max and min value.
In Step 2A Prong 2 of the analysis, examiner reviews the additional elements of the claim to determine if the additional elements of the claim integrate the abstract idea into a practical application. The step of “generating ... a ratio”, “summing the ratios”, and generating a weight” are indicated as a mathematical function and implies that the claimed invention is a mathematical concept which is being implemented to train a machine learning model in a generic manner. Therefore, the recited claims amount to an abstract idea of a mathematical concept. Training a neural network is a generic computer process and step of “generating ... a ratio”, “summing the ratios”, and generating a weight” are mere instructions for using a computer as a tool to perform a mathematical function. The use of a computer or other machinery in its ordinary capacity does not integrate a judicial exception into a practical application or provide significantly more. Therefore, the additional element fails to integrate the abstract idea into a practical application under the Step 2A Prong 2 analysis.
Applicant reference the example illustrate in MPEP 2106.04(a)(1), which shows various examples where claims do not recite any abstract ideas. The example is eligible under Step 2A Prong One because the claims do not recite an abstract idea. The claimed invention does recite an abstract idea and further analysis is required because the claims of the invention need to be analysis to determine if additional elements integrate a judicial exception into a practical application or if the claims provide significantly more.
Applicant’s Argument: On page 11-12 of Applicant’s response, applicant states “The claimed invention reflects a technical improvement in clinical computing system. More specifically, the additional elements of claim 1 recite a structured process for transforming historical medical records into numerical features through a statistically defined weight-generation techniques. These steps facilitate the conversion of unstructured clinical data into consistent and interpretable features usable for machine learning, including preprocessing the records using a scaler or encoder to produce scaled or encoded representations and applying statistically weight-generation techniques to calculate weights for each entry. Claim 1 further recites generating a prediction of whether a medical event will occur using a trained mole and providing the prediction via a device interface for clinical use. The claimed process enables real-time clinical risk assessment for historical data inputs.”
Examiner’s Response: Applicant’s argument is not persuasive. During examination, the examiner should analyze the "improvements" consideration by evaluating the specification and the claims to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement (see MPEP §2106.05(a)). The MPEP (§2106.05(a)(II)) also warns, “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” Here, the alleged improvement in the form of “applying statistically weight-generation techniques to calculate weights for each entry” is an improvement to the abstract idea of a mathematical calculation.
Applicant’s Argument: On page 14-15 of Applicant’s response for 35 U.S.C. § 103, applicant states “Claims 9 and 16 have been amended ...”
Examiner’s Response: There are no references in combination to teach all of the claim limitations. Thus, the amended claims have overcome 103 rejections and the 103 rejections have been withdrawn.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Claim 1:
Subject Matter Eligibility Analysis Step 1:
Claim 1 recites “A method, comprising” and is thus a process, one of the four statutory categories of patentable subject matter.
Subject Matter Eligibility Analysis Step 2A Prong 1:
“preprocessinq the plurality of historical records usinq a scaler ” (a mental process or mathematical function that can be performed in the human mind with the aid of pen and paper, i.e. evaluation; Determining the max and min values in the dataset and converting the dataset within the range.)
“for every entry in the sequences of medical entries: selecting a first entry in the sequences of medical entries” (a mental process that can be performed in the human mind, i.e. judgement)
“generating, for every record of the plurality of historical records, a ratio of a number of times the first entry is in the sequence of medical entries versus a total number of medical entries in the sequence” (a mathematical relationship)
“summing the ratios of the plurality of historical records indicating that the event did occur to yield a first summation (X)” (a mathematical equation)
“summing the ratios of the plurality of historical records indicating that the event did not occur to yield a second summation (Y)” (a mathematical equation)
“generating a weight for the first entry using the following:
X
Y
-
Y
X
” (a mathematical equation)
“generating, based on the combined weight, a prediction of whether the event will occur” (a mental process that can be performed in the human mind, i.e. judgement; The combined weight represents the likelihood an outcome will occur and a determination is made based on the probability whether an event will occur.)
Claim 1 therefore recites an abstract idea.
Subject Matter Eligibility Analysis Step 2A Prong 2:
"receiving a plurality of historical records, each comprising a sequence of medical entries and an indication whether an event occurred” (This step is directed to data gathering, which is understood to be insignificant extra solution activity - see MPEP 2106.05(g))
“preprocessinq ” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
“storing weights for the medical entries of the sequences of medical entries in a static model dictionary” (This step is directed to storing data in memory, which is understood to be insignificant extra solution activity - see MPEP 2106.05(g))
“using the static model dictionary to at least one of (i) train a first machine learning (ML) model or (ii) provide input to a second ML model to predict whether the event will occur” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
"providing the prediction for display via a device interface for clinical use” (This step is directed to data gathering, which is understood to be insignificant extra solution activity - see MPEP 2106.05(g))
The additional elements as disclosed above alone or in combination do not integrate the judicial exception into practical application as they are mere insignificant extra solution activity in combination of generic computer functions being implemented with generic computer elements in a high level of generality to perform the disclosed abstract idea above. Therefore, Claim 1 is directed to the abstract idea.
Subject Matter Eligibility Analysis Step 2B:
"receiving a plurality of historical records, each comprising a sequence of medical entries and an indication whether an event occurred” (This step is directed to transmitting or receiving information, which is understood to be insignificant extra solution activity and well understood, routine and conventional activity of transmitting and receiving data as identified by the court - see MPEP 2106.05(d))
“preprocessinq ” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
"storing weights for the medical entries of the sequences of medical entries in a static model dictionary” (This step is directed to storing data in memory, which is understood to be insignificant extra solution activity and well understood, routine and conventional activity of storing and retrieving information in memory as identified by the court - see MPEP 2106.05(d))
“using the static model dictionary to at least one of (i) train a first machine learning (ML) model or (ii) provide input to a second ML model to predict whether the event will occur” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
"providing the prediction for display via a device interface for clinical use” (This step is directed to transmitting or receiving information, which is understood to be insignificant extra solution activity and well understood, routine and conventional activity of gathering and analyzing information using conventional techniques and displaying the result as identified by the court - see MPEP 2106.05(d))
The additional elements as disclosed above alone or in combination do not recite significantly more than the abstract idea itself as they are mere insignificant extra solution activity in combination of generic computer functions being implemented with generic computer elements in a high level of generality to perform the disclosed abstract idea above. Therefore, Claim 1 is subject-matter ineligible.
Regarding Claim 9:
Subject Matter Eligibility Analysis Step 1:
Claim 9 recites “A method, comprising” and is thus a process, one of the four statutory categories of patentable subject matter.
Subject Matter Eligibility Analysis Step 2A Prong 1:
“a weight is generated from a first summation that comprises ratios of a plurality of historical records indicating that a corresponding event did occur, and a second summation that comprises ratios of the plurality of historical records indicating that the corresponding event did not occur, and the weight is determined by forminq two respective ratios between the first summation and the second summation and computinq a difference between the two respective ratios” (a mathematical calculation)
“preprocessinq the sequence of medical entries by applyinq a scaler ” (a mental process that can be performed in the human mind with the aid of pen and paper, i.e. evaluation; Determining the max and min values in the dataset and converting the dataset within the range.)
“converting each entry in the sequence of medical entries to a weight using the static model dictionary” (a mental process, i.e. judgement)
“combining the weights to yield a combined weight” (a mental process, i.e. judgement)
“generating, based on the combined weight, a prediction of whether the event will occur” (a mental process, i.e. judgement; The combined weight represents the likelihood an outcome will occur and a determination is made based on the probability whether an event will occur.)
Claim 9 therefore recites an abstract idea.
Subject Matter Eligibility Analysis Step 2A Prong 2:
"providing a static model dictionary storing weights, each corresponding to a different entry, ” (This step is directed to data gathering, which is understood to be insignificant extra solution activity - see MPEP 2106.05(g))
“receiving a record comprising a sequence of medical entries” (This step is directed to data gathering, which is understood to be insignificant extra solution activity - see MPEP 2106.05(g))
“preprocessinq ” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
“using the combined weights to at least one of (i) train a first machine learning (ML) model or (ii) provide input to a second ML model to predict whether the event will occur” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
"providing the prediction for display via a device interface for clinical use” (This step is directed to data gathering, which is understood to be insignificant extra solution activity - see MPEP 2106.05(g))
The additional elements as disclosed above alone or in combination do not integrate the judicial exception into practical application as they are mere insignificant extra solution activity in combination of generic computer functions being implemented with generic computer elements in a high level of generality to perform the disclosed abstract idea above. Therefore, Claim 9 is directed to the abstract idea.
Subject Matter Eligibility Analysis Step 2B:
"providing a static model dictionary storing weights, each corresponding to a different entry, ” (This step is directed to transmitting or receiving information, which is understood to be insignificant extra solution activity and well understood, routine and conventional activity of transmitting and receiving data as identified by the court - see MPEP 2106.05(d))
"receiving a record comprising a sequence of medical entries” (This step is directed to transmitting or receiving information, which is understood to be insignificant extra solution activity and well understood, routine and conventional activity of transmitting and receiving data as identified by the court - see MPEP 2106.05(d))
“preprocessinq ” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
“using the combined weight to at least one of (i) train a first machine learning (ML) model or (ii) provide input to a second ML model to predict whether the event will occur” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
"providing the prediction for display via a device interface for clinical use” (This step is directed to transmitting or receiving information, which is understood to be insignificant extra solution activity and well understood, routine and conventional activity of gathering and analyzing information using conventional techniques and displaying the result as identified by the court - see MPEP 2106.05(d))
The additional elements as disclosed above alone or in combination do not integrate the judicial exception into practical application as they are mere insignificant extra solution activity in combination of generic computer functions being implemented with generic computer elements in a high level of generality to perform the disclosed abstract idea above. Therefore, Claim 9 is subject-matter ineligible.
Regarding Claim 16:
The claim recites a system that performs the method as described in claim 9. Therefore, claim 16 is rejected for the same reasons as disclosed for claim 9. The limitations for additional elements of claim 16 are analyzed below.
Subject Matter Eligibility Analysis Step 2A Prong 1:
Please see Step 2A Prong 1 analysis of claim 9
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“A non-transitory computer readable medium comprising instructions to be executed in a processor, the instructions when executed in the processor perform an operation, the operation comprising” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
Regarding Claim 2:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein each of the plurality of historical records corresponds to a different living organism, a different apparatus, or a different system” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claims 3, 11, and 18:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“where the medical entries in the sequences of medical entries are codes defined according to a standard” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claim 4:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the codes are diagnosis codes used to diagnosis a patient” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claim 5:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the indication indicates whether or not the patient experienced the event, wherein the event is a medical event” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claim 6:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the codes are repair or maintenance codes for an apparatus or a system, wherein the indication indicates whether or not the apparatus or the system experienced a repair or maintenance event” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claim 7:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the medical entries in the sequences of medical entries are medications that are, or were, prescribed to patients” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claims 8, 10, and 17:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein larger, positive weights stored in the static model dictionary are correlated to the event occurring, while larger, negative weights stored in the static model dictionary are correlated to the event not occurring, and smaller negative and positive weights stored in the static model dictionary are weakly correlated to the event” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claims 12, and 19:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the medical entries in the sequence of medical entries are one of: diagnosis codes, medication codes, repair codes, or maintenance codes” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claims 13 and 20:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein combining the weights to yield the combined weight comprises averaging the weights according to a number of medical entries in the sequence of medical entries” (merely specifies a particular technological environment in which the abstract idea is to take place, ie. a field of use, and thus does not integrate the abstract idea into a practical application nor cannot provide significantly more than the abstract idea itself - see MPEP 2106.05(h))
Regarding Claim 14:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the combined weight is used to train the first ML model, wherein the record comprises an indication of whether or not the event occurred, the method further comprising: training the first ML model using the indication” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
Regarding Claim 15:
Subject Matter Eligibility Analysis Step 2A Prong 1: None
Subject Matter Eligibility Analysis Step 2A Prong 2 & 2B:
“wherein the combined weight is used to provide input to the second ML model, the method further comprising: generating, using the second ML model, a likelihood the event will occur” (mere instructions to apply the exception using a generic computer component - see MPEP 2106.05(f))
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY MAC whose telephone number is (703)756-1517. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abdullah Kawsar can be reached on (571) 270-3169. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY MAC/Examiner, Art Unit 2127
/ABDULLAH AL KAWSAR/Supervisory Patent Examiner, Art Unit 2127