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 .
DETAILED ACTION
Status of the Application
Claims 12, 15-16, 21, 28, 31-33, and 35-43 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Amendment to the Claims and Remarks filed on 01/20/2026.
Claims 1-11, 13-14, 17-20, 22-27, 29-30, and 34 remain cancelled and not considered at this time.
Claims 12, 15-16, 21, 28, 32-33, and 35-40 are currently amended.
Claims 41-43 are newly added.
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 12, 15-16, 21, 28, 31-33, and 35-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 12, 15-16 and 35-36, and 40-41 fall within the statutory category of an article of manufacture as a computer-readable medium. Claims 21, 37-38, and 42 fall within the statutory category of a process. Claims 28, 31-33, 39, and 43 fall within the statutory category of an article of manufacture as a computer-readable medium.
Step 2A, Prong One
As per Claims 12, 21, and 28, the limitation of determining a high-value itemset of codified clinical concepts occurring within the first plurality of codified clinical concepts, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by pen and paper but for the recitation of generic computer components. Determining a high value itemset of clinical concepts is performed by determining a minimum itemset support value for a potential high-value itemset by comparing the minimum item support values for each concept; selecting a smallest minimum item support value for the concepts within the potential high-value itemset, the minimum item support values respectively indicating a minimum frequency of instances of the codified clinical concepts; wherein the potential high-value itemset is the high-value itemset satisfying the minimum item support value and the minimum itemset support value. This determining involves mental processes such as observation and evaluation. This step also involves determining each high-value itemset satisfies a minimum itemset support value which is a mental process, but the determination of the minimum item support value involves comparing the minimum item support value with the high-value itemset, which can involve either or both of a mental process or a mathematical concept. A simple comparison of values involves a mental process including observation, evaluation using a human mind or pen and paper, but a more complicated comparison could involve the use of mathematical relationships to do the comparison if necessary. The claim limitations of, determining based on a statistical measure of association one or more particular clinical concepts of the high-value itemset are relevant to the target patient and a recommendation including a treatment for the target patient in relation to a diabetes/heart disease/hypertension condition indicated by the particular clinical concepts, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by pen and paper but for the recitation of generic computer components. For example, the above steps in the context of this claim encompasses using evaluation and judgement to determine clinical concepts are relevant to the patient. If a claim limitation, under its broadest reasonable interpretation, covers the performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. The claim limitations of performing a statistical comparison between the high-value itemset and the second plurality of codified clinical concepts associated with a target patient which corresponds to determining a statistical measure of association between the high-value itemset and the second plurality of codified clinical concepts associated with the target patient is a mathematical calculation or relationship and therefore it falls into the abstract grouping of mathematical concepts. As per the October 2019 Update on Subject Matter Eligibility, a claim can recite more than one judicial exception and claims which recite a series of steps that recite mental steps which are also mathematical calculations are identified as both. Accordingly, the claim recites an abstract idea.
Step 2A, Prong Two
This judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claim recites the additional elements – computer-readable storage media having computer-executable instructions, hardware processors, and a graphical user interface (GUI) to facilitate operations of the invention. The computer-readable storage media, processors, and GUI in these steps are recited at a high-level of generality, such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims also recite utilizing a neural network to perform the abstract concept of determining the measure of statistical association. The neural network is recited at a high-level of generality such that it is a known mathematical algorithm used to perform the abstract idea. As per MPEP 2106.05(f)(2), the courts have found that the use of a mathematical algorithm applied on a general purpose computer as an additional element which is mere instructions to apply the exception because this does no more than merely invoke computers as a tool to perform the abstract idea. The claims also recite the additional elements of receiving a reference set of clinical information, receiving a target set of clinical information, and receiving an input indicating that the caregiver has implemented the treatment for the target patient, which are insignificant extra-solution activity, as in MPEP 2106.05(g), because the steps of receiving reference set, target patient data, and input indicating caregiver has implemented a treatment is mere data gathering in conjunction with the abstract idea where the limitations amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). The claims also recite the additional element of presenting the recommendation for the intended purpose of implementation by a caregiver, wherein: following the presenting of the recommendation, the recommendation is accepted and implemented by the caregiver, which is insignificant extra-solution activity, as in MPEP 2106.05(g), because presenting the recommendation is mere data outputting in conjunction with the abstract idea where the limitations amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). The presented recommendation being used for the purpose of acceptance and implementation by a caregiver and inclusion of the description that the recommendation is accepted and implemented by the caregiver do not limit the claim in a functional way. These are the intended result of the claim but are not positively recited such that they provide anything more than the presentation of the recommendation to the GUI. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional elements of a computer-readable storage device having computer executable instructions, hardware processors, and a GUI to perform the method of the invention amounts to no more than mere instructions to apply the exception using a generic computing component. The GUI is merely described as an interface operated by a software application which could be one of any known applications such as software on a device such as a personal computer, laptop, etc. or an application such as PowerChart (specification [0031]). The claims also include utilizing a neural network to perform the abstract concept of determining the measure of statistical association, where the neural network is described in the specification as an example of an agent solver ([0069]) and as being used to determine the measure of statistical association ([00146]). There is no description of the neural network beyond a selection of one of a plurality of machine learning techniques/algorithms which amounts to mere instructions to apply the exception. The claims also include the additional elements of receiving a reference set of clinical information, receiving a target set of clinical information, and receiving an input indicating that the caregiver has implemented the treatment for the target patient, which are elements that are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)). The claims also include the additional element of presenting the recommendation, which is well-understood, routine, and conventional in the field of data management because they are claimed at a high level of generality and include presenting data, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(iv) Presenting offers and gathering statistics (OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 15-16, 31-33, and 35-40 add additional limitations. For example, Claims 15 and 31 include associating the high-value itemset with a clinical decision support event which is a mental process. Claims 16 and 33 include associating the high-value itemset with a clinical decision support event which is a mental process and determining a probability for the patient having the clinical decision support event which is a mathematical concept and thus the claim is directed to the abstract idea similar to the independent claims. The claims also include presenting the clinical decision support event to the caregiver which is mere data outputting that is well-understood, routine, and conventional in the art similar to the presenting in the independent claims. Claim 32 includes a description of the courses of the particular treatment as treating a hypertension and diabetes condition and also recite displaying an indication that the courses of the particular treatment have been acted upon to effectuate the particular treatment for the patient. The displaying step amounts to insignificant extra-solution activity as mere data outputting in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). As per MPEP 2106.05(d)(II), the courts have recognized the presenting of data to be well-understood, routine, and conventional activity such as Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93. Claims 35-38 recite a description of the courses of the particular treatment such that the treatment includes a particular laboratory test, a particular medical procedure, or a particular medication (Claims 36, 37, and 38, respectively). Although the claims use the word particular, the exact test, procedure, or medication is not identified in the claims. Claims 35, 36, and 37 also include a description of the recommendation as associated with courses of a particular treatment for treating a diabetes/heart disease condition and also to treat a heart disease or heart failure condition, hypertension disease or medical condition, and hyperglycemia disease or medical condition, but these do not limit the condition treated as they can be one of many varieties of conditions. The claim must recite the particular treatment, such as a beta blocker medication, as per MPEP 2106.04(d)(2). A particular laboratory test, a particular medical procedure, or a particular medication does not identify the laboratory test itself, or the exact medical procedure, or the exact medication that is to be administered to the patient and is therefore more similar to the example of “administering a suitable medication to a patient” from MPEP 2106.04(d)(2). Claim 38 includes a description of the recommendation associated with the courses of the particular treatment, but similar to Claim 32, 35-37 no particular treatment is clearly recited and therefore the claim does not integrate the abstract idea into a practical application and rather is merely descriptive. Claim 39, similar to the claims discussed above, does not provide a particular treatment, but rather provides a description of the recommendation associated with the courses of a particular treatment for treating the hypertension condition characterized by sustained elevated blood glucose levels but the treatment is recited as a medication or drug that facilitates stable blood sugar levels, which does not provide sufficient particularity. This is similar to the example of “administering a suitable medication to a patient” from MPEP 2106.04(d)(2). Claim 40 includes determining subsets of high-value itemsets are relevant to the target patient based on machine learning algorithm, agent, or solver and statistical measure of association between the high-value itemset and the second plurality of codified clinical concepts which amounts to mathematical concepts. Claims 41-43 include receiving input via the GUI based on the recommendation presented, which amounts to mere data gathering that is well-understood, routine, and conventional as receiving or transmitting data. The GUI is used to receive the data which amounts to mere instructions to apply the exception.
The dependent claims do not integrate the judicial exception into a practical application because the additional elements and combination of elements do not impose meaningful limits on the judicial exception. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
The dependent claims do not amount to significantly more than the abstract idea. As discussed with regards to the independent claims, the dependent claims include additional elements such as presenting subsets to the clinician, presenting to the clinician and receiving a selection. These additional elements are well-understood, routine and conventional computer functions in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data, which has been found to be well-understood, routine and conventional computer functions by the Court (MPEP 2106.05(d)(II)(i). Similar to the explanation above regarding the independent claims, the dependent claims do not provide an inventive concept and thus are not significantly more than the abstract idea.
Accordingly, Claims 12, 15-16, 21, 28, 31-33, and 35-40 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant’s arguments, see Pages 21-26, “Rejections under 35 U.S.C. §101”, filed 01/20/2026 with respect to claims 12, 15-16, 21, 28, 31-33, and 35-43 have been fully considered but they are not persuasive.
Applicant argues that the claims recite features similar or analogous to elements described as meaningful for finding a practical application of the judicial exception by virtue of applying the judicial exception in some other meaningful way. Specifically, Applicant argues that the claims have elements similar to the 2019 Guidance which includes that “treating a patient having a blood glucose level over [a threshold] within insulin” applies the exception in a meaningful way. Examiner respectfully disagrees. The 2019 Guidance provides administration of particular medication, insulin, as the treatment of a particular condition of the patient having a blood glucose level over 250 mg/dl. The instant claims do not provide an analogous particular treatment. The instant claims do not recite the particular treatment. The claims only include determining a recommendation of a treatment in relation to a diabetes/heart failure/hypertension condition, presenting these recommendations, and then receiving some type of indication of implementation. This does not specify any medication would be recommended or what the condition for the recommendation would be and does not include any administration of the medication. Additionally, by reciting in relation to a diabetes/heart failure/hypertension condition, this could be selected from any of a variety of specific medical conditions that a patient has. Therefore the treatment does not have more than a nominal or insignificant relationship to the treatment of the medical condition of the patient and does not pass the factors provided in MPEP 2106.04(d)(2).
Applicant further argues that the instant claims are analogous to Example 29. Examiner respectfully disagrees. The cited claims of Example 29 are found eligible not simply because of the recited step of administering an effective amount of anti-TNF antibodies to the diagnosed patient, which is found to be well-understood, routine, and conventional activity engaged in by doctors, but rather due to the combination of additional elements. The additional elements when viewed as a combination, provided meaningful limits on the use of the exception. In this Example, the condition diagnosed is extremely specific and the medication which is recited to be administered is also specific and applies to the particular specific diagnosis recited in the claims. The instant claims, Claims 12, 21, and 28, do not recite the specific diagnosis for the patient, but rather merely recite determining a recommendation including treatment for the patient in relation to a diabetes/heart failure/hypertension condition. A recommendation for the patient in relation to a diabetes/heart failure/hypertension condition, does not specify the condition as it can be any medical condition that relates to diabetes/heart failure/hypertension, which is a wide array of diagnoses. Additionally, the claims do not recite any actual administration for the patient. Therefore, the instant claims do not provide a particular treatment similar to the Example 29 claims.
Applicant argues that the claims do not recite an abstract idea because the elements are based at least in part on configuring and applying a model. Examiner respectfully disagrees. The claims of the instant application, although they may include the use of a neural network to calculate the statistical measure of association, the training of the model is not even included in the instant claims. Additionally, the instant claims recite limitations beyond the model which are directed to an abstract idea of a mental process and mathematical concepts, as per the rejection above. Therefore, the claims are not analogous to Example 39 in which there is no abstract idea.
Applicant argues that the instant claims integrate the abstract idea into a practical application because they use the output of a model to improve a technical field, similar to Example 47, claim 3. Examiner respectfully disagrees. Example 47, claim 3 is found eligible because the combination of additional elements provides an improvement to the computer or technical field because the specification sets out a specific technical problem which is solved by the combination of additional elements of the claims, specifically improving network security by dropping potentially malicious packets and blocking future traffic from the source address. These elements are rooted in technology and solve the specific problem described in the specification. The instant claims do not provide a similar technical improvement. The instant claims use the output of the model, which is the measure of statistical association, to determine particular clinical concepts of the high-value itemset are relevant to the target patient. This is part of the abstract idea itself and cannot integrate the abstract idea into a practical application. This is not analogous to claim 3 of Example 47. The output of the model in the instant claims is used for decision making which is not a technical improvement.
Applicant argues that the instant claims recite an inventive concept because utilizing a neural network to determine the measure of statistical association provides significantly more than the abstract idea. Examiner respectfully disagrees. The use of a mathematical algorithm such as a neural network to carry out steps of the abstract idea including determining a statistical measure of association amounts to mere instructions to apply the exception which cannot provide for significantly more than the abstract idea.
Applicant’s arguments, see Page 26, “Rejections under 35 U.S.C. §112(a)”, filed 01/20/2026 with respect to claims 12, 15-16, 21, 28, 31-33, and 35-40 have been fully considered and are persuasive. Therefore, the rejection of 11/04/2025 has been withdrawn.
Applicant’s arguments, see Page 26, “Rejections under 35 U.S.C. §112(b)”, filed 01/20/2026 with respect to claims 12, 15-16, 21, 28, 31-33, and 35-40 have been fully considered and are persuasive. Therefore, the rejection of 11/04/2025 has been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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