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 .
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) filed 7/27/26. Claims 1, 7-9, 13, 15, 16, 18, and 20 have been amended. Claims 1-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/20/26 has been entered.
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.
Step 1:
Claims 13-17 are directed to a method (i.e., a process) and claims 1-12 & 18-20 are directed to a system (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 13 and 18 includes limitations that recite at least one abstract idea. Specifically, independent claims 13 and 18 recite:
13. A computer implemented method comprising:
receiving operational data from a heart/lung machine during a procedure for a patient and parameters indicative of conditions of the patient during the procedure from one or more monitoring devices;
training a model for the procedure by correlating comparisons of the operational data from the heart/lung machine and the parameters from the one or more monitoring devices to data defining target ranges for operational parameters of the heart/lung machine and the one or more monitoring devices across one or more model layers using one or more machine learning algorithms; and
applying the model for the procedure to determine predictions that the operational data from the heart/lung machine or the parameters from the one or more monitoring devices are trending out of the target ranges based on applying the model;
generating one or more recommended adjustments to the heart/lung machine based at least in part on the predictions; and
transmitting instructions to the heart/lung machine based on the one or more recommended adjustments to control the heart/lung machine to automatically adjust one or more settings of the heart/lung machine.
18. A system for performing a procedure on a patient, the system comprising: a medical treatment system; one or more monitoring devices configured to monitor parameters indicative of conditions of the patient during the procedure; a database storing data defining target ranges for operational parameters of the medical treatment system and the one or more monitoring devices during the procedure; and a computer system including one or more processors, the one or more processors receiving instructions that configure the computer system to receive, during the procedure, operational data from the medical treatment system and the parameters from the one or more monitoring devices; the computer system further configured to: train a model for the procedure by correlating comparisons of the operational data from the medical treatment system and the parameters from the one or more monitoring devices to the data defining the target ranges for the operational parameters of the medical treatment system and the one or more monitoring devices during the procedure across one or more model layers using one or more machine learning algorithms; and apply the model for the procedure to determine predictions that the operational data from the medical treatment system or the parameters from the one or more monitoring devices are trending out of the target ranges based on applying the model; generate one or more recommended adjustments to the medical treatment system based at least in part on the predictions; and transmit instructions to the medical treatment system based on the one or more recommended adjustments to control the medical treatment system to automatically adjust one or more settings of the medical treatment system.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity” because for performing a procedure on a patient; monitor parameters indicative of conditions of the patient during the procedure; defining target ranges for operational parameters during the procedure; receive, during the procedure, operational data and the parameters; receiving operational data during a procedure for a patient and parameters indicative of conditions of the patient during the procedure; and generating one or more recommended adjustments based at least in part on the predictions amount to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), at the currently claimed high level of generality.
The Examiner submits that the foregoing underlined limitations constitute “mathematical concepts” because train a model for the procedure by correlating comparisons of the operational data and the parameters to the data defining the target ranges for the operational parameters during the procedure across one or more model layers using one or more machine learning algorithms; and apply the model for the procedure to determine predictions that the operational data or the parameters are trending out of the target ranges based on applying the model amount to mathematical relationships, mathematical formulas or equations, or mathematical calculations, at the currently claimed high level of generality.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 13, and 18, as drafted, is a process that, under its broadest reasonable interpretation, covers certain methods of organizing human activity and mathematical concepts but for the recitation of generic computer components. That is, other than reciting a heart/lung machine, one or more monitoring devices, a medical treatment system, a database, and a computer system including one or more processors to perform the limitations, nothing in the claim elements precludes the steps from practically being certain methods of organizing human activity and mathematical concepts. If a claim limitation, under its broadest reasonable interpretation, covers certain methods of organizing human activity and mathematical concepts but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and “mathematical concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the heart/lung machine, one or more monitoring devices, medical treatment system, database, and computer system including one or more processors are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of receiving data, training, correlating data, monitoring data, storing data, applying a model, generating data, and transmitting data) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-12, 14-17, 19, and 20 are ultimately dependent from Claim(s) 1, 13, and 18 and include all the limitations of Claim(s) 1, 13, and 18. Therefore, claim(s) 2-12, 14-17, 19, and 20 recite the same abstract idea. Claims 2-12, 14-17, 19, and 20 describe further limitations regarding wherein the comparisons further include analysis of medical data describing one or more conditions of the patient, wherein the medical data includes current conditions of the patient and historic conditions of the patient, wherein the comparisons further include analysis of general population medical data that summarizes health information of a general population of other patients, wherein the general population medical data includes historical health information of patients who have undergone the procedure, that the model is stored, wherein the one or more adjustments are generated in real-time, select at least one of the one or more recommended adjustments; autonomously implement at least one of the one or more recommended adjustments during the procedure, generating a second model, receive operational data, types of monitoring devices, generating/selecting/implementing additional recommended adjustments; storing medical data, select at least one of the one or more recommended adjustments based at least in part on analyzing: the operational data, the parameters, the medical data, and the general population medical data. These are all just further describing the abstract idea recited in claims 1, 13, and 18, without adding significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 13, and 18 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to receiving data from a machine and from one or more monitoring devices, transmitting instructions to the machine/system, and a database storing data, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network and storing and retrieving information in memory. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Claim Objections
Claims 8 and 20 are objected to because of the following informalities: claims 8 and 20 recite “the instructions.” It is unclear which “instructions” are being referred to in claims 8 and 20 since there are two mentions of “instructions” in independent claims 1 and 18. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 7/20/26 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 7/20/26.
(1) Reconsideration and withdrawal of the § 101 rejection are respectfully requested.
(A) As per the first argument, see 101 rejection above. Applicant’s arguments regarding Example 46 are not persuasive because Applicant’s claim is not analogous to claim 2 of Example 46. Note that eligible claim 2 of Example 46 recites: “wherein the system further comprises a feed dispenser that is connected to a feed and supplement supply and is operable to dispense individualized amounts of feed and optional supplements, and wherein the monitoring component is further configured for (d) automatically sending a control signal to the feed dispenser to dispense a therapeutically effective amount of supplemental salt and minerals mixed with feed when the analysis results for the animal indicate that the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany.” As stated in the Example, “Limitation (d) specifies that the monitoring component automatically sends a control signal to the feed dispenser to dispense a therapeutically effective amount of supplemental salt and minerals mixed with the feed when the analysis results for the animal indicate that the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany. Thus, limitation (d) does not merely link the judicial exceptions to a technical field, but instead adds a meaningful limitation in that it can employ the information provided by the judicial exception (the mental analysis of whether the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany) to operate the feed dispenser. Limitation (d) in combination with the feed dispenser enables the control of appropriate farm equipment based on the automatic detection of grass tetany, which goes beyond merely automating the abstract idea. Using the information obtained via the judicial exception to take corrective action such that the monitoring component is operable to control the feed dispenser in a particular way is an “other meaningful limitation” that integrates the judicial exception into the overall livestock management scheme and accordingly practically applies the exception, such that the claim is not directed to the judicial exception.” Note that in Applicant’s claim there is no limitation analogous to the “…feed dispenser that is connected to a feed and supplement supply and is operable to dispense individualized amounts of feed and optional supplements” such as a separate step in the claim with details regarding the heart/lung machine and medical treatment system. In Applicant’s case, the independent claims merely recite generating one or more recommended adjustments and transmitting instructions based on the one or more recommended adjustments to adjust one or more settings.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
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