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 amendment filed 1/29/26. Claims 1, 7, 13, 15, and 18 have been amended. Claims 1-20 are pending.
Terminal Disclaimer
The terminal disclaimer filed on 1/29/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,923,078 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
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.
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; and receiving operational data during a procedure for a patient and parameters indicative of conditions of the patient during the procedure 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, and applying a model) 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, generating recommended adjustments, select one or more adjustments of the recommended adjustments; autonomously implement the one or more adjustments during the procedure, generating a second model, receive operational data, types of monitoring devices, storing medical data, select 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 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “one or more monitoring devices configured to…” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Subject Matter Free of Prior Art
Claims 1-17 are free of prior art. Regarding independent claims 1 and 13, the closest prior art of record, Pappada (US 2015/0227710 A1), does not teach or fairly suggest: training a model for the procedure by correlating comparisons of the operational data (received during the procedure for a patient) from the heart/lung machine and the parameters (received during the procedure) 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.
Claims 18-20 are free of prior art. Regarding independent claim 18, the closest prior art, Degen (US 2018/0060520 A1) and Pappada (US 2015/0227710 A1), do not teach or fairly suggest: 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 (stored in a database during the procedure) 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.
Response to Arguments
Applicant's arguments filed 1/29/26 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 1/29/26.
(1) Applicant respectfully requests that the rejection of all claims under 35 U.S.C. § 101 be withdrawn.
(2) Applicant respectfully submits that a skilled artisan reading the specification would understand the term "one or more monitoring devices" to be the name of the structures that perform the function.
(A) As per the first argument, see 101 rejection above. Applicant’s arguments are not persuasive because Applicant has not explained what the “technical improvement” is. Improving predictions, as argued, is not a technical improvement. In addition, Applicant appears to argue features that have not been claimed (e.g., incorporating data from a wide variety of sources). 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, and applying a model) 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.
(B) As per the second argument, if applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Conclusion
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
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