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
Response to Amendment
In the amendment dated 23 July 2026, the following occurred: Claims 1-3, 5, 7, 8, 16, and 18 have been amended; Claims 4, 6, 11, 15, 17, and 19-38 have been cancelled; Claims 39-41 are new.
Claims 1-3, 5, 7-10, 12-14, 16, 18, and 39-41 are pending and have been examined.
Priority
This application claims priority to U.S. Provisional Patent Application No. 63/625,656 dated 26 January 2024.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claim. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: a machine learning model recommending a switch to a second mechanical circulatory support device, where the machine learning model is trained on historical patient cohort data associated with patients that have undergone escalation from a first type of mechanical circulatory support device to a second type of mechanical circulatory support device, the second type of mechanical circulatory support device having a higher maximum output than the first type of mechanical circulatory support device
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 1-3, 5, 7-10, 12-14, 16, 18, and 39-41 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.
Claims 1, 16, and 41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a method and system for determining an escalation recommendation for a patient having an implanted mechanical circulatory support device, which are within a statutory category.
Step 2A1
The limitations of Claims 1 and 16 (Claim 1 being representative):
receiving, in association with a first mechanical circulatory support device, an indication to determine an escalation recommendation for a patient;
determining values for a set of features, wherein the set of features includes one or more operational parameters associated with first the mechanical circulatory support device and one or more health parameters of the patient;
processing the values for the set of features by providing the values as input to […] model to generate a model output, wherein the trained […] model is trained on historical patient cohort data associated with patients that have undergone escalation from a first type of mechanical circulatory support device to a second type of mechanical circulatory support device, the second type of mechanical circulatory support device having a higher maximum output than the first type of mechanical circulatory support device; and
displaying on the user interface, an escalation recommendation for the patient based, at least in part, on the model output, the escalation recommendation including a recommendation to switch to a second mechanical circulatory support device based on a maximum output and/or a type of the second mechanical circulatory support device
and/or the limitations of Claim 41:
receiving, in association with a first mechanical circulatory support device, an indication to determine a first escalation recommendation for the patient at a first time during the PCI procedure;
determining first values for a set of features, wherein the set of features includes one or more first features associated with the first mechanical circulatory support device and one or more second features associated with the patient;
providing the first values for the set of features as a first input to a trained model to generate a first model output;
determining a first escalation recommendation for the patient based, at least in part, on the first model output;
determining, at a second time during the PCI procedure after the first time, second values for the set of features;
providing the second values for the set of features as a second input to the trained model to generate a second model output;
determining a second escalation recommendation for the patient based, at least in part, on the second model output;
based at least in part on the first escalation recommendation and the second escalation recommendation, determining that the first mechanical circulatory support device should be substituted for a second mechanical circulatory support device having a greater maximum flow rate than the first mechanical circulatory support device; and
removing the first mechanical circulatory support device from the patient and implanting the second mechanical circulatory support device in the patient during the PCI procedure.
, as drafted, is are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to determine an escalation recommendation for a patient (see Spec. Para. 0018 describing determining an escalation recommendation for a patient as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receiving… determining… processing… and displaying” or “receiving… determining… providing… determining… determining… providing… determining… and, determining” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a computer-implemented method, the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The Examiner notes that the training of a machine learning model of Claims 1 and 16 is recited in the claim. The type of training utilized by the claimed invention is not described by the Applicant. As such, the Examiner is required to analyze the training feature given the broadest reasonable interpretation. The step(s) performed to train the model/algorithm is/are considered to be part of the abstract idea because it/they fall(s) under data manipulations that humans perform (i.e., fitting a model to data) and thus are interpreted to be part of the abstraction--the rules or instructions that fall under Certain Methods of Organizing Human Activity.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of (Claim 1) a computer having a user interface and at least one processor or (Claim 16) a controller that implements the identified abstract idea. The Examiner notes that Claim 41 is not tied to any particular technological environment. The computer and controller are not described by the applicant and are recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The Examiner notes that the only description of the controller is that it is general purpose hardware having a processor (see Spec. Para. 0033) and thus the controller is presumed to be a generic computer. Even assuming that the controller is part of the MSC device, the MSC device is described as a device that is known in the art (see Spec. Para. 0018). 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 claim is directed to an abstract idea.
Claims 1 and 16 further recite the additional element of using a trained machine learning model to generate model output indicating whether to switch from a first circulatory device to a second circulatory device having a higher maximum output. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible).
Claims 16 and 41 recite the additional elements of (1) a heart pump having a sensor and (2) removing the first mechanical circulatory support device from the patient and implanting the second mechanical circulatory support device in the patient during the PCI procedure, respectively. Regarding (1), the heart pump having a sensor merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Regarding (2), the “removing” step equates to saying “apply it” to the abstract idea, i.e., apply the results of the abstract idea. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claim does 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 of (Claim 1) a computer having a user interface and one or more processors or (Claim 16) a controller to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using the trained machine learning model (Claims 1 and 16) to generate model output indicating whether to switch from a first circulatory device to a second circulatory device having a higher maximum output was found to represent mere instructions to implement the abstract idea on a generic computer. This has been re-evaluated under the “significantly more” analysis and determined to be insufficient to provide significantly more. MPEP 2106.05(I) indicates that mere instructions to implement the abstract idea on a generic computer cannot provide significantly more. See also Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 17 (Fed. Cir. April 18, 2025) (finding that applying machine learning to an abstract idea does not transform a claim into something significantly more).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) a heart pump having a sensor and (2) removing the first mechanical circulatory support device from the patient and implanting the second mechanical circulatory support device in the patient during a PCI procedure were determined to either generally link the abstract idea to a particular technological environment or field of use or represent an “apply it” step. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”).
For completeness, the Examiner makes the following findings:
Training of an AI/ML model (machine learning being a subset of AI) is well-understood, routine and conventional in the art as evidenced by:
Lai et al. (U.S. Patent No. 9,769,166) at Col. 4, Lns. 56-61;
Peterson et al. (U.S. Pre-Grant Patent Publication No. 2021/0059540) at Para. 0021;
Bradley et al. (U.S. Patent No. 11,594,311) at Col. 7, Lns. 6-22, Col. 13, Lns. 51-66;
Ogale et al. (U.S. Patent No. 10,769,809) at Col. 18, Lns. 25-31.
A heart pump having a sensor is well-understood, routine and conventional in the art as evidenced by:
Tao et al. (U.S. Pre-Grant Patent Publication No. 2025/0128044) at Para. 0046;
Sugiura (U.S. Pre-Grant Patent Publication No. 2005/0014991) at Para. 0004;
Gentile et al. (U.S. Pre-Grant Patent Publication No. 2024/0216670) at Para. 0045.
Removing the first mechanical circulatory support device from the patient and implanting the second mechanical circulatory support device in the patient during a PCI procedure is well-understood, routine and conventional in the art as evidenced by:
Lucertini et al. (Left ventricular assist device exchange: a review of indications, operative procedure, and outcomes) at Pg. 1;
Specification at Para. 0018.
Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 2, 3, 5, 7-10, 12-14, 18, and 39-40 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 3, 12, 18 merely describe(s) how/where data is displayed, which further defines the abstract idea.
Claims 2, 3, and 18 recite the additional elements of a controller or a computing device, respectively. These items generally link the claim invention to a particular technological environment or field of use. As described above, “generally linking” cannot provide a practical application or significantly more.
Claim(s) 5, 7, 8, 9, 10 merely describe(s) the operational parameters or one or more health parameters, which further defines the abstract idea.
Claim(s) 13 merely describe(s) the type of procedure, which further defines the abstract idea.
Claim(s) 14 merely describe(s) tracking values and updating the recommendation accordingly, which further defines the abstract idea.
Claim(s) 39 merely describe(s) the type of machine learning model (additional element). This is analyzed in the same manner as the machine learning model of Claim 1 and does not provide a practical application or significantly more for the same reasons.
Claim(s) 40 merely describe(s) labeling the cohort data, which further defines the abstract idea.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-16, 18, and 26-28, Applicant has cancelled Claims 4, 6, 11, 15, and 26-28, rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
Amended claim 1 is patent eligible under Step 2A Prong One at least because claim 1 as a whole does not recite a method of organizing human activity or any other type of abstract idea.
Regarding (a), the Examiner respectfully disagrees. The claim recites a method of organizing human activity as noted in the basis of rejection. The Applicant has described escalating a medical device as a human activity in their disclosure. The identified abstract idea may be a particular way of performing this escalation determination; however, a particular type of abstraction is still an abstraction.
Amended claim 1 recites an improvement in technology capturing this benefit by providing a method that leverages a specially trained machine learning model, operational parameters from an implanted mechanical circulatory support device, and patient health parameters for the patient to determine an escalation recommendation for switching a patient from a first mechanical circulatory support device to a second mechanical circulatory support device that provides greater cardiac support for the patient.
Regarding (b), the Examiner respectfully disagrees. Unfortunately, generic “improvement in technology” is not a test for a practical application. If it were, the claims at issue in the Alice Corp. decision would have been eligible. In any event, MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer; it is not made to run faster, perform more efficiently, or utilize less power. Nor is there an improvement to another technology because for Claim 1 and 16 no other technology is claimed. For Claim 16 there is also no improvement to technology because the claimed substitution of one mechanical circulatory support device does not improve the support devices; they are still operating in their designed manner. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
[There is a] technical improvement [as] described in the specification by specifying how the machine learning model is trained to perform a multi-faceted analysis of device data and patient data in determining an escalation recommendation that provides valuable clinical insights for a physician.
Regarding (c), the Examiner respectfully disagrees. How the machine learning model is trained and/or the data used to train the model does not provide an improvement. The claim does not state how the model is trained, merely that it is trained on certain data. As clearly indicated in Recentive (cited in the previous and current basis of rejection and discussed in the interview), the training of a model with particular data does not constitute an improvement to the machine learning model. It is using a machine learning model as it is intended to be used. Finally, while the “analysis of device data and patient data in determining an escalation recommendation that provides valuable clinical insights for a physician” is admirable, it represents an improvement to the abstraction, i.e., the determination of when to escalate.
As should be appreciated from the foregoing discussion, amended claim 16 is directed to patent eligible subject matter, and it is respectfully requested that the rejection of claim 16 under 35 U.S.C. § 101 be withdrawn.
Regarding (d), the Examiner respectfully disagrees for the reasons provided for Claim 1 and 16. The Examiner notes that Claim 41 does not even claim that the model is a machine learning model and thus a majority of applicant’s arguments with respect to Claims 1 and 16 are inapplicable.
Rejection under 35 U.S.C. § 112
Regarding the indefiniteness rejection of Claims 1-15, Applicant has cancelled Claims 4, 6, 11, and 15, rendering the rejection of those claims moot. Regarding the remaining claims, Applicant has amended the claim to overcome the basis of rejection.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1-16, 18, and 26-28, Applicant has cancelled Claims 4, 6, 11, 15, and 26-28, rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has considered the Applicant’s arguments and finds them persuasive. It would not be obvious to substitute the data of Theile into the machine learning step(s) of El Katerji with the outcome of providing a recommendation to escalate (or not) the mechanical circulatory support device of the patient. The prediction of El Katerji also does not equate to a recommendation.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Yoon et al. (U.S. Pre-Grant Patent Publication No. 2023/0321449) which discloses uploading the setting from a first implantable medical device into a subsequently implanted second implantable medical device.
Lucertini et al., Left ventricular assist device exchange: a review of indications, operative procedure, and outcomes, which discusses the exchange of left ventricle assist devices in general, including historical information.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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