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 .
Status of Claims
Claims 1-20 were previously pending and subject to a non-final Office Action having a notification date of October 1, 2025 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on January 2, 2026 (the “Amendment”), amending claims 1, 8, and 15.
The present Final Office Action addresses pending claims 1-20 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
On page 13 of the Amendment, Applicant asserts that claims 15-20 have been amended as suggested by the Examiner to overcome the 35 USC 101 rejection as not being directed to one of the four categories of patent eligible subject matter. The Examiner disagrees. Again, Applicant can amend these claims to recite --A non-transitory computer program product…-- or --A computer program product…consisting of a computer readable storage medium--. Applicant's amendment to claim 15 does not align with either of these suggestions and thus still leaves open the possibility that the product includes transitory signals (because of the word "comprising").
On pages 14-17 of the Amendment in relation to the rejection of the claims as being directed to an abstract idea without significantly more and after citing several paragraphs from the present specification, Applicant generally takes the position that the human mind is unable to practically perform the claims because the "underlying chemistry" is unpredictable. However, the Examiner notes that relevant inquiry under Step 2A of the Alice/Mayo test is whether the claims (i.e., as opposed to the specification) recite an abstract idea. MPEP 2106.04(II)(A)(1). In this regard, and with reference to the limitations of claim 1, a medical professional could readily in their mind with pen and paper monitor (e.g., watch, perceive) a patient for a patient measure (e.g., baseline state such as oxygen levels, etc.), use the patient measure (the baseline oxygen levels) to "condition" (e.g., adjust, update) patient parameters (e.g., surgical status, etc.), parameterize/develop a PK model with the patient parameters (e.g., indicative of how a pharmaceutical is absorbed/distributed through a patient's body) to obtain a parameterized PK model, sample conditioned model patient parameters of the PK model to obtain sampled patient parameters (e.g., obtaining a portion of the parameters), and calculate a dosage data of a pharmaceutical with the sampled patient parameters.
For instance, based on a particular patient urination/surgical status as well as absorption/distribution of a particular pharmaceutical within a patient’s body, a competent medical professional could calculate/determine (e.g., based on their experience/clinical guidelines/etc.) a particular effective dosage of a combination of drugs that achieves a particular inhibition or cure rate a defined confidence level (e.g., access optimal isobole for a therapeutic target for the patient) in a manner that avoids toxic effects while maintaining efficacy.
These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis that were equivalent to "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Furthermore, the underlined limitations constitute “certain methods of organizing human activity” because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). For instance, these limitations are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions. In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
The Examiner also notes that the present claims do not require the calculated dosage data to access the "optimal" isobole to achieve any particular standard or level of accuracy other than generally "avoiding toxic effects while maintaining efficacy" which the Examiner asserts can be determined by a competent medical professional at the claimed high level of generality.
The 35 USC 101 rejection is maintained.
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 15-20 are rejected under 35 U.S.C. 101 because the claims do not fall within at least one of the four categories of patent eligible subject matter.
Regarding claims 15-20 which are directed to “A product to access an optimal isobole for a therapeutic target for a patient, said product comprising a non-transitory computer readable storage medium,” the Examiner notes that the specification never appears to state that a “product” does not include such transitory signals. Furthermore, the open-ended nature of the term "comprising" leaves open the possibility that the recited product also includes transitory propagating signals per se.
When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
Therefore, the scope of claims 15-20 includes transitory signals which are not within one of the four statutory categories of 35 U.S.C. §101. Accordingly, claims 15-20 are rejected under 35 U.S.C. §101.
The Examiner recommends amending claims 15-20 to recite --A non-transitory product to access an optimal isobole…-- to overcome this rejection.
Claims 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-7 are directed to a system (i.e., a machine) and claims 8-14 are directed to a method (i.e., a process). Accordingly, claims 1-14 are all within at least one of the four statutory categories. 35 USC §101. While claims 15-20 are not within at least one of the four statutory categories as set forth above, they will be examined below in the interest of completeness.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), 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. MPEP 2106.04(II)(A)(1). 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. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A system to access an optimal isobole for a therapeutic target for a patient, said system comprising:
a memory; and
a processor in communication with said memory, said processor being configured to perform operations, said operations comprising:
monitoring said patient for a patient measure, wherein said patient measure is selected from the group consisting of a baseline patient state, an observed change from said baseline patient state, and a therapeutic target;
conditioning patient parameters with said patient measure;
parameterizing a pharmacokinetic model with said patient parameters to obtain a parameterized pharmacokinetic model;
sampling, with a constrained optimization generative adversarial network, conditioned model parameters of said parameterized pharmacokinetic model to obtain sampled patient parameters;
calculating dosage data of a pharmaceutical to access said optimal isobole for said therapeutic target for said patient, wherein said dosage data is calculated with said sampled patient parameters with said constrained optimization generative adversarial network, and wherein said optimal isobole avoids toxic effects while maintaining efficacy; and
communicating said dosage data to a user.
The Examiner submits that the foregoing underlined limitations constitute “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a medical professional could readily in their mind with pen and paper monitor (e.g., watch, perceive) a patient for a patient measure (e.g., baseline state such as oxygen levels, etc.), use the patient measure (the baseline oxygen levels) to "condition" (e.g., adjust, update) patient parameters (e.g., surgical status, etc.), parameterize/develop a PK model with the patient parameters (e.g., indicative of how a pharmaceutical is absorbed/distributed through a patient's body) to obtain a parameterized PK model, sample conditioned model patient parameters of the PK model to obtain sampled patient parameters (e.g., obtaining a portion of the parameters), and calculate a dosage data of a pharmaceutical with the sampled patient parameters.
For instance, based on a particular patient urination/surgical status as well as absorption/distribution of a particular pharmaceutical within a patient’s body, the medical professional could calculate/determine (e.g., based on their experience/clinical guidelines/etc.) a particular effective dosage of a combination of drugs that achieves a particular inhibition or cure rate a defined confidence level (e.g., access optimal isobole for a therapeutic target for the patient) in a manner that avoids toxic effects while maintaining efficacy.
These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis that were equivalent to "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Furthermore, the underlined limitations constitute “certain methods of organizing human activity” because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). For instance, these limitations are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions. In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Furthermore, dependent claims 3-6 and 10-13 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claims 3, 4, 10, 11, and 17 call for selecting the patient measure from a monitoring stream (e.g., a neurocritical monitoring stream) which just further defines the abstract idea(s) discussed above.
-Claims 5, 12, and 18 call for modeling a neurocritical care measure (e.g., brain swelling, etc.) with an associated pharmacokinetic model (e.g., how a particular pharmaceutical is absorbed, metabolized, etc. in the body) and assessing an effect of the neurocritical care measure on the pharmacokinetic model (e.g., assessing how such brain swelling affects the absorption, metabolism, etc. of the pharmaceutical) which just further defines the abstract idea(s) discussed above.
Claims 6, 13, and 19 recite how the patient is a critical care unit patient which just further defines the abstract idea(s) discussed above.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), 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 such as 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.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system to access an optimal isobole for a therapeutic target for a patient, said system comprising:
a memory (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)); and
a processor in communication with said memory, said processor being configured to perform operations, said operations comprising (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)):
monitoring said patient for a patient measure, wherein said patient measure is selected from the group consisting of a baseline patient state, an observed change from said baseline patient state, and a therapeutic target;
conditioning patient parameters with said patient measure;
parameterizing a pharmacokinetic model with said patient parameters to obtain a parameterized pharmacokinetic model;
sampling, with a constrained optimization generative adversarial network (merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished, see MPEP § 2106.05(f)), conditioned model parameters of said parameterized pharmacokinetic model to obtain sampled patient parameters;
calculating dosage data of a pharmaceutical to access said optimal isobole for said therapeutic target for said patient, wherein said dosage data is calculated with said sampled patient parameters with said constrained optimization generative adversarial network (merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished, see MPEP § 2106.05(f)), and wherein said optimal isobole avoids toxic effects while maintaining efficacy; and
communicating said dosage data to a user (extra-solution activity (transmitting data) as noted below, see MPEP § 2106.05(g)).
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the memory and processor, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of the sampling and calculating steps being performed with a constrained optimization GAN, the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). These additional limitations provide only a result-oriented solution and lack details as to how sampling and calculating steps actually occur.
Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13. Allowing a claim that functionally describes a mere concept without disclosing how to implement that concept risks defeating the very purpose of the patent system. Id.
Regarding the additional limitation of communicating the dosage data to the user, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (transmitting data) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claims 8 and 15 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 1 and analogous independent claims 8 and 15 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claims 2, 9, and 16 call for streaming the patient measure to the constrained optimization generative adversarial network which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claims 7, 14, and 20 recite how the dosage data is calculated in real time which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does 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 of the memory and processor, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of the sampling and calculating steps being performed with a constrained optimization GAN, the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). These additional limitations provide only a result-oriented solution and lack details as to how sampling and calculating steps actually occur.
Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13. Allowing a claim that functionally describes a mere concept without disclosing how to implement that concept risks defeating the very purpose of the patent system. Id.
Regarding the additional limitations directed to communicating the dosage data to the user which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea (see MPEP § 2106.05(g)), the Examiner has reevaluated such limitation and determined it to not be unconventional as it merely consists of receiving/transmitting data over a network. See Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1321, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); See MPEP 2106.05(d)(II).
The dependent claims also 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.
-Claims 2, 9, and 16 call for streaming the patient measure to the constrained optimization generative adversarial network which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claims 7, 14, and 20 recite how the dosage data is calculated in real time which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Therefore, claims 1-20 are ineligible under 35 USC §101 as being directed to an abstract idea without significantly more.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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