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 .
Response to Arguments
Rejection Under 101
Applicant's arguments filed 09/22/2025 have been fully considered.
Applicant argues that the claims recite a practical application by improving transplant monitoring technology.
In response to Applicant’s argument, the claims do not recite a practical applicant since the additional elements do not amount to anything more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. See the updated rejection below for further clarification.
Applicant argues the claims are not a method of organizing human activity, a mathematical concept, or any other abstract idea.
In response to Applicant’s argument, the claims recite steps to determine a risk for a patients transplant rejection. This evaluation of risk falls under methods of organizing human activity.
Applicant argues the claims recite improvements to machine learning models by tailoring the parameter training data.
In response to Applicant’s argument, the claims recites selecting and inputting parameters into the model. The model itself it not being improved, data is merely being defined and input into the model. This is mere data processing with the use known algorithms.
Applicant argues claim 1 (and 17) is not directed toward fundamental economic principles or practices, legal obligations, advertising, marketing or sales activities or behaviors, legal interactions, or managing personal behavior or relationships or interactions between people.
In response to Applicant’s argument, the claims recite steps to determine a risk for a patients transplant rejection. Following rules or instructions is part of managing personal behavior or relationships and thus falls under organizing human activity. See the updated rejection below for further clarification.
Applicant argues that based on the Federal Circuit cases the claims do not fall under organizing human activity.
In response to Applicant’s argument, as discussed above, the claims follow rules or steps to determine risk of transplant rejection for a recipient. Thus the claims fall under organizing human activity. See MPEP § 2106.04(a).
Applicant argues that the claims do not recite a mathematical concept but recite an improved machine learning framework.
In response to Applicant’s argument, Applicant’s argument regarding the mathematical concept is moot in light of the amendment. See the updated rejection for further clarification. Additionally, an improvement to the machine learning model was addressed above. The model itself it not being improved, data is merely being defined and input into the model. This is mere data processing with the use known algorithms.
Applicant argues that the claims recite a practical application by improving transplant monitoring technology. The claims improves computer technology directly tied to machine learning for predictive models.
In response to Applicant’s argument, the claims do not recite a practical applicant since the additional elements do not amount to anything more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. See the updated rejection below for further clarification.
Applicant argues that the claims provide an inventive concept and cannot be considered to be well understood, routine, and conventional in the industry since they do not appear to be taught by the prior art of record.
In response to Applicant’s argument, the claims recite additional elements that are well understood, routine, and conventional as evidenced below in the rejection. The prior art rejection is a separate analysis from the eligibility analysis.
Rejection Under 103
Applicant's arguments filed 09/22/2025 have been fully considered.
Applicant argues that the claims have been amended to include the subject matter from claim 8 which was found to be free of prior art. Thus the claims should be allowable and the rejections are moot.
In response to Applicant’s argument, Applicant’s argument is moot in light of the amendment. See “Subject Matter Free of Prior Art” below.
Applicant argues that the dependent claims includes the recitations of the independent claims and are therefore also patentably distinct from the cited references.
In response to Applicant’s argument, Applicant’s argument is moot in light of the amendment. See “Subject Matter Free of Prior Art” below.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites “one or more parameter weights” in the first outputting limitation, however, these amendments were not underlined to show them as amendments. Appropriate correction or clarification is required. For examination purposes, Examiner has examined them as if they were properly identified.
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.
Regarding Claim 1 – The claim recites “the scoring unit is configured to generate a predictive score...” See MPEP 2181. The claim limitation uses the term scoring unit. The “scoring unit” is modified by functional language “configured to generate a predictive score….” The scoring unit is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. [0035] which describes the scoring unit may be a tool for assessing the transplant recipient data, but this is in relation to processing lab results not for generating predictive scores. At the end of the paragraph the specification states that the scoring unit may output a predicted probability and/or projection. The specification at [0038] discusses using weighted parameters and their association to transplant rejection to calculate the score. The higher the parameter weight indicates the higher association of transplant rejection. The score is calculated by summing together a plurality of multiplications, where each multiplication for each parameter weight comprises multiplying the weight by the corresponding parameter of the transplant recipient data. While the specification details how to calculate the score, it does not tell us what is being used to calculate the score. For examination purposes the scoring unit is construed to be steps such as those discussed above in order to determine the score and is construed to be carried out by a processor.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-7, 9-18, 20-23, 25-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification at [0038] discusses how to perform the calculation steps to obtain the score using the scoring unit but does not detail what exactly is performing those steps. Thus, the specification is devoid of structure to perform the acts required of the claim in relation to generating a score.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-7, 9-18, 20-23, 25-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “scoring unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification at [0038] discusses how to perform the calculation steps to obtain the score using the scoring unit but does not detail what exactly is performing those steps. Thus, the specification is devoid of structure to perform the acts required of the claim in relation to generating a score. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-2, 4-7, 9-18, 20-23, 25-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-2, 4-7, 9-16 are drawn to a method, which is within the four statutory categories (i.e. process). Claims 17-18, 20-23, 25-32 are drawn to a system, which is within the four statutory categories (i.e. apparatus). Claim 33 is drawn to a non-transitory computer-readable storage medium, which is within the four statutory categories (i.e. manufacture).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 1 (and substantially similar with independent claim 17 and 33) recites:
A computer-implemented method comprising:
receiving, via a computer or an input function, transplant recipient data of an individual transplant recipient comprising a set of transplant recipient parameters, wherein the set of transplant recipient parameters comprises donor-derived cell-free DNA (dd-cfDNA) and does not comprise a histological parameter;
inputting a cohort dataset into a trained machine learning model, wherein the cohort dataset comprises a first set of parameters and corresponding cohort transplant rejection information, wherein the trained machine learning model is trained to output one or more parameter weights, and wherein training the machine learning model comprises:
analyzing a first set of model parameters for associations between a training cohort dataset and a corresponding training cohort transplant rejection information;
iteratively selecting one or more subsequent subsets of model parameters from the first set of model parameters or a preceding subset of model parameters;
selecting a last subset of model parameters from the one or more subsequent subsets of model parameters, wherein the last subset of model parameters comprises independent variables associated with transplant rejection and meeting one or more second criteria; and
outputting one or more parameter weights corresponding to the last subset of model parameters;
inputting the set of transplant recipient parameters of the received transplant recipient data and the one or more parameter weights output from the trained machine learning model into a scoring unit, wherein the scoring unit is configured to generate a predictive score; and
outputting, by the scoring unit for display to a graphical user interface, a predicted probability of whether or an extent to which transplant rejection in the individual transplant recipient will occur in the future based on the predictive score.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the computer, processors, display, storage medium, trained machine learning model, the limitations in the context of this claim encompass following steps to predict a patient’s likelihood of rejecting their transplant. By following these steps recited, we can evaluate the risk and therefore generate a score related to this risk for the patient’s transplant rejection. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2, 4-7, 9-16, 18, 20-23, 25-32 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 1 (and substantially similar with independent claim 17 and 33) recites:
A computer-implemented method comprising:
receiving, via a computer or an input function (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)), transplant recipient data of an individual transplant recipient comprising a set of transplant recipient parameters, wherein the set of transplant recipient parameters comprises donor-derived cell-free DNA (dd-cfDNA) and does not comprise a histological parameter;
inputting a cohort dataset into a trained machine learning model, wherein the cohort dataset comprises a first set of parameters and corresponding cohort transplant rejection information, wherein the trained machine learning model is trained to output one or more parameter weights, and wherein training the machine learning model comprises: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
analyzing a first set of model parameters for associations between a training cohort dataset and a corresponding training cohort transplant rejection information;
iteratively selecting one or more subsequent subsets of model parameters from the first set of model parameters or a preceding subset of model parameters;
selecting a last subset of model parameters from the one or more subsequent subsets of model parameters, wherein the last subset of model parameters comprises independent variables associated with transplant rejection and meeting one or more second criteria; and
outputting one or more parameter weights corresponding to the last subset of model parameters; (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))
inputting the set of transplant recipient parameters of the received transplant recipient data and the one or more parameter weights output from the trained machine learning model into a scoring unit, wherein the scoring unit is configured to generate a predictive score; and
outputting, by the scoring unit for display to a graphical user interface, a predicted probability of whether or an extent to which transplant rejection in the individual transplant recipient will occur in the future based on the predictive score. (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the computer, processors, display, storage medium, trained machine learning model, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0037], [0042], [0096]-[0098], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of outputting parameter weights, outputting a predicted probability, amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2, 4-7, 9-16, 18, 20-23, 25-32 recite additional limitations that further narrow or define the abstract idea, and claims 2, 4-7, 9-16, 18, 20-23, 25-32 additional limitations which generally link the abstract idea to a particular technological environment or field of use). 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 a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
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 discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the computer, processors, display, storage medium, trained machine learning model, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0037], [0042], [0096]-[0098]); using the computer, processors, display, storage medium, trained machine learning model, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): outputting parameter weights, outputting a predicted probability, e.g., outputting or providing access to the information, Symantec, 838 F.3d at 1321 and MPEP 2106.05(g)(3)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, further define the abstract idea or are generally linking the abstract idea to a particular field of environment. 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 a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 1-2, 4-7, 9-18, 20-23, 25-33 are free of prior art over Moshkevich et al. (US 2021/0198733) in view of University (WO 2021/021657). The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest prior art is Moshkevich et al. (US 2021/0198733), which teaches methods for determining the status of an allograft within a transplant recipient from genotypic data measured from a sample of DNA. University (WO 2021/021657) teaches using prediction models to generate predictions based on adjustments of the first predictions. The references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible hindsight and not provide any advantages over their present application. The dependent claims are also free of prior art due to their corresponding dependency of the independent claims.
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 AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686