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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 3/18/2026 has been entered and considered. Rejections and/or objections not reiterated from the previous office action mailed 12/19/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Status of the Claims
Claims 1-7, 9-10, and 13-17 are pending and under consideration in this action.
Priority
The instant application is a 371 of PCT/EP2020/058843, filed 3/27/2020, which claims priority to EPO Application Number 19165769.1, filed 3/28/2019, as reflected in the filing receipt mailed on 2/10/2022. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1-7, 9-10, and 13-17 is 3/28/2019.
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 1-7, 9-10, and 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Step 1:
In the instant application, claims 1-7, 9-10, and 13-15 are directed towards a method, claim 16 is directed towards a system, and claim 17 is directed towards a manufacture, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claim 1 recites a mental process (i.e., an evaluation of the treatment and imaging data) in “processing, at the computer, the treatment data and the imaging data to determine a received dose of radiation to be delivered to the one or more radiation-sensitive tissues in the subject during the particular radiotherapy treatment session”; and a mental process (i.e., an evaluation of the patient data and the received dose of radiation) in “processing, at the computer, the patient data and the received dose of radiation to obtain a risk of hematologic toxicity in the subject in response to the fractionated radiotherapy during the particular radiotherapy treatment session”.
Claim 2 recites a mental process (i.e., an evaluation of the hematologic toxicity and the patient data) in “wherein the hematologic toxicity comprises lymphopenia and the patient data includes lymphocyte numbers in the subject's blood”.
Claim 3 recites a mental process (i.e., an evaluation of the patient data) in “wherein the patient data further comprises age, gender and/or disease characteristics in the subject”.
Claim 4 recites a mental process (i.e., an evaluation of the treatment data) in “wherein the treatment data further comprises a distribution of radiation doses to be administered to treated areas within the subject”.
Claim 5 recites a mental process (i.e., an evaluation of the imaging data) in “wherein the imaging data is derived from computerized tomography, positron emission tomography or magnetic resonance imaging”.
Claim 6 recites a mental process (i.e., an evaluation of the imaging data) in “wherein the imaging data is indicative of proliferative and/or metabolic activity in the one or more radiation-sensitive tissues of the subject”.
Claim 7 recites a mental process (i.e., an evaluation of the imaging data) in “wherein the imaging data is derived from positron emission tomography (PET) imaging using 18F-fluorothymidine (18F-FLT) tracer”.
Claim 9 recites a mental process (i.e., an evaluation of the radiation-sensitive tissues) in “wherein the one or more radiation-sensitive tissues includes bone marrow of a thoracic vertebrae”.
Claim 10 recites a mental process (i.e., an evaluation of the radiation-sensitive tissues) in “wherein the one or more radiation-sensitive tissues include mucosa-associated lymphoid tissue and/or lymphoid organs provided from one or more of: a thymus, lymph nodes, or a spleen”.
Claim 13 recites a mental process (i.e., the observation of data on a computer) in “wherein the received dose of radiation to be delivered to the one or more radiation-sensitive tissues in the plurality of images is outputted to a display”.
Claim 14 recites a mental process (i.e., an evaluation of the risk being above a threshold) in “wherein if the risk of hematologic toxicity is determined to be above the predetermined threshold”; and a mental process (i.e., an evaluation of the risk based on the data) in “obtaining an updated risk of hematologic toxicity in the subject based on the updated patient data, treatment data, and imaging data”.
Claim 16 recites a mental process (i.e., an evaluation of the treatment and imaging data) in “process the treatment data and the imaging data to determine a received dose of radiation to be delivered to the one or more radiation-sensitive tissues in the subject during the particular radiotherapy treatment session”; and a mental process (i.e., an evaluation of the patient data and received dose of radiation) in “process the patient data and the received dose of radiation to obtain a risk of hematologic toxicity in the subject in response to the fractionated radiotherapy during the particular radiotherapy treatment session”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Specifically, claims 1 and 16 involve nothing more than processing the treatment, imaging, and patient data to determine a risk of hematologic toxicity. Since there are no specifics provided in the methodology, the steps of processing the treatment data and the imaging data as well as processing the patient data and received dose of radiation are steps that, under the BRI, one could perform mentally, or using a generic computer as a tool. Therefore, the claimed steps are not further defined beyond something that reads on using a computer as a tool to look at data and make a determination. As such, said steps are directed to judicial exceptions. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). The following independent claims recite limitations that equate to additional elements:
Claim 1 recites “at a computer”; “receiving, patient data associated with the subject, wherein the patient data includes blood cell counts in the subject”; “receiving, treatment data, wherein the treatment data includes a prescribed dose of radiation to be administered to the subject during a particular radiotherapy treatment session, and wherein the treatment data includes a plurality of fraction doses”; “receiving, imaging data, wherein the imaging data comprises a plurality of images depicting one or more radiation-sensitive tissues in the subject, the one or more radiation-sensitive tissues comprising regions of hematopoiesis and/or leukocyte maturation, activation, and/or proliferation in the subject, wherein the one or more radiation-sensitive tissues comprises bone marrow and/or lymphoid organs, and wherein respective images of the plurality of images are obtained at administration of a different radiotherapy fraction during the particular radiotherapy treatment session”; and “generating an output, to modify a treatment protocol of the prescribed dose of radiation and/or immunotherapy treatment, upon determining that the risk of hematologic toxicity in the subject is above a predetermined threshold”.
Claim 16 recites “a computer system with an interface, memory, and a processor”; “receive patient data associated with the subject, wherein the patient data includes blood cell counts in the subject”; “receive treatment data, wherein the treatment data includes a prescribed dose of radiation to be administered to the subject during a particular radiotherapy treatment session, and wherein the treatment data includes a plurality of fraction doses”; “receive imaging data, wherein the imaging data comprises a plurality of images depicting one or more radiation-sensitive tissues in the subject, the one or more radiation-sensitive tissues comprising regions of hematopoiesis and/or leukocyte maturation, activation, and/or proliferation in the subject, wherein the one or more radiation-sensitive tissues comprises bone marrow and/or lymphoid organs, and wherein respective images of the plurality of images are obtained at administration of a different radiotherapy fraction during the particular radiotherapy treatment session”; and “generate an output to modify a treatment protocol of the prescribed dose of radiation and/or immunotherapy treatment, upon determining that the risk of hematologic toxicity in the subject is above a predetermined threshold”.
Regarding the above cited limitations in claims 1 and 16 of (i) receiving, patient data associated with the subject, wherein the patient data includes blood cell counts in the subject (claims 1 and 16); (ii) receiving, treatment data, wherein the treatment data includes a prescribed dose of radiation to be administered to the subject during a particular radiotherapy treatment session, and wherein the treatment data includes a plurality of fraction doses (claims 1 and 16); and (iii) receiving, imaging data, wherein the imaging data comprises a plurality of images depicting one or more radiation-sensitive tissues in the subject, the one or more radiation-sensitive tissues comprising regions of hematopoiesis and/or leukocyte maturation, activation, and/or proliferation in the subject, wherein the one or more radiation-sensitive tissues comprises bone marrow and/or lymphoid organs, and wherein respective images of the plurality of images are obtained at administration of a different radiotherapy fraction during the particular radiotherapy treatment session (claims 1 and 16). These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exceptions of processing the data to obtain a risk of hematologic toxicity and outputting a modified treatment protocol if the risk of hematologic toxicity is above a threshold (see MPEP § 2106.04(d)).
Regarding the above cited limitations in claims 1 and 16 of (iv) at a computer (claim 1); and (v) a computer system with an interface, memory, and a processor (claim 16). These limitations require only a generic computer component, which does not improve computer technology. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the above cited limitation in claims 1 and 16 of (vi) generating an output, to modify a treatment protocol of the prescribed dose of radiation and/or immunotherapy treatment, upon determining that the risk of hematologic toxicity in the subject is above a predetermined threshold. This limitation is considered an extra-solution activity, as the limitation broadly recites the output of a modified treatment protocol for radiation and/or immunotherapy. The limitation does not provide, for example, administration of the modified treatment to the subject. Therefore, this limitation recites an intended use, because it does not actually provide a treatment or prophylaxis (see MPEP § 2106.04(d)(2)).
Additionally, none of the recited dependent claims recite additional elements which would integrate the judicial exception into a practical application. Specifically, claim 14 recites a data-gathering step analogous to claims 1 and 16 above; claim 15 recites a generic extra-solution analogous to claims 1 and 16 above; and claim 17 recites generic computer components that equate to mere instructions to implement an abstract idea on a generic computer. As such, claims 1-7, 9-10, and 13-17 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant independent claims recite the same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in claims 1 and 16 of (i) receiving, patient data associated with the subject, wherein the patient data includes blood cell counts in the subject (claims 1 and 16); (ii) receiving, treatment data, wherein the treatment data includes a prescribed dose of radiation to be administered to the subject during a particular radiotherapy treatment session, and wherein the treatment data includes a plurality of fraction doses (claims 1 and 16); and (iii) receiving, imaging data, wherein the imaging data comprises a plurality of images depicting one or more radiation-sensitive tissues in the subject, the one or more radiation-sensitive tissues comprising regions of hematopoiesis and/or leukocyte maturation, activation, and/or proliferation in the subject, wherein the one or more radiation-sensitive tissues comprises bone marrow and/or lymphoid organs, and wherein respective images of the plurality of images are obtained at administration of a different radiotherapy fraction during the particular radiotherapy treatment session (claims 1 and 16). These limitations do not include any specific steps for acquiring the patient data, treatment data, or imaging data, aside from the acquisition by a generic computer. Under the BRI, these limitations are merely receiving data for the subsequent step of processing the treatment, imaging, and patient data to determine a risk of hematologic toxicity. Therefore, these limitations equate to receiving/transmitting data over a network, which the courts have established as a WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
Regarding the above cited limitations in claims 1 and 16 of (iv) at a computer (claim 1); and (v) a computer system with an interface, memory, and a processor (claim 16). These limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitation in claims 1 and 16 of (vi) generating an output, to modify a treatment protocol of the prescribed dose of radiation and/or immunotherapy treatment, upon determining that the risk of hematologic toxicity in the subject is above a predetermined threshold. This limitation when viewed individually and in combination, is a well understood, routine, and conventional (WURC) limitation as taught by Extermann et al. (Predicting the Risk of Chemotherapy Toxicity in Older Patients: The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) Score. Cancer. 118(13): 3377-3386 (2012)). Extermann et al. discloses a risk assessment for severe hematologic toxicity in older patients (Title, Abstract). Extermann et al. further discloses that estimating the risk of toxicity is one aspect of treatment planning, and can be used as a tool for clinical decision making by oncologists when the risk of severe toxicity is high (limitation (vi)) (Pg. 3385, Col. 2, Para. 1-2).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-7, 9-10, and 13-17 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 1/28/2026 have been fully considered but they are not persuasive.
1. Applicant argues that the rejection is rendered moot in light of the present amendments to the independent claims to recite the element of “generating an output to modify a treatment protocol of the prescribed dose of radiation and/or immunotherapy treatment”. The claimed method, computer system, and computer program product unambiguously recite operations with a practical application, to determine a particular condition of hematologic toxicity and modify a treatment protocol for preventing a disease or medical condition (a cancer treatment). The claims now affirmatively recite a treatment action to modify the treatment protocol for the prescribed dose of radiation and/or immunotherapy treatment to be administered when a high risk of hematologic toxicity is determined (Applicant’s Remarks, Pg. 6).
It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
MPEP § 2106.04(d)(2) recites:
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
The newly recited limitation of “generating an output at the computer, to modify a treatment protocol of the prescribed dose of radiation and/or immunotherapy treatment, upon determining that the risk of hematologic toxicity in the subject is above a predetermined threshold” in independent claims 1 and 16 equates to an extra-solution activity in Step 2A, Prong Two above. This limitation is an extra-solution activity because it physically outputs a modified treatment protocol when the hematologic toxicity is greater than a threshold. However, as recited, the limitation broadly recites the output of the modified treatment protocol, without providing any positive steps to, for example, administer the modified treatment to the subject. Therefore, this limitation recites an intended use, because it does not actually provide the treatment or prophylaxis (see MPEP § 2106.04(d)(2)). Because the limitation recites an intended use, the limitation does not integrate the recited judicial exception into a practical application, and this argument is thus not persuasive.
2. Applicant also argues that the claims recite the use of computerized technology for the detection and quantification of hematologic toxicity, to provide a real-world improvement in the technical field of data processing for radiotherapy and oncology treatments, specifically with regards to the Ex Parte Desjardins precedential decision. The computer operations are the indispensable focus of the claimed invention, rather than a mere ''tool" for achieving a result (Applicant's Remarks, Pg. 6-7). It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
In the Ex Parte Desjardins precedential decision, “the claimed invention was a method of training a machine learning model on a series of tasks …The specification identified the improvement to machine learning technology by explaining how the machine learning model is trained to learn new tasks while protecting knowledge about previous tasks to overcome the problem of “catastrophic forgetting,” and that the claims reflected the improvement identified in the Specification. Indeed, enumerated improvements identified in the Desjardins Specification included disclosures of the effective learning of new tasks in succession in connection with specifically protecting knowledge concerning previously accomplished tasks; allowing the system to reduce use of storage capacity; and the enablement of reduced complexity in the system. Such improvements were tantamount to how the machine learning model itself would function in operation and therefore not subsumed in the identified mathematical calculation”. Therefore, the limitation of “adjust the first values of the plurality of parameters to optimize performance of the machine learning model on the second machine learning task while protecting performance of the machine learning model on the first machine learning task” reflected the improvement and integrated the judicial exceptions into a practical application (see Pg. 2-3, Memorandum to Patent Examining Corps. "Advance notice of change to the MPEP in light of Ex Parte Desjardins" (December 5, 2025)).
However, in the instant case, amended claims 1 and 16 recite a computer-implemented method or system with generic computer components (e.g., an interface, memory, or processor). The instant Specification (see Pg. 9, Line 24 – Pg. 11, Line 17) discloses the computer system with I/O, a processor, and memory, in communication with several data sources for receiving data and calculating the risk of hematologic toxicity. The Specification is silent on any changes or improvements to the computer system in order to perform the claimed invention. For example, the Specification (see Pg. 12, Lines 22-27) broadly recites the training and validation of the toxicity prediction models, without providing any details about the model or how the training is performed. Therefore, the processing limitations recited in amended claims 1 and 16 do not change the physical components of the computer nor the way that the computer operates (e.g., through training). The processing limitations thus use the computer as a tool (see also MPEP § 2106.05(a)(I)). Unlike Ex Parte Desjardins, where the limitations reflect an improvement in disclosed in the Specification to improve the training of the machine learning model, the instant claims and Specification do not reflect an improvement in the technical field of data processing for radiotherapy and oncology treatments, instead invoking the computer as a tool to perform the claimed invention. This argument is thus not persuasive.
Conclusion
No claims allowed.
Claims 1-7, 9-10, and 13-17 appear to be free from the prior art because the prior art does not fairly suggest or teach the receiving and processing of treatment/imaging data during a particular radiotherapy treatment session, and subsequent output of a modified treatment protocol based on the processed data during a particular radiotherapy treatment session, as claimed. The closest prior art is Sini et al. (Dose-volume effects for pelvic bone marrow in predicting hematological toxicity in prostate cancer radiotherapy with pelvic node irradiation. Radiother Oncol. 118(1):79-84 (2016); provided in the IDS dated 9/28/2021). Sini et al. discloses a method for identifying clinical predictors of hematologic toxicity for patients treated with fractionated radiotherapy. Sini et al. further discloses that the method includes steps of receiving patient data, receiving treatment data, receiving imaging data, and using the data to predict a risk of hematologic toxicity. However, Sini et al. does not appear to disclose receiving a plurality of images obtained at administration of different radiotherapy fractions during a particular treatment session, processing the treatment data and the imaging data to determine a received dose of radiation, or generating an output to modify a treatment protocol if the hematologic risk is above a threshold for a particular radiotherapy treatment session as disclosed in instant claims 1 and 16. Claims 2-7, 9-10, 13-15, and 17 appear to be free from the prior art due to their dependency on claims 1 and 16.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687