DETAILED ACTION
This office action is based on the claim set filed on 05/05/2026.
Claims 2, 7, and 10 have been amended.
Claims 1-20 are currently pending and have been examined.
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 .
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.
Claim 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-5 and 11-15 are drawn to a system and Claims 6-10 and 16-20 are directed to a method, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for recommending a treatment for a disease. Collecting disease associated data to determine a recommendation of treatment are steps that could have been performed by a human mind but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Mental Process that can be performed using human mind with the aid of pencil and paper.
Independent Claim 1 and similarly claim 6, 11, and 16, recites the steps of:
“collect population data about said disease (Acute Myeloid Leukemia);
build a population and patient model based on said population data;
record patient factors of said patient associated with said disease (Acute Myeloid Leukemia);
anonymize said patient factors by creating synthetic data of said patient factors;
merge said patient factors into said population and patient model;
prescribe said treatment to said disease (Acute Myeloid Leukemia) for said patient based on predicted outcomes from said population and patient model; and
store said treatment to said disease (Acute Myeloid Leukemia) for said patient in said memory”.
These limitations, as drafted, given the broadest reasonable interpretation cover performance of the limitations by a human mind with aid of pen and paper reciting an abstract idea for Mental Process along with Certain Methods of Organizing Human activity (following instructions to determine recommended treatment), but for the recitation of generic computer components. These limitations encompass a user the ability to collect a disease related data for a population and/or individual to create a model, document factors or features associated with the diseased population or individual, creating a data that mimics the real recorded factors/features and combine with the created model to predict and outcome and recommend a treatment, which are steps that that could have been performed by a human to implement the abstract idea and are steps reciting mental process that could have been performed using a human mind with aid of pen and paper but other than the mere nominal recitation of "processor, memory", to implement the abstract idea for performing the steps of observing, evaluating, judgment and opinion which can be performed using a human mind with the aid of pencil and paper, see MPEP § 2106.04(a)(2)(III). Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of the Mental Process are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as processor, memory” to perform the noted steps that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions, (e.g., store[ing]... ), for determining a recommended treatment such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f). 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 mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims are not patent eligible.
Dependent Claims 2-5, 7-10, 12-15, and 17-20 include all of the limitations of claim(s) 1, 6, 11, and 16, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2-3, 7-8, 10, 12-13, 17-18, and 20, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper, reciting an abstract idea for Mental Process. The claims are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
As for claims 4-5, 9, 14-15, and 19, the claim(s) recites limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers performance by a human mind with the aid of pen and paper but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept. This judicial exception is not integrated into a practical application. In particular, the claim(s) recite additional elements such as “sensors, system” recited in the claim(s) at a high level to perform the claims steps (e.g., record[ing]). These additional elements have been interpreted to be computing components with a general - purpose processor that it amounts to no more than mere instructions to perform the steps of the claim(s), such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f), and a mere data gathering process that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.04(d). Thus, the judicial exceptions recited in claims is/are not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-8, 10-13, 15-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Urbino et al. (“Evolving Therapeutic Approaches for Older Patients with Acute Myeloid Leukemia in 2021 –“Urbino”) in view of Noren et al. (WO-2025149395-A1– “Noren”)
Regarding Claim 1 (Original), Urbino teaches a system operable on a processor and memory for predicting and prescribing a treatment to a disease for a patient, configured to:
collect population data about said disease; Urbino discloses analyzed adults patients population (also including younger patients) with newly diagnosed with Acute Myeloid Leukemia (AML) treated with intensive chemotherapy to include age, performance status, platelet count, white blood cells, circulating blast percentage, albumin level, creatinine and diagnosis of secondary AML, (Urbino: [Table 1], [p. 3, 5]
build a population and patient model based on said population data Urbino discloses developing a model able to predict the risk of mortality and predicting treatment-related mortality (TRM) (Urbino: [p. 3-5]
record patient factors of said patient associated with said disease Urbino discloses noting the factors to be used for predicting treatment-related mortality (TRM) (Urbino: [p. 3-5])
prescribe said treatment to said disease for said patient based on predicted outcomes from said population and patient model Urbino discloses based on the predicted or anticipated outcomes of the model(s), a choice of a treatment is made (Urbino: [p. 3-5])
Urbino discloses randomizing the different treatment and patient factors and age is eliminated (interpreted as anonymized) to evaluate the model performance, however does not expressly discloses anonymizing the patient factors by creating a synthetic data and combine the data into a model.
anonymize said patient factors by creating synthetic data of said patient factors Noren discloses clinical enhancement module that is configured to enhance the synthetic data output by the synthetic data generation module using clinical data from selected actual clinical cases, where the clinical data is de-anonymized to provide privacy protection of the patients associated with the clinical data (Noren: [Fig. 1], [col. 5, line 20-23, 35], [p. 16, line 14-15 – p. 17 line 1-13])
merge said patient factors into said population and patient model Noren discloses data synthesizer may also be used to create operations data sets for the purpose of algorithm development and potentially combining with de-anonymized clinical data to generate semi-synthetic comprehensive hospital datasets (Noren: [p. 6, line 9-11], [p. 22, line 34-36], [claim 5])
store said treatment to said disease for said patient in said memory Noren discloses memory for storing plurality of different modules processing clinical data where the clinical data includes interventions (Noren: [Fig. 1], [p. 7, line 21-22, 25], [p. 8, line 36-37]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Urbino disclosing randomizing treatment and patient data to incorporate anonymizing the patient data, as taught by Noren which offers hospital operations analytics in order to provide situational awareness, staff planning, resource allocation, and the like to improve patient care and treatment (Noren: [p. 1, line 16-18]).
Regarding Claim 2 (Currently Amended), the combination of Urbino and Noren teaches the system as recited in Claim 1 wherein said population data comprise a diagnosed population, a population of patients under different treatments, cured population, actual treatment population, and treatment eligible population Urbino discloses the patient group or cohort that includes group being treated [actual treatment population], eligible group (FIT), non-eligible group (UNFIT) and patients did not benefit from any treatment beyond best supportive care (Urbino: [Table 1], [p. 5]).
Regarding Claim 3 (Original), the combination of Urbino and Noren teaches the system as recited in Claim 1 wherein said patient factors comprise patient diagnosis, patient treatment options, a cured patent, age of said patient, disease risk for said patient, fitness of said patient, and mortality rates Urbino discloses the patient group or cohort factors or attributes that include fitness of the patient(s) (FIT/UNFIT), activities of daily living, cytogenetic risk for cancer and genetic disorder, age, therapies, survival, and mortality (Urbino: [Table 1], [p. 5-6]).
Regarding Claim 5 (Original), the combination of Urbino and Noren teaches the system as recited in Claim 1 wherein said population data comprises an actual treatment population and a treatment eligible population and the system being configured to compare said actual treatment population to said treatment eligible population to determine a gap therebetween to refine said population and patient model Urbino discloses the different treatment and outcomes and comparing the results with eligible patients for treatment outcomes such that who did not benefit from some of the proposed treatments/therapies in order to enhance and improve outcomes and predicated survival rate (Urbino: [Table 1, 3], [p. 3-5, 12-17]).
Regarding Claim 6 (Original), Urbino teaches a method operable on a processor and memory for predicting and prescribing a treatment to a disease for a patient, comprising:
the claim recites substantially similar limitations to claim 1, as such, are rejected for similar reasons as given above.
Regarding Claim 7-8 and 10, the claims recite substantially similar limitations to claim 2-3 and 5, as such, are rejected for similar reasons as given above.
Regarding Claim 11 (Original), Urbino teaches a system operable on a processor and memory for predicting and prescribing a curative transplant to Acute Myeloid Leukemia for a patient, configured to:
the claim recites substantially similar limitations to claim 1, as such, are rejected for similar reasons as given above.
Regarding Claim 12 (Original), the combination of Urbino and Noren teaches the system as recited in Claim 11 wherein said population data comprises diagnosed population, palliative care population, chemotherapy population, remission population, actual curative transplant population, and curative transport eligible population Urbino discloses the patient population data comprises patients diagnosed with AML, receiving chemotherapy, remission and post-remission treatment, stem cells transplantation, palliative care (SCT) (Urbino: [p. 8-9, 20]).
Regarding Claim 13 (Original), the combination of Urbino and Noren teaches the system as recited in Claim 11 wherein said patient factors comprise patient diagnosis, patient palliative care option, patient intensive chemotherapy option, patient non-intensive chemotherapy option, patient remission, age of said patient, disease risk for said patient, fitness of said patient, and mortality rates (Urbino: [Table 1], [p. 5-8, 20]).
Regarding Claim 15 (Original), the combination of Urbino and Noren teaches the system as recited in Claim 11 wherein said population data comprises an actual curative transplant population and curative transplant eligible population and the system being configured to compare said actual curative transplant population to said curative transplant eligible population to determine a gap therebetween to refine said population and patient model Urbino discloses the different treatment and outcomes and comparing the results with eligible patients for treatment outcomes such that who did not benefit from some of the proposed treatments/therapies in order to enhance and improve outcomes and predicated survival rate (Urbino: [Table 1, 3], [p. 3-5, 12-17]).
Regarding Claim 16 (Original), Ambrose teaches A method operable on a processor and memory for predicting and prescribing a curative transplant to Acute Myeloid Leukemia for a patient, comprising:
the claim recites substantially similar limitations to claim 1, as such, are rejected for similar reasons as given above.
Regarding Claim 17-18 and 20, the claims recite substantially similar limitations to claim 12-13 and 15, as such, are rejected for similar reasons as given above.
Claims 4, 9, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Urbino et al. (“Evolving Therapeutic Approaches for Older Patients with Acute Myeloid Leukemia in 2021 –“Urbino”) in view of Noren et al. (WO-2025149395-A1– “Noren”) in view of Kuhn et al. (US 2022/0117514 Al – “Kuhn”)
Regarding Claim 4 (Original), the combination of Ryan and Ambrose teaches the system as recited in Claim 1 wherein said patient factors comprise fitness of said patient and fitness change of said patient recorded from sensors connected to said patient Urbino discloses recording patient activities of daily living (Urbino: [Table 1]),
However, the combination of Urbino and do not discloses using sensor to record the activity or fitness.
Kuhn discloses using physical activity senor recording activity performed by cancer patient and/or other information (Kuhn: [0106]
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Urbino patient factors including activities of daily living to incorporate using sensors to record the activity, as taught by Kuhn which improve medical professionals in understanding unexpected hospital visits in cancer patients receiving chemotherapy (Kuhn: [0008]).
Regarding Claim 9, 14, and 19, the claims recite substantially similar limitations to claim 4, as such, are rejected for similar reasons as given above.
Response to Amendment
Applicant's arguments filed 05/05/2026 have been fully considered by the Examiner and addressed as the following:
In the remarks, Applicant argues in substance that:
Applicant's arguments with respect to the 35 U.S.C. § 101 rejection on page 1-2.
On page 1 of the remarks, the Applicant argues “The systems, and related methods, of the independent claims transform patent factors into synthetic data, prescribe treatments to a disease for a patient based on predicted outcomes from a population and patient model, and store the treatment to the disease for the patient in memory for reporting and historical purposes. This is significantly more than an abstract idea”, Examiner respectfully disagree. Examiner respectfully asserts that the claims are given their broadest reasonable interpretation for the purpose of determining whether they encompass a judicial exception. Examiner asserts that the argued steps are still recite a process that can be performed by a human data analysis and organization of a patient and population disease and factors data to predict an outcome and determine treatment but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Mental process.
On page 1-2 of the remarks, the Applicant argues “the Examiner in the '539 Patent found that the "controlling" action was sufficient to meet Step 2A - Prong Two under 3 5 U.S. C. § 101. The Applicant is having difficulty reconciling the differences of opinion between Examiners in the '539 Patent and the present application”, Examiner respectfully disagree. Examiner respectfully disagrees. The claims of the current application are directed to determine and prescribing a treatment for a disease based on collected and analyzed information which is a different concept than the claim(s) in application 19/050,661 (now patent no.12,430,539).
Therefore, the Examiner has addressed the Applicant argument(s) and found this argument is not found to be persuasive. Hence, Examiner remains the 101 rejections of claims which have been updated to address Applicant's amendments.
Applicant's arguments with respect to the 35 U.S.C. § 103 rejection on page 2-4.
On page 2-3 of the remarks, the Applicant argues “Applicant argues “While Urbino summarizes patient data for acute myeloid leukemia ("AML") from several sources, the reference fails to prescribe a treatment to a disease (e.g., AML) for a patient based on predicted outcomes from a population and patient model (which includes the patient factors in the population and patient model) as recited in the independent claims ... Urbino does not prescribe an action to a disease for a patient based on the specific patient factors merged into the population and patient model as recited in independent”, Examiner respectful disagree. As described above, Urbino, under BRI, describes analyzing population adults whom diagnosed with the disease and develops a model to predict mortality and treatment-related mortality and based on the predicted outcome, a choice of treatment is made which is prescribing a treatment based on the predicted outcome and patient factors, see (Urbino [p. 3-5]).
On page 3 of the remarks, the Applicant argues “Again, this is clinical data from selected actual clinical cases, not the patient factors for a specific patent merged into a population and patient module to prescribe a treatment to a disease for the patient based on predicted outcomes (for the patient) from the population and patient model as recited in independent Claims 1 and 11 of the present application”, Examiner respectfully disagree. The reference Noren is describing management of patient health data which is in the same filed of endeavor for managing health and clinical data. In addition, merging health data and/or clinical data is the same concept as such using clinical data collected from actual cases does not make the merging of data different.
On page 3-4 of the remarks, the Applicant argues “While Noren discloses combining de-anonymized clinical data to generate semi-synthetic comprehensive hospital datasets, this is different than merging the patient factors into a population and patient model for the ultimate...”, Examiner respectfully disagree. The Applicant argues the de-anonymized clinical data in parallel to merging data which is making the argument not clear however Examiner points to the merging argument as described by the Examiner above.
On page 4 of the remarks, the Applicant argues “While Noren discloses memory (page 7, lines 21, 22, 25; page 8, lines 36, 37), the reference fails to disclose storing the treatment to the disease for the patient in memory as recited in independent Claims 1 and 11 of the present application”, Examiner respectfully disagree. As per the above rejection, Examiner cited the section of Noren which discloses memory for storing plurality of different modules processing clinical data where the clinical data includes interventions, see (Noren: [Fig. 1], [p. 7, line 21-22, 25], [p. 8, line 36-37]).
Therefore, Examiner find the Applicant argument is/are unpersuasive.
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 extension fee 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 date of this final action.
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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