DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to a response filed 2 April 2026, on an application filed 15 December 2023, which is a national stage entry of an application with an international filing date of 16 June 2022, which claims domestic priority to a provisional application filed 16 June 2021.
Claims 1, 9, 17, 25, 27, 29, 31 and 32 have been amended.
Claims 1-3, 5, 6, 9, 14, 16-20, 24-27 and 29-32 are currently pending and have been examined.
Drawings
New drawings were received on 2 Aril 2026. These drawings are accepted.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5, 6, 9, 14, 16-20, 24-27 and 29-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-3, 5, 6, 9, 14, 16-20, 24-27 and 29-32 are within the four statutory categories. Claims 1-3, 5, 6, 9, 14, 16-20, 24-27, 29 and 31 are drawn to a method, which is within the four statutory categories (i.e. process). Claim 32 is drawn to a system for predicting a patient medical event, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1 recites: A method comprising:
obtaining, by one or more processors, patient data, wherein the patient data includes clinical laboratory results of a patient with a disease state;
processing, by the one or more processors, the patient data to normalize the clinical laboratory results by patient-specific baseline levels or cohort-specific baseline levels of the clinical laboratory results; and
identifying, by the one or more processors, a position and a movement direction of the processed patient data within a phase-plane of a trajectory model, wherein the phase-plane comprises at least two clinical laboratory variables, and wherein the trajectory model defines a favorable recovery from the disease state as a recovery trajectory;
determining, by the one or more processors, a degree of deviation of the processed patient data from the recovery trajectory based on a distance between the identified position and the recovery trajectory and an angle between the identified movement direction and a change vector of the recovery trajectory; and
outputting, by the one or more processors and
based on the determined degree of deviation likelihood of an adverse outcome of the patient.
Claim 31 recites: A method comprising:
obtaining, by one or more processors, training patient data, wherein the training patient data includes clinical laboratory results of a plurality of patients with one or more disease states;
processing, by the one or more processors, the training patient data to normalize the clinical laboratory results of the plurality of patients by patient- specific or cohort-specific baseline levels;
identifying, by the one or more processors, at least two clinical laboratory variables to be used in a phase plane; and
fitting a trajectory model, by the one or more processors and using the at least two clinical laboratory variables, to the plurality of training patient data, wherein the phase-plane comprises the at least two clinical laboratory variables, and wherein the trajectory model characterizes the one or more disease states by a recovery trajectory in the phase plane.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of “mathematical concepts” and/or the abstract idea of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of using normalized patient data to apply to a trajectory model to characterize a patient disease state) or using a pen and paper, but for the recitation of generic computer components (i.e. the structural components of the computer) see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 1 and 32 are identical as the abstract idea for claims 1, because the only difference between claims 1 and 32 is that claim 1 recites a method, whereas claim 32 recites a system.
Dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29 include other limitations, for example claims 2 and 3 provide details on treatment recommendations, claims 5, 6, 19, 26 and 29 provide further details on various data results and variables, claims 14, 16-18, 24 and 30 provides details on the trajectory model and recovery tractor, claim 20 describes imputing data and claim 25 is directed to training data, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1.
Prong 2 of Step 2A
Claims 1, 31 and 32 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural components of the computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph 123 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to healthcare data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
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 (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29 include other limitations, but these limitations also amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29), and/or do not include any additional elements beyond those already recited in independent claim 1, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1, 31 and 32 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the dispensing device and the one or more processors), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Paragraph 123 of the Specification discloses that the additional elements (i.e. the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claim 1, and/or the additional elements recited in the aforementioned dependent claims similarly amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2, 3, 5, 6, 9, 14, 16-20, 24-27 and 29), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-3, 5, 6, 9, 14, 16-20, 24-27 and 29-32 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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, 6, 9, 14, 17-19, 31 and 32 are rejected under 35 U.S.C. 103 as being obvious over Kang et al.(U.S. PG-Pub 20190198150 A1), hereinafter Kang, further in view of Clark et al. (WIPO Pub 2021/034770 A1), hereinafter Clark.
As per claims 1, 31 and 32, Kang discloses a method and a system comprising:
one or more processors and one or more storage devices storing instructions that are operable, when executed by the one or more processors, to cause the one or more processors to perform operations (Kang discloses use of computer structure, see paragraph 8.) comprising:
obtaining, by one or more processors, patient data, wherein the patient data includes clinical … results of a patient with a disease state (Kang collects various patient data from patients recovering from surgery or with a disease state, such as current pain, anxiety, range of motion, mobility, patient, satisfaction, etc., see Kang, paragraphs 14, 27-31 and 37-38.);
identifying, by the one or more processors, a position and a movement direction of the processed patient data within a phase-plane of a trajectory model, wherein the phase-plane comprises at least two clinical … variables, and wherein the trajectory model defines a favorable recovery from the disease state as a recovery trajectory (Kang discloses creation of a plurality of patient profile maps (phase-planes) at various times in which two patient variables, such as pain and motivation are graphed, see Fig. 2 and corresponding text. The composite of at least two of these maps are the equivalent of a trajectory model, and result in a patient vector, see paragraphs 41-44. A vector inherently comprises a position and movement direction. Kang defines recoveries based comparison to various outcomes, including favorable recoveries, of similar patients, see paragraphs 46-50.);
determining, by the one or more processors, a degree of deviation of the processed patient data from the recovery trajectory based on a distance between the identified position and the recovery trajectory and an angle between the identified movement direction and a change vector of the recovery trajectory (Kang compares patient vector to grouped population vectors, see paragraphs 70-71.); and
outputting, by the one or more processors and based on the determined degree of deviation, a likelihood of an adverse outcome of the patient (System compares patient data to various groups of outcomes in order to output confidence scores indicating which outcome groups the patient corresponds to and by what confidence, see paragraphs 46-53.).
Kang fails to explicitly disclose:
clinical laboratory data; and
processing, by the one or more processors, the patient data to normalize the clinical laboratory results by patient-specific baseline levels or cohort-specific baseline levels of the clinical laboratory results.
Clark teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to collect clinical laboratory data and provide processing, by the one or more processors, the patient data to normalize the clinical laboratory results by patient-specific baseline levels or cohort-specific baseline levels of the clinical laboratory results (Clark, see paragraph 121.) in order to provide more potential data collection points that are processed to be more reliable across a group of patients.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen of Kang to include collecting clinical laboratory data and provide processing, by the one or more processors, the patient data to normalize the clinical laboratory results by patient-specific baseline levels or cohort-specific baseline levels of the clinical laboratory results, as taught by Clark, in order to arrive at a method for tracking patient recovery and outcomes during a recovery and wellness regimen that provides more potential data collection points that are processed to be more reliable across a group of patients. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Kang and Clark are directed to the electronic processing of patient healthcare data and specifically to the diagnosis and treatment based thereon.
As per claims 2, 3, 6, 14 and 17-19, Kang/Clark discloses claim 1, discussed above. Kang also discloses:
2. providing, by the one or more processors and based on the likelihood of adverse outcome of the patient, information indicative of a recommended treatment (Kang provides a recommended therapy regimen based on the identified patient subgroup based on the patient’s identified confidence scoring with that group, see paragraphs 53-56.);
3. wherein the recommended treatment comprises a recommendation to continue a current treatment regimen or to modify the current treatment regimen (Kang provides a recommended therapy regimen based on the identified patient subgroup based on the patient’s identified confidence scoring with that group, see paragraphs 53-56; Kang is operative to work continually across time, and therefore may modify or continue previous treatments, see paragraph 72.);
6. wherein the disease state comprises an acute inflammatory response (Kang discloses a disease state comprised of various diseases or ailments, see paragraph 14. The claimed invention operates the same way regardless of the name of the disease state, therefore the specific name of the disease state amounts to a mere design choice and does not arrive to a patentable difference.);
14. wherein the trajectory model is predictive of the adverse outcome, and wherein the adverse outcome comprises at least one outcome selected from the group consisting of: a complication and mortality (Various patient groupings are associated with various outcomes, including bad outcomes, which would comprise a complication, see Kang paragraphs 46-50 and 70-71.);
17. determining a degree to which the positions of the processed patient data deviate from the recovery trajectory at any given time point and over serial time points (Kang collects data over a plurality of timepoints and is operative to compare the patient data to historical data over any time point, see paragraphs 70-71.);
18. wherein determining the degree to which the positions of the processed patient data deviate from the recovery trajectory comprises computing a direction or angle between the positions of the processed patient data and the recovery trajectory in the phase-plane (Kang discloses comparing vectors, which would comprise comparing directions and angles, see paragraphs 70-71.); and
19. identifying, for the patient, the patient-specific or the cohort-specific baseline levels of the clinical laboratory results, wherein the baseline levels of the clinical laboratory results represent levels of the one or more variables before the patient is diagnosed with the disease state (Kang identifies and collects various patient data from the patient and population data, including data from before the surgical event, see, paragraphs 14, 27-31 and 37-38. Clark discloses clinical laboratory data, as shown above.).
As per claims 5 and 9, Kang/Clark discloses claim 1, discussed above. Kang fails to disclose:
5. wherein the clinical laboratory results are indicative of at least one of a blood count, a metabolic panel measurement, or a vital sign measurement; and
9. wherein the at least two clinical laboratory variables are selected from the group consisting of: a white blood cell count, a white blood cell count and a platelet count, a white blood cell count and a blood urea nitrogen level, and a white blood cell count and a red blood cell distribution width.
Clark teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention:
5. wherein the clinical laboratory results are indicative of at least one of a blood count, a metabolic panel measurement, or a vital sign measurement (Clark, paragraph 499.);
9. wherein the at least two clinical laboratory variables are selected from the group consisting of: a white blood cell count, a white blood cell count and a platelet count, a white blood cell count and a blood urea nitrogen level, and a white blood cell count and a red blood cell distribution width (Clark considers white blood cell measurements, see paragraphs 85 and 445.);
in order to provide more potential data collection points that are processed to be more reliable across a group of patients.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen of Kang to include
5. wherein the clinical laboratory results are indicative of at least one of a blood count, a metabolic panel measurement, or a vital sign measurement;
9. wherein the at least two clinical laboratory variables are selected from the group consisting of: a white blood cell count, a white blood cell count and a platelet count, a white blood cell count and a blood urea nitrogen level, and a white blood cell count and a red blood cell distribution width;
as taught by Clark, in order to arrive at a method for tracking patient recovery and outcomes during a recovery and wellness regimen that provides more potential data collection points that are processed to be more reliable across a group of patients. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claim 16 is rejected under 35 U.S.C. 103 as being obvious over Kang/Clark further in view of Zhang, JinFei, et al. "Platelet‐to‐white blood cell ratio: a novel and promising prognostic marker for HBV‐associated decompensated cirrhosis." Journal of Clinical Laboratory Analysis 34.12 (2020): e23556, hereinafter Zhang.
As per claim 16, Clark/Kurtz discloses claim 1, discussed above. Kang fails to explicitly disclose but Zhang teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide wherein the recovery trajectory comprises an exponential decay of white blood cell count and a linear increase in platelet count (Zhang discloses model for end stage liver disease score and platelet to white blood cell ratio for predicting 30 day mortality in patient, see page 4, Fig. 2.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen Kang/Clark to include wherein the recovery trajectory comprises an exponential decay of white blood cell count and a linear increase in platelet count, as taught by Zhang, in order to arrive at the method for tracking patient recovery and outcomes during a recovery and wellness regimen that models 30 day mortality in patients (Zhang, page 4, Fig. 2.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Kang and Zhang are directed to the processing of patient healthcare data and specifically to the diagnosis and treatment based thereon.
Claims 20 and 24 are rejected under 35 U.S.C. 103 as being obvious over Kang/Clark further in view of Mori, Makoto, et al. "Protocol for project recovery after cardiac surgery: a single-center cohort study leveraging digital platform to characterise longitudinal patient-reported postoperative recovery patterns." BMJ open 10.9 (2020): e036959, hereinafter Mori.
As per claims 20 and 24, Kang/Clark discloses claim 1, discussed above. Clark also discloses:
20. obtaining second patient data of a plurality of patients (Patient data from multiple studies, paragraph 591), wherein the plurality of patients does not include the patient (Patient data compared to second non-patient population, see Clark, paragraph 223.), and the plurality of patients and the patient share patient attributes (Multiple studies using same attributes, see paragraph 591.).
Kang/Clark fails to explicitly disclose but Mori teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide
20. imputing, based on the second patient data, missing values in the clinical laboratory results of the patient (Imputing missing data, see Mori, page 6, left column, bottom paragraph.); and
24. wherein the trajectory model further outputs a likelihood of a full and healthy recovery of the patient (Recovery scale, page 3, right column, top paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen Kang/Clark to include imputing, based on the second patient data, missing values in the clinical laboratory results of the patient and wherein the trajectory model further outputs a likelihood of a full and healthy recovery of the patient, as taught by Mori, in order to arrive at the method for tracking patient recovery and outcomes during a recovery and wellness regimen that fills missing data and provides more relevant outputs. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Kang and Mori are directed to the processing of patient healthcare data and specifically to the diagnosis and treatment based thereon.
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being obvious over Kang/Clark further in view of Visweswaran, Shyam, and Gregory F. Cooper. "Patient-specific models for predicting the outcomes of patients with community acquired pneumonia." AMIA Annual Symposium Proceedings. Vol. 2005. 2005.
As per claims 25 and 26, Kang/Clark discloses claim 1, discussed above. Kang/Clark also discloses:
26. wherein the clinical laboratory results comprise measurements of at least one parameter selected from the group consisting of: anion gap, blood-urea nitrogen, creatinine, hematocrit, glucose, platelet count, red cell distribution width, and white blood cell count (Clark considers white blood cell measurements, see paragraphs 85 and 445, as shown above.).
Kang/Clark fails to explicitly disclose but Visweswaran teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
25. obtaining training patient data, wherein the training patient data includes clinical laboratory results of a plurality of patients with one or more disease states (Visweswaran discloses trained the models on a set of 1601 patient cases; page abstract, see variables page 2, left column.); processing the training patient data to normalize the clinical laboratory results of the plurality of patients are normalized by the patient-specific or cohort-specific baseline levels (Visweswaran discloses Bayesian patient specific model, page 2, right column.); identifying the at least two clinical laboratory variables to be used in the phase plane; and fitting the trajectory model, using the at least two clinical laboratory variables, to the plurality of training patient data (Visweswaran discloses variables, see page 2 let column middle paragraph, and fitting the model thereon.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen Kang/Clark to include obtaining training data to normalize patient baseline levels and fitting the model based on identified variables, as taught by Visweswaran, in order to arrive at a method for tracking patient recovery and outcomes during a recovery and wellness regimen that provides benefits of using patient-specific models for making clinical predictions. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Kang and Visweswaran are directed to the processing of patient healthcare data and specifically to the diagnosis and treatment based thereon.
Claims 27 and 29 are rejected under 35 U.S.C. 103 as being obvious over Kang/Clark Visweswaran in view of Alashwal, Hany, et al. "The application of unsupervised clustering methods to Alzheimer’s disease." Frontiers in computational neuroscience 13 (2019): 31, hereinafter Alashwal, further in view of Ultsch, Alfred, and Jörn Lötsch. "Machine-learned cluster identification in high-dimensional data." Journal of biomedical informatics 66 (2017): 95-104, hereinafter Ultsch.
As per claims 27 and 29, Kang/Clark/Visweswaran discloses claim 25, discussed above.
Clark also discloses:
29. computing a significance of a generalized linear model predicting the adverse outcome (Clark discloses a generalized linear model using data across all grid sections and specimens, paragraph 184, used to predict an adverse outcome, paragraph 283.).
Kang fails to explicitly disclose but Alashwal teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
27. wherein identifying at least two clinical laboratory variables comprises: identifying, by applying unsupervised clustering to the plurality of training patient data, high-dimensional clusters (Alashwal uses unsupervised clustering to the patient data, page 3, left column, middle paragraph.); reducing dimensionality of the high-dimensional clusters; and identifying the at least two clinical laboratory variables that are significantly associated with the one or more disease states (Merge identified pair after removing clusters from distance matrix until reduced, page 5, left column, middle paragraph.).
29. wherein identifying the at least two clinical laboratory variables that are significantly associated with the one or more disease states (Alashwal, clusters linked to target variable, page 7, right column, top paragraph.) comprises: … using the at least two clinical laboratory variables in the plurality of training patient data; and determining that the significance meets a threshold (Examine patient subgroup with variable trajectories using extrapyramidal burden cluster had greater patients diagnosed with dementia, page 3, left column, bottom paragraph.)
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen Kang/Clark/Visweswaran to include processing of disease states, as taught by Alashwal, in order to arrive at a method for tracking patient recovery and outcomes during a recovery and wellness regimen that fills provides further unbiased results. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Neither Clark nor Alashwal disclose wherein the clusters are associated with the one or more disease states. Ultsch teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide wherein the clusters are associated with the one or more disease states (Ultsch, page 95, Abstract.)
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen of Kang/Clark/Visweswaran/Alashwal to include wherein the clusters are associated with the one or more disease states, as taught by Ultsch, in order to arrive at a method for tracking patient recovery and outcomes during a recovery and wellness regimen that fills provides more relevant outputs. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Kang, Alashwal and Ultsh are directed to the processing of patient healthcare data and specifically to the diagnosis and treatment based thereon.
Claim 30 is rejected under 35 U.S.C. 103 as being obvious over Kang/Clark/Visweswaran further in view of Santimone, Iolanda, et al. "White blood cell count, sex and age are major determinants of heterogeneity of platelet indices in an adult general population: results from the MOLI-SANI project." haematologica 96.8 (2011): 1180, hereinafter Santimone.
As per claim 30, Kang/Clark/Visweswaran discloses claim 25, discussed above. Clark fails to explicitly disclose but Santimone teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide wherein fitting the trajectory model comprises: fitting an exponential decay of white blood cell count using the plurality of training data; and fitting a linear increase in platelet count using the plurality of training data (Various parameters are negatively correlated with white blood cell count, see page 1182, right column, middle paragraph.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the method for tracking patient recovery and outcomes during a recovery and wellness regimen of Kang/Clark/Visweswaran to include wherein fitting the trajectory model comprises: fitting an exponential decay of white blood cell count using the plurality of training data; and fitting a linear increase in platelet count using the plurality of training data, as taught by Santimone, in order to arrive at a method for tracking patient recovery and outcomes during a recovery and wellness regimen that benefit of underlining the relation between platelets and inflammation (Santimone, page 1180, Abstract.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Kang and Santimone are directed to the processing of patient healthcare data and specifically to the diagnosis and treatment based thereon.
Response to Arguments
Applicant’s arguments filed 2 April 2026 concerning the rejection of all claims under 35 U.S.C. 112 have been fully considered and are deemed persuasive in view of the amendments to the claims. Accordingly, these rejections have been withdrawn.
Applicant’s arguments filed 2 April 2026 concerning the rejection of all claims under 35 U.S.C. 101 and 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 10-12 that the claims contain additional elements that integrate the abstract idea into a practical application, such as the reflection to improvements to diagnostic technologies as reflected in claim 1.
The Office respectfully disagrees. Please see the new statutory rejection of the claims, issued above, wherein the claims are shown to be directed to an abstract idea without significantly more.
MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine).
Accordingly, the statutory rejection is upheld.
With regard to the rejection of the claims under 35 USC 103, Applicant argues on pages 12-13 that the amendments to the claims overcome the prior art rejection.
Applicant's arguments have been fully considered but are moot in view of the new ground(s) of rejection, specifically with reference to the new reference necessitated by amendment, Kang, as detailed above, or because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Kang, Clark, Kurtz, Visweswaran and Santimone, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Action (6 April 2026), and incorporated herein.
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 of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
9 June 2025
Prosecution Insights