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 .
Formal Matters
Applicant’s response, filed 12/16/2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The drawings filed on 12/16/2025 have addressed the issues specified in the previous Non-Final Action mailed on 9/10/2025. Therefore, the drawings filed on 12/16/2025 have been accepted.
Status of Claims
Claims 1-4, 7-13, 15-20 and 24 are currently pending and have been examined.
Claims 1, 3, 10, 12, 18, and 20 have been amended.
Claims 5-6, 14 and 21-23 have been canceled with claims 22-23 being newly canceled in the claims filed on 12/16/2025.
Claim 24 is new.
Claims 1-4, 7-13, 15-20 and 24 have been rejected.
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 1-4, 7-13, 15-20 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 1-4, 7-13, 15-20 and 24 are directed to a system, method, or product which are one of the statutory categories of invention. (Step 1: YES).
Independent Claim 1 discloses a method for providing dialysis treatments to a patient, comprising performing, by a peritoneal dialysis device, renal replacement therapy for a patient; obtaining, by a computing device, patient data of the patient, wherein the patient data of the patient includes a plurality of predictors relating to transitioning from peritoneal dialysis to hemodialysis wherein the plurality of predictors include: a number of hospital admissions over a first predetermined time period: whether the patient was hospitalized over a second predetermined time period a current albumin level; a number of months since a last peritonitis infection a number of peritonitis infections over a third predetermined time period; a current residual renal function whether the patient had an edema over a fourth predetermined time period a current measure of weekly KT/V; a variability of creatinine over a fifth predetermined time period an average weekly KT/V over a sixth predetermined time period an average basophil level over a seventh predetermined time period; an average bicarbonate level over an eight predetermined time period; and a change in creatinine levels over a ninth predetermined time period; inputting, by the computing device, the plurality of predictors into a modality analysis model, wherein the modality analysis model was trained using predictor data from a patient population comprising a plurality of patients to identify a first set of drivers indicating a modality change from peritoneal dialysis to hemodialysis will be needed within a first timeframe and a second set of drivers, different from the first set of drivers, indicating that a modality change from peritoneal dialysis to hemodialysis will be needed within a second timeframe farther out than the first timeframe; determining, by the computing device, based on the patient data and using the modality analysis model, a timeframe for transitioning the patient from peritoneal dialysis to hemodialysis, and transitioning the patient from peritoneal dialysis to hemodialysis according to the timeframe determined using the modality analysis model, wherein transitioning the patient from peritoneal dialysis to hemodialysis comprises: performing, by a hemodialysis device, further renal replacement therapy for the patient
Independent Claim 10 discloses a system, comprising: a peritoneal dialysis device configured to perform renal replacement therapy for a patient; a hemodialysis device configured to perform further renal replacement therapy for the patient; and a computing device configured to: obtain patient data of the patient, wherein the patient data of the patient includes a plurality of predictors relating to transitioning from peritoneal dialysis to hemodialysis wherein the plurality of predictors include: a number of hospital admissions over a first predetermined time period: whether the patient was hospitalized over a second predetermined time period a current albumin level; a number of months since a last peritonitis infection a number of peritonitis infections over a third predetermined time period; a current residual renal function whether the patient had an edema over a fourth predetermined time period a current measure of weekly KT/V; a variability of creatinine over a fifth predetermined time period an average weekly KT/V over a sixth predetermined time period an average basophil level over a seventh predetermined time period; an average bicarbonate level over an eight predetermined time period; and a change in creatinine levels over a ninth predetermined time period; inputting, by the computing device, the plurality of predictors into a modality analysis model, wherein the modality analysis model was trained using predictor data from a patient population comprising a plurality of patients to identify a first set of drivers indicating a modality change from peritoneal dialysis to hemodialysis will be needed within a first timeframe and a second set of drivers, different from the first set of drivers, indicating that a modality change from peritoneal dialysis to hemodialysis will be needed within a second timeframe farther out than the first timeframe; determine, based on the patient data and using the modality analysis model, a timeframe for transitioning the patient from peritoneal dialysis to hemodialysis, and transition the patient from peritoneal dialysis to hemodialysis according to the timeframe determined using the modality analysis model, wherein transitioning the patient from peritoneal dialysis to hemodialysis comprises the hemodialysis device performing the further renal replacement therapy for the patient
Independent Claim 18 discloses one or more non-transitory computer readable mediums having processor-executable instructions stored thereon for providing dialysis treatments to a patient, wherein the processor-executable instructions, when executed, facilitate performance of the following performing, by a peritoneal dialysis device, renal replacement therapy for a patient; obtaining, by a computing device, patient data of the patient, wherein the patient data of the patient includes a plurality of predictors relating to transitioning from peritoneal dialysis to hemodialysis wherein the plurality of predictors include: a number of hospital admissions over a first predetermined time period: whether the patient was hospitalized over a second predetermined time period a current albumin level; a number of months since a last peritonitis infection a number of peritonitis infections over a third predetermined time period; a current residual renal function whether the patient had an edema over a fourth predetermined time period a current measure of weekly KT/V; a variability of creatinine over a fifth predetermined time period an average weekly KT/V over a sixth predetermined time period an average basophil level over a seventh predetermined time period; an average bicarbonate level over an eight predetermined time period; and a change in creatinine levels over a ninth predetermined time period; inputting, by the computing device, the plurality of predictors into a modality analysis model, wherein the modality analysis model was trained using predictor data from a patient population comprising a plurality of patients to identify a first set of drivers indicating a modality change from peritoneal dialysis to hemodialysis will be needed within a first timeframe and a second set of drivers, different from the first set of drivers, indicating that a modality change from peritoneal dialysis to hemodialysis will be needed within a second timeframe farther out than the first timeframe; determining, by the computing device, based on the patient data and using the modality analysis model, a timeframe for transitioning the patient from peritoneal dialysis to hemodialysis, and transitioning the patient from peritoneal dialysis to hemodialysis according to the timeframe determined using the modality analysis model, wherein transitioning the patient from peritoneal dialysis to hemodialysis comprises; performing, by a hemodialysis device, further renal replacement therapy for the patient
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining limitations are merely directed to rules or instructions for determining if a patient should switch from one treatment to another. The series of steps recited above describe managing personal behavior or relationships or interactions between people and thus are grouped as certain methods of organizing human activity which is an abstract idea. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) 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 (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Independent Claim 1 and 10 discloses the following additional elements:
Performing, by a peritoneal dialysis device, renal replacement therapy for a patient
A computing device
Performing, by a hemodialysis device, further renal replacement therapy for a patient (a hemodialysis device configured to perform further renal replacement therapy for the patient)
A modality analysis model trained using predictor data from a patient population comprising a plurality of patients
Independent Claim 18 discloses the following additional elements:
One or more non-transitory computer readable mediums having processor-executable instructions stored thereon
Performing, by a peritoneal dialysis device, renal replacement therapy for a patient
A computing device
A modality analysis model trained using predictor data from a patient population comprising a plurality of patients
Performing, by a hemodialysis device, further renal replacement therapy for a patient
In particular, the computing device (of claims 1, 10, and 18), the one or more non-transitory computer readable mediums having processor-executable instructions stored thereon (of claim 18), performing renal replacement therapy (by both a peritoneal dialysis and a hemodialysis device) (of claims 1, 10 and 18), and a modality analysis model trained using predictor data from a patient population comprising a plurality of patient are recited at a high-level of generality such that it amounts to no more than (1) mere instructions to implement an abstract idea by adding the words ‘apply it' (or an equivalent) with the judicial exception (the computer and the hemodialysis; “apply it” on a computer and apply the results of the abstract idea, respectively) or generally link the abstract idea to a particular technological environment or field of use (the peritoneal dialysis). Applicant' s specification states - Processing circuitry 120, modality analysis logic 122, and/or portions thereof may be implemented in hardware, software, or a combination thereof. A logic, circuitry, or a module may be and/or may include, but are not limited to, a process running on a processor, a processor, a hard disk drive, multiple storage drives (of optical and/or magnetic storage medium), an object, an executable, a thread of execution, a program, a computer, hardware circuitry, integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), a system-on-a-chip (SoC), memory units, logic gates, registers, semiconductor device, chips, microchips, chip sets, software components, programs, applications, firmware, software modules, computer code, a control loop, a computational model or application, an Al model or application, an ML model or application, a NN model or application, a tree-based model or application, a proportional-integral- derivative (PID) controller, variations thereof, combinations of any of the foregoing, and/or the like. (Paragraph 18) See Further: (Paragraphs 30-40). These citations further discloses broadly recited hardware elements that perform a routine function in an expected manner.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. The collective functions appear to be implemented using conventional computer systemization.
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Claims 1, 10, and 18 disclose performing renal replacement therapy for a patient (using both peritoneal dialysis and hemodialysis devices). Performing renal replacement therapy was found above to be mere instructions to apply an exception, because it recites no more than an idea or a solution or outcome. MPEP 2106.04(d)(2) discloses when determining whether a claim applies or uses a recited judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition the following factors are relevant:
The particularity or generality of the treatment or prophylaxis
Renal replacement therapy is generally claimed and not a particular treatment or prophylaxis as the claim does not recite a particular amount of renal replacement therapy (either with the peritoneal dialysis or hemodialysis devices). Nor is there any specificity of what timeframe results in treatment with the hemodialysis device.
Whether the limitations have more than a nominal or insignificant relationship to the exception
As claimed, there is no relationship between the generally claimed “modality analysis model” and the solution presented (performing, by a hemodialysis device, renal replacement therapy) as the modality analysis model determines the timeframe yet there is no connection between the timeframe and the renal replacement therapy with a hemodialysis device.
Whether the limitations are merely extra-solution activity or field of use
Performing, by a peritoneal device, renal replacement is directed to data gathering rather than treating the patient. This represents extra-solution data gathering activity and/or confining the claimed invention to a field of use (see, e.g., Mayo Collaborative Servs. V. Prometheus Labs, Inc. 566 U.S. 66 (2012) describing than an administration step that was used to gather information about the patient was merely a nominal data gathering step rather than a particular treatment/prophylaxis.
Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. Thus, claim(s) 1, 10, and 18 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements 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. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the computing device (of claims 1, 10, and 18), the one or more non-transitory computer readable mediums having processor-executable instructions stored thereon (of claim 18), performing renal replacement therapy (by both a peritoneal dialysis and a hemodialysis device) (of claims 1, 10 and 18), and a modality analysis model trained using predictor data from a patient population comprising a plurality of patient amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more' ). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
As discussed above with respect to integration of the abstract idea into a practical application, Claims 1, 10, and 18 disclose performing, by a peritoneal device, renal replacement therapy for a patient (to paraphrase: in order to obtain patient data to determine a timeframe for transitioning to hemodialysis treatment). This treatment is merely directed to data gathering rather than a particular treatment or prophylaxis for a patient and either generally links or applies the result of the abstract idea (“apply it”). Additionally, Applicant’s disclosure and the prior art of record indicates that PD/HD renal therapy is well understood, routine, and conventional activity (See Background of the Specification at Para. 0002; See Hamada Para 20 and 58 (a dialysis planning apparatus and includes a program (peritoneal function testing program), installed in a general-purpose computer, for performing a peritoneal dialysis testing method.) and Blanchard Para 64 (the risk of developing an infection includes the patient receiving dialysis treatment in a first modality of peritoneal dialysis).) This well understood, routine, and conventional activity does not integrate the judicial exception into significantly more.
Accordingly, even in combination, these additional elements do not provide significantly more. As such the independent claims 1, 10, and 18 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent Claims 2-4, 7-9, 11-13, 15-17, 19-20, and 24 further define the abstract idea that is presented in the respective Independent 1, 10, and 18 and are further grouped as certain methods of organizing human activity and are abstract for the same reasons and basis as presented above.
Dependent claim(s) 3 and 7-9 further narrow the abstract idea presented in independent claim 1 and/or claims it depends on with no recitation of any further additional elements.
Dependent claims 2, 4, and 24 further narrow the abstract idea presented in independent claim 1 while further disclosing the additional element(s) of a home hemodialysis device and an in-center hemodialysis device (claim 2), a decision tree of nodes (claim 4), and an XGBoost machine learning (ML) model (claim 24).
Dependent claims 12 and 15-17 further narrow the abstract idea presented in independent claim 10 and/or claims it depends on with no recitation of any further additional elements.
Dependent claims 11 and 13 further narrow the abstract idea presented in independent claim 10 while further disclosing the additional element(s) of a home hemodialysis and an in-center hemodialysis device (claim 11) and a decision tree of nodes (claim 13).
Dependent claims 20 further narrows the abstract idea presented in independent claim 18 and/or claims it depends on with no recitation of any further additional elements.
Dependent claim 19 further narrows the abstract idea presented in independent claim 18 while further disclosing the additional element(s) of a home hemodialysis device and an in-center hemodialysis device (claim 19).
In particular, the decision tree of nodes (of claims 4 and 13), home hemodialysis device and the in-center hemodialysis device (of claims 2, 11, and 19), and the XGBoost machine learning (ML) model (claim 24) are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it' (or an equivalent) with the judicial exception. Accordingly, 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 dependent claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the decision tree of nodes, home hemodialysis device and the in-center hemodialysis device, and the XGBoost machine learning (ML) model amount to no more than mere instructions to apply the exception. Mere instructions to apply an exception cannot provide an inventive concept ("significantly more' ). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Accordingly, even in combination, these additional elements do not provide significantly more. Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-4, 7-13, 15-20, and 24 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free of Prior Art
Below is relevant prior art, however, there is no obvious combination of prior references discloses the claimed invention as described in further detail below:
Hamada (US PG Pub 2009/0271119 A1) discloses performing a peritoneal dialysis testing method. Para 6 discloses this peritoneal dialysis system can evaluate peritoneal function such as the volume of water removal, MTAC (an overall mass transfer-area coefficient), Kt/V (urea nitrogen clearance), and CCr (creatinine clearance) by computing mathematical models [plurality of predictors]. Para 74-78 discloses a blood sample is taken on a regular schedule, and a urine sample is collected while the concentration of each solute is checked... items of clinical data obtained here include the amount of collected urine and the concentration of each solute in urine (urinary urea nitrogen, urinary creatinine, urinary protein, and urinary sodium). The items also include concentrations of blood-total protein, albumin, serum creatinine, urea nitrogen, glucose, sodium, chloride and so on, obtained from the blood samples... Para 20 discloses a switching point from peritoneal dialysis to hemodialysis [performing hemodialysis based on timeframe]… can be evaluated by taking into account a scope of the drained fluid volume in the numerical range.
Blanchard (US PG Pub 2020/0005947 A1) Para 83 discloses the medical professional may switch the patient from at-home peritoneal dialysis to hemodialysis, either administered at home and/or at a clinic setting, to further minimize and/or avoid developing an infection such as peritonitis. Para 73 discloses the algorithm (e.g., the gradient boosting framework and/or extreme gradient boosting tree algorithm) may analyze the specific patient's data in the context of the corresponding data of a pool of other patients. Para 22 discloses a respective patient risk score for developing an infection within a selected time period; generate a report… transmit the report to one or more health care facilities, the one or more health care facilities further identifying one or more patients from the portion of the identified subset of the pool of patients for interventional treatment [wherein para 64 discloses the interventional treatments may include retraining the patient regarding the first modality of peritoneal dialysis, modifying peritoneal dialysis treatment of the patient, and/or switching the patient from the first modality to a second modality of hemodialysis]. Specifically, Blanchard Paras 33-36 discloses the system comprises wherein the extracted patient data comprises patient demographics [34: gender, race, age, or marital status], laboratory values [35: albumin, calcium, creatinine level or a patient’s transferrin saturation level, 36: time period over which patient was last diagnoses with an infection, total number of previous infections…], recorded information, physician notes, or treatment data, or combinations thereof. Para 66 discloses it is understand that any number “n” of variables may be utilized for determining patient risk.
Kovatchev (US PG Pub 2005/0214892 A1) Para 86 discloses the invention provides a computerized method and system for evaluating the short term risk for severe hypoglycemia (SH) of a patient based on BG data collected over a predetermined duration.
Reasons why the subject matter of the instant application contain subject matter free of prior art:
In conclusion, while the above listed references list various embodiments related to various different predictors (Kt/V, albumin, time period over which patient was last diagnoses with an infection, total number of previous infections) claimed in the independent claims, there is no obvious combination of references that there is no obvious combination of references that inputs all thirteen predictors into a modality analysis model, wherein the modality analysis model was trained using predictor data from a patient population comprising a plurality of patients to identify a first set of drivers indicating a modality change from peritoneal dialysis to hemodialysis will be needed within a first timeframe and a second set of drivers, different from the first set of drivers, indicating that a modality change from peritoneal dialysis to hemodialysis will be needed within a second timeframe farther out than the first timeframe and determining, based on the patient data and using the modality analysis model, a timeframe for transition and then transitioning the patient from peritoneal dialysis to hemodialysis according to the timeframe determined using the modality analysis model based on the input of all thirteen predictors.
Wherein the plurality of predictors include: a number of hospital admissions over a first predetermined time period: whether the patient was hospitalized over a second predetermined time period; a current albumin level; a number of months since a last peritonitis infection; a number of peritonitis infections over a third predetermined time period; a current residual renal function; whether the patient had an edema over a fourth predetermined time period; a current measure of weekly KT/V; a variability of creatinine over a fifth predetermined time period; an average weekly KT/V over a sixth predetermined time period; an average basophil level over a seventh predetermined time period; an average bicarbonate level over an eight predetermined time period; and a change in creatinine levels over a ninth predetermined time period wherein, as presented above, there is no combination of references that inputs all thirteen predictors, wherein the predictors specify the specific predictors and that a plurality of the predictors are obtained from nine different predetermined time periods.
Response to Arguments
Applicant’s arguments filed 12/16/2025 with respect to 35 U.S.C. § 112(b) have been fully considered, and are persuasive in light of the Applicant amending to specify that there are two separate time frames. Therefore, the previous 35 U.S.C. § 112(b) rejection has been withdrawn.
Applicant’s arguments filed 12/16/2025 with respect to 35 U.S.C. § 101 have been fully considered, but are not persuasive. Applicant argues that the claimed invention integrates the abstract idea into a practical application. The Examiner respectfully disagrees. The Applicant cites MPEP 2106 for a particular treatment or prophylaxis, but does not explain why they believe the claimed invention integrates the abstract idea into a practical application. Examiner notes that MPEP 2106.04(d)(2) indicates that a practical application may be present where the abstract idea effects a particular treatment or provides particular prophylaxis for a disease or medical condition. A particular treatment/prophylaxis is present where: (a) there is a particular (i.e., named/described) treatment /prophylaxis that occurs when the claim is implemented; (b) the treatment/prophylaxis has more than a nominal connection/correlation to the abstract idea; and (c) the administration is more than extra-solution activity or a field of use.
Applicant’s claimed invention does not provide for a particular treatment/prophylaxis for the reasons noted in the basis of rejection. Although the claim recites the peritoneal dialysis and hemodialysis, these represent either generally linking the claimed invention to a particular technological environment or field of use or represent “apply it.” Further, the peritoneal dialysis represents data gathering activity. This represents extra-solution data gathering activity and/or confining the claimed invention to a field of use (see, e.g., Mayo Collaborative Servs. V. Prometheus Labs, Inc. 566 U.S. 66 (2012) describing than an administration step that was used to gather information about the patient was merely a nominal data gathering step rather than a particular treatment/prophylaxis).
Regarding the renal replacement therapy by a hemodialysis device. This does not provide a particular treatment/prophylaxis because, while the claim recites that a treatment/prophylaxis is provided to the patient, there is no particularity to the treatment; the claim does not state how often the treatment is applied, the amount/concentration of treatment, the length of treatment, etc. Because a particular treatment / prophylaxis is not present in the claims, a practical application is not present and this argument is not persuasive.
The Applicant also quotes the MPEP 2106.04(d), part 1 which states that “examiners should ensure that they give weight to all additional elements, whether or not they are conventional, when evaluating whether a judicial exception has been integrated into a practical application. Additional elements that represent well-understood, routine, conventional activity may integrate a recited judicial exception into a practical application.” Examiner notes that the Examiner did give weight to all additional elements as presented previously and above under the 101 rejection and the Applicant has not pointed to any specific additional elements that they believe the Examiner did not give weight to. Thus, this argument is not persuasive.
Additionally, the Applicant argues that the claims are directed to a practical application like in Diamond v. Diehr and argues that the Examiner “ignores the treatment aspects of the claimed invention (under the guise of characterizing them as “additional elements”). The Examiner does not ignore additional elements when determining if the claims are directed to a practical application. MPEP 2106.05 states “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. Because this approach considers all claim elements, the Supreme Court has noted that "it is consistent with the general rule that patent claims ‘must be considered as a whole.’" Alice Corp., 573 U.S. at 218 n.3, 110 USPQ2d at 1981 (quoting Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ 1, 8-9 (1981)).” As such, the Examiner analyzes the additional elements (such as the treatment aspects of the claimed invention) to determine whether they amount to significantly more than the judicial exception itself. As previously presented, performing renal replacement therapy (by both a peritoneal dialysis and a hemodialysis device) does not integrate the judicial exception into a practical application or provide significantly more and as such the treatment aspects were not ignored in the analysis and this argument is not persuasive.
Further, the Applicant argues that the claimed invention is directed to patent-eligible subject matter as consistent with claim 3 of Example 47 and claim 2 of Example 49.
In regards to Example 47, claim 3 was found to be directed to a mathematical concept (because it claimed a backpropagation algorithm and a gradient descent algorithm in step a) and it recited a mental process (steps b and c). However, when determining if the claim as a whole included an improvement to a computer or a technological field, the disclosed system detects network intrusions and takes real-time remedial actions, including dropping suspicious packets and blocking traffic from suspicious source addresses. The background section further explains that the disclosed system enhances security by acting in real time to proactively prevent network intrusions. The claimed invention reflects this improvement in the technical field of network intrusion detection. Steps (d)-(f) provide for improved network security using the information from the detection to enhance security by taking proactive measures to remediate the danger by detecting the source address associated with the potentially malicious packets. Specifically, the claim reflects the improvement in step (d), dropping potentially malicious packets in step (e), and blocking future traffic from the source address in step (f). Thus, the claim as a whole integrates the judicial exception into a practical application.
The claims of the instant application are not analogous to those of Example 47. First, the claims of the instant application were found to be directed to certain methods of organizing human activity and not a mathematical concept or a mental process. Secondly, the claims of the instant application do not provide an improvement to a computer or a technological field. The peritoneal dialysis device and the hemodialysis devices are performing the treatment as expected, there is no improvement to how the treatment is being administered. Further, the computing device that is analyzing the patient data and using the modality analysis model to output data is not performing more efficiently or being improved in any way. As such, there is no improvement to a computer or other technological field and as such the claims of the instant application do not integrate the judicial exception into a practical application and therefore the previous 35 U.S.C 101 rejection is maintained and the comparison to Example 47, claim 3 is not persuasive.
In regards to Example 49, claim 2 is eligible because the medicine administered is Compound X and the specification says that Compound X reduces scarring while being as effective in treating the condition as other medicines. Claim 2 requires that the appropriate treatment be Compound X eye drops and does not make the appropriate treatment optional. The abstract idea is used to identify the patient as belonging to a specific patient population (glaucoma patients at high risk of PI), and the patient is then administered a treatment (Compound X eye drops instead of any common anti-fibrotic treatment, such as drug A, after microstent implant surgery) that is particular to that specific patient population (glaucoma patients at high risk of PI) wherein the applicant of Example 49 developed a new anti-fibrotic drug, Compound X.
Applicant’s claimed invention does not provide for a particular treatment/prophylaxis for the reasons noted in the basis of rejection. Although the claim recites the peritoneal dialysis and hemodialysis, these represent either generally linking the claimed invention to a particular technological environment or field of use or represent “apply it.” Further, the peritoneal dialysis represents data gathering activity. This represents extra-solution data gathering activity and/or confining the claimed invention to a field of use (see, e.g., Mayo Collaborative Servs. V. Prometheus Labs, Inc. 566 U.S. 66 (2012) describing than an administration step that was used to gather information about the patient was merely a nominal data gathering step rather than a particular treatment/prophylaxis).
Regarding the renal replacement therapy by a hemodialysis device. This does not provide a particular treatment/prophylaxis because, while the claim recites that a treatment/prophylaxis is provided to the patient, there is no particularity to the treatment; the claim does not state how often the treatment is applied, the amount/concentration of treatment, the length of treatment, etc.
In comparison to Compound X of Example 49, claim 2: Compound X eye drops are administered instead of any common anti-fibrotic treatment, such as drug A, after microstent implant surgery. In the Applicant’s specification of the instant application, the background indicates that renal replacement therapy may be performed using various modalities, including peritoneal dialysis or hemodialysis (HD) (for instance, home hemodialysis (HHD) or in-center hemodialysis (ICHD)). Thus, further indicating that the hemodialysis is not claimed particularly.
Applicant’s arguments filed 12/16/2025 with respect to 35 U.S.C. § 102 and 103 have been fully
considered and are persuasive regarding the newly added limitations, specifically the amendment of inputting the 13 different plurality of predictors to the modality analysis model to identify a first set of drivers indicating a modality change from peritoneal dialysis to hemodialysis within two timeframes. Therefore, the previous 35 U.S.C. § 102 and 103 rejections have been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA J MORICE DE VARGAS whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681