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 .
Claims 1,4-7,8-9,12-16,19-20 are pending. Claims 1,4-7,8-9,12-16,19-20 are rejected herein.
Priority
This application does not claim priority to another application, the effective priority date is 29 June 2023.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 June 2026 has been entered.
Distinguishing Subject Matter
The prior art fails to teach or suggest the full totality of: “…identifying a subset of the data pertaining to the state of the patient as context, the context including the physical condition of the patient and environmental data including atmospheric data associated with the patient, wherein different physical conditions of the patient associated with different environmental data are identified, wherein the different environmental data are representative of different environment in which the medical treatment has been administered via the wearable medical device of the patient over time during which the patient has been undergoing the medical treatment including initial medical treatment at a clinic and subsequent medical treatment at different location outside the clinic, wherein at least some of the subsequent medical treatment at different locations outside the clinic have been self-administered by the wearable medical device of the patient;…”
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 1,4-7,8-9,12-16,19-20 are rejected under 35 USC 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: Statutory Categories
Claims 1,8,16 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. The claims are directed to a method of, a computer program product comprising a computer readable storage medium having program instructions to/for, and system for generating patient treatment recommendations. All are within a statutory class for subject matter eligibility purposes.
Step 2A Prong One: Abstract Idea
The limitations of (claim 1 being representative): receiving data associated with a patient undergoing a medical treatment, the data pertaining to a use of the medical treatment and a state of the patient […] the state of the patient being automatically received […], wherein changes to the state of the patient are automatically received […]; identifying a subset of the data pertaining to the state of the patient as context, the context including the physical condition of the patient and environmental data including atmospheric data associated with the patient, wherein different physical conditions of the patient associated with different environmental data are identified, wherein the different environmental data are representative of different environment in which the medical treatment has been administered […to the patient…] over time during which the patient has been undergoing the medical treatment including initial medical treatment at a clinic and subsequent medical treatments at different locations outside the clinic, wherein at least some of the subsequent medical treatments at different locations outside the clinic have been self-administered […]; learning a function that relates the context to a reward derived from the medical treatment over time, the function being expressed in terms of the context that parameterizes the reward, the subset of the data having been identified as the context based on an impact the subset of the data has on the reward, the reward being at least a pain level of the patient, mood level of the patient, number of steps taken by the patient in a given time period, and alertness of the patient; using the function based on a current state of the patient and current environmental data including current atmospheric data to identify a type of treatment to deliver to the patient at current time outside the clinic after the initial medical treatment has been administered at the clinic; and transmitting the type of treatment that is approved […], responsive to an approval […], automatically adjusting the type of treatment to the patient, including medication dosage level for the current time […], wherein different treatments are delivered to the patient in non-stationary environment with non-stationary information as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) and/or mathematical concepts but for the recitation of generic computer components.
That is, other than reciting (claim 1) a computer, and (claim 8) a computer program product comprising a computer readable storage medium having program instructions embodied therewith, and (claim 16) at least one processor and one memory device, the claimed invention amounts to managing personal behavior or interactions between people (i.e., a person following a series of rules or steps) and/or mathematical concepts, which falls under certain methods of organizing human activity and/or mathematical concepts. Note that recitations in the claim were identified as part of the mathematical concepts grouping. For example, but for the various general-purpose computer elements, the claims encompass a person receiving data and generating treatment recommendations via a learning function. The Examiner notes that “certain methods of organizing human activity” includes a person’s interaction with a computer (MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people and/or mathematical concepts but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas and/or mathematical concepts grouping. Accordingly, the claim recites an abstract idea.
Step 2A Prong Two: Practical Application
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of (claim 1) a computer, and (claim 8) a computer program product comprising a computer readable storage medium having program instructions embodied therewith, and (claim 16) at least one processor and one memory device that implements the abstract idea. These additional elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., a generic general-purpose computer or components thereof) such that they amount no more than mere instructions to apply the exception using a generic computer component. 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 claims are directed to an abstract idea.
The independent claims recite a wearable medical device. The wearable medical device generally links the judicial exception to a particular technological environment. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application. See MPEP 2106.04(d)(l), Relevant Consideration for Evaluating Whether Additional Elements Integrate A Judicial Exception Into A Practical Application, and MPEP 2106.05(h).
The claim further recites the additional element of receiving data associated with a patient undergoing medical treatment… Receiving data associated with a patient undergoing medical treatment is recited with high level of generality (i.e., as a general means of transmitting data) and amounts to the mere transmission of data, even if it recites further the type of data, and as such the limitation is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B: Significantly More
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 the integration of the abstract idea into a practical application, the additional element of using a general -purpose computer (and/or components thereof) to perform the noted steps amounts to no more than mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). As such the claims are not patient eligible.
The independent claims recite a wearable medical device. The wearable medical device generally links the judicial exception to a particular technological environment. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application or provide significantly more. See MPEP 2106.04(d)(l), Relevant Consideration for Evaluating Whether Additional Elements Integrate A Judicial Exception Into A Practical Application, and MPEP 2106.05(h).
The claim further recites the additional element of receiving data associated with a patient undergoing medical treatment… Receiving data associated with a patient undergoing medical treatment is recited with high level of generality (i.e., as a general means of transmitting data) and amounts to the mere transmission of data, even if it recites further the type of data, and as such the limitation is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application or provide significantly more.
Dependent Claims and Additional Elements
Dependent claims (4-7,9,12-15,19-20) are rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim 4 merely describes wherein the reward is related to a metric structured as a multi-dimensional vector describing certain patient features. Claim 5 merely describes wherein the reward is a scalar function of the context. Claim 6 merely describes wherein the subject of data includes certain features of the received data. Claim 7 merely describes wherein the function is learned using a certain algorithm with respect to super-gaussian noise. Claim 9 merely describes treatment options, and an instance of the type of treatment is selected based on the context of the patient in a given time. Claim 12 merely describes merely describes wherein the reward is related to a metric structured as a multi-dimensional vector describing certain patient features. Claim 13 merely describes wherein the reward is a scalar function of the context. Claim 14 merely describes wherein the subject of data includes certain features of the received data. Claim 15 merely describes wherein the function is learned using a certain algorithm with respect to super-gaussian noise. Claim 19 merely describes wherein the reward is related to a metric structured as a multi-dimensional vector describing certain patient features. Claim 20 merely describes wherein the function is learned using a certain algorithm with respect to super-gaussian noise.
The dependent claims recite a wearable medical device. The wearable medical device generally links the judicial exception to a particular technological environment. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application or provide significantly more. See MPEP 2106.04(d)(l), Relevant Consideration for Evaluating Whether Additional Elements Integrate A Judicial Exception Into A Practical Application, and MPEP 2106.05(h).
Response to Arguments
Applicant argues that the claim does not cover certain methods of organizing human activity and/or mathematical concepts, but for recitation of generic computer components. Applicant disagrees and maintains all of the applicant’s previous arguments.
See previous responses issued to those arguments, which address the assertion that the claim does not cover certain methods of organizing human activity and/or mathematical concepts.
Applicant argues that the amended claims, each considered as a whole, are not abstract, because claim 1 as a whole provides an improvement to medical treatment technique via a remote sensing and/or wearable medical device.
There is no improvement to the remote sensing system and/or wearable medical device, the quality of the medical data or the computer itself, there is only an application of technology recited, the automation of the abstract idea on the computer. Applying the remote sensing system and/or wearable medical device to a particular field or area of expertise is refining the application not establishing an improvement to technology through an ordered meaningful pattern of additional elements at step 2A prong two and Step 2B of the Alice/Mayo subject matter eligibility framework.
A wearable medical device that includes different programmed treatment options is not abstract but recites a concrete technical device.
This was labeled as an additional element and was dealt with in turn.
Further, causing the wearable medical device to automatically adjust the type of treatment to the patient including medication dosage level for the current time,” is not abstract. For instance, the wearable medical device is improved to be able to automatically adjust the type of treatment to the patient including medication dosage level for the current time.” A wearable medical device that can automatically adjust medication dosage level at different times based on different situations, is not abstract.
Again this was an additional element. No one claimed a wearable medical device that can automatically adjust medication dosage levels at different times was abstract.
The cited references do not appear to disclose or suggest amended claims 1, 8 and 16. For instance, those references do not appear to disclose or suggest “wherein different physical conditions of the patient has been undergoing the medical treatment including initial medical treatment at a clinic and subsequent medical treatments at different locations outside the clinic,” recited in amended claim 1.
Agreed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Z. Afkir, H. Guermah, M. Nassar and S. Ebersold, "Machine Learning Based Approach for Context Aware System," 2019 IEEE 28th International Conference on Enabling Technologies: Infrastructure for Collaborative Enterprises (WETICE), Napoli, Italy, 2019, pp. 43-48. Afkir teaches context aware systems with machine learning with applications relevant to E-health.
US 2014/0039923 A1 (hereafter Schaefer) teaches at the Abstract receiving data representative of a medical treatment to be administered to a patient (medical data).
WO 2020/180679 A1 (hereafter Zimmerman) teaches systems and methods for treating a patient for a medical condition using an interactive treatment pathway interfaces associated with the medical condition.
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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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