The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to Applicant’s submission filed on 5 January 2024. THIS ACTION IS NON-FINAL.
Status of Claims
Claims 1-6 are pending.
Claims 4-6 are rejected under 35 U.S.C. 101 for being directed to software per se.
Claim 1-3 are rejected under 35 U.S.C. 101 for being directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-2, 4-5 are rejected under 35 U.S.C. 103 as unpatentable.
There is no art rejection for claims 3 and 6.
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.
Non-Statutory Subject Matter
Claims 4-6 are directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to software per se.
Judicial Exception
Claims 1-3 of the claimed invention are directed to a judicial exception, an abstract idea, without significantly more.
Regarding claims 1-3,
(Independent Claims) With regards to claim 1,
Step 1: The claim recites a process, which falls into one of the statutory categories.
Step 2A – Prong 1: the claim, in part, recites: “ generating … user disease management data based on the user data” (mental process), as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting generic computer elements, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the language about generic computer elements, “generating”, in the limitation citied above encompasses observing / analyzing / processing data for disease prediction, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong 2: This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of: (a) “disease management device …”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)); (b) “receiving, by a disease management device, user data”, which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)). Accordingly. the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
Step 2B Analysis: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claim recites the additional elements of: (a) “disease management device …”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)); (b) “receiving, by a disease management device, user data”, which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, the additional elements individually or in combination do not amount to significantly more than the judicial exception. The claim is not patent eligible.
(Dependent claims)
Claims 2-3 are dependent on claim 1 and include all the limitations of claim 1. Therefore, claims 2-3 recite the same abstract ideas.
With regards to claim 2, the claim recites further limitation of “wherein the disease management data includes disease prediction data for a user or disease monitoring data for the user”, which is further process of observing / analyzing / processing data for disease prediction, which is a mental process.
The claim recites additional element of “the disease prediction data is generated based on a disease prediction artificial intelligence (AI) model, and the disease monitoring data is generated based on a disease monitoring Al model”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “the disease prediction data is generated based on a disease prediction artificial intelligence (AI) model, and the disease monitoring data is generated based on a disease monitoring Al model”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 3, the claim recites further limitation of “wherein the user data is preprocessed into user data (disease prediction) … the user data is preprocessed into user data (disease monitoring) … and the user data (disease prediction) and the user data (disease monitoring) are time-series data”, which is further process of observing / analyzing / processing data for disease prediction, which is a mental process.
The claim recites additional element of “…input into the disease prediction Al model”, “input into the disease monitoring Al model…”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of ““…input into the disease prediction Al model”, “input into the disease monitoring Al model…”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Regarding claims 4-6,
(Independent Claims) With regards to claim 4,
Step 1: The claim is directed to SW per se, which does not fall into one of the statutory categories. For compact prosecution, 101 judiciary analysis is performed as is can be applied after the claim is amended to be in one of the statutory categories.
Step 2A – Prong 1: the claim, in part, recites: “ generate user disease management data based on the user data” (mental process), as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting generic computer elements, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the language about generic computer elements, “generating”, in the limitation citied above encompasses observing / analyzing / processing data for disease prediction, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong 2: This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of: (a) “disease management device …”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)); (b) “receiving, by a disease management device, user data”, which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)). Accordingly. the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
Step 2B Analysis: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claim recites the additional elements of: (a) “receive user data …”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)); (b) “receive user data”, which is extra-solution activity of pre-solution data gathering (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, the additional elements individually or in combination do not amount to significantly more than the judicial exception. The claim is not patent eligible.
(Dependent claims)
Claims 5-6 are dependent on claim 4 and include all the limitations of claim 1. Therefore, claims 5-6 recite the same abstract ideas.
With regards to claim 5, the claim recites further limitation of “wherein the disease management data includes disease prediction data for a user or disease monitoring data for the user”, which is further process of observing / analyzing / processing data for disease prediction, which is a mental process.
The claim recites additional element of “the disease prediction data is generated based on a disease prediction artificial intelligence (AI) model, and the disease monitoring data is generated based on a disease monitoring Al model”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “the disease prediction data is generated based on a disease prediction artificial intelligence (AI) model, and the disease monitoring data is generated based on a disease monitoring Al model”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 6, the claim recites further limitation of “wherein the user data is preprocessed into user data (disease prediction) … the user data is preprocessed into user data (disease monitoring) … and the user data (disease prediction) and the user data (disease monitoring) are time-series data”, which is further process of observing / analyzing / processing data for disease prediction, which is a mental process.
The claim recites additional element of “…input into the disease prediction Al model”, “input into the disease monitoring Al model…”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of ““…input into the disease prediction Al model”, “input into the disease monitoring Al model…”, which is merely using computer as a tool to perform an abstract idea (see MPEP 2106.05(f). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barabasi et al, US-PGPUB NO.20080183454A1 [hereafter Barabasi].
With regards to claim 4, Barabasi teaches
“A disease management device for performing disease prediction and disease analysis for disease management (Barabasi, FIG.1,
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), the disease management device being implemented to: receive user data, and generate user disease management data based on the user data (Barabasi, FIG.1, FIG, 4A, B, C, [0007-0008] ‘…generating one or more disease predictions for the subject …’,
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)”.
Claim 1 is substantially similar to claim 4. The arguments as given above for claim 4 are applied, mutatis mutandis, to claim 1, therefore the rejection of claim 4 are applied accordingly.
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, 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.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Barabasi et al, US-PGPUB NO.20080183454A1 [hereafter Barabasi] in view of Shadid et al., US-PGPUB NO.20210098093A1 [hereafter Shadid].
With regards to claim 5, Barabasi teaches
“The disease management device of claim 4, wherein the disease management data includes disease prediction data for a user …, the disease prediction data is generated based on a disease prediction Al model (Barabasi, FIG.1, FIG.4A, B, C…,
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…
)”
Barabasi does not explicitly detail “… disease monitoring model …, the disease monitoring data is generated based on a disease monitoring Al model”.
However Shadid teaches “… disease monitoring model …, the disease monitoring data is generated based on a disease monitoring Al model (Shadid, FIG.3, 5-9, [0103] ‘… the system illustrated in FIG.6 includes a framework summarizing the functional requirements of interoperation within the system of the example embodiments and external data sources and models …’, [0117] … monitoring module 510 illustrates in FIG.5, monitors the patient’s vital sign …compare the monitored signals to known biological patterns … pattern matching may trigger an alert if the monitored signals correspond to a patient of disease or another medical emergency ….’,
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)”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and having the teachings of Barabasi and Shadid before him or her, to modify the distributed machine learning system and method of Barabasi to include intelligent monitoring as shown in Shadid.
The motivation for doing so would have been to provide integrated healthcare (Shadid, Abstract).
Claim 2 is substantially similar to claim 5. The arguments as given above for claim 5 are applied, mutatis mutandis, to claim 2, therefore the rejection of claim 5 are applied accordingly.
Additional Relevant Art
The prior art made of record is considered pertinent to applicant’s disclosure and is recorded on Form PTO-892. Applicant is required under 37 C.F.R. § 1.111 (c) to consider these references fully when responding to this action, with particular attention paid to:
Behzad et al., US-PGPUB NO.20230019703A1 [hereafter Behzad] shows disease prediction with ML models.
Park et al., US-PGPUB NO.20230129902A1 [hereafter Park] shows disease prediction using analyte measurement features and machine learning.
Garg et al., US-PATENT NO.12009107B2 [hereafter Garg] shows prediction with data preprocessing.
Junaid et al., “Recent advances in artificial intelligence and wearable sensors in healthcare delivery”, Applied science 12, 10271, 2022 [hereafter Junard] shows intelligent health monitoring system with AI models.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TSU-CHANG LEE whose telephone number is 571-272-3567. The fax number is 571-273-3567.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Omar Fernandez Rivas, can be reached 571-272-2589.
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/TSU-CHANG LEE/
Primary Examiner, Art Unit 2128