DETAILED ACTION
Claims 1-17 are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-15 are directed to a system (i.e., a machine); Claim 16 is directed to a method (i.e., a process); and Claim 17 is directed to a CRM (i.e., a manufacture). Accordingly, claims 1-17 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. An information processing device comprising:
a log accumulation unit that accumulates vital data of a patient for each medication date as a patient log;
an abnormality detection unit that detects abnormality data indicating an abnormal value from the patient log; and
an accumulated log reproduction unit that reproduces the patient log so as to have the abnormality data associated with the medication date.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because sending healthcare data from various parties, detecting a medical condition, generating and sending a notification are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Accordingly, independent claim 1 and analogous independent claims 16 & 17 recite at least one abstract idea.
Furthermore, dependent claims 2-15 further narrow the abstract idea described in the independent claims. Claims 2 recites generating observation data, Claims 3-7 recites generating question and answer data, Claim 8 recites generating message templates, Claims 9-10 recites outputting abnormality data, Claims 11-15 recites identifying vital sign data. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 1 and analogous independent claims 16 & 17, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
1. An information processing device comprising:
a log accumulation unit that accumulates vital data of a patient for each medication date as a patient log;
an abnormality detection unit that detects abnormality data indicating an abnormal value from the patient log; and
an accumulated log reproduction unit that reproduces the patient log so as to have the abnormality data associated with the medication date.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the device, log accumulation unit, abnormality detection unit, accumulated log reproduction unit, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 16 & 17 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite at least one abstract idea.
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 10 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitations of the device, log accumulation unit, abnormality detection unit, accumulated log reproduction unit, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-17 are ineligible under 35 USC §101.
Independent claim 17 is directed to a system as described in the preamble. However, the claim does not positively recite any elements that necessarily constitute a system or apparatus, such as computer hardware. It is not clear what structure is included or excluded by the claim language. Software per se is not patentable under § 101; therefore, the claimed invention does not fall within a statutory class of patentable subject matter. See MPEP 2106.01. Examiner recommends amending the claim to clearly include hardware in order to overcome this rejection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: log accumulation unit, abnormality detection unit, accumulated log reproduction unit in claim 1, medical inquiry content accumulation unit in claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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.
Claims 1, 9-10, & 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato (US20190385723).
As per claim 1, Sato discloses an information processing device comprising:
a log accumulation unit that accumulates vital data of a patient for each medication date as a patient log (para. 37, 43: vital data acquired from patient);
an abnormality detection unit that detects abnormality data indicating an abnormal value from the patient log (para. 68: abnormal values detected); and
an accumulated log reproduction unit that reproduces the patient log so as to have the abnormality data associated with the medication date (Fig. 4; para. 79-80: interface display shows patient vital log data with abnormality data and medication data).
As per claim 9, Sato discloses the information processing device according to claim 1, wherein
the accumulated log reproduction unit presents the abnormality data in a mode that enables distinction from normal data (Fig. 4: abnormal blood pressure data can be viewed).
As per claim 10, Sato discloses the information processing device according to claim 1, wherein
the accumulated log reproduction unit presents a tag indicating a content of abnormality in association with the abnormality data (Fig. 4: abnormal blood pressure data can be viewed; trend displayed along with abnormality values)
Claims 16-17 recite substantially similar limitations as those already addressed in claim 1, and, as such, are rejected for similar reasons as given above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 2-4 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Sato in view of Zuckerman (US20120102405).
As per claim 2, Sato discloses the information processing device according to claim 1, but does not expressly teach wherein the abnormality detection unit generates observation information according to the patient log using an observation model that has learned observation of a doctor.
Zuckerman, however, teaches to improving person-specific diagnostic analysis and personalized management of individuals where an artificial intelligence model generates diagnosis information based on evidence-based medical diagnosis and management including expert/physician-specific experience and expertise (para. 178-179).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Zuckerman with Sato based on the motivation of matching and mapping person-specific data with evidence that results in person-specific or personalized recommended actions (Zuckerman – para. 13).
As per claim 3, Sato and Zuckerman teach the information processing device according to claim 2. Sato does not expressly teach wherein
the abnormality detection unit selectively presents a question based on the observation information approved by the doctor to the patient.
Zuckerman, however, teaches to improving person-specific diagnostic analysis and personalized management of individuals where an artificial intelligence model generates diagnosis information based on evidence-based medical diagnosis and management including expert/physician-specific experience and expertise (para. 178-179). Zuckerman also teaches to outputting follow up questions to the doctor based on the previously generating diagnosis data (para. 165-167).
The motivations to combine the above mentioned references are discussed in the rejection of claim 3, and incorporated herein.
As per claim 4, Sato and Zuckerman teach the information processing device according to claim 2. Sato does not expressly teach wherein the abnormality detection unit generates answer information according to the patient log by using an answer model that has learned an answer of the patient to a question.
Zuckerman, however, teaches to improving person-specific diagnostic analysis and personalized management of individuals where an artificial intelligence model generates diagnosis information based on evidence-based medical diagnosis and management including expert/physician-specific experience and expertise (para. 178-179). Zuckerman also teaches to outputting follow up questions to the doctor based on the previously generating diagnosis data (para. 165-167). Zuckerman further teaches to receiving answer information the patient and using the answer information in the artificial intelligence model (para. 25, 173).
The motivations to combine the above mentioned references are discussed in the rejection of claim 3, and incorporated herein.
As per claim 6, Sato and Zuckerman teach the information processing device according to claim 4. Sato does not expressly teach comprising:
a medical inquiry content accumulation unit that stores a content of the question and an answer of the patient to the question in association with each other.
Zuckerman, however, teaches to storing question and answer data together in a database (para. 109, 161).
The motivations to combine the above mentioned references are discussed in the rejection of claim 3, and incorporated herein.
Claims 5 & 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sato in view of Zuckerman (US20120102405) as applied to claim 4 above, and in further view of Algoo (US20120165618).
As per claim 5, Sato and Zuckerman teach the information processing device according to claim 4, but do not expressly teach wherein
the accumulated log reproduction unit presents, in a mode in which a question generated by the doctor and a question based on the observation information are distinguishable, a history of the question in association with the patient log.
Algoo, however, teaches to a system for interactive digital data collection where a physician can generate their own questions in combination with computer generated questions and where the different questions are stored together for later usage (Fig. 16; para. 106-109).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Algoo with Sato and Zuckerman based on the motivation of provide an intelligent health avatar which will aid in the care of patients (Lyon – para. 2).
As per claim 7, Sato and Zuckerman teach the information processing device according to claim 6, but do not expressly teach wherein
the medical inquiry content accumulation unit generates a question message regarding a data range designated by the doctor.
Algoo, however, teaches to a system for interactive digital data collection where a physician can generate their own questions in combination with computer generated questions and where the different questions are stored together for later usage (Fig. 16; para. 106-109). Algoo also teaches to where the user can create a question that has a time range (Fig. 16; para. 106).
The motivations to combine the above mentioned references are discussed in the rejection of claim 5, and incorporated herein.
As per claim 8, Sato, Zuckerman, & Algoo teach the information processing device according to claim 7. Sato and Zuckerman do not expressly teach wherein
the medical inquiry content accumulation unit changes a template of the message on the basis of a designation method of the data range.
Algoo, however, teaches to a system for interactive digital data collection where a physician can generate their own questions in combination with computer generated questions and where the different questions are stored together for later usage (Fig. 16; para. 106-109). Algoo also teaches to where the user can create a question that has a time range (Fig. 16; para. 106). Algoo also teaches to changing the answer types for a question based on a date range, such as asking a patient to compare their symptoms from a day before (Fig. 16; para. 106).
The motivations to combine the above mentioned references are discussed in the rejection of claim 5, and incorporated herein.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sato in view of Gotz (US20140095186).
As per claim 11, Sato discloses the information processing device according to claim 1, but does not expressly teach wherein
the accumulated log reproduction unit presents a UI for identifying a normal vital data group from a vital data group of the patient as a normal cluster.
Gotz, however, teaches to stratifying patients into various clusters including low-risk, high risk, and general population clusters (para. 8-9).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Gotz with Sato based on the motivation of customize a personalized care management process or may be displayed for clinical decision support at the point-of-care or for patient education (Gotz – para. 20).
As per claim 12, Sato and Gotz teach the information processing device according to claim 11. Sato does not expressly teach wherein
the accumulated log reproduction unit presents a vital data group similar to vital data of a healthy person as a stable candidate, and
the abnormality detection unit identifies the stable candidate approved by a doctor as the normal cluster.
Gotz, however, teaches to stratifying patients into various clusters including low-risk, high risk, and general population clusters (para. 8-9). Gotz also teaches to determining which patients in a population should be assigned as a low-risk cluster by identifying risk factors (para. 29). Gotz does not expressly teach to a doctor manually approving the patient classification but the Examiner asserts that Gotz teaches to a computer automatically classifying the patient population and broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see MPEP 2144.04(III)).
The motivations to combine the above mentioned references are discussed in the rejection of claim 11, and incorporated herein.
As per claim 13, Sato and Gotz teach the information processing device according to claim 11. Sato does not expressly teach wherein
the accumulated log reproduction unit presents, as a stable candidate, a vital data group with a medication period of a medicine designated by a doctor, and
the abnormality detection unit identifies the stable candidate approved by the doctor as the normal cluster.
Gotz, however, teaches to stratifying patients into various clusters including low-risk, high risk, and general population clusters (para. 8-9). Gotz also teaches to determining which patients in a population should be assigned as a low-risk cluster by identifying risk factors and other data such as medication data (para. 28-29). Gotz does not expressly teach to a doctor manually approving the patient classification but the Examiner asserts that Gotz teaches to a computer automatically classifying the patient population and broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see MPEP 2144.04(III)).
The motivations to combine the above mentioned references are discussed in the rejection of claim 11, and incorporated herein.
As per claim 14, Sato and Gotz teach the information processing device according to claim 11. Sato does not expressly teach, wherein
the accumulated log reproduction unit presents, as a stable candidate, a vital data group similar to a vital data group designated by a doctor, and
the abnormality detection unit identifies the stable candidate approved by the doctor as the normal cluster together with the vital data group designated by the doctor.
Gotz, however, teaches to stratifying patients into various clusters including low-risk, high risk, and general population clusters (para. 8-9). Gotz also teaches to determining which patients in a population should be assigned as a low-risk cluster by identifying risk factors and other data such as medication data (para. 28-29). Gotz does not expressly teach to a doctor manually approving the patient classification but the Examiner asserts that Gotz teaches to a computer automatically classifying the patient population and broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see MPEP 2144.04(III)).
The motivations to combine the above mentioned references are discussed in the rejection of claim 11, and incorporated herein.
As per claim 15, Sato and Gotz teach the information processing device according to claim 11. Sato does not expressly teach wherein
the accumulated log reproduction unit presents a data space of the vital data, and the abnormality detection unit identifies a vital data group included in a space designated by a doctor as the normal cluster.
Gotz, however, teaches to stratifying patients into various clusters including low-risk, high risk, and general population clusters (para. 8-9). Gotz also teaches to determining which patients in a population should be assigned as a low-risk cluster by identifying risk factors and other data such as medication data (para. 28-29). Gotz does not expressly teach to a doctor manually approving the patient classification but the Examiner asserts that Gotz teaches to a computer automatically classifying the patient population and broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see MPEP 2144.04(III)).
The motivations to combine the above mentioned references are discussed in the rejection of claim 11, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Maeta (US20200279654) teaches to a health status determination device and a health status determination method which reflect vital signs or daily conditions in consideration of the individual differences of the subjects, enable the subjects to grasp the intra-individual variation with high accuracy, and contribute to the subject's health care or the provision of medical care for the characteristics of each individual.
Brooks (US20200005916) teaches to , a user interface may display a first timeline area with a first indication of a timespan that represents a portion of the timeline. The first indication of the timespan may be scrollable to change the portion of the timeline displayed. The first timeline area may further comprise a set of clinical diagnoses with corresponding duration indicators. The user interface may also display a second timeline area with a second indication of a timespan, which may mirror the first indication of the timespan. The second timeline area may further comprise a set of diagnostic parameters and associated measurements. The user interface may also present a medication area having lists of medications separated by classification.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/ Primary Examiner, Art Unit 3619