DETAILED ACTION
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-7 are directed to a method (i.e., a process), claims 8-13 are directed to a system (i.e., a machine), and claims 14-20 are directed to one or more non-transitory media (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
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. 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.
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A computer-implemented method, comprising:
receiving target information, associated with a first patient, from a first set of records at an electronic health records system;
receiving reference information, associated with a reference population of patients, from a second set of records at the electronic health records system;
based on the reference information associated with the reference population and based further on one or more attributes of interest, determining a set of timeseries data elements, wherein determining the set of timeseries data elements comprises:
determining, via one or more hardware processors associated with the electronic health records system, a set of blocking variables based at least on the target information;
generating a set of hash-encoded elements associated with the reference population based on applying a hash function to the reference information associated with the reference population;
based on the set of blocking variables and the set of hash-encoded elements, extracting from the first set of records a subset of records containing values lexically similar to values associated with the set of blocking variables; and
generating the set of timeseries data elements based on the subset of records;
based on the set of timeseries data elements, determining a set of trajectory clusters that are each associated with a timeseries trajectory;
identifying a similarity of a first health record from the first set of health records to a first trajectory cluster of the set of trajectory clusters; and
based on the identifying of the similarity of the first health record to the first trajectory cluster,
electronically writing, via the one or more hardware processors, encoded data to a digital memory at the electronic health records system, wherein the encoded data indicates the similarity.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because receiving target information, associated with a first patient, from a first set of records; receiving reference information, associated with a reference population of patients, from a second set of records;
based on the reference information associated with the reference population and based further on one or more attributes of interest, determining a set of timeseries data elements, wherein determining the set of timeseries data elements comprises: determining a set of blocking variables based at least on the target information; generating a set of elements associated with the reference population; based on the set of blocking variables and the set of elements, extracting from the first set of records a subset of records containing values lexically similar to values associated with the set of blocking variables; and generating the set of timeseries data elements based on the subset of records; based on the set of timeseries data elements, determining a set of trajectory clusters that are each associated with a timeseries trajectory; identifying a similarity of a first health record from the first set of health records to a first trajectory cluster of the set of trajectory clusters; and wherein the data indicates the similarity amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or via pen and paper.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. 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.”
The limitations of claims 1, 8, and 14, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting an electronic records system, one or more hardware processors, a digital memory, and one or more non-transitory media to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. 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 claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the electronic records system, one or more hardware processors, digital memory, and one or more non-transitory media are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of receiving information, determining data, generating data, extracting data, identifying data, and writing data) such that it amounts no more than mere instructions to apply the exception using generic computer components. The limitations regarding “applying a hash function“ and hash-encoded elements do not amount to more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the 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, 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 is not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-7, 9-13, and 15-20 are ultimately dependent from Claim(s) 1, 8, and 14 and include all the limitations of Claim(s) 1, 8, and 14. Therefore, claim(s) 2-7, 9-13, and 15-20 recite the same abstract idea. Claims 2-7, 9-13, and 15-20 describe further limitations regarding retrieving time data associated with condition-recovery durations indicated by the second set of records; retrieving date- time stamps associated with condition episodes indicated by the second set of records; wherein the condition episodes comprise a set of acute-care episodes selected from a group comprising at least a set of time- stamped orders that differ, a set of order recommendations that differ, and a set of time stamped patient conditions that differ; wherein the one or more attributes of interest include at least one attribute selected from a group comprising a patient demographics attribute, a clinical conditions attribute, an acute-care episodes attribute, and a clinical orders attribute; and the at least one blocking variable being an independent metric corresponding to one or more patients. The limitations regarding generating a data structure are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. These are all just further describing the abstract idea recited in claims 1, 8, and 14, without adding 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 integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 8, and 14 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 reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to receiving information at an electronic health records system, extracting records, and electronically writing encoded data to a digital memory, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network and storing and retrieving information in memory. See MPEP 2106.05(d)(II).
The dependent claims 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 1-20 are ineligible under 35 USC §101.
Claim Objections
Claims 8 and 14 are objected to because of the following informalities: change “determining, via the one or more hardware processors associated with the electronic health records system, a set of blocking variables based at least on the target information“ to “determining, via the one or more hardware processors , wherein the one or more hardware processors are associated with the electronic health records system“. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly added recitation of “generating a set of hash-encoded elements associated with the reference population based on applying a hash function to the reference information associated with the reference population…based on the identifying of the similarity of the first health record to the first trajectory cluster, electronically writing, via the one or more hardware processors, encoded data to a digital memory at the electronic health records system, wherein the encoded data indicates the similarity” within claim 1, 8, and 14, “wherein the condition episodes comprise a set of acute-care episodes selected from a group comprising at least a set of time- stamped orders that differ, a set of order recommendations that differ, and a set of time stamped patient conditions that differ“ within claims 4, 11, and 17, and “generating a trajectory-detection data structure based on a longitudinal sequence of patient conditions and based further on at least one blocking variable of the set of blocking variables, the at least one blocking variable being an independent metric corresponding to one or more patients“ within claims 7, 13, and 20 appear to constitute new matter.
In particular, Applicant does not point to, nor was the Examiner able to find support for this newly added language within the specification as originally filed. As such, Applicant is respectfully requested to clarify the above issues and to specifically point out support for the newly added limitations in the originally filed specification and claims.
Applicant is required to cancel the new matter in the reply to this Office Action.
Subject Matter Free of Prior Art
Regarding independent claims 1, 8, and 14, the closest prior art, Cookson et al. (CA 2585678 A1), JP 2005508544 A, Hutchins et al. (US 2006/0059181 A1), and Kil (US 2008/0146334 A1), does not teach or fairly suggest: wherein determining the set of timeseries data elements comprises…generating a set of hash-encoded elements associated with the reference population (of patients) based on applying a hash function to the reference information associated with the reference population; based on the set of blocking variables and the set of hash-encoded elements, extracting from the first set of records (at an electronic health records system) a subset of records containing values lexically similar to values associated with the set of blocking variables (determined based at least on the target information associated with a first patient); and generating the set of timeseries data elements based on the subset of records; based on the set of timeseries data elements, determining a set of trajectory clusters that are each associated with a timeseries trajectory.
As such, claims 1-20 are free of prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches a disease management system (AU-2007201421-B2); "Duplicate record detection: A survey" (Elmagarmid et al.); and "Automatic de-identification of textual documents in the electronic health record: a review of recent research" (Meystre et al.).
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687