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 .
Specification
The abstract of the disclosure is objected to because the abstract exceeds 150 words.
Subject Matter Free of Prior Art
Claim(s) 1-15 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular: “obtaining criteria of a current step, identifying, among patients included in a history table of a just previous step, current step patients having an event corresponding to the criteria of the current step, and updating a bit string for each event of the current step patients included in the history table of the just previous step, and generating a history table of the current step by adding new events extracted in the current step; and sequentially generating a history table for each step, and then generating a cohort table by using a history table of a final step” and “recording event identifiers, a patient identifier, and an updated bit string of all events of the current step patient included in the first history table, in a second history table; when a new event corresponding to the criteria is extracted, recording an event identifier of the new event, a patient identifier, and a bit string representing the event extracted in the current step in a second history table; and storing the second history table as a history table of the current step,” respectively. Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in claims 1, 9, 13, claims 1, 9, 13 are hereby deemed to be allowable over prior art. Originally numbered dependent claims 2-8, 10-12, 14-15 incorporate the allowable features of originally numbered independent claims 1, 9, 13 through dependency, respectively.
However, the claims are still rejected under 101.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a method which is within the four statutory categories (i.e., method). Claim 9 is drawn to a method which is within the four statutory categories (i.e., method). Claim 13 is drawn to a computer program stored on a computer program stored in a computer-readable storage medium which, for purposes of compact prosecution, is presumed to be within the four statutory categories (i.e., manufacture).
Independent claim 1 (which is representative of independent claim 13) recites… obtaining cohort entry criteria and extracting events corresponding to the cohort entry criteria from a clinical data warehouse; generating an initial history table including an event identifier, a patient identifier, and a bit string indicating satisfaction of criteria of an initial step for each extracted event; obtaining criteria of a current step, identifying, among patients included in a history table of a just previous step, current step patients having an event corresponding to the criteria of the current step, and updating a bit string for each event of the current step patients included in the history table of the just previous step, and generating a history table of the current step by adding new events extracted in the current step; and sequentially generating a history table for each step, and then generating a cohort table by using a history table of a final step.
Independent claim 9 recites… obtaining criteria; based on clinical data of patients included in a first history table generated in a just previous step, identifying a current step patient satisfying the criteria among the patients included in the first history table; recording event identifiers, a patient identifier, and an updated bit string of all events of the current step patient included in the first history table, in a second history table; when a new event corresponding to the criteria is extracted, recording an event identifier of the new event, a patient identifier, and a bit string representing the event extracted in the current step in a second history table; and storing the second history table as a history table of the current step.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output based on the analysis accordingly (i.e., page 3 of the specification describes “Cohort extraction” as human activity performed by a “researcher”) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps, as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., a clinical data warehouse). Claim 9 recites additional elements (i.e., a clinical data warehouse). Claim 13 recites additional elements (i.e., A computer program stored in a computer-readable storage medium and comprising instruction; at least one processor; a clinical data warehouse). Looking to the specifications, a computing system having a computer program stored in a computer-readable storage medium and comprising instruction; at least one processor is described at a high level of generality (i.e., page 17-18), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, the claims add “a clinical data warehouse,” which is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., providing, storing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only provides the input data for the performance of the abstract idea, and as such, amounts to insignificant extrasolution activity (i.e., mere data gathering), which does not impose meaningful limits on the scope of the claim. See: MPEP § 2106.05(g). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The 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. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computing system having a computer program stored in a computer-readable storage medium and comprising instruction; at least one processor) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, the claims add “a clinical data warehouse,” which is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., providing, storing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent). Furthermore, receiving or transmitting data over a network, electronic recordkeeping, and storing and retrieving information in memory has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-8, 10-12, 14-15 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-8, 10-12, 14-15 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claim(s) 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because independent claim 1 is directed to “A computer program stored in a computer-readable storage medium and comprising instructions.”
The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a “computer program stored in a computer-readable storage medium and comprising instructions” may cover forms of software per se in view of the ordinary and customary meaning of “computer program stored in a computer-readable storage medium,” particularly when the specification is silent. See MPEP 2111.01.
When the broadest reasonable interpretation of a claim covers a software per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to a system that covers software per se, which the USPTO must reject under 35 U.S.C. §101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. §101 in this situation, the USPTO suggests the following approach. A claim drawn to such an application that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. §101 by adding the limitation "non-transitory" to the claim. Cf. Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. §101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes software per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a software per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2015/0142821 A1 teaches storing patient activity as a bitmap index and analyzing cohorts accordingly.
WO 2021/035224 A1 teaches identifying cohorts of patients using chronologically aligned similarities.
“ACE: the Advanced Cohort Engine for searching longitudinal patient records” teaches organizing patient data by a chronological feature index and searching for cohorts accordingly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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