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 .
Notice to Applicant
This communication is in response to the amendment filed 09-16/2026. Claims 1-2, 9, 13-14 have been amended. Claims 7-8 have been canceled. Claims 1-6, 9-15 are presented for examination.
Page 10 of the “Remarks” states, “Claims 1-20 are currently pending in this application, of which claims 1 and 10-12 are independent. Claims 1-5 and 7-20 are amended.” However, this seems to be an error because claims 1-6, 9-15 are currently pending in this application, of which claims 1, 9, 13 are independent. For purposes of compact prosecution, claims 1-6, 9-15 are currently pending in this application.
Subject Matter Free of Prior Art
Claim(s) 1-6, 9-15 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, wherein the bit string for each event of the current step patients indicates whether criteria of each step have been satisfied from the initial step up to the current step and is updated by updating a digit assigned to the current step; sequentially generating a history table for each step to generate a sequence of history tables, 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 for each of all events of the current step patient included in the first history table, in a second history table, wherein the updated bit string indicates whether criteria of each step have been satisfied from the initial step up to the current step and is updated by updating a digit assigned to the current step; 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; storing the second history table as a history table of the current step to generate a sequence of history tables,” 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 2-6, 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.
Claims 1-6, 9-15 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 non-transitory 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…; 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, wherein the bit string for each event of the current step patients indicates whether criteria of each step have been satisfied from the initial step up to the current step and is updated by updating a digit assigned to the current step; sequentially generating a history table for each step to generate a sequence of history tables, and then generating a cohort table by using a history table of a final step; obtaining changed criteria of a specific step; retrieving a just previous step history table generated in a just previous step of the specific step; identifying, among patients included in the just previous step history table, specific step patients having events corresponding to the changed criteria of the specific step; updating a bit string for each event of the specific step patients included in the just previous step history table by updating a bit assigned to the specific step; regenerating a history table of the specific step by adding new events extracted by querying the clinical data…only for the changed criteria of the specific step; and sequentially regenerating a history table of a step after the specific step by using the regenerated history table of the specific step.
Independent claim 9 recites… obtaining criteria of a current step; 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 for each of all events of the current step patient included in the first history table, in a second history table, wherein the updated bit string indicates whether criteria of each step have been satisfied from the initial step up to the current step and is updated by updating a digit assigned to the current step; 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; storing the second history table as a history table of the current step to generate a sequence of history tables; obtaining changed criteria of a specific step; retrieving a third history table generated in a just previous step of the specific step from the sequence of history tables; identifying, among patients included in the third history table, specific step patients having events corresponding to the changed criteria of the specific step; updating a bit string for each event of the specific step patients included in the just previous step history table by updating a bit assigned to the specific step; regenerating a history table of the specific step by adding new events extracted by querying a clinical data…only for the changed criteria of the specific step; and sequentially regenerating a history table of a step after the specific step by using the regenerated history table of the specific 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 non-transitory computer-readable storage medium and comprising instructions; at least one processor; a clinical data warehouse). Looking to the specifications, a computing system having a computer program stored in a non-transitory computer-readable storage medium and comprising instructions; 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 instructions; 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 2-6, 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 2-6, 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.
Response to Arguments
Applicant's arguments filed 09/16/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 09/16/2026.
In the remarks, Applicant argues in substance that:
Regarding the 101 rejections,
“The specification describes a specific technological problem inherent in conventional cohort extraction systems…it utilizes a specific, unconventional data structure, namely, a sequence of history tables generated for a plurality of steps where whether each event satisfies criteria of each step is tracked using a bit string. This specialized data structure provides a specific technical improvement to the manner in which the cohort extracting apparatus stores, indexes, and retrieves data…a specific improvement to the functioning of the database system itself by reducing the volume of data queried from the history table, eliminating repeated extraction operations, and significantly improving processing speed…This also improves the functioning of the database system itself by reducing the volume of data queried from the clinical data warehouse and improving the speed with which the cohort table is generated…claim 1 is directed to a specific technological solution that solves the recognized problems in the database retrieval operations and provides the specific improvement to the functioning of the database system itself.”
It is respectfully submitted that Examiner has considered Applicant’s arguments and does not find them persuasive. Examiner has attempted to address all of the arguments presented by Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
In response to Applicant’s argument that (a) regarding the 101 rejections,
“The specification describes a specific technological problem inherent in conventional cohort extraction systems…it utilizes a specific, unconventional data structure, namely, a sequence of history tables generated for a plurality of steps where whether each event satisfies criteria of each step is tracked using a bit string. This specialized data structure provides a specific technical improvement to the manner in which the cohort extracting apparatus stores, indexes, and retrieves data…a specific improvement to the functioning of the database system itself by reducing the volume of data queried from the history table, eliminating repeated extraction operations, and significantly improving processing speed…This also improves the functioning of the database system itself by reducing the volume of data queried from the clinical data warehouse and improving the speed with which the cohort table is generated…claim 1 is directed to a specific technological solution that solves the recognized problems in the database retrieval operations and provides the specific improvement to the functioning of the database system itself”:
It is respectfully submitted that Applicant argues “a specific technological problem inherent in conventional cohort extraction systems.” However, “cohort extraction” addresses administrative problems, which is described as human activity performed by a “researcher” on page 3 of the specification, and not a technical problem to any specific devices, technology, or computers for that matter, and thus, the claims do not provide a technical solution. For example, the computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined. Even if the claims provide the alleged improvements, any alleged benefits of the invention are at best, an improvement to the abstract idea of rules or instructions to collect data, analyze the data, and provide an output based on the analysis accordingly. However, an improved abstract idea is still an abstract idea and the claims do not provide a technical improvement.
Applicant argues “a specific, unconventional data structure, namely, a sequence of history tables generated for a plurality of steps where whether each event satisfies criteria of each step is tracked using a bit string.” However, the claim limitations to which Applicant refer as providing the alleged improvements (i.e., “a specific, unconventional data structure, namely, a sequence of history tables generated for a plurality of steps where whether each event satisfies criteria of each step is tracked using a bit string”) are interpreted as part of the 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 in the manner described in the identified abstract idea, supra, which is the abstract idea and not additional elements to be interpreted in Step 2A, Prong Two. As stated previously above, even if the claims provide the alleged improvements, any alleged benefits of the invention are at best, an improvement to the abstract idea of rules or instructions to collect data, analyze the data, and provide an output based on the analysis accordingly. However, an improved abstract idea is still an abstract idea and the claims do not provide a technical improvement.
Applicant argues “a specific improvement to the functioning of the database system itself by reducing the volume of data queried from the history table, eliminating repeated extraction operations, and significantly improving processing speed…This also improves the functioning of the database system itself by reducing the volume of data queried from the clinical data warehouse and improving the speed with which the cohort table is generated…claim 1 is directed to a specific technological solution that solves the recognized problems in the database retrieval operations and provides the specific improvement to the functioning of the database system itself.” However, “reducing the volume of data queried from the history table, eliminating repeated extraction operations” and “improving the speed with which the cohort table is generated” addresses administrative problems of cohort extraction, which is described as human activity performed by a “researcher” on page 3 of the specification, and not a technical problem to any specific devices, technology (i.e., databases), or computers for that matter, and thus, the claims do not provide a technical solution. Even if the claims provide the alleged improvements, any alleged benefits of the invention are at best, an improvement to the abstract idea of rules or instructions to collect data, analyze the data, and provide an output based on the analysis accordingly. However, an improved abstract idea is still an abstract idea and the claims do not provide a technical improvement.
Examiner cannot find any problem caused by the technological environment to which the claims are confined, which per broadest reasonable interpretation of the claim in light of the specification, is a well-known, general purpose computer. The computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined. While the specification need not explicitly set forth the improvement, the disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing any technical improvement or any physical improvement to the computer. See MPEP § 2106.04(d)(1) and 2106.05(a).
Thus, the claim as a whole does not integrate the recited judicial exception into a practical application or amount to significantly more than the judicial exception.
Thus, Examiner maintains the 101 rejections of claims 1-6, 9-15, which have been updated to address Applicant’s remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance and the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence in the above Office Action.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
