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 .
Claims 1, 4, 7, 11 and 14 have been amended. Claims 3, 10, 13 and 20 are cancelled. Claims 21-38 were previously cancelled. Claims 1-2, 4-9, 11-12, 14-19 and 39-40 are pending.
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 1-2, 4-9, 11-12, 14-19 and 39-40 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.
Claims 1-10 and 39 are drawn to a system for changing a prescribed medication for a patient, which is within the four statutory categories (i.e. machine). Claims 11-19 and 40 are drawn to a method for changing a prescribed medication for a patient which is within the four statutory categories (i.e. process).
Claims 1-10 and 39 (Group I) recite a system for changing a prescribed medication for a patient, the system comprising:
one or more processors (apply it, MPEP § 2106.05(f)); and
a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to (apply it, MPEP § 2106.05(f)):
monitor, using a triggering engine (apply it, MPEP § 2106.05(f)), one or more databases to detect activity that would trigger an automated outreach;
determine alternative medications for the patient when triggered by the trigger engine by causing the one or more processors to (apply it, MPEP § 2106.05(f)):
identify one or more therapeutically equivalent alternative medications corresponding to one or more of the patient's preexisting prescribed medications based on a clinical equivalency of the alternative and preexisting prescribed medications;
build a query batch for two or more of: a current medication database, a clinical content database, a payer formulary database, a payer pharmacy claims database, a payer member eligibility database, and a provider group and National Provider Identifier (NPI) database;
queue and independently schedule the two or more queries of the query batch during periods of low network activity;
receive query results from the two or more queried databases;
execute a data matching and scoring module configured to identify, link, and organize the query results into a consolidated patient data file;
consolidate, using the consolidated patient data file and a configurable alternatives engine, the one or more therapeutically equivalent alternative medications with one or more of:
pharmacy benefit information for the patient,
a diagnosis,
therapeutically equivalent alternative medications previously taken by the patient including a date of last fill, and
a database comparing costs by dispensed form of the therapeutically equivalent alternative medications;
determine a copay amount, a patient savings and a total savings for each of the one or more therapeutically equivalent alternative medications based on consolidated patient data file;
determining, using a rebate estimation engine (apply it, MPEP § 2106.05(f)), an unpublished rebate amount for one or more of the therapeutically equivalent alternative medications, wherein the unpublished rebate amount is inferred from historical user feedback data and updated based on additional user feedback;
modify the total savings based on the rebate amount;
determine a composite rank score for each preexisting prescribed medication based at least in part on: the therapeutically equivalent alternative medications, the consolidated patient data file, and the unpublished rebate amount, wherein the composite rank score indicates a historic frequency of substitution of a preexisting prescribed medication with a lower cost therapeutically equivalent medication; and
output a list of a patient's preexisting prescribed medications ranked by the composite rank score; and
transmit the list of the patient's preexisting prescribed medications ranked by the composite rank score to a prescriber, the patient and/or a pharmacist.
The bolded limitations, given the broadest reasonable interpretation, a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 11-19 and 40 is identical as the abstract idea for Claims 1-10 and 39 (Group I), because the only difference between is they are directed towards different statutory categories.
Dependent Claims 2-10, 12-20 and 39-40 include other limitations, for example Claims 2 and 12 recite wherein the instructions are further configured to cause the one or more processors to request to change the prescribed medication to an alternative medication of the one or more therapeutically equivalent alternative medications, Claims 4 and 14 recite wherein the instructions are configured to cause the one or more processors to identify the one or more therapeutically equivalent alternative medications using the configurable alternatives engine (apply it, MPEP § 2106.05(f)), Claims 5 and 15 recite wherein the instructions are configured to cause the one or more processors to build the batch query using a data query and transfer engine (apply it, MPEP § 2106.05(f)), Claims 6 and 16 recite wherein the instructions are configured to cause the one or more processors to determine the composite rank score based at least in part on one or more of: a payer claim database, a drug formulary database, a payer rules database, a patient drug cost database, or a combination thereof, Claims 7 and 17 recite wherein the instructions are configured to cause the one or more processors to determine the composite rank score based on at least in part on: the one or more therapeutically equivalent alternative medications, the consolidated patient data file, and the unpublished rebate amount, Claims 8 and 18 recite wherein the list of a patient's preexisting prescribed medications comprises a drug savings report, Claims 9 and 19 recite wherein the instructions are further configured to cause the one or more processors to interactively sort the drug savings report, and Claims 39 and 40 recite wherein the activity that would trigger an automated outreach comprises a medication reconciliation, an appointment for the patient, scheduling a meeting between the pharmacist and the prescriber, an introduction of a new medical provider, adding a new prescriber, adding a new patient under the care of the prescriber, prescribing a new medication for the patient, changing payer formularies and/or a manual request for providing alternatives for one or more preexisting prescribed medications, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 11.
Furthermore, Claims 1-2, 4-9, 11-12, 14-19 and 39-40 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of one or more processors, a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to, a triggering engine, an unpublished rebate estimation engine, a configurable alternatives engine, and a data query and transfer engine, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0079], [0156-0158] of the present Specification, see MPEP 2106.05(f).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0079] and [0156-0158] of the Specification discloses that the additional elements (i.e. processor, memory and engines) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare).
Dependent Claims 2-10, 12-20 and 39-40 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims recite the additional elements already recited in the independent claims or further recite engines, which are recited at an “apply it” level.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-20 and 39-40 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-9, 11-12, 14-19 and 39-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “queue and independently schedule the two or more queries of the query batch during periods of low network activity.”
The term “low” in claim 1 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification ([0032], [0040], and [0045]) merely repeats the same phrase as the claim, “low network activity,” but fails to provide what the means. As “low” is a relative term and what is considered low one day may not be low another day, it renders the claim indefinite.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 09/17/2026 have been fully considered.
Claim Rejection under 35 U.S.C. § 101
Applicant asserts that that claimed invention “features reduce redundant database accesses, reduce repeated record-matching computations, improve resource utilization during multi-source data analysis, and permit automated ranking operations that could not be performed using the raw source data alone (Remarks, page 10).” Examiner maintains that the claims do not appear to be solving a technical problem as determining the lowest cost alternative medication is not a technical problem, but rather a business problem particular to healthcare.
Regarding the composite score, Applicant asserts that it “may involve large amounts of data traffic that may increase network (communication) traffic” and that in “some variations, the composite rank score may advantageously be determined during lower network traffic periods (e.g., off-peak times) to avoid network congestion (Remarks, page 10).” The additional elements themselves (i.e. computing devices/processors) are not improved as a result of this condition on when the analysis or retrieval is performed. Examiner maintains it is an improvement to the abstract idea itself.
Regarding the query batch scheduling, Applicant asserts that it “frees system resources to complete individual real time requests needed on a priority basis (Remarks, page 10).” Examiner maintains that this is an improvement to the abstract idea and does not improve any of the recited additional elements found in the claims (one or more processors, a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to, a triggering engine, an unpublished rebate estimation engine, a configurable alternatives engine, and a data query and transfer engine).
Regarding the unified patient file, Applicant asserts that “[a]ssembling DSR data may involve the challenge of matching data from multiple platforms and sources into a unified patient data file” and that “he system may utilize a dynamic matching logic that is able to identify, link, and organize these multiple data sources into a unified data file (Remarks, page 11).” Assembling the results of the analysis into a drug savings report is part of the abstract idea and does not result in a technical improvement.
Regarding the unpublished rebate estimation engine, Applicant asserts that it provides a “technical solution to this problem using an unpublished rebate estimation engine.” However, Examiner maintains that obtaining the data from the unpublished rebate engine to analyze is part of the abstract idea.
Applicant argues that “the architecture of the system and alternative medication and savings determination is a non-conventional arrangement of elements, including batched queries based on optimizing system resources to give priority to individual real time requests, a unified patient data file that consolidates multiple data sources from underlying repositories, and an unpublished rebate estimation engine (Remarks, page 12).” Examiner maintains that these limitations are part of the abstract idea and do not result in a non-conventional arrangement of elements as alleged by Applicant.
Therefore, the claims remain rejected as being directed towards ineligible subject matter.
Claim Rejection under 35 U.S.C. § 112
The previous section 112 rejection has been withdrawn in view of the amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
