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 and 11 have been amended. Claims 21-38 were previously cancelled. Claims 1-20 and 39-40 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
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 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 11-20 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:
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;
consolidate, via 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, the one or more therapeutically equivalent alternative medications previously taken by the patient including date of last fill, a database comparing costs by a dispensed form of the one or more therapeutically equivalent alternative 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, and independently schedule the two or more queries of the query batch;
determine a copay amount, a patient savings and a total savings for each of the one or more therapeutically equivalent alternative medications based on the responses to the two or more queries of the query batch;
determine a composite rank score for each preexisting prescribed medication based at least in part on the therapeutically equivalent alternative medications, 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 11-20 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 3 and 13 recite wherein the instructions are further configured to cause the one or more processors to output, from an unpublished 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 reply data from prior users, further wherein the total savings includes the unpublished rebate amount for 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 the patient's clinical status, 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, Claims 10 and 20 recite wherein the instructions are further configured to cause the one or more processors to independently schedule the two or more queries of the query batch during periods of low network activity for each of the queried databases of the current medication database, clinical content database, payer formulary database, payer pharmacy claims database, and payer member eligibility database, 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 patients under the care of the prescriber, prescribing a new medications for the patient, changing a 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 1-20 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 1-20 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 "the configurable alternatives engine." There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the configurable alternatives engine” will be interpreted as “configurable alternatives engine.” Claims 2-10 and 39 are rejected as the depend from claim 1.
Claims 11 and its dependents, claims 12-20 and 40 are rejected for similar reasons.
As a result of the amendment to claim 1, claim 4 is also rejected for being indefinite as it is unclear if claim 4, reciting “using a configurable alternatives engine” is the same configurable alternatives engine as recited in claim 1. For purposes of examination, it will be interpreted as the same engine as recited in claim 1.
Claim 14 is rejected for similar reasons.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered.
Claim Rejection under 35 U.S.C. § 101
Applicant asserts that that claimed invention “solves an important technical problem - finding appropriate lower- cost medications for patients given their specific attributes and healthcare system considerations (Remarks, page 8).” Examiner maintains that this is a business problem particular to the field of healthcare. Applicant further asserts that the claims “uses non-generic processing and applies data transformation to improve the technical field of pharmacy benefits and cost” and that the “transformation performed by the claimed invention identifies alternative drugs, integrates payer rules, cost comparisons and pharmacist/provider preferences and customizations” and “goes beyond merely reporting or representing information (Remarks, page 9).” Pharmacy benefits and costs is not technical in nature. There is no apparent technical problem to be solved by the claimed invention.
Applicant asserts that “the transformation is not a process that can be performed by humans due to its complexity and lack of resources available to pharmacists (Remarks, page 9).” The claims are not categorized as a mental process, and therefore is argument is not persuasive as it is irrelevant.
Applicant asserts that “McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315 (Fed. Cir. 2016) supports patentability of claims involving automated technical results and transforming data in a way that humans cannot practically perform (Remarks, page 9).” The claims in McRO enabled “automatic lip synchronization and facial expression animation [that was] directed to an improvement in computer-related technology and not directed to an abstract idea. See MPEP § 2106.04(d)(1). The computers involved in the instant claims are not improved as a result of the abstract idea.
Therefore, the claims remain rejected as being directed towards ineligible subject matter.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached at (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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