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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
In the submission dated 9/30/2025, to amendments were made.
Claims 1 – 20 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 – 20 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.
The claim(s) recite(s) subject matter within a statutory category as a process (claims 1 – 10), machine (claims 11 – 20), which recite the abstract idea steps of
Claim 1
obtaining a prior authorization question set including a plurality of questions including a first question;
parsing the plurality of questions including the first question in a prior authorization question set;
determining a question type associated with the first question;
associating the first question with the determined question type;
matching a set of user-associated data to the first question;
presenting a user interface to a user, wherein the user interface includes:
a first portion including the first question and
a second portion including the user-associated data matched to the first question; and
receiving user input associated with a selection from the user-associated data matched to the first question, the user input indicating that the selected user-associated data is responsive to the first question
Claim 11
obtain a prior authorization question set including a plurality of questions including a first question;
parse the plurality of questions including the first question in a prior authorization question set;
determine a question type associated with the first question;
associate the first question with the determined question type;
match a set of user-associated data to the first question;
present a user interface to a user, wherein the user interface includes:
a first portion including the first question and
a second portion including the user-associated data matched to the first question; and
receive user input associated with a selection from the user-associated data matched to the first question, the user input indicating that the selected user-associated data is responsive to the first question.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The claims, as a whole, are directed towards prescription creation. The invention is emphasized several times within the Specification including
BACKGROUND
[0003] Current processes for prescribing a medication (particularly a specialty medication) and the fulfillment of that prescription include many highly manual and inefficient steps. This negatively affects the experience of both medical doctors and their staff (MDOs) as well as their patients. One particular issue with fulfillment of prescribed medications is payor (e.g., insurance company) requirements for prior authorization before fulfilling the prescribed medications. Current procedures for receiving a prior authorization require several communications between MDOs, patients, and payor, manual data gathering, clinical reviews, and data entry steps.
SUMMARY
[0004] A system and method for obtaining prior authorization and fulfilling a prescription is described. One general aspect includes a computer-implemented method including: receiving, by a computing device, prescription information associated with a patient; collecting, by the computing device, medical information associated with the patient from an electronic health record of the patient; processing, by the computing device, a claim for the prescription and obtaining prior authorization for the claim; and packaging and delivering, by the computing device, the medication for which the prescription was received. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.
DETAILED DESCRIPTION
[0017] As set forth in detail below, the technology described herein provides an innovative approach to deliver a full-service experience for specialty medications, that relieves MDOs of administrative burden, improves patient delivery timeframes, improves clinical outcomes, and increases patient adherence and satisfaction. For example, the technology described herein provides a connection to an electronic health record associated with a patient which includes information that can be leveraged for identifying benefit information (e.g., insurance carrier, etc.) of the patient and automatically initiating submission of a claim and/or requesting a prior authorization (PA) for payment of the claim and/or facilitating pharmacist clinical review of the relevant patient medical information. The electronic health record system connection allows this to all be done with minimal to no manual intervention by the MDO staff and/or the patient. Additionally, the technology described herein provides for continuous monitoring of the process by the MDO and/or the patient.
The invention is directed toward applying technology to an abstract idea to achieve all the benefits of applying that technology to the abstract idea. As claimed and disclosed, there is no technological improvement to overcome a problem of technology. As claimed and disclosed, the result of the invention is data. That data has a potential application, filling a prescription, however there is no actual practical application.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 10 and 12 – 20, reciting particular aspects of how prescription creation may be performed but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of using one or more processors amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of obtaining… amounts to mere data gathering, recitation of determining… amounts to selecting a particular data source or type of data to be manipulated, recitation of presenting amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10 and 12 – 20, additional limitations which amount to invoking computers as a tool to perform 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. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 20; obtaining, parsing, determining, associating, matching, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii))
Additional elements
Network – paragraph 20 Internet
Computer including display, input device, processor, memory – paragraph 21
Electronic health record – paragraph 23
Machine learning – paragraph 40
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10 and 12 – 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, creating questions, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to Arguments
Applicant’s arguments, see Response to Rejections under 35 U.S.C. § 112, filed 9/30/2025, with respect to claims 2, 4, 5, 8, 9, 12, 14, 15, 18, and 19 have been fully considered and are persuasive. The Response to Rejections under 35 U.S.C. § 112 of claims 2, 4, 5, 8, 9, 12, 14, 15, 18, and 19 has been withdrawn.
Applicant's arguments filed 9/30/2025 have been fully considered but they are not persuasive.
The Applicant states, “Regarding the allegation that the "invention is emphasized several times within the Specification," the Applicant respectfully reminds the Office that it is claims that define the scope of the invention, and the claims are to be analyzed when determining whether the claims, as a whole, are directed to eligible, or ineligible, subject matter.” The Examiner is following the MPEP 2106(II) ESTABLISH BROADEST REASONABLE INTERPRETATION OF CLAIM AS A WHOLE (Emphasis added)
It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility. The BRI sets the boundaries of the coverage sought by the claim and will influence whether the claim seeks to cover subject matter that is beyond the four statutory categories or encompasses subject matter that falls within the exceptions. See MyMail, Ltd. v. ooVoo, LLC, 934 F.3d 1373, 1379, 2019 USPQ2d 305789 (Fed. Cir. 2019) (“Determining patent eligibility requires a full understanding of the basic character of the claimed subject matter”), citing Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1273-74, 103 USPQ2d 1425, 1430 (Fed. Cir. 2012); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc ), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010) (“claim construction … is an important first step in a § 101 analysis”). Evaluating eligibility based on the BRI also ensures that patent eligibility under 35 U.S.C. 101 does not depend simply on the draftsman’s art. Alice, 573 U.S. 208, 224, 110 USPQ2d at 1984, 1985 (citing Parker v. Flook, 437 U.S. 584, 593, 198 USPQ 193, 198 (1978) and Mayo, 566 U.S. at 72, 101 USPQ2d at 1966). See MPEP § 2111 for more information about determining the BRI.
Claim interpretation affects the evaluation of both criteria for eligibility. For example, in Mentor Graphics v. EVE-USA, Inc., 851 F.3d 1275, 112 USPQ2d 1120 (Fed. Cir. 2017), claim interpretation was crucial to the court’s determination that claims to a “machine-readable medium” were not to a statutory category. In Mentor Graphics, the court interpreted the claims in light of the specification, which expressly defined the medium as encompassing “any data storage device” including random-access memory and carrier waves. Although random-access memory and magnetic tape are statutory media, carrier waves are not because they are signals similar to the transitory, propagating signals held to be non-statutory in Nuijten. 851 F.3d at 1294, 112 USPQ2d at 1133 (citing In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007)). Accordingly, because the BRI of the claims covered both subject matter that falls within a statutory category (the random-access memory), as well as subject matter that does not (the carrier waves), the claims as a whole were not to a statutory category and thus failed the first criterion for eligibility.
The Applicant further states, “Thus, the Office's alleged abstract idea is uncoupled from the actual claim language, and the Office fails to establish that the independent claims are "directed to," a "prescription creation," as alleged.” The Examiner notes that the first line of the Abstract states, “A system and method for obtaining prior authorization and fulfilling a prescription is described.” The Applicant may narrowly define “creation” as the final step of creating a prescription or the entire creation process.
The Applicant states, “Therefore, the MPEP and US Supreme Court have made clear that "directed to" is more onerous standard than mere involvement of the alleged abstract idea.” The Examiner cannot find the Applicant’s solution with the Examiner’s guidance.
The Applicant states, “Moreover, the Applicant respectfully directs the Office's attention to paragraph [0036] of the Applicant's Specification, which states, in part that…” and continues, “The conventional prior authorization process is time consuming and typically conducted by phone, fax, email, text message. The techniques introduced herein advantageously provide for a semi- or fully-automated computer process with little or no human interaction, which provides faster turnaround time and less effort by MDOs.” And here the Applicant then proves the Examiner’s point. The invention regards the Certain Method of Organizing a Human Activity. The abstract idea is applied to technology via automation to achieve all the benefits of applying the abstract idea to technology.
The Applicant states, “Therefore, the pending claims should be analogized to those found patent eligible in McRO, as the claims recite how to automate, or semi-automate, a previously manual process.” However, McRO teaches that the inventive concept was a technological improvement as discussed within the Specification. The Specification does not have that technological improvement but rather, as stated above regarding additional elements, uses known technology. Further arguments to technological improvements, such as Core Wireless are considered moot. If the invention was directed towards a technological improvement then the Specification would state that the invention was directed towards a technological improvement.
The Applicant states, “Rather, the claims articulate "how" to semi, or fully, automate a previously manual task and describes an improved user interface. Accordingly, the claims are a practical application of any alleged abstract idea.” Here, the Examiner believes that the Applicant is arguing that the usage of technology to obtain the benefits of technology leads to a technological improvement and therefore a practical application. MPEP 2106.05(f) is probably applicable here because it discusses the idea of “Mere instructions to apply an exception.”
The Applicant states, “Therefore, (1) the Office fails to establish a prima facie case of subject matter ineligibility; (2) the claims are not directed to a judicial exception; and (3) even if the claims were determined to the directed to judicial exception (arguendo), the claims are a practical application and do not amount to mere instructions to "apply it;" and the claims are not well understood, routine, and conventional.” However, the Examiner has established a prima facie case; the Examiner believes that the claims are directed towards a judicial exception; the Examiner understands the claimed invention as a whole in light of the Specification to show that there is no practical application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Todhunter et al Pub. No.: US 2010/0235164 A question-answering system for searching exact answers in text documents provided in the electronic or digital form to questions formulated by user in the natural language is based on automatic semantic labeling of text documents and user questions.
Bugay et al Pub. No.: US 2017 /0017897 Methods and systems of providing related information to a source document are described
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 Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626