DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 21-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites “determine whether the drug is authorized for said identified patient based on health plan eligibility data, and when authorized, said logic engines of said prospective drug access generator determine whether the drug is authorized based on: the authorization request received from the healthcare provider interface that includes the data that identifies the patient; respective health plan eligibility data associated with the patient identified in the authorization request, and the prospective drug access generator providing a unique authorization code with a relational link between said identified patient, said selected drug and said healthcare provider on the condition that the identified patient is authorized to receive the selected drug; wherein the determination is made prospectively before unique authorization code is produced and before the drug selected is dispensed”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “computing device” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computing device” language, determining and providing in the context of this claim encompasses the user manually making a determination.
For example, but for the “computing device” language, determining and providing in the context of this claim encompasses the user thinking that the result of the analysis. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a “computing device” to perform determining and providing. The “computing device” in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of processing data according to rules and displaying a result) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. Examiner notes that the features of steps A. and B. are directed to insignificant data gathering.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a “computing device” to perform both the steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
The dependent only further limit the same abstract idea claim or extra solution activity of the independent claim and do not therefore, in combination, recite significantly more than the abstract idea or provide a practical application of the abstract idea.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,977,702 and claims 1-20 of U.S. Patent 11,676,186. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a broader embodiment of the same invention.
Allowable Subject Matter
Claims 21-37 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 and resolution of the double patenting rejection set forth in this Office action.
Response to Arguments
Applicant's arguments filed 6/25/2025 have been fully considered but they are not persuasive. Applicant argues that the claims recite a variety of hardware and software components that perform interactions that cannot be performed by the human brain, in particular providing a health provider interface including a login interface with data input and review and an automated data processor in operative communication with one or more databases. However, these features are not part of the identified abstract idea (“determine whether the drug is authorized for said identified patient based on health plan eligibility data, and when authorized, said logic engines of said prospective drug access generator determine whether the drug is authorized based on: the authorization request received from the healthcare provider interface that includes the data that identifies the patient; respective health plan eligibility data associated with the patient identified in the authorization request, and the prospective drug access generator providing a unique authorization code with a relational link between said identified patient, said selected drug and said healthcare provider on the condition that the identified patient is authorized to receive the selected drug; wherein the determination is made prospectively before unique authorization code is produced and before the drug selected is dispensed”). Applicant argues that the human brain cannot determines whether the selected drug is authorized based on the request from the healthcare provider interface and health plan data or provide a unique authorization code with a relational link between said identified patient, said selected drug and said healthcare provider. However, the broadest reasonable interpretation of this limitation merely requires data identifying a patient and health plan data and then providing a unique code. Checking patient data against plan eligibility is a routine function in the medical field that predates the use of computers. Additionally, creating a string of characters that uniquely identify a patient or a patient record containing patient, drug, and health provider data also predate computers. Receiving and transmitting data and generic user interfaces are routine computing functions that are considered additional elements.
Applicant argues that the claims recite a technical solution to a technical problem. Applicant points to paragraph [0005] of the specification which discusses benefits of the invention particularly with respect to a feedback loop which tracks the corresponding drugs that were ordered and ultimately administered. This feature does not appear to be claimed. The feature of calculating utilization data merely creates a report that is stored. It does not provide a technical solution to a technical problem.
Applicant argues that the claims are directed to a practical application of the abstract idea. In particular that it provides new and previously unavailable functionality of conventional PBM systems. A new functionality is not a practical application of the abstract idea.
The rejections are therefore maintained.
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 Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Choi can be reached on 469-295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZA A LAM/Primary Examiner, Art Unit 3681
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