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 .
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites an electronic prescription processing system performing the limitations of:
a multi-path clearinghouse comprising […], the multi-path clearinghouse is electronically disposed between a plurality of physician office practice management [… locations …] and at least one pharmacy [… location …], such that the electronic prescription is [… provided …] from one of the plurality of physician office practice one management [… locations …] by the multi-path clearinghouse to the at least one pharmacy [… location …] and the at least one pharmacy [… location …] [… obtains …]the electronic prescription and initiates a query about the electronic prescription that is [… provided …] back to the multi-path clearinghouse,[…] transfer the query to the one of the physician office practice management [… locations …] that initiated the electronic prescription, electronically, to the resolve the query about the electronic prescription, and the multi-path clearinghouse automatically correlates an answer [… providing …] the answer to the at least one pharmacy [… location …] that initiated the query and updating a database of the at least one pharmacy [… location …] that initiated the query with the answer to the query such that a [… output …] of the at least one pharmacy system [… provides …] the answer to the query initiated by the at least one pharmacy [… location …].
, as drafted, is a system, which under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions). That is, by a human user interacting with a reply server comprising memory and a processor and various systems with a display, the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. For example, but for a reply server comprising memory and a processor and various systems with a display, the claim encompasses using a clearinghouse to organize data for human activity between various pharmacies and healthcare providers for prescription processing. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” 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 recites the additional elements of a reply server comprising memory and a processor and various systems with a display which implements the abstract idea. The reply server comprising memory and a processor and various systems with a display are recited at a high-level of generality (i.e., a general-purpose computers/ computer component implementing generic computer functions; see Applicant’s Specification Figure 5, paragraphs [0055]-0056]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these 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.
The claim recites the additional elements of “transmitted… receives… transmitting…” and “a display… shows”. The “transmitted… receives… transmitting…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. The “a display… shows” steps are recited at a high level of generality (i.e., simply outputting data on a generic display for a user) and amounts to simply output of data, which is a form of extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
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 elements of a reply server comprising memory and a processor and various systems with a display, to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “transmitted… receives… transmitting…” and “a display… shows” were considered extra-solution activity and/or generally linking to a particular technological environment. The “transmitted… receives… transmitting…” has been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.0S(d)(II)(i) "Receiving or transmitting data over a network" is well-understood, routine, and conventional. The “a display… shows” has been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Brock-Fisher (20050086081): see below but at least Fig. 5, paragraph [0056]; Brushwood (20080201171): Fig. 12-32; Kost (20060161453): paragraphs [0108]-[0109]; displaying data on a user interface is well-understood, routine and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 2-20 are similarly rejected because either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible.
Claim 2 recites using a unique identifier and matching of data, but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claim 3 further describes accessing a database, however transmission of data was already considered and is incorporated herein.
Claims 4-8 further describe providing of notifications, however transmission of data was already considered and is incorporated herein.
Claim 9-10 recites verification of a user, but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claim 11 describes using batched data, but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claims 12 recites the additional element of a biometric data reader, however this is recited at a high level of generality (i.e., as a generic sample capturing device) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a biometric data reader was considered generally linking the abstract idea to a particular technological environment. This has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Brushwood (20080201171): paragraph [0052]; Green (20110258002): paragraph [0052]; use of biometric reader is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 13-16 recite the additional element of an interface system comprising a data input device and editing device, however these are recited at a high-level of generality (i.e., a general-purpose computers/ computer component implementing generic computer functions; see Applicant’s Specification Figure 5, paragraphs [0055]-0056]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these 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.
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 elements of an interface system comprising a data input device and editing device, to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Claim 17 further describes the pharmacy system already considered above and incorporated herein.
Claims 18-20 describe providing a user insurance notifications, but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 9, 11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20050086081 (hereafter “Brock-Fisher”), in view of U.S. Patent Pub. No. 20040059600 (hereafter “Ball”).
Regarding claim 1, Brock-Fisher teaches an electronic prescription processing system for an electronic prescription (Brock-Fisher: Figure 1, paragraph [0007], “a system and method for an electronic system for the prescribing and dispensing of drug prescriptions”) comprises:
a multi-path clearinghouse comprising a reply server, the reply server comprises a data memory and a processor (Brock-Fisher: Figures 1, 6, paragraph [0009], “clearinghouse subsystem that is responsible for authenticating requests as having come from a certified, licensed, or otherwise qualified source, and redirecting the prescriptions electronically to a specified drug provider or to a provider chosen by the clearinghouse system”, paragraph [0057], “The clearinghouse subsystem is accessed via a network interface 104 to a network 160, such as the Internet, in a preferred embodiment. New and renewal prescription requests are decrypted and processed by the control processor 107, the control processor accesses clearinghouse databases 141 to determine if the requested prescription or renewal is allowed by any insurance carried by the patient, and stores the resulting authorization or denial in appropriate clearinghouse databases 141 while informing the prescriber and patient via encrypted transmissions”. The Examiner notes this functions as a reply server and teaches what is required under the broadest reasonable interpretation),
the multi-path clearinghouse is electronically disposed between a plurality of physician office practice management systems and at least one pharmacy system, such that the electronic prescription is transmitted from one of the plurality of physician office practice one management systems by the multi-path clearinghouse to the at least one pharmacy system and the at least one pharmacy system receives the electronic prescription and initiates a query about the electronic prescription that is transmitted back to the multi-path clearinghouse (Brock-Fisher: Figure 1, paragraphs [0010]-[0011], “a drug provider subsystem specifically utilizing a network, such as the Internet, for receiving and filling/refilling/renewing/modifying prescriptions cleared by the clearinghouse… A prescriber or patient/caregiver enters the new or refill or renewal request for a drug prescription into a prescription entry subsystem… is then electronically transmitted to an authenticating clearinghouse subsystem… Once entered, information is transmitted to the clearing house subsystem or directly to a drug provider subsystem and once validated is forwarded to a drug provider subsystem”. The Examiner notes that “such that the electronic prescription is transmitted… and the at least one pharmacy system receives…” is an intended use of the multi-path clearinghouse that is not required to occur. This feature has been fully considered by the Examiner; however, the limitation does not provide patentable distinction over the cited prior art because it is an intended use or result of the multi-path clearinghouse),
wherein the processor of the reply server is configured to transfer the query to the one of the physician office practice management systems that initiated the electronic prescription, electronically, […], and the multi-path clearinghouse automatically [… responds …] (Brock-Fisher: Figure 1, paragraph [0011], “Once entered, information is transmitted to the clearing house subsystem or directly to a drug provider subsystem and once validated is forwarded to a drug provider subsystem”, paragraph [0027], “A networked electronic prescription entry application running on a computer based prescription entry system at a prescriber's location, e.g., doctor's office, that can optionally authorize a drug prescription by a patient's insurer (if any) and forwards the drug prescription to a clearinghouse subsystem”, claim 17, “validation by the clearinghouse subsystem of the drug requester and the drug provider and provided responses”) and
updating a database of the at least one pharmacy system that initiated the query with the answer to the query such that a display of the at least one pharmacy system shows the answer to the query initiated by the at least one pharmacy system (Brock-Fisher: Figure 1, paragraphs [0040]-[0042], “receiving and decrypting update data from clearinghouse subsystem… updating appropriate prescription entry subsystem databases 414 with the received update data”, claim 2, “user interface for entering data, displaying a response, and informing”. The Examiner notes that “such that a display of the at least one pharmacy system shows the answer” is an intended use of the updating of a database that is not required to occur. This feature has been fully considered by the Examiner; however, the limitation does not provide patentable distinction over the cited prior art because it is an intended use or result of the updating of a database).
Brock-Fisher may not explicitly teach (underlined below for clarity):
wherein the processor of the reply server is configured to transfer the query to the one of the physician office practice management systems that initiated the electronic prescription, electronically, to the resolve the query about the electronic prescription, and the multi-path clearinghouse automatically correlates an answer to the reply server, transmitting the answer to the at least one pharmacy system that initiated the query and updating a database of the at least one pharmacy system that initiated the query with the answer to the query such that a display of the at least one pharmacy system shows the answer to the query initiated by the at least one pharmacy system.
Ball teaches wherein the processor of the reply server is configured to transfer the query to the one of the physician office practice management systems that initiated the electronic prescription, electronically, to the resolve the query about the electronic prescription, and the multi-path clearinghouse automatically correlates an answer to the reply server, transmitting the answer to the at least one pharmacy system that initiated the query and updating a database of the at least one pharmacy system that initiated the query with the answer to the query such that a display of the at least one pharmacy system shows the answer to the query initiated by the at least one pharmacy system (Ball: Figures 1-6, paragraphs [0028]-[0035], “The exemplary operating environment encompasses a pharmacy point-of-service ("POS") device 102, a host server 104 and a payer system 108… The pharmacy POS device 102 may be configured for receiving prescription claim data, creating prescription transactions therefrom and transmitting said prescription transactions to the host server 104… the host server 104 may serve as a clearinghouse for multiple payer systems… the host server 104 parses prescription claim transactions and forwards them to the appropriate payer system 108 for processing. Approval, authorization or rejection messages may be returned to the host server 104 from the payer systems 108 and such messages may be forwarded by the host server 104 to the pharmacy POS device 102”).
One of ordinary skill in the art before the effective filing date would have found it using the clearinghouse to resolve answers as taught by Ball within the clearinghouse for resolving prescriptions as taught by Brock-Fisher with the motivation of “improving the sensitivity and specificity of the above-described LASA medication error screening processes” (Ball: paragraph [0100]).
Regarding claim 2, Brock-Fisher and Ball teach the limitations of claim 1, and further teach wherein the reply server correlates the query by assigning the query a unique identifier embedded within the query and the answer, wherein the reply server matches the unique identifier within the answer to the unique identifier of the query (Brock-Fisher: paragraphs [0034]-[0038], “records identified by prescription ID storing prescription details”; Ball: paragraph [0021], “Drug products are commonly identified by a unique identifier”, paragraph [0054], “Prescription Matching involves identifying all prescriptions claims having the same date of service and prescription number from the same pharmacy”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 3, Brock-Fisher and Ball teach the limitations of claim 1, and further teach wherein the multi-path clearinghouse accesses information from a drug file database providing the one of the plurality of physician office management systems access to drug inventory and prices (Brock-Fisher: Fig. 1-4, paragraph [0005], “cost or low usage of the drug”, paragraph [0104], “The drug provider subsystem may perform auditing or inventorying functions”, Ball: Figure 1, paragraph [0032], “price comparisons, average wholesale price ("AWP") edits”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 4, Brock-Fisher and Ball teach the limitations of claim 3, and further teach wherein the multi-path clearinghouse automatically notifies a prescriber of an alternative drug and allows the prescriber to substitute the alternative drug prior to submitting the electronic prescription to the at least one pharmacy system (Brock-Fisher: Fig. 1-4, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 5, Brock-Fisher and Ball teach the limitations of claim 4, and further teach wherein the multi-path clearinghouse automatically notifies the prescriber of a generic equivalent available at the at least one pharmacy prior to submitting the electronic prescription (Brock-Fisher: Fig. 1-4, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 9, Brock-Fisher and Ball teach the limitations of claim 1, and further teach wherein the multi-path clearinghouse verifies the identity and authority of the prescriber to enter the electronic prescription using an electronic signature, biometric data, a password or a combination thereof prior to submitting the electronic prescription to the at least one pharmacy system (Brock-Fisher: paragraph [0012], “Only authorized user is permitted to access the data and protections, such as passwords”, paragraph [0031], “a clearinghouse subsystem 140 for authentication and authorization or directly to a drug provider subsystem 120, for decryption, authentication and dispensing”, paragraph [0056], “To protect patients' privacy all transmissions to and from the handheld device are encrypted and access to patient records is secured, e.g., by a prescriber key such as a password”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 11, Brock-Fisher and Ball teach the limitations of claim 1, and further teach wherein the reply server connects to the one of the plurality of physician office management systems which initiated the electronic prescription and provides a utility for answering the query initiated by the at least one pharmacy system in a batch mode, and the reply server directs the answer to the query to the respective one of the at least one pharmacy system that initiated the query along a path separate from other answers contained within the batch mode response (Ball: Fig. 1-6, paragraph [0031], “Prescription claim transactions may be transmitted from the pharmacy POS device 102 to the host server 104 in batch, real-time or near real-time. In certain embodiments, the host server 104 may serve as a clearinghouse for multiple payer systems 108… In its capacity as a clearinghouse, the host server 104 parses prescription claim transactions and forwards them to the appropriate payer system 108 for processing. Approval, authorization or rejection messages may be returned to the host server 104 from the payer systems 108 and such messages may be forwarded by the host server 104 to the pharmacy POS device 102”. The Examiner notes claims are processed in batches and return messages are individually returned as necessitated and teaches what is required of the claim under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 13, Brock-Fisher and Ball teach the limitations of claim 1, and further teach further comprising an interface system coupled to at least one of the plurality of physician office management systems such that the interface system couples the at least one of the plurality of physician office management systems to the multi-path clearinghouse, wherein two-way communications are established between the interface system and the multi-path clearinghouse by at least two separate paths correlated automatically by the reply server (Brock-Fisher: Fig. 1-6, paragraph [0032], “control processor 107 authenticates the prescriber, stores the captured data in prescriber databases 101, encrypts the prescription and either transmits the encrypted prescription via the network interface 104 over the network 160 (e.g., the Internet) to a clearinghouse system 140 or directly to a drug provider system 120”, paragraph [0109], “email or other notification (voice mail, fax, telephone call)”, claim 7, “network comprises at least one of a wireless network, an intranet (local area network) and an internet (wide area network)”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 14, Brock-Fisher and Ball teach the limitations of claim 13, and further teach wherein the interface system comprises a data input device coupled to a database, an editing device and a display showing fields of the databased populated by information provided by the electronic prescription (Brock-Fisher: Fig. 1-5, paragraph [0056], “displayed on a handheld device… a digest of the pertinent information is displayed that is particularized to each record displayed”; Ball: Fig. 1-4, paragraph [0034], “I/O interface(s) 114 facilitate communication between the processor 110 and various I/O devices, such as a keyboard, mouse, printer, microphone, speaker, monitor, etc.”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 15, Brock-Fisher and Ball teach the limitations of claim 14, and further teach wherein the data input device comprises a keyboard, a voice recognition system, a pointing device, a touch screen, a bar code reader, a scanner or a combination thereof (Brock-Fisher: Fig. 1-5, paragraph [0056], “displayed on a handheld device… a digest of the pertinent information is displayed that is particularized to each record displayed”; Ball: Fig. 1-4, paragraph [0034], “I/O interface(s) 114 facilitate communication between the processor 110 and various I/O devices, such as a keyboard, mouse, printer, microphone, speaker, monitor, etc.”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 16, Brock-Fisher and Ball teach the limitations of claim 15, and further teach wherein the data input device includes both a keyboard and a pointing device (Brock-Fisher: Fig. 1-5, paragraph [0056], “displayed on a handheld device… a digest of the pertinent information is displayed that is particularized to each record displayed”; Ball: Fig. 1-4, paragraph [0034], “I/O interface(s) 114 facilitate communication between the processor 110 and various I/O devices, such as a keyboard, mouse, printer, microphone, speaker, monitor, etc.”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 17, Brock-Fisher and Ball teach the limitations of claim 1, and further teach wherein the at least one pharmacy system is a plurality of pharmacy systems, independent from one another, and each of the plurality of pharmacy systems are electronically coupled to the multi-path clearinghouse electronically (Brock-Fisher: Figure 1, paragraphs [0010]-[0011], “a drug provider subsystem specifically utilizing a network, such as the Internet, for receiving and filling/refilling/renewing/modifying prescriptions cleared by the clearinghouse… A prescriber or patient/caregiver enters the new or refill or renewal request for a drug prescription into a prescription entry subsystem… is then electronically transmitted to an authenticating clearinghouse subsystem… Once entered, information is transmitted to the clearing house subsystem or directly to a drug provider subsystem and once validated is forwarded to a drug provider subsystem”, paragraph [0050], “a drug provider, such as a pharmacy”. As seen in at least Fig. 1, a plurality of pharmacy systems independent of one another is taught).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 18, Brock-Fisher and Ball teach the limitations of claim 17, and further teach wherein the multi-path clearinghouse is coupled to at least one insurance formulary, and the prescriber is notified, automatically if a drug prescribed by the electronic prescription is not included in the at least one insurance formulary prior to submitting the electronic prescription (Brock-Fisher: Fig. 1-4, paragraph [0003], “need to contact the patient's insurance carrier to obtain authorization because the particular drug is not on the carrier's formulary or the amount exceeds coverage limits”, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 19, Brock-Fisher and Ball teach the limitations of claim 18, and further teach wherein the multi-path clearinghouse notifies the prescriber of at least one alternative drug included in the at least one insurance formulary as an acceptable substitute for the drug prescribed by the prescriber, and the multi-path clearinghouse provides a utility for selecting the at least one alternative drug prior to submitting the electronic prescription to one of the plurality of pharmacy systems (Brock-Fisher: Fig. 1-4, paragraph [0003], “need to contact the patient's insurance carrier to obtain authorization because the particular drug is not on the carrier's formulary or the amount exceeds coverage limits”, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 20, Brock-Fisher and Ball teach the limitations of claim 19, and further teach wherein the multi-path clearinghouse provides the prescriber with a utility for selecting one of the plurality of pharmacy systems based on availability of the acceptable substitute (Brock-Fisher: Fig. 1-4, paragraphs [0003]-[0004], “need to contact the patient's insurance carrier to obtain authorization because the particular drug is not on the carrier's formulary or the amount exceeds coverage limits… ascertain whether a drug is even available at the drug provider to be delivered to a patient/caregiver… the patient/caregiver is directed to another drug provider”, paragraph [0011], “the drug prescription is first checked for adverse interactions with other drugs being taken by a patient, for availability from a drug provider subsystem”, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”, paragraphs [0104]-[0108], “The drug provider subsystem may perform auditing or inventorying functions based on prescription requests filled. The new/renewal requests may be directly transmitted to a drug provider subsystem… generates feedback to the drug prescriber in real time, such feedback provided within a pre-determined time and comprising: availability/out-of-stock status of particular drugs… insurance reimbursement information about different drugs/generics”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”).
The motivation to combine is the same as in claim 1, incorporated herein.
Claim(s) 6-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20050086081 (hereafter “Brock-Fisher”) and U.S. Patent Pub. No. 20040059600 (hereafter “Ball”) as applied to claim 1 above, and further in view of U.S. Patent Pub. No. 20080201171 (hereafter “Brushwood”).
Regarding claim 6, Brock-Fisher and Ball teach the limitations of claim 3, and further teach wherein the multi-path clearinghouse automatically provides notification to the prescriber of a […] drug (Brock-Fisher: Fig. 1-4, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”).
Brock-Fisher and Ball may not explicitly teach (underlined below for clarity):
wherein the multi-path clearinghouse automatically provides notification to the prescriber of a recalled drug.
Brushwood teaches wherein the multi-path clearinghouse automatically provides notification to the prescriber of a recalled drug (Brushwood: Fig. 1-5, paragraph [0005], “notifying affected personnel in the event of a pharmaceutical event such as a recall”, paragraphs [0056]-[0057], “the drug sample data may also be validated 166 for any errors in the data entry process. This validation process may be used to identify typographical errors in the data entry process or to validate that the sample 50 is one which the medical office is configured to dispense. If the sample 50 is subject to a recall or has expired… a notification flag or alarm may be generated to initiate removing the expired or recalled drug sample 156”).
One of ordinary skill in the art before the effective filing fate would have found it obvious to notify of recalled drugs as taught by Brushwood with the providing of notifications for drug prescriptions as taught by Brock-Fisher and Ball with the motivation of “reducing errors in the delivery and dispensing process while allowing for prompt and systematic notification” (Brushwood: paragraph [0007]).
Regarding claim 7, Brock-Fisher, Ball and Brushwood teach the limitations of claim 6, and further teach wherein the multi-path clearinghouse automatically provides at least one acceptable alternative to the recalled drug prior to submitting the electronic prescription (Brock-Fisher: Fig. 1-4, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”; Brushwood: paragraphs [0056]-[0057], “If the sample 50 is subject to a recall or has expired… a notification flag or alarm may be generated to initiate removing the expired or recalled drug sample 156”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 8, Brock-Fisher, Ball and Brushwood teach the limitations of claim 7, and further teach wherein the multi-path clearinghouse provides the prescriber an opportunity to substitute the at least one acceptable alternative of the recalled drug, electronically, in response to a query transmitted and correlates an answer to the query prior to submitting the electronic prescription (Brock-Fisher: Fig. 1-4, paragraph [0048], “the prescription entry subsystem displays patient use and sensitivities, drug interactions with other drugs being used by patient, drug characteristics, drug sources, generics for the drug, and substitutes for the drug 404”; Ball: Fig. 1-4, paragraph [0006], “alert systems are used to alert pharmacists of potential LASA errors. Such systems generate a warning message”, paragraph [0020], “The systems and methods of the present invention monitor prescription transactions and return appropriate messages to pharmacists or other health care providers when the characteristics of a prescription transaction indicate the possibility that a different medication, different dispense quantity or different daily supply is more appropriate”; Brushwood: paragraphs [0056]-[0057], “If the sample 50 is subject to a recall or has expired… a notification flag or alarm may be generated to initiate removing the expired or recalled drug sample 156”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding claim 12, Brock-Fisher and Ball teach the limitations of claim 1, but may not explicitly teach further comprising a biometric data reader, wherein the biometric data reader captures biometric data of a prescriber, and the electronic prescription processing system uses the biometric data of the prescriber to authenticate the electronic prescription and any change to the electronic prescription authorized by the prescriber associated with the biometric data.
Brushwood teaches a biometric data reader, wherein the biometric data reader captures biometric data of a prescriber, and the electronic prescription processing system uses the biometric data of the prescriber to authenticate the electronic prescription and any change to the electronic prescription authorized by the prescriber associated with the biometric data (Brushwood: Fig. 1-6, paragraph [0052], “The user accounts may also be configured with secured access, requiring the user to provide login credentials, or optionally use biometrics such as fingerprint, hand print or other user identifying credentials”, paragraph [0064], “sign-in using the attached biometrics scanner”).
The motivation to combine is the same as in claim 6, incorporated herein.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20050086081 (hereafter “Brock-Fisher”) and U.S. Patent Pub. No. 20040059600 (hereafter “Ball”) as applied to claim 1 above, and further in view of U.S. Patent Pub. No. 20060161453 (hereafter “Kost”).
Regarding claim 10, Brock-Fisher and Ball teach the limitations of claim 9, but may not explicitly teach wherein the clearinghouse verifies the identity and authority of the prescriber to enter the electronic prescription using an electronic signature.
Brock-Fisher and Ball may not explicitly teach (underlined below for clarity):
wherein the clearinghouse verifies the identity and authority of the prescriber to enter the electronic prescription using an electronic signature.
Kost teaches wherein the clearinghouse verifies the identity and authority of the prescriber to enter the electronic prescription using an electronic signature (Kost: paragraph [0018], “the User ID and password are the electronic signature of the prescriber”, paragraph [0078], “A claim is entered into the computer system at the pharmacy 215, and a clearinghouse, such as a pharmacy benefit manager, approves the claim”).
One of ordinary skill in the art before the effective filing fate would have found it obvious to use an electronic signature as taught by Kost with the providing of verification for drug prescriptions as taught by Brock-Fisher and Ball with the motivation of “Accuracy of the authentication may be improved” (Kost: paragraph [0016]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Pub. No. 20110258002 (hereafter “Green”) teaches automated prescription management using a clearinghouse
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/A.E.L./Examiner, Art Unit 3684 /RAJESH KHATTAR/Primary Examiner, Art Unit 3684
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