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 .
Status of Claims
This action is in reply to an application filed on 02/12/2025. Claims 1-13 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 recites “A computer-readable medium storing instructions that, when executed by a processor, cause a system to perform the method of claim 7“. When, as here, an independent claim recites a particular method, a dependent claim drawn to a computer-readable medium capable of performing the method of the independent claim is not a proper dependent claim, since the dependent claim could conceivably be infringed by mere possession of the computer program on a computer-readable medium without performing any particular method steps at all, thereby infringing the dependent claim without necessarily infringing the independent claim, in violation of the infringement test for proper dependency of claims. See MPEP § 608.01(n)(III). Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-13 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), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept — i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a system and method which is included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea (based on claim 7) of:
A method for real-time pharmacy inventory synchronization and prescriber-pharmacist communication, comprising: a. receiving pharmacy inventory data; b. processing and standardizing the received inventory data; c. updating real-time or near real-time inventory records to reflect stock availability; d. enabling prescribers to query said inventory records to determine medication availability before issuing prescriptions; e. providing prescribers with a list of pharmacies where the prescribed medication is in stock, based on real-time inventory data; and f. facilitating bidirectional communication between prescribers and pharmacists to resolve stock shortages, suggest alternative medications, and address prescription- related issues.
The claims, as illustrated by the limitations of Claim 1 above, recite an abstract idea within the “certain methods of organizing human activity” grouping — managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite providing prescribers with pharmacies where prescribed medication is in stock and facilitating communications between prescribers and pharmacists. Providing prescribers with pharmacies where prescribed medication is in stock and facilitating communications between prescribers and pharmacists is a process that merely organizes human activity, as it involves following rules and instructions to receive inventory data, process inventory data, query inventory data, determine medication availability, providing list of pharmacies, and facilitating communications. It also involves an interaction between a person and a computer. Interaction between a person and computer qualifies as interaction under certain methods of organizing human activity. See MPEP 2106.04(a)(2)(II). As such, the claims recite an abstract idea within the categories of certain methods of organizing human activity.
The dependent claims 2-6, 8, 9, 11, and 12 recite further abstract ideas within the category of certain methods of organizing human activity, such as 2 retrieves inventory data at predefined intervals or upon detecting a stock change event to ensure continuous data accuracy; 3 allows prescribers to filter inventory data based on geographic location, pharmacy network affiliation, insurance formulary preferences, or patient-specific pharmacy selections; 4 supports alerts notifying prescribers of medication unavailability and suggesting clinically appropriate alternatives; 5 employs role-based access controls (RBAC) to restrict access to inventory data and communication features based on user credentials and permissions; 6 analyzes historical prescription trends, seasonal demand patterns, and pharmacy restocking behaviors to forecast potential medication shortages and recommend proactive inventory adjustments; 8 updating real-time inventory records further comprises receiving push notifications when stock changes occur; 9 prescribers receive alerts when a prescribed medication is unavailable, along with suggested alternative medications; 11 integrating predictive analytics to forecast future medication demand based on historical prescription and inventory data trends; 12 securing inventory data using role-based access controls to ensure compliance with healthcare data privacy regulations.
STEP 2A PRONG TWO
The claims recite additional elements beyond those that encompass the abstract idea above including:
Independent claim 1:
a cloud-based infrastructure configured to
from one or more pharmacy management systems (PMS)
a plurality of application programming interfaces (APIs)
between said cloud-based infrastructure and electronic health records (EHRs) used by prescribers
a synchronization engine configured to
a query module accessible by prescribers via EHRs to
from said cloud-based infrastructure
an integrated communication module configured to
Dependent claim 2:
the synchronization engine
Dependent claim 3:
the query module
Dependent claim 4:
the integrated communication module
automated
Dependent claim 5:
the cloud-based infrastructure
Dependent claim 6:
a predictive analytics engine that
Independent claim 7:
from one or more PMS via APIs or middleware
within a cloud-based infrastructure
via EHR systems
Dependent claim 8:
from pharmacy systems
Dependent claim 9:
automatic
Dependent claim 12:
encryption protocols and
Dependent claim 13:
A computer-readable medium storing instructions that, when executed by a processor, cause a system to perform the method of claim 7
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with considerations laid out by the Supreme Court or the Federal Circuit. (see MPEP 2106.05 a-c and e) The additional elements integrate the abstract idea into a practical application when they: improve the functioning of a computer or improving any other technology, apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, apply the judicial exception with, or by use of, a particular machine, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The additional limitations do not integrate the abstract idea into a practical application when they merely serve to link the use of the abstract idea to a particular technological environment or field of use — i.e. merely uses the computer as a tool to perform the abstract idea; or recite insignificant extra-solution activity (see MPEP 2106.05 f - h).
The cloud-based infrastructure, pharmacy management systems, application programming interfaces, electronic health records, synchronization engine, query module, integrated communication module, predictive analytics engine, encryption protocols, computer-readable medium, and processor are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Nothing in the claim recites specific limitations directed to an improved cloud-based infrastructure, pharmacy management systems, application programming interfaces, electronic health records, synchronization engine, query module, integrated communication module, predictive analytics engine, encryption protocols, computer-readable medium, and processor. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception to computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a basic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claims do not integrate the abstract prescription fulfillment process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract prescription fulfillment process. The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting basic computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently straightforward such that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination, the limitations recited in the claims add nothing that is not already present when the steps are considered individually.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. For example, dependent claim limitations 2 retrieves inventory data at predefined intervals or upon detecting a stock change event to ensure continuous data accuracy; 3 allows prescribers to filter inventory data based on geographic location, pharmacy network affiliation, insurance formulary preferences, or patient-specific pharmacy selections; 4 supports alerts notifying prescribers of medication unavailability and suggesting clinically appropriate alternatives; 5 employs role-based access controls (RBAC) to restrict access to inventory data and communication features based on user credentials and permissions; 6 analyzes historical prescription trends, seasonal demand patterns, and pharmacy restocking behaviors to forecast potential medication shortages and recommend proactive inventory adjustments; 8 updating real-time inventory records further comprises receiving push notifications when stock changes occur; 9 prescribers receive alerts when a prescribed medication is unavailable, along with suggested alternative medications; 11 integrating predictive analytics to forecast future medication demand based on historical prescription and inventory data trends; 12 securing inventory data using role-based access controls to ensure compliance with healthcare data privacy regulations are directed to the abstract idea of certain methods of organizing human activity without integrating into a practical application or amounting to significantly more. Dependent claim limitations 10 bidirectional communication between prescribers and pharmacists includes structured message templates for common prescription modification scenarios, including dosage changes, therapeutic substitutions, and insurance prior authorization requirements; 13 a computer-readable medium storing instructions that, when executed by a processor, cause a system to perform the method of claim 7 merely serve to further narrow the abstract idea above. As such, the additional elements do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention. Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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.
Claims 1-4, 6-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Siegel (US 2023/0290472 A1) in view of Bogaerts, et al. (US 2024/0404675 A1).
With regards to claim 1, Siegel teaches a system for real-time pharmacy inventory synchronization and integrated communication, comprising: a. a cloud-based infrastructure configured to receive, process, and store inventory data from one or more pharmacy management systems (PMS) (see at least ¶ 0029, tracking pharmacies that have specific medicines in stock; ¶ 0046-0050. cloud-based system); b. a plurality of application programming interfaces (APIs) enabling bidirectional data exchange between said cloud-based infrastructure and electronic health records (EHRs) used by prescribers (see at least ¶ 0074, cloud uses application programming interface (API) between different systems to identify availability of treatment (medicine) [bidirectional data exchange]; ¶ 0058, 0060, healthcare professional provides prescription information including user name, address, treatment, refill information, via a computing platform [EHRs used by prescribers] through the cloud); c. a synchronization engine configured to update medication availability in real time or near real time based on changes in pharmacy inventory levels (see at least ¶ 0037, real-time; ¶ 0032, 0073, system tracks pharmacies that have the medication in stock or do not have it available at a given time); d. a query module accessible by prescribers via EHRs to retrieve real-time inventory data from said cloud-based infrastructure (see at least ¶ 0037, real-time; ¶ 0032, 0071-0073, system provides list of potential pharmacies based on particular query criteria and identifies whether a potential pharmacy has the medication in stock at a given time).
Siegel does not explicitly teach …and e. an integrated communication module configured to facilitate direct messaging between prescribers and pharmacists regarding stock shortages, alternative medications, prescription modifications, or prior authorization requirements. Bogaerts teaches …and e. an integrated communication module configured to facilitate direct messaging between prescribers and pharmacists regarding stock shortages, alternative medications, prescription modifications, or prior authorization requirements (see at least figure 12, ¶ 0116, user interface 1200 is generated by the prescription optimization system 140 to allow the pharmacist to efficiently interact with and send messages/requests to a prescriber in the event any problems are encountered, such as needing approval for a therapeutic alternative). It would have been obvious to one of ordinary skill in the art to combine the pharmacist/prescriber messaging method of Bogaerts with the prescription fulfillment system of Siegel with the motivation of optimization of prescription fulfillment (Bogaerts, ¶ 0001).
With regards to claim 2, Siegel teaches the system of claim 1, wherein the synchronization engine retrieves inventory data from PMS at predefined intervals or upon detecting a stock change event to ensure continuous data accuracy (see at least ¶ 0032, 0073, system retrieves pharmacy inventory data from the pharmacy systems at a given time or a projected time).
With regards to claim 3, Siegel teaches the system of claim 1, wherein the query module allows prescribers to filter inventory data based on geographic location, pharmacy network affiliation, insurance formulary preferences, or patient-specific pharmacy selections (see at least ¶ 0055).
With regards to claim 4, Siegel teaches the system of claim 1, wherein the integrated communication module supports automated alerts notifying prescribers of medication unavailability and suggesting clinically appropriate alternatives (see at least ¶ 0071-0073, system outputs pharmacies and whether or not a given pharmacy has that medication in stock or available [alert notifying medication unavailability]; ¶ 0065-0067, system suggests alternative medications).
With regards to claim 6, Siegel teaches the system of claim 1, further comprising a predictive analytics engine that analyzes historical prescription trends, seasonal demand patterns, and pharmacy restocking behaviors to forecast potential medication shortages and recommend proactive inventory adjustments (see at least ¶ 0094, aggregated historical prescription data is used to determine trending data is a large number of prescriptions for certain medications are being fulfilled at certain pharmacies and if a pharmacy’s supply is going to be limited or needs to be stocked).
With regards to claim 7, Siegel teaches the method for real-time pharmacy inventory synchronization and prescriber-pharmacist communication, comprising: a. receiving pharmacy inventory data from one or more PMS via APIs or middleware (see at least ¶ 0032, electronic system receives medication availability information directly from each of the pharmacies [PMS]; ¶ 0074, cloud uses application programming interface (API) between different systems to identify availability of treatment (medicine)); b. processing and standardizing the received inventory data within a cloud-based infrastructure (see at least figure 6-7, ¶ 0032, 0081-0084, system receives and lists pharmacies with medication availability in a standardized format [processing and standardizing received inventory data; ¶ 0046-0050. cloud-based system); c. updating real-time or near real-time inventory records to reflect stock availability (see at least ¶ 0037, real-time; ¶ 0032, 0073, system tracks pharmacies that have the medication in stock or do not have it available at a given time); d. enabling prescribers to query said inventory records via EHR systems to determine medication availability before issuing prescriptions (see at least ¶ 0032, 0071-0073, system provides list of potential pharmacies based on particular query criteria and identifies whether a potential pharmacy has the medication in stock at a given time); e. providing prescribers with a list of pharmacies where the prescribed medication is in stock, based on real-time inventory data (see at least ¶ 0032, 0071-0073, system provides list of potential pharmacies based on particular query criteria and identifies whether a potential pharmacy has the medication in stock at a given time).
Siegel does not explicitly teach …and f. facilitating bidirectional communication between prescribers and pharmacists to resolve stock shortages, suggest alternative medications, and address prescription-related issues. Bogaerts teaches …and f. facilitating bidirectional communication between prescribers and pharmacists to resolve stock shortages, suggest alternative medications, and address prescription-related issues (see at least figure 12, ¶ 0116, user interface 1200 is generated by the prescription optimization system 140 to allow the pharmacist to efficiently interact with and send messages/requests to a prescriber in the event any problems are encountered, such as needing approval for a therapeutic alternative). It would have been obvious to one of ordinary skill in the art to combine the pharmacist/prescriber messaging method of Bogaerts with the prescription fulfillment system of Siegel with the motivation of optimization of prescription fulfillment (Bogaerts, ¶ 0001).
With regards to claim 8, Siegel teaches the method of claim 7, wherein updating real-time inventory records further comprises receiving push notifications from pharmacy systems when stock changes occur (see at least ¶ 0032, 0073, system retrieves pharmacy inventory data from the pharmacy systems at a given time or a projected time).
With regards to claim 9, Siegel teaches the method of claim 7, wherein prescribers receive automatic alerts when a prescribed medication is unavailable, along with suggested alternative medications (see at least ¶ 0071-0073, system outputs pharmacies and whether or not a given pharmacy has that medication in stock or available [alert notifying medication unavailability]; ¶ 0065-0067, system suggests alternative medications).
With regards to claim 10, Bogaerts teaches the method of claim 7, wherein bidirectional communication between prescribers and pharmacists includes structured message templates for common prescription modification scenarios, including dosage changes, therapeutic substitutions, and insurance prior authorization requirements (see at least figures 12-13, ¶ 0116-0117, user interface 1200 is generated by the prescription optimization system 140 to allow the pharmacist to efficiently interact with and send messages/requests to a prescriber in the event any problems are encountered, such as needing approval for a therapeutic alternative, where the user interface is pre-populated and/or auto-populated with different information [structured message templates]; ¶ 0107, problems include prior authorization). It would have been obvious to one of ordinary skill in the art to combine the pharmacist/prescriber messaging method of Bogaerts with the prescription fulfillment system of Siegel with the motivation of optimization of prescription fulfillment (Bogaerts, ¶ 0001).
With regards to claim 11, Siegel teaches the method of claim 7, further comprising integrating predictive analytics to forecast future medication demand based on historical prescription and inventory data trends (see at least ¶ 0094, aggregated historical prescription data is used to determine trending data is a large number of prescriptions for certain medications are being fulfilled at certain pharmacies and if a pharmacy’s supply is going to be limited or needs to be stocked).
With regards to claim 13, Siegel teaches a computer-readable medium storing instructions that, when executed by a processor, cause a system to perform the method of claim 7 (see at least ¶ 0109).
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Siegel (US 2023/0290472 A1) in view of Bogaerts, et al. (US 2024/0404675 A1) in further view of Bose, et al. (US 2015/0213204 A1).
With regards to claim 5, Siegel teaches the system of claim 1, wherein the cloud-based infrastructure …restrict access to inventory data and communication features based on user credentials and permissions (see at least ¶ 0058, prescription transmitted to secure server, HIPPA compliant server; ¶ 0112, system connected to networks, networks divided into sub-networks, sub-networks restrict access between components, network connection uses encryption or other security mechanism).
Siegel does not explicitly teach …employs role-based access controls (RBAC) to... Bose teaches …employs role-based access controls (RBAC) to... (see at least ¶ 0039). It would have been obvious to one of ordinary skill in the art to combine the role-based access controls of Bose with the prescription fulfillment system of Siegel with the motivation of enhancing prescription fraud prevention, patient safety and security (Bose, ¶ 0003).
With regards to claim 12, Siegel teaches the method of claim 7, further comprising securing inventory data using encryption protocols to ensure compliance with healthcare data privacy regulations (see at least ¶ 0058, prescription transmitted to secure server, HIPPA compliant server; ¶ 0112, system connected to networks, networks divided into sub-networks, sub-networks restrict access between components, network connection uses encryption or other security mechanism).
Siegel does not explicitly teach …and role-based access controls... Bose teaches …and role-based access controls... (see at least ¶ 0039). It would have been obvious to one of ordinary skill in the art to combine the role-based access controls of Bose with the prescription fulfillment system of Siegel with the motivation of enhancing prescription fraud prevention, patient safety and security (Bose, ¶ 0003).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hans (US 2009/0157424 A1) which discloses an electronic prescription processing system which is capable of direct two-way electronic communication between the physician and the pharmacist, in one example, uses a multi-path clearinghouse between the physician's office practice management system and a pharmacy computer system. In one example, the multi path electronic prescription processing system allows a physician to create electronic prescriptions using an electronic signature, and using the multi-path clearinghouse, allow for interface with the pharmacy computer system such that an image of an electronic prescription and prescription information are directly auto-populated into an entry screen of the pharmacy computer system.
Hill, Sr., et al. (US 2018/0075558 A1) which discloses a system and methods for automatically processing healthcare data associated with submission and fulfillment of pharmaceutical prescriptions by providers in real time, including claim processing, are enabled by a clinical services platform configured with a review processor and operable with a clinical analytical message (CAM) data file. The system includes the use of first and second databases respectively containing pharmaceutical data and standardized healthcare data. This data is extracted during processing by the system and translated into a common format for storage in a third electronic patient outcome record (EPOR) that is accessible, with full security and patient safety, to authorized providers and patients.
Singer A, Duarte Fernandez R. The effect of electronic medical record system use on communication between pharmacists and prescribers. BMC Fam Pract. 2015 Oct 28;16:155. doi: 10.1186/s12875-015-0378-7. PMID: 26507839; PMCID: PMC4624664 which discloses the Electronic Medical Record (EMR) is becoming increasingly common in health care settings. Research shows that EMRs have the potential to reduce instances of medication errors and improve communication between pharmacists and prescribers; however, more research is required to demonstrate whether this is true. This study aims to determine the effect of a newly implemented EMR system on communication between pharmacists and primary care clinicians.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joey Burgess whose telephone number is (571)270-5547. The examiner can normally be reached Monday through Friday 9-6.
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/JOSEPH D BURGESS/ Primary Examiner, Art Unit 3681