DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the application filed on 3/7/23. 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 1-14 are drawn to a method, claims 15-19 are drawn to a system; and claim 20 is drawn to a product/article of manufacture.
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1-20 recite(s) a method and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method, system, and product are drawn to processing prescription requests/medication requests. (i.e. commercial interactions-order fulfillment; managing interactions)
In particular, claims 1, 15, and 20 recite a method, system and product for:
receiving… a request from a customer to fulfill an order for a medication of a particular type;
when the customer is authorized to process requests via an enhanced medication workflow that includes one or more legacy medication fulfillment steps for fulfilling medications that are not of the particular type as well as one or more enhanced medication fulfillment steps for fulfilling medications that are of the particular type;
processing…the request according to the one or more legacy medication fulfillment steps, and
processing…the request according to the one or more enhanced medication fulfillment steps, including processing a representation of the request by an automated device that is associated with preparing medications of the particular type;
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 1, 15, and 20 additionally recite: storing data indicating that the order for the medication of the particular type has been fulfilled. The additional step is a generic function which is a well-understood, routine and conventional activity that amounts to no more than implementing the abstract idea with a computerized system.
Claims 1, 15, and 20 further recites: “cloud-based medication fulfillment system.” Claim 15 further recites “one or more computers” and “one or more storage devices.” Claim 20 further recites: One or more non-transitory computer-readable storage media storing instructions and one or more computers. The additional claim language recites generic components performing well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “The system can store the data in any appropriate repository such as an order tracking system, a relational database, an object storage system, a block storage system and so on. " (par. 72 of PG-Pub) The disclosure also states: “A computer program (also known as a program, software, software application, script, or code) can be written in any suitable form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any suitable form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system.” (par. 83)
The application explains: “Processors suitable for the execution of a computer program include, by way of example, special purpose microprocessors. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for performing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), to name just a few. Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM (Erasable Programmable Read-Only Memory), EEPROM (Electrically Erasable Programmable Read-Only Memory), and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.” (see par. 85) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 1, 15, and 20:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Claims 2-14 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 2-14 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. It is noted that Therefore, claim(s) 2-14 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 16-19 are dependent from Claim 15 and include(s) all the limitations of claim(s) 15. However, the additional limitations of the claims 16-19 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 16-19 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s)1, 3-11; 13-15; and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill et al (US 20180075213 A1)
Claims 1, 15 and 20 Hill discloses a system comprising one or more computers and one or more storage devices (par. 36-39; par. 55; Fig. 1) storing instructions that when executed by the one or more computers cause the one or more computers (par. 65) to perform a computer-implemented method comprising:
receiving, by a cloud-based medication fulfillment system, a request from a customer to fulfill an order for a medication of a particular type; (par. 21- plurality of communication links for receiving the submitted prescription and transmitting (a) the submitted prescription to the pharmacy for fulfillment following the review process)
when the customer is authorized to process requests via an enhanced medication workflow that includes one or more legacy medication fulfillment steps for fulfilling medications that are not of the particular type as well as one or more enhanced medication fulfillment steps for fulfilling medications that are of the particular type (par. 24-26-accepting prescription or requirement for editing of prescription):
processing, by the cloud-based medication fulfillment system, the request according to the one or more legacy medication fulfillment steps, and (par. 65-67-cloud system; par. 21; par. 25-27-processing prescriptions)
processing, by the cloud-based medication fulfillment system, the request according to the one or more enhanced medication fulfillment steps, including processing a representation of the request by an automated device that is associated with preparing medications of the particular type; and (par. 25-27-processing review, and processing edited Rx; par. 54-56)
storing, by the cloud-based medication fulfillment system, data indicating that the order for the medication of the particular type has been fulfilled. (par. 27- generating via the CAM data file a message to one or more authorized recipients that the clinical and educational services information for the specialty drug were delivered, thereby authorizing for release a specified quantity of the specialty drug for dispensing to the patient; notifying a manufacturer of the specialty drug through a group purchasing organization that delivery of a specified quantity of the specialty drug is released; par. 42-43; par. 67-70-storage of records for patient and prescriptions)
Claims 3, 17 Hill discloses the computer-implemented method/system wherein processing the request according to the one or more enhanced medication fulfillment steps comprises:
obtaining, by the cloud-based medication fulfillment system, within a threshold period of time after receiving the request, clinical data; (par. 20- performing a review process of patient clinical data upon a submitted prescription from a healthcare provider in real time before it is received by a pharmacy for fulfillment, comprising a consolidated database that receives and stores patient clinical data from a plurality of sources in a patient clinical data record)
performing, by the cloud-based medication fulfillment system, and using the clinical data, a verification; and (par. 56-verification of medical data)
in response the verification, providing, by the cloud-based medication fulfillment system, a representation of the request to the automated device. (par. 56- The pre-CAM data file includes data about each drug and the required clinical education or clinical service information that must be delivered to the patient. The post-CAM data file includes notices that (a) informs the dispensing pharmacy when a drug can be ordered and dispensed; and (b) informs via the clinical services platform all providers involved in the patient's episode of care that the clinical education or other clinical services were performed.)
Claim 4. Hill discloses the computer-implemented method /system, wherein the clinical data is obtained in real- time. (par. 53- a comprehensive and innovative clinical services platform and an electronic patient outcome (EPO data) database—to create in combination with an electronic pharmacy record (ePR) database a novel, consolidated electronic patient outcomes record (EPOR) so that this unique EPOR patient record receives data updates in real time when processing submission and fulfillment of a submitted prescription that is sufficient to report, also in real time, measureable outcomes provided during an episode of care.)
Claim 5 Hill discloses the computer-implemented method wherein the verification includes a Drug Utilization Review (DUR). (par. 80-completing DUR)
Claims 6, 18 Hill teaches the computer-implemented method/system, wherein the verification comprises processing an input that includes the clinical data by a machine learning model that is configured to verify the request. (par. 50-developing a patient specific algorithm; par. 61; par. 78-80; par. 83)
Claim 7. Hill teaches the computer-implemented method/system, further comprising: adjusting, by the cloud-based medication fulfillment system, the ordered medication based on performing the DUR. (par. 20; par. 25-27: process for selecting a pharmacy for fulfillment of an edited prescription based on pharmacy authorization data stored in the database corresponding to a prescribed drug identified in the edited prescription; par. 54- The EPO data may also receive the data for e-scripts (electronic prescriptions) involved in editing of the prescription submission and fulfillment transactions (to properly align with payment requirements))
Claim 8. Hill discloses the computer-implemented method/system where processing the representation comprises sending the representation from the cloud-based medication fulfillment system to the automated device via an API that is established by the by the cloud-based medication fulfillment system. (Fig. 3,4B. 5; par. 95-96: fulfillment processing)
Claim 9 Hill discloses the computer-implemented method /system , where processing the representation comprises: generating, by the cloud-based medication fulfillment system, a code that is associated with preparing the medications of the particular type; (Fig. 4B; par. 93-93) and providing, by the cloud-based medication fulfillment system to the automated device, the code. (par. 88-90 authorisation for the release of the medication; eCoupon issued: Confirmation of delivery 340 of the clinical and educational services to the patient via path 264 authorizes release of the specialty drug by the manufacture 360 via path 342 to the GPO 370, which delivers the specialty drug to the pharmacy along path 348.; par. 96-
Claim 10 Hill teaches the computer-implemented method of claim 1, wherein processing the one or more enhanced medication fulfillment steps, by the cloud-based medication fulfillment system, includes, after preparing the medication by the automated compounding device and before the order is completed, decrementing an inventory of ingredients of the medication and incrementing an inventory of the medication. (par. 88- It also includes processing of payments to the manufacturer 360 of the specialty drugs after it delivers the drugs to the inventory of a Group Purchasing Organization or structure 370 (aka GPO 370″). The GPO 370 is established to serve a warehouse function by member pharmacies to maintain an inventory of specialty drugs and facilitate processing of payments and credits for its costs.)
Claim 11. Hill teaches the computer-implemented method/ system wherein processing the request according to one or more legacy medication fulfillment requests includes providing, to a third-party authorization system that is not included in the cloud-based medication fulfillment system, an indication that the order for the medication of the particular type has been fulfilled. (par. 56- par. 56- The pre-CAM data file includes data about each drug and the required clinical education or clinical service information that must be delivered to the patient. The post-CAM data file includes notices that (a) informs the dispensing pharmacy when a drug can be ordered and dispensed; and (b) informs via the clinical services platform all providers involved in the patient's episode of care that the clinical education or other clinical services were performed)
Claim 13. Hill teaches the computer-implemented method/ system further comprising: obtaining, by the cloud-based medication fulfillment system, from a medication- administration device and though an Application Programming Interface provided by the cloud- based medication fulfillment system, an indication that the medication has been administered; and providing, by the cloud-based medication fulfillment system and to accounts- receivable system, a charge associated with preparing the medication. (par. 56- providing information on fulfillment of product an services; par. 87-90-payment processing when requirements are met)
Claims 14, 19 Hill teaches the computer-implemented method/system, further comprising canonicalizing the clinical data. (par. 95-formatting of data )
Claim Rejections - 35 USC § 103
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.
Claim(s) 2, 12 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable Hill in view of Kamen et al (AU 2013364131 A1)
Claims 2, 12; 16 Hill teaches the system and the computer-implemented method of claim 1 and 15, but does not expressly disclose , wherein the automated device is an automated compounding device.
Kamen teaches automated compounding devices receiving prescription information (par. 254-255; par. 257) Kamen further discloses submission of information to an infusion delivery system for scheduling (par. 254-255; par. 257;par. 313). At the time of filing it would have been obvious to one of ordinary skill in the art to modify the system of Hill with Kamen to facilitate the transmission of healthcare data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684