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 .
Prosecution History Summary
Claims 2, 11, and 21-22 are cancelled.
Claims 21-22 are new.
Claims 1, 10, and 17 are amended.
Claims 1, 3-10, and 12-20 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-10, and 12-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 10 and 17 recite the limitation “wherein the system is configured to update inventory data in real time and allocate returned medications to new orders prior to arrival at a central location to improve the speed of updating inventory and fulfillment of new orders.” Examiner is unable to find support in the specification regarding updating of inventory in real-time and prior to arrival at a central location. Examiner asks the Applicant for clarification.
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, 3-10, and 12-20 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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 10 and 12-16), machine (claims 1 and 3-9), and article of manufacture (claims 17-20). Accordingly, claims 1, 3-10, and 12-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A system, comprising:
-a delivery cart, the delivery cart comprising a reader device, wherein the reader device comprises an RFID scanner configured to automatically and wirelessly scan identification information from one or more identification devices affixed to a package without an action taken by a participant when the package including the one or more identifications devices is loaded into the delivery cart, and wherein the system is configured to update inventory data in real time and allocate returned medications to new orders prior to arrival at a central location to improve the speed of updating inventory and fulfillment of new orders;
-one or more processors; and
-a machine-readable memory having instructions stored thereon that, when executed by the one or more processors, cause a first computing device to perform operations comprising:
-identifying a first medication, at a first location associated with a first patient within a healthcare facility, to be returned to a second location remote from the first location and associated with preparing or filling orders within the healthcare facility, before the first medication is administered to the first patient;
-providing, to a remote computing device separate from the system, instructions to retrieve the first medication from the first location for delivery to the second location;
-receiving, after the instructions are provided to the remote computing device, a first indication of a scanning of a respective active identification device affixed to a package of the first medication at the first location associated with the first patient, by the reader device of the delivery cart when the package is loaded in the delivery cart, the first indication indicating that the first medication is available for re-use before it is returned to the second location and including identification information for the first medication that is automatically obtained wirelessly without an action taken by a participant from the active identification device affixed to the package of the first medication by the reader device when the package is loaded in the delivery cart;
-determining, based on the scanning, an expiration time for the first medication based on a preparation time of the first medication and a stability and sterility of the first medication, wherein the expiration time is greater when the first medication was prepared in a sterile zone than if the first medication was not prepared in a sterile zone;
-re-entering, responsive to receiving the first indication, the medication into an inventory data store prior to the first medication arriving at the second location; and
-receiving a new order for a second medication to be administered to a second patient;
-determining, based on the first indication, whether the first medication, re-entered into the inventory data store, is usable for completing the new order of the second medication prior to a delivery time associated with the second medication, whether the first medication is usable being determined based on the determined expiration time being within the amount of time required to prepare the second medication using the first medication and deliver to and administer the order for the second medication at a third location of the patient;
-responsive to determining that the first medication is usable, sending a first notification to a display device indicating that the first medication is to be used for completing the new order at the second location for delivery and administration to the second patient at the third location; and
-responsive to the first medication not being usable to complete the new order, placing the new order in an infusion preparation queue for preparation at the second location.
Examiner states submits that the foregoing underlined limitations constitute: “certain methods of organizing human activity” because determining whether the first medication can complete another order and providing instructions to retrieve from the first location to a second location is managing pharmacy orders and providing instructions for it (i.e. following rules or instructions).
Furthermore, the foregoing underlined limitation constitute: a “mental process” because determination of first medication being usable for a second order can all be performed in the human mind.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception into a practical application in a manner that imposes a
meaningful limit on the judicial exception. The courts have indicated that additional elements
merely using a computer to implement an abstract idea, adding insignificant extra solution
activity, or generally linking use of a judicial exception to a particular technological environment
or field of use do not integrate a judicial exception into a “practical application.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim are as follows (where the bolded portions are the “additional
limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system, comprising:
-a delivery cart, the delivery cart comprising a reader device (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 22-23, figure 1, 90), wherein the reader device comprises an RFID scanner configured to automatically and wirelessly scan identification information from one or more identification devices affixed to a package without an action taken by a participant when the package including the one or more identifications devices is loaded into the delivery cart (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 23, para. 29 (barcode reader)), and wherein the system is configured to update inventory data in real time and allocate returned medications to new orders prior to arrival at a central location to improve the speed of updating inventory and fulfillment of new orders (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 31, examiner citing the communications interface);
-one or more processors (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 26); and
-a machine-readable memory having instructions stored thereon that (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 35, 57), when executed by the one or more processors (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 26), cause a first computing device to perform operations comprising:
-identifying a first medication, at a first location associated with a first patient within a healthcare facility, to be returned to a second location remote from the first location and associated with preparing or filling orders within the healthcare facility, before the first medication is administered to the first patient;
-providing, to a remote computing device separate from the system (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 62), instructions to retrieve the first medication from the first location for delivery to the second location;
-receiving, after the instructions are provided to the remote computing device (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 35, 62), a first indication of a scanning of a respective active identification device affixed to a package of the first medication at the first location associated with the first patient, by the reader device of the delivery cart when the package is loaded in the delivery cart (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 23, para. 29 (barcode reader)), the first indication indicating that the first medication is available for re-use before it is returned to the second location and including identification information for the first medication that is automatically obtained wirelessly without an action taken by a participant from the active identification device affixed to the package of the first medication by the reader device when the package is loaded in the delivery cart (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 30);
-determining, based on the scanning, an expiration time for the first medication based on a preparation time of the first medication and a stability and sterility of the first medication, wherein the expiration time is greater when the first medication was prepared in a sterile zone than if the first medication was not prepared in a sterile zone;
-re-entering, responsive to receiving the first indication, the medication into an inventory data store prior to the first medication arriving at the second location (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 32); and
-receiving a new order for a second medication to be administered to a second patient;
-determining, based on the first indication, whether the first medication, re-entered into the inventory data store, is usable for completing the new order of the second medication prior to a delivery time associated with the second medication, whether the first medication is usable being determined based on the determined expiration time being within the amount of time required to prepare the second medication using the first medication and deliver to and administer the order for the second medication at a third location of the patient;
-responsive to determining that the first medication is usable, sending a first notification to a display device indicating that the first medication is to be used for completing the new order at the second location for delivery and administration to the second patient at the third location (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); specification para. 59); and
-responsive to the first medication not being usable to complete the new order, placing the new order in an infusion preparation queue for preparation at the second location.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, 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 does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2).
For these reasons, representative independent claims 10 and 17 and analogous independent claim 1 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claims 12 and 17 and analogous independent claim 1 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claims 3, 12, 18: The claim specifies determination of the first medication usable to complete the order of second medication (mental process), receiving a second indication that the medication was received at the second location (extra-solution activity, see MPEP 2106.05(g)), and providing for display a second notification of receiving the medication (uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f))).
Claim 4: The claim specifies when the instructions are provided, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claims 5, 13: The claim specifies the medication used for an infusion device, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claims 6, 14: The claim specifies remote computing device to be a mobile device, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claims 7, 15, 19: The claim specifies determination that the first medication cannot complete the order of the second medication (mental process) and providing a notification, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claims 8, 16, 20: The claim specifies receiving a delivery progress of a medication from scanning the medication (extra-solution activity, see MPEP 2106.05(g)), receiving a request for location information (extra-solution activity, see MPEP 2106.05(g)), and providing the location information (uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f))).
Claim 9: The claim specifies the computing device to be a mobile device, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 21: The claim specifies a delivery cart having a reader device to scan wirelessly when the package is loaded into the delivery card, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 22: The claim specifies the reader device attached to the cart to wirelessly scan, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 1, 10, and 17 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as providing instructions to retrieve the first medication, receiving a first indication, receiving an order for second medication, sending a notification to a display device, placing new order in the queue, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); re-entering medication into inventory datastore, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 3-4, 7-8, 12, 15-16, and 18-20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 3, 12, 18 (receiving a second indication, providing a second notification), 4 (instructions provided after determination), 7, 15, 19 (determining and providing to display), 8, 16, 20 (receiving delivery progress and providing notification of the progress), e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1, 3-10, and 12-22 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed for claims 1, 3-10, and 12-22 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues that the claim is not directed to an abstract idea because the features of the claims are tied to a particular machine, i.e. a specialized delivery cart comprising an RFID reader device configured to automatically and wirelessly scan identification information from medication packages as they are loaded. While claims require various delivery carts with a reader device, which are in the physical realm of things, it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources to have invented, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. Neither the claims nor the specification calls for any parallel processing system different from those available in existing systems.
Applicant argues that the claim provides a technical solution on specific configuration and operation of the delivery cart and reader device. The present invention solves the problem associated with updating inventory, which is not a problem of technical nature, but an administrative problem solved by a scheme. The present application does not involve more than a generic utilization of well-known functions of a computer, including the particular arrangement/combination of functions, and therefore does not involve any invention or ingenuity in any program or operation of a computer, or implementation by a computer to operate the method.
The alleged improvement that the Applicant touts does not concern an improvement to computer capabilities but instead relates to an alleged improvement in receiving and processing inventory information for which a computer is used as a tool in its ordinary capacity. Here, the Applicant is not trying to cure a shortcoming in existing computer technology. The Applicant does not contend that it was necessary to develop innovative computer hardware/software in order to perform the steps. Additionally, although the claimed process of updating inventory information may be done more quickly using computer components. See FairWarning IP, LLC v. latric Sys., Inc., 839 F.3d 1089, 1095 (2016) (“While the claimed system and method certainly purport to accelerate the process of analyzing audit log data, the speed increase comes from the capabilities of a general-purpose computer, rather than the patented method itself' ); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012) (“[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter”).
Examiner states that the claims have an abstract idea limited solely by mere instructions to implement the idea on a computer, or by recitation of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the industry. The claims are silent as to how a computer aids the method, the extent to which a computer aids the method, or the significance of a computer to the performance of the method. Simply adding a computer aided limitation to a claim covering an abstract concept, without more, is insufficient to render the claim patent eligible. Therefore, Examiner maintains the rejection.
Applicant argues that the claim features enable real-time automated re-entry and allocation of medications. The use of the term “real-time” does not disqualify the limitation from being categorized as an abstract idea. Language such as concurrently, automatically, instantly, or simultaneously to describe the automation of a manual process is not enough to overcome a subject matter eligibility rejection (MPEP § 2106.05(a)(I) Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality no. (iii) mere automation of manual processes). Examiner also notes that language such as this is not restricted to computer processes, humans can automatically/instantly/simultaneously complete different tasks (see MPEP § 2106.04(a)(2)(III) stating that the mental processes may be completely by humans plural – not just a singular human mind).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vahlberg et al. – WO 2012/151332 – Facilitates returned medications to a central storage location
Louie et al. – U.S. Patent No. 7,672,859 – A prescription order tracking system by tracking tags of prescriptions at different locations.
Tong – U.S. Publication No. 2005/0096941 – Method of saving medication costs by redistributing unused medications.
Greenwald et al. – U.S. Publication No. 2002/0198624 – A hospital drug distribution system.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Choi can be reached on 469-295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEETAL R PAULSON/ Primary Examiner, Art Unit 3686