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 .
Notice to Applicant
Receipt of Applicant’s Amendment filed June 10, 2026 is acknowledged.
Response to Amendment
Claims 1-22 have been cancelled. Claims 23-44 have been added. Claims 23-44 are pending and are provided to be examined upon their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 6, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 43 is objected to because of the following informalities:
Claim 43 recites an “RFID tag or NFC tag”. Both acronyms must be written out for clarification.
Appropriate correction is required.
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 23-44 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 and a machine
(claims 23-44). Accordingly, claims 23-44 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).
The Examiner has identified method Claim 23 as the claim that represents the claimed invention for analysis and is similar to system claim 33.
Claim 1:
A method of providing instructions for preparing and verifying the preparation of a medication that is to be administered to a patient using a drug delivery system based upon a medication order, the method comprising:
receiving, at a system, an indication of the medication to be prepared for administration to the patient;
displaying, on a user interface of the system, a list of one or more items required for medication preparation, including medication, device, and label components;
scanning, at a scan-enabled client module of the system, a scannable code on each of the one or more items;
for at least one item of the one or more items, displaying, on the user interface of the system, a set of one or more instructions specific to the at least one item of the one or more items; and
after assembling the one or more items required for medication preparation into an assembled unit, verifying one or more features of the assembled unit.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity under managing personal behaviors of people. The claim elements are directed towards “preparing and verifying the preparation of a medication”, “displaying,…, a list of one or more items required for medication preparation, including medication, device, and label components”, “displaying,…, a set of one or more instructions specific to the at least one item of the one or more items”, and “verifying one or more features of the assembled unit”, which encompasses providing instructions for a person to follow and verifying that the instructions were followed.
Accordingly, the claim recites at least one abstract idea.
Claim 33 is abstract for the same reasons as above.
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 idea into a practical application. As noted at MPEP §2106.04 (ID)(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 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(I)(A).
Additional elements cited in the claims:
system (23,27-28,33-44); user interface (23,26-28,31-33,35-36,38-39); scan-enabled client module (23-24,29-30,33-37); items (23-24,29-30,33-34,35-36); assembled unit (23,33,42,43); quick response code (25); radio frequency identification (25,43); video (32,39); memory storage element (33); processor (33); program instructions (33); NFC (43)
Any computing devices that would be able to perform the method (processor, system) and their associated software elements (memory storage element, program instructions) are taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. Pg. 11 of Applicant specification recites: “Depending on the desired configuration, the at least one processor 108 can be any type of processor including, but not limited to, a microprocessor, a microcontroller, a digital signal processor, or any combination thereof.” No specific, technical improvements are being made to computing devices as a generic computing device is applied to perform the abstract idea of providing instructions and verifying the instructions were followed.
User interfaces are also taught at a high level of generality. Pg. 10 recites: “The user interface 102 may be, for example, an optical see-through display, an optical see-around display, or a video see-through display, as non-limiting examples.” No specific, technical improvements are being made to user interfaces as any generic interface display is applied as mere instructions to apply the abstract idea of providing instructions to a user without any specific, technical improvements to the functioning of the interface itself.
Items and the assembled unit is also taught at a high level of generality. Pg. 9 recites: “In particular, when scanning a scannable item (such as barcode, QR code or in the future RFID) on a medication, medication package, patient-specific medication label, auxiliary medication label, label that indicates medication delivery instructions or sequencing instruction, device, device component (e.g., tubing set), or device package that includes the product identifier to complete the "recipe" of a sterile preparation for the 20 medication for administration, the scannable item could lead the electronic health record (EHR) system to provide instructions for the preparation/use in the sidebar, another tab, or separate window on the user interface of the system.” Pg. 13 further recites: “In another example, the request to verify one or more features of the assembled unit directs a user to scan one or more components of the assembled unit to verify if the set of one or more instructions have been completed correctly.” No specific, technical improvements are being made to items or assembled units as a variety of different components are merely applied to be the subject of the abstract idea of providing a user with instructions to follow for assembling the items.
Scanning (scan-enabled client module) and scannable codes/tags (quick response, radio frequency identification, NFC) are also taught at a high level of generality. Pg. 7 recites: “In another embodiment of the second aspect, the request to verify one or more features of the assembled unit directs a user to scan one or more components of the assembled unit to verify if the set of one or more instructions have been completed correctly.” Pg. 9 recites: “In particular, when scanning a scannable item (such as barcode, QR code or in the future RFID) on a medication, medication package, patient-specific medication label, auxiliary medication label, label that indicates medication delivery instructions or sequencing instruction, device, device component (e.g., tubing set), or device package that includes the product identifier to complete the "recipe" of a sterile preparation for the 20 medication for administration, the scannable item could lead the electronic health record (EHR) system to provide instructions for the preparation/use in the sidebar, another tab, or separate window on the user interface of the system.” No specific, technical improvements are made to scanning technologies as a generic scanning method is applied to perform an insignificant extra-solution activity of data gathering (see MPEP 2106.05(g)) for the purpose of performing the abstract idea of providing instructions and verifying that the items were assembled correctly.
Video functionality is also taught at a high level of generality. Pgs. 21-13 recite: “In another example, the set of one or more instructions specific to the at least one item of the one or more items are displayed as a video on the user interface 102. The video may comprise an instructional video that walks the HCP through the necessary steps.” No specific, technical improvements are made to video technologies as videos are generically provided to perform an abstract idea of providing instructions for a user to follow.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Pg. 5 recites: “In another embodiment of the first aspect, the set of one or more instructions specific to the at least one item of the one or more items are displayed as a video on the user interface.” No specific, technical improvements are made to video technologies as video is provided as mere instructions to apply the abstract idea of providing instructions for a user to follow.
Looking at the additional elements 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 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 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).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 24 and 34: These claims recite wherein the list of one or more items for preparing the medication are displayed in a sequential order, and wherein the one or more items are scanned at the scan-enabled client module in the sequential order; which only serves to further limit the abstract idea of the list and performance of scanning by the user.
Claim 25: This claim recites wherein the scannable code comprises one of a barcode, a quick response (QR) code, or a radio frequency identification (RFID); which only serves to further limit the type of scannable code without providing any specific, technical improvements to the functioning of scanning modules or codes themselves.
Claim 26: This claim recites wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a pop-up in one of a sidebar, an additional tab, or a separate window of the user interface; which teaches the user interface at a high level of generality such that it is merely applied to perform an abstract idea of providing instructions for a user to follow.
Claim 27: This claim recites the method further comprising: displaying, on the user interface of the system, a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been read; which teaches the user interface at a high level of generality such that it is merely applied to perform an abstract idea of instructing a user to perform a task.
Claim 28: This claim recites the method further comprising: displaying, on the user interface of the system, a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been completed; which teaches the user interface at a high level of generality such that it is merely applied to perform an abstract idea of instructing a user to perform a task.
Claim 29: This claim recites wherein a next item of the one or more items cannot be scanned at the scan-enabled client module until the user input is received; which teaches an abstract idea of managing the behavior of the user by providing a conditional limit on when items are scanned by the user.
Claims 30 and 37: These claims recite wherein a next item of the one or more items cannot be scanned at the scan-enabled client module until a threshold amount of time has elapsed after displaying the set of one or more instructions specific to the at least one item of the one or more items; which teaches an abstract idea of managing the behavior of the user by providing a conditional limit on when items are scanned by the user.
Claims 32 and 39: These claims recite wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a video on the user interface; which teaches video technologies at a high level of generality such that is merely applied to perform an abstract idea of providing instructions for a user to follow.
Claim 35 does not recite a practical application for the same reasons as claims 27 and 29.
Claim 36 does not recite a practical application for the same reasons as claims 28 and 29.
Claim 40: This claim recites wherein the set of one or more instructions comprise one or more of a component selection instruction, a component unpackaging instruction, a component handling instruction, a component assembly instruction, a component dispensing instruction, a component storage instruction, an administration instruction, a disposal instruction, a recycling instruction, a labeling instruction, a programming instruction or a packaging instruction; which only serves to further limit the abstract idea of the instructions.
Claim 41: This claim recites wherein the set of one or more instructions are expressed as a positive or a negative instruction; which only serves to further limit the abstract idea of the instructions.
Claim 42: This claim recites wherein the request to verify one or more features of the assembled unit directs a user to scan one or more components of the assembled unit to verify if the set of one or more instructions have been completed correctly; which teaches an abstract idea of providing instructions for a user to follow.
Claim 43: This claim recites wherein the request to verify one or more features of the assembled unit directs a user to scan one or more components of the assembled unit to verify one or more of a physical presence, a physical characteristic, a physical location, a visual readability, a machine readability, information contained on/in RFID tag or NFC tag, or combinations thereof; which only serves to further limit the abstract idea of the verification.
Claim 44: This claim recites wherein the verification step is performed in comparison to expected information contained in a medication order; which only serves to further limit the abstract idea of the verification.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 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.
These 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 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 known activities in particular fields (such as 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), MPEP §2106.05(d)(II)(i);storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv)).
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 additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 24-32 and 34-44 additional limitations which amount to elements that have been recognized as known activities in particular fields, claims 24-32 and 34-44, e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 24-32 and 34-44, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv). 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 23-44 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
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.
Claims 23, 25-26, 33, and 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over Martucci (US 20030135388) in view of Eberting (US 20190214116).
Regarding claim 23, Martucci teaches a method of providing instructions for preparing and verifying the preparation of a medication that is to be administered to a patient using a drug delivery system based upon a medication order, the method comprising:
scanning, at a scan-enabled client module of the system, a scannable code on each of the one or more items ([0033], “FIG. 7 shows an IV container scan initiation display. The display has a soft-key display 68(a) and 68(b), as well as a help icon 70 for jumping to an IV container information help display page, shown in FIG. 19.” [0063], “In one embodiment, the operator may scan the bar code 39 on the catheter 37 by the scanning device 36 on the PDA 22 to confirm that the medication 27 is being delivered to the patient via the correct catheter 37. The operator may also scan the bar code 31 on the pump 30 by the scanning device 36 on the PDA 22 to confirm that the proper pump channel is being used if a multi-channel pump is utilized.”);
for at least one item of the one or more items, displaying, on the user interface of the system, a set of one or more instructions specific to the at least one item of the one or more items ([0011], “Data on the medication is contained in a first label on the medication container. The first label also contains the instruction on how the medication is delivered to the patient, including the appropriate settings for an electronic medication delivery device for delivering the medication to the patient.” [0047], “If the IV scan was successful, the PDA 22 provides an IV scan display as shown in FIGS. 8(a) and 8(b), which includes a scan information section 74. The scan information in these display pages includes patient identification number, patient name, patient location, patient weight, order number, bag identification number, medication identification, volume, and rate, medication preparer's name and the date and time the preparation was completed, the expiration time and date, the delivery time and date, the administration route.” [0027], “The medication data may include but is not limited to: patient name, patient identification number, physician name, order number, date, drug name, drug amount, diluent amount, and route of administration. The delivery instruction which is to be transmitted and downloaded to the medication delivery device 30 may include but is not limited to: delivery rate, delivery volume, dose, dose time, duration of delivery, and duration of therapy.”); and
[No Patentable Weight is given to non-functional descriptive claim language of “displaying… a set of one or more instructions specific to the at least one item of the one or more items;]
after assembling the one or more items required for medication preparation into an assembled unit, verifying one or more features of the assembled unit ([0063], “In one embodiment, the operator may scan the bar code 39 on the catheter 37 by the scanning device 36 on the PDA 22 to confirm that the medication 27 is being delivered to the patient via the correct catheter 37. The operator may also scan the bar code 31 on the pump 30 by the scanning device 36 on the PDA 22 to confirm that the proper pump channel is being used if a multi-channel pump is utilized.”).
Martucci does not teach receiving, at a system, an indication of the medication to be prepared for administration to the patient; and
displaying, on a user interface of the system, a list of one or more items required for medication preparation, including medication, device, and label components.
However, Eberting does teach receiving, at a system, an indication of the medication to be prepared for administration to the patient ([0129], “The telemedicine system may allow the healthcare provider 202 to issue the prescription and, in some embodiments, initiate delivery of the prescription through the telemedicine system, the healthcare provider's 202 mini-store, and/or a third-party prescription vendor.”);
displaying, on a user interface of the system, a list of one or more items required for medication preparation, including medication, device, and label components ([0136], “The master list of the products that may be included by selection in the healthcare provider's preselected product platform 300 may include any of a wide variety of healthcare or other items, such as, but not limited to: bandages, medical supplies, medical equipment, skin care, personal care, supplements, medications, treatment plans,...” [0198], “For example, a physician may populate the order form 514 with data associated with a prescription. This data may include a clinic name, patient's info (name, date of birth, gender, email, and address), …, preparation information,…”).
Martucci in view of Eberting are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci with Eberting for the advantage of “automatically send[ing] the analysis output to one or more healthcare providers” (Eberting; [0392]).
Regarding claim 25, Martucci in view of Eberting teaches the method of claim 23. Martucci further teaches wherein the scannable code comprises one of a barcode, a quick response (QR) code, or a radio frequency identification (RFID) ([0030], “a first label 28 on the container 26 can be an RFID label and the second label 29 on the patient tag 24 can be a bar code label.”).
Regarding claim 26, Martucci in view of Eberting teaches the method of claim 23. Martucci further teaches wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a pop-up in one of a sidebar, an additional tab, or a separate window of the user interface (Fig. 29(a)). Fig. 29(a), below, shows instructions for delivering the medication in a new window on the user interface.
PNG
media_image1.png
452
357
media_image1.png
Greyscale
Regarding claim 33, this claim is rejected for the same reasons as claim 23, as described above. Martucci further teaches a system for providing instructions for preparing a medication for administration to a patient, the system comprising: a user interface; a scan-enabled client module; at least one memory storage element including data associated with the medication and/or the patient; at least one processor; and data storage including program instructions stored thereon that when executed by the at least one processor, cause the system to perform the method ([0031], “The handheld computing device 22 is equipped with: means for reading the prescribed medication data, the medication delivery instruction, and the patient data; means for storing information, and means to communicate with other electronic devices… Suitable handheld computing devices include but are not limited to laptop or palmtop computers and personal digital assistants (PDA's).” [0032], “The first information input device 36 is integrated into the handheld computing device 22. The device 36 will correspond to the machine readable format selected for the medication information and patient data. Such device includes bar code readers, smart tag readers, magnetic stripe or tape readers, and optical readers.”).
Regarding claim 40, Martucci in view of Eberting teaches the system of claim 33. Martucci further teaches wherein the set of one or more instructions comprise one or more of a component selection instruction, a component unpackaging instruction, a component handling instruction, a component assembly instruction, a component dispensing instruction, a component storage instruction, an administration instruction, a disposal instruction, a recycling instruction, a labeling instruction, a programming instruction or a packaging instruction ([0011], “it transmits the medication delivery instruction to the electronic medication delivery device, which downloads the instruction, programs the delivery device, and prompts an operator to begin delivering the medication to the patient according to the downloaded instruction”).
Regarding claim 41, Martucci in view of Eberting teaches the system of claim 33. Martucci further teaches wherein the set of one or more instructions are expressed as a positive or a negative instruction ([0011], “it transmits the medication delivery instruction to the electronic medication delivery device, which downloads the instruction, programs the delivery device, and prompts an operator to begin delivering the medication to the patient according to the downloaded instruction”). Examiner interprets an instruction that programs a delivery device to encompass a positive instruction, as performing a step is a positive step.
Regarding claim 42, Martucci in view of Eberting teaches the system of claim 33. Martucci further teaches wherein the request to verify one or more features of the assembled unit directs a user to scan one or more components of the assembled unit to verify if the set of one or more instructions have been completed correctly ([0063], “In one embodiment, the operator may scan the bar code 39 on the catheter 37 by the scanning device 36 on the PDA 22 to confirm that the medication 27 is being delivered to the patient via the correct catheter 37. The operator may also scan the bar code 31 on the pump 30 by the scanning device 36 on the PDA 22 to confirm that the proper pump channel is being used if a multi-channel pump is utilized.”).
Regarding claim 43, Martucci in view of Eberting teaches the system of claim 33. Martucci further teaches wherein the request to verify one or more features of the assembled unit directs a user to scan one or more components of the assembled unit to verify one or more of a physical presence, a physical characteristic, a physical location, a visual readability, a machine readability, information contained on/in RFID tag or NFC tag, or combinations thereof ([0063], “In one embodiment, the operator may scan the bar code 39 on the catheter 37 by the scanning device 36 on the PDA 22 to confirm that the medication 27 is being delivered to the patient via the correct catheter 37. The operator may also scan the bar code 31 on the pump 30 by the scanning device 36 on the PDA 22 to confirm that the proper pump channel is being used if a multi-channel pump is utilized.” [0025], “Any information to be downloaded to a particular pump channel 33 from the handheld device 22 has to match with the unique pump channel identification so that only the appropriate information is downloaded to the correct pump channel 33.” [0030], “Examples of machine readable formats are: linear bar codes, two-dimensional bar codes such as the two-dimensional data matrix bar codes, other two-dimensional bar code symbologies, other printed data encoding techniques, smart tag or Radio Frequency Identification (RFID) technology, magnetic stripe or tape, Optical Character Recognition (OCR), optical hologram, and the like.”).
Regarding claim 44, Martucci in view of Eberting teaches the system of claim 33. Martucci further teaches wherein the verification step is performed in comparison to expected information contained in a medication order ([0031], “Because pumps are mobilized frequently, disconnecting them from power and wired data communication, as well as programming the pumps with prescription data and verifying the prescription data in a mobile environment is important.” [0034], “The adapter 34 includes hardware and a processor programmed for receiving the prescription data from the handheld computing device 22, determining whether the received prescription data is consistent with operational data input directly to the medication delivery device 30, and enabling the delivery device 30 for operation.” [0035], “If the adapter 34 determines that the delivery device and patient data match, a green light signal is preferably provided and the adapter 34 continues to run.”). Examiner interprets the prescription data to be the expected information contained in a medication order.
Claims 24 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Martucci (US 20030135388) in view of Eberting (US 20190214116) further in view of Niedenzu (WO 2013189860 A2).
Regarding claim 24, Martucci in view of Eberting teaches the method of claim 23. Martucci further teaches wherein one or more items are scanned at the scan-enabled client module in the sequential order ([0047], “If the IV scan was successful, the PDA 22 provides an IV scan display as shown in FIGS. 8(a) and 8(b), which includes a scan information section 74... The IV scan display also includes a pump icon 76 for proceeding to the pump page.” [0063], “Referring to FIG. 36(a), the PDA 22 automatically prompts the operator after two medication bar codes have been scanned. Referring to FIG. 36(c), if the operator does not wish to proceed with two medications, the PDA 22 displays a series of option menus for proceeding with either the first or second scanned medication, or returning to the initial screen. Referring to FIG. 36(b), if the operator wished to proceed with two medications, the PDA 22 prompts the operator to indicate which medication is to be the primary and which is to be the secondary... In one embodiment, the operator may scan the bar code 39 on the catheter 37 by the scanning device 36 on the PDA 22 to confirm that the medication 27 is being delivered to the patient via the correct catheter 37. The operator may also scan the bar code 31 on the pump 30 by the scanning device 36 on the PDA 22 to confirm that the proper pump channel is being used if a multi-channel pump is utilized.”). Examiner notes that the medication (IV) is scanned prior to moving on to scanning the pump or catheter via the pump page.
Martucci does not teach wherein the list of one or more items for preparing the medication are displayed in a sequential order.
However, Niedenzu does teach wherein the list of one or more items for preparing the medication are displayed in a sequential order (Niedenzu, pg. 102, “Determine in which position the at least one element, the part of the at least one element and / or the at least one reference or the like the at least one element and / or its parts, in which at least one display list is arranged or arranged, Create an ordered display list, and Providing the thus arranged display list and / or at least part of the display list arranged in this way for at least one user in visual, acoustic and / or haptic form.” pg. 108, “Thus, for example, countermeasures can also be initiated very quickly if it is recognized via the displayed list that z, B, the medication or the detected ingredients or components do not or no longer correspond to the actual desired fluid, i. e.g. Drug or drug equivale” pg. 100, “If there should be a barcode on a label of an infusion container which clearly describes all ingredients and their concentrations in the infusion solution, e.g. by means of an index from an in-house drug database, a comparison of the prescription prepared by a physician with the label data of the infusion container read out via the barcode reader can be made.”).
Martucci in view of Eberting further in view of Niedenzu are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Niedenzu for the advantage of providing entries “whose hierarchy is determined by their order in the list” (Niedenzu; pg. 137).
Regarding claim 34, this claim is rejected for the same reason as claim 24.
Claims 27-29 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Martucci (US 20030135388) in view of Eberting (US 20190214116) further in view of Chudy (US 20130218330).
Regarding claim 27, Martucci in view of Eberting teaches the method of claim 23. Martucci in view of Eberting does not teach the method further comprising: displaying, on the user interface of the system, a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been read.
[No Patentable Weight is given to intended use language of “displaying… a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been read” as user input to confirm does not happen.]
However, Chudy does teach the method further comprising: displaying, on the user interface of the system, a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been read ([0310], “The words "Please scan the bar code for the tray" 1377 may appear to prompt the user to scan bar code 1132 on holder 1013, 1013' with bar code reader 1131. Controller 1017 validates bar code 1132 and associates the holder 1013, 1013' with the prescription order in database 1371. The user may touch the "Ok" icon 1379 following the scan to signal to controller 1017 that the bar code 1132 has been read or controller 1017 may automatically move to the next step.”). Under the broadest reasonable interpretation, pressing an “Ok” icon in response to performing an instruction displayed on a user interface encompasses a confirmation that the instruction has been read.
Martucci in view of Eberting further in view of Chudy are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Chudy for the advantage of “permitting a technician to input information to controller 17 by simply touching her finger on a desired portion of the display 125” (Chudy; [0141]).
Regarding claim 28, Martucci in view of Eberting teaches the method of claim 23. Martucci in view of Eberting does not teach the method further comprising: displaying, on the user interface of the system, a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been completed.
[No Patentable Weight is given to intended use language of “displaying… a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been completed” as user input to confirm does not happen.]
However, Chudy does teach the method further comprising: displaying, on the user interface of the system, a window requesting a user input to confirm that the set of one or more instructions specific to the at least one item of the one or more items have been completed ([0310], “The words "Please scan the bar code for the tray" 1377 may appear to prompt the user to scan bar code 1132 on holder 1013, 1013' with bar code reader 1131. Controller 1017 validates bar code 1132 and associates the holder 1013, 1013' with the prescription order in database 1371. The user may touch the "Ok" icon 1379 following the scan to signal to controller 1017 that the bar code 1132 has been read or controller 1017 may automatically move to the next step.”).
Martucci in view of Eberting further in view of Chudy are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Chudy for the advantage of “permitting a technician to input information to controller 17 by simply touching her finger on a desired portion of the display 125” (Chudy; [0141]).
Regarding claim 29, Martucci in view of Eberting further in view of Chudy teaches the method of claims 23 and 27. Martucci in view of Eberting does not teach wherein a next item of the one or more items cannot be scanned at the scan-enabled client module until the user input is received.
However, Chudy does teach wherein a next item of the one or more items cannot be scanned at the scan-enabled client module until the user input is received ([0362], “Selection of the Update icon 1477 completes verification for Medicament-identification field 1388 and the exemplary Naproxen. Once all cells 1033 associated with a Medicament-identification field 1388 are verified, the user then selects the next Medicament-identification field 1388 to be verified. This process is repeated until all medicaments 1011 have been verified as called for by Verification screen 1475, 1475'.” [0363], “Referring next to FIGS. 70 and 89, once all Medicament-identification fields 1388 and medicaments 1011 are verified, controller 1017 displays a Barcode scan Field 1480 with instructions prompting the user to scan a bar code 1132 on the holder 1013, 1013' with bar code scanner 1131. Scanning of the bar code 1132 and touching the Ok icon 1481 sends a signal to controller 1017 indicating to system 1010, 1010' that holder 1013 has been fully verified and that the medicament 1011 contents are in the correct cells 1033 ready for use with automated dispensing machine 45 or that holder 1013' has been fully verified and that the medicament 1011 contents are in the correct cells 1033 and that holder 1013' is ready to be sealed by closure 1042.”). It would be obvious to one of ordinary skill in the art that only displaying a next instruction for scanning a next item (holder or dispensing machine) only after inputs for verifying all medicaments are received encompasses the claimed limitation.
Martucci in view of Eberting further in view of Chudy are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Chudy for the advantage of “facilitate[ing] more accurate item management and distribution” (Chudy; [0025]).
Regarding claim 35, this claim is rejected for the same reason as claims 27 and 29.
Regarding claim 36, this claim is rejected for the same reason as claims 28 and 29.
Claims 30 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Rezai (US 20210162216) in view of Martucci (US 20030135388) further in view of Carlberg (US 20120310669).
Regarding claim 30, Martucci in view of Eberting teaches the method of claim 23. Martucci in view of Eberting does not teach wherein a next item of the one or more items cannot be scanned at the scan-enabled client module until a threshold amount of time has elapsed after displaying the set of one or more instructions specific to the at least one item of the one or more items.
However, Carlberg does teach wherein a next item of the one or more items cannot be scanned at the scan-enabled client module until a threshold amount of time has elapsed after displaying the set of one or more instructions specific to the at least one item of the one or more items ([0060], “After sending the identifiers and their associated time stamp, the process continues at step S306 where the registration device prevents the scanning/obtaining of additional identifiers for a predetermined time-out period, thereby providing a minimum time interval separating the time stamps associated with identifiers that relate to different registration events.”).
Martucci in view of Eberting further in view of Chudy are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Chudy for the advantage of “prevent[ing] registration of further identifiers for a period sufficiently long to allow the host system to reliably associate measurement events and registration events” (Carlberg; [0060]).
Regarding claim 37, this claim is rejected for the same reason as claim 30.
Claims 31 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Rezai (US 20210162216) in view of Martucci (US 20030135388) further in view of Tandem (Tandem Diabetes Care, t:slim X2 Insulin Pump with Basal-IQ Technology User Guide, 2020, Tandem Diabetes Care).
Regarding claim 31, Martucci in view of Eberting teaches the method of claim 23. Martucci in view of Eberting does not teach wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a numbered list on the user interface.
However, Eberting in view of Tandem does teach wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a numbered list on the user interface (Tandem, pg. 76 Eberting, [0197], “FIG. 5 illustrates a screenshot of one possible embodiment of a GUI displaying a preview of an order form.” [0198], “For example, a physician may populate the order form 514 with data associated with a prescription. This data may include a clinic name, patient's info (name, date of birth, gender, email, and address), …, preparation information,…”). See pg. 76, below, which displays instructions in a numbered list of steps. It would be obvious to one of ordinary skill in the art that combining the GUI of Eberting, which displays prescription preparation information, with the numerical list of instructions of Tandem would result in the claimed limitation.
PNG
media_image2.png
485
741
media_image2.png
Greyscale
Martucci in view of Eberting further in view of Tandem are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Tandem for the advantage of “provid[ing] step-by-step instructions to help [a user] properly program, manage and care for the System.” (Tandem; pg. 21).
Regarding claim 38, this claim is rejected for the same reason as claim 31.
Claims 32 and 39 rejected under 35 U.S.C. 103 as being unpatentable over Rezai (US 20210162216) in view of Martucci (US 20030135388) further in view of Bauss (US 20170235919).
Regarding claim 32, Martucci in view of Eberting teaches the method of claim 23. Martucci in view of Eberting does not teach wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a video on the user interface.
However, Bauss does teach wherein the set of one or more instructions specific to the at least one item of the one or more items are displayed as a video on the user interface ([0043], “the targeted web page may include a video recording, that also could include a narrator, showing and describing how to use the device.”).
Martucci in view of Eberting further in view of Bauss are considered analogous to the claimed invention because they are in the field of managing prescription information. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martucci in view of Eberting with Bauss for the advantage of providing “high-quality, consistent and repeatable patient instruction” (Bauss; [0006]).
Regarding claim 39, this claim is rejected for the same reason as claim 32.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Verification Systems And Methods For High Risk Packaging Operations (US 20200265378), which teaches verification systems and methods for high risk packaging.
System And Method For Vial Amount Selection And Dosage Verification For Modularly Assembled Medicaments (US 20200098457), which teaches systems and methods for selecting vial amounts for a modular format medicament assembly and verifying contents of a medicament containers for a modular format medicament assembly including using scanning data-containing tags and unique serial numbers in order to verify that the medicaments match information entered in a software system to provide a quality control of medicament information administered to patients.
Systems And Methods For Medication Management (US 20190326006), which teaches a medication management system, having a pill dispensing system having: a funnel having an open bottom end; a tube holder; a tube having: a hollow interior; means for securing the tube to the tube holder, such that a rotational movement of the tube holder causes a same rotational movement of the tube; a pill receiving hole facing upwards when the pill dispensing system is not actuated, and providing access to the hollow interior; wherein the open bottom end is aligned with the pill receiving hole when the pill dispensing system is not actuated, such that the pill receiving hole is configured to receive a pill, the pill dropping from the funnel into and housed within the hollow interior; and means for causing the rotational movement, such that the pill receiving hole faces downwards and thus dispenses the pill housed within the hollow interior out of the pill dispensing system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID CHOI whose telephone number is (571)272-3931. The examiner can normally be reached M-Th: 8:30-5:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on (571)270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.C./Examiner, Art Unit 3684
/KENNETH BARTLEY/Primary Examiner, Art Unit 3684
