DETAILED ACTION
Claims 1, 3-4, 6-13, 15-16 and 18-21 are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/27/2026 has been entered.
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, 3-4, 6-13, 15-16 and 18-21 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1, 3-4, 6-13, 15-16 and 18-21 are directed to a system (i.e., a machine). Accordingly, claims 1, 3-4, 6-13, 15-16 and 18-21 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, 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:
1. A medication compounding workstation system comprising:
a medication compounding workstation including:
a communications interface configured to receive a compounded medication dose order over a network in communication with a server,
a digital camera configured to record digital images,
a display screen, and
a processor communicatively coupled to the communications interface, the digital camera, and the display screen, the processor configured to:
receive or retrieve an electronically stored protocol having a sequence of a set of steps to prepare a compounded medication dose specified by the compounded medication dose order,
the protocol being electronically stored with a plurality of different protocols, wherein the processor is configured to determine the compounded medication dose order is associated with the protocol before retrieving the protocol,
sequentially display each step in the set of steps on the display screen to guide a pharmacy operator through the preparation of the compounded medication dose, wherein, for each step in the set of steps to prepare the compounded medication dose, the processor is configured to prompt the pharmacy operator for verification before moving to a next step that at least one of:
(1) a source medication container suitable for preparing the compounded medication dose, as identified in medication information recorded by the digital camera of the source medication container, is present at the medication compounding workstation, wherein the medication compounding workstation is configured to display an error in real-time requiring the pharmacy operator to repeat the respective step if the processor does not receive verification that the source medication container suitable for preparing compounded medication dose, is present at the medication compounding workstation, or
(2) if required by the step, a digital image corresponding to completion of the step is received, and
store in a database of the server the compounded medication dose order and information used to verify completion of each step in the set of steps to prepare the compounded medication dose, wherein the information used to verify completion of each step includes the digital image or a measurement performed by at least one of a scale, a hydrometer, or a spectrometer on at least one of a completed compounded medication dose, medication in the source medication container, or an intermediary mixture formed during one of the steps; and
a portal that is accessible remotely from the medication compounding workstation via the server and in communication with the database of the server that stores the compounded medication dose order and the information used to verify completion of each step in the set of steps to prepare the compounded medication dose, the portal configured to at least one of:
display the stored compounded medication dose order and the information used to verify completion of each step in the set of steps to prepare the compounded medication dose for subsequent inspection or approval of the completed compounded medication dose order,
receive and store in the database of the server a user input corresponding to approval or rejection of the completed compounded medication dose order, and
display reports relating to the preparation of a plurality of compounded medication doses.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because receiving dose orders, displaying compounding medication steps in a sequence, obtaining verification that each step has been performed, and displaying medication dose order information are associated with managing personal behavior or relationships or interactions between people such as managing interactions between a technician and a pharmacist. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Accordingly, independent claim 1 and analogous independent claim 13 recite at least one abstract idea.
Furthermore, dependent claims 3-4, 6-13, 15-16 and 18-21 further narrow the abstract idea described in the independent claims. Claims 3-4, 15-16 recites determining an associated protocol with a dose order; claims 6-8 and 18-19 recite obtaining verification data from another source and determining that the verification data is correct; claims 9-10 recite flagging medication errors and permitting future processing of a next order; claims 11-12 & 20-21 recite obtaining image data regarding a source container and labelling the container. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 1 and analogous independent claim 13, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: 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(II)(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(I)(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”):
1. A medication compounding workstation system comprising:
a medication compounding workstation including:
a communications interface configured to receive a compounded medication dose order over a network in communication with a server,
a digital camera configured to record digital images,
a display screen, and
a processor communicatively coupled to the communications interface, the digital camera, and the display screen, the processor configured to:
receive or retrieve an electronically stored protocol having a sequence of a set of steps to prepare a compounded medication dose specified by the compounded medication dose order,
the protocol being electronically stored with a plurality of different protocols, wherein the processor is configured to determine the compounded medication dose order is associated with the protocol before retrieving the protocol,
sequentially display each step in the set of steps on the display screen to guide a pharmacy operator through the preparation of the compounded medication dose, wherein, for each step in the set of steps to prepare the compounded medication dose, the processor is configured to prompt the pharmacy operator for verification before moving to a next step that at least one of:
(1) a source medication container suitable for preparing the compounded medication dose, as identified in medication information recorded by the digital camera of the source medication container, is present at the medication compounding workstation, wherein the medication compounding workstation is configured to display an error in real-time requiring the pharmacy operator to repeat the respective step if the processor does not receive verification that the source medication container suitable for preparing compounded medication dose, is present at the medication compounding workstation, or
(2) if required by the step, a digital image corresponding to completion of the step is received, and
store in a database of the server the compounded medication dose order and information used to verify completion of each step in the set of steps to prepare the compounded medication dose, wherein the information used to verify completion of each step includes the digital image or a measurement performed by at least one of a scale, a hydrometer, or a spectrometer on at least one of a completed compounded medication dose, medication in the source medication container, or an intermediary mixture formed during one of the steps; and
a portal that is accessible remotely from the medication compounding workstation via the server and in communication with the database of the server that stores the compounded medication dose order and the information used to verify completion of each step in the set of steps to prepare the compounded medication dose, the portal configured to at least one of:
display the stored compounded medication dose order and the information used to verify completion of each step in the set of steps to prepare the compounded medication dose for subsequent inspection or approval of the completed compounded medication dose order,
receive and store in the database of the server a user input corresponding to approval or rejection of the completed compounded medication dose order, and
display reports relating to the preparation of a plurality of compounded medication doses.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the workstation, communications interface, display screen, processor, portal, server with a database; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of a digital camera recording images and receive and store in the database of the server a user input corresponding, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering via a camera; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of transmitting data over a network (see MPEP § 2106.05(d)(II)).
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 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(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 13 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite 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:
Claim 8: This claim recite receiving data from various measurement devices and therefore merely represent insignificant extra-solution activity (e.g., receiving and transmitting data)(see MPEP § 2106.05(g)) and conventional activities as they merely consist of receiving and transmitting data over a network (see MPEP § 2106.05(d)(II)).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does 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.
As discussed above, regarding the additional limitations of the workstation, communications interface, display screen, processor, portal; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of a digital camera recording images and receive and store in the database of the server a user input corresponding which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea, the Examiner has reevaluated such limitation and determined it to not be unconventional as it merely consists of transmitting data over a network. See MPEP 2106.05(d)(II).
The dependent claims also 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 the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Regarding the additional limitations of recite receiving data from various measurement devices and therefore merely represent insignificant extra-solution activity (e.g., receiving and transmitting data)(see MPEP § 2106.05(g)) and conventional activities as they merely consist of receiving and transmitting data over a network (see MPEP § 2106.05(d)(II)). The Examiner has reevaluated such limitations and determined them to not be unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
Therefore, claims 1, 3-4, 6-13, 15-16 and 18-21 are ineligible under 35 USC §101.
Response to Arguments
Applicant’s arguments on pages 8-10 regarding claims 1,3-4,6-13,15-16 and 18-21 being rejected under 35 USC § 101 have been fully considered but they are not persuasive. Applicant claims that:
The configuration and operations performed by the compounding workstation provide a technology-based solution tied to the process of the preparation of compounded medication doses and include elements that are integral to the claimed solution and are not extra-solution activity.
The Examiner, however, asserts that the instant application fails to provide any description of a technical problem and a technical solution. Applicant’s specification presents a non-technical problem – ensuring proper preparation for compounded medication (see the instant Specification in para. 8). Merely reciting a generic computer performing generic computer functions that are well-understood, routine and conventional activities does not result in patent eligibility under Step 2A Prong 2. The instant claims and instant disclosure does not attempt to improve on an existing technology or technical field, but instead employs generic computing elements to solve a problem with the particular judicial exception of ensuring proper preparation for compounded medication. The solution to the problem is rooted in an improvement to the abstract idea itself and not a technical failure of a computer system or technology. The additional elements can best be characterized as tools to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2) see case requiring the use of software to tailor information and provide it to the user on a generic computer within the ""Other examples., v."")."
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kalies (US 8,744,868) teaches to a method for accumulating, storing and using pharmacy data using an electronic network as a communications and data transfer medium.
Reese (US 6,711,460) teaches to a pharmaceutical system and method of operation in which a single remote professional provides pharmaceutical care and oversight of multiple local pharmacies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/Primary Examiner, Art Unit 3619
