DETAILED ACTION
Claims 1, 3-4, 6-13, 15-16 and 18-21 are currently pending and have been examined.
This action is in response to the arguments filed on 1/2/2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/3/2025 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,
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 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 and in communication with the database 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, 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,
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 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 and in communication with the database 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, 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, 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, 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 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 8-11 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:
Similar to BASCOM and Desjardins, the claims recite a technology-based solution under Step 2B of the Alice test and recite an improvement to a technological field
The Examiner, however, asserts that that there is no indication here that the claimed invention addresses a problem specifically arising in the realm of a technology; the Applicant does not provide adequate evidence or technical reasoning how the process improves the efficiency of the technology or computer, as opposed to the efficiency of the process, or of any other technological aspect. The Examiner asserts that the claims are not similar to the examples seen in BASCOM or Desjardins. The BASCOM case contained limitations that included a non-conventional and non-generic arrangement of various computer components for filtering Internet content. The Desjardins case recited that the claimed improvement allows artificial intelligence (AI) systems to ‘us[e] less of their storage capacity’ and enables ‘reduced system complexity.’ The same cannot be said here. Applicant has not demonstrated that the arrangement of the workstation, communications interface, display screen, processor, and portal is non-conventional and non-generic. In addition, there is no improvement to a technology like artificial intelligence systems as was present in Desjardins. Further, the problems the invention is attempting to solve are ensuring compounded medications dosages are correctly prepared. These are not technological problems, but difficulties arising from verifying that a medication was prepared according to a protocol. The solution provided here has not been described or claimed as anything more than a generic use of existing technology performing based, purely conventional functions of a computer, including a workstation, communications interface, display screen, processor, and portal. Therefore, the Examiner asserts that the claims as a whole are not directed significantly more than an abstract idea.
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.
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 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