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 .
Status of the Claims
The office action is in response to the claims filed on December 3, 2025, for the application filed on October 13, 2023, which claims the benefit of U.S. Provisional Application No. 63/433,349 filed on December 16, 2022. Claims 2 – 6, 8, 10, 12 – 16, 18, and 20 have been cancelled, and claims 1, 7, 11, and 17 have been amended. Claims 1, 7, 9, 11, 17, and 19 are currently pending and have been examined as discussed below.
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, 7, 9, 11, 17, and 19 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.
Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the flowchart in MPEP 2016(III).
Eligibility Step 1:
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim as a whole falls within one of the statutory categories of invention (i.e., a process, machine, manufacture, or composition of matter). See MPEP 2106.03. In the instant application, claim 1, 7, and 9 are directed to a system (i.e., a machine), and claims 11, 17, and 19 are directed to a method (i.e., a process).
While each one of claims 1, 7, 9, 11, 17, and 19 appears to fall within one or more statutory categories of invention, the Office has determined that the full eligibility analysis is required because there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself. The eligibility of each claim is not self-evident at least because each claim as a whole did not appear to clearly improve a technology or computer functionality. To the contrary, each claim as a whole appeared to merely apply one or more judicial exceptions to a computer.
Accordingly, it has been determined that each one of claims 1, 7, 9, 11, 17, and 19 as a whole falls within one or more statutory categories under Step 1, and the Office proceeds with the full eligibility analysis (the Alice/Mayo test described in MPEP 2106(III)) as discussed below.
Eligibility Step 2A, Prong One:
Under Step 2A, Prong One of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim is directed to one or more of the judicial exceptions (i.e., an abstract idea, law of nature, or natural phenomenon). See MPEP 2106.04(II)(A)(1). After evaluation, it has been determined that claims 1, 7, 9, 11, 17, and 19 recite a judicial exception, i.e., a certain method of human activity (CMOHA).
Independent claims 1 and 11 are determined to be directed to a judicial exception because a CMOHA is recited in the claims. Regarding representative claim 1, the mental process is identified in the limitations in bold as:
A system comprising:
one or more processors;
an electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements;
a memory storing a plurality of instructions, which, when executed on the one or more processors, causes the system to:
provide a platform application enabling, from a plurality of computing devices, entry of inventory and usage records of one or more controlled substances for a medical practice;
receive, via the platform application from a first computing device, a request to record entry of a first controlled substance into a digital log book associated with the medical practice, the request specifying at least a date of the entry and a quantity of the first controlled substance;
receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance;
determine a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement;
generate, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container and comprising container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance;
associate, via the platform application, the virtual container object to the digital log book;
determine an expected quantity of the first controlled substance in the physical container based on dispensing records in the digital log book;
automatically compare the measured quantity to the expected quantity to detect whether a deviation is present;
in response to a detection of the deviation, automatically correct the deviation by updating one or more of the container-specific attributes of the virtual container object based on one or more predefined rules;
automatically determine, based on the updated container-specific attributes, that the physical container has become depleted;
automatically update the state attribute of the virtual container object to indicate that the physical container is closed; and
generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes.
Claim 1 recites the combination of limitations identified in bold as “determine a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement,” “determine an expected quantity of the first controlled substance in the physical container based on dispensing records in the digital log book,” “compare the measured quantity to the expected quantity to detect whether a deviation is present,” “in response to a detection of the deviation, … correct the deviation by updating one or more of the container-specific attributes … based on one or more predefined rules,” “determine, based on the updated container-specific attributes, that the physical container has become depleted,” “update the state attribute … to indicate that the physical container is closed,” and “generate an audit report of controlled substance usage for a specified time period.” A broadest reasonable interpretation of this combination amounts to monitoring audit log data associated with controlled substance inventory management. This activity may be practically performed in the human mind using observation, evaluation, judgment, and opinion, and thus represents an abstract idea falling in the “mental process” grouping.. With the exception of generic computer-implemented steps, there is nothing in each of claims 1 and 11 themselves that forecloses them from being performed by a human, mentally or with tools such as pen and paper. Thus, this activity is an abstract idea in the "mental process" grouping.
Accordingly, claims 1 and 11 recite a judicial exception under Step 2A, Prong One.
Dependent claims 7, 9, 17, and 19 are directed to one or more judicial exceptions (i.e., abstract idea exceptions) under Step 2A, Prong One of the full eligibility analysis as follows:
Regarding claims 7, 9, 17, and 19, each combination of limitations identified in bold as “the plurality of instructions further causes the system to … determine an accounting of the controlled substances for the specified time period based on at least a distribution of the controlled substances to respective virtual container objects over the specified time period; and generate the audit report based on the accounting of the controlled substances” in claims 7 and 17 and “the plurality of instructions further causes the system to ... update, via the platform application, the digital log book based on the one or more updates” in claims 9 and 19 defines the activity of monitoring audit log data associated with controlled substance inventory management. This activity may be practically performed in the human mind using observation, evaluation, judgment, and opinion, and thus represents an abstract idea falling in the “mental process” grouping. With the exception of generic computer-implemented steps, there is nothing in each of claims 7, 9, 17, and 19 themselves that forecloses them from being performed by a human, mentally or with tools such as pen and paper.
Accordingly, claims 7, 9, 17, and 19 recite a judicial exception under Step 2A, Prong One.
Eligibility Step 2A, Prong Two:
Claims 1 and 11 recite additional limitations beyond the judicial exception. Representative claim 1 recites the additional limitations identified in bold as:
A system comprising:
one or more processors;
an electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements;
a memory storing a plurality of instructions, which, when executed on the one or more processors, causes the system to:
provide a platform application enabling, from a plurality of computing devices, entry of inventory and usage records of one or more controlled substances for a medical practice;
receive, via the platform application from a first computing device, a request to record entry of a first controlled substance into a digital log book associated with the medical practice, the request specifying at least a date of the entry and a quantity of the first controlled substance;
receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance;
determine a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement;
generate, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container and comprising container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance;
associate, via the platform application, the virtual container object to the digital log book;
determine an expected quantity of the first controlled substance in the physical container based on dispensing records in the digital log book;
automatically compare the measured quantity to the expected quantity to detect whether a deviation is present;
in response to a detection of the deviation, automatically correct the deviation by updating one or more of the container-specific attributes of the virtual container object based on one or more predefined rules;
automatically determine, based on the updated container-specific attributes, that the physical container has become depleted;
automatically update the state attribute of the virtual container object to indicate that the physical container is closed; and
generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes.
Claim 1 recites the additional limitations identified in bold as “a system,” “one or more processors,” “an electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements,” “a memory storing a plurality of instructions, which, when executed on the one or more processors,” “provide a platform application enabling, from a plurality of computing devices, entry of inventory and usage records of one or more controlled substances for a medical practice,” “receive, via the platform application from a first computing device, a request to record entry of a first controlled substance into a digital log book associated with the medical practice, the request specifying at least a date of the entry and a quantity of the first controlled substance,” “receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance,” “generate, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container and comprising container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance,” “associate, via the platform application, the virtual container object to the digital log book,” “automatically compare the measured quantity to the expected quantity to detect whether a deviation is present,” “automatically correct the deviation by updating one or more of the container-specific attributes of the virtual container object based on one or more predefined rules,” “automatically determine, based on the updated container-specific attributes, that the physical container has become depleted,” “automatically update the state attribute of the virtual container object to indicate that the physical container is closed,” and “generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes.” Each of these elements is an additional limitation beyond the judicial exception. At best, looking at the combination of all additional elements and the judicial exception, the claim as a whole amounts to the activity of monitoring audit log data associated with controlled substance inventory management.
MPEP 2106.05(a) states: “In determining patent eligibility, examiners should consider whether the claim ‘purport(s) to improve the functioning of the computer itself’ or ‘any other technology or technical field.’… [A]n improvement in the abstract idea itself is not an improvement in technology.” Furthermore, MPEP 2106.05(a)(II) states: “Merely adding generic computer components to perform the method is not sufficient... Accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer.” In the instant application, claim 1 as a whole does not improve the functioning of the general-purpose computer components (i.e., the one or more processors, the electronic scale, the memory, the platform application, the plurality of computing devices, and the first computing device); nor does the claim as a whole improve any other technology or technical field. The processors, the electronic scale, the memory, the platform application, the plurality of computing devices, and the first computing device are general purpose computer components added post-hoc to the abstract idea of monitoring audit log data associated with controlled substance inventory management. The claim as a whole improves exclusively upon the abstract idea itself by automating the manual process of checking for missing entries and unmatched levels of controlled substance usage, such that the process is performed more quickly, more efficiently, and with less errors. See Paragraph [0006] of the Specification as filed and MPEP 2106.05(a). The claim as a whole represents mere instructions to apply the abstract idea to conventional and generic computer technology recited at a high level of generality. See MPEP 2106.05(f). The claim as a whole amounts to a process for monitoring audit log data that is executed on a general-purpose computer where the increased speed in the process comes solely from the capabilities of the general-purpose computer. Regarding the consideration under MPEP 2106.05(g), the limitations of “provide a platform application enabling, from a plurality of computing devices, entry of inventory and usage records of one or more controlled substances for a medical practice,” “receive, via the platform application from a first computing device, a request to record entry of a first controlled substance into a digital log book associated with the medical practice, the request specifying at least a date of the entry and a quantity of the first controlled substance,” and “receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance” are determined to not add no more than insignificant extra-solution activities to the judicial exception. These limitations represent the well-known pre-solution activity of necessary data gathering because it is incidental to the primary process of the claim as a whole (i.e., monitoring audit log data) and thus those limitations are merely nominal or tangential additions to the claim. The limitations of the digital log book and the virtual container object corresponding to the physical container merely amount to selecting information, based on types of information and availability of information in a computer environment, for collection, analysis and display. The step of generating an audit report is an insignificant computer implementation of insignificant extra-solution activity (i.e., data outputting). Regarding the consideration under MPEP 2106.05(h), the additional limitations, individually or in combination, also amount to merely indicating a field of use or technological environment in which to apply the judicial exception. In the instant application, the claim a whole does no more than link the abstract idea (i.e., monitoring audit log data) to the particular technological environment of computers. Thus, the additional limitations fail to add an inventive concept to the claims.
Accordingly, in view of these considerations, the Office has determined that the claims 1 and 11 do not have one or more additional limitations, individually or in combination, that sufficiently integrate the abstract idea exception into a practical application under Step 2A, Prong Two, and thus each claim as a whole is directed to a judicial exception..
Dependent claims 7, 9, 17, and 19 present additional information in tandem with further details regarding elements and the abstract idea from an associated one of independent claims 1 and 11 and are therefore directed to an abstract idea for similar reasons as given Under Step 2A, Prong One above. Claims 7, 9, 17, and 19 further recite additional limitations, and these additional limitations fail to integrate the abstract idea into a practical application under Step 2A, Prong Two as follows:
Claims 7, 9, 17, and 19 recite the additional limitations identified in bold as “the plurality of instructions further causes the system to: receive, via the platform application and from the first computing device, a request to generate the audit report for the inventory and usage of the one or more controlled substances over the specified time period; determine an accounting of the controlled substances for the specified time period based on at least a distribution of the controlled substances to respective virtual container objects over the specified time period; and generate the audit report based on the accounting of the controlled substances” in claims 7 and 17 and “the plurality of instructions further causes the system to: receive, via the platform application, one or more updates relating to a usage of the first controlled substance from a practice management system of the medical practice; and update, via the platform application, the digital log book based on the one or more updates” in claims 9 and 19. Each of these elements in bold is an additional limitation beyond the judicial exception. At best, looking at the combination of all additional elements and the judicial exception, each claim as a whole defines the activity of monitoring audit log data associated with controlled substance inventory management.
Regarding the consideration under MPEP 2106.05(a), each one of claims 7, 9, 17, and 19 as a whole does not improve the functioning of the general-purpose computer components (i.e., the one or more processors, the electronic scale, the memory, the platform application, the plurality of computing devices, and the first computing device); nor does each claim as a whole improve any other technology or technical field. The Office has determined that each claim amounts to these general purpose computer components being added post-hoc to the abstract idea of monitoring audit log data. Each claim as a whole improves exclusively upon the abstract idea itself by automating the manual process of checking for missing entries and unmatched levels of controlled substance usage, such that the process is performed more quickly, more efficiently, and with less errors. See Paragraph [0006] of the Specification as filed and MPEP 2106.05(a). The claim as a whole represents mere instructions to apply the abstract idea to conventional and generic computer technology recited at a high level of generality. See MPEP 2106.05(f). The claim as a whole amounts to a process for monitoring audit log data that is executed on a general-purpose computer where the increased speed in the process comes solely from the capabilities of the general-purpose computer. Regarding the consideration under MPEP 2106.05(g), the limitations of “receive, via the platform application and from the first computing device, a request to generate the audit report for the inventory and usage of the one or more controlled substances over the specified time period,” and “receive, via the platform application, one or more updates relating to a usage of the first controlled substance from a practice management system of the medical practice” are determined to not add no more than insignificant extra-solution activities to the judicial exception. These limitations represent the well-known pre-solution activity of necessary data gathering because it is incidental to the primary process of the claim as a whole (i.e., monitoring audit log data) and thus those limitations are merely nominal or tangential additions to the claim. The step of updating the digital book is an insignificant computer implementation of insignificant extra-solution activity (i.e., data outputting). Regarding the consideration under MPEP 2106.05(h), the additional limitations, individually or in combination, also amount to merely indicating a field of use or technological environment in which to apply the judicial exception. In the instant application, the claim a whole does no more than link the abstract idea (i.e., monitoring audit log data) to the particular technological environment of computers. Thus, the additional limitations fail to add an inventive concept to the claims.
Accordingly, in view of these considerations, the Office has determined that each one of claims 7, 9, 17, and 19 as a whole does not integrate the abstract idea exception into a practical application under Step 2A, Prong Two, and thus each claim as a whole is directed to a judicial exception under Step 2A.
Eligibility Step 2B:
Regarding independent claims 1 and 11, the Office carries over its identification of the additional elements (and combinations thereof) from Step 2A, Prong Two so as to apply the same additional elements in Step 2B. See MPEP 2106.05(II). The Office further carries over its conclusions from the considerations discussed in MPEP 2106.05(a) through (c), (e) through (h) in Step 2A, Prong Two so as to apply the same considerations in Step 2B.
Under Step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claim provides an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, each claim as a whole does not provide an improvement to technology or technical field under MPEP 2106.05(a). The additional limitations amount to mere instructions to apply an abstract idea under MPEP 2106.05(f) and/or necessary data gathering and/or outputting under MPEP 2106.05(g). Each claim as a whole recites monitoring audit log data received, transmitted, stored, and received in association with controlled substance inventory management at a high level of generality. These functions are claimed, individually and in combination, in a merely generic manner such that each claim as a whole represents the well‐understood, routine, and conventional functions of receiving and transmitting data over a network to gather data, electronic recordkeeping, and storing and retrieving information in memory. Evidence that receiving and transmitting data over a network to gather data, electronic recordkeeping, and storing and retrieving information in memory are well‐understood, routine, and conventional functions is provided by MPEP 2106.05(d), subsection II.
Furthermore, looking at the limitations individually or as any ordered combination adds nothing that is not already present when looking at each claim as a whole. There is no indication that the individual elements or combinations of elements amount to an inventive concept.
Therefore, claims 1 and 11 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Regarding claims 7, 9, 17, and 19, the Office carries over its determination from Step 2A, Prong Two that claims 7, 9, 17, and 19 further recite additional limitations and claims 3 – 8 and 13 – 18 do not recite additional elements so as to apply the same determination in Step 2B. See MPEP 2106.05(II). The Office further carries over its conclusions from the considerations discussed in MPEP 2106.05(a) through (c), (e) through (h) in Step 2A, Prong Two so as to apply the same considerations in Step 2B. The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. Claims 7, 9, 17, and 19 further recite additional limitations, and these additional limitations do not amount to significantly more than the judicial exception under Step 2B as follows:
Each claim as a whole does not provide an improvement to technology or technical field under MPEP 2106.05(a), but rather only improves the abstract idea itself. Each claim as a whole amounts to mere instructions to apply the abstract idea to general-purpose computer components (i.e., the one or more processors, the electronic scale, the memory, the platform application, the plurality of computing devices, and the first computing device) under MPEP 2106.05(f). Each claim as a whole amounts to necessary data gathering and/or outputting under MPEP 2106.05(g). The general-purpose computer components are recited at a high level of generality, with their functions claimed in a merely generic manner such that each claim as a whole represents the well‐understood, routine, and conventional functions of receiving and transmitting data over a network to gather data, electronic recordkeeping, and storing and retrieving information in memory. Evidence that receiving and transmitting data over a network to gather data, electronic recordkeeping, and storing and retrieving information in memory are well‐understood, routine, and conventional functions is provided by MPEP 2106.05(d), subsection II.
Therefore, claims 7, 9, 17, and 19 are 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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 1 and 11 are rejected under 35 U.S.C. 103(a) as being unpatentable over D’Amato (U.S. Pub. No. 2018/0247703 A1) in view of Abal (U.S. Pub. No. 2021/0358257 A1), Yuyama (U.S. Pub. No. 2008/0083769 A1), and Burgess (U.S. Pub. No. 2021/0027259 A1).
Regarding independent claims 1 and 11, D’Amato teaches the limitations of representative claim 1 in bold as:
A system (Paragraphs [0036] and [0040] of D’Amato. In the instant application, the broadest reasonable interpretation of “system” reads on the medication administration auditing computing system in D’Amato (Paragraphs [0036] and [0040]).) comprising:
one or more processors (Paragraph [0040] of D’Amato. In the instant application, the broadest reasonable interpretation of “one or more processors” reads on the processor in D’Amato (Paragraph [0040]).);
an electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements;
a memory storing a plurality of instructions, which, when executed on the one or more processors (Paragraph [0040] of D’Amato. In the instant application, the broadest reasonable interpretation of “a memory storing a plurality of instructions, which, when executed on the one or more processors” reads on the storage media in D’Amato (Paragraph [0040]) including an analysis application and a reporting application, with the analysis application being a software module that is executed by processor(s).), causes the system to:
provide a platform application enabling, from a plurality of computing devices, entry of inventory and usage records of one or more controlled substances for a medical practice (Paragraphs [0037] and [0041] – [0042] of D’Amato. In the instant application, the broadest reasonable interpretation of “provide a platform application enabling, from a plurality of computing devices, entry of inventory and usage records of one or more controlled substances for a medical practice” reads on the medication dispensing control module in D’Amato (Paragraphs [0037] and [0041] – [0042]) for each of one or more automated medication dispensing stations (AMDS), with each medication dispensing control module being a software module that manages controlled access to the appropriate drawers, pockets, or bins and further stores and analyzes AMDS data, e.g., inventory and usage records for a medical practice.);
receive, via the platform application from a first computing device, a request to record entry of a first controlled substance into a digital log book associated with the medical practice, the request specifying at least a date of the entry and a quantity of the first controlled substance (Paragraphs [0029], [0042] – [0043], and [0047] of D’Amato. In the instant application, the broadest reasonable interpretation of “first controlled substance” reads on the controlled substance in D’Amato (Paragraph [0029]). The broadest reasonable interpretation of “receive, via the platform application from a first computing device, a request to record entry of a first controlled substance into a digital log book associated with the medical practice, the request specifying at least a date of the entry and a quantity of the first controlled substance” reads on the activity in D’Amato (Paragraphs [0042] – [0043] and [0047]) of receiving, via the system (and its medication dispensing control module) from the AMDS, AMDS data for storage in a data store or other data storage media, with the AMDS transaction data including the name of the medication, the amount of the medication, and the time and date.);
receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance (Paragraphs [0029], [0042] – [0043], and [0047] of D’Amato. In the instant application, the broadest reasonable interpretation of “receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance” reads on the activity in D’Amato (Paragraphs [0042] – [0043] and [0047]) of receiving, via the system (and its medication dispensing control module) from the AMDS, AMDS transaction data, e.g., the amount of removed/dispensed medication.);
determine a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement;
generate, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container and comprising container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance (Paragraph [0041] of D’Amato. In the instant application, the broadest reasonable interpretation of “the platform application” reads on the medication dispensing control module in D’Amato (Paragraph [0041]).);
associate, via the platform application, the virtual container object to the digital log book;
determine an expected quantity of the first controlled substance in the physical container based on dispensing records in the digital log book (Paragraphs [0003] – [0004] and [0150] of D’Amato. In the instant application, the broadest reasonable interpretation of “determine an expected quantity of the first controlled substance in the physical container based on dispensing records in the digital log book” reads on the activities in D’Amato (Paragraphs [0003] – [0004] and [0150]) of determining, from the electronic health record data stored in the data store or other storage media, medication orders and comparing medication orders, ADMS transactions, and/or infusion pump history to determine expected waste amounts.);
automatically compare the measured quantity to the expected quantity to detect whether a deviation is present (Paragraphs [0003] – [0004] and [0150] of D’Amato. In the instant application, the broadest reasonable interpretation of “automatically compare the measured quantity to the expected quantity to detect whether a deviation is present” reads on the activities in D’Amato (Paragraphs [0003] – [0004] and [0150]) of comparing the actual waste amounts determined by assay with the expected waste amounts.);
in response to a detection of the deviation, automatically correct the deviation by updating one or more of the container-specific attributes of the virtual container object based on one or more predefined rules (Paragraphs [0198] – [0199] of D’Amato. In the instant application, the broadest reasonable interpretation of “updating one or more of the container-specific attributes of the virtual container object” reads on the volume discrepancies of D’Amato (Paragraphs [0198] – [0199]) greater than a predetermined threshold being documented via the electronic controlled substance discrepancy form using the virtual container of Yuyama.);
automatically determine, based on the updated container-specific attributes, that the physical container has become depleted;
automatically update the state attribute of the virtual container object to indicate that the physical container is closed; and
generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes (Paragraphs [0040] and [0134] of D’Amato. In the instant application, the broadest reasonable interpretation of “generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes” reads on the activity in D’Amato (Paragraphs [0040] and [0134]) of automatically generating reports or alerts on a periodic basis.);
D'Amato does not appear to explicitly disclose, but Abal teaches the “an electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements” (Paragraph [0042] of Abal. In the instant application, the broadest reasonable interpretation of “an electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements” reads on the scales, load cells, and/or weight sensors in Abal (Paragraph [0042]) configured to measure and/or calculate a weight of the medication wasted and deposited into the waste container. i.e., measure a total weight of the medication waste container and the waste deposited into the medication waste container, with the sensors coupled to the controller to transmit signals indicative of the weight measurements to the controller.).
D'Amato does not appear to explicitly disclose, but Abal teaches the “receive, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance” (Paragraphs [0044] and [0097] of Abal. In the instant application, the broadest reasonable interpretation of “a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance” reads on the activity in Abal (Paragraphs [0044] and [0097]) of measuring and/or calculating a total combined weight of the container and any medication deposited in the container and a total combined weight of the container and any medication remaining in the container after medication is removed from the container.).
D'Amato does not appear to explicitly disclose, but Abal teaches the “determine a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement” (Paragraphs [0042], [0044], [0055], and [0062] of Abal. In the instant application, the broadest reasonable interpretation of “determine a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement” reads on the activity in Abal (Paragraphs [0042], [0044], [0055], and [0062]) of determining the measured weight of waste medication deposited into the waste container based on measuring the change in measured total weight. It was well-known in the art of pharmaceutical inventory management at the time of filing that the activity of measuring change in the total combined weight of a container and any medication therein, e.g. before and after medication is removed from the container.)
D'Amato does not appear to explicitly disclose, but Yuyama teaches the “generate, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container and comprising container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance” (Paragraphs [0042] – [0043] of Yuyama. In the instant application, the broadest reasonable interpretation of “generate … a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container” reads on the container map in Yuyama (Paragraphs [0042] – [0043]) dividing the interior of the physical tray (into which the drugs are disposed) into a plurality of container virtual regions, with the container map being stored in the storage device to associate with the drugs disposed within the physical tray.).
D'Amato does not appear to explicitly disclose, but Burgess teaches the “generate, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container and comprising container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance” (Paragraphs [0043], [0063], and [0104] of Burgess. In the instant application, the broadest reasonable interpretation of “container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed” reads on the event log in Burgess (Paragraphs [0043], [0063], and [0104]) used to determine when the container was open and/or closed (i.e., time and date details) and the capacity and/or fill threshold of container).).
D’Amato does not appear to explicitly disclose, but Yuyama teaches the “associate, via the platform application, the virtual container object to the digital log book” (Paragraph [0042] of Yuyama. In the instant application, the broadest reasonable interpretation of “associate, via the platform application, the virtual container object to the digital log book” reads on the activity in Yuyama (Paragraph [0042]) of imparting an identification number to each container virtual region in the container map and soring the container map in the storage device according to the kind of physical tray/container.).
D’Amato does not appear to explicitly disclose, but Abal teaches the limitation identified in bold as: “in response to a detection of the deviation, automatically correct the deviation by updating one or more of the container-specific attributes of the virtual container object based on one or more predefined rules” (Paragraph [0101] of Abal. In the instant application, the broadest reasonable interpretation of “in response to a detection of the deviation, automatically correct the deviation … based on one or more predefined rules” reads on the activity in Abal (Paragraph [0101]), in response to determining a suspected diversion (i.e., deviation), generating an alert, flagging the wasting workflow for later audit, generating an alert at a remote location, etc.).
D'Amato does not appear to explicitly disclose, but Yuyama teaches the “automatically determine, based on the updated container-specific attributes, that the physical container has become depleted” (Paragraphs [0060] – [0066] of Yuyama, [I]f it is determined that the corresponding virtual container area is empty for all medicine virtual areas, the upper side of all the virtual container areas determined to be empty is displayed. In the instant application, the broadest reasonable interpretation of “automatically determine, based on the updated container-specific attributes, that the physical container has become depleted” reads on the activity in Yuyama (Paragraphs [0060] – [0066]) of determining that all container virtual regions exhibit absence data and thus the associated regions in the physical container are vacant.).
D'Amato does not appear to explicitly disclose, but Yuyama teaches the “automatically update the state attribute of the virtual container object to indicate that the physical container is closed” (Paragraph [0043] of Burgess. In the instant application, the broadest reasonable interpretation of “automatically update the state attribute of the virtual container object to indicate that the physical container is closed” reads on the activity in Burgess (Paragraph [0043]) of maintaining/updating an event log to determine when the waste container was closed.).
D'Amato does not appear to explicitly disclose, but Yuyama teaches the limitations identified in bold as “generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes” (Paragraphs [0042] – [0043] of Yuyama. In the instant application, the broadest reasonable interpretation of “at least the virtual container object” reads on the container map in Yuyama (Paragraphs [0042] – [0043]) and the activity in Burgess (Paragraph [0043]) of maintaining/updating an event log to determine when the waste container was closed.), and Burgess teaches the “generate an audit report of controlled substance usage for a specified time period based on at least the virtual container object and the updated container-specific attributes” (Paragraph [0043] of Burgess. In the instant application, the broadest reasonable interpretation of “the updated container-specific attributes” reads on the event log in Burgess (Paragraph [0043]) being maintained/updated to indicate when the waste container was closed.).
Therefore, it would have been obvious to one of ordinary skill in the art of pharmaceutical inventory management to modify the system and method of D’Amato to include: the electronic scale configured to obtain weight measurements and transmit signals indicative of the weight measurements, the activity of receiving, from the electronic scale, a first weight measurement and a second weight measurement of a physical container that includes the first controlled substance, the activity of determining a measured quantity of the controlled substance based on the first weight measurement and the second weight measurement, and the activity, in response to a detection of the deviation, of automatically correcting the deviation … based on one or more predefined rules, as taught by Abal (Paragraphs [0042], [0044], [0055], [0062], [0097], [0101]) in order to provide incentives to not engage in predatory or improper practices, such as the diversion of medication and/or improper wasting of medication, and to identify clinicians or other users who may be engaged in the predatory practices (Paragraph [0024] of Abal); implement the activity of generating, via the platform application, a virtual container object stored in the memory to associate with the first controlled substance, the virtual container object corresponding to the physical container, the activity of associating, via the platform application, the virtual container object to the digital log book, the activity of automatically determining, based on the updated container-specific attributes, that the physical container has become depleted, and the virtual container object, as taught by Yuyama (Paragraphs [0042] – [0043], [0060] – [0066]) in order to provide an article dispensing device that is capable of dispensing articles such that they can be accommodated in the limited space in the tray appropriately without involving any inutile space (Paragraph [0004] of Yuyama); and implement the container-specific attributes including a capacity attribute, a state attribute indicating whether the physical container is unopened, open, or closed, and the at least the date of the entry and the quantity of the first controlled substance, the activity of automatically updating the state attribute of the virtual container object to indicate that the physical container is closed, and the updated container-specific attributes, as taught by Burgess (Paragraphs [0043], [0063], and [0104]) in order to determine when the diversion actually occurred and to further identify the person or persons responsible for the diversion (Paragraph [0025] of Burgess).
Regarding claims 7 and 17, D’Amato as modified by Abal, Yuyama, and Burgess and applied to an associated one of claims 1 and 11 teaches the limitations of representative claim 7 identified in bold as:
receive, via the platform application and from the first computing device, a request to generate the audit report for the inventory and usage of the one or more controlled substances over the specified time period (Paragraphs [0040] and [0134] of D’Amato. In the instant application, the broadest reasonable interpretation of “receive, via the platform application and from the first computing device, a request to generate the audit report for the inventory and usage of the one or more controlled substances over the specified time period” reads on the activity in D’Amato (Paragraphs [0040] and [0134]) of the user requesting that the processor generate reports concerning the medication auditing analysis or reports on a periodic basis.);
determine an accounting of the controlled substances for the specified time period based on at least a distribution of the controlled substances to respective virtual container objects over the specified time period (Paragraphs [0076] – [0077] of D’Amato. In the instant application, the broadest reasonable interpretation of “determine an accounting of the controlled substances for the specified time period based on at least a distribution of the controlled substances to respective virtual container objects over the specified time period” reads on the activity in D’Amato (Paragraphs [0076] – [0077]) of determining the net amount of medication dispensed from the AMDS for comparison, accounting for remove, return to stock, return to external bin, cancel, and waste transactions.); and
generate the audit report based on the accounting of the controlled substances (Paragraphs [0044] – [0045] and [0134] of D’Amato. In the instant application, the broadest reasonable interpretation of “generate the audit report based on the accounting of the controlled substances” reads on the activity in D’Amato (Paragraphs [0044] – [0045] and [0134]) of generating, by the reporting application 136, a variety of reports to provide users with both qualitative and quantitative data regarding auditing of medication administration, such as the report over the time periods (e.g., February 1-28 of 2012, February 1-28 of 2013, February 1-28 of 2014, February 1-18 of 2015).).
Regarding claims 9 and 19, D’Amato as modified by Abal, Yuyama, and Burgess and applied to an associated one of claims 1 and 11 teaches the limitations of representative claim 9 identified in bold as:
receive, via the platform application, one or more updates relating to a usage of the first controlled substance from a practice management system of the medical practice (Paragraphs [0198] – [0199] of D’Amato. In the instant application, the broadest reasonable interpretation of “receiving, via the platform application, one or more updates relating to a usage of the first controlled substance from a practice management system of the medical practice” reads on the activity in D’Amato (Paragraphs [0198] – [0199]) of documenting volume discrepancies greater than a predetermined threshold for future testing.); and
update, via the platform application, the digital log book based on the one or more updates (Paragraph [0199] of D’Amato. In the instant application, the broadest reasonable interpretation of “update, via the platform application, the digital log book based on the one or more updates” reads on the activity in D’Amato (Paragraph [0199]) of maintaining/updating the electronic controlled substance discrepancy form in the appropriate database.).
Response to Argument
Applicant's amendment filed December 3, 2025 regarding the objections to claims 1 and 11 have been fully considered and are persuasive. Thus, the objections to claims 1 and 11 have been withdrawn.
Applicant's argument filed December 3, 2025 regarding claims 1 – 20 being rejected under 35 USC § 101 have been fully considered but they are moot in view of the new grounds of rejection necessitated by the amendment.
In Applicant’s response (Amendment filed December 3, 2025), extensive subject matter (including subject matter not previously presented in original claims 1 – 20) were added to independent claims 1 and 11.
Applicant's argument filed December 3, 2025 regarding claims 1 – 20 being rejected under 35 U.S.C. § 103 have been fully considered but they are moot in view of the new grounds of rejection necessitated by the amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/V.C.I./Examiner, Art Unit 3686
/DEVIN C HEIN/Examiner, Art Unit 3686