DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/9/2025 has been entered.
Claims 1, 13, 19 and 20 have been amended. Claims 1, 3-13 and 15-20 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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, 3-13 and 15-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are directed to an abstract idea without significantly more.
Here, under step 1 of the Alice analysis, method claims 1, 3-13 and 15-18 are directed to a series of steps. Thus the claims are directed to a process.
Under step 2A Prong One of the analysis, the claimed invention is directed to an abstract idea without significantly more. The claims recite organizing a plurality of scripts, including receiving, performing, organizing, determining, communicating and operating steps.
The limitations of receiving, performing, organizing, determining, communicating and operating, are a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind, but for the recitation of generic computer components.
Specifically, the claim elements recite receiving a first plurality of batches, each of the first plurality of batches comprising a plurality of scripts identifying a plurality of drug products, respectively, and each of the first plurality of batches defining a first packaging sequence for the plurality of drug products identified by the plurality of scripts; receiving operational status information for each of a plurality of drug product packaging systems;
tuning an artificial intelligence engine by testing a plurality of functions to establish a quantitative relationship between first training batches defining first training packaging sequences and comprising first training scripts, which identify the plurality of drug products, and second training batches defining second training packaging sequences for the plurality of drug products;
organizing the plurality of scripts from the first plurality of batches into a second plurality of batches based on the operational status information received for each of the plurality of drug product packaging systems, the second plurality of batches defining a second packaging sequence for the plurality of drug products identified by the plurality of scripts;
determining a packaging order distribution among the plurality of drug product packaging systems for the plurality of batches based on the operational status information received for each of the plurality of drug product packaging systems and the urgency indicator;
communicating the second plurality of batches to the plurality of drug product packaging systems for packaging the plurality of drug products identified by the plurality of scripts; and operating the plurality of drug product packaging systems to package the plurality of drug products responsive to communicating the second plurality of batches to the plurality of drug product packaging systems.
That is, other than reciting tuning an artificial intelligence engine, nothing in the claim elements preclude the steps from practically being performed in the mind. If the claim limitations, under the broadest reasonable interpretation, cover performance of the limitations in the mind, but for the recitation of generic computer components, then they fall within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Here, method claims 1, 3-13 and 15-18 fail to recite any computer components implementing the method steps.
Under Step 2A Prong Two, the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This judicial exception is not integrated into a practical application. The claims include an artificial intelligence engine, and system claims comprising: a processor; and a memory. The artificial intelligence engine and system claims comprising: a processor; and a memory in the steps is recited at a high-level of generality, such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As a result, the claims are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of an artificial intelligence engine and system claims comprising: a processor; and a memory amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
None of the dependent claims recite additional limitations that are sufficient to amount to significantly more than the abstract idea. Claim 3 further describes the operational status information. Claims 4 and 5 recite additional identifying and organizing steps. Claim 6 further describes the modeling technique. Claim 7 further describes the plurality of drug product packaging systems. Claims 8-10 recite additional determining, communicating, and identifying steps. Claims 11 and 12 further describe determining, using the artificial intelligence engine, the packaging order distribution, and the modeling technique. Similarly, dependent claims 15-18 recite additional details that further restrict/define the abstract idea. A more detailed abstract idea remains an abstract idea.
Under step 2B of the analysis, the claims include, inter alia, tuning an artificial intelligence engine.
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
There isn’t any improvement to another technology or technical field, or the functioning of the computer itself. Moreover, individually, there are not any meaningful limitations beyond generally linking the abstract idea to a particular technological environment, i.e., implementation via a computer system. Further, taken as a combination, the limitations add nothing more than what is present when the limitations are considered individually. There is no indication that the combination provides any effect regarding the functioning of the computer or any improvement to another technology.
In addition, as discussed in paragraph 0056 of the specification, “Referring now to FIG. 7, a data processing system 700 that may be used to implement the batch and routing engine server 155 of FIG. 1, in accordance with some embodiments of the inventive concept, comprises input device(s) 702, such as a keyboard or keypad, a display 704, and a memory 706 that communicates with a processor 708. The data processing system 700 may further include a storage system 710, a speaker 712, and an input/output (I/O) data port(s) 714 that also communicate with the processor 708. The processor 708 may be, for example, a commercially available or custom microprocessor. The storage system 710 may include removable and/or fixed media, such as floppy disks, ZIP drives, hard disks, or the like, as well as virtual storage, such as a RAMDISK. The I/O data port(s) 714 may be used to transfer information between the data processing system 700 and another computer system or a network (e.g., the Internet). These components may be conventional components, such as those used in many conventional computing devices, and their functionality, with respect to conventional operations, is generally known to those skilled in the art.”
As such, this disclosure supports the finding that no more than a general purpose computer, performing generic computer functions, is required by the claims.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. See Alice Corporation Pty. Ltd. v. CLS Bank Int’l et al., No. 13-298 (U.S. June 19, 2014).
Response to Arguments
In the Remarks, Applicant argues Independent Claim 1 is amended to clarify that an artificial intelligence engine is tuned by testing a plurality of functions to establish a quantitative relationship between first training batches defining first training packaging sequences and comprising first training scripts, which identify a plurality of drug products, and second training batches defining second training packaging sequences for the plurality of drug products. Such embodiments are described, for example, in the Specification at paragraph 49, which states, in part: The machine learning engine 240 may process both the featured training data 205, including the labels provided by the labeling module 230, and may be configured to test numerous functions to establish a quantitative relationship between the featured and labeled input data and the predicted outputs. The machine learning engine 240 may use modeling techniques to evaluate the effects of various input data features on the predicted outputs. These effects may then be used to tune and refine the quantitative relationship between the featured and labeled input data and the predicted outputs. The tuned and refined quantitative relationship between the featured and labeled input data generated by the machine learning engine 240 is output for use in the AI engine 245.
Applicant submits that testing a plurality of functions to establish a quantitative relationship between first training batches and second training batches cannot be practically performed in the human mind and accordingly does not recite a mental process. MPEP § 2106.04(a)(2)(III)(A) citing Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1148 (Fed. Cir. 2016). Similarly, a human is not configured with an AI engine and a human mind cannot practically test various functions to determine a quantitative relationship between first training batches and second training batches, which is on a similar order of complexity as data encryption. MPEP 2106.04(a)(2)(III)(A) states that "a claim to a specific data encryption method for computer communication involving a several-step manipulation of data" cannot be practically performed in the human mind.
The claims stand in stark contrast to the MPEP's examples of claims directed to processes that can be performed in the human mind, as seen in MPEP §§ 2106.04(a)(2)(III)(A) and 2106.04(a)(2)(III)(B). The instant claims bear no resemblance to any such mental processes.
Furthermore, the USPTO Memo of September 4, 2025, includes a reminder that the mental process grouping is not without limits and that claim recitations should not be treated as a mental process if it cannot be practically performed in the human mind or with pen and paper. The mental process group should not be stretched to cover claim recitations that require machine-based operations, like those tied to AI models or hardware-executed functions. It is not reasonable to assert that the human mind is capable of testing multiple functions to establish a quantitative relationship between first and second training batches as recited in independent Claims 1, 13, 19, and 20.
Applicant submits that independent Claims 1, 13, 19, and 20, as amended, do not recite a judicial exception under the first prong of Step 2A. Thus, Applicant submits that the pending claims, as amended, are directed to statutory subject matter as not falling within any of the three categories of judicial exceptions. As a result, an evaluation of the Step 2A prong two and Step 2B are unnecessary. Nevertheless, for the sole sake of advancing prosecution, Applicant submits that even if independent Claims 1, 13, 19, and 20, as amended, were considered to recite a judicial exception, they integrate any alleged judicial exceptions into a practical application thereof under the second prong of Step 2A. Applicant submits that independent Claims 1, 13, 19, and 20 include recitations that integrate the claimed subject matter into a practical application as set forth, at least, in the fifth example directed to using the judicial exception in some meaningful so that the claim as a whole does not monopolize the exception.
Applicant submits that the novel and non-obvious recitations of independent Claims 1, 13, 19, and 20, as amended, are integrated into the practical application of generating a packaging order distribution for a plurality of drug products for packaging through a plurality of drug product packaging systems by testing multiple functions to establish a quantitative relationship between first and second training batches, which can then be used by an artificial intelligence to generate the packaging order distribution. Such operations are in alignment with the fifth MPEP example set forth above indicating that the claims are integrated into a practical application.
The Final Action states that the courts do not distinguish between claims that recite mental processed performed by humans and claims that recite mental processed performed on a computer. (Final Action, page 23). But as described above, it is not feasible for a person to test numerous functions in their mind to determine a quantitative relationship between first and second training batches as recited in the independent claims.
As described above with respect to example five of the Step 2A, Second Prong Analysis, independent Claims 1, 13, 19, and 20, as amended, include recitations that are directed to tuning an artificial intelligence engine by testing a plurality of functions to establish a quantitative relationship between first training batches defining first training packaging sequences and comprising first training scripts, which identify a plurality of drug products, and second training batches defining second training packaging sequences for the plurality of drug products. The claimed technique is confined to a particular application of generating a packaging order distribution for a plurality of drug products for packaging through a plurality of drug product packaging systems by testing multiple functions to establish a quantitative relationship between first and second training batches, which can then be used by an artificial intelligence to generate the packaging order distribution. The confinement to a particular useful application for generating a packaging order distribution for drug products amounts to significantly more than the judicial exception of mental processes. The Examiner respectfully disagrees.
As an initial note, here, unlike system claims 19 and 20, method claims 1, 3-13 and 15-18 fail to recite any computer components implementing the steps.
Following, as discussed in the MPEP 2106.04(a)(2)(III), “Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").”
As described in paragraph 0042 of Applicant’s specification, “The user 150 may interact with the packaging system server 120 to approve or override various recommendations made by the packaging system server 120 in operating the drug product packaging systems 130a and 130b. The user 150 may also initiate the running of various reports as described above for the drug product packaging systems 130a and 130b.”
Following, as discussed in the MPEP 2106.04(a)(2)(III)(C), “An example of a case in which a computer was used as a tool to perform a mental process is Mortgage Grader, 811 F.3d. at 1324, 117 USPQ2d at 1699. The patentee in Mortgage Grader claimed a computer-implemented system for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The interface prompts a borrower to enter personal information, which the grading module uses to calculate the borrower’s credit grading, and allows the borrower to identify and compare loan packages in the database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at 1695. The Federal Circuit determined that these claims were directed to the concept of "anonymous loan shopping", which was a concept that could be "performed by humans without a computer." 811 F.3d. at 1324, 117 USPQ2d at 1699. Another example is Berkheimer v. HP, Inc., 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in which the patentee claimed methods for parsing and evaluating data using a computer processing system. The Federal Circuit determined that these claims were directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform the processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53.” Importantly, here method claims 1, 3-13 and 15-18 fail to recite any computer components implementing the steps.
Under Step 2A Prong Two, the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Besides the abstract idea, the claims include tuning an artificial intelligence engine.
The tuning an artificial intelligence engine in the steps is recited at a high-level of generality, such that it amounts no more than mere instructions to apply the exception using a generic computer component. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Even when viewed in combination, the additional elements in the claims do no more than use computer components as a tool (i.e., tuning an artificial intelligence engine). There is no change to the computers and/or other technology recited in the claims, thus the claims do not improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
There isn’t any improvement to another technology or technical field, or the functioning of the computer itself. Moreover, individually, there are not any meaningful limitations beyond generally linking the abstract idea to a particular technological environment, i.e., implementation via a computer system. Further, taken as a combination, the limitations add nothing more than what is present when the limitations are considered individually. There is no indication that the combination provides any effect regarding the functioning of the computer or any improvement to another technology.
Allowable Subject Matter
With respect to independent claims 1 and 19, none of the prior art of record, taken individually or in any combination, teach inter alia, tuning an artificial intelligence engine by testing a plurality of functions to establish a quantitative relationship between first training batches defining first training packaging sequences and comprising first training scripts, which identify the plurality of drug products, and second training batches defining second training packaging sequences for the plurality of drug products; and organizing, using the artificial intelligence engine that was tuned, the plurality of scripts from the first plurality of batches into a second plurality of batches based on the operational status information received for each of the plurality of drug product packaging systems, the second plurality of batches defining a second packaging sequence for the plurality of drug products identified by the plurality of scripts.
With respect to independent claims 13 and 20, none of the prior art of record, taken individually or in any combination, teach inter alia, tuning an artificial intelligence engine by testing a plurality of functions to establish a quantitative relationship between first training batches defining first training packaging sequences and comprising first training scripts, which identify the plurality of drug products, and second training batches defining second training packaging sequences for the plurality of drug products; and determining, using the artificial intelligence engine that was tuned, a packaging order distribution among the plurality of drug product packaging systems for the plurality of batches based on the operational status information received for each of the plurality of drug product packaging systems and the urgency indicator.
Additionally, regarding the previously pending 35 USC 101 rejection, claims 19 and 20 as a whole, recite additional elements that integrate the judicial exception into a practical application, under Prong Two of Step 2A of the Alice analysis.
Specifically, claims 19 and 20 recite, inter alia, a processor; and a memory coupled to the processor and comprising computer readable program code embodied in the memory that is executable by the processor to perform operations comprising:…tuning an artificial intelligence engine by testing a plurality of functions to establish a quantitative relationship between first training batches defining first training packaging sequences and comprising first training scripts, which identify the plurality of drug products, and second training batches defining second training packaging sequences for the plurality of drug products.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE D BOYCE whose telephone number is (571)272-6726. The examiner can normally be reached M-F 10a-6:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rutao (Rob) Wu can be reached at (571) 272-6045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDRE D BOYCE/Primary Examiner, Art Unit 3623 December 23, 2025