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 .
DETAILED ACTION
Response to Amendment
In the response dated 08 December 2025, the following occurred:
No claims were amended.
Claims 1-5, 10, and 11 are pending.
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 1-5, 10, and 11 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.
Claims 1 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite methods and systems for tray rationalization and supply optimization, and therefore meet step 1.
Step 2A1
The limitations of (Claim 1 being representative) determining and storing equipment information related to equipment inventory; determining and storing disposable article information related to disposable article inventory; determining and storing preference card information related to surgical equipment and disposable articles used during a procedure; determining a tray configuration for a procedure based on the preference card information, the equipment information, and the disposable article information, wherein the tray configuration identifies articles to be placed within an instrument tray; determining instrument usage information for articles placed within the instrument tray during the procedure; determining, based on the instrument usage information, whether the articles placed within the instrument tray are used at a frequency below a predetermined threshold; and in response to determining that the articles placed within the instrument tray are used at a frequency below the predetermined threshold, updating the preference card information and the tray configuration for the procedure, wherein updating the tray configuration comprises: […] predicting instrument buffer requirements based on aggregated benchmark data using… usage patterns across procedures; […] and generating optimized tray configurations that satisfy constraints across affected preference cards while minimizing total tray count through multi-dimensional constraint optimization, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
The limitations of …calculating mathematical overlap percentages between proposed tray configurations and existing trays across multiple preference cards simultaneously to identify consolidation opportunities; …calculating projected inventory requirements based on sterilization turnaround time, par stock standards, and historical volume data…, as drafted, is a process that, under the broadest reasonable interpretation, covers mathematical concepts but for recitation of generic computer components. The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people and/or covers mathematical calculations but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. That is, other than reciting a method and system implemented by a computer-readable storage medium and processor (a general-purpose computing device), the claimed invention amounts to organizing human activity and mathematical concepts. The abstract ideas identified in the claims are considered together as a single abstract idea for further analysis. Accordingly, the claims recite an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a hardware processor of a computer (claims 1 and 11) and a computer-readable storage medium (claim 1) that implement the identified abstract idea. The computing elements are not exclusively described by the applicant and are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims recite the additional elements of a network, at least one SaaS provider, and at least one SaaS user. The network, at least one SaaS provider, and at least one SaaS user merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
The claim further recites the additional element of using machine learning analysis to predict instrument buffer requirements. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). The Examiner notes that the machine learning-based software is described in the Specification at Para. 0062 as calculating coefficients and hyper parameters of a decision tree, using Bayesian algorithms or clustering algorithms, and using artificial neural networks and/or deep learning algorithms to develop models. Alternatively, or in addition, the implementation of machine learning-based software to the aggregated benchmark data merely confines the use of the abstract idea (i.e., the machine learning-based software) to a particular technological environment or field of use (the noted types of ML) and thus fails to add an inventive concept to the claims. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
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 using a general-purpose computer to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a network, at least one SaaS provider, and at least one SaaS user were considered to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more.
Claims 2-5 and 10 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim 2 merely describes receiving information. Claim 3 merely describes generating an alert. Claim 4 merely describes sending an alert. Claim 5 merely describes initiating data collection. Claim 10 merely describes displaying, receiving, and providing search results. Claim 10 further recites a user interface on a remote computer, which is considered to “generally link” under both the practical application and significantly more analysis.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-5, 10, and 11, the Examiner has considered the arguments but they are not persuasive. Applicant argues:
Ex parte Desjardins establishes that § 101 should not be used to reject claims that satisfy the traditional patentability requirements… "§§ 102, 103, and 112 are the traditional and appropriate tools to limit patent protection to its proper scope. These statutory provisions should be the focus of examination."
Regarding (a), the Examiner respectfully disagrees that Desjardins established that § 101 should not be evaluated. As cited above, Desjardins says 102, 103, and 112 should be the focus. 103 was initially the focus, and now that those matters have been resolved, 101 is the focus. Further, the Examiner is bound by the MPEP to determine whether all applicable statutory requirements are met.
The Claims Are Not Directed to “Organizing Human Activity” … They recite a specific computational process: calculating mathematical overlap percentages across multiple preference cards simultaneously, predicting buffer requirements through machine learning analysis of usage patterns, calculating projected inventory requirements from sterilization turnaround time, par stock standards, and historical volume data, and generating optimized configurations through multidimensional constraint optimization… The present claims involve no human interactions.
Regarding (b), the Examiner respectfully disagrees. The portions of the claim identified as certain methods of organizing human activity represent rules or instructions for a person or persons to follow to manage surgical trays. The argument that “The present claims do not recite the goal of managing surgical trays” is belied by the claim itself which is clearly directed to this; to argue otherwise defies logic. See also arguments at Pg. 8 (“Modem healthcare facilities must configure thousands of instruments into hundreds of trays….”). Because managing the content of a surgical tray has been a human activity since the advent of surgical trays, the identified portion of the claim fall under certain methods of organizing human activity. Applicant’s claimed invention may be a certain way of managing surgical trays, but that does not remove it from being certain methods of organizing human activity.
Further, Multiple CAFC decisions that the Office has characterized as Certain Method of Organizing Human Activity did not actively recite a person or persons performing the steps of the claims (see, e.g., EPG, TLI communications, Ultramercial). Because whether a human is required to perform the step of the claim is not a requirement for claims to encompass certain method of organizing human activity, this argument is not persuasive.
The calculating portions of the claim were determined to fall under “mathematical calculations and not certain methods of organizing human activity as indicated in the rejection. The word “multiple” indicates more than one, and therefore the claim is interpreted as calculating percentages across two preference cards. Further, calculating mathematical overlap percentages is a process that, under the broadest reasonable interpretation, covers mathematical concepts but for recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers mathematical calculations but for the recitation of generic computer components, then it falls within the “mathematical concepts” grouping of abstract ideas. The machine learning-based software has been analyzed as an additional element in the 101 rejection.
The Claims Do Not Recite Mental Processes… Calculating mathematical overlap percentages between proposed tray configurations and existing trays across multiple preference cards simultaneously requires processing configurations containing dozens of instruments against multiple preference cards and computing numerical percentages for each combination… The human mind is not equipped to track and calculate these relationships at that scale. Similarly, the machine learning analysis of usage patterns, the inventory projections integrating sterilization turnaround time with par stock standards and historical volume, and the multi-dimensional constraint optimization all require computational processing beyond human mental capacity.
Regarding (c), the Examiner respectfully submits that the abstract idea was not characterized as being directed to a mental process. The claimed invention was characterized as falling under Certain Methods of Organizing Human Activity and Mathematical Concepts (see Final Office Action dated 08/07/2025 at Pg. 5). As such, this argument cannot be persuasive.
The present case is at minimum a close call. The Examiner has acknowledged the claims are non-obvious, confirming they recite specific technical features. Under the Memorandum's guidance, this uncertainty should be resolved in favor of eligibility.
Regarding (d), the Examiner respectfully submits that the claims are not a “close call.” They are far from it. The Examiner does not dispute that the claims recite “specific technical features;” however, these features do not provide a practical application by any measure in MPEP 2106. Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).”
The Claims Are Directed to a Technological Improvement… Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) … The claims address a specific technical problem in healthcare inventory management.
Regarding (e), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves the functioning of a computer. See also MPEP 2106.05(a)(I). The technological environment of Applicant’s claim is a general-purpose computer. Applicant has not identified nor can the Examiner locate any physical improvement to the functioning of the computer that results from the implementation of Applicant’s claim. There is no indication that the computer is made to run faster, more efficiently, or utilize less power. In fact, the computer may be caused to operate slower and less efficiently through the implementation of Applicant’s claimed invention; we do not know. Because there is no improvement to the function of the computer, a practical application is not present. The claimed features are merely invoking a computer as a tool to implement an abstract idea. Further, Applicant’s claimed invention is not even remotely like that in Enfish because Applicant’s claims are not directed to a new form of database structure.
There is also no improvement to the recited machine learning. The Machine learning is merely used as a tool to perform prediction. This is not an improvement to the machine learning itself. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). The Examiner notes that the type of machine learning used by the claim is not even recited.
The Claims Recite Significantly More Than Any Judicial Exception… BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1350 (Fed. Cir. 2016) … The finding of non-obviousness necessarily implies that the ordered combination of claim elements is non-conventional… The claims recite an integrated system where mathematical overlap calculations inform consolidation decisions, machine learning predictions feed into inventory projections, and multidimensional constraint optimization generates configurations satisfying all constraints simultaneously.
Regarding (f), the Examiner respectfully disagrees. Mathematical overlap calculations and multidimensional constraint optimization are the abstract idea. The abstract idea cannot provide significantly more. MPEP 2106.05(I) states that it is only the additional elements that can provide practical application. Again, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted).” As such, the arguments are not persuasive.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Guru et al. (U.S. 2019/0328477) which discloses systems and methods for streamlining surgical processes.
Yates et al. (U.S. 2019/0201117) which discloses a cloud interface for coupled surgical devices.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683