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 .
Claims 1 and 7 are amended. Claims 1-10 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 1-10 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 1-9 are drawn to a method for programming an automated medical device reprocessing equipment, which is within the four statutory categories (i.e. process). Claim 10 is drawn to a non-transitory computer readable medium, which is within the four statutory categories (i.e. manufacture).
Claim 1 recites a method for programming an automated medical device reprocessing equipment for automatic execution of a plurality of procedural steps including at least one of: automated chemical cleaning and disinfection, thermal sterilization, drying, and storage, the method comprising:
acquiring, by a processor (MPEP § 2106.05(f), apply it), log data corresponding to completed reprocessing procedures including the plurality of procedural steps, the log data including, for each procedural step of a completed reprocessing procedure:
a type of procedural step,
an identifier of a medical device undergoing the procedural step,
a start time of the procedural step,
a duration or an end time of the procedural step, and
a success indicator of the procedural step;
analyzing, by the processor (MPEP § 2106.05(f), apply it), the plurality of procedural steps across the completed reprocessing procedures by compiling, for each completed reprocessing procedure, a sequence string including an ordered list of data elements representing the type of each procedural step performed in the completed reprocessing procedure, counting how often each sequence string occurs, identifying a sequence string having a highest count as a standard sequence of procedural steps, and comparing one or more deviating sequence strings with the standard sequence of procedural steps to identify one or more deviations from the standard sequence of procedural steps;
calculating, by the processor (MPEP § 2106.05(f), apply it), a duration value for each procedural step;
based on the identified standard sequence of procedural steps and the one or more deviations from the standard sequence of procedural steps, computing, by the processor (MPEP § 2106.05(f), apply it), a process description of a semi-automated or automated reprocessing procedure including the duration value for each procedural step;
connecting, by the processor (MPEP § 2106.05(f), apply it), the automated medical device reprocessing equipment to a database storing the process description;
downloading, by the processor (MPEP § 2106.05(f), apply it), from the database to the automated medical device reprocessing equipment (MPEP § 2106.05(g), insignificant extra solution activity), the process description including a description of the procedural steps to be executed by the automated medical device reprocessing equipment and corresponding relevant process parameters for execution of the procedural steps, the corresponding relevant process parameters including the duration value for each procedural step; and
programming, by the processor (MPEP § 2106.05(f), apply it), the automated medical device reprocessing equipment using the downloaded description of the procedural steps and the downloaded corresponding relevant process parameters including the duration value for each procedural step.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the method of organizing human activity are underlined and deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 2-10 include other limitations, for example Claim 2 recites computing, by the processor (MPEP § 2106.05(f), apply it), for at least one procedural step, a process constraint selected from a minimum duration and a maximum duration of the procedural step, Claim 3 recites identifying, by the processor (MPEP § 2106.05(f), apply it), undocumented procedural steps of the semi-automated or automated reprocessing procedure, and including such undocumented procedural steps in the process description, Claim 4 recites identifying, by the processor (MPEP § 2106.05(f), apply it), fallback loops of the semi-automated or automated reprocessing procedure, Claim 5 recites identifying, by the processor (MPEP § 2106.05(f), apply it), variations in one procedural step correlating with variations and/or absence of a preceding procedural step, Claim 6 recites wherein the log data comprises log data of reprocessing procedures applied to different types of medical devices, the method further comprising computing, by the processor (MPEP § 2106.05(f), apply it), separate process descriptions for each type of medical device, Claim 7 recites wherein the log data includes a type indicator of the medical device undergoing semi-automated or automated reprocessing procedure, Claim 8 recites wherein the log data includes log data of reprocessing procedures applied at different locations and data identifying a location at which a respective reprocessing procedure has been applied, Claim 9 recites identifying, by the processor (MPEP § 2106.05(f), apply it), differences between corresponding procedural steps at different locations, Claim 10 recites a one or more non-transitory computer readable storage media and program instructions stored on the one or more non-transitory computer readable storage media, the program instructions including instructions to execute method of claim 1 (MPEP § 2106.05(f), apply it) to execute the method claim 1, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Furthermore, Claims 1-10 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of processor, non-transitory computer readable medium, and computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see page 5 of the present Specification, see MPEP 2106.05(f);
add insignificant extra-solution activity to the abstract idea – for example, the recitation of downloading/storing data, which amounts to an insignificant application, see MPEP 2106.05(g); and
generally link the abstract idea to a particular technological environment or field of use – for example, the recitation of a computer, which amounts to limiting the abstract idea to the field of computing, see MPEP 2106.05(h)).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Page 5 of the Specification discloses that the additional elements (i.e. computer, processor, non-transitory computer readable medium) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well-understood, routine, and conventional activities (i.e. downloading data) previously known to the pertinent industry (i.e. healthcare).
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives process descriptions data, and transmits the data from the database to the automated medical device reprocessing equipment, for example the Internet;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of instructions data on a database and/or electronic memory.
Dependent Claims 2-10 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims repeat those found in the independent claim or include elements such as a computer recited at the apply level as found in claim 10.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-10 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
The prior art of recording, including Cousin (U.S. Pub. No. 2021/0151174 A1), Carlson (U.S. Pub. No. 2016/0008079 A1), Lenzenhuber (U.S. Pub. No. 2024/0170140 A1), Flynn (U.S. Pub. No. 2024/0347185 A1) and Gnanasundram (U.S. Pub. No. 2023/0343448 A1), do not disclose or render obvious the limitations of claim 1.
Cousins discloses a method for programming an automated medical device reprocessing equipment for automatic execution of a plurality of procedural steps including at least one of: automated chemical cleaning and disinfection, thermal sterilization, drying, and storage, (Paragraphs [0020] and [0038] discuss electronically documenting the reprocessing of endoscopes and programming to execute the reprocessing steps.).
Carlson teaches wherein the method comprises a start time of the procedural step (Paragraph [0014] discuss capturing the start time of the reprocessing operation.).
Lenzenhuber teaches based on the identified standard sequence of procedural steps and the one or more deviations from the standard sequence of procedural steps, computing, a process description of the semi-automated or automated reprocessing procedure (Paragraphs [0064], [0095] and [0102] discuss identifying a missing procedural step or a step that is not part of the protocol using a computer and generating a sequence of the steps, construed as a process description.).
Flynn teaches extracting and programming, by the processor, from the process description, a description of procedural steps to be executed by the automated medical device reprocessing equipment and downloading the instructions for use for each instrument (Paragraphs [0053-0055], [0066-0069] and [0071] discuss parsing data and using data analysis to make recommendations to changes for the instructions for use, construed as extracting a description of procedural steps for reprocessing and updating the rules based on the new terms or updates, construed as downloading and programming the automated medical device reprocessing equipment using the extracted description of the procedural steps to be executed.).
Gnanasundram teaches identifying, by the processor, differences between corresponding procedural steps at the different locations (Paragraphs [0071-0074] discuss the computer analyzing reprocessing data including location data of the various steps.).
However, the prior art of record does not disclose or render obvious the limitation of “analyzing, by the processor, the plurality of procedural steps across the completed reprocessing procedures by compiling, for each completed reprocessing procedure, a sequence string including an ordered list of data elements representing the type of each procedural step performed in the completed reprocessing procedure, counting how often each sequence string occurs, identifying a sequence string having a highest count as a standard sequence of procedural steps, and comparing one or more deviating sequence strings with the standard sequence of procedural steps to identify one or more deviations from the standard sequence of procedural steps” in combination with the other limitations of claim 1.
Claims 2-10 are also free from prior art as they depend from claim 1.
Response to Arguments
Applicant's arguments filed 08/20/2026 have been fully considered.
Rejection of Claim 1-10 under 35 U.S.C. § 101
Applicant argues that claim 1 “directed to a practical, computer-implemented method for programming an automated medical device reprocessing equipment based on machine-generated reprocessing data” and that these “limitations go beyond merely collecting, analyzing, or displaying data (Remarks, page 7).” Examiner maintains that the claims are directed to an abstract idea without a practical application or significantly more. The majority of the claimed steps are considered abstract. Those that are not considered abstract are either recited an “apply it” level or recite insignificant extra-solution activity. The Examiner maintains that the claims recite an abstract idea as they recite steps taken to program an automated medical device reprocessing equipment.
The device itself is still not claimed with the amendments, as the claims simply require steps to be taken with the device, but does not positively recite the device itself.
Applicant asserts that “the processor performs a sequence of operations that culminates in programming automated medical device reprocessing equipment by connecting the equipment to a database, downloading a computed process description together with corresponding relevant process parameters, and programming the equipment with the downloaded procedural steps and corresponding relevant process parameters (Remarks, page 8).” Examiner maintains that the processor is recited an “apply it” level at is merely used to implement the recited abstract idea. The processing device is not improved as a result of the claimed invention.
Applicant argues that the claim “addresses the technical problem of deriving a validated reprocessing procedure from machine-generated operation log data and automatically programming automated medical device reprocessing equipment using the computed process description and corresponding relevant process parameters (Remarks, page 8).” This is not a technical problem as alleged by Applicant. The problem arises from the workflow for the reprocessing of medical devices per the background of the instant specification pages 1-2. The fact it is implemented on a computer does not change the problem to a technical one.
Applicant states that “directed to a concrete practical implementation of a technical process in which a processor analyzes machine-generated reprocessing data, computes a process description from the analyzed data, and uses the computed process description together with corresponding relevant process parameters to program automated medical device reprocessing equipment for execution of the procedural steps identified in the computed process description (Remarks, page 9).” The additional elements recited in the claims do not result in a practical application as described in MPEP § 2106(d)(I).
The claims remain rejected as being directed towards an abstract idea without a practical application or significantly more.
Rejection of Claim 1-10 under 35 U.S.C. § 103
Applicant’s arguments with respect the prior art rejection have been considered but are moot as the art rejection has been withdrawn in response to the amendments.
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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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
