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, 3-4 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 to identify a standard sequence of procedural steps and 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;
extracting, by the processor (MPEP § 2106.05(f), apply it), from the process description, a description of procedural steps to be executed by the automated medical device reprocessing equipment; and
programming, by the processor (MPEP § 2106.05(f), apply it), the automated medical device reprocessing equipment using the extracted description of the procedural steps to be executed.
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 automated medical device reprocessing equipment 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); 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 previously known to the pertinent industry (i.e. healthcare).
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cousin (U.S. Pub. No. 2021/0151174 A1) in view of Carlson (U.S. Pub. No. 2016/0008079 A1), Lenzenhuber (U.S. Pub. No. 2024/0170140 A1), and Flynn (U.S. Pub. No. 2024/0347185 A1).
Regarding claim 1, Cousin 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.), the method comprising:
acquiring, by a processor, log data corresponding to completed reprocessing procedures including the plurality of procedural steps (Paragraphs [0041], [0046] and [0105] discuss the system, which includes a processor, capturing the status of the endoscopes through each of the steps.), the log data including, for each procedural step of a completed reprocessing procedure:
a type of procedural step (Paragraphs [0105-0106] discuss each step and the status of the medical device being captured.),
an identifier of a medical device undergoing the procedural step (Paragraph [0072] discusses each device being identified with a serial number.),
a duration or an end time of the procedural step (Paragraph [0114] discusses the information captured including the duration of the reprocessing.), and
a success indicator of the procedural step (Paragraph [0089] discusses each step being marked as completed when finished, construed as a success indicator.);
analyzing, by the processor, the plurality of procedural steps across the completed reprocessing procedures to identify a standard sequence of procedural steps and one or more deviations from the standard sequence of procedural steps (Paragraphs [0020], [0046] and [0077] discuss documenting the steps of reprocessing the medical devices using a computer with a processor that implements the method. Examiner notes that the “to identify a standard sequence of procedural steps and one or more deviations…” part of the limitation is a recitation of intended use and therefore not given patentable weight.);
calculating, by the processor, a duration value for each procedural step (Paragraph [0114] discusses the information captured including the duration of the reprocessing.);
based on the identified standard sequence of procedural steps, computing, by the processor, a process description of a semi-automated or automated reprocessing procedure including the duration value for each procedural step (Paragraphs [0020], [0074], [0077], [0103] and [0114] discuss documenting the steps of reprocessing the medical devices using a computer and that the duration of the steps is included.);
but Cousin does not appear to explicitly disclose wherein:
a start time of the 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 a process description,
extracting, by the processor, from the process description, a description of procedural steps to be executed by the automated medical device reprocessing equipment; and
programming, by the processor, the automated medical device reprocessing equipment using the extracted description of the procedural steps to be executed.
Carlson teaches wherein the method comprises a start time of the procedural step (Paragraph [0014] discuss capturing the start time of the reprocessing operation.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Cousin to include the start time of the procedural step, as taught by Carlson, in order “to improve the monitoring of reprocessing devices for endoscopes and of endoscopes (Carlson, Paragraph [0009]).”
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.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Cousin to include deviations from procedure, as taught by Lenzenhuber, in order to improve tracking and traceability (Lenzenhuber, Paragraph [0024]).”
Flynn teaches:
extracting, by the processor, from the process description, a description of procedural steps to be executed by the automated medical device reprocessing equipment (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
programming, by the processor, the automated medical device reprocessing equipment using the extracted description of the procedural steps to be executed (Paragraph [0054] discusses updating the rules based on the new terms or updates, construed as programming the automated medical device reprocessing equipment using the extracted description of the procedural steps to be executed.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cousin to including programming the automated medical device reprocessing equipment, as taught by Flynn, in order to “improve the quality and efficiency of the reprocessing workflow (Flynn, Paragraph [0063]).”
Regarding claim 2, Cousin does not appear to explicitly disclose computing, by the processor, for at least one procedural step, a process constraint selected from a minimum duration and a maximum duration of the procedural step.
Carlson teaches computing, by the processor, for at least one procedural step, a process constraint selected from a minimum duration and a maximum duration of the procedural step (Paragraphs [0034] and [0039-0040] discuss analyzing the time of reprocessing steps using upper and lower limits using an evaluation device/computer.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Cousin to include computing a process constraint, as taught by Carlson, in order “to improve the monitoring of reprocessing devices for endoscopes and of endoscopes (Carlson, Paragraph [0009]).”
Regarding claim 3, Cousin does not appear to explicitly disclose identifying, by the processor, undocumented procedural steps of the semi-automated or automated reprocessing procedure, and including such undocumented procedural steps in the process description.
Lenzenhuber teaches identifying, by the processor, undocumented procedural steps of the semi-automated or automated reprocessing procedure, and including such undocumented procedural steps in the process description (Paragraphs [0064] and [0095] discuss the processing device, construed as a computer, including steps that are not part of original protocol in the documentation of the product.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Cousin to include undocumented procedural steps, as taught by Lenzenhuber, in order to improve tracking and traceability (Lenzenhuber, Paragraph [0024]).”
Regarding claim 4, Cousin discloses identifying, by the processor, fallback loops of the semi-automated or automated reprocessing procedure (Paragraph [0089] discusses aborting current reprocess sequence and starting a new reprocess sequence if a step is not completed.).
Regarding claim 5, Cousin does not appear to explicitly disclose identifying, by the processor, variations in one procedural step correlating with variations and/or absence of a preceding procedural step.
Lenzenhuber teaches identifying, by the processor, variations in one procedural step correlating with variations and/or absence of a preceding procedural step (Paragraphs [0064] and [0102] discuss identifying a missing procedural step, construed as a variation using a computer.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Cousin to include variations in one procedural step, as taught by Lenzenhuber, in order to improve tracking and traceability (Lenzenhuber, Paragraph [0024]).”
Regarding claim 6 recites wherein the log data comprises log data of reprocessing procedures applied to different types of medical devices (Paragraph [0092] discusses a plurality of endoscopes undergoing reprocessing steps an that the details of each can be found on the system. See also figure 7 showing various types of endoscopes.), the method further comprising computing, by the processor, separate process descriptions for each type of medical device (Paragraph [0073] discussing determining which cleaning protocol to use based on the specific endoscope.).
Regarding claim 7, Cousin discloses wherein the log data includes a type indicator of the automated medical device reprocessing equipment undergoing the semi-automated or automated reprocessing procedure (Paragraph [0084] discusses the information including the type of endoscope being reprocessed.).
Regarding claim 8, Cousin discloses 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 (Paragraph [0074] discusses the log data including location data of the endoscopes.).
Regarding claim 10, Cousin discloses a computer program product comprising 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 the method claim 1 (See claim 1 above. Paragraph [0020] of Cousin discloses the method being executed on a computer using a non-transitory computer-readable medium.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cousin in view of Carlson, Lenzenhuber and Flynn, and in further view of Gnanasundram (U.S. Pub. No. 2023/0343448 A1).
Regarding claim 9, Cousin does not appear to explicitly disclose identifying, by the processor, differences between corresponding procedural steps at the different locations.
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.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify Cousin to include variations in one procedural step, as taught by Gnanasundram, in order to “meet hygiene standards and guidelines relevant to the location of the facility and activity course correct malpractice through workflow management real time alerts and notifications to help reduce clinician and cleaning agent non-compliance and therefore patient risk of cross contamination (Gnanasundram, Paragraph [0104]).”
Response to Arguments
Applicant's arguments filed 08/01/2025 have been fully considered but they are not persuasive.
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” as the “applies the analysis of (historical machine-generated) log data to produce a process description that is specifically tailored to the needs of automated or semi-automated reprocessing systems (Remarks, page 6).” Examiner maintains that the claims are directed to an abstract idea without a practical application or significantly more. All of the steps are considered abstract. The only limitations that are not abstract are the processor that is implementing the abstract idea. The Examiner maintains that the claims recite an abstract idea as they recite steps someone would take to program an automated medical device reprocessing equipment.
Applicant asserts that claim 1 “recites a concrete improvement to a technical process and has a direct effect in the physical world, namely controlling medical device reprocessing hardware to improve consistency, traceability, and safety in healthcare environments (Remarks, page 7).” The only improvement resulting from the claims is to the workflow of the reprocessing. The reprocessing device is not positively recited. There is not a technical problem associated with the workflow, rather it is a business problem. The claims do not result in a technical improvement.
The additional elements recited in the present claims include generic computer components (processor, non-transitory computer readable medium, and computer), none of which are improved by the abstract idea. Furthermore, the problem being solved is not technical in nature nor is the solution provided by claim 1.
MPEP § 2106.04(d)(I) states limitations that the courts have found indicative of an additional element (or combination of elements) may have integrated the exception into a practical application include:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
Adding insignificant extra-solution activity to the judicial exception, as discussed
in MPEP § 2106.05(g); and
Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
The claims do not contain any limitations similar to those above that are indicative of a practical application as the computer is merely used as tool to implement the abstract idea. The claimed invention is solving a business problem, not a technical problem.
The dependent claims do not contain any additional elements beyond those recited in claim 1, and therefore, are also not directed to patent eligible subject matter.
Therefore, the claims do not result in a practical application of the recited abstract idea.
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 in view of the new grounds of rejection necessitated by the amendments. Furthermore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached at (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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