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 .
Response to Arguments
Applicant’s arguments, see Pages 5-7, filed 7/28/2025, with respect to the 101 rejection of claims 1-14 have been fully considered and are not persuasive. The 101 rejection of 3/28/2025 maintained in light of the amendments made to claim 1.
Specifically, the newly recited limitation of “the computing device being configured to pass/fail determination of the sufficiency of the sterilization process through comparing a Delta E value of the developed modified visible color of the biological sterilization indicator in an image captured by the image capturing device against a Delta E value of the pantone reference color using spectrodensitometric analysis” does not obviate the 101 rejection of 3/28/2025. The Applicant asserts that the measurement of the color difference between the expected and actual values constitutes a practical application of the abstract idea of determining the sufficiency of the sterilization process. However, the Examiner respectfully disagrees as the limitation merely adds insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea), and that the comparison of color can instead be done by visual inspection of the two values of δE and doing hand calculations to determine if the sterilization has passed or failed.
Applicant’s arguments, see Pages 7-10, filed 7/28/2025, with respect to the rejection(s) of claims 1-14 under U.S.C. 102 and U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Chandrapati et al. (US 2011/0182770), and further in view of Patel (US 2008/0023647).
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code 101 not included in this action can be found in a prior Office action.
Claims 1-10, 12-13, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the step of comparing collected color information to a predefined reference standard, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping.
The limitation of determination of the sufficiency of the sterilization process through comparing a Delta E value of the developed modified visible color of the biological sterilization indicator in an image captured by the image capturing device against a Delta E value of the pantone reference color using spectrodensitometric analysis, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generation color measuring components. That is, other than reciting the computing device with an associated server and image capturing device, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “using spectrodensitometric analysis” language, “determining” in the context of this claim encompasses the user manually calculating the difference between the Delta E values. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using an image capturing device and associated computing device with additional server to perform both the comparison and determining steps. The computing unit in both steps is recited at a high-level of generality (i.e., as a generic computer function of comparing expected to actual experimental values) 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, and once the comparison is completed, the pass/fail determination is generated and no further action is taken by the machine. The claim is directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the vessel, scannable code, biological indicator, and computing device are routine in the art of devices for tracking sterilization indicators, see Thompson et al. (US20170252474). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claims 2-10, 12-13, and 15 do not refer to or clarify the usage of the comparison of the color data using the computing device, nor do they provide further structure to the pass/fail determination limitations of claim 1.
Claims 10, 12-13, and 15 are not patent eligible.
Prior Art
The claims are free of the prior art. The closest prior art is Chandrapati et al. (US 2011/0182770) in view of Patel (US 2008/0023647).
Claims 1-10, 12-13, and 15 have been found free of the current prior art of record.
Regarding claim 1, Chandrapati et al. in view of Patel teaches a system for measuring a sufficiency of a sterilization process (a biological sterilization indicator system for determining the effectiveness of a sterilization process, see [0008] – [0009]), the system comprising:
a vessel, a scannable code thereupon, with a color-changing sterilization indicator that is exposed to a germinating composition, and a computing device to determine if sterilization has passed or failed based on a color change of the indicator (see [0055], [0112] – [0115]).
Patel teaches teaches a system for the determination of a treatment condition (see Abstract), including a reader system, analogous to the detecting device of Chandrapati et al, comprising a server configured to store a specimen database, wherein the specimen database comprises information describing the specimen, the sterilization data associated with the sterilization process, and a pantone reference color for the pass/fail determination (computer 85 of reader 87 stores data regarding the identity of the test, test conditions, and reference color images of the indicator before and after being subjected to a process treatment, see [0083]-[0084]).
the computing device configured to render a pass/fail determination of the sufficiency of the sterilization process through comparing a color difference of the developed modified visible color of the biological sterilization indicator in an image captured by the image capturing device against a Delta E value of the pantone reference color using spectrodensitometric analysis (the reader is configured to compare the color values of the stored reference color to the actual value of the color after reading by a spectrophotometer and outputs a result on treatment range, see [0083]).
The modification of a device to implement a computer to differentiate between colors of a sterilization device was known in the art before the effective filing date of the instant invention as exemplified by Patel (see [0018], [0068], and [0091]).
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the instant invention to modify the detecting device of Chandrapati et al. to include the associated computer as exemplified by Patel to complete processing and enhancing of the signal captured by the spectrophotometer of the invention, see [0116] in Patel. Further, the modification of the device of Chandrapati et al. to include the computer would have yielded the predictable result of providing an apparatus for comparing stored reference images to an actual indicator image.
However, regarding claim 1, the combination of Chandrapati et al. and Patel does not teach that the comparison of color is done through comparing a Delta E value of the developed modified visible color of the biological sterilization indicator in an image captured by the image capturing device against a Delta E value of the pantone reference color using spectrodensitometric analysis. While the invention teaches that the determination of the process of sterilization can be accomplished using color analysis, the prior art combination does not teach that the comparison of colors is done using a Delta E value, which is a value customary to the CIELAB and CIELUV color spaces. Therefore, the implementation of the limitation would not be possible with the current prior art combination on record.
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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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758