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
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on 01/06/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
RESPONSE TO ARGUMENTS
35 USC 101 REJECTION
The examiner acknowledges the amendment of claims 1, 4, 18, 22-23 & 25-26 filed 02/26/2026. Applicants’ arguments filed on (02/26/2026) have been fully considered but are deemed moot in view of new grounds of rejection. Due to the variation in claim scope via amendments a new ground of rejection is proper.
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 1-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to as ineligible under subject eligibility test. In the Subject Matter Eligibility Test for Products and Processes (Federal Register, Vol. 79, No. 241, dated Tuesday, December 16, 2014, page 74621), The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional device elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea.
Claims 1, 21 & 26
Step 1
This step inquires “is the claim to a process, article of machine, manufacture or composition of matter?” Yes,
Claims 1 & 23 – “Method” is a process.
Claim 26 - “Systems” are machines.
Step 2A - Prong 1
This step inquires “does the claim recite an abstract idea, law or natural phenomenon”. This claim appears to directed to an abstract idea.
The limitation of “an imaging device configured to capture an image of a specimen container containing a specimen, the captured image comprising a plurality of pixels; and a computer configured to: characterize the captured image using a first artificial intelligence (AI) model based on pixel appearance as indicated by respective pixel data values of the plurality of pixels; determining whether a characterization confidence of the captured image is below a pre-selected threshold based on a predetermined percent or number of pixel data values representing pixel appearance in a region of the image that exceeds a predetermined limit; and retrain the first AI model with at least the captured image having the characterization confidence below the pre-selected threshold to a second AI model, wherein the retraining includes non-image sensor data generated by one or more non-image sensors at the same time as the capturing of the image”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind (e.g. mathematical concepts, mental processes or certain methods of organizing human activity) but for the recitation of generic computer components. That is, other than reciting “imaging device” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “imaging device” language, “capturing, characterizing, determining, retraining” in the context of this claim encompasses covers performance of the limitation in the mind (e.g. mathematical concepts, mental processes or certain methods of organizing human activity).
STEP 2A – PRONG 1 - CONCLUSION
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.
Step 2A - Prong 2
This step inquires “does the claim recite additional elements that integrate the judicial exception into a practical application”. This judicial exception is not integrated into a practical application. In particular, the claim recites one additional element – using a “imaging device” to perform “capturing, characterizing, determining, retraining” steps. The “imaging device” are recited at a high-level of generality (i.e., as a generic processor “an imaging device configured to capture an image of a specimen container containing a specimen, the captured image comprising a plurality of pixels; and a computer configured to: characterize the captured image using a first artificial intelligence (AI) model based on pixel appearance as indicated by respective pixel data values of the plurality of pixels; determining whether a characterization confidence of the captured image is below a pre-selected threshold based on a predetermined percent or number of pixel data values representing pixel appearance in a region of the image that exceeds a predetermined limit; and retrain the first AI model with at least the captured image having the characterization confidence below the pre-selected threshold to a second AI model, wherein the retraining includes non-image sensor data generated by one or more non-image sensors at the same time as the capturing of the image” such that it amounts no more than mere instructions to apply the exception using a generic computer component.
STEP 2A – PRONG 2 - CONCLUSION
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. The claim is directed to an abstract idea.
Step 2B
The critical inquiry here is does the claim recite additional elements that amount to “significantly more” than the judicial exception? The claim does 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 “imaging device” to perform “capturing, characterizing, determining, retraining” steps 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. The claim is not patent eligible.
Dependent Claims
As to claim 2, this claim is directed to mental process (“validating that the second AI model performs the characterizing with a characterization confidence above a pre-established threshold.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 3, this claim is directed to mental process (“validating the second AI model on a validation dataset.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 4, this claim is directed to insignificant extra-solution activity (“Storing images in a database is extra solution data collection/organization”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 5, this claim is directed to mental process (“wherein retraining the first AI model comprises replacing the first AI model with the second AI model.”) and insignificant extra-solution activity (“deployment/selection of which model to use”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 6, this claim is directed to mental process (“pooling datasets from multiple labs/locations”) and insignificant extra-solution activity (“broadening the training data source”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 7, this claim is directed to mental process (“deciding when I press a button do retraining”) and insignificant extra-solution activity (“conventional user trigger for a software update”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 8, this claim is directed to mental process (“a human can visually examine the specimen image and decide whether H/I/L is present”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 9, this claim is directed to mental process (“once you have intensity/appearance, assigning a graded index is mental”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 10, this claim is directed to mental process (“humans can segment (visually divide) the image into regions. Segmentation is image classification i.e. a mental/algorithm process”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 11, this claim is directed to mental process (“a human can look at an image and label this region is plasma or this is settled blood”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 12, this claim is directed to mental process (“determining a height of at least one of the serum or plasma portion or the settled blood portion.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 13, this claim is directed to mental process (“wherein the characterizing comprises determining whether a cap is present on the specimen container.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 14, this claim is directed to mental process (“wherein the characterizing comprises determining a color of a cap on the specimen container.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 15, this claim is directed to mental process (“wherein the characterizing comprises determining a type of a cap on the specimen container.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 16, this claim is directed to mental process (“wherein identifying if the characterization confidence is below the pre-selected threshold comprises identifying if the characterization confidence is less than 0.9 in a range between 0.0 and 1.0.”) and insignificant extra-solution activity (“changing the threshold value is trivial parameter choice/tuning of the same abstract confidence based scheme. No technical improvement”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 17, this claim is directed to mental process (“wherein identifying if the characterization confidence is below a pre-selected threshold comprises identifying if the characterization confidence is less than 0.8 in a range between 0.0 and 1.0.”) and insignificant extra-solution activity (“swapping values is insignificant tuning”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 18, this claim is directed to mental process (“segmenting an image of the specimen or the specimen container, wherein identifying if the characterization confidence is below a pre-selected threshold comprises determining if less than 90 percent of pixel values in a segment are classified the same.”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 19, this claim is directed to mental process (“wherein the non-image data includes temperature data.”) and insignificant extra-solution activity (“specifying the type of auxillary data (temperature) is extra-solution data gathering”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 20, this claim is directed to mental process (“wherein the non-image data includes humidity data.”) and insignificant extra-solution activity (“selection of another sensor is data gathering data selection”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 21, this claim is directed to mental process (“wherein the non-image data includes at least one of vibration data, current data, and acoustic data.”) and insignificant extra-solution activity (“These are just additional sensor feeds which are data collection that does not materially limit the abstract model retraining concept”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 22, this claim is directed to mental process (“wherein the text data includes information related to a person from whom the specimen was taken.”) and insignificant extra-solution activity (“extra informational context for model training does not change the abstract idea or improve technology”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 24, this claim is directed to mental process (“wherein the non-image data includes at least one of temperature data, humidity data, vibration data, current data, and acoustic data.”) and insignificant extra-solution activity (“auxiliary data types feeding into the abstract HIL-detection model is data gathering/feature selection”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
As to claim 25, this claim is directed to mental process (“wherein the text data includes information related to a person from whom the specimen was taken.”) and insignificant extra-solution activity (“extra informational context not a technological improvement”). Thus, this claim does not integrate the abstract idea into a practical application or constitute significantly more than the abstract.
CONCLUSION
No prior art has been found for claims 1-26 in their current form.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stephen P Coleman whose telephone number is (571)270-5931. The examiner can normally be reached Monday-Thursday 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Moyer can be reached at (571) 272-9523. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen P. Coleman
Primary Examiner
Art Unit 2675
/STEPHEN P COLEMAN/Primary Examiner, Art Unit 2675
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