I. ACKNOWLEDGEMENTS
This Office Action addresses U.S. Application No. 18/827903 (“’903 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is September 9, 2024.
This Office Action is being issued following Applicant’s response of 5/15/2026, which included 1) claim amendments and 2) arguments.
II. STATUS OF CLAIMS
Claims 1-19 were filed with the application. The amendment of 5/15/2026 amends claims 1, 3, 4, 10, 12, 13 and 19. Accordingly, as of the date of this Office Action, the status of the claims is:
a. Claim 1-19 (“Pending Claims”).
b. Claim 1-19 are examined (“Examined Claims”)
III. PRIORITY AND CONTINUING DATA
The ‘903 application claims no priority. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. REJECTIONS UNDER 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 1-19 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Claim 1 recites the limitations:
An AI based method for detecting fracture, the method comprising:
capturing a plurality of images of an affected area …
determining surface temperature of the affected area …
comparing, using an AI-ML model, the captured plurality of images with baseline images or a digital twin …
identifying swelling in the affected area …
correlating the swelling related data with the determined surface temperature …
generating a severity index based on the correlation …
displaying … one or more recommendation along with the severity index to the user
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is drawn to a method, which is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. The comparing, identifying, correlating, and generating steps amount to a mental process that can be performed mentally. Mental processes are recognized as judicial exceptions that recite an abstract idea. See MPEP 2164
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application.
The capturing and determining steps are additional elements. However, both the capturing and determining steps are data gathering steps and hence amount to insignificant pre-solution activity which does not integrate the claim into a practical application. Furthermore, the displaying step is insignificant post-solution activity and does not integrate the claim into a practical application.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Here, the additional steps and structure are simply well-understood, routine, and conventional processing steps and structure. Hence, the step does not recite an inventive concept.
As such, claim 1 is directed to an abstract idea and is not patent eligible.
As to claim 2, providing a recommendation is insignificant post solution activity and does not integrate the claim into a practical application.
Claims 3-9 do not add anything that changes the analysis and hence, are also drawn to an abstract idea.
Claims 10-19 are directed to an abstract idea for the same reason as claims 1-9, noting that the structure added in the claims is generic structure and does not integrate the exception into a practical application.
VI. REJECTIONS UNDER 35 USC 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected in that there is no antecedent basis for the swelling related data in line 10. Applicant has asserted that there is proper antecedent basis for this term. The Examiner disagrees. The claim recites identifying swelling, not mention of data related to swelling. Identifying swelling does not inherently require obtaining data. Hence, the rejection stands.
Claim 10 is rejected in that there is no antecedent basis for the swelling related data in line 14.
Claim 19 is rejected in that there is no antecedent basis for the swelling related data in line 10.
Claims 2-9 and 11-18 are rejected as being dependent on a rejected base claim.
VII. ALLOWABLE SUBJECT MATTER
Claims 1-19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112 (b) and if the rejection under 35 USC 101 were overcome.
Claims 1-19 define over the art in that none of the art correlates the swelling related data, obtained by correlating in an AI-ML model, captured images with baseline images or a digital twin, with determined surface temperature, and using the correlation to generate a severity index, as claimed.
VIII. ANSWER TO ARGUMENTS
As to the 101 rejection, Applicant has asserted that the claims are integrated into a practical application by providing an improvement to a technological field. Specifically, Applicant has argued that paragraphs [0004] and [0007] set forth a problem that prior devices for detecting a fracture require expensive hardware that is not readily available in rural areas and that the specification identifies a need to provide a technique which overcomes that problem by detecting fractures using existing capabilities of smart phones. Applicant has then asserted that the claims recite the specific technical solution to this problem.
The Examiner notes that the claims do not limit the method of use in a smart phone. As such, the claim does not reflect the alleged improvement recited in the specification and therefore the claims do not recite an improvement to a technological field (see MPEP 2106.05(a)).
Applicant has asserted that the specification describes how the AI-ML model is specifically trained to perform the functions recited in the claim. Whether, or not this is true, the alleged improvement is not in the use of an trained AI-ML model, but in supposedly providing a smart phone based fracture detecting system.
Applicant has further argued that the specification discloses specific techniques to train the AI-ML model. Applicant then argues that this is not using a generic AI model, but a specifically trained model that performs technical functions. The Examiner notes that what the disclosure recites is not relevant to the 101 analysis. The issue is whether the claims integrate the exception into a practical invention. Here, the claim simply refers comparing using an AI-ML model. There is no mention of how the model is trained in the claimed invention. As such, the claim merely amounts to applying a generic AI-ML model.
Applicant has cited to Ex Parte Desjardins for the proposition that training a machine learning model was an improvement to the technology itself. The Examiner notes that Desjardins is distinguishable from the current claims. First, the claims in Desjardins were directed to a method of training a machine learning model, not a method of applying a trained model. Second, the claims in Desjardins reflected the improvement, while, as noted above, the current claims do not. Third, the Director in Desjardins found that the claim amounted to an improvement in how an improvement in how the machine learning model itself operates. The current specification and claims do not recite an improvement as to how the model operates, but merely recite using a model. In fact, in Recentive Analytics, Inc. v. Fox Corp 134 F. 4th 1205, the Federal Circuit found that the claims at issue recited ineligible abstract subject matter because the claims merely recited the use of generic machine learning technology in carrying out the claimed methods. It is the Examiner’s position that the current claims recite no more than applying a trained generic AI-ML model to data. In fact, if all that was needed to overcome a 101 rejection was to assert that the claimed invention was specifically trained for a task, then no methods using an AI model would ever be patent ineligible, as every model is trained for its task. It is the Examiner’s position that the current disclosure and claims do not recite a method of training the model that improves the functioning of the model.
Applicant has further asserted that capturing and determining steps or more than data gathering and are integral to the claimed invention. The Examiner sees nothing in the claimed capturing and determining steps that is more than taking images and determining the temperature, which are generic steps for providing data to the model.
Applicant has also asserted that the comparing, identifying, correlating, and generating steps are not mental processes. Specifically Applicant recites that the correlating requires an AI-ML model. However, the model, as discussed above is just a generic application of a model. It is settled that using a computer generically to perform a task that otherwise can be performed mentally does not integrate the claim into a practical application. Here, the correlation can be performed using a pen and paper.
Applicant has asserted that the claims are not steps than can be performed with pen and paper. For example, Applicant has argued that correlating multimodal streams and generating a severity index requires specialized AI-ML processing. The Examiner disagrees. First, the claim says nothing about multimodal streams. Rather, it says correlating swelling with thermal images. This can be done by comparing side by side printouts of the images/data.
Applicant has asserted that the disclosure recites an improvement to compute technology. The Examiner disagrees, noting that the disclosure trains an existing model and uses the model in a conventional manner.
Applicant has also argued that the claims recite more than the abstract idea. The Examiner disagrees. Again, Applicant is referring to features of the disclosure and not the claims in this argument, such as the use of a smart phone.
As such, the 101 rejection stands
IX. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT L NASSER/ Primary Examiner, Art Unit 3992