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 .
Notice to Applicant
This communication is in response to the amendment filed 8/31/26. Claims 1, 10, and 21 have been amended. Claims 7, 8, and 15-20 are canceled. Claims 1-6, 9-14 and 21-26 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 1-6, 9-14 and 21-26 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-6 & 9 are directed to a method (i.e., a process), claims 10-14 are directed to a system (i.e., a machine), and claims 21-26 are directed to a non-transitory computer-readable storage medium (i.e., a machine). Accordingly, claims 1-6, 9-14 and 21-26 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A computer-implemented method of compensating for image quality issue in an image study, comprising: measuring a patient positioning parameter indicating a deviation of a patient position in the image study to an optimal patient position for an image exam type of the image study; analyzing, by a trained neural network, the image study and the measured patient positioning parameter to determine a relationship between positioning errors and an observed grading of a diagnostic finding for the image study, wherein the observed grading of the diagnostic finding includes one of a severity of the diagnostic finding or a certainty classification of the diagnostic finding; and generating, by the trained neural network, a reference grading of the diagnostic finding for the optimal patient position, wherein the trained neural network is trained to generate the reference grading by compensating for impact of the deviation of the patient position on the observed grading of the diagnostic finding based on a relationship between positioning errors and diagnostic gradings determined from previous image studies, and wherein the trained neural network is trained to automatically decompose the observed grading of the diagnostic finding into the reference grading of the diagnostic finding for the optimal patient position and an offset of the deviation of the patient position; and outputting the reference grading of the diagnostic finding for diagnosing or treating the patient.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because measuring a patient positioning parameter indicating a deviation of a patient position in the image study to an optimal patient position for an image exam type of the image study; analyzing the image study and the measured patient positioning parameter to determine a relationship between positioning errors and an observed grading of a diagnostic finding for the image study, wherein the observed grading of the diagnostic finding includes one of a severity of the diagnostic finding or a certainty classification of the diagnostic finding; and generating a reference grading of the diagnostic finding for the optimal patient position, generate the reference grading by compensating for impact of the deviation of the patient position on the observed grading of the diagnostic finding based on a relationship between positioning errors and diagnostic gradings determined from previous image studies; decompose the observed grading of the diagnostic finding into the reference grading of the diagnostic finding for the optimal patient position and an offset of the deviation of the patient position; and outputting the reference grading of the diagnostic finding for diagnosing or treating the patient amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or with pen and paper.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 10, and 21, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a processor, a non-transitory computer readable storage medium, and an executable program to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. 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 claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the processor, non-transitory computer readable storage medium, and executable program are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of obtaining data, measuring data, analyzing data, decomposing data, generating data, outputting data) such that it amounts no more than mere instructions to apply the exception using generic computer components. The limitations regarding a “trained neural network” do not amount to more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-6, 9, 11-14, and 22-26 are ultimately dependent from Claim(s) 1, 10, and 21 and include all the limitations of Claim(s) 1, 10, and 21. Therefore, claim(s) 2-6, 9, 11-14, and 22-26 recite the same abstract idea. Claims 2-6, 9, 11-14, and 22-26 describe further limitations regarding retrieving the previous image studies; wherein the first and second image studies correspond to the same patient; applying the trained neural network; wherein the trained neural network is trained; and wherein the image study is an X-ray study. These are all just further describing the abstract idea recited in Claim(s) 1, 10, and 21, without adding significantly more.
The claims do 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 elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 10, and 21 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to a processor obtaining an imaging study and measuring a parameter, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network and/or storing and retrieving information in memory, and performing repetitive calculations. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-6, 9-14 and 21-26 are ineligible under 35 USC §101.
Response to Arguments
Applicant’s arguments, see page 15, filed 8/31/26, with respect to claims 1, 10, and 21 have been fully considered and are persuasive. The 103 rejection of claims 1-6, 9-14 and 21-26 has been withdrawn.
Applicant's additional arguments filed 8/31/26 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 8/31/26.
(1) Applicant respectfully requests withdrawal of the § 101 rejections of claims 1-14 and 21-26.
(A) As per the first argument, see 101 rejection above. The Examiner submits that the foregoing underlined limitations in the 101 rejection above constitute “a mental process” because measuring a patient positioning parameter indicating a deviation of a patient position in the image study to an optimal patient position for an image exam type of the image study; analyzing the image study and the measured patient positioning parameter to determine a relationship between positioning errors and an observed grading of a diagnostic finding for the image study, wherein the observed grading of the diagnostic finding includes one of a severity of the diagnostic finding or a certainty classification of the diagnostic finding; and generating a reference grading of the diagnostic finding for the optimal patient position, generate the reference grading by compensating for impact of the deviation of the patient position on the observed grading of the diagnostic finding based on a relationship between positioning errors and diagnostic gradings determined from previous image studies; decompose the observed grading of the diagnostic finding into the reference grading of the diagnostic finding for the optimal patient position and an offset of the deviation of the patient position; and outputting the reference grading of the diagnostic finding for diagnosing or treating the patient amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or with pen and paper. Accordingly, the claim recites at least one abstract idea. Applicant’s argument that the steps cannot be practically performed in the human mind are not persuasive because paragraph 1 of Applicant’s Specification, pointed to by Applicant, clearly states that a radiologist can perform the steps. This judicial exception is not integrated into a practical application. In particular, the processor, non-transitory computer readable storage medium, and executable program are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of obtaining data, measuring data, analyzing data, decomposing data, generating data, outputting data) such that it amounts no more than mere instructions to apply the exception using generic computer components. The limitations regarding a “trained neural network” do not amount to more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Examiner disagrees that inaccurate grading or medical diagnosis error is a technical problem. Applicant is reminded that limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, 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) and the Vanda Memo issued in June 2018.
Limitations that are not indicative of integration into a practical application when recited in a claim with a judicial exception include:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses 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 the judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h).
Applicant’s arguments regarding Ex Parte Desjardins are not persuasive because the limitations of the claims in this case are not analogous to Ex Parte Desjardins. In Ex Parte Desjardins the specification identified the improvement to machine learning technology by explaining how the machine learning model is trained to learn new tasks while protecting knowledge about previous tasks to overcome the problem of “catastrophic forgetting,” and the claims reflected the improvement identified in the specification. Indeed, enumerated improvements identified in the Desjardins specification included disclosures of the effective learning of new tasks in succession in connection with specifically protecting knowledge concerning previously accomplished tasks; allowing the system to reduce use of storage capacity; and the enablement of reduced complexity in the system. Such improvements were tantamount to how the machine learning model itself would function in operation and therefore not subsumed in the identified mathematical calculation.
Regarding the subject matter of claim 7, when identifying abstract ideas, applicants should keep in mind that judicial exceptions need not be old or long‐prevalent, and that even newly discovered judicial exceptions are still exceptions, despite their novelty. For example, the mathematical formula in Flook, the laws of nature in Mayo, and the isolated DNA in Myriad were all novel, but nonetheless were considered by the Supreme Court to be judicial exceptions because they were “‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection.” The Supreme Court’s cited rationale for considering even “just discovered” judicial exceptions as exceptions stems from the concern that “without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’” The Federal Circuit has also applied this principle, for example, when holding the concept of using advertising as an exchange or currency abstract in Ultramercial, despite the patentee’s arguments that the concept was “new.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches an oral orthodontic digital intelligent diagnosis method (CN-111709959-A).
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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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
