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 .
This communication is in response to the amendment received on 09/17/2025. Claims 1-8, 10-17 and 19-20 remain pending in this application.
The objection to the abstract has been withdrawn.
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 1-8, 10-17 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-8, and 10 are drawn to a method which is within the four statutory categories (i.e. process). Claims 11-18 and 19 are drawn to a system which is within the four statutory categories (i.e. machine). Claim 20 is drawn to a non-transitory medium which is within the four statutory categories (i.e. manufacture).
Step 2A, Prong 1:
Claims 1, 11 and 20 have been amended to recite “accessing a plurality of electronically stored historical patient data for a plurality of historical patients, each historical patient datum comprising a historical radiotherapy prescription and a historical set of diagnostic features, wherein the set of diagnostic features comprises: treatment technique, treatment energy, treatment intent, diagnostic code, morphology code, and patient age; determining, by an electronic processor, a first measure and a second measure, wherein the first measure comprises a distance between the radiotherapy prescription represented as a point in a first multidimensional space and a historical radiotherapy prescription represented as a point in the first multidimensional space, and wherein the second measure comprises a distance between a set of diagnostic features of the patient represented as a point in a second multidimensional space and a historical set of diagnostic features, for a historical patient with a similar historical radiotherapy prescription, represented as a point in the second multidimensional space; detecting, by the electronic processor, at least one of the first measure exceeding a first threshold or the second measure exceeding a second threshold; …” and these limitations correspond to “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processor does not take the claim out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 2-8, 10 and 12-18, 19 are ultimately dependent from claims 1, 11 and include all the limitations of claims 1, 11. Therefore, claims 2-8, 10 and 12-18, 19 recite the same abstract idea. Claims 2-8, 10 and 12-18, 19 describe a further limitation regarding the basis for determining radiotherapy treatment. These are all just further describing the abstract idea recited in claims 1, 11, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “an electronic processor”, and using the processor to perform the accessing, determining, detecting steps. The processor in these steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining similarity between the therapies) 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. The claims are directed to an abstract idea.
Claims also recite other additional limitations beyond abstract idea, including functions such as issuing an alert/outputting data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
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 element of using a processor to perform both the determining and detecting 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 claims are not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10-18 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Purdie et al. (hereinafter Purdie) (US 2018/0211725 A1).
Claim 1 has been amended to recite a method of detecting that a radiotherapy prescription for a patient is anomalous, the method comprising:
accessing a plurality of electronically stored historical patient data for a plurality of historical patients, each historical patient datum comprising a historical radiotherapy prescription and a historical set of diagnostic features, wherein the set of diagnostic features comprises: treatment technique, treatment energy, treatment intent, diagnostic code, morphology code, and patient age (Purdie; [0021], [0059]);
determining, by an electronic processor, a first measure and a second measure, wherein the first measure comprises a distance between the radiotherapy prescription represented as a point in a first multidimensional space and a historical radiotherapy prescription represented as a point in the first multidimensional space, and wherein the second measure comprises a distance between a set of diagnostic features of the patient represented as a point in a second multidimensional space and a historical set of diagnostic features, for a historical patient with a similar historical radiotherapy prescription, represented as a point in the second multidimensional space (Purdie; [0114], [0164], [0236]);
detecting, by the electronic processor, at least one of the first measure exceeding a first threshold or the second measure exceeding a second threshold (Purdie; [0297]-[0299], [0330]); and
issuing an alert, by the electronic processor, in response to the detecting (Purdie; [0297]-[0299]).
Claim 2 recites the method of claim 1, further comprising treating the patient according to a replacement prescription for the radiotherapy prescription (Purdie; [0097]).
Claim 3 recites the method of claim 1, wherein the first measure comprises an average of distances between the radiotherapy prescription represented as a point in a first multidimensional space and multiple of the plurality of the historical radiotherapy prescriptions represented as points in the first multidimensional space (Purdie; [0220]).
Claim 4 recites the method of claim 1, wherein the second measure comprises an average of distances between the set of diagnostic features of the patient represented as a point in a second multidimensional space and multiple historical sets of diagnostic features, each for a historical patient with a similar historical radiotherapy prescription, represented as points in the second multidimensional space (Purdie; [0220]).
Claim 5 recites the method of claim 1, wherein the first threshold comprises an average of distances between pairs of the plurality of historical radiotherapy prescriptions represented as points in the first multidimensional space (Purdie; [0220]).
Claim 6 recites the method of claim 1, wherein the second threshold comprises an average of distances between pairs of historical sets of diagnostic features of the plurality of historical patients represented as points in the second multidimensional space (Purdie; [0220]).
Claim 7 recites the method of claim 1, further comprising: generating simulated anomalous patient data, the simulated anomalous patient data comprising at least one of: a simulated radiotherapy prescription mismatched with a set of diagnostic features, or a simulated radiotherapy prescription that occurs in less than a predetermined proportion of the plurality of historical patient data; and optimizing model parameters using the simulated anomalous patient data (Purdie; [0330]).
Claim 8 recites the method of claim 1, further comprising: determining that an element of the radiotherapy prescription occurs in less than some predetermined proportion of the historical radiotherapy prescriptions for a same technique as the radiotherapy prescription; and issuing an alert, by the electronic processor, in response to the determining that an element of the radiotherapy prescription occurs in less than some predetermined proportion of the historical radiotherapy prescriptions for a same technique as the radiotherapy prescription (Purdie; [0220], [0240]).
Claim 10 recites the method of claim 1, wherein the issuing the alert comprises one of: issuing an alert indicating that the radiotherapy prescription is unlike historical radiotherapy prescriptions, or issuing an alert indicating that the radiotherapy prescription is mismatched to the diagnostic features of the patient (Purdie; [0056]).
As per claims 11-17, 19, they are system claims which repeat the same limitations of claims 1-8, 10, the corresponding method claims, as a collection of elements as opposed to a series of process steps. Since the teachings of Purdie disclose the underlying process steps that constitute the methods of claims 1-8, 10, it is respectfully submitted that they provide the underlying structural elements that perform the steps as well. As such, the limitations of claims 11-17, 19 are rejected for the same reasons given above for claims 1-8, 10.
As per claim 20, it is an article of manufacture claim which repeats the same limitations of claim 1, the corresponding method claim, as a collection of executable instructions stored on machine readable media as opposed to a series of process steps. Since the teachings of Purdie disclose the underlying process steps that constitute the method of claim 1, it is respectfully submitted that they likewise disclose the executable instructions that perform the steps as well. As such, the limitations of claim 20, are rejected for the same reasons given above for claim 1.
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Arguments about 35 USC 101 rejection:
Step 2A, prong one: Applicant argues that the limitations of “accessing a plurality of electronically stored historical patient data…”, “determining, by an electronic processor, a first measure and a second measure,…” and “detecting, by the processor, at least one on the first measure exceeding a first threshold or the second measure exceeding a second threshold” correspond to an abstract idea of certain methods of organizing human activity.
In response, Examiner submits that these claim limitations correspond to managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processor does not take the claim out of the methods of organizing human interactions grouping. The MPEP recites “…the sub-groupings encompass both activity of a single person…and an activity involves multiple people…and thus, certain activity between a person and a computer…may fall within the “certain methods of organizing human activity” grouping” (MPEP 2106.04(a)(2) II). Therefore, the limitations of using a generic processor to access a plurality of patient data, determine a first and a second measure comprising distances between patient data and historical and similar patients’ data and detect a measure exceeding a threshold correspond to certain activities between a person and a computer in order to determine treatment measures for patient.
Step 2A, prong two: Applicant argues that the current specification links the limitations of “accessing a plurality of electronically stored historical patient data…”, “determining, by an electronic processor, a first measure and a second measure,…” and “detecting, by the processor, at least one on the first measure exceeding a first threshold or the second measure exceeding a second threshold” to improvements over the prior art. Applicant argues that [0023] and [0024] of the specification recites using historical data with an imposed separation between prescription and diagnostic feature for two different distances in multidimensional space to identify anomalies based on exceeding thresholds allows for the claimed invention to detect a wider array of anomalies than are detectable by the prior art, without voluminous machine learning training data.
In response, Examiner submits that these feature may improve the result/outcome of the data, however, there is no indication in the current claims nor in the current specification that there is an improvement to the technology itself. Applicant argues that the distance-based approach is superior to prior art machine learning clustering techniques, such as k-means clustering. Examiner submits that the feature of “determining, by an electronic processor, a first and a second measures” corresponds to certain methods of organizing human activity, using a generic computing component, and determining the measures comprising distances between points in a multidimensional space corresponds to 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.
Therefore, the arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Argument about 35 USC 102 rejection:
Applicant argues that Purdie does not teach “determining, by a processor, a first measure and a second measure, wherein the first measure comprises a distance…and wherein the second measure comprises a distance…” and “detecting, by the electronic processor, at least one of the first measure exceeding a first threshold or the second measure exceeding a second threshold”.
In response, Examiner submits that Purdie teaches “If the treatment plan class is automatically determined, this determination may be based on a comparison of the inputted patient data with historical data, to determine the similarity of the inputted patient data to previous patients and the treatment plans used. This automatic classification may be performed using machine learning. Where machine learning is used, such learning may be ongoing, as additional historical data becomes available, such that the classification of a given treatment plan may be refined over time, for example. Determining the treatment plan class may be based on determining the similarity (e.g., as calculated through distances) of features of the image data to features of historical image data which have historical treatment plans.” in [0164], and “…automated planning by jointly examining patient features from the images and/or other sources, e.g. ROIs, patient history, treatment intent, etc. Instead of learning densities, distance metrics [49] between patients and distance metrics between plans may be learned or used, thereby matching a new patient to the most similar patient in the patient database. For automated QA, the plan for the new patient can then be compared to the plans of the most similar patients using calculated features and/or a learned distance…” in [0236].
Purdie also teaches “…a quality estimate (or confidence level) for the proposed treatment plan may be calculated. The quality estimate may be calculated as a confidence value, a simple pass/fail determination, or any other suitable estimate of quality. The calculation may also include determination of how well certain plan features match with expected plan characteristics and may include generation of error and/or warnings if the quality estimate is below a certain threshold value.” in [0119].
Conclusion
THIS ACTION IS MADE FINAL. 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 DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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