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 .
Applicant filed a response dated 12/23/2025 in which claims 1, 6, 12, and 17 have been amended, claims 9-11 have been canceled. Thus, the claims 1-8 and 12-19 are pending in the application.
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 and 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of providing medical imaging decision support data without significantly more.
Examiner has identified claim 12 as the claim that represents the claimed invention presented in independent claims 1 and 12-15.
Claim 12 is directed to a system, which is one of the statutory categories of invention (Step 1: YES).
The claim 12 describes a system comprising: an interface unit configured to receive natural language data, the natural language data comprising patient-specific clinical information; and a computing unit configured to, generate structured information by applying a large language model to the natural language data, the structured information comprising the patient-specific clinical information in a structured format, calculate the medical imaging decision support data based on the structured information, wherein the interface unit is further configured to provide the medical imaging decision support data, and wherein the interface unit is further configured to provide explanation data indicative of at least one of an explanation or a reason for at least one of the generating the structured information or for the calculating the medical imaging decision support data, the explanation data includes at least one of a citation of content from the natural language data, an interactive explanation or reasoning about the structured information or the medical imaging support data, or an explanation or reasoning about a tuning of the large language model, and the medical imaging decision support data is indicative of at least one of a value of a scan parameter of a scan protocol, a value of a reconstruction parameter of a reconstruction algorithm, a value of an image processing parameter of an image processing algorithm, a value change of the scan parameter of the scan protocol for a medical imaging examination of a patient by a medical imaging device, a value change of the reconstruction parameter of the reconstruction algorithm for reconstructing a medical image based on medical imaging data, or a value change of the image processing parameter of the image processing algorithm for processing the medical image which corresponds to a certain method of organizing human activity. Furthermore, if a claim limitation, under its broadest reasonable interpretation, covers interactions between people, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The additional elements of an interface unit, a computing unit, a large language model, a structured format/information, algorithm, and a medical imaging device do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 12 recites an abstract idea (Step 2A-Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of an interface unit, a computing unit, a large language model, a structured format/information, algorithm, and a medical imaging device result in no more than simply applying the abstract idea using generic computer elements. The additional elements of an interface unit, a computing unit, a large language model, a structured format/information, algorithm, and a medical imaging device are recited at a high level of generality, and under their broadest reasonable interpretation comprises a generic computing device. The presence of a generic computing device does nothing more than to implement the claimed invention (MPRP 2106.05(f)). The additional elements of an interface unit, a computing unit, a large language model, a structured format/information, algorithm, and a medical imaging device are no more than mere instructions to apply the exception using a generic computer element. Therefore, the recitation of additional elements does not meaningfully apply the abstract idea and hence does not integrate the abstract idea into a practical application. Thus, the claim 12 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim does not include additional elements that is sufficient to amount to significantly more than the judicial exception because the additional elements of an interface unit, a computing unit, a large language model, a structured format/information, algorithm, and a medical imaging device are recited at a high level of generality in that it result in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as the additional elements provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 12 is not patent eligible.
Similar arguments can be extended to other independent claims 1 and 13-15, and thus rejected on similar grounds as claim 12.
Dependent claims 2-11 and 16-19 further define the abstract idea that is present in their respective independent claim 1 and thus correspond to Certain Methods of Organizing Human Activity and hence are abstract in nature for the reasons presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 2-12 and 14 are directed to an abstract idea. Thus, the claims 1-19 are not patent-eligible.
Response to Arguments
Examiner withdraws 35 U.S.C 103 rejection of claims 1-19 in view of the amendment/argument.
Applicant's arguments filed dated 12/23/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-19 under 35 U.S.C. 101, Applicant states that claim 1 is not directed to an abstract idea, specifically at least within the alleged grouping of certain methods of organizing human activity.
Examiner respectfully disagrees and notes that the claim recites the steps of receiving, generating, calculating, providing, which all relate to medical imaging decision support data by first receiving patient specific clinical information, generating the patient-specific clinical information in a structured format, calculating the medical imaging decision support data and then providing the medical imaging decision support data. These steps deal with receiving, generating, calculating and providing data which is an abstract concept and in the absence of additional elements, these steps correspond to a certain method of organizing human activity. Thus, the claim recites an abstract idea. The additional elements are considered in more detail under Step 2A, Prong 2 and Step 2B to determine if the additional elements transform the abstract idea into a patent eligible subject matter.
Applicant also states that by structured information comprising patient-specific clinical information in a structured format by applying a large language model to natural language data, further calculating medical imaging decision support data based on the structured information, and providing the medical imaging support data along with explanation data indicative of at least one of an explanation or reason for at least one of the generating the structured information or the calculating the medical imaging decision support data, the technology supporting the method of providing imaging decision support data is significantly improved.
Examiner respectfully disagrees and notes that it is unclear how the technology supporting the method is improved. The technical steps recited in the claim makes use of a computing unit, an interface unit, a large language model that is used to generate structured information/format. There is no discussion in the specification that the technology has been improved. The specification in [0003] and [0004] states that in clinical application, making quick and accurate decisions is of utmost importance and patient-specific clinical information must be steadily passed on to the next point of treatment… directly treatment-relevant information may be lost in medical assessments, with many patients receiving a delayed or disrupted treatment and/or being thereby exposed to an additional risk of harm. The paragraphs [0037] and [0038] provide detail of the explanation data including allowing for cross-checking the automated inference and that the explanation data provides information as a verifiable source for the generated structured information and/or for the calculated medical imaging decision support data. The disclosure relates to an improvement to an abstract idea and not to technology. The improvement to an abstract idea is not sufficient to integrate the abstract idea into a practical application. Thus, these arguments are not persuasive.
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 RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684