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 .
Status of Claims
This action is in response to the reply received 3/30/2026.
Claims 1, 10, and 15 were amended 3/30/2026.
Claims 1, 4-10, 13-15, and 17-23 are currently pending and have been examined.
Claim Objections
Claims 1, 10 and 15 are objected to because of the following informalities: “computing a pair-wise distances” is grammatically incorrect. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1, 10 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The independent claims recite “projecting the lesion-related features stored in the biomarker bank: and “computing a pair-wise distances between…the projected lesion-related features in the low-dimensional space”. These are not present in the specification. The specification recites in paragraph 30 that the computation of the pair-wise distances are between the feature vector generated for the target lesion and the one or more feature vectors maintained in the biomarker bank. The specification is silent that features are used in computing the pair-wise distances. The features, as recited in the specification paragraph 22, correspond to feature vectors. However, it is the comparison of vectors (not vectors compared with features) that create a pair-wise distance computation as is well-known to one of ordinary skill in the art. Clarification is required.
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, 4-10, 13-15 and 17-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 4-10, 13-15 and 17-23 are drawn to a method, apparatus, and non-transitory computer readable medium which are statutory categories of invention (Step 1: YES).
Independent claims 1, 10, 15 recite maintaining, storing lesion-related features extracted from medical images of a patient population, the lesion-related features being extracted from the medical images and stored as a respective feature vector for each lesion depicted in the medical images, each of the feature vectors having standardized format with a fixed length and comprising features of a plurality of types, wherein the features of a same type of the plurality of types are located at same indices in the feature vectors; performing an analysis on the patient population based on the lesion-related features stored by; projecting the lesion-related features stored and a feature vector for a target lesion of a patient to a low-dimensional space and computing a pair-wise distances between the projected feature vector for the target lesion in the low-dimensional space and the projected lesion-related features n the low-dimensional space, and determining a treatment for the patient based on the pair-wise distances; and outputting the treatment for the patient.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity between a user and patients as reflected in the specification, which states that “In one exemplary analysis of the patient population, during a treatment planning period, given a target lesion of a new patient, a feature vector may be generated for the target lesion according to the standardized format… Based on the comparison, a user (e.g., clinicians) may determine the k nearest feature vectors to the feature vector for the target lesion. Each retrieved feature vector is associated with a previously diagnosed or treated lesion, and therefore the treatment outcome can be also retrieved. If the previous treatment outcomes for a similar lesion indicates that the treatment approach was effective, then the clinicians may implement a similar treatment approach to the new lesion. Otherwise, the clinicians may implement an alternative treatment approach other than the treatment approach that was not effective.” (see: specification paragraph 30). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “Data retrieval 206-B may comprise identifying patients of the patient population with similar features of the lesion-related features. Treatment suggestion 206-C may comprise determining a treatment plan for a particular patient based on treatment plans of patients of the patient population identified as having similar features as the particular patient (paragraph 29 of specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “computer”, “biomarker bank”, “computer database”, “machine learning based algorithms”, “apparatus”, “non-transitory computer readable medium” and “processor” are recited at a high level of generality (e.g., that the analyzing and outputting is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, Figure 6 and
Paragraph 68, where “Systems, apparatuses, and methods described herein may be implemented using digital circuitry, or using one or more computers using well-known computer processors, memory units, storage devices, computer software, and other components. Typically, a computer includes a processor for executing instructions and one or more memories for storing instructions and data. A computer may also include, or be coupled to, one or more mass storage devices, such as one or more magnetic disks, internal hard disks and removable disks, magneto-optical disks, optical disks, etc.”
Paragraph 18, where “At step 102 of Figure 1, a biomarker bank storing lesion-related features extracted from medical images of a patient population is maintained. The biomarker bank is a computer database implemented by one or more computing devices (computer 602 of Figure 6) comprising memory or storage (e.g., memory 610 of Figure 6) for storing the lesion-related features.”
Paragraph 30, “In one exemplary analysis of the patient population, during a treatment planning period, given a target lesion of a new patient, a feature vector may be generated for the target lesion according to the standardized format. The newly generated feature vector can be compared with one or more feature vectors generated from previously analyzed lesions and maintained in the biomarker bank. In one embodiment, the comparison may be performed by computing pair-wise distances between the feature vector generated for the target lesion and the one or more feature vectors maintained in the biomarker bank. In another embodiment, in a more computationally efficient approach, the comparison may be performed by projecting the feature vector for the target lesion and the one or more feature vectors maintained in the biomarker bank to a pre-built low-dimensional space and computing the pair-wise distance between the target lesion and the one or more feature vectors maintained in the biomarker bank in the low-dimensional space. Based on the comparison, a user (e.g., clinicians) may determine the k nearest feature vectors to the feature vector for the target lesion. Each retrieved feature vector is associated with a previously diagnosed or treated lesion, and therefore the treatment outcome can be also retrieved. If the previous treatment outcomes for a similar lesion indicates that the treatment approach was effective, then the clinicians may implement a similar treatment approach to the new lesion. Otherwise, the clinicians may implement an alternative treatment approach other than the treatment approach that was not effective.”
Paragraph 21, where “The lesion-related features may be automatically or semi-automatically extracted from the medical images using Al (artificial intelligence) / ML (machine learning) based algorithms. For example, such Al/ML based algorithms may comprise known Al/ML based algorithms for detection, classification, segmentation, quantification, or any other medical imaging analysis task.”
Paragraph 72, where “Computer 602 includes a processor 604 operatively coupled to a data storage device 612 and a memory 610. Processor 604 controls the overall operation of computer 602 by executing computer program instructions that define such operations. The computer program instructions may be stored in data storage device 612, or other computer readable medium, and loaded into memory 610 when execution of the computer program instructions is desired. “
Paragraph 73, where “Processor 604 may include both general and special purpose microprocessors, and may be the sole processor or one of multiple processors of computer 602. Processor 604 may include one or more central processing units (CPUs), for example. Processor 604, data storage device 612, and/or memory 610 may include, be supplemented by, or incorporated in, one or more application-specific integrated circuits (ASICs) and/or one or more field programmable gate arrays (FPGAs).”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 4-9, 11, 13-14 and 16-23 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. The dependent claims recite analyzing, determining, and generating data and comprising blank data that does not provide significantly more to the abstract idea. These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
The arguments filed 3/30/2026 have been fully considered.
Regarding the arguments pertaining to the 101 rejection, these arguments are not persuasive. Applicant argues that the claimed invention is not directed towards “Certain Methods of Organizing Human Activity” as the claimed invention does not recite multiple users. Examiner respectfully disagrees. Under broadest reasonable interpretation, the claimed invention is directed towards a user performing an analysis on a patient population in order to render a treatment plan (paragraphs 29-30 of specification) and the claimed invention positively recites that a treatment for a patient is outputted. The feature vectors projected to a low-dimensional space are part of calculating the feature vectors on a generic biomarker bank (specification paragraph 30) and that the calculations of the low dimensional space is calculated during a treatment planning period for a new patient. The claimed invention is directed towards “Certain Methods of Organizing Human Activity”.
Applicant argues that the claimed invention provides a practical application of an improvement in the functioning of a computer or other technology. Applicant argues that the claimed invention provides a computationally efficient approach for analyzing a patient population for lesion analysis as shown in paragraph 30 of the specification and in the filed SMED. Examiner respectfully disagrees. Under broadest reasonable interpretation of the claimed invention, the computations of the comparison of a feature vector and one or more feature vectors generated from previously analyzed lesions does not provide a computationally efficient approach. Computationally comparing two vectors (as recited in the specification) on a generic computing device as shown in the rejection above, does not provide a practical application to overcome the abstract idea. Further, the radiomic features are not directly compared in the specification, but the feature vectors are compared (paragraph 30).
Applicant further argues that the feature vectors are compressed in a meaningful way, however the specification is silent on the compression of data and recites that the features are stored in indexes (paragraph 22).
The claimed invention is recited on a generic computing device (paragraph 18, Figure 6) and does not show reduced memory and processing requirements and reduced computation times. Analyzing relationships between data to filter said data does not provide an improvement to technology as the data recited, under broadest reasonable interpretation of the claimed invention, could be two sets of data. The functionality of the computing device is not improved upon by calculating comparisons between two feature vectors and by a clinician determining the k nearest feature vectors to the feature vector for the target lesion (paragraph 30).
The dependent claims rely on the arguments of the independent claims and are rejected for the reasons stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Park (US 20190380656 A1) teaches monitoring evolution of tumors using feature comparison calculations.
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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/K.A.S./Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
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