DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted April 17, 2026. Claims 1 and 13 are amended. Claims 2, 3, 16, and 17 were previously cancelled. Claims 1, 4 – 15,and 18 – 20 are pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 17, 2026 has been entered.
Claim Objections
Claims 4, 18, and 19 are objected to because of the following informalities: Claims 4, 18, and 19 are identified as previously presented, however, the claims have been amended. Each amendment document that includes a change to an existing claim, including the deletion of an existing claim, or submission of a new claim, must include a complete listing of all claims ever presented (including previously canceled and non-entered claims) in the application. After each claim number, the status identifier of the claim must be presented in a parenthetical expression, and the text of each claim under examination as well as all withdrawn claims (each with markings if any, to show current changes) must be presented. The listing will serve to replace all prior versions of the claims in the application. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended. See paragraph (E) below for acceptable alternative status identifiers. Claims added by a preliminary amendment must have the status identifier (new) instead of (original), even when the preliminary amendment is present on the filing date of the application and such claim is treated as part of the original disclosure. If applicant files a subsequent amendment, applicant must use the status identifier (previously presented) if the claims are not being amended, or (currently amended) if the claims are being amended, in the subsequent amendment. Claims that are canceled by a preliminary amendment that is present on the filing date of the application are required to be listed and must have the status identifier (canceled) in the preliminary amendment and in any subsequent amendment. . Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The phrase “if the certainty is too high” in claim 1 is a relative term which renders the claim indefinite. The phrase “if the certainty is too high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase “if the certainty is too high” is subjective.
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 – 15,and 18 – 20 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.
Step One
Claims 1, 4 – 15,and 18 – 20 are drawn to a system and method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1 and 13 recite analyzing at least one medical image from a specified local population for a disease risk score and determine if it is calibrated for the local population comprising: receiving at least one input medical image; determining a disease risk score for the medical image; receiving the normalized distribution of disease risk scores taken over time; wherein the determination of sufficient data uses a statistical method to calculate the uncertainty in the calibration assessment and prevent it from being provided if the uncertainty is too high; and, outputting a disease risk score for the input medical image.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that present invention “relates to the field of Computer Aided Diagnosis (CADx) systems and methods for assisting determination of medical images, used to support clinicians in healthcare. In particular, the field relates to risk Computer Aided Diagnosis systems, determination of whether a CADx system is calibrated, the calibration of the CADx system, where the CADx system assists the reading and reporting of medical images by radiologists and the interpretation of the radiologist's report by the physician responsible for patient care.” (paragraph 1 of the published specification). 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 this inventions addresses “two previously unrecognized needs for CADx devices, namely: an internal system to assess if the CADx device is uncalibrated to a local population,
and, given the device is uncalibrated, to optionally recalibrate it to a local population.
(paragraph 1 of the published specification). This problem is addressed by “recalibrating complex machine learning models, such as CNNs (convolutional neural networks). The invention is also able to identify when sufficient data from is available to perform each of these tasks.” (paragraph 47 of the published specification).
In addition, Claims 7 and 20, under their broadest reasonable interpretation, cover mathematical relationships, mathematical formulas or equations, or mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas.
Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “Computer Aided Diagnosis System (CADx) system”, “input circuit”, “machine learning model”, “calibration auditor circuit”, “CADx system”, “wherein the calibration auditor circuit further comprises a safety lock that prevents outputting of the indication of the calibration state when there is insufficient CADx derived data to determine the calibration state”, “wherein the calibration auditor circuit further comprises a calibrator to recalibrate the CADx system when the calibration state is determined to be uncalibrated for the specified local population”, “output circuit”, “the input medical image is one of: a CT image, an MRI image, a PET image, an X-ray image, an ultrasound image or a SPECT image”
Claim 4: “Computer Aided Diagnosis System (CADx) system”, “calibration auditor circuit”
Claims 5 – 6: “Computer Aided Diagnosis System (CADx) system”, “CADx system”
Claims 7 – 12: “Computer Aided Diagnosis System (CADx) system”
Claim 13: “Computer Aided Diagnosis System (CADx) system”, “CADx system”, “machine learning model”, “calibration auditor”, “the input medical image is one of: a CT image, an MRI image, a PET image, an X-ray image, an ultrasound image or a SPECT image”
Claims 14 – 15, 20: “CADx”
Claim 18: “machine learning model”, “output module”, “score mapper”
Claim 19: “calibration auditor”, “CADx”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
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).
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, 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 components 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 not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
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 published specification supports this conclusion as follows:
[0098] The invention may be implemented in a computer program for running on a computer system, at least including code portions for performing steps of a method according to the invention when run on a programmable apparatus, such as a computer system or enabling a programmable apparatus to perform functions of a device or system according to the invention.
[0099] A computer program is a list of instructions such as a particular application program and/or an operating system. The computer program may for instance include one or more of: a subroutine, a function, a procedure, an object method, an object implementation, an executable application, an applet, a servlet, a source code, an object code, a shared library/dynamic load library and/or other sequence of instructions designed for execution on a computer system. Therefore, some examples describe a non-transitory Computer program product having executable program code stored therein for receiving at least one input medical image of a patient in which the patient's lungs are visible.
[0100] The computer program may be stored internally on a tangible and non-transitory computer readable storage medium or transmitted to the computer system via a computer readable transmission medium. All or some of the computer program may be provided on computer readable media permanently, removably or remotely coupled to an information processing system. The tangible and non-transitory computer readable media may include, for example and without limitation, any number of the following: magnetic storage media including disk and tape storage media; optical storage media such as compact disk media e.g., CD ROM, CD R, etc. and digital video disk storage media; non-volatile memory storage media including semiconductor-based memory units such as FLASH memory, EEPROM, EPROM, ROM; ferromagnetic digital memories; MRAM; volatile storage media including registers, buffers or caches, main memory, RAM, etc.
[0102] The computer system may for instance include at least one processing unit, associated memory and a number of input/output I/O devices. When executing the computer program, the computer system processes information according to the computer program and produces resultant output information via I/O devices.
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 routine, 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 claim(s) 4 – 14 and 18 – 20 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 limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
The rejection of Claim(s) 1, 3 – 6, 9 – 15, and 18 – 19 under 35 U.S.C. 103 as being unpatentable over Weese et al., herein after Weese (U.S. Publication Number 2022/0083814 A1) in view of Cohen et al., herein after Cohen (U.S. Publication Number 2019/0131016 A1) were withdrawn in the Office Action dated June 3, 2025.
The rejection of Claim(s) 7 and 20 under 35 U.S.C. 103 as being unpatentable over Weese et al., herein after Weese (U.S. Publication Number 2022/0083814 A1) in view of Cohen et al., herein after Cohen (U.S. Publication Number 2019/0131016 A1) further in view of Watson et al., herein after Watson (U.S. Publication Number 2020/0320379 A1) were withdrawn in the Office Action dated June 3, 2025.
The rejection of Claim(s) 8 under 35 U.S.C. 103 as being unpatentable over Weese et al., herein after Weese (U.S. Publication Number 2022/0083814 A1) in view of Cohen et al., herein after Cohen (U.S. Publication Number 2019/0131016 A1) further in view of Stavros et al., herein after Stavros (U.S. Publication Number 2020/0345292 A1) were withdrawn in the Office Action dated June 3, 2025.
Response to Arguments
Applicant's arguments filed April 17, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections - 35 USC § 101
The Applicant argues the claimed subject matter does not fall within the “mental process” category of abstract ideas. The Examiner respectfully submits the present claims were cited as falling within the “Certain Methods of Organizing Human Activity” grouping. 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” category. The analysis of the risk score of the medical images, and the interpretation by a radiologist is provided to a physician responsible for a patient’s care indicating a relationship or interaction between people. The present claims use existing computers as tools in aid of processes focused on abstract ideas. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
The Applicant argues the rejection of the claims is inconsistent with USPTO Guidance on “Close Calls”. The Examiner respectfully disagrees and directs the Applicant to the response above.
The Applicant argues the amended claims recite additional elements that integrate the judicial exception into a practical application. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite 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.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The Applicant argues the claimed invention improves the functioning of CADx Systems citing Desjardins. The Examiner respectfully disagrees. The Examiner submits it was the incorporation of the claimed rules in McRo, not the use of the computer that improved the technological process by allowing the automation of further tasks. In the present invention, the claims are merely assisting determination of medical images, used to support clinicians in healthcare. The Applicants invention is not an improvement to the technology as the invention can be performed on any computer, per Applicants own specification. In addition, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception; the claims are directed to a generic component that performs functions well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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 KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682
