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 .
Specification
The substitute specification filed 19 September 2025 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: the amended specification includes new matter. Specifically, although applicant argues that the amendments to the specification are supported by paragraphs [0003]-[0004] and Figure 1 of the Specification as filed (see Arguments, page 9), paragraphs [0003]-[0004] and Figure 1 do not support the instant amendments to the Specification.
The Examiner initially notes that the Specification, as filed, makes no explicit reference to computerized performance of the disclosed methods. Applicant argues that paragraphs [0003]-[0004] reference “an improvement in the field of supervised machine learning” implying the use of computer systems. See Arguments, pages 8-9. Only paragraph [0003] makes reference to machine learning, but not with explicit reference to the purported invention. Instead, paragraph [0003] merely discusses machine learning generally as an evolving technology, exclusively as background, and without making an explicit connection to the rest of the disclosure.
Figure 1 depicts a person using what appears to be a personal computer; however, Figure 1 does not imply computerization of the disclosed methods— just a person using a computer to perform “annotation” in the way a person might also use a notepad and pen to perform annotation. Applicant also notes Figures 2-8, but these figures are merely functional diagrams of the disclosed processes. Applicant argues that “modules 310, 320, 330, 340, 350, 360, and 370…must also be digital systems or processes” because they “execute their associated tasks simultaneously”. Arguments at 9. However, the instant specification provides no definition of “simultaneously” limiting the processes in any particular way requiring a computer, nor does it preclude performance by a human mind or multiple human minds.
Lastly, applicant argues that the amendment to the specification providing “simultaneously perform[ing]…associated task on…up to 200,000 images” is supported by Specification paragraph [0038] as filed. However, Specification paragraph [0038] as filed merely notes that 5 to 200,000 fundus images can be used, not that a process is executed on up to 200,000 images simultaneously. Consequently, applicant’s amendments to the specification are not entered as they introduce new matter.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 36 (the second consecutive claim numbered “36.”) has been renumbered 37.
Response to Arguments
Applicant's arguments filed 19 September 2025 regarding the rejection of claims 28-33, 35, and 37 under 35 U.S.C. 112(b) have been fully considered but they are not persuasive. Specifically, applicant argues that because “the specification has been amended to clearly define that the modules of quality control system 300 are software functions/processes, not physical systems with a defined structure. …. [and therefore,] there are no generic components or systems which are claimed but undefined in the specification.” See Arguments, page 22. However, as noted supra, the instant amendments to the specification are not entered as the amendments do not conform to 37 CFR 1.125. Further, the limitations noted would still invoke 35 U.S.C. 112(f) even assuming arguendo that the instant amendment to the specification was entered because the limitations would meet the 3-prong analysis laid out in MPEP 2181(I). The invocation of 112(f) would require a corresponding structure in the specification specifically mapping to the claimed generic placeholder. See MPEP 2181(I). Consequently, claims 28-33, 35, and 37 remain rejected under 35 U.S.C. 112(b).
Applicant’s arguments/amendments regarding the separate 35 U.S.C. 112(b) rejection of 35 U.S.C. 112(b) for terms having a lack of antecedent basis are persuasive and claim 31 is no longer separately rejected under 35 U.S.C. 112(b) for lack of antecedent basis.
Applicant's arguments filed 19 September 2025 regarding the rejection of claims 14-36 under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant refers to Example 39 of the 2019 Revised PEG, arguing that the instant claims are eligible subject matter for the same reasons Example 39 is directed towards eligible subject matter. Specifically, applicant notes that “[l]ike the example, the instant claim also does not recite mere mathematical relationships, formulas or calculations” and that “[t]he similarity between the complexity of claim 14 and Example 39 clearly demonstrates that claim 14 cannot be practically performed in the human mind and thus does not recite mere abstract ideas”. Arguments at 24.
However, the Examiner notes that Example 39 of the 2019 Revised PEG regards to a computer-implemented method of training a neural network for facial detection with explicitly recited digital facial image modifications, the creation of a first training set, training a neural network, and creation of a second training set. The instant claims recite none of these limitations, nor limitations analogous to these limitations. Indeed, as noted supra, the instant specification does not support a computerized implementation of the claimed methods and systems, much less the training of a neural network. Further, the instant rejection under 35 U.S.C. 101 references the claims containing the abstract idea of a mental performance of a human doctor/technician making observations, evaluations, judgments, and rendering opinions on a set of annotations for fundus images- essentially grading the correctness of the annotation— not that it recites mere mathematical relationships, formulas, or calculations.
Applicant then argues that the claims are directed towards significantly more than a mental process because “the claimed method is fundamentally manipulating the computer data structures of a plurality of fundus images and outputting the modified data structures”. Arguments at 25. Applicant continues: “Following collection, a "standardization processing" occurs, in which each of the plurality of fundus images are standardized. The standardization process is defined in specification [0039] to include scrubbing patient names or converting them into hash format (i.e., encrypting), modifying the photos picture format (i.e., changing file type), and modifying the background of the images into a uniform format (i.e., pictures unified to have black backgrounds).” Id. However, scrubbing patient names amounts to redacting, a process that has been performed manually since time immemorial. While the specification references, but does not define, standardization possibly including changing file format of the pictures, even assuming arguendo such a change would amount to “significantly more”, these features from the specification are not recited in the instant claims. And— changing file formats is a conventional computing process and would not amount to significantly more even if it was hypothetically added to the instant claims.
Applicant also references the recited “standardization processing” as being significantly more, arguing that the standardization processing necessarily includes a number of steps which together amount to significantly more. See Arguments at pages 25-26. However, paragraph [0039], referenced by applicant (Id.), does not meaningfully limit the standardization processing, noting that “[i]n some examples, the standardization may include….”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding newly added claims 34 and 35, the claims additionally recite each step of the series of quality control steps is performed on the plurality of fundus images simultaneously. However, nothing precludes simultaneous consideration of the multiple processes by a human mind or by a group of people. Therefore, claims 34-35 neither integrate the exception into a practical application nor constitute significantly more.
Regarding newly added claim 36 and 37, the claims additionally recite wherein the quality control steps can be performed on up to 200,000 fundus images. However, even assuming arguendo that 200,000 fundus images cannot be considered over a period of time by one or multiple people, the claim merely puts a maximum on the number of fundus images and does not preclude the use of smaller numbers of fundus images. As such, claims 36 and 37 still encompass the same abstract idea and neither integrate the exception into a practical application nor constitute significantly more.
Claim Interpretation/Claim Rejections – 35 U.S.C. 112
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Acquisition module
Standardization module
Preliminary filtering module
Data preparation module
Annotation module
Evaluation module
Gathering module
in claims 28-33, 35, and 37
Because these claim limitation(s)are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
However, the instant specification fails to specifically link the above-noted modules to particular structure performing the function. As such, claims 28-33, 35, and 37 (listed as 36) are rejected under 35 U.S.C. 112(b) as indefinite for failing to particularly point out the subject matter regarded as the invention.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 14-37 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.
Specifically, all of claims 14-37, via the instant amendment, all recite a “computerized quality control system” or “computerized quality control method”. As noted supra, the Specification, as filed, makes no explicit reference to computerized performance of the disclosed methods and the instant amendment to the specification is not entered. Consequently, the addition of “computerized” to claims 14-36 constitutes new matter and claims 14-36 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement.
Claims 34-35 are further rejected for new matter as the Specification, as filed, makes no explicit reference to each step of the series of quality control steps being performed on the plurality of fundus images simultaneously. While the instant amendment to the Specification may provide support for these claims, the instant amendment to the specification is not entered. Consequently, claims 34-35 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement.
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 14-37 are rejected under 35 U.S.C. 101 as directed towards ineligible subject matter.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) (1) “acquiring a plurality of fundus images”, (2) “performing standardization processing on each of the plurality of fundus images to obtain a plurality of standardized fundus images”, (3) “performing preliminary filtering on quality of each of the plurality of standardized fundus images to obtain a plurality of qualified fundus images “, (4) “preparing a target fundus image set, wherein the target fundus image set comprises a data set to be calibrated comprising the plurality of qualified fundus images, a gold- standard data set comprising a first preset number of gold-standard fundus images with a known correct annotation result, and a self-consistency determination data set composed of at least one image in the data set to be calibrated, and taking each image of the target fundus image set as a respective target fundus image”, (5) “annotating respective images of the target fundus image set by a plurality of first annotation doctors respectively to obtain a plurality of groups of doctor annotation results, wherein the doctor annotation results comprise at least one determination result and the determination result comprises at least disease information of no obvious abnormality or of a disease”, (6) “calculating self-consistency and gold-standard consistency of corresponding first annotation doctors based on the doctor annotation results to acquire the doctor annotation results of the first annotation doctors satisfying a preset condition as target annotation results, wherein: the self-consistency is obtained by taking any one of two groups of annotation results of the doctor annotation result of each image in the self-consistency determination data set and the doctor annotation result of an image, which is repeated with respective image in the self-consistency determination data set, in the data set to be calibrated as a first group of annotation results and taking another group as a second group of annotation results and performing evaluation using a self-consistency determination and evaluation method, and the gold-standard consistency is obtained by taking the correct annotation result of the gold-standard data set as a first group of annotation results and the doctor annotation result of each image in the gold- standard data set as a second group of annotation results and using a gold-standard consistency determination and evaluation method”, and (7) “gathering a plurality of sets of the target annotation results to obtain a final annotation result.”
Regarding the first prong of Step 2A, the limitations (2), (3), (4), (5), and (6) are steps that, as drafted and under broadest reasonable interpretation, covers a mental performance of a human doctor/technician making observations, evaluations, judgments, and rendering opinions on a set of annotations for fundus images- essentially grading the correctness of the annotation. Further, step (1) merely constitutes a data gathering/input step. Lastly, step (7) merely constitutes organizing the results of the rendered judgments as output. Thus, nothing in the recited claim elements precludes performing the recited steps in the mind. While the preamble now recites “computerized”, the body of the claim remains without reference to any reference to a computerized method, much less an improvement to one.
Regarding the second prong of Step 2A, the above-described judicial exception is not integrated into a practical application. In addition to the limitations noted above, the claims merely additionally recites “a quality control method”, which does not meaningfully communicate any limitation to any particular application outside of the abstract idea noted supra.
Regarding step 2B, the above-noted processes are recited at a high-level of generality such that they amount to no more than the mental process itself. “Fundus images” merely restricts the field in which the evaluation is occurring. “Calibration” does not amount to significantly more than the recited judicial exception itself as it encompasses a manual adjusting of data/annotations. “Self-consistency determination data” and “gold-standard consistency” are mere organizations of data that could be done mentally or with pen and paper. Thus, claim 1 is therefore rejected as not subject matter eligible under 35 U.S.C. 101.
Regarding claim 15, the claim additionally recites “the preset condition is that the self-consistency is greater than a self-consistency threshold value” and “the gold-standard consistency is greater than a gold-standard consistency threshold value.” These limitations merely characterize the preset condition as using a threshold and using a gold standard consistency higher than a threshold during the mental consideration/judgement. Therefore, claim 15 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 16, the claim additionally recites “target self-consistency and target gold-standard consistency of doctors with different threshold value annotation are analyzed” and “abnormality detection comprises determining the self-consistency threshold value and the gold-standard consistency threshold value.” These limitations merely encompass additional metrics being analyzed during the mental/consideration/judgement. Therefore, claim 16 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 17, the claim additionally recites “the abnormality detection comprises acquiring the target self-consistency of the doctors with different threshold value annotation and calculate a self-consistency mean value µ0 and a self-consistency variance σ0, under assumption that the target self- consistency satisfies a Gaussian distribution, the self-consistency threshold value is µ0 -1.96 x σ0” and “the abnormality detection comprises acquiring the target gold-standard consistency of the doctors with different threshold value annotation and calculate a gold-standard consistency mean value µ1 and a gold-standard consistency variance σ1, under assumption that the target gold-standard consistency satisfies a Gaussian distribution, the gold-standard consistency threshold value is µ1 -1.96 x σ1” These limitations merely specify the parameters of the mental calculations being performed. Therefore, claim 17 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 18, the claim additionally recites “wherein the doctor annotation result of the first annotation doctor which does not meet the preset condition is re-annotated by the second annotation doctor on each image in the target fundus image set until the doctor annotation result meeting the preset condition is obtained as the target annotation result.” This limitation merely encompasses re-annotating when a preset condition is not met; such a replication of annotation is similarly a mental organization/judgement. Therefore, claim 18 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 19, the claim additionally recites “the self-consistency determination method comprises calculating a disease self- consistency of each first annotation doctor determining each disease by a quadratic weighted kappa coefficient and weighs each disease self-consistency to calculate the self-consistency of each first annotation doctor” and “the gold-standard consistency determination method comprises calculating the gold- standard consistency of a disease of each first annotation doctor determining each disease using a quadratic weighted kappa coefficient and weighs the gold- standard consistency of the disease to calculate the gold-standard consistency of each first annotation doctor.” These limitations merely encompass additional metrics being analyzed during the mental consideration/judgement. Therefore, claim 19 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 20, the claim additionally recites “the quadratic weighted kappa coefficient K is
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94
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” and “
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represents a quadratic weighting coefficient,
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represents a number of the target fundus images for which the determination result in the first group of annotation results is i and the determination result in the second group of annotation results is j, and
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represents an expected number of the target fundus images for which the determination result in the first group of annotation results is i and the determination result in the second group of annotation results is j”. These limitations merely encompass the particular formula and variables used in the calculation. Therefore, claim 20 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 21, the claim additionally recites “the gathering comprises comparing each annotation result of each the target fundus image in a plurality of groups of the target annotation results using an absolute majority voting method to determine the final annotation result of each the target fundus image, and if the final annotation result is not able to be determined, the target fundus image is annotated as a difficult fundus image” and “the difficult fundus image is annotated and arbitrated to obtain the final annotation result”. These limitations merely encompass details related to factors for how the mental judgment should be arrived at. Therefore, claim 21 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 22, the claim additionally recites “the gathering comprises comparing each annotation result of each target fundus image in the plurality of groups of the target annotation results”, “if each annotation result is consistent, taking the annotation result as the final annotation result of the target fundus image”, “while if the plurality of annotation results are inconsistent, if the plurality of annotation results simultaneously comprise a same determination result and only one annotation result comprises a determination result which is not identified in other annotation results, the target fundus image is annotated as a fundus image to be quality-controlled”, “otherwise, the target fundus image is annotated as a difficult fundus image”, and “quality control is performed on the fundus image to be quality-controlled and the final annotation result is obtained, and the difficult fundus image is annotated and arbitrated to obtain the final annotation result”. These limitations merely encompass details related to factors for how the mental judgment should be arrived at. Therefore, claim 22 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 23, the claim additionally recites “in the preliminary filtering, the quality of the standardized fundus image is determined by a plurality of first annotation doctors to classify the standardized fundus image into a plurality of image quality grades” and “the qualified fundus image is the standardized fundus image of which the image quality grade is qualified”. These limitations merely encompass details related to factors for how the mental judgment should be arrived at. Therefore, claim 23 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 24, the claim additionally recites “the standardized fundus image are ranked based on factors that affect the quality of the fundus image” and “the factors affecting the quality of the fundus image comprise at least one of location at which the fundus image was taken, exposure, and definition”. These limitations merely encompass details related to factors for how the mental judgment should be arrived at. Therefore, claim 24 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 25, the claim additionally recites “in the annotation, each image of the target fundus image set is classified into three image quality grades of qualified, barely qualified, and unqualified” and “the qualified fundus image is the standardized fundus image with an image quality grade of qualified and barely qualified.” These limitations merely encompass details related to factors for how the mental judgment should be arrived at. Therefore, claim 25 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 26, the claim additionally recites “wherein the disease comprises at least one of diabetic retinopathy, hypertensive retinopathy, glaucoma, retinal vein occlusion, retinal artery occlusion, age-related macular degeneration, high myopia macular degeneration, retinal detachment, optic nerve disease, and congenital abnormalities of disc development.” This limitation merely relates to the types of determinations that the annotations can contain. Therefore, claim 26 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 27, the claim additionally recites:
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These limitations merely encompass the particular formula and variables used in the calculation. Therefore, claim 27 neither integrates the exception into a practical application nor constitutes significantly more.
Regarding claim 28-33, the claims mirror the subject matter of claims 14-27 above. Specifically, claim 28 mirrors the subject matter of claim 14. Claim 29 mirrors the subject matter of claim 15. Claim 30 mirrors the subject matter of claim 17. Claim 31 mirrors the subject matter of claim 19. Claim 32 mirrors the subject matter of claim 20. Claim 33 mirrors the subject matter of claim 27. Therefore claims 28-33 are rejected under 35 U.S.C. 101 for analogous reasons to those outlined above.
Regarding claims 34 and 35, the claims additionally recite each step of the series of quality control steps is performed on the plurality of fundus images simultaneously. However, nothing precludes simultaneous consideration of the multiple processes by a human mind or by a group of people. Therefore, claims 34-35 neither integrate the exception into a practical application nor constitute significantly more.
Regarding claim 36 and 37, the claims additionally recite wherein the quality control steps can be performed on up to 200,000 fundus images. However, even assuming arguendo that 200,000 fundus images can not be considered over a period of time by one or multiple people, the claim merely puts a maximum on the number of fundus images and does not preclude the use of smaller numbers of fundus images. As such, claims 36 and 37 still encompass the same abstract idea and neither integrate the exception into a practical application nor constitute significantly more.
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 JOHN R WALLACE whose telephone number is (571)270-1577. The examiner can normally be reached Monday-Friday from 8:30-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benny Tieu can be reached at 571-272-7490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R WALLACE/Primary Examiner, Art Unit 2682