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 .
Response to Preliminary Amendment
This action is responsive to the preliminary amendments and remarks received 11 March 2024. Claims 1 - 16 are currently pending.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The abstract of the disclosure is objected to because of undue length as it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains embedded hyperlinks and/or other form of browser-executable code, see for example line 603, line610, lines 614 - 615, line 618 and lines 630 - 631 on page 15 and line 678 on page 16 of the instant specification. Applicant is required to delete the embedded hyperlinks and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 2 is objected to because of the following informalities: Lines 2 - 3 of claim 2 recite, in part, “wherein ensemble is a modular ensemble, wherein” which appears to contain inconsistent claim terminology, a grammatical error and/or a minor informality. The Examiner suggests amending the claim to --wherein the ensemble is a modular ensemble, wherein-- in order to maintain consistency with line 2 of claim 2 and to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Line 3, line 5 and lines 5 - 6 of claim 2 recite, in part, “the convolutional neural networks”, the trained convolutional neural networks” and “the convolutional neural networks”, respectively, which appear to contain inconsistent claim terminology and/or minor informalities. The Examiner suggests amending line 3, line 5 and lines 5 - 6 of claim 2 to --the ensemble of trained convolutional neural networks--, --the ensemble of trained convolutional neural networks-- and --the ensemble of trained convolutional neural networks--, respectively, in order to maintain consistency with line 2 of claim 2 and to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Line 4 of claim 2 recites, in part, “processor of computer” which appears to contain a grammatical error and/or a minor informality. The Examiner suggests amending the claim to --processor of a computer-- in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Line 10 of claim 6 recites, in part, “infor- mation relates to constraints” which appears to contain a typographical error and/or a minor informality. The Examiner suggests amending the claim to --information relates to constraints-- in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Line 10 of claim 6 includes a period that is not at the end of the claim. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Lines 28 - 29 of claim 6 recite, in part, “sheet, l) wherein” which appears to contain a grammatical error and/or a minor informality. The Examiner suggests amending the claim to --sheet, and l) wherein-- in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Line 8, line 10 and line 11 of claim 7 recite, in part, “file”, “system” and “B-scan”, respectively, which appear to contain grammatical errors and/or minor informalities. The Examiner suggests, for example, amending line 8, line 10 and line 11 of claim 7 to --file,--, ---system,-- and --B-scan, and--, respectively, in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Line 15 of claim 7 includes a period that is not at the end of the claim. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Claim 8 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Claim 11 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Lines 4 - 5 of claim 13 recite, in part, “b) optic disc segmentation using the center mass according to the equation b) optic disc segmentation using the center mass according to the equation” which appears to contain a typographical error and/or a minor informality. The Examiner suggests amending the claim to --b) optic disc segmentation using the center mass according to the equation. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 4, line 6 and line 8 of claim 14 recite, in part, “(BM)”, “data” and “step”, respectively, which appear to contain grammatical errors and/or minor informalities. The Examiner suggests amending line 4, line 6 and line 8 of claim 14 to --(BM),--, ---data,-- and --step, and--, respectively, in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 5 of claim 14 recites, in part, “by substraction of BM height values” which appears to contain a typographical error and/or a minor informality. The Examiner suggests amending the claim to --by subtraction of BM height values-- in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 10 of claim 14 recites, in part, “representing the fovea centrals is” which appears to contain inconsistent claim terminology and/or a minor informality. The Examiner suggests amending the claim to --representing the fovea centralis is-- in order to maintain consistency with line 9 of claim 14 and to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Line 3, line 4 and line 5 of claim 15 recite, in part, “time”, “system” and “cases”, respectively, which appear to contain grammatical errors and/or minor informalities. The Examiner suggests amending line 3, line 4 and line 5 of claim 15 to --time,--, ---system,-- and --cases, and--, respectively, in order to improve the clarity and precision of the claim. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 15 does not end in a period. The Examiner asserts that claims end with a period and that periods “may not be used elsewhere in the claims except for abbreviations.” See MPEP § 608.01(m). 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.
Claims 1 - 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to whether the claim(s) is/are directed towards a method or a computer program at least because lines 1 - 2 of claim 1 recite, in part, “A method, particularly a computer-implemented method or a computer program that when executed on a computer executes the steps of the method”. Thus, the Examiner asserts it is unclear as to whether the Applicant intends to claim a method or a computer program. Clarification and appropriate correction are required. The Examiner suggests amending the claim(s) so that they are directed towards one of the four categories of patent eligible subject matter, for example, by amending lines 1 - 2 of claim 1 as follows: --A method
Claim 1 recites the limitation "the steps of the method" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the measurement device," in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the OCT image data" (emphasis added) in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the server or server network" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the retina OCT image data" (emphasis added) in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the uploaded OCT image" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which information “the infor- mation” recited on line 10 is referencing. Is it referring to the ”information” recited on lines 4 - 5 of claim 6 or the “information” recited on line 9 of claim 6? Additionally, it is unclear as to whether the ”information” recited on lines 4 - 5 of claim 6 and the “information” recited on line 9 of claim 6 are the same information or different sets of information. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat line 10 of claim 6 as referencing any one of the ”information” recited on lines 4 - 5 of claim 6 or the “information” recited on line 9 of claim 6.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because the claim includes the following abbreviation and/or acronym, “DCNN”, see for example line 11 of claim 6, which is not clearly defined in the claims and thus it is unclear as to what the aforementioned abbreviation and/or acronym refers and/or means. Therefore, the claim is found to be indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which ROI “the ROI” recited on line 11 of claim 6 is referencing at least because line 5 of claim 6, which recites, in part, “regions of interest (ROIs)”, makes it clear that there are a plurality of ROIs. Thus, the Examiner asserts that it is unclear as to which ROI of the ”regions of interest (ROIs)” recited on line 5 of claim 6 “the ROI” recited on line 11 of claim 6 is referencing. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the ROI” recited on line 11 of claim 6 as referencing any ROI of the ”regions of interest (ROIs)” recited on line 5 of claim 6.
Claim 6 recites the limitation "the center of the landmarks, macula center and/or optic nerve head center" in lines 12 - 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the landmarks, " macula center and/or optic nerve head center" in lines 12 - 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the quality assessment" in line 21. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the quality assessment results" in line 22. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, the phrase "e.g." recited on line 27 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites the limitation "the user" in line 29. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, the phrase "e.g." recited on lines 30 - 31 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites the limitation "the surrounding B-scans" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the retina OCT image" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the B-scans inside the ROI" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which ROI “the ROI” recited on line 8 is referencing at least because lines 3 - 5 of claim 6 disclose a configuration file comprising a plurality of “regions of interest (ROIs)”, lines 11 - 12 of claim 6 recite, in part, “the ROI in configuration file” and lines 29 - 30 of claim 6 disclose a configuration file predefining “ROIs”. Thus, the Examiner asserts that it is unclear as to which of the aforementioned ROIs, if any, “the ROI” recited on line 8 of claim 7 is referencing. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the ROI” recited on line 8 of claim 7 as referencing any of the aforementioned ROIs.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which configuration file “the configuration file” recited on line 8 is referencing. Is it referring to the “configuration file” recited on line 3 of claim 6, the “configuration file” recited on line 12 of claim 6, the “configuration file” recited on line 29 of claim 6 or the “configuration file” recited on line 6 of claim 7? Additionally, it is unclear as to whether the “configuration file” recited on line 3 of claim 6, the “configuration file” recited on line 12 of claim 6, the “configuration file” recited on line 29 of claim 6 and the “configuration file” recited on line 6 of claim 7 are the same configuration file or different configuration files. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the configuration file” recited on line 8 of claim 7 as referencing any of the aforementioned configuration files.
Claim 7 recites the limitation "the low signal strength metric" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the optic disc" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the computerized system" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the neighboring B-scans" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the detected low quality B-scan" (emphasis added) in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the pixel gray level" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the mean pixel value and pixel gray values" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "The indices I and j" in lines 15 - 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the row and column of the pixels in the B-scans" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the pixels in the B-scans" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which B-scans “the B-scans” recited on line 16 are referencing. Are they referring to the ”single low quality B-scans” recited on line 3 of claim 7, the “surrounding B-scans” recited on line 3 of claim 7, the “low quality B-scans” recited on line 5 of claim 7, “the B-scans inside the ROI” recited on line 8 of claim 7 and/or the “neighboring B-scans” recited on line 11 of claim 7? Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the B-scans” recited on line 16 of claim 7 as referencing the “neighboring B-scans” recited on line 11 of claim 7.
Claim 7 recites the limitation "the number of the B-scan" in lines 16 - 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the B-scan in the OCT volume" in lines 16 - 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the OCT volume" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the original low quality B-scan" (emphasis added) in lines 1 - 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the final quality metrics and reports" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the newly arithmetic mean computed B-scan" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the substituted B-scans" (emphasis added) in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the predefined ROI" (emphasis added) in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which configuration file “the configuration file” recited on line 3, along with subsequent recitations of “the configuration file”, are referencing. Are they referring to the “configuration file” recited on line 3 of claim 6, the “configuration file” recited on line 12 of claim 6 or the “configuration file” recited on line 29 of claim 6? Additionally, it is unclear as to whether the “configuration file” recited on line 3 of claim 6, the “configuration file” recited on line 12 of claim 6 and the “configuration file” recited on line 29 of claim 6 are the same configuration file or different configuration files. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the configuration file” recited on line 3 of claim 9, along with subsequent recitations of “the configuration file”, as referencing any of the aforementioned configuration files.
Claim 9 recites the limitation "the distance between the fovea center and optic disk" in lines 3 - 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the fovea center and optic disk" in lines 3 - 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the area of the optic disc" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because the variable “psm” recited on line 5 of claim 10 is undefined and it is therefore unclear as to how rmin is calculated. Therefore, the claim is found to be indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 10 recites the limitation "the x and y coordinates of the fovea centralis on the SLO fundus image or generated projection image" in lines 7 - 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the SLO fundus image" (emphasis added) in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the x and y SLO or generated projection image coordinates of the optic disc contour" in lines 8 - 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the contour point" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the automated computerized quality assessment system" in lines 2 - 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the reports" (emphasis added) in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the adaptive ROI" (emphasis added) in lines 3 - 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the retina OCT image" in line 2 . There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the re- centering coordinates" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the correct center coordinates" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the phrase "can be" recited on line 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 13 recites the limitation "the region detected" in lines 1 - 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the optic disc" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the center mass" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the x- and y-coordinates of the center mass" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the x- and y- coordinates at position i" in lines 9 - 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the total pixel value" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the pixel value of pixel i" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the region detected" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the macula" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the boundary information of two surfaces delimiting the retina" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the inner limiting membrane (ILM)" in lines 3 - 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the Bruch’s membrane (BM)" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the macula center" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the deepest pit" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the deepest point" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the center of the fovea centralis" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the fovea centralis" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the deepest point detected" (emphasis added) in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the fitting parameters" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the phrase "can be" recited on line 12 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 15 recites the limitation "the computerized quality assessment system" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the thresholds sets" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which configuration file “the configuration file” recited on line 5, and subsequent recitations of “the configuration file”, are referencing. Are they referring to the “configuration file” recited on line 3 of claim 6, the “configuration file” recited on line 12 of claim 6 or the “configuration file” recited on line 29 of claim 6? Additionally, it is unclear as to whether the “configuration file” recited on line 3 of claim 6, the “configuration file” recited on line 12 of claim 6 and the “configuration file” recited on line 29 of claim 6 are the same configuration file or different configuration files. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the configuration file” recited on line 5 of claim 15, and subsequent recitations of “the configuration file”, as referencing any of the aforementioned configuration files.
Regarding claim 15, the phrase "may comprise" recited on line 6 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because it is unclear as to which threshold “the threshold” recited on lines 6 - 7 is referencing at least because line 4 of claim 6 recites, in part, “thresholds”, line 30 of claim 6 recites, in part, “thresholds” and line 5 and claim 15 recites, in part, “the threshold sets”. Thus, the Examiner asserts that it is unclear as to which of the aforementioned thresholds, if any, “the threshold” recited on lines 6 - 7 of claim 15 is referencing. Clarification and appropriate correction are required. For purposes of examination, the Examiner will treat “the threshold” recited on lines 6 - 7 of claim 15 as referencing any threshold of the aforementioned thresholds.
Claim 15 recites the limitation "the values in the configuration file" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the disease specific ROIs and image characteristics" in lines 7 - 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 2, 3, 5 and 16 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, due to being dependent upon a rejected base claim(s) but would be withdrawn from the rejection if their base claim(s) overcome the rejection.
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 - 5, 14 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. The claims are directed towards assessing a quality of an optical coherence tomography (OCT) retinal image (OCT image), which is an abstract idea.
The claims recite, at a high level of generality, a method “configured for a quality control of an optical coherence tomography (OCT) retinal image (OCT image).”
The limitation of a “method configured for a quality control of an optical coherence tomography (OCT) retinal image (OCT image)”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind using observation, evaluation, judgment, and opinion but for the recitation of generic computer components. That is, other than reciting “a computer-implemented method or a computer program that when executed on a computer executes the steps of the method” (see claim 1) and a “system configured to execute the method… particularly wherein the system comprises at least one computer configured to execute the quality control” (see claim 16) nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the recitation of the aforementioned generic computer components, the claimed quality control of an optical coherence tomography (OCT) retinal image (OCT image) encompasses a user observing an optical coherence tomography (OCT) retinal image (OCT image) and performing an evaluation, judgment and/or opinion to mentally decide whether or not the OCT image is of an acceptable level of quality. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, with or without the use of a physical aid such as pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(III).
This judicial exception is not integrated into a practical application. In particular, the claims recite additional elements of: “a computer-implemented method or a computer program that when executed on a computer executes the steps of the method” and a “system configured to execute the method… particularly wherein the system comprises at least one computer configured to execute the quality control.”
The limitations of “a computer-implemented method or a computer program that when executed on a computer executes the steps of the method” and a “system configured to execute the method… particularly wherein the system comprises at least one computer configured to execute the quality control” are recited at a high level of generality such that they amount to no more than mere instructions to apply the exception using generic computer components. Furthermore, the claims as a whole merely describe how to generally “apply” the concept of predicting a future deformation in a computer environment. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. See MPEP § 2106.05(f).
Even when viewed in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
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 elements of: “a computer-implemented method or a computer program that when executed on a computer executes the steps of the method” and a “system configured to execute the method… particularly wherein the system comprises at least one computer configured to execute the quality control” amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Even when considered in combination, these additional elements represent mere instructions to implement an abstract idea or other exception on a computer, which do not provide an inventive concept. The claims are not patent eligible.
Furthermore, with regards to dependent claim 2, the limitation of “wherein the quality control is performed by an ensemble of trained convolutional neural networks”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, an ensemble of trained convolutional neural networks. That is, other than reciting “an ensemble of trained convolutional neural networks”, nothing in the claim element precludes the step from practically being performed in the mind. The Examiner asserts that the claim does not provide any details nor limit how the ensemble of trained convolutional neural networks operate or how the quality control is performed, and the plain meaning of performing quality control encompasses mental observations, evaluations, judgments, and/or opinions, e.g., a user observing an optical coherence tomography (OCT) retinal image (OCT image) and mentally deciding whether or not the OCT image is of an acceptable level of quality. Under its broadest reasonable interpretation when read in light of the specification, performing quality control encompasses mental processes practically performed in the human mind by observation, evaluation, judgment, and opinion. For example, the claimed quality control of an optical coherence tomography (OCT) retinal image (OCT image) encompasses a user observing an optical coherence tomography (OCT) retinal image (OCT image) and performing an evaluation, judgment and/or opinion to mentally decide whether or not the OCT image is of an acceptable level of quality. See MPEP § 2106.04(a)(2)(I) and § 2106.04(a)(2)(III). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Additionally, the limitation of “wherein the quality control is performed by an ensemble of trained convolutional neural networks”, provides nothing more than mere instructions to implement an abstract idea on a generic computer. See MPEP § 2106.05(f). MPEP 2106.05(f) provides the following considerations for determining whether a claim simply recites a judicial exception with the words “apply it” (or an equivalent), such as mere instructions to implement an abstract idea on a computer: (1) whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished; (2) whether the claim invokes computers or other machinery merely as a tool to perform an existing process; and (3) the particularity or generality of the application of the judicial exception. Moreover, the aforementioned trained convolutional neural networks are used to generally apply the abstract idea without placing any limits on how the aforementioned trained convolutional neural networks function. See MPEP 2106.05(f). Additionally, the recitations of “trained convolutional neural networks” merely indicate a field of use or technological environment in which the judicial exception is performed. Although the additional element of “trained convolutional neural networks” limits the identified judicial exception assessing a quality of an optical coherence tomography (OCT) retinal image (OCT image), this type of limitation merely confines the use of the abstract idea to a particular technological environment (machine learning) and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h). The claim is not patent eligible.
Moreover, with regards to dependent claims 3 - 5, the claims recite further additional elements of: “an OCT measurement device configured to record the OCT image”, “receiv[ing] the OCT image, particularly from the measurement device” and “wherein… a feedback of a quality metric is provided to a user of the method, particularly wherein the feedback is provided by means of a displayed message or information.” The limitations of “an OCT measurement device configured to record the OCT image”, “receiv[ing] the OCT image, particularly from the measurement device” and “wherein… a feedback of a quality metric is provided to a user of the method, particularly wherein the feedback is provided by means of a displayed message or information” are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP § 2106.05(g). In addition, all uses of the recited judicial exception require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claims. These limitations amount to necessary data gathering. See MPEP § 2106.05. Additionally, the elements of the aforementioned limitations amount to recording and transmitting digital images and information by use of conventional or generic technology in a nascent but well-known environment and are well-understood, routine, conventional activity. See MPEP § 2106.05(d). Even when viewed in combination, these further 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 nor are they sufficient to amount to significantly more than the judicial exception. Accordingly, the claims are directed to an abstract idea and are not patent eligible.
Additionally, with regards to dependent claim 14, the Examiner asserts that none of the steps a) - d) are required to be performed by the broadest reasonable interpretation of dependent claim 14 at least because claim 14 is a method (process) claim, the steps a) - d) in dependent claim 14 are contingent limitations that are only required to be performed if a condition precedent is met, i.e., when “the region detected is that of the macula”, and the invention claimed in claim 14 may be practiced without the condition precedent happening, i.e., the invention claimed in claim 14 may be practiced without a detecting a macula region. See MPEP § 2111.04(II).
In addition, with regards to dependent claims 2 - 5 and 14, the Examiner asserts that claims 2 - 5 and 14 are also directed to the abstract idea of assessing a quality of an optical coherence tomography (OCT) retinal image (OCT image) and dependent claims 2 - 5 merely further limit the abstract idea claimed in independent claim 1, for example by further identifying additional generic computer components, and/or by further identifying additional insignificant pre/post extrasolution activity that is performed. However, the Examiner asserts that a more detailed abstract idea remains an abstract idea and that none of the limitations of the dependent claims considered as an ordered combination provide eligibility because taken as a whole the claims merely instruct the practitioner to apply the abstract idea using generic computer components. The claims are not eligible.
Claims 1 - 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the broadest reasonable interpretation of the claims is directed towards “a computer program” which is neither a process, a machine, manufacture, nor composition of matter. The Examiner suggests amending the claim(s) so that they are directed towards one of the four categories of patent eligible subject matter, for example, by amending lines 1 - 2 of claim 1 as follows: --A method
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al., “A Deep Learning-based Quality Assessment and Segmentation System with a Large-scale Benchmark Dataset for Optical Coherence Tomographic Angiography Image”, arXiv, arXiv:2107.10476v1, 22 Jul. 2021, pages 1 - 14.
- With regards to claim 1, Wang et al. disclose a method, particularly a computer-implemented method or a computer program that when executed on a computer executes the steps of the method, (Wang et al., Pg. 1 Abstract, Pg. 2 Right-Hand Column Second-Full Paragraph, Pg. 5 § 3 - § 3.1 ¶ 2, Pg. 8 § 4.1) wherein the method is configured for a quality control of an optical coherence tomography (OCT) retinal image (OCT image). (Wang et al., Pg. 1 Abstract, Pg. 2 Right-Hand Column Second-Full Paragraph, Pg. 3 Left-Hand Column Sub-Section 2. - Sub-Section 4., Pg. 5 § 3 - § 3.2, Pg. 6 Fig. 3, Pg. 8 § 4.1 - § 4.4)
- With regards to claim 2, Wang et al. disclose the method according to claim 1 wherein the quality control is performed by an ensemble of trained convolutional neural networks, (Wang et al., Pg. 1 Abstract, Pg. 2 Right-Hand Column First-Full Paragraph - Second-Full Paragraph, Pg. 3 Left-Hand Column Sub-Section 2. - Sub-Section 4., Pg. 5 § 3.2 ¶ 1 - 2, Pg. 6 Fig. 3, Pg. 9 Table 5) particularly wherein ensemble is a modular ensemble, wherein the convolutional neural networks are executed on a processor of computer that is in communication with a data memory for storing parameters of the trained convolutional neural networks or wherein the convolutional neural networks are configured to execute the quality control. (Wang et al., Pg. 1 Abstract, Pg. 2 Right-Hand Column First-Full Paragraph - Second-Full Paragraph, Pg. 3 Left-Hand Column Sub-Section 2. - Sub-Section 4., Pg. 5 § 3.2 ¶ 1 - 2, Pg. 6 Fig. 3, Pg. 9 Table 5)
- With regards to claim 16, Wang et al. disclose a system (Wang et al., Pg. 1 Abstract, Pg. 2 Right-Hand Column Second-Full Paragraph, Pg. 5 § 3 - § 3.1 ¶ 2, Pg. 6 Fig. 3, Pg. 8 § 4.1) configured to execute the method according to claim 1, ([Wang et al. disclose the method according to claim 1, see analysis of claim 1 provided herein above.]) particularly wherein the system comprises at least one computer configured to execute the quality control. (Wang et al., Pg. 1 Abstract, Pg. 2 Right-Hand Column Second-Full Paragraph, Pg. 8 § 4.1, Pg. 9 § 5 ¶ 1 - 2)
Claims 1, 3, 4 and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sobol et al. U.S. Publication No. 2021/0378505 A1.
- With regards to claim 1, Sobol et al. disclose a method, particularly a computer-implemented method or a computer program that when executed on a computer executes the steps of the method, (Sobol et al., Abstract, Figs. 1, 2 & 5, Pg. 1 ¶ 0013 - Pg. 2 ¶ 0015, Pg. 2 ¶ 0023 - 0029, Pg. 3 ¶ 0033, Pg. 9 ¶ 0079 - Pg. 10 ¶ 0081) wherein the method is configured for a quality control of an optical coherence tomography (OCT) retinal image (OCT image). (Sobol et al., Abstract, Figs. 2 & 5, Pg. 2 ¶ 0023 - 0024, Pg. 3 ¶ 0037 - Pg. 4 ¶ 0038, Pg. 6 ¶ 0058, Pg. 9 ¶ 0077)
- With regards to claim 3, Sobol et al. disclose the method according to claim 1, wherein the method is executed on an OCT measurement device configured to record the OCT image and to execute the method. (Sobol et al., Figs. 1 & 2, Pg. 3 ¶ 0030, Pg. 3 ¶ 0036 - Pg. 4 ¶ 0038 [“An image quality metric can be computed for the OCT image. The quality metric can be determined, by program code executed by the OCT device 12, the control device 22, the mobile device 14 or the remote system 16.”])
- With regards to claim 4, Sobol et al. disclose the method according to claim 1, wherein the method is executed on a server or a server network, (Sobol et al., Figs. 1 & 2, Pg. 1 ¶ 0013 - 0014, Pg. 2 ¶ 0027, Pg. 2 ¶ 0029 - Pg. 3 ¶ 0031, Pg. 3 ¶ 0037, Pg. 4 ¶ 0042 - 0044, Pg. 6 ¶ 0053 and 0057 - 0058) that is configured to receive the OCT image, (Sobol et al., Figs. 1 & 2, Pg. 1 ¶ 0013 - 0014, Pg. 2 ¶ 0027, Pg. 3 ¶ 0037, Pg. 5 ¶ 0048 - 0051, Pg. 6 ¶ 0053 and 0058, Pg. 9 ¶ 0077) particularly from the measurement device, (Sobol et al., Figs. 1 & 2, Pg. 1 ¶ 0013 - 0014, Pg. 2 ¶ 0027, Pg. 3 ¶ 0037, Pg. 5 ¶ 0048 - 0051, Pg. 6 ¶ 0053 and 0058, Pg. 9 ¶ 0077) particularly via a data network connection provided by the internet or a mobile data network, (Sobol et al., Figs. 1 & 2, Pg. 1 ¶ 0013 - 0014, Pg. 2 ¶ 0027, Pg. 3 ¶ 0030 - 0031, 0034 and 0037, Pg. 4 ¶ 0042 - 0044, Pg. 6 ¶ 0052 - 0053) and particularly wherein the quality control is performed as part of a remote computer service over a network. (Sobol et al., Figs. 1 & 2, Pg. 1 ¶ 0013 - 0014, Pg. 2 ¶ 0027, Pg. 2 ¶ 0029 - Pg. 3 ¶ 0031, Pg. 3 ¶ 0037, Pg. 4 ¶ 0042 - 0044, Pg. 6 ¶ 0053 and 0057 - 0058 [“An image quality metric can be computed for the OCT image. The quality metric can be determined, by program code executed by the OCT device 12, the control device 22, the mobile device 14 or the remote system 16.”])
- With regards to claim 16, Sobol et al. disclose a system (Sobol et al., Abstract, Figs. 1, 2 & 5, Pg. 1 ¶ 0013 - Pg. 2 ¶ 0015, Pg. 2 ¶ 0023 - 0029, Pg. 3 ¶ 0033, Pg. 9 ¶ 0079 - Pg. 10 ¶ 0081) configured to execute the method according to claim 1, ([Sobol et al. disclose the method according to claim 1, see analysis of claim 1 provided herein above.]) particularly wherein the system comprises at least one computer configured to execute the quality control. (Sobol et al., Abstract, Figs. 1, 2 & 5, Pg. 1 ¶ 0013 - Pg. 2 ¶ 0015, Pg. 2 ¶ 0023 - 0029, Pg. 3 ¶ 0033, Pg. 9 ¶ 0079 - Pg. 10 ¶ 0081)
Claims 1, 5, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kauer et al., “Automatic Quality Evaluation as Assessment Standard for Optical Coherence Tomography”, SPIE, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, Vol. 10868, Feb. 2019, pages 1 - 11.
- With regards to claim 1, Kauer et al. disclose a method, particularly a computer-implemented method or a computer program that when executed on a computer executes the steps of the method, (Kauer et al., Pg. 1 Abstract - Pg. 2 § 1 ¶ 1, Pg. 2 § 1 ¶ 4, Pg. 3 § 2.1 - Pg. 4 First-Full Paragraph, Pg. 4 Figs. 1 & 2, Pg. 5 § 2.2, Pg. 9 § 4) wherein the method is configured for a quality control of an optical coherence tomography (OCT) retinal image (OCT image). (Kauer et al., Pg. 1 Abstract - Pg. 2 § 1 ¶ 1, Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 First-Full Paragraph, Pg. 4 Figs. 1 & 2, Pg. 5 § 2.2 ¶ 1, Pg. 7 Fig. 6, Pg. 8 Fig. 7)
- With regards to claim 5, Kauer et al. disclose the method according to claim 1, wherein the method automatically rejects or accepts OCT images, (Kauer et al., Pg. 1 Abstract, Pg. 3 § 2.1 - Pg. 4 First-Full Paragraph, Pg. 4 Figs. 1 & 2, Pg. 5 § 2.2 ¶ 1, Pg. 5 Fig. 3, Pg. 8 Fig. 7, Pg. 9 § 4 ¶ 3, Pg. 9 Fig. 8) and a feedback of a quality metric is provided to a user of the method, particularly wherein the feedback is provided by means of a displayed message or information. (Kauer et al., Pg. 1 Abstract, Pg. 3 § 2.1 - Pg. 4 First-Full Paragraph, Pg. 4 Figs. 1 & 2, Pg. 5 § 2.2 ¶ 1, Pg. 5 Fig. 3, Pg. 8 Fig. 7, Pg. 9 § 4 ¶ 3, Pg. 9 Fig. 8)
- With regards to claim 14, [As Best Understood by the Examiner] Kauer et al. disclose the method according to claim 1, where in case the region detected is that of the macula, (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2 [The Examiner asserts that none of the limitations of claim 14 are required by the broadest reasonable interpretation of claim 14 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., when “the region detected is that of the macula”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without the region detected being that of the macula, the Examiner asserts that none of the limitations of claim 14 are required by the broadest reasonable interpretation of claim 14. See MPEP § 2111.01(II).]) the following steps are executed: a) acquisition of the boundary information of two surfaces delimiting the retina, the inner limiting membrane (ILM) and that of the Bruch's membrane (BM) b) compensation for high angled B-scan by substraction of BM height values from ILM data c) computation of the macula center using a grid search for the deepest pit, where the search is performed on the computed compensated ILM data from the previous step d) check to ensure that the deepest point is the center of the fovea centralis, whereas the check to ensure that the deepest point detected is representing the fovea centrals is computed using a paraboloid fit and evaluating the fitting parameters, whereas the paraboloid fit can be performed using a least square method. ([The Examiner asserts that none of the limitations of claim 14 are required by the broadest reasonable interpretation of claim 14 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., when “the region detected is that of the macula”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without the region detected being that of the macula, the Examiner asserts that none of the limitations of claim 14 are required by the broadest reasonable interpretation of claim 14. See MPEP § 2111.01(II).])
- With regards to claim 16, Kauer et al. disclose a system (Kauer et al., Pg. 1 Abstract - Pg. 2 § 1 ¶ 4, Pg. 3 § 2.1 - Pg. 4 First-Full Paragraph, Pg. 4 Fig. 2, Pg. 5 § 2.2 ¶ 2, Pg. 9 § 4) configured to execute the method according to claim 1, ([Kauer et al. disclose the method according to claim 1, see analysis of claim 1 provided herein above.]) particularly wherein the system comprises at least one computer configured to execute the quality control. (Kauer et al., Pg. 1 Abstract - Pg. 2 § 1 ¶ 4, Pg. 3 § 2.1 - Pg. 4 First-Full Paragraph, Pg. 4 Fig. 2, Pg. 5 § 2.2 ¶ 2, Pg. 9 § 4)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 - 8, 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kauer et al., “Automatic Quality Evaluation as Assessment Standard for Optical Coherence Tomography”, SPIE, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, Vol. 10868, Feb. 2019, pages 1 - 11 as applied to claim 6 above, and further in view of Iwase et al. U.S. Publication No. 2022/0110521 A1.
- With regards to claim 6, [As Best Understood by the Examiner] Kauer et al. disclose the method according to claim 1, wherein the method further comprises the steps of: a) starting and executing a user application with a default configuration file comprising information on a scan type and OCT image dimensions, quality features, thresholds and regions of interest (ROIs) of the OCT image, (Kauer et al., Pg. 1 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Fig. 2, Pg. 5 § 2.2 ¶ 1, Pg. 5 Fig. 3) b) providing, particularly uploading the OCT image data to the method, particularly to the user application or the server or server network, (Kauer et al., Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Fig. 2, Pg. 5 § 2.2 ¶ 1) c) reading the retina OCT image data, (Kauer et al., Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Fig. 2, Pg. 5 § 2.2 ¶ 1) d) matching information from the configuration file to the uploaded OCT image, particularly wherein the infor- mation relates to constraints for the OCT image. (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Fig. 2) e) employing a DCNN for a centering check such that the information about the ROI in configuration file from the center of the landmarks, macula center and/or optic nerve head center is comprised in the OCT image, (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 5 § 2.2 ¶ 1, Pg. 4 Figs. 1 & 2 [“Included in the quality control are the signal quality, the anatomical completeness of the imaged retina, the plausibility of the segmentation data and the correct centering of the scan”]) f) employing a DCNN for signal strength and completeness of each slice (B-scan) comprised in the OCT image, (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 5 § 2.2 ¶ 1, Pg. 4 Figs. 1 & 2) g) executing a segmentation plausibility assessment for any segmentation that is differentiating between different regions and /or layers of each B-scan comprised in the OCT image, (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 5 § 2.2 ¶ 1, Pg. 4 Figs. 1 & 2) h) generating of metrics for each of the steps e)- g), (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 3 § 2.1 ¶ 2, Pg. 4 Figs. 1 & 2) i) applying the thresholds comprised in the information of the configuration file to the metrics from h) in order to complete the quality assessment (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 3 § 2.1 ¶ 2, Pg. 4 Figs. 1 & 2) and generate j) a report of the quality assessment results (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 3 § 2.1 ¶ 2, Pg. 4 Figs. 1 & 2) accompanied by visual aids as user feedback particularly in form of color coded maps generated from the quality features overlayed atop of an image associated to or comprised by the OCT image data, or if the image is unavailable from a projection image generated from the OCT image, (Kauer et al., Pg. 1 Abstract, Pg. 2 § 1 ¶ 3 - Pg. 3 § 2.1 ¶ 2, Pg. 4 Figs. 1 & 2) k) generating and providing, e.g. in form of displaying, a detailed quality result spread sheet, (Kauer et al., Pg. 1 Abstract - Pg. 2 § 1 ¶ 1, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Figs. 1 & 2, Pg. 5 Fig. 3, Pg. 8 Fig. 7, Pg. 9 Fig. 8) l) wherein the user has the possibility to predefine using a configuration file different analysis procedures, quality features, thresholds and ROIs regarding their data, e.g. circular- or volume-scans. (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 5 § 2.2 ¶ 1) Kauer et al. fail to disclose explicitly a scanning laser ophthalmoscopy (SLO) image. Pertaining to analogous art, Iwase et al. disclose a scanning laser ophthalmoscopy (SLO) image associated to or comprised by the OCT image data, or if the SLO image is unavailable from a projection image generated from the OCT image. (Iwase et al., Figs. 1, 2C, 3 & 5A - 7, Pg. 2 ¶ 0026 - 0027, Pg. 3 ¶ 0037 - 0038, Pg. 7 ¶ 0066, Pg. 9 ¶ 0088) Kauer et al. and Iwase et al. are combinable because they are both directed towards image processing systems that process and assess optical coherence tomography (OCT) retinal images. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kauer et al. with the teachings of Iwase et al. This modification would have been prompted in order to substitute the undisclosed type of fundus image of Kauer et al. for the scanning laser ophthalmoscope (SLO) fundus image of Iwase et al. The scanning laser ophthalmoscope (SLO) fundus image of Iwase et al. could be substituted in place of the undisclosed type of fundus image of Kauer et al. utilizing well-known techniques in the art and would likely yield predictable results, in that in the combination scanning laser ophthalmoscopy would be utilized to generate the fundus image of the retina utilized by the base device of Kauer et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that scanning laser ophthalmoscopy would be utilized to generate the fundus image of the retina utilized by the base device of Kauer et al. Therefore, it would have been obvious to combine Kauer et al. with Iwase et al. to obtain the invention as specified in claim 6.
- With regards to claim 7, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. disclose the method according to claim 6, further comprising the steps of: interpolating single low quality B-scans, if the surrounding B-scans are of sufficient quality ([The Examiner asserts that none of the limitations of claim 7 are required to be performed by the broadest reasonable interpretation of claim 7 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., “if the surrounding B-scans are of sufficient quality”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without there being surrounding B-scans of sufficient quality, the Examiner asserts that none of the limitations of claim 7 are required by the broadest reasonable interpretation of claim 7. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. disclose the method of claim 7.]) wherein: low quality B-scans comprised in the retina OCT image are automatically detected as defined by the metrics and configuration file, wherein the metrics considered are low signal and incompleteness comprising the steps of: a) detecting the B-scans inside the ROI the configuration file b) excluding the low signal strength metric inside the optic disc automatically detected by the computerized system c) determining the neighboring B-scans of the detected low quality B-scan d) computing the arithmetic mean of the neighboring B-scans, wherein this computation is performed on the pixel gray level according to the equation:
p
-
i
j
n
=
1
2
p
i
j
n
-
1
+
p
i
j
n
+
1
,
where
p
-
and p are the mean pixel value and pixel gray values respectively. The indices i and j denote the row and column of the pixels in the B-scans and n the number of the B- scan in the OCT volume. ([The Examiner asserts that none of the limitations of claim 7 are required to be performed by the broadest reasonable interpretation of claim 7 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., “if the surrounding B-scans are of sufficient quality”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without there being surrounding B-scans of sufficient quality, the Examiner asserts that none of the limitations of claim 7 are required by the broadest reasonable interpretation of claim 7. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. disclose the method of claim 7.])
- With regards to claim 8, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. disclose the method according to claim 7 where the original low quality B-scan is substituted with the newly arithmetic mean computed B-scan, whereas the final quality metrics and reports are recomputed with the substituted B-scans. ([The Examiner asserts that none of the limitations of claim 8 are required to be performed by the broadest reasonable interpretation of claim 8 at least because they are contingent limitations since the newly arithmetic mean computed B-scan is computed if the condition precedent in claim 7 is met, i.e., “if the surrounding B-scans are of sufficient quality”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without there being surrounding B-scans of sufficient quality, the Examiner asserts that none of the limitations of claim 8 are required by the broadest reasonable interpretation of claim 8. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. disclose the method of claim 8.])
- With regards to claim 12, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. disclose the method according to claim 6 whereas the correct center coordinates can be employed in further OCT retina image analysis. ([The Examiner asserts that the broadest reasonable interpretation of “whereas the correct center coordinates can be employed in further OCT retina image analysis” does not require that the correct center coordinates are employed in further OCT retina image analysis. “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed”. See MPEP § 2111.04.]) Kauer et al. fail to disclose explicitly further automatically re-centering the retina OCT image, and where the re-centering coordinates are saved within the quality report. Pertaining to analogous art, Iwase et al. disclose further automatically re-centering the retina OCT image, (Iwase et al., Figs. 1 - 6, Pg. 3 ¶ 0035 - 0036 and 0039, Pg. 5 ¶ 0052 - 0057, Pg. 6 ¶ 0059 - 0060, Pg. 8 ¶ 0073 and 0076, Pg. 9 ¶ 0088) where the re-centering coordinates are saved within the quality report, (Iwase et al., Figs. 1 - 6, Pg. 3 ¶ 0039, Pg. 5 ¶ 0052 - 0057, Pg. 6 ¶ 0059 - 0062, Pg. 6 ¶ 0065 - Pg. 7 ¶ 0068, Pg. 8 ¶ 0073 and 0076, Pg. 9 ¶ 0088) whereas the correct center coordinates can be employed in further OCT retina image analysis. ([The Examiner asserts that the broadest reasonable interpretation of “whereas the correct center coordinates can be employed in further OCT retina image analysis” does not require that the correct center coordinates are employed in further OCT retina image analysis. “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed”. See MPEP § 2111.04.]) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Kauer et al. in view of Iwase et al. with additional teachings of Iwase et al. This modification would have been prompted in order to enhance the combined base device of Kauer et al. in view of Iwase et al. with the well-known and applicable technique Iwase et al. applied to a similar device. Automatically re-centering the retina OCT image, as taught by Iwase et al., would enhance the combined base device by improving its ability to properly locate and assess whether or not the entirety of the region of interest to be examined is represented in the OCT image and has a sufficient level of quality to be usable in subsequent medical interpretation and diagnosis. Furthermore, this modification would have been prompted by the teachings and suggestions of Kauer et al. that correct centering of the scan is evaluated when assess the quality of OCT images, see at least page 3 section 2.1 paragraph 1 of Kauer et al. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the retina OCT image of the combined base device would be automatically re-centered so as to improve its ability to properly locate and assess whether or not the entirety of the region of interest to be examined is represented in the OCT image and has a sufficient level of quality to be usable in subsequent medical interpretation and diagnosis. Therefore, it would have been obvious to combine Kauer et al. in view of Iwase et al. with additional teachings of Iwase et al. to obtain the invention as specified in claim 12.
- With regards to claim 13, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. disclose the method according to claim 12, wherein in case the region detected is that of the optic nerve head, (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2 [The Examiner asserts that none of the limitations of claim 13 are required by the broadest reasonable interpretation of claim 13 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., when “the region detected is that of the optic nerve head”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without the region detected being that of the optic nerve head, the Examiner asserts that none of the limitations of claim 13 are required by the broadest reasonable interpretation of claim 13. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. disclose the method of claim 13.]) the following steps are executed: a) semantic segmentation of the optic disc using a DCNN approach on the SLO image, b) optic disc segmentation using the center mass according to the equation b) optic disc segmentation using the center mass according to the equation xcom =
1
M
∑
i
=
1
n
m
i
x
i
, ycom =
1
M
∑
i
=
1
n
m
i
y
i
, M =
∑
i
=
1
n
m
i
, where xcom and ycom are the x- and y-coordinates of the center of mass, xi and yi the x- and y-coordinates at position i, M the total pixel value and mi the pixel value of pixel i. ([The Examiner asserts that none of the limitations of claim 13 are required by the broadest reasonable interpretation of claim 13 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., when “the region detected is that of the optic nerve head”. Because the claimed invention may be practiced without the condition precedent being met, i.e., without the region detected being that of the optic nerve head, the Examiner asserts that none of the limitations of claim 13 are required by the broadest reasonable interpretation of claim 13. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. disclose the method of claim 13.])
- With regards to claim 15, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. disclose the method according to claim 6 further comprising the steps of: a) collecting different retina OCT image datasets over time (Kauer et al., Pg. 1 Abstract, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Figs. 1 & 2, Pg. 5 § 2.2 ¶ 1, Pg. 8 § 3.2 - Pg. 9 § 4) b) automated analysis of these datasets with the computerized quality assessment system (Kauer et al., Pg. 1 Abstract, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Figs. 1 & 2, Pg. 5 § 2.2 ¶ 1, Pg. 8 § 3.2 - Pg. 9 § 4) c) adapting the thresholds sets in the configuration file for different use cases (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2) d) whereas different use cases may comprise specific diseases in which case adapting the threshold means updating the values in the configuration file according to the disease specific ROls and image characteristics. (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2)
Claims 9 - 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kauer et al., “Automatic Quality Evaluation as Assessment Standard for Optical Coherence Tomography”, SPIE, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, Vol. 10868, Feb. 2019, pages 1 - 11 in view of Iwase et al. U.S. Publication No. 2022/0110521 A1 as applied to claim 6 above, and further in view of Abramoff et al. U.S. Publication No. 2015/0124216 A1.
- With regards to claim 9, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. disclose the method according to claim 6 further comprising the steps of: adapting the predefined ROI from the configuration file. (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Figs. 1 & 2) Kauer et al. fail to disclose explicitly adapting the ROI to the distance between the fovea center and optic disk. Pertaining to analogous art, Iwase et al. disclose adapting the predefined ROI from the configuration file to the fovea center and optic disk. (Iwase et al., Figs. 4A - 7, Pg. 3 ¶ 0035 - 0036 and 0039, Pg. 5 ¶ 0052 - Pg. 6 ¶ 0060) Iwase et al. fail to disclose explicitly adapting the ROI to the distance between the fovea center and optic disk. Pertaining to analogous art, Abramoff et al. disclose adapting the predefined ROI from the configuration file to the distance between the fovea center and optic disk. (Abramoff et al., Abstract, Fig. 3, Pg. 5 ¶ 0064 - 0066) Kauer et al. in view of Iwase et al. and Abramoff et al. are combinable because they are all directed towards image processing systems that process and assess optical coherence tomography (OCT) retinal images. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined teachings of Kauer et al. in view of Iwase et al. with the teachings of Abramoff et al. This modification would have been prompted in order to enhance the combined base device of Kauer et al. in view of Iwase et al. with the well-known and applicable technique Abramoff et al. applied to a similar device. Adapting the predefined ROI to the distance between the fovea center and optic disk, as taught by Abramoff et al., would enhance the combined base device by compensating for individual differences in patients’ anatomies so as to help ensure that the entirety of a region of interest to be examined is properly defined and evaluated for quality in the OCT images. This combination could be completed according to well-known techniques in the art and would likely yield predictable results, in that the predefined ROI would be adapted based on the distance between the fovea center and optic disk in the OCT image so as to ensure that the entirety of the region of interest to be examined is properly defined and evaluated for quality in the OCT image. Therefore, it would have been obvious to combine Kauer et al. in view of Iwase et al. with Abramoff et al. to obtain the invention as specified in claim 9.
- With regards to claim 10, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. in view of Abramoff et al. disclose the method according to claim 9, in which a ROI is downsized if it is too close or overlapping the area of the optic disc defined by a safety margin, ([The Examiner asserts that none of the limitations of claim 10 are required by the broadest reasonable interpretation of claim 10 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., “if [a ROI] is too close or overlapping the area of the optic disc defined by a safety margin”. Because the claimed invention may be practiced without the condition precedent being met, i.e., when a ROI is not too close or overlapping the area of the optic disc defined by a safety margin, the Examiner asserts that none of the limitations of claim 10 are required by the broadest reasonable interpretation of claim 10. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. in view of Abramoff et al. disclose the method of claim 10.])whereas the safety margin is computed as the smallest euclidean distance according to the equation rmin = min(
(
x
f
c
-
x
i
o
d
)
2
+
(
y
f
c
-
y
i
o
d
)
2
) - psm, wherein rmin is the smallest distance between fovea centralis and optic disc contour, Xfc and yfc the x and y coordinates of the fovea centralis on the SLO fundus image or generated projection image and xiod and ytod the x and y SLO or generated projection image coordinates of the optic disc contour with i the index of the contour point. ([The Examiner asserts that none of the limitations of claim 10 are required by the broadest reasonable interpretation of claim 10 at least because they are contingent limitations that are performed when a condition precedent is met, i.e., “if [a ROI] is too close or overlapping the area of the optic disc defined by a safety margin”. Because the claimed invention may be practiced without the condition precedent being met, i.e., when a ROI is not too close or overlapping the area of the optic disc defined by a safety margin, the Examiner asserts that none of the limitations of claim 10 are required by the broadest reasonable interpretation of claim 10. See MPEP § 2111.01(II). Thus, Kauer et al. in view of Iwase et al. in view of Abramoff et al. disclose the method of claim 10.])
- With regards to claim 11, [As Best Understood by the Examiner] Kauer et al. in view of Iwase et al. in view of Abramoff et al. disclose the method according to claim 9, where the predefined ROI in the configuration file is automatically exchanged by the adapted ROI, (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Figs. 1 & 2) wherein the automated computerized quality assessment system generates the reports using the adaptive ROI. (Kauer et al., Pg. 2 § 1 ¶ 3 - 4, Pg. 3 § 2.1 ¶ 1 - 2, Pg. 4 Figs. 1 & 2) Additionally, analogous art Iwase et al. disclose where the predefined ROI in the configuration file is automatically exchanged by the adapted ROI, (Iwase et al., Figs. 4A - 7, Pg. 3 ¶ 0035 - 0036 and 0039, Pg. 5 ¶ 0052 - Pg. 6 ¶ 0063, Pg. 6 ¶ 0065 - Pg. 7 ¶ 0068, Pg. 8 ¶ 0073) wherein the automated computerized quality assessment system generates the reports using the adaptive ROI. (Iwase et al., Figs. 4A - 7, Pg. 3 ¶ 0035 - 0036 and 0039, Pg. 5 ¶ 0052 - Pg. 6 ¶ 0063, Pg. 6 ¶ 0065 - Pg. 7 ¶ 0068, Pg. 8 ¶ 0073) In addition, analogous art Abramoff et al. disclose where the predefined ROI in the configuration file is automatically exchanged by the adapted ROI, (Abramoff et al., Abstract, Fig. 3, Pg. 5 ¶ 0063 - 0066) wherein the automated computerized quality assessment system generates the reports using the adaptive ROI. (Abramoff et al., Abstract, Fig. 3, Pg. 5 ¶ 0063 - 0066)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Iwase et al. U.S. Publication No. 2021/0390696 A1; which is directed towards a medical image processing apparatus, wherein machine learning models are utilized to evaluate and improve the quality of retinal optical coherence tomography images.
Li et al. U.S. Publication No. 2021/0407666 A1; which is directed towards a medical image processing system, wherein deep learning neural networks are utilized to assess the quality of retinal optical coherence tomography images.
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/ERIC RUSH/Primary Examiner, Art Unit 2677