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 Arguments
Applicant’s arguments, see page 6, filed 2/4/26, with respect to claim 6 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection has been withdrawn.
Applicant’s arguments, see page 6, filed 2/4/26, with respect to claims 1-20 have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) and 103 rejections have been withdrawn.
Claim Objections
Claim 26 is objected to because of the following informalities: “signal strength ≥ 5” appears to be missing the “%”. Appropriate correction is required.
Election/Restrictions
Newly submitted claims 35 and 36 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims, drawn to training a model, represent a combination usable together with originally elected claim 1, drawn to using a model.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 35 and 36 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
1) Claim(s) 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. patent application publication 2022/0319708 by Hart et al., and further in view of U.S. patent application publication 2023/0337908 by Nakazawa et al.
2) Regarding claim 1, Hart teaches a classification workflow apparatus, comprising: an OCT imaging device (paragraph 20; an OCT imaging device); a computing device in communication with the OCT imaging device (figure 1, item 112; analysis system), the computing device configured to: perform automated quality assessment on a captured OCT volume (figure 6, item 604; paragraph 80; image quality is assessed prior to disease detection), conditionally route gradable volumes to a multi-task classification model (paragraph 25; only images of sufficient quality are sent for classification as shown in figure 6, item 606), output a combined classification result indicating presence or absence of GON (paragraphs 43 and 83; figures 2 and 6; multiple diseases are detected simultaneously, including glaucoma [paragraph 52]), and provide real-time feedback to an operator regarding scan quality (paragraph 25; quality detection can cause instructions output to user to retake images).
Hart does not specifically teach classification result indicating presence or absence of MF.
Nakazawa teaches classification result indicating presence or absence of MF (paragraphs 39, 40 and 70; myopia can be one of multiple diseases classified by the models).
NOTE: Nakazawa could modify the system of Hart to include myopia classification within the disease detection models.
Hart and Nakazawa are combinable because they are both from the OCT disease detection field of endeavor.
It would have been obvious to a person of ordinary skill in the art at the time the invention was effectively filed to combine Hart with Nakazawa to add myopia detection. The motivation for doing so would have been so that “accurate and highly precise medical diagnosis can be promptly performed” (paragraph 3). Therefore it would have been obvious to combine Hart with Nakazawa to obtain the invention of claim 1.
3) Regarding claim 34, Hart teaches the apparatus of claim 33, wherein the computing device is further configured to log quality metrics and classification outcomes for audit, training, or regulatory compliance (paragraph 70; quality assessment can exclude images from training thereby logging the outcome).
Allowable Subject Matter
Claims 21-32 and 37-40 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 21 and 28, the prior art does not contain a valid combination of references that disclose a reliability-constrained classification system for ophthalmic image analysis, comprising: a quality assessment module configured to receive a three-dimensional optical coherence tomography (OCT) volumetric scan and classify the scan as gradable or ungradable based on predefined image quality criteria; a multi-task inference module configured to process only those three-dimensional scans classified as gradable, wherein the multi-task inference module simultaneously outputs: (i) a classification result for glaucomatous optic neuropathy (GON), and (ii) a classification result for myopic features (MF); and a reporting module configured to generate a result report based on outputs from the multi- task inference module, wherein the report includes at least the GON and MF classification results. Similar prior art such as U.S. patent application publication 2022/0319708 by Hart et al. disclose assessing quality of OCT images prior to classifying a plurality of diseases but fails to disclose simultaneously outputting a classification for GON and MF with one model.
Claims 22-27, 29-32 and 37-40 are allowed because they depend upon allowed claims.
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.
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BENJAMIN O. DULANEY
Primary Examiner
Art Unit 2676
/BENJAMIN O DULANEY/ Primary Examiner, Art Unit 2683
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