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 .
Information Disclosure Statement
Acknowledgement is made of receipt of Information Disclosure Statement(s) (PTO-1449) filed 11/22/2024 and 4/8/2026. An initialed copy is attached to this Office Action.
Election/Restrictions
Claims 11-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/15/2026.
Applicant’s election without traverse of claims 1-10 in the reply filed on 9/15/2026 is acknowledged.
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.
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.
Claim 1 states “the pre-existing reference image being unique to the patient and associated with personal information and/or scan settings” and “according to the acquired personal information and/or scan settings”. The limitation and/or is not clear. Applicant need to clarify if the limitation is “and” or “or”. For examination purposes, “and/or” will be taken as “or”.
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.
Claim(s) 1, 3-4, and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sadda et al. (2021/0204808), hereinafter Sadda.
Regarding claim 1, Sadda discloses a method (methods; Abstract) comprising: receiving an input from a patient (paragraph 0135 discloses a set of input and output devices to receive signals from the user), and upon receiving the input: acquiring a pre-existing reference image of an object from a remote database (paragraphs 0060 and 0065 discloses in non-linear (elastic) registration, dissimilarity of image gray values between a reference image and a target image is calculated; storing the affine or linear registration information into a database, and accessing in the database; accessing, in the database, the saved registration information for applying to the other tissue image layers), the preexisting reference image indicating a desired scan location (paragraph 0051 discloses the systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant features, and/or characteristics that can be used to align different OCT data sets; features such as vessel (eye) characteristics, including for example, vessel (eye) location); acquiring personal information and/or scan settings regarding the patient from the remote database (paragraph 0065 discloses elastic registration to align a plurality of optical coherence tomography angiography images or videos at corresponding superficial vascular layers having well-defined features to apply elastic registration settings and/or data to corresponding deeper tissue layer; accessing, in the database, the saved registration information for applying to the other tissue image layers), the pre-existing reference image being unique to the patient and associated with personal information and/or scan settings (paragraphs 0051, 0060, and 0065 disclose the systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant features, or characteristics that can be used to align different OCT data sets; features such as vessel (eye) characteristics; in non-linear (elastic) registration, dissimilarity of image gray values between a reference image and a target image is calculated; storing the affine or linear registration information into a database, and accessing in the database; accessing, in the database, the saved registration information for applying to the other tissue image layers); acquiring a real-time image of the object (paragraphs 0088 and 0137 disclose OCT scans of an eye of a patient (object); uploading, downloading, or viewing interactive data in real time); registering the real-time image to the pre-existing reference image (paragraph 0060 discloses in non- linear (elastic) registration, dissimilarity of image gray values between a reference image and a target image is calculated); determining the desired scan location on the real-time image based on the registration (paragraphs 0051 and 0137 disclose the systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant features, and/or characteristics that can be used to align different OCT data sets; features such as vessel characteristics, including for example, vessel location, and any other features can be utilized in the registration of the superficial layer; uploading, downloading, or viewing interactive data in real time); and automatically acquiring an OCT image of the object at the desired scan location (paragraph 0051 and Abstract disclose employing optical coherence tomography (OCT) for in vivo visualization of blood vessels and the flow of blood in an eye of a patient; the systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant features, and/or characteristics that can be used to align different OCT data sets; features such as vessel (eye) characteristics, including for example, vessel (eye) location) and according to the acquired personal information or scan settings (paragraph 0040 and Abstract disclose elastic registration to align a plurality of optical coherence tomography angiography images or videos at corresponding superficial vascular layers having well-defined features to apply elastic registration settings and/or data to corresponding deeper tissue layer).
Regarding claim 3, Sadda discloses wherein the real-time image is an OCT en- face image (paragraphs 0053 and 0137 disclose OCT data can also be viewed and analyzed by looking at the OCT image in an enface manner; uploading, downloading, or viewing interactive data in real time).
Regarding claim 4, Sadda discloses further comprising: authorizing the patient based on the input from the patient and acquired personal information (paragraph 0139 discloses the URLs can include a username, a password (personal information)).
Regarding claim 8, Sadda discloses wherein the scan settings comprise a patient- specific scan pattern (paragraph 0051 discloses systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant landmarks, features, and/or characteristics that can be used to align different OCT data sets; features such as vessel characteristics, including for example, vessel patterns and any other features can be utilized in the registration of the superficial layer) and the OCT image is automatically acquired according to the scan pattern (paragraph 0051 discloses systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant landmarks, features, and/or characteristics that can be used to align different OCT data sets; features such as vessel characteristics, including for example, vessel patterns).
Regarding claim 9, Sadda discloses further comprising: aligning the OCT imaging system according to the desired scan location (paragraph 0051 and Abstract discloses employing optical coherence tomography (OCT) for in vivo visualization of blood vessels and the flow of blood in an eye of a patient; the systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant features, and/or characteristics that can be used to align different OCT data sets; features such as vessel (eye) characteristics, including for example, vessel (eye) location).
Regarding claim 10, Sadda discloses wherein the object is an eye (paragraphs 0024 and 0052 discloses different OCT scans of an eye of a patient; using OCT to better visualize the blood vessels and the flow of blood in the eye).
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadda et al. (2021/0204808), hereinafter Sadda as applied to claim 1 above, and further in view of Toyoda et al. (2022/0108804), hereinafter Toyoda.
Regarding claim 2, Sadda discloses all the limitations in common with claim 1, and such is hereby incorporated.
Sadda fails to disclose wherein the pre-existing reference image was originally obtained by a clinician.
Toyoda discloses wherein the pre-existing reference Image was originally obtained by a clinician (paragraph 0033 discloses a medical reference image is referred to as image information acquired by a health professional).
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teaching of Sadda with the wherein the pre-existing reference image of Toyoda for the purpose of providing patient information acquired by a health professional but also image information, as a medical image or a medical reference image, in order to enable enhancement in ease of medical practice.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include wherein the pre-existing reference image was originally obtained by a clinician as taught by Olympus into the system of DEI '808 for the purpose of providing patient information acquired by a health professional but also image information, as a medical image or a medical reference image, in order to enable enhancement in ease of medical practice.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadda et al. (2021/0204808), hereinafter Sadda as applied to claim 1 above, and further in view of Bhattacharya Arindam (WO 2020/165196), hereinafter ‘196.
Regarding claim 5, Sadda discloses all the limitations in common with claim 1, and such is hereby incorporated.
Sadda discloses a real-time image (paragraphs 0088 and 0137 discloses OCT scans of an eye of a patient (object); uploading, downloading, or viewing interactive data in real time).
Sadda fails to disclose wherein registering the real-time image and determining the desired scan location on the real time image is performed by a machine learning system.
‘196 discloses wherein registering the image (paragraphs 0059, 0065, and 0097 discloses registering and averaging the individual scans/images within each of multiple image sets; multiple image registration techniques known in the art; identify common features in the collected images, register together (e.g., align) the collected images based on their identified common features) and determining the desired scan location on the image is performed by a machine learning system (paragraph 0093 and Abstract discloses a machine learning (ML) model trained to receive a single OCT scan/image; a set of A-scans measured at neighboring locations in the sample produces a cross-sectional image (tomogram or B-scan) of the sample).
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teaching of Sadda with the registering the image and determining the desired scan location on the image of ‘196 for the purpose of providing an OCT system with improved resolution and for improving the imaging capability of an existing OCT, or OCT angiography (OCTA), system with minimal hardware modification to the OCT or OCTA system.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sadda et al. (2021/0204808), hereinafter Sadda as applied to claim 1 above, and further in view of Walsh et al. (2019/0090733), hereinafter Walsh.
Regarding claim 6, Sadda discloses all the limitations in common with claim 1, and such is hereby incorporated.
Sadda fails to disclose wherein the OCT image at the desired scan location is automatically acquired based on whether the desired scan location is within a threshold range of a center of the real-time image.
Walsh discloses wherein the OCT image at the desired scan location is automatically acquired based on whether the desired scan location is within a threshold range of a center of the real-time image (paragraphs 0325 and 0459 disclose analyzing whether the location of the fovea is located within a threshold range; the eye tracking scans are completed in real-time during the confrontation visual fields test, so that presentation of the stimulus can be contingent upon central fixation).
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teaching of Sadda with the OCT image at the desired scan location of Walsh for the purpose of providing an OCT-based ophthalmic testing center system configured to modify the test strategy in real-time based on a subject's performance in order to improve the quality and/or accuracy of the test.
Regarding claim 7, Sadda discloses further comprising: acquiring a second real-time image of the object (paragraphs 0088, 0098, and 0137 discloses different OCT scans of an eye of a patient; the computer may utilize tests of past images to select the initial sector sizes and/or shapes for a new (second) set of OCT images; uploading, downloading, or viewing Interactive data in real time); registering the second real-time image to the reference image (paragraphs 0088, 0098, and 0137 discloses the computer may utilize tests of past images to select the initial sector sizes and/or shapes for a new set of OCT images; uploading. downloading, or viewing interactive data in real time); and determining the desired scan location on the second real-time Image based on the registration of the second real-time image (paragraph 0051 and Abstract discloses employing optical coherence tomography (OCT) for in vivo visualization of blood vessels and the flow of blood in an eye of a patient; the systems can be configured to align different OCT data sets by utilizing superficial layers where there are significant features, and/or characteristics that can be used to align different OCT data sets; features such as vessel (eye) characteristics, including for example, vessel (eye) location).
Sadda fails to disclose determining the desired scan location is not within the threshold range of the center of the real-time image.
Walsh discloses determining the desired scan location is not within the threshold range of the center of the real-time image (paragraph 0171 discloses intensity values within an A-scan can be compared to other values within the A-scan and/or to a threshold; the intensity value corresponding to the preferred location may be greater than a preset or relative threshold and/or may be different from the rest of the intensity values).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDI N THOMAS whose telephone number is (571)272-2341. The examiner can normally be reached Monday - Friday 7:30 - 3:30.
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/BRANDI N THOMAS/ Primary Examiner, Art Unit 2872
