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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-8 in the reply filed on 8/17/2026 is acknowledged.
Claims 9-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/17/2026.
Information Disclosure Statement
Acknowledgement is made of receipt of Information Disclosure Statement(s) (PTO-1449) filed 11/04/2024. An initialed copy is attached to this Office Action.
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) 1-2, 4, and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rutschman et al. (2018/0064335), hereinafter Rutschman in view of Koronyo, Maya (WO 2023004436), hereinafter Koronyo.
Regarding claim 1, Rutschman discloses a device for neurodegenerative disease screening, the devise comprising: an imaging assembly (402, retinal imager device) (paragraph 0024) including: an image sensor (408, image sensor) for capturing a retinal image (paragraph 0024); a lens unit (404, optical lens arrangement) focusing light reflection from an eye toward the image sensor (408, image sensor) (paragraph 0025), the lens unit at least partially defining an optical path for receiving the light reflection (paragraphs 0026, 0030, and 0034); and an illumination unit (204, illumination lens arrangement and/or illumination source) having one or more light-emitting diodes emitting light in an illumination path for illuminating the eye (paragraphs 0015 and 0135), the illumination unit being mounted relative to the lens unit such that the illumination path is offset with respect to the optical path (figure 1); at least one processing device (408, image processor) (paragraph 0024-0025); and at least one computer readable data storage device (406, computer readable memory) storing software instructions that, when executed by the at least one processing device, cause the device to: operate the imaging assembly to capture the retinal image using the illumination path offset with respect to the optical path (paragraph 0024).
Rutschman does not specifically disclose receiving a recommendation based on detection of a biomarker in the retinal image, the biomarker being associated with a neurodegenerative disease.
Koronyo disclose receiving a recommendation based on detection of a biomarker in the retinal image, the biomarker being associated with a neurodegenerative disease (paragraph 0008 and 0027).
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 device of Rutschman with the biomarker and neurodegenerative disease of Koronyo for the purpose of providing a more accurate disease diagnosis.
Regarding claim 2, Koronyo discloses wherein the biomarker is amyloid plaque, and the recommendation includes identification of a risk for developing Alzheimer's disease (pargrpahs 0002, 0008, and 0085).
Regarding claim 4, Koronyo discloses wherein the instructions, when executed by the at least one processing device, further cause the device to: receive a detection of one or more conditions in the retinal image associated with eye diseases including at least one of retinopathy, macular degeneration, glaucoma, and papilledema (paragraphs 0002 and 0090 disclose macular degeneration and glaucoma).
Regarding claim 6, Koronyo discloses wherein the biomarker is detected by an algorithm trained by machine learning (paragraph 0043).
Regarding claim 7, Rutschman discloses wherein the retinal image is captured using a non-mydriatic workflow (paragraph 0033).
Regarding claim 8, Rutschman discloses wherein the instructions, when executed by the at least one processing device, further cause the device to: store the retinal image and the recommendation in an electronic medical record that is accessible by a specialist for further clinical assessment (paragraphs 0102 and 0133).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rutschman et al. (2018/0064335), hereinafter Rutschman in view of Koronyo, Maya (WO 2023004436), hereinafter Koronyo as applied to claim 1 above, and further in view of Redei (9782072).
Regarding claim 3, Rutschman in view Koronyo disclose all the limitations in common with claim 1, and such is hereby incorporated.
Rutschman in view Koronyo does not specifically disclose wherein the recommendation further includes a referral for following up with a neurologist.
Redei discloses disclose wherein the recommendation further includes a referral for following up with a neurologist (col. 3, lines 2-5, col. 5, lines 26-33 and claim 9).
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 device of Rutschman in view Koronyo with the referrals of Redei for the purpose of improving the diagnosis certainty.
Regarding claim 5, Redei discloses wherein the recommendation further includes a referral for following up with an ophthalmologist (col. 3, lines 2-5, col. 5, lines 26-33 and claim 9).
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
