Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . See 35 U.S.C. § 100 (note).
Oath/Declaration
The receipt of Oath/Declaration is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawing(s) filed on December 14, 2023 are accepted by the Examiner.
Election/Restrictions
Applicant’s election of group II, with traverse directed to claims 10–17 in the reply filed on February 2, 2026 is acknowledged.
Issues Under 35 U.S.C. § 112
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“an external display module” in claim(s) 10–17.
“a communication module” in claim(s) 10–17.
“image-capturing module” in claim(s) 10–17.
“a processing module” in claim(s) 10–17.
“an internal display module” in claim(s) 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
(a) Claim(s) 10–17: ‘an external display module corresponds to Fig. 1 – element 20. The external display module 20 is coupled to the processing module 140. After the processing module 140 has completed image capturing, the external display module 20 displays one of the plurality of displayed images and a status light, wherein the status light indicates the status of the image capturing performed by the image-capturing module, Applicant Pub ¶ [0026].
(b) Claim(s) 10–17: ‘a communication module’ corresponds to Fig. 1 – element 30. The communication module 30 is connected with the processing module 140 and transmits the plurality of ocular images to the exterior, Applicant Pub ¶ [0026].
(c) Claim(s) 10–17: ‘image-capturing module’ corresponds to Fig. 1 – element 100. The image-capturing module 100 includes a first lens assembly 102, a second lens assembly 103, a third lens assembly 104, an illumination element 105, a sensing module 106, a splitter 109, an internal display module 107, a first focal-length regulator 110, and a second focal-length regulator 111, Applicant Pub ¶ [0027].
(d) Claim(s) 10–17: ‘a processing module’ corresponds to Fig. 1 – element 140. The processing module 140 is connected with the image-capturing module 100, determining whether the position offset value between the center of the pupil of a tested eyeball 90 and the optical axis O of the image-capturing module 100 is within a preset error range., Applicant Pub ¶ [0025].
(e) Claim(s) 11: ‘an internal display module’ corresponds to Fig. 2 – element 107. The internal display module 107 is connected with the processing module 140 and disposed at the third-lens second side 104B. The processing module 140 transmits a plurality of displayed images to the internal display module 107. The internal display module 107 presents a plurality of displayed images each including a picture frame of the area of the captured image. The internal display module 107 generates an imaging light L3, which is corresponding to the plurality of the displayed images. The imaging light L3, which passes through the third lens assembly 104, the splitter 109 and the first lens assembly 102 in sequence, is focused to the tested eyeball 90, Applicant Pub ¶ [0030].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Art Rejections
Obviousness 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.
Claim 10 is rejected under 35 U.S.C. § 103 as being unpatentable over the combination of US Patent Application Publication 2009/0244485 (published Oct. 1, 2009) (Walsh et al. hereinafter referred to as “Walsh”) in view of Draelos et al. “Automatic Optical Coherence Tomography Imaging of Stationary and Moving Eyes with a Robotically-Aligned Scanner” (hereinafter referred to as “Draelos”).
With respect to claim 10, Walsh discloses an optical coherence tomography method (¶ [0046] – methods, systems, and devices for generating and utilizing optical coherence tomography image data to perform precision measurements on retinal tissue for the detection of disease features, and generating a risk assessment and/or diagnosis based on data obtained by optical coherence tomography imaging techniques …), which is applied to an optical coherence tomography self-testing system (¶ [0092], Fig. 9 – the process begins at block 901 wherein the user approaches the optical coherence tomography system 100 and activates the system … After the main body 106 and the interpupillary distance has been appropriately calibrated and/or adjusted by the user, the user inputs into or indicates to the user interface module 805 to begin the scan …), wherein the optical coherence tomography self-testing system comprises a camera device, an external display module, and a communication module (¶¶ [0006], [0008], [0047], Figs. 1, 8 – discloses a self-administered OCT instrument with a camera (main body 106), output/display device (102), and communications module (108, 110) …), wherein the camera device includes an image-capturing module and a processing module (¶¶ [0047], [0052], [0053], [0084], Fig. 8 – main body 106 includes image-capturing hardware (lenses, sensors) and computer system 104 for processing …), wherein the optical coherence tomography method uses the optical coherence tomography self-testing system (Abstract, [0006], [0047], [0092], Figs. 1, 8, 9 – “self-administered system”, “user positions and activates”, “device undertakes scan” …) to undertake steps:
using the image-capturing module to capture a plurality of ocular images and storing the plurality of ocular images, which is captured within the first time interval, as a plurality of displayed images (¶ [0095], Figs. 6A–6C, 9 – multiple A-scans/B-scans are captured during each scan sequence, stored for analysis and display …);
after the image-capturing module has completed image capturing, using the external display module to display one of the plurality of displayed images and a status light (¶¶ [0084], [0107], Figs. 10A–11B – display module shows scan results, images, and status/recommendations to user (e.g., health grade, color-coded recommendations); status lights and/or on-screen indicators are described …); and
using the communication module to transmit the plurality of ocular images to exterior (¶¶ [0047], [0089]–[0091], Figs. 1, 8, 12 – communications medium (108), remote systems (110), and network interface (812) transmit images and results to remote servers, physicians, or cloud …).
Although Walsh teaches an alignment system for adjusting and/or calibrating interpupillary distance and fixation targets ([0079]-[0081], Figs. 7A–7F), and detects user/patient movement and repeats scanning if movement is detected ([0093]-[0096], Fig. 9), Walsh fails to explicitly disclose using the processing module to determine whether a position offset value between a center of a pupil of a tested eyeball and an optical axis of the image-capturing module is within a preset error range; and, if the position offset value is within the preset error range, using the processing module to determine whether the position offset value is unchanged within a first preset time interval.
Draelos, working in the same field of endeavor, recognizes this problem and teaches using the processing module to determine whether a position offset value between a center of a pupil of a tested eyeball and an optical axis of the image-capturing module is within a preset error range; if the position offset value is within the preset error range (Section III-B, Fig. 3 – We tracked the pupil’s 3D position… by triangulating the pupil seen in both the inline and offset pupil cameras… identified the pupil… estimated the pupil’s pixel position… projected… performed a line search for the pupil. This yielded the pupil position in 3D space relative to the scanner.” … Draelos uses software to measure and align the pupil relative to the optical axis and applies quantitative thresholds …), using the processing module to determine whether the position offset value is unchanged within a first preset time interval; if the position offset value is unchanged within the first preset time interval (Section III-C, Fig. 4, Section IV-B – “The controller implemented this strategy in a state machine… If pupil tracking failed or the estimated pupil position deviated significantly… the robot tracked only the coarse eye position… Otherwise, the scanner relied on pupil tracking for fine alignment… controller applied distinct control methods… smoothing the eye position… moving average filter…” … Draelos uses software to ensure alignment is stable for a preset interval before imaging …).
At the time of the invention, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Walsh to include the automated, software-based determination of pupil-to-optical axis offset within a preset error range and automated stability checking for a preset time interval, as taught by Draelos. Doing so would have predictably and advantageously improved ease-of-use, reduced operator error, and ensured consistent image quality in a self-administered OCT system, as both references address the need for robust, automated, user-friendly eye imaging.
Therefore, the claimed subject matter would have been obvious to a person having ordinary skill in the art at the time the invention was made.
Summary
Claim 10 is/are rejected under at least one of 35 U.S.C. §§ 102 and 103 as being unpatentable over the cited prior art. 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
ALLOWABLE SUBJECT MATTER
Claims 11–17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 11–17 contain subject matter that is not disclosed or made obvious in the cited art.
In regard to claim 11, when considering claim 11 as a whole, prior art of record fails to disclose or render obvious, alone or in combination:
“[…]wherein the optical coherence tomography method further comprises steps: according to a preset tracking rule and a preset focusing rule, using the processing module to analyze a relative position of the optical axis of the image-capturing module and the center of the pupil of the tested eyeball to generate the plurality of displayed images; using the processing module to transmit the plurality of displayed images to the internal display module, and using the internal display module to present the plurality of displayed images each including a picture frame of an area of the captured image.”
In regard to claims 12–17, claims 12–17 depends on objected claim 11. Therefore, by virtue of their dependency, claims 12–17 are also indicated as objected subject matter.
ADDITIONAL CITATIONS
The following table lists several references that are relevant to the subject matter claimed and disclosed in this Application. The references are not relied on by the Examiner, but are provided to assist the Applicant in responding to this Office action.
Citation
Relevance
Walsh et al. (2019/0090733)
Describes An optical coherence tomography device (2816) obtains optical coherence tomography scan of anterior eye region and intermediate posterior eye region. A processor (2812) analyzes the optical coherence tomography scan and generates optical coherence tomography-based image based on optical coherence tomography scan. An output interface device (2804) outputs a report based on the analysis of optical coherence tomography scan or optical coherence tomography-based image.
Lujan et al. (9,427,147)
Describes an optical coherence tomography system that includes an optical device having an adjustable optical element configured to displace a pupil entry point of light is provided. Optical coherence tomography methods using the optical coherence tomography system are also provided. The subject optical coherence tomography systems and methods find use in a variety of different applications, including imaging applications.
Arar et al. (2016/0004303)
Describes an eye gaze tracking system (2) has a gaze data acquisition system (4) with light sources (16) and image sensors (18). The light source emits light to a head of the user. The image sensor receives light from the head of the user to capture gaze data. A gaze tracking module (6) has an ocular feature extraction module, a POR calculation module and a POR averaging module. The extraction module processes a gaze data (22) and extracts a set of ocular features. The extraction module determines a confidence value associated with an accuracy of the parameter for each set of ocular features.
Table 1
CONCLUSION
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/Henok Shiferaw/Supervisory Patent Examiner, Art Unit 2676
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