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 Amendment
The amendment filed on June 10, 2026 has been entered. Claims 2-3 have been canceled in the present application. Claims 1 and 4-8 have been amended in the present application. Claims 1 and 4-9 are pending in the present application. Applicant’s amendments to the specification and claims have each and every objection and 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed March 11, 2026.
Response to Arguments
Applicant's arguments filed June 10, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 1 on page 6 section A. have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s arguments on page 7 section B. that substituting Hara’s hot mirror for Yao’s dichroic mirror would render Yao unsatisfactory for it intended purpose, Examiner respectfully disagrees.
Applicant argues that substituting the dichroic mirror 132 taught by Yao for the hot mirror 203 taught by Hara would render the OCT device taught by Yao inoperable by reflecting the 850 nm OCT beam away from the intended optical path and transmitting the 505 nanometer through the mirror. However, as seen in Figure 1 of Yao the infrared light produced by light source 101 is reflected at the dichroic mirror 132 to the eye while visible stimulation light from LED 161 is transmitted through the dichroic mirror 132 to the eye. Thus the dichroic mirror taught by Yao reflects infrared light and transmits visible like similar to the hot mirror taught by Hara which reflects infrared light while allowing visible light to pass and one of ordinary skill in the art would be able to swap the dichroic mirror of Yao for the hot mirror of Hara. Furthermore, “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. See MPEP §2141.03(I). Thus one of ordinary skill in the art would be able to adapt the optical arrangement and pathways taught by Yao to account for any changes to the transmitted and reflected beam directions that may occur during substitution. Therefore, Applicant’s argument is not persuasive.
Regarding Applicant’s arguments on page 8 section C. that there is no reason to combine Samec’s head-mounted augmented reality display with Yao’s benchtop instrument, Examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, teaches using optotypes to evoke a response in a particular portion of the visual field of the user ([0676]). Although the reasoning provided by Samec is the same reasoning used in the claim invention, it still provides a reason for modification in the prior art. In addition, Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, Samec teaches that its device may be used for OCT angiography (Figure 11, [0787]) making Samec analogous art to the OCT device taught by Yao. Therefore, Applicant’s arguments are unpersuasive and Examiner the rejects of claim 1 over Yao, Hara, and Samec.
Regarding Applicant’s arguments on page 9 section D. that claim 9’s categorical heat-map annotation is not a mere matter of design choice, Examiner respectfully disagrees.
Applicant argues that since Yao’s hemodynamic maps depict continuous gradations of signal magnitude and do not categorize regions as increased, decreased, or unchanged, a functionally different diagnostic output is produced which is not a mere design choice. However, Yao uses hemodynamic-IOS maps to observe different time courses and signal magnitudes of responses ([0025]-[0026] hemodynamic-IOS map and changes to the hemodynamic map are analyzed). These provide local hemodynamics including blood flow, vessel size, and vessel location at different time points with the degree of blood flow indicated by differences in lightness to darkness (Figure 5 shows spatial hemodynamic maps for different time periods and hemodynamic changes, [0047]-[0048]). This is essentially evaluating areas of increased, decrease, or unchanged blood flow, the same purpose of the claimed invention. Categorizing these areas with specific labels would be a matter of design choice since Yao is still analyzing changes in hemodynamics. Therefore Applicant’s argument is not persuasive and Examiner maintains the rejection of claim 9.
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.
Claims 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al. (U.S. Patent Application Publication No. 2020/0375452 – cited by Applicant – hereinafter referred to as “Yao”) in view of Hara et al. (U.S. Patent Application Publication No. 2021/0059519 – hereinafter referred to as “Hara”), and in further view of Samec et al. (U.S. Patent Application Publication No. 2017/0365101 – hereinafter referred to as “Samec”).
Regarding claim 1, Yao teaches an angio-OCT-based dynamic functional retinal blood flow imaging apparatus (Figure 1, [0025]), comprising an angio-OCT sample optical path (Figure 1 path from light source 101 to eye 146) and an angio-OCT signal acquisition path (Figure 1 path between light source 101, mirror 115, lens 141 and sensor array 157), and further comprising a visual stimulation module (Figure 1 retinal stimulator 134, [0028]) arranged on the same axis as the sample arm optical path (Figure 1 retinal stimulator is along same axis from dichroic mirror 132 to eye 146), the visual stimulation module projecting a stimulation image to different parts of the retina in the eye ([0030] retinal stimulator generates visible light flicker stimuli), wherein the imaging apparatus further comprises a data acquisition and control module (Figure 8 processor 310, [0062]), the data acquisition and control module controlling an acquisition trigger signal for the angio-OCT signal acquisition path (Figure 7 step 251 acquire raw spectrum image data; [0062] processor 310 executes program according to figure 7 which includes step 251 of acquiring image data), and the visual stimulation module (Figure 1 retinal stimulator 134, [0028]) comprises a generator (Figure 1 light emitting diode (LED) 161, [0030]) and the generator being controlled by the data acquisition and control module to generate a control signal for the stimulation image (Figure 8 and [0062] processor 310 controls the OCT program 340).
Yao fails to teach a hot mirror to project the stimuli to the eye. However, Hara teaches an OCT apparatus (Figures 1 and 2) with a hot mirror (Figure 2 hot mirror 203). Furthermore, a hot mirror is a well-known in the art and is a type of dichroic mirror that reflects infrared light. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the dichroic mirror taught by Yao be a hot mirror as taught by Hara in order to reflect infrared light while allowing visible light to pass.
Yao and Hara fail to teach an optotype display. However, Samec teaches a display system configured to perform OCT angiography (Figure 11, [0787]) with an optotype display (Figure 6 display system 250, [0662] display system can be configured to project different stimuli such as patterns of dots or a checkerboard which are examples of optotypes). Samec further teaches using optotypes to evoke a response in a particular portion of the visual field of the user ([0676]). Therefore, 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 angio-OCT device taught by Yao and Hara by adding an optotype display as taught be Samec in order to display changing optotypes in order to evoke responses in different portions of the field of view of user (Samec [0676]).
Regarding claim 4, Yao, Hara, and Samec teaches all the limitations of the claimed invention with respect to claim 3. Yao further teaches the visual stimulation module (Figure 1 retinal stimulator 134, [0028]) comprises a resting mode ([0036] pre-stimulation phase) and a stimulation mode ([0036] stimulation phase); in the resting mode, black screens of the same size including a central fixation optotype are used as baseline images ([0036], [0058] pre-stimulation phase is measured without light to produce a baseline); and a flipping frequency ([0030] visible light flicker of 10 Hz) of the stimulation mode is synchronously controlled by a trigger signal for the data acquisition and control module to control the generator and the acquisition trigger signal for the angio-OCT signal acquisition path ([0062] processor 310 executes program; LED 161 is synchronized with OCT system 100, which comprises the angio-OCT signal acquisition path).
Yao and Hara fail to teach the optotype display and in the stimulation mode, a black and white flipping checkerboard graph under a black background is used as the stimulation image. However, Samec teaches an optotype display (Figure 6 display system 250, [0662] display system can be configured to project different stimuli such as patterns of dots or a checkerboard which are examples of optotypes) that displays a black and white flipping checkboard as the stimulation image ([0662] and [0676] checkerboard with dark and light squares that reverse pattern are used as a stimulus). Samec further teaches using pattern flipping checkerboard optotypes to evoke a unique response in a particular portion of the visual field of the user ([0676]). Therefore, 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 angio-OCT device taught by Yao and Hara by adding an optotype display and using the pattern flipping checkerboard optotypes as taught be Samec in order to display changing optotypes in order to evoke responses in different portions of the field of view of user (Samec [0676]).
Regarding claim 5, Yao, Hara, and Samec teach all the limitations of the claimed invention with respect to claim 1. Yao further teaches the angio-OCT sample optical path (Figure 1 path from light source 101 to eye 146) comprises a light source (Figure light source 101), a first lens (lens 141, an X/Y galvanometer (scanning mirrors 131, [0028], a second lens (lens 142), and an eyeball (sample 146) sequentially from the light source to the eyeball (Figure 1 light source 101, lens 141, scanning mirrors 131, lens 142, and sample 146 are in sequence); the light source is connected to the first lens through an optical fiber (Figure 1 light source 101 is connected to lens 141 through optical fibers 102,107, [0026]); and an optical fiber coupling is also provided on the optical fiber (Figure 1 fiber coupler 103 on optical fiber 102, [0026]).
Regarding claim 6, Yao, Hara, and Samec teach all the limitations of the claimed invention with respect to claim 5. Yao further teaches a dichroic mirror is arranged between the X/Y galvanometer and the eyeball (Figure 1 dichroic mirror 132 is between scanning mirrors 131 and sample 146), and the dichroic mirror projects the stimulation image of the visual stimulation module to different parts of the retina in the eye (Figure 1, [0030] dichroic mirror 132 projects light from retinal stimulator 134 onto retina of eye (sample 146)).
Yao fails to teach a hot mirror. However, Hara teaches an OCT apparatus (Figures 1 and 2) with a hot mirror (Figure 2 hot mirror 203). Furthermore, a hot mirror is a well-known in the art and is a type of dichroic mirror that reflects infrared light. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the dichroic mirror taught by Yao be a hot mirror as taught by Hara in order to reflect infrared light while allowing visible light to pass.
Regarding claim 7, Yao, Hara, and Samec teach all the limitations of the claimed invention with respect to claim 5. Yao further teaches the angio-OCT signal acquisition path (Figure 1 path between light source 101, mirror 115, lens 141 and sensor array 157) comprises an optical fiber coupling (Figure 1 fiber coupler 103), a polarization controller (polarization controller 111, [0027]) and lens (lens 121), an optical fiber coupling (coupler 103), and the data acquisition and control module (Figure 8 processor 310, [0062] processor 310 receives output from sensor array 157) sequentially from the optical fiber coupling to the data acquisition and control module (Figure 1, [0062] fiber coupler 103 to polarization controller 111 to lens 121 to optical coupler 103 to processor 310 are in sequential order); and components of the angio-OCT signal acquisition path are all connected by the optical fiber (Figure 1 components are all connected by optical fibers 106, 151).
Yao fails to teach a balance detector. However, Hara teaches a balance detector (Figure 1 balance detector 110, [0028]). Hara further teaches using a balance detector to receive measurement interference light and output a measurement interference signal in order to obtain a tomographic image of the sample ([0028]). Therefore, 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 OCT apparatus taught by Yao, Hara, and Samec by adding the balance detector taught by Hara in order to obtain a tomographic image of the sample (Hara [0028]).
Regarding claim 8, Yao, Hara, and Samec teach all the limitations of the claimed invention with respect to claim 1. Yao further teaches the data acquisition and control module (Figure 8 processor 310, [0062]) comprises a data acquisition (DAQ) board card (Figure 8 processor 310, [0062]; process is inherently on a board).
Regarding claim 9, Yao, Hara, and Samec teach an imaging method for an angio-OCT visual stimulation-induced retinal dynamic functional blood flow change image of the angio-OCT-based dynamic functional retinal blood flow imaging apparatus according to claim 1 (see rejection of claim 1 above), comprising the following steps: successively acquiring, according to an acquisition trigger signal controlled by the data acquisition and control module (Figure 8 processor 310, [0062]), retinal angio-OCT vascular signals of the same eye under a black screen condition in a resting mode of a visual stimulation module ([0036], [0058] pre-stimulation phase is measured without light to produce a baseline) and under stimulation condition of a stimulation mode ([0036] stimulation phase; [0036] pre-stimulation and stimulus occur successively); analyzing a difference between vascular signals under the two states by an existing angio-OCT algorithm in a system (Method of Figure 7, described in [0053]-[0060]); quantitatively analyzing a blood flow density in an area having the difference ([0024] hemodynamic responses at capillary resolution, Figure 7 hemodynamic-IOS data, [0055]); and showing blood flow increase, blood flow decrease and no change after visual stimulation by a map to obtain the visual stimulation- induced retinal dynamic functional blood flow change image ([0025]-[0026] hemodynamic-IOS map and changes to the hemodynamic map are analyzed; Figure 5 shows spatial hemodynamic maps for different time periods and hemodynamic changes, [0047]-[0048]). Although Yao fails to specifically teach a producing a hemodynamic heat map and annotating areas of the heat map, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce and annotate heat maps using the hemodynamic map generated by Yao as heat maps are well-known in the art and selection of how data is visualized is merely a matter of design choice. In this instance, an annotated heat map may be chosen in order to better visualize data and denote areas of interest.
Yao and Hara fail to teach checkerboard stimulation. However, Samec teaches a checkboard stimulation ([0662] and [0676] checkerboard with dark and light squares that reverse pattern are used as a stimulus). Samec further teaches using pattern flipping checkerboard optotypes to evoke a unique response in a particular portion of the visual field of the user ([0676]). Therefore, 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 angio-OCT device taught by Yao and Hara by adding an optotype display and using the pattern flipping checkerboard optotypes as taught be Samec in order to display changing optotypes in order to evoke responses in different portions of the field of view of user (Samec [0676]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jai et al. (U.S. Patent Application Publication No. 2021/0045672) teaches a similar angio-OCT apparatus as the instant invention.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX PARK RICKEL whose telephone number is (703)756-4561. The examiner can normally be reached Monday-Friday 8:30 a.m. - 6 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bumsuk Won can be reached at (571)272-2713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alex Rickel
Examiner
Art Unit 2872
/A.P.R./Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872
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