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 .
Applicant' s arguments, filed 3/3/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 3/3/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the currently pending claims. Claims 1-13 and 20 are hereby under examination. Claims 14-19 have been previously withdrawn.
Claim Interpretation
Relative terms such as ‘essentially’, ‘substantially homogeneous’, and ‘related to’ in claims 1–13 are interpreted under the broadest reasonable interpretation consistent with the Specification (see, e.g., ¶[0015], ¶[0022], ¶[0023], ¶[0052], ¶[0057]), and do not render the claims indefinite under 35 U.S.C. § 112(b) unless otherwise noted below.
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:
Claim 1 recites "means for obtaining the retinal ERG signals as an electrical response signal from the target area" in line 2. The phrase "means for" followed by purely functional language invokes 35 U.S.C. § 112(f). In light of the Specification, the corresponding structure for performing the function of obtaining an electrical response signal from the retinal target area is interpreted to include at least an electroretinography (ERG) signal acquisition arrangement comprising one or more electrodes positioned to detect ERG responses from the retina and associated signal acquisition circuitry configured to record those responses, as described in the Specification for obtaining ERG signals from a target area of the retina (Instant Application, ¶[0057] (primary structural disclosure), ¶[0002] (defines ERG as recorded electrical signals)). Under 35 U.S.C. § 112(f), this limitation is construed to cover the ERG acquisition structures disclosed in the Specification and their statutory equivalents.
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.
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.
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 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 13 recites “A method for obtaining an ERG signal” (line 1) in the preamble while the body recites “obtaining at least one signal related to an ERG signal of the retina” (line 11) without clearly indicating whether the obtained signal is the ERG signal itself or a different, derived or processed signal. Applicant is advised to clarify whether the method obtains the ERG signal per se or a related signal, and to use consistent terminology between the preamble and the body. The Examiner is interpreting that the preamble and body are referring to the same signal and that signal is related to an ERG signal (including being the ERG signal itself).
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 1-3, 7-9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns.
Regarding claim 1, Mizuochi teaches that
a device for obtaining retinal ERG signals from a target area of the retina (Mizuochi, FIG. 1; ¶[0027]: "FIG. 1 shows a first embodiment of an ophthalmological examination apparatus configured as a light stimulus apparatus comprising a light stimulus main unit 10", this supports that the apparatus structure shown in FIG. 1 corresponds to the claimed device; ¶[0027]: "In FIG. 1, R is the position conjugate with the ocular fundus 1a of the eye 1 to be examined", this shows that region R represents the retinal target area onto which stimulus and background beams are directed; ¶[0002]: "The present invention relates to an ocular light stimulus apparatus, and more particularly relates to an ocular light stimulus apparatus in which the ocular fundus of an examinee's eye is irradiated with ocular fundus observation light to observe the ocular fundus and is irradiated with background light and stimulus light to locally stimulate the retina with the stimulus light and perform a biological examination using a bioelectrical signal obtained from the retina", this teaches an ocular light stimulus apparatus that locally stimulates a portion of the retina with stimulus light and performs a biological examination using a bioelectrical (ERG) signal obtained from that locally stimulated region); comprises means for obtaining the retinal ERG signals as an electrical response signal from the target area (Mizuochi, ¶[0038]–¶[0039]: "An ERG electrode 86 is mounted on the eye 1 to be examined, and a signal from the electrode 86 is inputted to a computer (personal computer) 80 provided with a display 81 and a storage device 82", this teaches that an ERG electrode mounted on the eye obtains retinal ERG signals from the stimulated retinal region and provides those signals to the computer, corresponding to means for obtaining the retinal ERG signals from the target area; FIG. 1: showing ERG electrode 86 connected to computer 80, this visually reinforces the structural relationship between the ERG electrode and the signal-receiving computer as the claimed means for obtaining the retinal ERG signals; ¶[0052]: "The bioelectric signal from the ERG electrode 86 is inputted to the computer 80, and an electroretinogram is created, displayed on the display device 81, and stored in the storage device 82", this further shows that the bioelectric signal obtained from the ERG electrode corresponds to retinal ERG signals generated in response to retinal stimulation, reinforcing that Mizuochi provides means for obtaining the retinal ERG signals from the target area); the device additionally comprising at least one light source configured to provide a stimulus beam configured to illuminate the target area for inducing an ERG signal (Mizuochi, FIG. 1; ¶[0004]–¶[0005]: "electroretinogram (ERG) examination in which stimulus light is projected onto a retina to measure an action potential generated in the retina, and an electroretinogram is created to perform an ophthalmological biological examination… When the stimulus light is projected locally (local ERG) on a macular spot of the ocular fundus to perform the ERG examination, the background light is projected as visible light onto the ocular fundus", this teaches that stimulus light is projected locally on a macular spot of the ocular fundus to perform an ERG examination, corresponding to a stimulus beam illuminating a retinal target area to induce an ERG signal; ¶[0034]: "The stimulus light source 51 is turned on by a control unit 84 when a switch 46a provided to a joystick 46 is operated… The visible light from the stimulus light source 51 that has passed through a magnification lens 47a (47b) is divided and reflected by the half mirror 36, and is projected as stimulus light onto the ocular fundus 1a from the pupil 1b of the eye to be examined via the mirror 34, the lenses 33, 32, the photographic stop 31, the aperture of the apertured full reflection mirror 21, the objective lens 22, and the like", this teaches that a stimulus light source projects visible stimulus light onto the ocular fundus, corresponding to a light source providing a stimulus beam that illuminates a retinal area; ¶[0050]–¶[0051]: "In the biological examination, the liquid crystal panel 43a is turned on, and the background light from the liquid crystal panel 43a is projected from the anterior ocular segment (pupil) 1b onto the ocular fundus 1a via the photographic stop 31. The stimulus light source 51 is also turned on, and the stimulus light from the stimulus light source 51 is similarly projected from the anterior ocular segment 1b onto the ocular fundus 1a via the photographic stop 31. The retina of the eye illuminated by the background light is thus locally stimulated by the stimulus light, and a bioelectrical signal is generated from the retina", this shows that the stimulus light locally stimulates the retina and generates a bioelectrical signal, corresponding to the stimulus beam inducing an ERG signal; These teachings corresponds to a stimulus beam configured to illuminate the target area for inducing an ERG signal); and a light adapting background beam configured to illuminate the retina at least in an area outside of the target area (Mizuochi, FIG. 1; ¶[0054]: "the background light and the stimulus light are projected onto the ocular fundus via the central part of the pupil", this shows that both background and stimulus beams are directed onto the retinal area including the region labeled R in FIG. 1, corresponding to illumination covering and extending beyond the targeted region; ¶[0027]: "In FIG. 1, R is the position conjugate with the ocular fundus 1a of the eye 1 to be examined", this indicates the retinal region reached by the beams and supports that background light extends beyond the stimulus-targeted region; ¶[0005]: "In an ERG examination, the ocular fundus is irradiated with visible stimulus light, and the background irradiated with the stimulus light has to be illuminated by background light… When the stimulus light is projected locally (local ERG) on a macular spot of the ocular fundus to perform the ERG examination, the background light is projected as visible light onto the ocular fundus", this teaches that when stimulus light is projected locally on a macular spot (a target area), background light is projected onto the ocular fundus as a whole, corresponding to a background beam illuminating at least an area outside the locally stimulated region; ¶[0035]–¶[0036]: "In addition to the stimulus light, the background light, which is visible light, is projected onto the ocular fundus 1a in the ERB examination… The background light from the liquid crystal panel 43a is projected onto the ocular fundus 1a via the half mirror 34, the imaging lens 33, the focus lens 32, the photographic stop 31, and the objective lens 22… the background light from the liquid crystal panel 43a is projected via the center of the anterior ocular segment (pupil) 1b radially onto the ocular fundus 1a", this teaches that visible background light is projected radially onto the ocular fundus around the stimulus location, corresponding to a light adapting background beam that illuminates retinal areas including those outside the target area; ¶[0053]: "In a local ERG examination, the background light acts to cancel the effect of the scattered stimulus light and the ocular fundus is therefore to be illuminated in a uniform fashion in a wider range about the center of the projected stimulus light, i.e., the entire visual range of the ocular fundus… This allows the background light to be projected to a wide range about the position in which the stimulus light is projected", this teaches that background light is projected in a wider range about the center of the stimulus, illuminating the entire visual range of the ocular fundus outside the stimulus spot, corresponding to a background beam illuminating at least the area outside the target area; ¶[0054]: "the background light and the stimulus light are projected onto the ocular fundus via the central part of the pupil", this shows that both background and stimulus beams are directed onto the retinal area including the region labeled R in FIG. 1, corresponding to illumination covering and extending beyond the targeted region); for light adapting the area outside of the target area and suppressing ERG signaling therefrom (Mizuochi, ¶[0012]: "Therefore, the background light is projected onto the ocular fundus in such a manner that it spreads to the four corners about the center of the anterior ocular segment, and the entire ocular fundus can be uniformly illuminated by the background light about the position onto which the stimulus light is projected. This allows the effect of scattered light due to the stimulus light to be canceled out and an accurate local ERG examination to be performed", this teaches that the background light spreads broadly over the ocular fundus and uniformly illuminates regions outside the stimulus position, canceling scattered light and thereby suppressing unwanted ERG contributions from areas outside the target region; ¶[0053]: "In a local ERG examination, the background light acts to cancel the effect of the scattered stimulus light and the ocular fundus is therefore to be illuminated in a uniform fashion in a wider range about the center of the projected stimulus light, i.e., the entire visual range of the ocular fundus… Therefore, the entire ocular fundus can be uniformly illuminated, the effect of scattered light by the stimulus light is canceled out, and an accurate local ERG examination can be performed", this teaches that the background light illuminates a wide region of the ocular fundus and cancels the effect of scattered stimulus light so that an accurate local ERG examination can be performed, which is conceptually equivalent to light adapting the retina outside the target area to suppress unwanted ERG contributions from outside the locally stimulated region).
Also regarding claim 1, Mizuochi does not teach using a heating system for heating at least the target area, wherein the heating system comprises a heating light source for providing a heating beam to heat at least the target area. Mizuochi teaches a retinal examination apparatus in which visible stimulus light and visible background light are projected onto the ocular fundus and retinal ERG signals are obtained from the stimulated retinal region during a local ERG examination. Mizuochi teaches that “the stimulus light from the stimulus light source 51 is similarly projected from the anterior ocular segment 1b onto the ocular fundus 1a via the photographic stop 31” and that “[t]he retina of the eye illuminated by the background light is thus locally stimulated by the stimulus light, and a bioelectrical signal is generated from the retina” (Mizuochi, ¶[0050]). Mizuochi further teaches that “the amount of stimulus light and the amount of background light are adjusted by a rotary switch or the like provided to the controller 80” (Mizuochi, ¶[0051]). Thus, Mizuochi teaches projecting controlled light beams to a selected retinal target area during ERG testing, but Mizuochi does not teach using a heating system for heating at least the target area, nor does Mizuochi teach a heating light source for providing a heating beam to heat at least the target area.
Chen teaches a treatment beam source configured to transmit a treatment beam having an infrared wavelength and a power from 1 to 100 W, with a processor configured to direct the treatment beam onto retinal tissue of the patient's eye and deliver a series of pulses to a first treatment spot (Chen, claim 1: "a treatment beam source configured to transmit a treatment beam along a treatment beam path, the treatment beam having an infrared wavelength and a power from 1 to 100 W"; "deliver a series of pulses from the treatment beam onto the retinal tissue at a first treatment spot to treat the retinal tissue"). Chen further teaches that the treatment beam is configured to heat the retinal tissue at the first treatment spot to a range of 50 to 55 degrees C. in a substantially uniform manner without scanning (Chen, claims 2 and 7; ¶[0005]). This corresponds to a heating system comprising a heating light source for providing a heating beam to heat at least the target area.It would have been prima facie obvious before the effective filing date of the claimed invention to modify Mizuochi to further include Chen’s heating system so that the same retinal target area from which Mizuochi obtains retinal ERG signals could also be heated in a controlled manner during examination.One of ordinary skill in the art would have found this combination feasible because both Mizuochi and Chen are directed to ophthalmic systems that project controlled light beams through the pupil to a defined retinal region, and both use processor or controller-based control of beam delivery to the retina. Mizuochi projects stimulus and background light onto the ocular fundus through the projection optics and pupil during the biological examination, while Chen projects an infrared treatment beam onto a defined retinal treatment spot of 1 to 6 mm in diameter through the same type of pupil-conjugate optical arrangement. The shared optical architecture of both systems makes it technically straightforward to incorporate Chen's treatment beam path into Mizuochi's existing projection optics. One of ordinary skill in the art would have been motivated to make this combination in order to permit controlled retinal heating at a defined retinal target area while simultaneously monitoring the retinal ERG response from that area using Mizuochi's local ERG measurement system, thereby enabling real-time ERG-based monitoring of retinal temperature and treatment effect at the heated retinal region. Chen expressly teaches that ERG measurements may be used during treatment of the retina to provide real-time feedback and that, as treatment is ongoing, "real-time ERG measurements may be taken and retinal temperatures may be determined and displayed to the operator to ensure that the retinal temperatures do not exceed an upper limit that would cause permanent damage" (Chen, ¶[0047]). Chen further expressly teaches a pre-treatment evaluation method in which ERG signals generated by laser pulses delivered to the retinal target area are used to determine optimal treatment laser power values (Chen, ¶[0016]–¶[0020]; FIG. 9). These express teachings provide a direct, non-hindsight motivation to combine Chen's heating system with Mizuochi's local ERG measurement platform.
Also regarding claim 1, the modified Mizuochi does not fully teach that a central background light beam is configured to illuminate at least the target area for maintaining a light adaptation level of the target area. Rather, the modified Mizuochi teaches that liquid crystal panel 43a is a circular panel disposed with its center in coincidence with the optical axis 26 of the projection optical system, and that the background light is projected via the center of the anterior ocular segment (pupil) 1b radially onto the entire ocular fundus 1a, including the area onto which the stimulus beam is projected (Mizuochi, ¶[0035]–¶[0036]: "A liquid crystal (LCD) plate 43 is used as a light source for the background light, and is disposed behind the half mirror 34 so that the center thereof is in coincidence with the optical axis 26 of the projection optical system"; "the background light from the liquid crystal panel 43a is projected via the center of the anterior ocular segment (pupil) 1b radially onto the ocular fundus 1a"; ¶[0012]: "the entire ocular fundus can be uniformly illuminated by the background light about the position onto which the stimulus light is projected"). It further teaches that the intensity of the background illumination is adjustable by the controller 80 as a measurement condition (Mizuochi, ¶[0051]: "The amount of stimulus light and the amount of background light are adjusted by a rotary switch or the like provided to the controller 80"). However, the modified Mizuochi does not teach configuring the centrally projected background light beam specifically for the purpose of maintaining a light adaptation level of the target area, and does not expressly recognize light adaptation maintenance at the target area as an objective of the background illumination.
Severns teaches configuring background illumination to establish and maintain a known light adaptation state of the retina. Severns expressly teaches that "the intensity of the LED or light source 38 is also modulated to produce a constant background illumination" and that "[t]hat background illumination allows the eye 44 to be brought to a known state of light adaptation, which is important for a consistent response" (Severns, ¶[0032]). Severns further teaches that the background illumination level is controlled by a microcontroller as a deliberate operational parameter, and that establishing and maintaining a known light adaptation state through controlled background illumination is a recognized technical requirement for obtaining reliable and consistent ERG responses from the retina (Severns, ¶[0031]–¶[0032]; FIG. 4). This corresponds to a central background light beam configured to illuminate at least the target area for maintaining a light adaptation level of the target area.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Mizuochi device in view of Severns to configure the centrally projected background light beam of Mizuochi to illuminate at least the target area for the purpose of maintaining a light adaptation level of the target area during ERG examination and during the heating of the target area by the Chen heating system. One of ordinary skill in the art would have found this modification feasible because Mizuochi already discloses a centrally projected background light beam that illuminates the entire ocular fundus including the target area, and already discloses that the intensity of that background light is adjustable by the controller as a measurement condition (Mizuochi, ¶[0051]). Severns discloses the same type of controller-modulated background illumination arrangement in an ERG measurement device (Severns, ¶[0031]–¶[0032]). No structural modification to Mizuochi's existing hardware is required; the modification consists of configuring the already-present adjustable background light controller to maintain a deliberate light adaptation level at the target area, consistent with the express teaching of Severns that such control is important for consistent ERG responses. One of ordinary skill in the art would have been motivated to make this modification because, in the combined Mizuochi-plus-Chen device, the Chen heating beam delivers additional photon flux to the target area during thermal treatment, which alters the total illuminance at the target area and thereby changes the retinal light adaptation state at that location. Since Chen expressly relies on ERG signals to monitor retinal temperature during heating (Chen, ¶[0047]), and since Severns expressly establishes that a known, stable light adaptation state is required for consistent and reliable ERG responses (Severns, ¶[0032]), one of ordinary skill in the art would have recognized that maintaining a controlled light adaptation level at the target area during heating is necessary to ensure that the ERG signals recorded during heating accurately reflect retinal temperature changes rather than changes in adaptation state caused by the heating beam. Configuring Mizuochi's existing adjustable background light source to maintain this controlled adaptation level at the target area achieves this objective using hardware already present in the Mizuochi device, and produces the predictable benefit of improving the reliability and interpretability of ERG-based retinal temperature monitoring during laser treatment as expressly contemplated by Chen.
Regarding claim 2, the modified Mizuochi teaches that the background beam is adapted to illuminate an area on the fundus from an outer perimeter of the target area to at least the equator of the eye (Mizuochi, ¶[0012]: "the background light is projected onto the ocular fundus in such a manner that it spreads to the four corners about the center of the anterior ocular segment, and the entire ocular fundus can be uniformly illuminated by the background light about the position onto which the stimulus light is projected", this teaches that the background light is configured to spread over essentially the entire ocular fundus surrounding the stimulus position, illuminating retinal regions extending outward from the outer perimeter of the locally stimulated target area toward the periphery of the fundus; ¶[0053]: "the background light acts to cancel the effect of the scattered stimulus light and the ocular fundus is therefore to be illuminated in a uniform fashion in a wider range about the center of the projected stimulus light, i.e., the entire visual range of the ocular fundus", this teaches that the background light extends over the entire visual range of the ocular fundus around the stimulus location; the human retina extends from the posterior pole to the ora serrata, which lies at or just anterior to the anatomical equator of the eye, and illumination of the entire visual range of the ocular fundus as taught by Mizuochi therefore inherently illuminates the fundus from the outer perimeter of the target area to at least the equatorial region of the eye, corresponding to the background beam being adapted to illuminate an area on the fundus from an outer perimeter of the target area to at least the equator of the eye).
Regarding claim 3, the modified Mizuochi teaches that the background beam is prevented from reaching a fundus imaging system (Mizuochi, ¶[0030]: "The infrared light that has passed through the half mirror 36 is reflected by a mirror 38, passes through an imaging lens 37, and is incident on an image-capturing device 40 that is disposed in the position R conjugate with the ocular fundus and that is composed of an infrared CCD sensitive to infrared light and visible light regions", this teaches that the ocular fundus imaging system is formed by the imaging lens 37 and the image-capturing device 40 disposed in conjugate relation with the ocular fundus; ¶[0064]: "there is an advantage in that the background light from the background light source 72 passes through the half mirror 36 and enters into the image-capturing device 40, and the background light can be observed on the monitor 41… On the other hand, there is a drawback in that the background light interferes with ocular fundus observation. In view of this fact, a third embodiment is proposed as shown in FIG. 7 in which the background light from the background light source 72 is prevented from entering into the image-capturing device 40", this explains that the third embodiment is specifically configured so that the background light is prevented from entering the image-capturing device, i.e., prevented from reaching the fundus imaging system; ¶[0065]: "In the third embodiment, a dichroic mirror 36' for reflecting visible light and transmitting infrared light is used as shown in FIG. 8 in place of the half mirror 36 of FIGS. 1 and 4… However, since the dichroic mirror 36' does not transmit visible light, the visible light from the background light source 72 does not pass through the dichroic mirror 36' and enter into the image-capturing device 40, and the draw back in which the background light interferes with ocular fundus observation can be eliminated", this teaches that, by using the dichroic mirror 36' that reflects visible light and transmits infrared light, the visible background light is blocked from entering the image-capturing device 40, thereby preventing the light adapting background illumination from reaching the fundus imaging system while still allowing infrared ocular fundus observation light to reach the image-capturing device; see also ¶[0040] and FIG. 4).
Regarding claim 7, the modified Mizuochi does not fully teach that the background beam comprises an area of lower or no illumination corresponding to the stimulus beam such that when the stimulus beam and the background beam are directed at a final location with respect to an eye, the area of lower or no illumination essentially overlaps with the stimulus beam. Rather, the modified Mizuochi explains that the background light is used to cancel the effect of scattered stimulus light and that the entire ocular fundus is uniformly illuminated in a wide range about the center of the projected stimulus light (Mizuochi, ¶[0053]: "the background light acts to cancel the effect of the scattered stimulus light and the ocular fundus is therefore to be illuminated in a uniform fashion in a wider range about the center of the projected stimulus light, i.e., the entire visual range of the ocular fundus"). the modified Mizuochi further states that, in the configuration of FIG. 4, the background light is projected onto the ocular fundus so that the entire ocular fundus is uniformly illuminated while scattered stimulus light is canceled (Mizuochi, ¶[0060]: "With the configuration of FIG. 4 as well, the background light is projected onto the ocular fundus via the photographic stop 31. Therefore, the entire ocular fundus is uniformly illuminated, and the effect of scattered stimulus light is canceled"). In the second embodiment, the background light source 72 is realized by visible light LEDs 72a arranged around a ring plate 72b and projected through the observation/projection optics onto the fundus (Mizuochi, ¶[0057]; ¶[0059]: "The background light source 72 is composed of visible light light-emitting diodes 72a arranged in equidistant intervals about the periphery of a ring plate 72b"; "the background light is projected from the background light source 72, passes through the magnification lens 47a, and is reflected by the half mirrors 36, 34"). Collectively, these passages show that the modified Mizuochi provides a controllable background illumination projected through the pupil along substantially the same optical axis as the stimulus light for the purpose of canceling scattered stimulus light and enabling accurate local ERG examination, but the modified Mizuochi does not describe configuring the background illumination so that it includes an area of lower or no illumination that spatially corresponds to the stimulus beam such that, at the fundus, a central region with reduced background light essentially overlaps the stimulus spot.
Chen fills this gap by teaching a retinal illumination configuration in which an aiming beam is shaped into a concentric ring surrounding a central treatment spot. Chen describes delivering an aiming beam from an aiming beam source along an aiming beam path and directing the aiming beam through a convex lens to focus the aiming beam onto a concentric ring on the retinal tissue surrounding the first treatment spot (Chen, ¶[0011]; ¶[0014]: "delivering an aiming beam from an aiming beam source along an aiming beam path"; "directing the aiming beam through the convex lens disposed between the patient and the aiming beam source to focus the aiming beam onto a concentric ring on the retinal tissue surrounding the first treatment spot"). Chen further explains that the convex lens focuses the aiming beam onto a concentric aiming ring 130 that surrounds the treatment beam at the treatment spot such that the aiming beam is always larger than the treatment beam (Chen, ¶[0037]: "the convex lens focuses the aiming beam onto a concentric aiming ring 130 that surrounds the treatment beam at the treatment spot on the patient's eye such that the aiming beam is always larger than the treatment beam"). These teachings show that an ophthalmic laser system can form a ring-shaped illumination pattern on the retina that encircles, but does not overlap, a central treatment beam, effectively providing a peripheral illumination region with a central zone in which a different beam is applied.
Both the modified Mizuochi and Chen are directed to ophthalmic systems in which controlled light patterns are projected onto the retina and there is concern with accurate localization of the effect of a particular beam and reduction of interference from surrounding regions. The modified Mizuochi expressly teaches that the background light is used to cancel the effect of scattered stimulus light so that "accurate local ERG examination" can be performed (Mizuochi, ¶[0053]), while Chen teaches shaping an aiming beam into a concentric ring that surrounds the treatment beam at the treatment spot so that the treatment area is clearly defined on the retina (Chen, ¶[0014]; ¶[0037]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Chen to configure the light adapting background beam so that it forms an annular illumination pattern on the retina with a central area of lower or no background illumination that is aligned to essentially overlap the stimulus beam. In doing so, one of ordinary skill in the art would have been applying Chen's known ring-shaped illumination pattern, used to surround and indicate a central beam, to the modified Mizuochi's background illumination for the familiar purpose of defining a central region where a different beam acts while maintaining surrounding illumination, in accordance with the modified Mizuochi's teaching that background light is used to control scattered stimulus light during local ERG examination. The expected result would be a retinal illumination pattern that uses background light around the stimulus region in a controlled fashion while avoiding unnecessary background light directly at the stimulus location, consistent with the known goals in both the modified Mizuochi and Chen of reducing unwanted light effects and maintaining precise localization of the area being probed.
Regarding claim 8, the modified Mizuochi does not teach that the heating beam has an essentially circular, substantially homogenous irradiance profile and a diameter of 1–6 mm at the fundus.
Chen, in contrast, is directed to a retinal treatment system in which a treatment beam at an infrared wavelength is delivered to a retinal treatment spot that is defined as 1 to 6 mm in diameter and is heated in a substantially uniform manner without scanning the beam, using a VCSEL array whose laser-delivery elements are individually adjusted so as to ensure substantially uniform tissue heating at the treatment spot (Chen, ¶[0009]: "the therapeutic treatment is delivered only to a single treatment spot on the retinal tissue . In some embodiments , the method further includes heating the tissue at the treatment spot in a substantially uniform manner without scanning the treatment beam"; claim 16: "the treatment beam being delivered at an infrared wavelength, and along a treatment beam path and the treatment spot being 1 to 6 mm in diameter"; claim 20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Chen to provide the device with a heating system comprising a heating light source configured to deliver an essentially circular heating beam with a substantially homogenous irradiance profile and a diameter of about 1–6 mm at the fundus to heat at least the target area while ERG measurements are performed. Both the modified Mizuochi and Chen deliver controlled light beams through the pupil to defined regions of the fundus, and the modified Mizuochi already discloses multiple light sources (illumination, background, and stimulus) coupled into the same observation/projection optics, while Chen teaches how to define a treatment spot of 1–6 mm diameter and adjust the outputs of multiple laser-delivery elements so as to ensure substantially uniform tissue heating over that spot (Mizuochi, ¶[0047]–[0051]; ¶[0053]; Chen, ¶[0009]; claim 16; claim 20). Accordingly, one of ordinary skill in the art would have found it straightforward and technically feasible to add a Chen-type infrared treatment beam path and associated heating system to the existing projection optics of the modified Mizuochi so that the same retinal target area used for local ERG measurements could also be heated in a substantially uniform fashion using a spot size in the 1–6 mm range.
A person of ordinary skill in the art would have been motivated to integrate a heating system like Chen’s into the modified Mizuochi’s ERG device because controlled retinal heating is known to modulate retinal physiology and to produce measurable changes in the ERG response, and ERG-based functional monitoring during thermal exposure is a recognized approach in retinal diagnostics and subthreshold laser therapy. the modified Mizuochi already delivers precisely localized optical stimuli and measures localized ERG responses from the same target area, while Chen provides a complementary system for delivering substantially uniform retinal heating to a circular 1–6 mm region. Combining these systems would therefore have been seen as a predictable use of known techniques to enable controlled thermal stimulation while simultaneously monitoring retinal function at the heated site. Such a combination would have provided the predictable benefit of enabling controlled, substantially uniform retinal heating over a well-defined circular target area while simultaneously monitoring ERG responses from that same area, thereby improving the ability to titrate non-damaging therapeutic heating, reduce spatial temperature gradients within the heated zone, and enhance the safety and reliability of combined ERG examination and retinal treatment compared to using either system alone.
Regarding claim 9, the modified Mizuochi as modified in view of Chen does not fully teach that the stimulus beam is of equal size or smaller than the heating beam used for heating at least the target area. The modified Mizuochi as modified in view of Chen for claim 8 teaches a device that projects a controllable stimulus light onto a local target area of the ocular fundus for ERG measurements while a separate treatment beam can be delivered to a retinal treatment spot that is 1 to 6 mm in diameter and is heated in a substantially uniform manner, but the modified Mizuochi and Chen do not expressly teach that the stimulus beam is of equal size or smaller than the heating beam used for heating at least the target area; instead, the modified Mizuochi allows the spot diameter of the stimulus light to be set as a measurement condition using an indicator disc with apertures of mutually different diameters (Mizuochi, ¶[0033]; ¶[0044]) and Chen defines a treatment spot of 1 to 6 mm and configures the treatment beam to ensure substantially uniform tissue heating at that spot without describing any constraint on the size of a separate ERG stimulus beam relative to the treatment spot (Chen, ¶[0005]; claim 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Chen to select the stimulus beam size to be equal to or smaller than the heating beam size so that the ERG stimulus region is confined within the retinal region heated by Chen’s treatment beam. the modified Mizuochi explicitly permits the operator to set the spot diameter of the local ERG stimulus as a controllable parameter using the indicator disc and computer-controlled measurement conditions (Mizuochi, ¶[0033]; ¶[0044]), while Chen teaches delivering therapeutic heating to a defined treatment spot that is 1 to 6 mm in diameter with substantially uniform tissue heating (Chen, ¶[0005]; claim 2). In light of these teachings, one of ordinary skill in the art seeking to correlate ERG responses with the effects of controlled retinal heating would have found it a straightforward and technically feasible design choice to set the ERG stimulus spot to lie wholly within, and therefore be equal to or smaller than, the heated treatment spot so that the measured ERG signal arises predominantly from tissue that is being thermally modulated by the treatment beam rather than from unheated surrounding retina.
Such a configuration would have provided the predictable benefit of improving the specificity and interpretability of ERG measurements during thermal treatment by ensuring that the functional response is localized to the heated retinal region, thereby yielding a clearer relationship between delivered thermal dose and recorded ERG changes, reducing confounding contributions from unheated tissue, and enhancing the safety and efficacy of combined diagnostic and therapeutic procedures compared to using independent, unconstrained spot sizes for stimulation and heating.
Regarding claim 13, Mizuochi teaches a method for obtaining an ERG signal comprises: directing a stimulus light beam towards a target area of the retina (Mizuochi, FIG. 1; ¶[0050], "the liquid crystal panel 43a is turned on, and the background light from the liquid crystal panel 43a is projected from the anterior ocular segment (pupil) 1b onto the ocular fundus 1a via the photographic stop 31. The stimulus light source 51 is also turned on, and the stimulus light from the stimulus light source 51 is similarly projected from the anterior ocular segment 1b onto the ocular fundus 1a via the photographic stop 31. The retina of the eye illuminated by the background light is thus locally stimulated by the stimulus light, and a bioelectrical signal is generated from the retina", explaining that during the local ERG examination Mizuochi expressly describes turning on a stimulus light source and projecting stimulus light through the pupil onto the ocular fundus so that a localized region of the retina is stimulated by the stimulus light, corresponding to directing a stimulus beam toward a defined target area of the retina; ¶[0051], "The stimulus light from the stimulus light source 51 can be varied in position in the xy plane vertical to the projection optical axis 26', as described above, and the spot size of the stimulus light can be changed by the indicator disc 60", explaining that Mizuochi further teaches actively positioning and sizing the stimulus spot on the ocular fundus, which corresponds to selecting and directing the stimulus beam to a specific target area on the retina); directing a background beam for inducing light adaptation at least towards an area of the retina outside of the target area for suppressing ERG signaling from area of the retina outside of the target area by light adapting the retina at least at the area outside of the target area (Mizuochi, FIG. 1; ¶[0050]; ¶[0011]: "the ocular fundus of an examinee's eye is irradiated with ocular fundus observation light to observe the ocular fundus and is irradiated with background light and stimulus light to locally stimulate the retina with the stimulus light and perform a biological examination using a bioelectrical signal obtained from the retina", explaining that Mizuochi describes irradiating the ocular fundus with both background light and stimulus light so that the retina is locally stimulated while under background illumination, corresponding to having a separate background beam in addition to the localized stimulus; ¶[0012], "With such an arrangement, the background light is projected onto the ocular fundus of the eye to be examined via a photographic stop that is disposed in the position conjugate with the anterior ocular segment of the examinee's eye. Therefore, the background light is projected onto the ocular fundus in such a manner that it spreads to the four corners about the center of the anterior ocular segment, and the entire ocular fundus can be uniformly illuminated by the background light about the position onto which the stimulus light is projected. This allows the effect of scattered light due to the stimulus light to be canceled out and an accurate local ERG examination to be performed", explaining that the background light is projected so as to spread broadly around the position of the projected stimulus light and uniformly illuminate essentially the entire ocular fundus surrounding the stimulus location, thereby light-adapting retinal regions outside the target area and canceling (suppressing) the effect of stimulus-induced scattered light on ERG measurement; ¶[0053], "In a local ERG examination, the background light acts to cancel the effect of the scattered stimulus light and the ocular fundus is therefore to be illuminated in a uniform fashion in a wider range about the center of the projected stimulus light, i.e., the entire visual range of the ocular fundus", explaining that for the local ERG examination the background light is specifically used to uniformly illuminate a wider area of the ocular fundus around the stimulus spot so as to cancel scattered stimulus light, which corresponds to directing a light-adapting background beam to retinal regions outside the target area to suppress ERG contributions arising from outside the target); and obtaining at least one signal related to an ERG signal of the retina (Mizuochi, ¶[0050], "The retina of the eye illuminated by the background light is thus locally stimulated by the stimulus light, and a bioelectrical signal is generated from the retina", explaining that when the retina is locally stimulated under background illumination, a bioelectrical signal is generated from the retina corresponding to an ERG response; ¶[0052], "The bioelectric signal from the ERG electrode 86 is inputted to the computer 80, and an electroretinogram is created, displayed on the display device 81, and stored in the storage device 82", explaining that Mizuochi explicitly teaches acquiring a bioelectric signal from an ERG electrode, inputting it to a computer, and generating an electroretinogram, which corresponds to obtaining at least one signal related to an ERG signal of the retina).
Also, regarding claim 13, Mizuochi does not teach heating the target area. Rather, Mizuochi teaches a retinal examination method in which visible stimulus light and visible background light are projected onto the ocular fundus and retinal ERG-related signals are obtained from the stimulated retinal region during a local ERG examination. Mizuochi teaches that “the stimulus light from the stimulus light source 51 is similarly projected from the anterior ocular segment 1b onto the ocular fundus 1a via the photographic stop 31” and that “[t]he retina of the eye illuminated by the background light is thus locally stimulated by the stimulus light, and a bioelectrical signal is generated from the retina” (Mizuochi, ¶[0050]). Mizuochi further teaches that “the amount of stimulus light and the amount of background light are adjusted by a rotary switch or the like provided to the controller 80” (Mizuochi, ¶[0051]). Thus, Mizuochi teaches projecting controlled light beams to a selected retinal target area during ERG testing, but Mizuochi does not teach heating the target area.
Chen teaches heating the target area. Chen teaches a method for providing a therapeutic treatment to a patient’s eye comprising “delivering, via a treatment beam from a treatment beam source, a therapeutic treatment to retinal tissue of the patient’s eye,” with “the treatment beam being delivered at an infrared wavelength, and along a treatment beam path and the treatment spot being 1 to 6 mm in diameter” (Chen, claim 16). Chen further teaches “heating the tissue at the treatment spot in a substantially uniform manner without scanning the treatment beam” (Chen, claim 19), and also teaches that “the treatment beam heats the retinal tissue at the first treatment spot in a range of 50 to 55 degrees C” (Chen, claim 7). This corresponds to heating the target area.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify Mizuochi to further include Chen’s heating step so that the same retinal target area from which Mizuochi obtains ERG-related signals could also be heated in a controlled manner during examination. One of ordinary skill in the art would have found this combination feasible because both Mizuochi and Chen are directed to ophthalmic methods that project controlled light beams through the pupil to a defined retinal region. Mizuochi projects stimulus and background light onto the ocular fundus through the projection optics and pupil during the biological examination, while Chen delivers an infrared treatment beam to a retinal treatment spot of 1 to 6 mm in diameter. The shared retinal-beam-delivery framework makes it technically straightforward to incorporate Chen’s heating step into Mizuochi’s local ERG method. One of ordinary skill in the art would have been motivated to make this combination in order to permit controlled retinal heating at a defined retinal target area while simultaneously monitoring the retinal response from that area, thereby enabling ERG-based monitoring of retinal temperature and treatment effect at the heated retinal region. Chen expressly teaches a pre-treatment evaluation method in which ERG data are received, pulses of an optical beam are delivered toward the retina, first ERG data reflecting measured ERG signals generated by retinal cells in response to the pulses are received, and one or more optimal laser power values are determined for performing a laser treatment (Chen, Fig. 9; claim 39). Chen further teaches that ERG measurements provide reliable measurements of temperature by measuring retinal cellular responses directly.
Also, regarding claim 13, the modified Mizuochi does not fully teach directing a central background light beam at least towards the target area for maintaining a light adaptation level of the target area. Rather, the modified Mizuochi teaches that liquid crystal panel 43a is a circular panel disposed with its center in coincidence with the optical axis 26 of the projection optical system, and that the background light is projected via the center of the anterior ocular segment (pupil) 1b radially onto the ocular fundus 1a, including the area onto which the stimulus beam is projected. Mizuochi teaches that “A liquid crystal (LCD) plate 43 is used as a light source for the background light, and is disposed behind the half mirror 34 so that the center thereof is in coincidence with the optical axis 26 of the projection optical system” (Mizuochi, ¶[0035]). Mizuochi further teaches that “The liquid crystal plate 43 is composed of a circular liquid crystal panel 43a arranged in the center of opaque rectangular plate 43b,” and that “The background light from the liquid crystal panel 43a is projected onto the ocular fundus 1a” and “the background light from the liquid crystal panel 43a is projected via the center of the anterior ocular segment (pupil) 1b radially onto the ocular fundus 1a” (Mizuochi, ¶[0036]). Mizuochi also teaches that during the biological examination “the liquid crystal panel 43a is turned on, and the background light from the liquid crystal panel 43a is projected from the anterior ocular segment (pupil) 1b onto the ocular fundus 1a,” while “[t]he retina of the eye illuminated by the background light is thus locally stimulated by the stimulus light” (Mizuochi, ¶[0050]). Mizuochi further teaches that “[t]he amount of stimulus light and the amount of background light are adjusted by a rotary switch or the like provided to the controller 80” (Mizuochi, ¶[0051]). However, the modified Mizuochi does not teach directing that centrally projected background light specifically for the purpose of maintaining a light adaptation level of the target area.
Severns teaches configuring background illumination to establish and maintain a known light adaptation state of the retina. Severns expressly teaches that “the intensity of the LED or light source 38 is also modulated to produce a constant background illumination” and that “[t]hat background illumination allows the eye 44 to be brought to a known state of light adaptation, which is important for a consistent response” (Severns, ¶[0032]). Severns further teaches controlled background illumination in an ERG measurement device as a deliberate operational parameter for obtaining reliable and consistent ERG responses.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Mizuochi method in view of Severns to direct the centrally projected background light beam of Mizuochi at least towards the target area for the purpose of maintaining a light adaptation level of the target area during ERG examination and during heating of the target area by the Chen treatment beam. One of ordinary skill in the art would have found this modification feasible because Mizuochi already discloses a centrally projected background light beam that illuminates the ocular fundus including the target area, and already discloses that the intensity of that background light is adjustable by the controller as a measurement condition. Severns discloses the same type of controlled background illumination arrangement in an ERG device. No structural change to Mizuochi’s beam-projection hardware is required. The modification consists of controlling the already-present background illumination so as to maintain a deliberate light adaptation state at the target area, consistent with the express teaching of Severns that such controlled background illumination is important for a consistent ERG response. One of ordinary skill in the art would have been motivated to make this modification because, in the combined Mizuochi-plus-Chen method, the Chen treatment beam adds light energy at the target area during thermal treatment, which changes the total illuminance at that location and therefore can alter the retinal light adaptation state at the target area. Chen expressly relies on ERG-based retinal-response information during laser treatment, and Severns expressly teaches that a known, stable light adaptation state is important for a consistent ERG response. One of ordinary skill in the art would therefore have recognized that maintaining the light adaptation level at the target area during heating would improve the reliability and interpretability of the ERG signal obtained during treatment.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns, and further in view of Sharifzadeh et al. (Sharifzadeh, Mohsen, Paul S Bernstein, and Werner Gellermann. “Nonmydriatic Fluorescence-Based Quantitative Imaging of Human Macular Pigment Distributions.” Journal of the Optical Society of America. A, Optics, image science, and vision 23.10 (2006): 2373–2387. Web.), hereto referred as Sharifzadeh.
The modified Mizuochi teaches claim 1 as described above.
Regarding claim 4, the modified Mizuochi does not fully teach that the background beam is blocked from fundus imaging using an optical notch filter. Rather, the modified Mizuochi teaches using spectral filtering in the fundus imaging optical path to prevent visible background and stimulus light from entering the image-capturing device while passing infrared fundus observation light as shown in claim 3 above. Specifically, the modified Mizuochi explains that “in order to prevent the reflected visible light from entering the image-capturing device 40, a filter 90 for transmitting infrared light and reflecting visible light is inserted between the half mirror 36 and the infrared-transmitting visible light reflecting mirror 93” and that “the infrared ocular fundus observation light enters the image-capturing device 40 without being blocked by the filter 90 because the filter 90 has infrared-transmitting properties” (Mizuochi, ¶[0040]). In a further embodiment, the modified Mizuochi teaches that “since the dichroic mirror 36' does not transmit visible light, the visible light from the background light source 72 does not pass through the dichroic mirror 36' and enter into the image-capturing device 40, and the draw back in which the background light interferes with ocular fundus observation can be eliminated” (Mizuochi, ¶[0065]). Thus, the modified Mizuochi clearly teaches blocking visible background light (including the light adapting background illumination) from the fundus imaging path using broadband spectral elements (filter 90 and dichroic mirror 36'), but it does not expressly disclose an optical notch filter that selectively blocks the light adapting background beam while passing other imaging wavelengths.
Sharifzadeh fills this gap by teaching the use of a holographic optical notch filter in a retinal imaging setup to block excitation-beam wavelengths while transmitting desired fluorescence to the detector. In describing the detection path, Sharifzadeh states that “the lipofuscin fluorescence is routed through beam splitter BS1, which is transparent for wavelengths above ~580 nm, through holographic notch filter F2, which blocks excitation light wavelengths, and through a long-pass filter F3, which becomes transmissive above 700 nm” (Sharifzadeh, p. 2378, Sec. 3). This expressly teaches a wavelength-selective notch filter (F2) placed in the detection path to reject the excitation beam while passing longer-wavelength signal light to the imaging CCD, i.e., blocking light associated with the excitation/background source from the fundus imaging channel in a controlled, narrowband manner.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Sharifzadeh to block the light adapting background beam from fundus imaging using an optical notch filter. Both the modified Mizuochi and Sharifzadeh use multi-element optical trains that separate fundus illumination beams from detected imaging light using spectral filters positioned between beam-splitting optics and the imaging detector. Given the modified Mizuochi’s express goal of preventing visible background light from entering the image-capturing device and Sharifzadeh’s explicit teaching of holographic notch filter F2 that “blocks excitation light wavelengths” in a retinal imaging system, one of ordinary skill in the art would have found it technically straightforward and feasible to substitute or supplement the modified Mizuochi’s broadband visible-blocking elements (filter 90 and/or dichroic mirror 36') with an optical notch filter tuned to the wavelength(s) of the light adapting background beam so that the background beam is selectively rejected while desired observation wavelengths continue to reach the image-capturing device.
The benefit of this combination would be to further reduce interference from the light adapting background beam at the imaging sensor and to improve the contrast and stability of fundus images acquired during ERG recording, by preserving needed fundus observation light while more precisely suppressing unwanted background illumination at the detector. This improved suppression of background-beam contributions would directly support more accurate monitoring of the stimulus-evoked retinal response in local ERG examinations.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns, and further in view of Ma et al. (Ma, Chen et al. “Design, Simulation and Experimental Analysis of an Anti-Stray-Light Illumination System of Fundus Camera.” Ed. by José Sasián et al. vol. 9272. SPIE, 2014. 92720H-92720H–8. Web.), hereto referred as Ma.
The modified Mizuochi teaches claim 1 as described above.
Regarding claim 5, the modified Mizuochi does not fully teach that the background beam comprises polarized light and the background beam is blocked from fundus imaging using a polarizer. Rather, the modified Mizuochi teaches blocking visible background and stimulus light from entering the fundus imaging system using spectral filtering elements in the shared optical path as shown above in claim 3 (Mizuochi, ¶[0040], ¶[0065]). Thus, the modified Mizuochi clearly discloses an ocular fundus imaging system and the concept of blocking the visible background illumination from reaching the image-capturing device, but it does not teach configuring the light adapting background beam itself as polarized light or using a polarizer as the blocking element in the imaging path.
Ma fills this gap by teaching an anti-stray-light fundus camera in which the illumination beam is deliberately polarized and a polarizer/analyzer combination is used to block unwanted light from the imaging system based on polarization. Ma explains that "to weaken the stray light, a polarized light source is used, and an analyzer plate is placed after beam splitter in the imaging system" (Ma, Abstract), and further describes that "to eliminate stray light caused by the latter, a linear polarizer is placed between the rod and the condensing lens, and an analyzer whose light vector is perpendicular to the polarizer is placed after the beam splitter in the imaging system" (Ma, p. 3, Sec. 2.4). Ma therefore expressly teaches configuring the illumination as polarized light and placing a polarizer/analyzer combination in the shared illumination and imaging path so that light maintaining a particular polarization state is blocked from reaching the imaging sensor, thereby reducing ghost images and stray light in fundus images.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Ma to configure the light adapting background beam as polarized light and to block the light adapting background beam from fundus imaging using a polarizer. Both the modified Mizuochi and Ma concern fundus camera-type systems in which illumination and imaging share portions of the optical path and where stray or background light entering the imaging system degrades image quality. Given the modified Mizuochi’s express goal of preventing visible background light from entering the image-capturing device and Ma’s explicit teaching of using a polarized light source together with a polarizer/analyzer pair placed in the shared illumination/imaging path to block stray light based on polarization, one of ordinary skill in the art would have found it technically straightforward and feasible to apply Ma’s polarization-based stray-light suppression to the light adapting background beam in the modified Mizuochi, for example by implementing the background light source as a polarized source and inserting a polarizer or analyzer in front of the image-capturing device so that the polarized background beam is blocked while desired observation light components are transmitted.
The benefit of this combination would be to further reduce the amount of light adapting background illumination reaching the fundus imaging system and to improve the signal-to-noise ratio and contrast of fundus images acquired during local ERG examinations, by combining the modified Mizuochi’s spectral separation of observation and background bands with Ma’s polarization-based suppression of stray illumination. This would enhance the clarity of the fundus image without sacrificing the light adaptation function of the background beam, thereby supporting more accurate correlation of the localized ERG signal with the imaged retinal region.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns, and further in view of Yates et al. (US 20170280995 A1), hereto referred as Yates.
The modified Mizuochi teaches claim 1 as described above.
Regarding claim 6, the modified Mizuochi does not fully teach that the background beam is modulated with an on/off waveform and a camera sensor of an imaging module is synchronized to be exposed only when the background beam is off. Rather, the modified Mizuochi explains that the computer 80 can set measurement conditions including background light intensity and the on-off state of various light sources 11, 65, 30, 94, 43 (Mizuochi, ¶[0044]: "The measurement conditions include background light intensity (amount of light) obtained from the liquid crystal plate 43, stimulus light intensity (amount of light) from the stimulus light source 51, the wavelength component of the background light and the stimulus light, the spot diameter of the stimulus light (aperture position of the indicator disc 60), the irradiation time (lighting time) of the stimulus light, the number of irradiation cycles of the stimulus light, the on-off interval of the stimulus light, the position of the fixation marker (which fixation markers 43c is turned on), and the on-off state of the various light sources 11, 65, 30, 94, 43"). The modified Mizuochi further provides a relay unit 83 for synchronizing retina stimulation with measurement conditions set in the computer 80 (Mizuochi, ¶[0046]: "a relay unit 83 is provided for relay between the light stimulus apparatus and the computer 80, and for synchronizing retina stimulation with measurement conditions set in the computer 80"). In addition, the modified Mizuochi discloses an image-capturing device 40 at a position conjugate with the ocular fundus that serves as the camera sensor for fundus imaging (Mizuochi, ¶[0030]; ¶[0040]). Together, this shows that the modified Mizuochi allows software control of on-off states and intensities for the stimulus and background sources coupled with a camera sensor, but does not describe a specific on/off waveform for the background beam or any particular exposure timing relationship with the camera sensor.
Yates fills the gap regarding synchronized control of illumination on/off behavior and image recording by teaching that the electronic controller 50 powers the illumination projectors 30a-30n in a programmable manner and synchronizes them with the image recording device to take multiple retinal images with various on-off configurations and time sequences (Yates, ¶[0042]: "...the illumination projectors 30a-30n can be synchronized with the image recording device 20 to take multiple retinal images with various on-off configurations and time sequences"). Yates therefore supplies the explicit teaching that illumination sources in a fundus camera can be driven with programmable on-off patterns and that the camera exposure is synchronized with those patterns when capturing retinal images.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Yates to modulate the light adapting background beam with an on/off waveform and to synchronize the camera sensor of the imaging module such that the sensor is exposed during selected portions of that waveform, including intervals when the background beam is off. Both the modified Mizuochi and Yates disclose wide field fundus imaging systems in which illumination sources and an image recording device share an optical path, and both references recognize the importance of controlling illumination conditions and timing during image acquisition. Given the modified Mizuochi’s programmable control over on-off states and intensities of its stimulus and background light sources and Yates’s explicit teaching that illumination projectors can be synchronized with the image recording device using various on-off configurations and time sequences, one of ordinary skill in the art would have found it technically straightforward and feasible to apply Yates’s synchronized on-off illumination control to the modified Mizuochi’s light adapting background beam and the image-capturing device 40, implementing a controller-driven on/off waveform for the background illumination and gating camera exposure to intervals when that background component is off while other desired signals are recorded. The benefit of this combination would be to reduce the influence of the light adapting background beam on the fundus images and ERG recordings, improving signal-to-noise ratio and image contrast during ERG examinations while maintaining the desired degree of retinal light adaptation from the background illumination, thereby enhancing simultaneous imaging and localized ERG measurement from the target area.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns, and further in view of Sramek et al. (Sramek, Christopher et al. “Improved Safety of Retinal Photocoagulation with a Shaped Beam and Modulated Pulse.” Proceedings of SPIE. vol. 7550. N.p., 2010. 75500V-75500V–10. Web.), hereto referred as Sramek.
The modified Mizuochi teaches claim 1 as described above.
Regarding claim 10, the modified Mizuochi does not fully teach that the heating light source is configured to provide an aiming beam having essentially equivalent beam size and irradiance profile as the heating beam. Rather, it teaches a device that includes localized ERG measurement as described in Mizuochi together with a heating light source as taught by Chen, where Chen provides a treatment beam that heats substantially circular retinal spots of 1–6 mm in diameter uniformly (Chen, ¶[0035], "the treatment laser may be controlled or delivered to treat single, large target spots ( e.g., macula ), positions, or locations with diameters from 1-6 mm ( e.g., above 5 mm ) and heat the spots uniformly") and further includes a visible aiming beam used to localize the treatment area (Chen, ¶[0037], "the convex lens focuses the aiming beam onto a concentric aiming ring 130 that surrounds the treatment beam at the treatment spot on the patient's eye such that the aiming beam is always larger than the treatment beam"); however, the combined teachings do not disclose an aiming beam configured to have essentially equivalent beam size and irradiance profile as the heating beam.
Chen further provides a visible aiming beam that is delivered along a separate but co-aligned optical path and focused so that "the convex lens focuses the aiming beam onto a concentric aiming ring 130 that surrounds the treatment beam at the treatment spot on the patient's eye such that the aiming beam is always larger than the treatment beam" (Chen, ¶[0037], "As illustrated, the convex lens focuses the aiming beam onto a concentric aiming ring 130 that surrounds the treatment beam at the treatment spot on the patient's eye such that the aiming beam is always larger than the treatment beam"). Thus, Chen demonstrates combining a heating treatment beam with an aiming beam to localize retinal therapy but uses an aiming beam that encircles the treatment beam rather than having essentially equivalent beam size and irradiance profile.
Sramek teaches retinal photocoagulation with a shaped therapeutic beam and a low-power aiming beam coupled into the same optical mode so that both beams share the same spatial profile and irradiance distribution. In particular, Sramek explains that "a ring-shaped illumination pattern was achieved by coupling the beam into the fiber tip at an angle (~5º) with respect to normal incidence" and that "a low-power 640 nm laser is coupled into the same mode for use as an aiming beam" (Sramek, FIG. 2; p. 4, Sec. 2.3). By coupling the aiming laser into the same multimode fiber mode as the therapeutic laser, Sramek shows an aiming beam that shares essentially the same annular beam size and irradiance profile as the treatment beam, differing primarily in wavelength and power while preserving the spatial distribution at the retina.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Chen and Sramek to configure a heating light source that provides an aiming beam having essentially equivalent beam size and irradiance profile as the heating beam at the retinal target area. One of ordinary skill in the art would have found it straightforward to incorporate Chen's large, uniformly heated retinal spots into the modified Mizuochi's fundus illumination and ERG measurement system by adding a therapeutic heating beam and co-aligned aiming beam along the same optical path, and would have recognized from Sramek that coupling a low-power visible aiming laser into the same optical mode or beam-shaping optics as the therapeutic laser naturally yields an aiming beam sharing the same spatial profile as the heating beam. The slit-lamp style optics, beam combiners, multimode fibers, and lenses used in the modified Mizuochi, Chen, and Sramek are standard in ophthalmic laser systems and readily interoperable, so adapting the modified Mizuochi's device to include a heating light source and a same-profile aiming beam would not require undue experimentation.
The resulting combination would provide clear practical benefits by allowing the clinician to see exactly the region of retina that will be uniformly heated while maintaining alignment between the heated region and the ERG target area, improving targeting accuracy, ensuring that ERG responses are captured from tissue exposed to the intended thermal stimulus, and reducing the risk of off-target heating or variability in the recorded ERG signals.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns, and further in view of Bach et al. (Bach, Michael, and Margret Schumacher. “The Influence of Ambient Room Lighting on the Pattern Electroretinogram (PERG).” Documenta ophthalmologica 105.3 (2002): 281–289. Web), hereto referred as Bach, as evidence, and further in view of Tomioka et al. (US 5057102 A), hereto referred as Tomioka.
The modified Mizuochi teaches claim 1 as shown above.
Regarding claim 11, the modified Mizuochi does not fully teach that the brightness of the central background light beam is configured to reduce as the heating system is turned on to maintain a steady illuminance at the target area. As established in the rejection of claim 1 above, the combined Mizuochi, Chen, and Severns device comprises a centrally projected background light beam whose intensity is adjustable by the controller as a measurement condition (Mizuochi, ¶[0051]), a heating system comprising a heating beam that delivers additional photon flux to the target area (Chen, claim 1; ¶[0005]), and a background light beam configured to maintain a light adaptation level at the target area (Severns, ¶[0032]). However, the modified Mizuochi does not teach configuring the brightness of the central background light beam to specifically reduce as the heating system is turned on, nor does it teach the compensatory control relationship between background-beam brightness and heating-beam contribution for the purpose of maintaining a steady illuminance at the target area.
Tomioka teaches the broader control principle that, in an ophthalmic laser treatment system, the brightness of one light source may be actively adjusted relative to another illumination condition at the retinal treatment site in order to maintain a desired illuminance or visibility condition there. Tomioka expressly teaches “a control unit for controlling an illuminance of the aiming light with respect to the illumination light by adjusting a ratio of the quantity of light reflected from the aiming site to the quantity of light reflected from the site around the aiming site so as to reach a predetermined ratio” (Tomioka, Abstract). Tomioka further teaches that “the control unit 15 is to control the illuminance of the aiming light with respect to light for illumination by allowing the setting unit to adjust the ratio of the quantity of light reflected from the aimed portion to the quantity of light reflected from the portion around the aimed portion” (Tomioka, Col. 2, ll. 20–32). Tomioka additionally teaches that when the measured illuminance ratio deviates from the optimum ratio, the control unit increases or decreases the brightness of the aiming light source accordingly: “If the ratio (a) is found to be greater than the ratio (b), the brightness of the aiming light lacks so that the quantity of the aiming light is increased by controlling the source 2 for the aiming light by means of the control unit 15... If the ratio (a) is found to be smaller than the ratio (b), on the contrary, the brightness of the aiming light is so excessive that the quantity of the aiming light is decreased by controlling the source 2 for the aiming light by means of the control unit 15” (Tomioka, Col. 5, ll. 1–22). These teachings show that Tomioka teaches a known ophthalmic control approach in which one light source is actively brightened or dimmed relative to another site-illumination condition in order to maintain a desired condition at the retinal treatment site.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Mizuochi device in view of Tomioka to configure the brightness of the central background light beam to reduce when the Chen heating beam contributes additional light at the target area, so as to maintain a steady illuminance at the target area. One of ordinary skill in the art would have found this modification feasible because the combined Mizuochi, Chen, and Severns device already comprises the hardware and control architecture required to implement compensatory brightness control. Mizuochi already adjusts background light intensity as a measurement condition (Mizuochi, ¶[0051]) and discloses measurement conditions including background-light intensity and stimulus-light intensity under controller control (Mizuochi, ¶[0044]). Chen’s heating system is processor-controlled and delivers the treatment beam to the target area (Chen, ¶[0034]; claim 1). Tomioka demonstrates that actively coordinating the brightness of one light source relative to another site-illumination condition through a controller is a known and feasible implementation in ophthalmic laser treatment systems (Tomioka, Abstract; Col. 2, ll. 20–32; Col. 5, ll. 1–22). No new hardware is required. The modification consists of programming the already-present controller to reduce the background-beam brightness in response to the added light contribution of the heating beam, using the compensatory brightness-control approach that Tomioka teaches. One of ordinary skill in the art would have been motivated to make this modification because, in the combined device, the Chen heating beam delivers additional photon flux to the target area when it is turned on, increasing the total illuminance at that location above the level established by the background beam alone. Severns expressly teaches that a known, stable background illumination level is important for a consistent ERG response because “that background illumination allows the eye to be brought to a known state of light adaptation, which is important for a consistent response” (Severns, ¶[0032]). Bach further confirms that changes in illuminance produce systematic changes in ERG measurements, reporting that PERG amplitude and peak time vary with illuminance level and concluding that “lighting conditions should be moderately standardized at low or medium luminance levels for reproducible amplitudes and peak times” (Bach, p. 281, Abstract; p. 287–288, Conclusions). Tomioka teaches that actively reducing the brightness of one light source relative to another illumination condition is a known ophthalmic control technique for maintaining a desired site condition (Tomioka, Col. 5, ll. 1–22). In view of these teachings, one of ordinary skill in the art would have found it obvious to apply Tomioka’s compensatory brightness-control approach to the combined Mizuochi-Chen-Severns device by reducing the central background-light brightness when the Chen heating beam contributes additional light at the target area, thereby maintaining steady illuminance and improving the reliability and interpretability of the ERG signals used for retinal temperature monitoring during treatment.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mizuochi (US 20100253910 A1), hereto referred as Mizuochi, and further in view of Chen et al. (US 20200069463 A1), hereto referred as Chen, and further in view of Severns (US 20080058655 A1), hereto referred as Severns, and further in view of Bach et al. (Bach, Michael, and Margret Schumacher. “The Influence of Ambient Room Lighting on the Pattern Electroretinogram (PERG).” Documenta ophthalmologica 105.3 (2002): 281–289. Web), hereto referred as Bach.
The modified Mizuochi teaches claim 1 as described above.
Regarding claim 12, the modified Mizuochi does not teach that the central background light beam has a brightness of over 50 lux. Rather, the modified Mizuochi teaches a local ERG system in which the ocular fundus is illuminated by a centrally projected background light whose intensity is controlled as a measurement condition via a computer, so that the background light level can be set during the examination (Mizuochi, ¶[0044], "A computer (controller) 80 can set various measurement conditions in order to perform a local ERG examination. The measurement conditions include background light intensity (amount of light) obtained from the liquid crystal plate 43"), but the modified Mizuochi does not specify any particular brightness value in lux for this central background light beam
Bach teaches that pattern ERG recordings are carried out under explicitly quantified ambient illumination levels and that these levels affect both PERG amplitudes and peak times (Bach, Abstract: "We recorded the transient PERG (0.8◦ check size) and steady-state PERG (15 rev/s, 0.8◦ and 16◦ check size) under three lighting conditions: dark room, only illuminated by the stimulus (resulting in 30 lux), our standard room lighting (windows occluded, one lighted lamp, 200 lux) and fully lit room (full ceiling illumination with eight fluorescent tubes) resulting in rather bright 2300 lux"; "Peak times decreased significantly with illumination (dark, medium or bright)" ... "This suggests that bright sunlight should be excluded, and that lighting conditions should be moderately standardized at low or medium luminance levels for reproducible amplitudes and peak times"), thereby teaching that ERG measurements are commonly standardized using quantified ambient illumination above low thresholds (e.g., 200 lux) to ensure consistent light adaptation and reproducible response characteristics
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Mizuochi in view of Bach to configure the central background light beam in the modified Mizuochi’s ERG device to have a brightness over 50 lux so that the retinal background illumination level is quantitatively standardized within a low-to-medium luminance range suitable for reproducible ERG responses. In view of Bach’s explicit teaching that PERG measurements should avoid very bright conditions yet use moderately standardized low or medium luminance levels for reproducible amplitudes and peak times, and given that the modified Mizuochi already allows the background light intensity to be set as a measurement condition via the controller, one of ordinary skill in the art would have found it straightforward and technically feasible to select a numerical brightness threshold (such as greater than 50 lux) for the centrally projected background light beam by adjusting the drive level of the background light source until the measured or calculated illuminance at the eye exceeded the desired threshold. The benefit of such a modification would have been to ensure that the target retinal area remains in a stable, quantifiable state of light adaptation consistent with standardized ERG practice, thereby improving the reproducibility and comparability of local ERG measurements across sessions and subjects, as emphasized by Bach in the context of ambient lighting control.
Regarding claim 20, the modified Mizuochi does not explicitly teach that the central background light beam has a brightness of over 100 lux. Rather, the modified Mizuochi, as applied in claim 12, teaches a local ERG system in which the ocular fundus is illuminated by a centrally projected background light whose intensity is controlled as a measurement condition via a computer, and is at least over 50 lux. However, it does not expressly teach that the brightness value is over 100 lux.
Bach teaches that pattern ERG recordings are carried out under explicitly quantified ambient illumination levels and that these levels affect both PERG amplitudes and peak times (Bach, p.1, l.8–13, "We recorded the transient PERG (0.8◦ check size) and steady-state PERG (15 rev/s, 0.8◦ and 16◦ check size) under three lighting conditions: dark room, only illuminated by the stimulus (resulting in 30 lux), our standard room lighting (windows occluded, one lighted lamp, 200 lux) and fully lit room (full ceiling illumination with eight fluorescent tubes) resulting in rather bright 2300 lux"; Bach, p.2, l.1–6, "Peak times decreased significantly with illumination (dark, medium or bright)" ... "This suggests that bright sunlight should be excluded, and that lighting conditions should be moderately standardized at low or medium luminance levels for reproducible amplitudes and peak times"), thereby teaching that ERG measurements are commonly standardized using quantified ambient illumination above low thresholds (e.g., 200 lux) to ensure consistent light adaptation and reproducible response characteristics
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified in view of Bach to configure the central background light beam in the modified Mizuochi’s ERG device to have a brightness over 100 lux so that the retinal background illumination level is quantitatively standardized within a low-to-medium luminance range suitable for reproducible ERG responses. In view of Bach’s explicit teaching that PERG measurements should avoid very bright conditions yet use moderately standardized low or medium luminance levels for reproducible amplitudes and peak times, and given that the modified Mizuochi already allows the background light intensity to be set as a measurement condition via the controller, one of ordinary skill in the art would have found it straightforward and technically feasible to select a numerical brightness threshold (such as greater than 100 lux) for the centrally projected background light beam by adjusting the drive level of the background light source until the measured or calculated illuminance at the eye exceeded the desired threshold. The benefit of such a modification would have been to ensure that the target retinal area remains in a stable, quantifiable state of light adaptation consistent with standardized ERG practice, thereby improving the reproducibility and comparability of local ERG measurements across sessions and subjects, as emphasized by Bach in the context of ambient lighting control.
Response to Arguments
Objections
Applicant's arguments filed 3/3/2026, page 6, regarding the previous Objections of claims 1 and 11 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 3/3/2026, page 6, regarding the previous 112(b) Rejections of claims 1-13 and 20 have been fully considered and are persuasive with respect to claims 1-12 and 20. The previous 112(b) rejections to claims 1-12 and 20 have been withdrawn. However, the 112(b) rejection of prior claim 13 remains as shown above.
35 U.S.C. §102 and 103
Applicant's arguments filed 3/3/2026, pages 6-8, regarding the previous 102 Rejections of claims 1-3, 11, and 13 as well as the previous 103 Rejections of claims 4-10, 12, and 20 have been fully 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. That is, there are new grounds of rejection. Additionally, for the reasons discussed below.
Applicant's Argument 1: Applicant amended independent claim 1 to recite a heating system comprising a heating light source for providing a heating beam to heat at least the target area, and argues that Mizuochi fails to disclose this element, thereby overcoming the prior § 102 rejection.
Examiner's Response: The § 102 rejection of claims 1 and 13 over Mizuochi alone is withdrawn. Applicant correctly observes that Mizuochi does not disclose a heating system or a heating beam for raising retinal tissue temperature. The rejection of claims 1 and 13 is now maintained under § 103 over Mizuochi in view of Chen and Severns. As explained in the rejection above, Chen expressly teaches a treatment beam source configured to deliver an infrared heating beam at 1 to 100 W to a retinal treatment spot of 1 to 6 mm in diameter, heating the retinal tissue to 50 to 55 degrees C. in a substantially uniform manner (Chen, claim 1; claims 2 and 7). The motivation to combine Mizuochi with Chen is expressly provided by Chen's own disclosure that ERG measurements are used to monitor retinal temperature during laser treatment and to determine optimal treatment parameters (Chen, ¶[0047]; ¶[0016]–¶[0020]).
In the prior Office Action the limitation relating to a “central background light beam configured to illuminate at least the target area for maintaining a light adaptation level of the target area,” which previously appeared in dependent claim 11, was treated as anticipated by Mizuochi alone. That treatment corresponded to the earlier claim structure in which the limitation appeared without any heating requirement. In that context, Mizuochi’s background illumination during ERG measurement was considered sufficient to read on the limitation because the prior claim did not require the background beam to maintain adaptation in the presence of additional illumination directed to the target area.
Applicant’s amendment to claim 1 alters the context in which this limitation must be evaluated. In amended claim 1, the “central background light beam…for maintaining a light adaptation level of the target area” limitation is now recited together with a heating system that directs an additional beam to the same retinal region. In that context, maintaining the light adaptation level of the target area represents a more demanding functional requirement than simply having background illumination present during a static ERG measurement. It requires configuring the background illumination to maintain a controlled adaptation state at the target area despite the presence of a co-operating heating beam that adds to the total illuminance at that location. Mizuochi does not expressly disclose this scenario and does not describe a device in which a background beam and a heating beam are simultaneously active at the same retinal target area. The amendment therefore introduces a functional requirement that is not expressly addressed in Mizuochi alone. Severns is cited to address this aspect of the claim. Because the additional references are relied upon in response to limitations introduced by Applicant’s amendment, the rejection is properly made final in accordance with MPEP §706.07(a).
Applicant's Argument 2: Applicant argues that Mizuochi does not teach providing both a light adapting background beam specifically for the area outside the target area and a separate central background light beam specifically for illuminating and maintaining the light adaptation level of the target area. Applicant characterizes Mizuochi's background beam as a single, undifferentiated background illumination source and argues that Mizuochi does not disclose the functional distinction between the two beam types now recited in claim 1.
Examiner's Response: This argument has been considered but does not alter the conclusion of obviousness for two independent reasons.
First, amended claim 1 recites "at least one light source configured to provide" the stimulus beam, the background beam for inducing light adaptation, and the central background light beam. This claim language expressly contemplates that a single light source may provide more than one of the recited beam functions. The claim language itself does not require separate or independently housed light sources for each beam type. See MPEP §2111.01. Because claim 1 requires only at least one light source providing these functions without structural separation, the fact that Mizuochi discloses a single liquid crystal panel 43a as the background light source does not distinguish the claim from the prior art.
Second, and as a direct consequence of this claim language, Mizuochi's single centrally projected background beam satisfies both the light adapting background beam element and the structural illumination component of the central background light beam element simultaneously because of its optical geometry. Mizuochi expressly teaches that liquid crystal panel 43a projects background light via the center of the anterior ocular segment radially onto the entire ocular fundus 1a (Mizuochi, ¶[0036]) and that "the entire ocular fundus can be uniformly illuminated by the background light about the position onto which the stimulus light is projected" (Mizuochi, ¶[0012]). The phrase "the entire ocular fundus" necessarily encompasses both the region outside the target area and the target area itself. There is no optical mechanism disclosed in Mizuochi by which light projected radially from the center of the pupil onto the entire fundus would reach the surrounding area while not reaching the target area. The single background beam therefore illuminates both the area outside the target and the target area, satisfying the structural illumination requirements of both claim elements. The additional functional requirement of configuring the beam to maintain a light adaptation level of the target area in the context of a co-operating heating system is addressed by the modification in view of Severns as set forth in the rejection above.
Applicant's Argument 3: Applicant argues that Mizuochi does not teach a central background light beam configured for the specific purpose of maintaining a light adaptation level of the target area, and that this functional purpose is not disclosed in Mizuochi's description of its background illumination.
Examiner's Response: Applicant’s observation that Mizuochi does not expressly describe maintaining light adaptation in the presence of a heating beam is noted. However, this limitation is addressed by the modification in view of Severns, as discussed in the rejection above.
Severns expressly teaches that constant background illumination is maintained specifically because "that background illumination allows the eye to be brought to a known state of light adaptation, which is important for a consistent response" (Severns, ¶[0032]). This corresponds to the functional objective recited in the claim: maintaining a light adaptation level of the target area. Severns further teaches that this is achieved through microcontroller-based modulation of background light intensity and that doing so is a recognized technical requirement for reliable ERG responses. As explained in the rejection above, Mizuochi already discloses a centrally projected background beam that structurally illuminates the target area and discloses that its background light intensity is adjustable by the controller as a measurement condition (Mizuochi, ¶[0051]). The modification in view of Severns consists of configuring that existing adjustable background light controller to deliberately maintain a light adaptation level at the target area in the context of the combined device, consistent with the express teaching of Severns that this is important for consistent ERG responses. No new hardware is required, and the result is a predictable improvement in ERG reliability as confirmed by Severns.
Additionally, Bach establishes quantitatively that changes in illuminance at the eye produce systematic and measurable changes in ERG amplitude and peak time, further confirming that maintaining a controlled illuminance level at the retinal target area during ERG measurement is a recognized technical necessity and not a novel insight of the present application (Bach, p. 281, Abstract; pp. 287–288, Conclusions).
Applicant's Argument 4: Applicant argues that neither Mizuochi nor Chen, alone or in combination, discloses providing a central background beam for maintaining adaptation at the target area during retinal heating, that the technical advantages of this combination are not taught or suggested by the cited references, and that a person of ordinary skill in the art would not have been motivated to arrive at the claimed device without relying on hindsight from the present application.
Examiner's Response: This argument has been considered but does not alter the conclusion of obviousness.
The motivation to combine Mizuochi and Chen does not depend on hindsight. It is expressly provided by Chen's own specification. Chen teaches that ERG measurements are used to monitor retinal temperature during laser treatment in real time, stating that "as treatment is ongoing, real-time ERG measurements may be taken and retinal temperatures may be determined and displayed to the operator" (Chen, ¶[0047]). Chen further describes a pre-treatment ERG evaluation method in which laser pulses are delivered to the retina and the resulting ERG signals are used to predict treatment effects and determine optimal power values (Chen, ¶[0016]–¶[0020]; FIG. 9). These teachings establish that the combination of retinal laser heating and ERG signal monitoring at the same retinal target area is a concept explicitly proposed by Chen itself rather than a combination reconstructed through hindsight. Because the motivation arises directly from the prior art itself, the combination does not rely on hindsight reconstruction. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
The motivation to further configure the background beam to maintain a light adaptation level at the target area follows directly from the combination of Chen and Severns. Chen establishes that reliable ERG signals are required during heating to monitor retinal temperature. Severns establishes that reliable ERG responses require a known, stable light adaptation state maintained by controlled background illumination. A person of ordinary skill in the art combining these teachings would recognize that maintaining a controlled light adaptation level at the retinal target area during heating would improve the reliability and interpretability of the ERG signals obtained during treatment and would configure Mizuochi's existing adjustable background light controller to serve that purpose. This conclusion follows directly from references already in the record without reliance on the present application's disclosure.
For these reasons, Applicant’s arguments do not overcome the rejection, and the rejection of claim 1 and claim 13 under §103 over Mizuochi in view of Chen and Severns is maintained.
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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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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