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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 May 2026 has been entered. Claims 18 – 32 are pending.
Claim Objections
Claim 18 is objected to because of the following informalities:
regarding the term “elevating the temperature of at least the target area”. It is suggested to revise the term to be “elevating the temperature of at least the target area of the retina” for readability and consistency in the claim.
Regarding the term “retinal ERG stimulus and heating” in the preamble, it is suggested to revise the term to be “retinal ERG stimulus and retinal heating” for readability and consistency in the claims.
Appropriate correction is required.
Claim 29 is objected to because of the following informalities: it appears that there is an extra comma after “determine”. It is suggested to remove this comma for readability of the claim. Appropriate correction is required.
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.
Claims 18 – 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 (line 3) recites the term “a target area of the retina”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited retina. For the purposes of examination, the term “a target area of the retina” is deemed to claim “a target area of a retina”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 18 (line 4) and Claim 25 (line 2) each recite the term “the temperature of at least the target area”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited temperature. For the purposes of examination, the term “the temperature of at least the target area” is deemed to claim “a temperature of at least the target area”. Claims 19 – 32 are similarly rejected due to their dependence on Claims 18 and 25.
Claim 18 (lines 5 and 11) recites the terms “wherein the processor is configured” and “the processor is additionally configured”. It is unclear if this processor is intended to be the same or different than the previously-recited at least one processor. For the purposes of examination, the term “wherein the processor is configured” and “the processor is additionally configured” is deemed to claim “wherein the at least one processor is configured” and “the at least one processor is additionally configured”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 18 (line 6) recites the term “a retinal ERG signal”. It is unclear if this is intended to be the same or different than the previously-recited ERG signal induced from a target area of the retina. For the purposes of examination, the term “a retinal ERG signal” is deemed to claim “the ERG signal”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 18 (lines 14 and 16) recites the term “for the same retina”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited same retina. It is unclear if this is intended to be the same or different than the previously-recited retina. For the purposes of examination, the term “for the same retina” is deemed to claim “for the retina”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 18 (lines 13 - 16) recites the term “a predetermined threshold relative to a previously determined reference ERG response amplitude determined for the same retina”. As there is no previously-recited reference ERG response, it is unclear if this “previously determined” ERG is referring to a response that was determined prior to use of the claimed arrangement, prior to when the predetermined threshold was determined, such that the metes and bounds of when it was determined are unclear. For the purposes of examination (and given the interpretation above), the term “a predetermined threshold relative to a previously determined reference ERG response amplitude determined for the same retina” is deemed to claim “a predetermined threshold relative to a reference ERG response amplitude determined for the same retina”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 19 (lines 2 - 3) recites the term “the temperature elevation per unit heating power”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited temperature elevation. For the purposes of examination, the term “the temperature elevation per unit heating power” is deemed to claim “a temperature elevation per unit heating power”. Claims 20 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 19.
Claim 19 (lines 2 - 3) recites the term “determine, as an indicator, the temperature elevation per unit heating power”. It is unclear if this indicator is intended to be the same or different than the previously-recited “one or more indicators”. For the purposes of examination (and given the interpretation above), the term “determine, as an indicator, the temperature elevation per unit heating power” is deemed to claim “determine, as a first indicator of the one or more indicators, the temperature elevation per unit heating power”. Claims 20 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 19.
Claim 19 (line 3) recites the term “use said indicator”. It is unclear if this is intended to be the same or different than the previously-recited indicator or one or more indicators. For the purposes of examination (and given the interpretation above), the term “use said indicator” is deemed to claim “use said first indicator of the one or more indicators”. Claims 20 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 19.
Claim 19 (line 3) recites the term “the target area of a fundus”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited target area of a fundus. For the purposes of examination, the term “the target area of a fundus” is deemed to claim “a fundus target area”. Claims 20 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 19.
Regarding Claims 19 and 20, looking to Applicant’s specification, the calibration protocol of Claim 19 appears to be denoted at [Page 2, Line 26] – [Page 3, Line 8] as “ a power calibration protocol”, disclosing the steps that are recited in Claim 20. Relative to Claim 19, with the term “configured to run a calibration protocol”, it becomes unclear if the contents of Claim 20 are intended to be the calibration protocol, or if there is an additional calibration protocol that is being run. Should the contents of Claim 20 be “a calibration protocol” of Claim 19, then it is unclear how Claim 20 further limits Claim 19. For the purposes of examination, the terms of Claim 20, beginning with “The arrangement of claim 19, wherein the processor is configured to:” is deemed to claim “The arrangement of claim 19, wherein the processor is configured to execute the calibration protocol, which further includes a power calibration protocol comprising”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (lines 5 - 6) recites the term “a target area with a first power”. It is unclear if this target area is intended to be the same or different than the previously-recited target area of either the fundus or of the retina. For the purposes of examination, the term “a target area with a first power” is deemed to claim “the target area of the retina with a first heating power”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (line 8) recites the term “a second or subsequent laser power”. There is no previously-recited first laser power, so it is unclear if this laser power is intended to be the same or different than the previously-recited power or heating power. For the purposes of examination (and given the interpretation above), the term “a second or subsequent laser power” is deemed to claim “a second or subsequent heating power”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (line 12) recites the term “compare the first pre-heating ERG signals and/or first post-heating ERG signals”. AS previously-recited in the claim, it appears that there is only a singular first pre-heating ERG signal and a singular first post-heating ERG signal obtained. It is therefore unclear how multiple of each of these signals are compared. For the purposes of examination, the term “compare the first pre-heating ERG signals and/or first post-heating ERG signals” is deemed to claim ““compare the first pre-heating ERG signal and/or first post-heating ERG signal”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (lines 13 - 14) recites the term “determine the temperature elevation of the retinal tissue”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited temperature elevation or retinal tissue. It is unclear if this is intended to be the same or different than the previously-recited retina. For the purposes of examination, the term “determine the temperature elevation of the retinal tissue” is deemed to claim “determine a retina temperature elevation”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (line 14) recites the term “the used heating power(s)”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “used heating power”. It is unclear if this is intended to be the same or different than the calibrated heating power or unit of heating power. For the purposes of examination, the term “the used heating power(s)” is deemed to claim “each of one or more heating powers including one or more of the first, the second, and the subsequent heating power”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (line 15) recites the term “the determined temperature elevation(s)”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the previously-recited temperature elevation of the retinal tissue (or as interpreted above, retina temperature elevation). It is further unclear if the steps between h) and i) are performed iteratively to obtain a possible multiple “temperature elevation”, if all of steps a) – i) are performed iteratively, or the metes and bounds of what would constitute multiple temperature elevations to be determined. For the purposes of examination, the term “the determined temperature elevation(s)” is deemed to claim “the determined retina temperature elevation”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 20 (lines 15 - 16) recites the term “determine the temperature increase(s) of the target area per unit of heating power”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited temperature increase(s). It is unclear if this is intended to be the same or different than the previously-recited temperature elevation per unit heating power in Claim 19, from which this claim depends. It is also unclear how multiple temperature increases are being determined. For the purposes of examination, and in light of the interpretation above, the term “determine the temperature increase(s) of the target area per unit of heating power” is deemed to claim “determine the temperature elevation per a unit of heating power for the fundus target area”. Claims 21 – 23, 25 – 26, and 28 are similarly rejected due to their dependence on Claim 20.
Claim 21 (line 1), Claim 27 (line 1), Claim 29 (line 1), and Claim 32 (line 1) each recite the term “wherein the processor is configured”. It is unclear if this processor is intended to be the same or different than the previously-recited at least one processor. For the purposes of examination, the term “wherein the processor is configured” is deemed to claim “wherein the at least one processor is configured”.
Claim 21 (lines 1 – 3) recites the term “repeat at least steps c – d with a predetermined set of heating powers”. As recited, Claim 20 recites “provide retinal heating to a target area with a first power”. Regarding the repetition, it is unclear if the heating powers are intended to be in the place of the “first power”, or if they are an additional element not recited within steps c and d of Claim 20. Further, in light of this limitation in Claim 21, it is additionally unclear if step e is restating the “repeat at least steps c – d with a predetermine set of heating powers” of Claim 20, or if a different option would result in those steps not being repeated.
For the purposes of examination in light of this limitation in Claim 21 (and the interpretations above),,
Claim 20’s term “c. initiate retinal heating by controlling the heating system to provide retinal heating to a target area with a first power and continue the retinal heating for a preset duration; d. determine a first heating ERG signal; e. optionally repeat steps c - d with a second or subsequent laser power to determine second or subsequent heating ERG signals; f. terminate the retinal heating” is deemed to claim “c. initiate retinal heating by controlling the heating system to provide retinal heating to the target area of the retina with a first heating power with one or more heating powers each for a preset duration, d. determine one or more heating ERG signals, e. terminate the retinal heating”.
Claim 21’s term “repeat at least steps c – d with a predetermined set of heating powers” is deemed to claim “wherein the one or more heating power is a predetermined set of heating powers.”
Claim 21 (lines 2 - 3) recites the term “determine, as an indicator, an aggregate temperature increase”. It is unclear if this indicator is intended to be the same or different than the previously-recited “one or more indicators” and indicator. For the purposes of examination (and given the interpretation above), the term “determine, as an indicator, an aggregate temperature increase” is deemed to claim “determine, as a second indicator of the one or more indicators, an aggregate temperature increase”.
Claim 21 (line 4) recites the term “an aggregate temperature increase of the target area per unit of heating power”. It is unclear if this target area is intended to be the same or different than the previously-recited target area of the retina or the fundus. For the purposes of examination (and given the interpretation above), the term “an aggregate temperature increase of the target area per unit of heating power” is deemed to claim “an aggregate temperature increase of the fundus target area per the unit of heating power”.
Claim 22 (line 1) recites the term “wherein ERG signal(s) obtained”. It is unclear if this is intended to be the previously-recited ERG signal, reference ERG signal, first pre-heating ERG signal, second or subsequent heating ERG signal, etc. For the purposes of examination, the term “wherein ERG signal(s) obtained” is deemed to claim “wherein the heating ERG signals obtained”. Claim 28 is similarly rejected due to its dependence on Claim 22.
Claim 22 (line 2) recites the term “initiating retinal heating” and “change in retinal heating”. It is unclear if this is intended to be the same or different than the previously-recited retinal heating. For the purposes of examination, the terms “initiating retinal heating” and “change in retinal heating” are deemed to claim “initiating the retinal heating” and “change in the retinal heating”. Claim 28 is similarly rejected due to its dependence on Claim 22.
Claim 23 (line 1) recites the term “wherein ERG signal(s) obtained”. It is unclear if this is intended to be the previously-recited ERG signal, reference ERG signal, first pre-heating ERG signal, second or subsequent heating ERG signal, etc. For the purposes of examination, the term “wherein ERG signal(s) obtained” is deemed to claim “wherein the heating ERG signals obtained”.
Claim 23 (line 2) recites the term “after the heating is initiated” and “caused by the heating”. It is unclear if this is intended to be the same or different than the previously-recited retinal heating. For the purposes of examination, the terms “after the heating is initiated” and “caused by the heating” are deemed to claim “after the retinal heating is initiated” and “caused by the retinal heating”.
Claim 23 (line 3) recites the term “the heating procedure”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the previously-recited heating or retinal heating. For the purposes of examination, the term “the heating procedure” is deemed to claim “the retinal heating”.
Claim 24 (line 1) recites the term “wherein the heating is terminated”. It is unclear if this is intended to be the same or different than the previously-recited retinal heating. For the purposes of examination, the term “wherein the heating is terminated” is deemed to claim “wherein the retinal heating is terminated”. Claim 25 is similarly rejected due to its dependence on Claim 24.
Claim 25 (line 7) recites the term “the heating”. It is unclear if this is intended to be the same or different than the previously-recited heating or retinal heating. For the purposes of examination, the term “the heating” is deemed to claim “the retinal heating”. Claim 26 is similarly rejected due to its dependence on Claim 25.
Claim 25 (lines 8 – 11) recites the term “if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount or a user of the arrangement is informed if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount.” It is unclear if the threshold amounts recited are intended to be the same or different than each other or the same or different than the previously-recited threshold amount. For the purposes of examination, the term “if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount or a user of the arrangement is informed if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount” is deemed to claim “if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over the threshold amount, then either i) the heating is terminated or adjusted or ii) a user of the arrangement is informed.” Claim 26 is similarly rejected due to its dependence on Claim 25.
Claim 26 (lines 1 – 2) recites the term “wherein the threshold amount of the difference between expected and observed change in kinetics parameter corresponds to between 2°C and 8° of temperature change”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited difference regarding the expected and observed changes. It is unclear if this is intended to be the same or different than the previously-recited threshold amount. For the purposes of examination, the term “wherein the threshold amount of the difference between expected and observed change in kinetics parameter” is deemed to claim “wherein the first or second threshold amount corresponds to between 2°C and 8° of temperature change”.
Claim 27 (line 2) recites the term “extrapolate a heating power that provides a predetermined temperature elevation”. It is unclear if this is intended to be the same or different than the previously-recited heating power types. For the purposes of examination, the term “extrapolate a heating power that provides a predetermined temperature elevation” is deemed to claim “extrapolate a temperature-goal heating power that provides a predetermined temperature elevation”.
Claim 27 (line 2 and line 3) recites the term “at the target area”. It is unclear if this is intended to be the same or different than the previously recited target area of the retina or target area of the fundus. For the purposes of examination, the term “at the target area” is deemed to claim “at the target area of the retina”.
Claim 28 recites the term “how the ERG signaling kinetics should change”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited ERG signaling kinetics. For the purposes of examination, the term “how the ERG signaling kinetics should change” is deemed to claim “how an ERG signaling kinetics should change”.
Claim 28 (line 2) recites the term “during the treatment”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited treatment. For the purposes of examination, the term “during the treatment” is deemed to claim “during the retinal heating”.
Claim 28 (line 3) recites the term “terminate the retinal heating or lower the treatment power”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited treatment power. For the purposes of examination, the term “terminate the retinal heating or lower the treatment power” is deemed to claim “terminate or reduce the retinal heating”.
Claim 28 (line 3) recites the term “if the change in kinetics deviates from the expectation”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited change in kinetics, nor an expectation. For the purposes of examination, the term “ if a change in kinetics parameter deviates from the extrapolation of how the ERG signaling kinetics should change during the treatment.”
Claim 29 (line 2) recites the term “the signal-to-noise ratio”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited signal-to-noise ratio. For the purposes of examination, the term “the signal-to-noise ratio” is deemed to claim “a signal-to-noise ratio”.
Claim 30 (lines 2 – 3) recites the term “retinal heating and the amplitude of a previously determined reference ERG response amplitude”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “amplitude”. It is unclear if this is intended to be the same or different than the previously-recited reference ERG response amplitude or the amplitude of the ERG signal during the retinal heating. For the purposes of examination, the term “retinal heating and the reference ERG response amplitude”.
Claim 31 (lines 1 – 2) recites the term “wherein the threshold amount of slowing in kinetics”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited slowing in kinetics. It is unclear if this is intended to be the same or different than the previously-recited predetermined threshold amount. For the purposes of examination, the term “wherein a threshold amount of slowing in kinetics”.
Claim 31 (line 3) recites the term “the relationship between kinetics and temperature”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited relationship. For the purposes of examination, the term “the relationship” is deemed to claim “a relationship between kinetics and temperature”.
Claim 32 (line 1) recites the term “the impedance between ERF electrodes”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited impedance. For the purposes of examination, the term “the impedance between ERF electrodes” is deemed to claim “an impedance between ERF electrodes”.
Claim 32 (line 2) recites the term “determine, as an indicator, the impedance between ERG electrodes”. It is unclear if this indicator is intended to be the same or different than the previously-recited “one or more indicators”. Further, there is insufficient antecedent basis for “the impedance” in the claim, as there is no previously-recited impedance. For the purposes of examination (and given the interpretation above), the term “determine, as an indicator, the impedance between ERG electrodes” is deemed to claim “determine, as an impedance indicator of the one or more indicators, an impedance between ERG electrodes.”
Claim 32 (line 3) recites the term “terminate or disable the initiation of retinal heating”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited initiation. For the purposes of examination, the term “terminate or disable the initiation of retinal heating” is deemed to claim “terminate or disable an initiation of retinal heating”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18 – 28, and 30 - 31 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et. al., (US 2020/0069463 A1) in view of Pitkänen et. al., (“A Novel Method for Mouse Retinal Temperature Determination Based on ERG Photoresponses”). Examiner notes that Chen incorporates Pitkänen into its disclosure by reference at [0040].
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Figure A: Examiner-annotated Chen Fig. 4A, overlaying amplitudes on the temperature tracings
Regarding Claim 18, Chen discloses An arrangement for providing retinal ERG stimulus and heating ([Abstract]; [0005] “heating”; [0040] “stimulus”), the arrangement comprising at least one processor ([Abstract] “processor”) and at least one light source for providing at least a stimulus beam ([0040] “stimulus such as light (e.g. from a light source such as a laser”) to induce an ERG signal from a target area of the retina ([0040] “ERG measures voltages (or biopotentials)…electrical signal generated by photoreceptors of a retina…”);
the arrangement additionally comprising a heating system (Fig 2B; [0038] “treatment beam…generated by a treatment source 102”, “to cause uniform tissue heating…”) for elevating the temperature of at least the target area ([0038] “cause tissue heating over a region defined by the large spot”), wherein the processor ([Abstract] “processor”) is configured
to receive a retinal ERG signal induced by the stimulus beam during retinal heating ([0040] “ERG measures voltages (or biopotentials)…electrical signal generated by photoreceptors of a retina…”), to determine, based on said ERG signal, one or more indicators being indicative of a temperature of the retina [0018] “fits on the initial ERG data and the first ERG data…wherein the line describes the relationship between retinal temperature and laser power values.”), and to control the heating system based on said one or more indicators ([0018] “generating a lookup table that correlates laser power values to ERG signal data or retinal temperatures.”; [0034] computer 109 may control treatment beam source 102… to deliver the treatment laser…with desired treatment parameters”; [0042]) said one or more indicators comprising at least an amplitude of the ERG signal (Fig 4A; [0040] “an a-wave 410 and a b-wave 420”, amplitude shown; [0040] incorporated by reference--Pitkänen: Figure 2B caption “…response recorded…kinetics and amplitude”)(Examiner notes that Pitkänen et. al., “A Novel Method for Mouse Retinal Temperature Determination Based on ERG Photoresponses” Figure 2B is the same as Chen’s Figure 4A, and has been incorporated by reference in Chen at [0040].) or a kinetics of the ERG signal ([0018]; Fig 4A kinetics of a-wave and b-wave shown for 440 and 430; [0040] incorporated by reference--Pitkänen: Figure 2B caption “…response recorded…shows accelerated kinetics”), wherein
the processor ([Abstract] “processor”) is additionally configured to terminate or reduce the retinal heating ([0018] “generating a lookup table that correlates laser power values to ERG signal data or retinal temperatures.”; [0042] “The processor may be used to control the power of the light source 510.”; [0045] “…adjusted”); a previously determined reference ERG response amplitude determined for the same retina ([0041] “pre-treatment measurements for a retina in a manner so as to address the deficiencies of the conventional titration techniques”; [0042] “prediction model…”)
Chen does not specifically disclose if the amplitude of the ERG signal during the retinal heating decreases below a predetermined threshold relative to a previously determined reference ERG response amplitude determined for the same retina or terminate or reduce the retinal heating if the kinetics of the ERG signal decelerates to a kinetics value that is slower than a previously determined kinetics determined for the same retina by over a predetermined threshold amount (Examiner notes that as recited in the alternative, the limitation after “or” is not necessary to be present in order for the metes and bounds of the claim to be satisfied.)
PItkänen teaches relationships between ERG signal kinetics (including amplitudes) and temperature, as measured in mice retinas, and it is incorporated by reference into Chen ([0040]). Specifically for Claim 18, Pitkänen teaches configured to terminate or reduce the retinal heating if the amplitude of the ERG signal during the retinal heating decreases below a predetermined threshold ([Page 2362 - 2363, “Experiment Protocol” Section] “Experiments were discontinued if the dim flash b-wave amplitude decreased below 15 µV at 37.0 °C or below 10 µV at any other temperature.”)(Examiner notes that discontinuing the experiment would terminate the retinal heating.) relative to a previously determined reference ERG response amplitude determined for the same retina [Page 2362 - 2363, “Experiment Protocol” Section] “To compensate for these changes, reference photoresponses at 37.0 °C were recorded every ~20 min…”).
Chen and Pitkänen both teach measuring amplitudes of ERG signals during retinal heating procedures, Chen shown in Figure A above, and Pitkänen in regard to recording reference photoresponses relative to the experiment value [Page 2363, “Experiment Protocol” Section]. Further, Chen incorporates Pitkänen by reference at [0040]. Pitkänen provides a motivation to combine at [Page 2363, “Experiment Protocol” Section, Left Column, Top] “ with “some deceleration of photoresponse kinetics and variation in photoreceptor sensitivity may take place over time, and the b-wave usually decreases in amplitude. To compensate for these changes, reference photoresponses at 37.0°C were recorded every ~20 min. Experiments were discontinued if the dim flash b-wave amplitude decreased below 15 µV at 37.0°C or below 10 µV at any other temperature.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that discontinuing the retinal heating when the deceleration of photoresponse kinetics are evident due to a decrease in b-wave amplitude would be useful for ensuring a proper treatment temperature within desired therapeutic kinematics bounds for a subject.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the retina heating and stimulus system with ERG-feedback measurements and electrodes disclosed in Chen with the threshold to discontinue heating based on a reduction in b-wave amplitude taught by Pitkänen, creating a single ERG-based retina heating and stimulus system that is configured to discontinue heating when the amplitude of the b-wave of the ERG signal decreases more than a threshold amount, ensuring a proper treatment temperature within desired therapeutic kinematics bounds for a subject.
Regarding Claim 19, Chen in view of Pitkänen discloses as described above The arrangement of claim 18. For the remainder of Claim 19, Chen discloses wherein the arrangement is configured to run a calibration protocol (Fig 9, [0049] “pre-treatment evaluation of an eye of a patient.”) and determine, as an indicator ([0018] “generating a lookup table…”), the temperature elevation per unit heating power for the target area of a fundus ([0018] “the line describes the relationship between retinal temperature and laser power values.“; “…C=Xβ+ε, where C is retinal temperature, X is a power value for the treatment laser, β is a regression coefficient, and c is an error term.“)(Examiner notes that the equation can be solved for temperature elevation per unit heating power), and use said indicator to control the heating system to provide a calibrated heating power to elevate the temperature of the retina ([All of 0042] “Prediction model….predict a power…The processor may be used to control the power of the light source 510.”).
14. Regarding Claim 20, Chen discloses as described above The arrangement of claim 19. For the remainder of Claim 20, Chen discloses wherein the processor ([Abstract] “processor”) is configured to:
a. initiate retinal stimulation by controlling the at least one light source to provide the stimulus beam ([0040] “stimulus such as light (e.g. from a light source such as a laser”; [0042] “processor may be used to control…light source 510”),
b. determine a first pre-heating reference ERG signal (Fig 9, Box 902 “Initial electroretinography (ERG) data)”; [0018] “initial ERG data”)
c. initiate retinal heating by controlling the heating system to provide retinal heating to a target area with a first power (Fig 9, “904: Delivering one or more first pulses of an optical beam”) and continue the retinal heating for a preset durations ([0031] “a series of short duration light pulses (e.g. between 5 – 30 microseconds, 10 – 30 microseconds, or 5 – 15 microseconds)”)
d. determine a first heating ERG signal (Fig 9, “906: Receiving first ERG data”; [0018] “the first ERG data”),
e. optionally repeat steps c - d with a second or subsequent laser power (Fig 6, “Set Higher Laser Power 635” and “Fire Laser 640”) to determine second or subsequent heating ERG signals (Fig 6, “Record ERG Signals”; [0047] “real-time ERG measurements may be taken and retinal temperatures may be determined…”; [0044])
f. terminate the retinal heating ([0047] “may even prevent operation of the treatment laser”),
g. optionally determine a first post-heating reference ERG signals ([0018] “the first ERG data”)
h. compare the first pre-heating ERG signals and/or first post-heating ERG signals to the heating ERG signals to determine the temperature elevation of the retinal tissue with the used heating power(s) ([0018] “fits on the initial ERG data and the first ERG data…wherein the line describes the relationship between retinal temperature and laser power values.”); and
i. utilize the determined temperature elevation(s) to determine the temperature increase(s) of the target area per unit of heating power (([0018] “the line describes the relationship between retinal temperature and laser power values.“; “…C=Xβ+ε, where C is retinal temperature, X is a power value for the treatment laser, β is a regression coefficient, and c is an error term.“)(Examiner again notes that the equation can be solved for retinal temperature elevation per unit heating power).
Regarding Claim 21, Chen in view of Pitkänen discloses as described above The arrangement of claim 20. For the remainder of Claim 21, Chen discloses wherein the processor ([Abstract] “processor”) is configured to repeat at least steps c-d with a predetermined set of heating powers (Fig 6, Box 620 “Lower Laser Power” and Box 635 “Higher Laser Power”), and based on the obtained plurality of temperature increases (Fig 6, Box 620 “Lower Laser Power” and Box 635 “Higher Laser Power”, [0047] “real-time ERG measurements may be taken and retinal temperatures may be determined…; [0044] “Although FIG. 6 illustrates only two
ERG measurements…any suitable number of ERG measurements are performed ( e.g., a series of ERG measurements performed sequentially with gradually increasing a power value of the laser).”), of the target area per unit of heating power ([0018] equation), determine, as an indicator, an aggregate temperature increase of the target area per unit of heating power ([0018] “the line describes the relationship between retinal temperature and laser power values.“; “…C=Xβ+ε, where C is retinal temperature, X is a power value for the treatment laser, β is a regression coefficient, and c is an error term.“)(Examiner notes that using the equation to go from the first power setting to the second (or third, etc.) power setting would yield a value for the change in total or aggregate temperature increase over the power settings from the initial state.)
Regarding Claim 22, Chen in view of Pitkänen discloses as described above The arrangement of claim 20. For the remainder of Claim 22, Chen discloses wherein ERG signal(s) obtained ([0049] “ERG data”; Fig 6, “630: Record ERG signals”) between a predetermined time after changing or initiating retinal heating ([0031] “thermal relaxation time delay”, “a series of short duration light pulses”; Fig 6, “625: Fire Laser”) and a subsequent termination or change in retinal heating (Fig 6, “635 Set Higher Laser Power” then “640 Fire Laser”; [0031] “a series of short duration light pulses”)(Examiner notes that the “630 Record ERG signals” occurs after there has been a predetermined time after changing or initiating the retinal heating, which are the thermal relaxation time delays in the light pulse, and before the retinal heating has been changed to its next power setting. Further, the stop and start of each individual pulse could broadly be deemed a termination and change in retinal heating, as it stops, then changes from that stop to a start again) are used as the heating ERG signals for temperature determination (Fig 9 “determining one or more optimal laser power values..”, [0018] equation…temperature; [0049] “one or more first pulses…first ERG data reflects measured ERG signal generated by retinal cells as a response to the first pulses”);
Regarding Claim 23, Chen in view of Pitkänen discloses as described above The arrangement of claim 20. For the remainder of Claim 23, Chen discloses wherein ERG signal(s) obtained immediately after the heating is initiated are used as the heating ERG signals (Fig 6; [0044] “ERG signal data may be recorded (e.g., during or immediately following the firing of the treatment laser in step 625”) for temperature determination to determine a rate of temperature increase in the target area of the retina ([0018] “linear representation”; Equation “C = Xβ + ε”)(Examiner notes that the equation can be used to determine the slope of the temperature relative to a light power, which would yield a rate of temperature increase) caused by the heating at the beginning of the heating procedure (Fig 6; “Step 625: Fire Laser”)
Regarding Claim 24, Chen in view of Pitkänen discloses as described above The arrangement of claim 18. For the remainder of Claim 24, Chen discloses wherein the heating is terminated ([0047] “…prevent operation of the treatment laser (e.g. by disabling a foot switch or other means of operating…”) or adjusted ([0047] “real-time ERG measurements…”); [0045] “laser-delivery element ( or subsets of the laser-delivery elements) may be controlled separately and adjusted…”) and/or a user of the arrangement is informed ([0047] “..an alarm notification”) if a value of the one or more indicators differs from an expected value ([0047] “upper limit”; [0035] “maximum temperature from 50 to 55 degrees C”)by over a threshold amount ([0047] “… as treatment is ongoing, real-time ERG measurements…taken and retinal temperatures…determined. ”,”feedback data from the ERG measurement system…retinal temperatures are within a threshold of the upper limit”; [0035] “maximum temperature…50 to 55 degrees C”; [0042] “…prediction model…a power that is necessary to increase a retinal temperature to a desired amount”; Fig 4A)(Examiner notes that the determined temperature, amplitude, or kinetics as indicators differ from the expected value at the “upper limit” of temperature if the temperature is not yet at, or lower than, the “upper limit” of temperature.)
Regarding Claim 25, Chen in view of Pitkänen discloses as described above The arrangement of claim 24. For the remainder of Claim 25, Chen discloses wherein a calibration protocol ([Abstract] “pre-treatment evaluation”) is used to determine a heating power that is expected to elevate the temperature of at least the target area to a target temperature or temperature elevation (Fig 6, “Laser-ERG Lookup Table”; [0042] “…prediction model…a power that is necessary to increase a retinal temperature to a desired amount”), and a kinetics parameter of the ERG signal is continuously determined ([0047] “real-time ERG measurements…retinal temperatures may be determined…and displayed…”; [0044] “The least-squares fit may be performed to generate, based on the measured ERG signal data, waveforms similar to the waveform depicted in FIG. 4B.” ; Fig 4A and 4B; [0040] incorporated by reference—Pitkänen: [[Page 2364, Right Column] and Fig 2 caption]: “temperature dependence of ERG photoresponse kinetics is illustrated in Figs. 2b and 2c.”)(Examiner notes that Fig 4A in Chen is Figure 2(b) in Pitkänen, which Chen incorporates by reference at [0040]. The caption in [Pitkänen: Fig 2(b)] as cited includes greater detail than that in Chen) during the retinal heating by providing the heating power based on said calibration protocol ([0018] “generating a lookup table that correlates laser power values to ERG signal data or retinal temperatures.”; [0042] “The processor may be used to control the power of the light source 510.”)) and a change in kinetics parameter of the ERG signal determined during the retinal heating ([0040] “the ERG waveforms 430…37.0 degrees C”; [0047] “…real-time ERG…retinal temperatures determined”; [0044] “generate…waveforms similar to…Fig 4B”; [0040] incorporated by reference—Pitkänen: [[Page 2364, Right Column] and Fig 2 caption]: “temperature dependence of ERG photoresponse kinetics”) is compared ([0040] the ERG waveforms 430 and 440 measured while at the two retinal temperatures (37.0 degrees C. and 40.7 degrees C., respectively) are consistently different…”) to an expected change in kinetics parameter based on a determined target temperature or temperature elevation ([0040] “ERG waveform…440…40.7 degrees C”, “; [0047] “…real-time ERG…retinal temperatures determined”; [0044] “generate…waveforms similar to…Fig 4B”; [0040] incorporated by reference—Pitkänen: [[Page 2364, Right Column] and Fig 2 caption]: “temperature dependence of ERG photoresponse kinetics”), and the heating is terminated ([0047] “may even prevent operation of the treatment laser”) or adjusted ([0018] “generating a lookup table that correlates laser power values to ERG signal data or retinal temperatures.”; [0042] “The processor may be used to control the power of the light source 510.”); [0045] “…adjusted”) if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount([0035] “…maximum temperature from 50 to 55 degrees C”; [0047] “…ensure that the retinal temperatures do not exceed an upper limit that would cause permanent damage…prevent operation of the treatment laser”, “ERG measurements may be taken and retinal temperatures may be determined ( e.g., using a lookup table…)”)(Examiner notes that the heating is terminated or discontinued if the measured kinetics appear to represent the pre-determined “upper limit” temperature range for eye safety, the 50 – 55 degrees C. The expectation is that the heating kinetics will not reach this zone, so readings within it that zone are over a predetermined amount) .
or
a user of the arrangement is informed ([0047] “real-time ERG measurements may be taken and retinal temperatures may be determined…and displayed to the operator”)(Examiner notes that the “operator” is the “user of the arrangement”) if the determined change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount ([0035] “…maximum temperature from 50 to 55 degrees C”; [0047] “…ensure that the retinal temperatures do not exceed an upper limit that would cause permanent damage…prevent operation of the treatment laser”, “ERG measurements may be taken and retinal temperatures may be determined ( e.g., using a lookup table…)”)(Examiner notes that the heating is terminated or discontinued if the measured kinetics appear to represent the pre-determined “upper limit” temperature range for eye safety, the 50 – 55 degrees C. The expectation is that the heating kinetics will not reach this zone, so readings within it that zone are over a predetermined amount) .
Regarding Claim 26, Chen in view of Pitkänen discloses as described above The arrangement of claim 25. For the remainder of Claim 26, Chen discloses wherein the threshold amount ([0035] “…maximum temperature from 50 to 55 degrees C”)(Examiner notes that the threshold amount is a window range of 5°C.) of the difference between expected ([0042] “prediction model…”; [0044] “generate…waveforms similar to…Fig 4B”; [0040] incorporated by reference—Pitkänen: [[Page 2364, Right Column] and Fig 2 caption]: “temperature dependence of ERG photoresponse kinetics”) and observed change in kinetics parameter ([0047] “…real-time ERG…retinal temperatures determined”; [0044] “generate…waveforms similar to…Fig 4B”; [0040] incorporated by reference—Pitkänen: [[Page 2364, Right Column] and Fig 2 caption]: “temperature dependence of ERG photoresponse kinetics”; [0035] “maximum temperature…”) corresponds to between 20C and 80C of temperature change ([0035] “in a range or up to a maximum temperature from 50 to 55 degrees C)(Examiner notes that this upper limit threshold amount is a range of 5°C of temperature change. The threshold range in which observed temperature-related kinetics parameters are flagged to correspond to the higher temperatures (a range of 5 degrees between 50 and 55°C), different than the expected safe range below 50°C.
Regarding Claim 27, Chen in view of Pitkänen discloses as described above The arrangement of claim 18. For the remainder of Claim 27, Chen discloses wherein the processor is configured to extrapolate a heating power that provides a predetermined temperature elevation at the target area or a predetermined absolute temperature at the target area (Fig 6, [0044] “creating a prediction model”; [0042] “…prediction model…a power that is necessary to increase a retinal temperature to a desired amount”) in cases where a body temperature is determined ([0044] “the retinal temperature may be a baseline temperature (e.g., 37 degrees C.).”)(Examiner notes that 37 degrees C is body temperature.).
Regarding Claim 28, Chen in view of Pitkänen discloses as described above The arrangement of claim 22. For the remainder of Claim 28, Chen discloses wherein the arrangement extrapolates how the ERG signaling kinetics should change during the treatment with higher laser power (Fig 6, [0044] “creating a prediction model”; Fig 2A and 2B, a-wave and b-wave kinetics; [0040] incorporated by reference--Pitkänen: Figure 2B caption “…response recorded…shows accelerated kinetics”; [0047] “real-time ERG measurements”) and is configured to terminate the retinal heating ([0047] “prevent operation of the treatment laser…”) or lower the treatment power ([0045] “controlled separately and adjusted…”; [0047] “treatment laser…limited to a maximum power value lime of 3W…”) if the change in kinetics deviates from the expectation over a predetermined amount ([0035] “…maximum temperature from 50 to 55 degrees C”; [0047] “…ensure that the retinal temperatures do not exceed an upper limit that would cause permanent damage…prevent operation of the treatment laser”, “ERG measurements may be taken and retinal temperatures may be determined ( e.g., using a lookup table…)”)(Examiner notes that the heating is terminated or discontinued if the measured kinetics appear to represent the pre-determined “upper limit” temperature range for eye safety, the 50 – 55 degrees C. The expectation is that the heating kinetics will not reach this zone, so readings within it that zone are over a predetermined amount) .
Regarding Claim 30, Chen in view of Pitkänen discloses as described above, The arrangement of claim 18.
For the remainder of Claim 30, Chen does not disclose wherein a threshold relative amplitude between the amplitude of the ERG signal determined during the retinal heating and the amplitude of a previously determined reference ERG response amplitude is between 0.4 and 0.9.
The applicant's specification provides no specific reasoning or critical functionality for the use of a threshold relative amplitude between 0.4 and 0.9 (between the amplitude of the ERG signal determined during the retinal heating and the amplitude of a previously determined reference ERG response amplitude), thus the claimed limitation is a design choice. Through routine experimentation using the measurement of a-wave and b-wave amplitudes as shown in Chen (Fig 4A), a person having ordinary skill in the art can alter the system values to find the threshold ratio for measured EMG amplitudes against a reference for the safest operating values. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the threshold relative amplitude between 0.4 and 0.9 as desired by the user as a matter of routine engineering design choice.
Regarding Claim 31, Chen in view of Pitkänen discloses as described above The arrangement of claim 18. For the remainder of Claim 31, Chen discloses wherein the relationship between kinetics and temperature is determined ([0018]; Fig 4A kinetics of a-wave and b-wave shown for 440 and 430; [0040] incorporated by reference--Pitkänen: Figure 2B caption “…response recorded at the higher temperature…shows accelerated kinetics”) in a predetermined therapeutic window of retinal temperature ([0035] “tissue at the target location may be heated in a range or up to a maximum temperature from 50 to 55 degrees C.”; Figure 4A: 37°C and 40.7°C, both lower than 50°C - 55°C)
Chen does not disclose wherein the threshold amount of slowing in kinetics is determined to correspond to a change of temperature between 0.50C to 40C, wherein the relationship between kinetics and temperature is determined based on a previously determined change in kinetics per one degree of temperature change.
PItkänen teaches relationships between ERG signal kinetics and temperature, as measured in mice retinas, and it is incorporated by reference into Chen ([0040]). Specifically for Claim 31, PItkänen teaches wherein the threshold amount of slowing in kinetics (Pitkänen Page 2367 Figure d)—Temperature determination error—the most errors in the determination error based on kinetics at 37.0°C was -1°C to +1.25°C) (Examiner notes that this is a 2.25°C threshold range for difference the kinetics, slow or fast for the expected temperature.) is determined to correspond to a change of temperature between 0.50C to 40C ((Page 2367 Figure 4d)—Temperature determination error—-1°C to +1.25°C)(Examiner notes that this range is a change due to error of up to 2.25°C, which is between 0.50C and 40C), wherein the relationship between kinetics and temperature is determined based on a previously determined change in kinetics per one degree of temperature change ([Table 1, Page 2365] “…the unit of the slope is relative feature value per degree of Celsius.”; Figure 2B caption “…response recorded at the higher temperature…shows accelerated kinetics”)
PItkänen provides a motivation to combine at [Page 2369, “Comparison to Previous Data” Section, Paragraph 1] with “The data by Kong et al. demonstrated an increase in time-to-peak of the b-wave of approximately 3% per 1°C decrease in body temperature within the temperature range of 35–37°C, which is close to the temperature dependence observed by us.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that in light of the changing kinetics in different temperature ranges, it would be important to put a threshold error to account for this change. For a system in which good ERG feedback data for temperature determination is critical to maintain safety, a person with ordinary skill in the art would also recognize that accounting for resultant temperature determination error (1°C to +1.25°C) to compensate for the observed kinetics differences, as taught by PItkänen, would be helpful to form the correlation between measurements at the ERG electrodes and possible retinal temperatures, allowing for a more safely operating heating device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the retina heating and stimulus system with ERG-feedback measurements and electrodes disclosed in Chen with the temperature determination error compensation range and kinetics changes taught by PItkänen, creating a single ERG-based retina heating and stimulus system that is configured to account for possible error in the correlation model between temperature and kinetics, enhancing treatment efficacy and user safety.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Chen view of Pitkänen et. al., (“A Novel Method for Mouse Retinal Temperature Determination Based on ERG Photoresponses”), further in view of Reinhard et. al, (“Step-By-Step Instructions for Retina Recordings with Perforated Multi Electrode Arrays”).
Regarding Claim 29, Chen in view of Pitkänen discloses as described above The arrangement of claim 18, wherein the processor is configured to determine. For the remainder of Claim 29, Chen discloses and terminate the retinal heating ([0047] “may even prevent operation of the treatment laser”)
Chen does not disclose determine the signal-to-noise ratio of the ERG signal and terminate the retinal heating if the signal- to-noise ratio is below a predetermined threshold value.
Reinhard teaches instructions for obtaining retina recordings of ERGs while accounting for poor signal-to-noise ratios due to poor contact between the electrodes and tissue. Specifically for Claim 29, Reinhard teaches wherein the processor is configured to determine, the signal-to-noise ratio of the ERG signal ([Page 7] Figure 6, “good signal-to-noise” measurements are shown) and terminate the if the signal- to-noise ratio is below a predetermined threshold value ([Page 10, 1st full paragraph] “Step 5: Check electrode contact…use visual inspection and check the signal-to-noise ratio”; Figure 6, examples of poor SNR in B and C “due to wet electronics” or “electronics not fully dry yet or…irreversibly harmed”; [Page 10, “c) Signal-to-noise ratio” section] “noise level should not exceed 20 µV…signal-to-noise ratio of at least 5”; [Page 12, Left Column, 4th full paragraph, “2. Noise observed on (almost) all electrodes: Required actions” section] “the recording should be stopped and the MEA amplifier should be removed immediately”)(Examiner notes that the electrode recording and MEA amplifier is the tool being used, and it is disabled per feedback from the SNR measurements.)
Both Chen and Reinhard incorporate functionality to their ERG devices to disable the tools (Chen’s ERG-based heater and Reinhard’s ERG electrode measurement and MEA amplifier) when feedback measurements are deemed outside of a threshold: Chen, [0047] “when retinal temperatures will exceed an upper limit” or if an operator tries to adjust the laser to higher than the threshold power, and Reinhard, when the SNR level of noise is too high, showing poor electrode connection (or wet system) for the ERG electrode. Reinhard provides a motivation to combine at [Page 10, Left Column, Paragraph 1] with “To check the contact of the retina with the electrodes, one can use visual inspection and check the signal-to-noise ratio.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that SNR would be a helpful secondary check for electrode contact to visual inspection. Furthermore, for a system in which good data from electrodes is critical to maintain safety, a person with ordinary skill in the art would also recognize that checking for high noise on the ERG electrodes, as taught by Reinhard, would be helpful to ensure that the ERG electrodes from which the temperature feedback signals originate have good connection, allowing for a more safely operating heating device. It would have been predictable to use the SNR check taught by Reinhard in any similar ERG electrode device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the retina heating and stimulus system with ERG-feedback measurements and electrodes disclosed in Chen with the SNR/noise check taught by Reinhard, creating a single ERG-based retina heating and stimulus system that is configured to operate only with proper electrode connection, enhancing user safety.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Pitkänen et. al., (“A Novel Method for Mouse Retinal Temperature Determination Based on ERG Photoresponses”), further in view of Toth et. al., (United States Patent Application Publication US 2017/0231490 A1).
Regarding Claim 32, Chen in view of Pitkänen discloses as described above The arrangement of claim 18. For the remainder of Claim 32, Chen discloses ERG electrodes ([0040] “one or more skin-mounted sensors (e.g., electrodes)”; “biopotentials”), and terminate or disable the initiation of retinal heating ([0047] including “may even prevent operation of the treatment laser”)
Chen does not disclose wherein the processor is configured to determine, as an indicator, the impedance between ERG electrodes based on said obtained ERG signal and terminate or disable the initiation of retinal heating if the impedance is above a predetermined threshold value.
Toth teaches a device to measure physiologic signals from a subject, including electroretinogram (ERG), with capability to check electrode impedance levels for proper connection. Specifically for Claim 32, Toth teaches determine, as an indicator, the impedance between ERG electrodes based on said obtained ERG signal ([0095] “electrodes arranged…so as to interface with the eye…to measure one or more of…electroretinogram (ERG)”, “bioimpedance”; [0183]) and terminate or disable the initiation ([0188] “determine whether such data should be trusted in the collected data stream or not…raising an alarm, alert, etc. if the quality of recording cannot be maintained in light of the issue.”; [0200] “If impedance levels are deemed outside acceptable ranges, the processor may opt not to monitor the subject during the monitoring session.”)(Examiner notes that the ERG measurement electrodes are the tool being used, and it is disabled per feedback from the impedance measurements.) if the impedance is above a predetermined threshold value ([0188] “determination of high electrode impedance, etc.)”).
Both Chen and Toth incorporate functionality to their ERG devices to disable the tools (Chen’s ERG-based heater and Toth’s ERG measurement electrodes and reporting device) when feedback measurements are deemed outside of a threshold: Chen, [0047] “when retinal temperatures will exceed an upper limit” or if an operator tries to adjust the laser to higher than the threshold power, and Toth, when the impedance level is too high, showing poor electrode connection for the ERG electrode. Toth provides a motivation to combine at [0188] with “…to determine whether such data should be trusted in the collected data stream or not”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that checking the impedance of the electrodes during the measurement of interest would indicate if there is good connection and if the associated measurements are reliable. For a system in which good data from electrodes is critical to maintain safety, a person with ordinary skill in the art would also recognize that checking for high impedance on the ERG electrodes, as taught by Toth, would be helpful to ensure that the ERG electrodes from which the temperature feedback signals originate have good connection, allowing for a more safely operating heating device. It would have been predictable to use the impedance check taught by Toth in any similar ERG electrode device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the retina heating and stimulus system with ERG-feedback measurements and electrodes disclosed in Chen with the high-impedance check taught by Toth, creating a single ERG-based retina heating and stimulus system that is configured to operate only with proper electrode connection, enhancing user safety.
Response to Arguments
Applicant's arguments filed 18 May 2026 have been fully considered but they are not persuasive to overcome the 35 U.S.C. 103 Rejections.
Regarding 35 U.S.C. 101 Rejections:
Based on the amendments to the claims, such that the limitations involve applying the judicial exception abstract ideas recited in the claims to the practical application of informing the arrangement’s physical action to terminate or reduce the retinal heating, the 35 U.S.C. 101 rejections are withdrawn.
Regarding 35 U.S.C. 102 Rejections:
Based on the applicant’s arguments and amendments to Claim 18, the rejections under 35 U.S.C. 102 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chen in view of Pitkänen.
Regarding 35 U.S.C. 103 Rejections:
Applicant argues at [Page 8, “II. Rejections Under 35 U.S.C. 103” Section, 1st Paragraph] and [Page 9, Top] that Claims 29 – 32 are variously rejected over combination of Chen, Pitkänen, Toth, and Reinhard, but since none of the applied references remedy the deficiencies of Chen, Claim 18 is allowable and also Claims 29 – 32. Based on the 35 U.S.C. 103 rejection and the discussion above, Chen in view of Pitkänen discloses the elements of claim 18. The argument is not persuasive.
Applicant argues at [Page 8, “II. Rejections Under 35 U.S.C. 103” Section, 2nd Paragraph] that regarding Claim 30’s rejection, the criticality of the amplitude is explained at paragraph [0029], and that the other features of the claims are not disclosed by Chen. The specification states at [0029] that “the threshold relative amplitude between the amplitude of the ERG signal determined during the retinal heating and the amplitude of a previously determined reference ERG response amplitude may for instance be between 0.4 and 0.9, advantageously between 0.5 and 0.7.“ There is no particular reason given in [0029] for why these values are chosen or why a subset of them is “advantageous”. As such, through routine experimentation using the measurement of a-wave and b-wave amplitudes as shown in Chen (Fig 4A), a person having ordinary skill in the art can alter the system values to find the threshold ratio for measured EMG amplitudes against a reference for the safest operating values that could be between 0.4 and 0.9. The argument is not persuasive.
Applicant argues at [Page 8, “II. Rejections Under 35 U.S.C. 103” Section, 3rd Paragraph] that Pitkänen fails to disclose the subject matter of claims 31 and 19 for the same reason as Chen because the disclosure relied on in Chen is incorporated by reference from Pitkänen. Based on the newly-applied 35 U.S.C. 103 rejection and the discussion above, Chen in view of Pitkänen discloses the elements of claim 18. The argument is not persuasive.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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