DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed 10 NOVEMBER 2025 have been entered. Claims 18 – 32 are pending. Applicant’s amendments to the claims have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 11 AUGUST 2025.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding the term “the kinetics” in line 10. For readability, it is suggested to revise the term to “a kinetics of the ERG signal”
Regarding the term “the kinetics” in each line 14 and line 19 : for readability and consistency throughout the claim, it is suggested to revise the terms to be “the kinetics of the ERG signal”.
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 recites the term “a predetermined threshold relative to a previously determined reference ERG response amplitude” in lines 17 – 18. It is unclear if this predetermined threshold and previously determined reference ERG response amplitude are intended to be the same or different than the previously-recited predetermined threshold and previously determined reference ERG response amplitude. For the purposes of examination, the term “a predetermined threshold relative to a previously determined reference ERG response amplitude” is deemed to claim “the predetermined threshold relative to the previously determined reference ERG response amplitude”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 18 recites the term “a kinetics value that is slower than a previously determined kinetics” in lines 19 - 20. It is unclear if the kinetics value and “previously determined kinetics” are supposed to be the same or different than each the previously-recited “kinetics value” and “previously determined kinetics”. For the purpose of examination, the term “a kinetics value that is slower than a previously determined kinetics” is deemed to claim “the kinetics value that is slower than the previously determined kinetics”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim 18 recites the term “over a predetermined threshold amount” in line 20. 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 “over a predetermined threshold amount” is deemed to claim “over the predetermined threshold amount”. Claims 19 – 32 are similarly rejected due to their dependence on Claim 18.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18 – 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 18, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 18 – 32 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 18 – 32 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 18 – 32 recites an abstract idea.
Specifically, Independent Claim 18 recites (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 18
An arrangement for providing retinal ERG stimulus and heating, the arrangement comprising at least one processor and at least one light source for providing at least a stimulus beam to induce an ERG signal from a target area of the retina;
the arrangement additionally comprising a heating system for elevating the temperature of at least the target area, wherein the processor is configured
to receive a retinal ERG signal induced by the stimulus beam during retinal heating, to determine, based on said ERG signal, one or more indicators being indicative of a temperature of the retina, and to control the heating system based on said one or more indicators, said one or more indicators comprising at least an amplitude of the ERG signal and/or the kinetics of the ERG signal, wherein
the processor is additionally configured to terminate or adjust the retinal heating if the amplitude of the ERG signal during the retinal heating falls below a predetermined threshold relative to a previously determined reference ERG response amplitude
or terminate or adjust the retinal heating if the kinetics decelerates to a kinetics value that is slower than a previously determined kinetics by over a predetermined threshold amount,
or inform a user of the arrangement if the amplitude of the ERG signal during the retinal heating falls below a predetermined threshold relative to a previously determined reference ERG response amplitude,
or inform a user of the arrangement if the kinetics decelerates to a kinetics value that is slower than a previously determined kinetics by over a predetermined threshold amount.
Note that adjusting the retinal heating would not be considered a mental process, but given limitations with the optionality with “informing”, the claim does not necessarily require any adjustment of retinal heating and can just require “informing”, which would be a mental process.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claim 18 these limitations include:
Observation and judgment of a retinal ERG signal induced by the stimulus beam during retinal heating,
Observation and judgment to evaluate, based on observation and judgment of said ERG signal, one or more indicators being indicative of a temperature of the retina
Observation and judgment to control the heating system based on said indicatory said indicator comprising at least an amplitude of the ERG signal and/or the kinetics of the ERG signal
Observation and judgment to communicate to a user of the arrangement if the amplitude of the ERG signal during the retinal heating falls below a predetermined threshold relative to a previously determined reference ERG response amplitude
Observation and judgment to communicate to a user of the arrangement if the kinetics decelerates to a kinetics value that is slower than a previously determined kinetics by over a predetermined threshold amount
As noted above, “adjusting” the retinal heating would not be considered a mental process, but given the optionality with “informing”, the claim does not require any adjustment of retinal heating and can just require “informing”, which would be a mental process.
Similarly, Dependent Claims 19 - 32 include the following abstract limitations, in addition the aforementioned limitations in Independent Claim 18 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
run a calibration protocol
Observation and judgment to run a calibration protocol
determine, as an indicator, the temperature elevation per unit heating power for the target area of a fundus
Observation and judgment to evaluate, as an indicator, the temperature elevation per unit heating power for the target area of a fundus
use said indicator to control the heating system to provide a calibrated heating power to elevate the temperature of the retina.
Observation and judgment of said indicator to control the heating system to provide a calibrated heating power to elevate the temperature of the retina
initiate retinal stimulation by controlling the at least one light source to provide the stimulus beam,
Observation and judgment to initiate retinal stimulation by controlling the at least one light source to provide the stimulus beam
determine a first pre-heating reference ERG signal,
Observation and judgment of a first pre-heating and first heating reference ERG signal,
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 durations
Observation and judgment to 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 durations
optionally repeat steps c - d with a second or subsequent laser power to determine second or subsequent heating ERG signals,
Observation and judgment to optionally repeat steps c - d with a second or subsequent laser power to observe and judge second or subsequent heating ERG signals,
optionally determine a first post-heating reference ERG signals
Observation and judgment to optionally determine a first post-heating reference ERG signals
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)
Observation and judgment to compare the first pre-heating ERG signals and/or first post-heating ERG signals to the heating ERG signals to observe and judge the temperature elevation of the retinal tissue with the used heating power(s)
utilize the determined temperature elevation(s) to determine the temperature increase(s) of the target area per unit of heating power.
Observation and judgment of the determined temperature elevation(s) to evaluate the temperature increase(s) of the target area per unit of heating power
repeat at least steps c-d with a predetermined set of heating powers
Observation and judgment to repeat at least steps c-d with a predetermined set of heating powers
based on the obtained plurality of temperature increases of the target area per unit of heating power, determine, as an indicator, an aggregate temperature increase of the target area per unit of heating power.
based on the obtained plurality of temperature increases of the target area per unit of heating power, observation and judgment to evaluate, as an indicator, an aggregate temperature increase of the target area per unit of heating power.
ERG signal(s) obtained between a predetermined time after changing or initiating retinal heating and a subsequent termination or change in retinal heating are used as the heating ERG signals for temperature determination
ERG signal(s) observed and judged between a predetermined time after changing or initiating retinal heating and a subsequent termination or change in retinal heating are used as the heating ERG signals for temperature determination
determine a rate of temperature increase in the target area of the retina caused by the heating at the beginning of the heating procedure
Observation and judgment of a rate of temperature increase in the target area of the retina caused by the heating at the beginning of the heating procedure
or a user of the arrangement is informed if a value of the one or more indicators differs from an expected value by over a threshold amount.
Observation and judgment such that a user of the arrangement is informed if a value of the one or more indicators is observed of judged to differ from an expected value by over a threshold amount.
Again noting that “adjusting” the retinal heating would not be considered a mental process, but given the optionality with “informing”, the claim does not require any adjustment of retinal heating and can just require “informing”, which would be a mental process.
a calibration protocol 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,
Observation and judgment of calibration protocol 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,
a kinetics parameter of the ERG signal is essentially continuously determined during the retinal heating by providing the heating power based on said calibration protocol
a kinetics parameter of the ERG signal is essentially continuously evaluated during the retinal heating by providing the heating power based on said calibration protocol
a change in kinetics parameter of the ERG signal determined during the retinal heating is compared to an expected change in kinetics parameter based on a determined target temperature or temperature elevation, and/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.
a change in kinetics parameter of the ERG signal determined during the retinal heating is comparatively observed and judged to an expected change in kinetics parameter based on a determined target temperature or temperature elevation, and/or a user of the arrangement is informed if the observed and judged change in kinetics parameter differs from the expected change in kinetics parameter by over a threshold amount.
As noted above, “adjusting” the retinal heating would not be considered a mental process, but given the optionality with “informing”, the claim does not require any adjustment of retinal heating and can just require “informing”, which would be a mental process.
extrapolate a heating power that provides a predetermined temperature elevation at the target area or a predetermined absolute temperature at the target area in cases where a body temperature is determined.
Observation and judgment to evaluate a heating power that provides a predetermined temperature elevation at the target area or a predetermined absolute temperature at the target area in cases where a body temperature is determined.
wherein the arrangement extrapolates how the ERG signaling kinetics should change during the treatment with higher laser power
Observation and judgment to evaluate how the ERG signaling kinetics should change during the treatment with higher laser power
terminate the retinal heating if the change in kinetics differs from the expected change in kinetics parameter by over a predetermined amount.
Observation and judgment to discontinue the retinal heating if the change in kinetics are observed or judged to differ from the expected change in kinetics parameter by over a predetermined amount.
Similarly to the “adjusting the heating” noted above, “lowering the treatment power” would not be considered a mental process, but given the optionality with “terminating”, the claim does not require any “lowering the treatment power” and can just require ending the data collection per observation or judgment of a change in kinetics, which would be a mental process.
determine, the signal-to-noise ratio of the ERG signal
Observation and judgment to evaluate the signal-to-noise ratio of the ERG signal
terminate the retinal heating if the signal- to-noise ratio is below a predetermined threshold value.
Observation and judgment to end the retinal heating if observation and judgment of the signal- to-noise ratio is below a predetermined threshold value.
the threshold amount of slowing in kinetics is determined to correspond to a change of temperature between 0.50C to 40C
the threshold amount of slowing in kinetics is observed and judged to correspond to a change of temperature between 0.50C to 40C
the relationship between kinetics and temperature is determined based on a previously determined change in kinetics per one degree of temperature change in a predetermined therapeutic window of retinal temperature.
the relationship between kinetics and temperature is observed and judged based on a previously observed and judged change in kinetics per one degree of temperature change in a predetermined therapeutic window of retinal temperature.
determine, as an indicator, the impedance between ERG electrodes based on said obtained ERG signal
Observation and judgment to evaluate, as an indicator, the impedance between ERG electrodes based on said obtained ERG signal
terminate or disable the initiation of retinal heating if the impedance is above a predetermined threshold value.
Observation and judgment to terminate or disable the initiation of retinal heating if observation and judgment of the impedance is above a predetermined threshold value.
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claim 18 (and its Dependent Claims 19 – 32) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 18 - 32), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“at least one processor”, “processor”
“at least one light source”
“heating system”
Additional elements recited include “at least one processor”, “at least one light source”, and “heating system” in Independent Claim 18 (and its Dependent Claims 19 – 32). These components are recited at a high level of generality, i.e., as a generic processor performing a generic function of processing data (the receiving, determining, controlling, and terminating); a light source performing the generic function of providing a light beam (the providing at least a stimulus beam); and a heating system performing a generic function of heating (the elevating the temperature). These generic hardware component limitations for “at least one processor”, “at least one light source”, and “heating system” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claim 1 includes extra-solution activity limitations, such as:
the arrangement comprising at least one processor and at least one light source for providing at least a stimulus beam to induce an ERG signal from a target area of the retina;
the arrangement additionally comprising a heating system for elevating the temperature of at least the target area, wherein the processor is configured
the processor is additionally configured to terminate [the retinal heating]
In addition the aforementioned extra-solution activity limitations in Independent Claim 25, additional extra-solution activity limitations recited in Dependent Claims 19 - 32 include:
ERG signal(s) obtained between a predetermined time after changing or initiating retinal heating and a subsequent termination or change in retinal heating are used as the heating ERG signals for temperature determination.
wherein ERG signal(s) obtained essentially immediately after the heating is initiated are used as the heating ERG signals for temperature determination
the threshold amount of the difference between expected and observed change in kinetics parameter corresponds to between 20C and 80C of temperature change.
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.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “at least one processor”, “at least one light source”, and “heating system” as recited in Independent Claim 18 (and its Dependent Claims 19 – 32) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claim 18 (and its Dependent Claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claim 18 (and its Dependent Claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claim 18 (and its Dependent Claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 18 - 32 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “at least one processor”, “at least one light source”, and “heating system” as recited in Independent Claim 18 (and its Dependent Claims).
The additional elements of the “at least one processor”, “at least one light source”, and “heating system” in Independent Claim 18 (and its Dependent Claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “processor” and “at least one processor” is described in terms of the steps of functions that it performs, including on [Page 2, Paragraph 1], [Page 2, Paragraph 4, a - i], [Page 4m Paragraph 1], and [Page 5, full page]. It is shown as generic computer desktop tower icon, “processor 102” in Figure 2.
Per Applicant’s specification, the “at least one light source” is described generically on [Page 9, 2nd and 3rd Full Paragraphs] as “a light-emitting diode configured to provide a stimulus beam having wavelength of 500 – 600 nm”. The “at least one light source” is shown as “LED2” and ”LED3” in Figure 1.
Per Applicant’s specification, the “heating system” is described at [Page 11, 2nd full paragraph] “A heating system comprises at least a heat source, such as heating laser LF “blood pressure measurement accessory 502 and sensor accessory 611,” and [Page 11, 5th full paragraph] “Also other heating systems or means for heating may be utilized in connection with devices that are associated with retinal heating” including ultrasound. The “heating system” is shown as element “LF” in Figures 1 and 2.
Accordingly, in light of Applicant’s specification, the claimed terms “at least one processor”, “at least one light source”, and “heating system” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “at least one processor”, “at least one light source”, and “heating system”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in independent Claim 18 (and its dependent claims) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claims 18 - 32 is directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 18 - 32 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in independent Claim 18 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 18 - 32 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 18 - 32 amounts to significantly more than the abstract idea itself. Accordingly, Claims 18 - 32 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18 – 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et. al., US 2020/0069463 A1), hereinafter Chen.
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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 the 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 adjust 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”) if the amplitude of the ERG signal during the retinal heating falls below a predetermined threshold ([0047] “…real-time ERG measurements…displayed”; [0042] “…prediction model…a power that is necessary to increase a retinal temperature to a desired amount”; Fig 4A)(Examiner notes that the amplitude is below a predetermined threshold if the temperature is not yet at, or lower than, the “desired amount” of target temperature. Therefore the adjustment would be to increase the retinal heating in order to increase the retinal temperature to closer to the predetermined threshold, such as 40.7°C. As shown in Figure A: Examiner-annotated Chen Fig. 4A, the amplitude of the 37.0°C wave falls below, or exists below the amplitude of the 40.7°C wave.) relative to a previously determined reference ERG response amplitude ([0041] “pre-treatment measurements for a retina in a manner so as to address the deficiencies of the conventional titration techniques”; [0042] “prediction model…”)
or
terminate or adjust the retinal heating if the kinetics decelerates to a kinetics value that is slower than a previously determined kinetics by over a predetermined threshold amount (Examiner notes that as recited in the alternative, this limitation is not necessary to be present in order for the metes and bounds of the claim to be satisfied.)
or
inform a user of the arrangement if the amplitude of the ERG signal during the retinal heating falls below a predetermined threshold relative to a previously determined reference ERG response amplitude (Examiner notes that as recited in the alternative, this limitation is not necessary to be present in order for the metes and bounds of the claim to be satisfied.)
or
inform a user of the arrangement if the kinetics decelerates to a kinetics value that is slower than a previously determined kinetics by over a predetermined threshold amount.(Examiner notes that as recited in the alternative, this limitation is not necessary to be present in order for the metes and bounds of the claim to be satisfied.)
Regarding Claim 19, Chen 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 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 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 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 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 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 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 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 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) .
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.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Reinhard et. al, “Step-By-Step Instructions for Retina Recordings with Perforated Multi Electrode Arrays”, hereinafter Reinhard.
Regarding Claim 29, Chen 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 30 is rejected under 35 U.S.C. 103 as being unpatentable over Chen.
Regarding Claim 30, Chen 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 specifical 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.
Claim 31 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”, hereinafter Pitkänen. Examiner notes that Chen incorporates Pitkänen into its disclosure by reference at [0040].
Regarding Claim 31, Chen 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 32 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Toth et. al., (United States Patent Application Publication US 2017/0231490 A1), hereinafter Toth.
Regarding Claim 32, Chen 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 10 NOVEMBER 2025 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 101 Rejections:
Applicant argues at [Page 10, Paragraphs 1 - 2] that the claims implement the judicial exception with a particular machine or manufacture that is integral to the claim and are directed to a system “for providing retinal ERG stimulus and heating” with a processor configured to determine overtreatment by the ERG signal by providing a particular prophylaxis. However, the limitations of “terminate or adjust” are recited in alternative in Claim 18, such that they are not necessarily present when the metes and bounds of the claim are met. Therefore, there remains a condition such that the system is not physically providing “a particular prophylaxis” by adjusting or terminating the heating. Rather, in the condition that only an “inform” limitation is present, then the recipient of the information is under no requirement to do anything with this information, particularly regarding the machine settings or heating. Rather, it is merely displaying information that can be routinely observed by a human from a graph. Similarly, a human could observe the output of the machine and inform another user (or themself in a notebook entry) about what they have observed and judged. From MPEP § 2106.04(d)(2): If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient. The argument is not persuasive.
Applicant argues at [Page 10, Paragraph 3] that looking to 2019 Subject Matter Eligibility Guidance Example 42, a system for transmitting medical notifications can be patent eligible when it performs “a specific improvement over prior art systems”. Applicant argues that the specific improvement to retinal heating systems is that they are enabled to prevent overtreatment. It is noted that there is nothing particularly recited in the claims that indicates informing the user will prevent overtreatment. In one condition, the amplitude falls below a threshold, which would potentially encourage the user to increase the temperature to meet a higher temperature retinal heating specification. The term falls below can colloquially, broadly indicated that the value that is recorded is lower than a threshold, not necessarily that the magnitude has actively decreased or reduced. Further, there is no particular action that is suggested by inform the user of the arrangement if …by over a threshold amount. This information could be a Boolean “yes” or “no”, and the user could choose to do nothing with the information.
Looking to the example 42, Claim 1, the claims describe a database that recites a combination of additional elements including storing information, providing remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message, etc. It is not the broad idea of informing a user of something that makes Example 42’s subject matter eligible. Rather, the additional elements recite a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user. The argument is not persuasive.
Applicant argues at [Page 10, Paragraph 2] that claims that improve the functionality of a particular conventional system are eligible per Finjan Inc. v. Blue Coat Systems; MPEP 2106. 04(c ). MPEP 2106. 04(c ) refers to “The Markedly Different Characteristics Analysis” that courts used to identify product of nature exceptions. It does not appear that Applicant’s amended claim limitations recite an analogous limitation that requires differentiation from nature in the way that bio-engineered sheep would be differentiated from any sheep found in nature. Regarding Finjan Inc. v. Blue Coat Systems of 2106.04(d)(1), the claim was directed to “behavioral-based” virus scanning rather that traditional “code-matching” virus scanning, which improves the functionality of the computer itself. It does not appear that Applicant’s amended claims necessarily demonstrate an improvement to the computer itself, particularly with the limitations in alternative. The inform limitations use the processor to present information based on a processed result, which is an ordinary function that does not improve the functionality or efficiency of the processor. The argument is not persuasive.
Applicant argues at [Page 11, Paragraphs 1 and 2] that the amended claims improve the functioning of the claimed systems for retinal heating because they prevent overtreatment of the retina and improve the safety of such procedures by detecting decreasing kinetics, rather than recognizing that increased kinetics corresponded to more treatment. The amended limitations of Claim 18 are presented in the alternative, and the amplitude-associated limitations do not positively recite amplitudes actually decreasing. Rather, the amplitude broadly falls below a predetermined threshold, which would broadly include being below a required heating threshold (requiring more heat). The limitations describing the deceleration of kinetics value are recited in the alternative and not required for the metes and bounds of the claim to be met. The argument is not persuasive.
Applicant argues that examples of improved user interfaces in MPEP 2106.05(a)(I) x. and MPEP 2106.05(a)(II) vii. are analogous claims. Looking to example x, the interface displays an application summary of unlaunched application, where the particular data in the summary is selectable by the user to launch the respective application. There is no user interface positively recited in the instant claims. Further, the optional inform limitations do not recite any potential action that the user may take with the information (as with launching an application).
Further, looking to the Thales Visionix Opinion, [Thales: Page 3, 2nd Full Paragraph], “The inertial sensors disclosed in the ‘159 patent do not use the conventional approach of measuring inertial changes with respect to the earth.” As such, the measurement abilities of the sensors themselves are being improved by being used in an unconventional way. The recited hardware in the instant claims are the generically recited processor, light source, and heating system. There are no recited sensors. There is nothing recited in the claims that indicates that “determined” signals are anything more than conventional data-gathering from a well-understood, routine, and conventional processor. The use of a generic processor in the instant claims to do a routine function of processing data and presenting a result is also insufficient to add inventive concepts to an abstract idea. The argument is not persuasive.
Regarding 35 U.S.C. 102 and 103 Rejections:
Applicant argues at [Page 6, “II. Rejections Under 35 U.S.C. 102 and 103” Section] and [Page 7, Paragraph 1] – [Page 9, Top] that the rejections are traversed because the prior art of Chen, Pitkanen, and Reinhard do not disclose a system where “if the kinetics decelerates to a kinetics value that is slower than a previously determined kinetics by over a predetermined threshold amount” as recited in Applicant’s amended claim 18. While this amended limitation clarifies the scope of the kinetics value relationship, the limitation is recited in the alternative in Claim 18. It is therefore not necessary to be met for the overall metes and bounds of the claim to be satisfied. The argument is not persuasive.
Applicant argues at [Page 7, All] – [Page 9, Top] that the prior art does not disclose a higher temperature where the ERP amplitude drops. s recited in the claim, it is not positively specified that the heating actually reaches a higher temperature within a session, and that the retina signal at the higher temperature demonstrates an amplitude that “drops” or “falls”. Rather, as recited, the claim broadly reads on the concept that a calibration measurement could occur that heats a retina to a temperature (such at the 40.7 °C of Chen Fig 4A), and a amplitude threshold is set for that temperature reading. Then at a later date, a retina is heated to 37.0°C and demonstrates the smaller amplitude of the shown in Chen Fig. 4A, which broadly “falls below”, or colloquially is data that is the current amplitude below the expectation of a higher threshold limit that could be reached by heating to a higher temperature. Therefore, the heating is adjusted to reach a higher temperature closer to a potentially desired higher heating amount. It is not specified that the amplitudes are from the same retina or heating session. Further, it is not specified that the amplitude has actively decreased during a session in a way that would demonstrate the Applicant’s described intended kinetics deceleration and amplitude reduction within the arguments. The argument is not persuasive.
Applicant argues at [Page 9, “Rejections under 35 U.S.C. 103” Section, Paragraphs 1 - 4] that combinations of Chen, Pitkanen, Toth, and Reinhard do not disclose the subject matter of claim 18 for the same reason as Chen alone. Based on the discussion above, Chen alone does disclose the limitations of Claim 18 as currently amended. The argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791