DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 12/27/2023. Claims 1-20 are pending and examined below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In claim 1, “means for obtaining an electrical response signal from the target area” is electrodes as described in paragraph [0061] in the PGPub US 20240382139 A1.
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 2, 7, 10, 15, and 18, and claims dependent thereof, 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.
Regarding claim 2, the claim recites “herein the device additionally comprises a heating system, optionally a heating laser, that is configured to elevate the temperature of the target area”. The phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 7, the claim recites “wherein the intervals and/or durations are between 10 and 200 ms, advantageously between 20 and 70 milliseconds”. The phrase "advantageously" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 10, the claim recites “wherein the longest interval and/or duration is 10 to 150%, advantageously 40 to 100%, longer than the shortest interval and/or duration”. The phrase "advantageously" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 15, the claim recites “wherein the device additionally comprises a heating system, optionally a heating laser, that is configured to elevate the temperature of the target area, wherein the processor is further configured to additionally determine at least one parameter indicative of a change in temperature of the retinal tissue based on determined ERG responses”. The phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 18, the claim recites “wherein the method comprises determining a temperature elevation of the retina per unit of heating power and optionally controlling a heating power used for retinal heating based on the determined temperature elevation of the retina per unit of heating power”. The phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020240092 A1 (cited in IDS; hereinafter referred to as “Kaikkonen”).
Regarding claim 1, Kaikkonen, a method and device for determining changes in retinal and/or brain temperature, teaches a device (100/150; page 15, lines 12 to page 16, line 2; Figure 3) for obtaining retinal ERG signals from a target area of the retina (page 15, line 26-30),
the device comprising means for obtaining an electrical response signal from the target area (114, 115 ERG electrodes; page 15, line 24 to page 16, line 2; Figure 3),
the device additionally comprising at least one light source (106, 107; page 15, lines 12-26; Figure 3) configured to provide a stimulus beam towards the target area (106a, 107a; page 15, lines 12-26; Figure 3), wherein the stimulus beam is modulated to provide a plurality of single pulses of light, where consecutive single pulses are separated by predetermined intervals of which at least a portion differ from each other (claim 3) and/or wherein at least a portion of the single pulses of light comprise predetermined durations of which at least a portion differ from each other.
Regarding claim 2, Kaikkonen teaches wherein the device additionally comprises a heating system, optionally a heating laser, that is configured to elevate the temperature of the target area (“The method can be used, for example, to monitor temperature changes in the retinal pigment epithelium and the retina during temperature change, e.g. heating treatment, by near-infrared radiation directed to the eye from e.g. lasers or light emitting diodes“; page 10, lines 19-25; “105 used for heating a retinal tissue inside an eye”; page 15, lines 12-26; Figure 3).
Regarding claim 3, Kaikkonen teaches wherein the intervals and/or durations are selected to provide an ERG signal exhibiting selected overlap of electrical responses that are related to consecutive single pulses (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 4, Kaikkonen teaches wherein the selected overlap comprises overlap of consecutive electrical responses in essentially different phases (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 5, Kaikkonen teaches wherein the selected overlap provides a selected waveform for a determined ERG response obtained from an ERG signal comprising a plurality of overlapped electrical responses through an averaging method, such as cross-correlation between the ERG signal and a stimulus series used to modulate the stimulus beam (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 6, Kaikkonen teaches wherein the selected waveform essentially corresponds to the electrical responses or differs from them by under a threshold amount or wherein the selected waveform essentially corresponds to an obtained reference ERG response or differs from said reference ERG by under a threshold amount (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 7, Kaikkonen teaches wherein the intervals and/or durations are between 10 and 200 ms, advantageously between 20 and 70 milliseconds (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 8, Kaikkonen teaches wherein the intervals and/or durations are selected such that minimized or reduced signal contribution is provided at or near a mains frequency, such as 50 or 60 Hz, and/or its harmonic frequencies in the frequency band where the ERG signal has spectral content (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 9, Kaikkonen teaches wherein the intervals and/or durations and/or an order of the single pulses and associated intervals and/or durations are selected to provide a stimulation pulse train with broad spectral content (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 10, Kaikkonen teaches wherein the longest interval and/or duration is 10 to 150%, advantageously 40 to 100%, longer than the shortest interval and/or duration (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 11, Kaikkonen teaches wherein the intervals and/or durations are approximately evenly spaced between the shortest and the longest interval and/or duration (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 12, Kaikkonen teaches wherein a first set of single pulses of light is provided and an ordering of the single pulses and respective intervals and/or durations is varied at least once to provide at least a second set of single pulses, further wherein said at least second set of single pulses is provided following said first set of single pulses to provide at least one extended set of single pulses of light (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 13, Kaikkonen teaches wherein the single pulses are impulse-like pulses of light or wherein the single pulses are non-impulse-like pulses of light (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3).
Regarding claim 14, Kaikkonen teaches the arrangement comprising the device of claim 1 and at least one processor, the processor being configured to determine a denoised ERG response from an obtained ERG signal comprising overlapping ERG responses (page 19, lines 16-25).
Regarding claim 15, Kaikkonen teaches wherein the device additionally comprises a heating system, optionally a heating laser, that is configured to elevate the temperature of the target area, wherein the processor is further configured to additionally determine at least one parameter indicative of a change in temperature of the retinal tissue based on determined ERG responses (“The method can be used, for example, to monitor temperature changes in the retinal pigment epithelium and the retina during temperature change, e.g. heating treatment, by near-infrared radiation directed to the eye from e.g. lasers or light emitting diodes“; page 10, lines 19-25; “105 used for heating a retinal tissue inside an eye”; page 15, lines 12-26; Figure 3).
Regarding claim 16, Kaikkonen teaches A method for determining an ERG response (page 15, lines 12 to page 16, line 2; Figure 3), the method comprising
directing a stimulus light beam towards a target area of the retina (page 15, lines 12 to page 16, line 2; Figure 3),
modulating the stimulus beam to provide a plurality of single pulses of light, wherein consecutive single pulses are separated by predetermined intervals, of which at least a portion differ from each other and/or wherein at least a portion of the single pulses of light comprise predetermined durations of which at least a portion differ from each other (claim 3, page 15, lines 12 to page 16, line 2; Figure 3),
obtaining at least one ERG signal related to an electrical response of the retina (page 15, lines 12 to page 16, line 2; Figure 3),
determining an ERG response of the retina comprising a response of the retinal tissue essentially corresponding to the response of the tissue to at least one of the single pulses based on the ERG signal (page 15, lines 12 to page 16, line 2; Figure 3).
Regarding claim 17, Kaikkonen teaches wherein the method additionally comprises directing a heating beam to at least the target area and obtaining at least two measured signals related to an ERG signal of the retina (“105 used for heating a retinal tissue inside an eye”; page 15, lines 12-26; Figure 3) and determining at least one parameter indicative of a change in temperature of the retinal tissue based on the determined ERG responses (page 8, lines 5-30).
Regarding claim 18, Kaikkonen teaches wherein the method comprises determining a temperature elevation of the retina per unit of heating power and optionally controlling a heating power used for retinal heating based on the determined temperature elevation of the retina per unit of heating power (page 19, lines 9-15).
Regarding claim 19, Kaikkonen teaches wherein the method additionally comprises removing or reducing artifacts from the obtained ERG signal based on one or more artifact-rejection criteria (claim 5, 21).
Regarding claim 20, Kaikkonen teaches wherein, when the intervals and/or durations of the single pulses have been selected such that minimized or reduced signal contribution is provided at or near a mains frequency, such as 50 or 60 Hz, and/or its harmonic frequencies in the frequency band where the ERG signal has spectral content, the method additionally comprises removing from the determining of an ERG response or weighting differently also ERG signal data that would otherwise be considered suitable for the analysis such that the contribution of noise in mains-related frequencies is minimized or sufficiently reduced (page 5, lines 23 to page 6, line 2; page 16, line 6-12; page 18, line 20 to page 19, line 8; claim 3; page 9, lines 10-16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABID A MUSTANSIR whose telephone number is (408)918-7647. The examiner can normally be reached M-F 10 am to 6 pm Pacific Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABID A MUSTANSIR/ Examiner, Art Unit 3791