DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14, 16-20 are pending.
This action is Non-Final.
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-13) in the reply filed on 2/2/2026 is acknowledged. The traversal is on the ground(s) that the amended claim 14 contains the same special technical feature of claim 1 due to the amended features. This is not found persuasive in view of US 2020/0054618 which teaches using a background noise in [0066] and the stimulation features (see [0065]-[0066]) as such, the additional feature does not form a special technical feature (see also prior art rejection of claim 1); different diagnosing conditions/methods that may form the inventive features which are the features not common among claims 1 and 14 do not share a special technical feature as each process is unique to the respective group.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
There is an issue in the presentation of clam 1 counter to the priority documents which raises the questions as to what applicant had possession of and when. The issue is raised here for priority of the claims and in section 112 for written description and indefiniteness.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
Statement of Facts:
The instant application is a 371 entry of PCT/IL2022/050523 filed 11/13/2023.
The PCT/IL2022/050523 was filed on 5/19/2022 and claims the benefit of IL283304 filed 5/19/2021.
Explanation for lack of benefit:
-in review of the certified foreign patent document provided, the published PCT document, and US application documents, it is clear that between the priority filing and the PCT filing the claim 1 features were amended differently than originally presented in the parent foreign patent document. Specifically, the inclusion of diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population finds no basis in the original foreign patent document.
-the description as filed in the US application, including specification and drawings, does not support the scope of claim 1 as set forth in the claims as filed due to the reasons previously explained and which will be addressed further in the 112a/b sections of this action.
-the only basis for “diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population” is paragraph 13.
-paragraph 13 (of the PCT and US filing) is directed to the unelected embodiment of Figure 7 related to diagnosing emotional dysregulation and/or impulse response, not attention disorder;
-paragraph 13 states “In some aspects of the invention, diagnosing emotional dysregulation and/or impulsive dysregulation is comprised from a series of auditory stimulations in various intensities that generates startle responses. These responses are then classified using machine learning to identify specific patterns unique to emotional dysregulation and/or impulsive dysregulation compared to healthy participants.” (emphasis added). This is the only reference in the disclosure as filed to such comparison with healthy participants (“population”).
-in review of paragraphs 13 of the instant application and PCT published document, as compared to the priority document paragraph 12 there is no discussion into healthy participants at all, let alone with diagnosis of attention disorder as it appears such features were amended later than the priority document and are new matter:
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- Clearly, the features related to instant claim 1 are not disclosed in the description of the priority document, and neither are they found in the priority document claims, including claim1 and 14:
-Claim 1 of the priority document is as follows:
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-claim 14 of the priority document is as follows:
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-As is clearly evident from the claims and the description of the priority document, there is no description of “diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population”
-As such, the instant claims as presented and the instant disclosure as filed contain new matter not present in the description as filed in the priority document and as such are not afforded the priority date. The earliest date the claims as filed are entitled to is that of the PCT filing of 5/19/2022.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1" and "10" have both been used to designate computing device. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Figures 2, 6a,b, 8a,b use shading improperly which detracts from the drawings and is unnecessary, and for Figures 6a,b, 8a-b has text improperly embedded in the shadings; Figures4a,b, 5a,b text is too small as all numbers in the Figures should meet the minimum height/size requirements set forth in Rule 1.84; Figure 3 step 350 is incorrect as it appears to be the same as step 330 but this is at odds with the specification explanations. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 214, 216, 218. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0044] computing device 1 is incorrect; [0047] refers to Fig. 1, there is no Fig.1 but Figs. 1a and 1b are present; [0053] MCY 210 is incorrect.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, as addressed in the priority section above, the description as filed, including specification and drawings, does not support the scope of claim 1 as set forth in the claims as filed due to the features of “diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population”. In review of the certified foreign patent document provided, the published PCT document, and US application documents, it is clear that between the priority filing and the PCT filing the claim 1 features were changed from the original filed foreign parent document, specifically in relation to the limitations related to comparison to “healthy population” in diagnosing attention disorder and lack adequate written description support. The disclosure does not define what healthy means, such that it is not clear where such comparison can be gleaned from the original document as filed. The specification as filed only contains one passage in relation to “healthy” population and that is paragraph 13. Paragraph 13 states “In some aspects of the invention, diagnosing emotional dysregulation and/or impulsive dysregulation is comprised from a series of auditory stimulations in various intensities that generates startle responses. These responses are then classified using machine learning to identify specific patterns unique to emotional dysregulation and/or impulsive dysregulation compared to healthy participants.” (emphasis added). This is the only reference in the disclosure as filed to such comparison with healthy participants (“population”). However, this passage is in reference to the embodiment of Figure 7, and not to the embodiment for Figure 3 which corresponds to the diagnosis of attention disorder. According to the disclosure of Figure 3 and paragraphs 65 and 67, the diagnosis is based on reduction in startle response from first to second startles, and specifically in Figure 3, as filed, a threshold amount of 20% the ratio is the only reference to any comparison for diagnostic threshold determinations. Plainly, there is no support for the algorithm attempting to be set forth in claim 1 for diagnosing attention disorder to generate the claimed results using such inhibition values comparisons to inhibition values of “healthy population”. What makes a population healthy and unhealthy and how does the data differ? The disclosure as filed does not set forth the meaning of “healthy” for comparison, which is a relative designation of health. Based on common medicine, a person having or not having attention disorder is not a definitive indication of health marker. Such that persons with or without the attention disorder could be healthy or not healthy. Perhaps this is meant to distinguish values of a population that is confirmed to not have attention disorder to allow for comparison(?), as a person could be healthy and either have or not have attention disorder which is a neurodevelopmental disorder; however, the disclosure as filed is silent to any such aspect in relations to attention disorder as previously explained as the embodiment of Figure 7 relies on such comparisons. Thus algorithmically speaking, the diagnosis is determined based on calculation of inhibition values and then comparison to some unknown healthy values that are not discussed in the disclosure as filed to set forth any standard for making such affirmation, as Figure 3 merely compares the value to a percent threshold and there is no indication that such threshold is in relations to healthy population. For these reasons, one of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
The dependent claims are rejected for depending on a rejected claim.
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 1-13 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 1, the limitations “diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population” is rejected as being indefinite as being inconsistent with the description, see MPEP 2173.03
“A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971);In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). For example, a claim with a limitation of “the clamp means including a clamp body and first and second clamping members, the clamping members being supported by the clamp body” was determined to be indefinite because the terms “first and second clamping members” and “clamp body” were found to be vague in light of the specification which showed no “clamp member” structure being “supported by the clamp body.” In re Anderson, 1997 U.S. App. Lexis 167 (Fed. Cir. January 6, 1997) (unpublished). In Cohn, a claim was directed to a process of treating an aluminum surface with an alkali silicate solution and included a further limitation that the surface has an “opaque” appearance. Id. The specification, meanwhile, associated the use of an alkali silicate with a glazed or porcelain-like finish, which the specification distinguished from an opaque finish. Cohn, 438 F.2d at 993, 169 USPQ at 98. Noting that no claim may be read apart from and independent of the supporting disclosure on which it is based, the court found that the claim was internally inconsistent based on the description, definitions and examples set forth in the specification relating to the appearance of the surface after treatment, and therefore indefinite. Id. In addition, inconsistencies in the meaning of terms or phrases between claims may render the scope of the claims to be uncertain. Tvngo Ltd. (BVI) v. LG Elecs. Inc., 861 Fed. Appx. 453, 459-60, 2021 USPQ2d 697 (Fed. Cir. 2021) ("The issue is not breadth of the dependent claims but their use of the disputed phrase in a way that contradicts the independent claims. The dependent claims state that 'said overlay activation criterion includes . . . a user command information,' which conflicts with the independent claim's use of this same phrase."). "When faced with this unknown and undefined phrase, a skilled artisan would look for clarification not only in the specification but also in '[o]ther claims of the patent in question,' which 'can also be valuable sources of enlightenment as to the meaning of a claim term.'" Id. at 460 (quoting Philips v. AWH Corp., 415 F.3d 1303, 1314, 75 USPQ2d 1321, 1327 (Fed. Cir. 2005)).”
As addressed in the priority section above, the description as filed, including specification and drawings, does not support the scope of claim 1 as set forth in the claims as filed due to the features of “diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population”. In review of the certified foreign patent document provided, the published PCT document, and US application documents, it is clear that between the priority filing and the PCT filing the claim 1 features were changed from the original filed foreign parent document, specifically in relation to the limitations related to comparison to “healthy population” in diagnosing attention disorder. The disclosure does not define what healthy means, such that it is not clear where such comparison can be gleaned from the original document as filed. The specification as filed only contains one passage in relation to “healthy” population and that is paragraph 13. Paragraph 13 states “In some aspects of the invention, diagnosing emotional dysregulation and/or impulsive dysregulation is comprised from a series of auditory stimulations in various intensities that generates startle responses. These responses are then classified using machine learning to identify specific patterns unique to emotional dysregulation and/or impulsive dysregulation compared to healthy participants.” (emphasis added). This is the only reference in the disclosure as filed to such comparison with healthy participants (“population”). However, this passage is in reference to the embodiment of Figure 7, and not to the embodiment for Figure 3 which corresponds to the diagnosis of attention disorder. According to the disclosure of Figure 3 and paragraphs 65 and 67, the diagnosis is based on reduction in startle response from first to second startles, and specifically in Figure 3, as filed, a threshold amount of 20% the ratio is the only reference to any comparison for diagnostic threshold determinations. Plainly, there is no support for the algorithm attempting to be set forth in claim 1 for diagnosing attention disorder to generate the claimed results using such inhibition values comparisons to inhibition values of “healthy population”. What makes a population healthy and unhealthy and how does the data differ? The disclosure as filed does not set forth the meaning of “healthy” for comparison, which is a relative designation of health. Based on common medicine, a person having or not having attention disorder is not a definitive indication of health marker. Such that persons with or without the attention disorder could be healthy or not healthy. Perhaps this is meant to distinguish values of a population that is confirmed to not have attention disorder to allow for comparison(?), as a person could be healthy and either have or not have attention disorder which is a neurodevelopmental disorder; however, the disclosure as filed is silent to any such aspect in relations to attention disorder as previously explained as the embodiment of Figure 7 relies on such comparisons. Thus algorithmically speaking, the diagnosis is determined based on calculation of inhibition values and then comparison to some unknown healthy values that are not discussed in the disclosure as filed to set forth any standard for making such affirmation, as Figure 3 merely compares the value to a percent threshold and there is no indication that such threshold is in relations to healthy population. For these reasons, the metes and bounds of the claim are unclear which renders the claim indefinite.
The dependent claims are rejected for depending on a rejected claim.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1:
detecting a first startle response (under a BRI, such step could amount to data gathering steps or could be a judicial exception with narrowed scope and fall under mental process/mathematical concepts, the analysis considers both options)
detecting a second startle response (under a BRI, such step could amount to data gathering steps or could be a judicial exception with narrowed scope and fall under mental process/mathematical concepts, the analysis considers both options)
diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population (mental process, mathematical concepts)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1:
providing to a user a predetermined continuous background noise; providing to the user, a first audio stimulation comprising a single sound in a first known intensity; detecting a first startle response; providing to the user, a second audio stimulation comprising two sounds, a first sound in a second intensity and a second sound having the first intensity, wherein the second intensity is selected to be higher than the background noise in an amount that allows the first sound to be noticed by the user; detecting a second startle response; (pre-solution activities related to data gathering of an evoked response)
sending a signal comprising the diagnosis to an external computing device (insignificant post-solution activities of communicating a signal to a computer)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those provided above identified in step 2A. Such limitations related to the providing noise and sounds and detecting startle response are limitations related to evoking a response to gather such response data. The claims do not limit to any particular structures such that these components could be completed with off the shelf known systems and are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental process, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental process. In addition, these data gathering structures are known from US 2020/0054618, US 2005/0273017, US 2020/0100719, and as admitted in paragraph [006] used since at least 1975 known as the “San Diego” test. The method does not contain any structures for completing any steps, but merely sends a signal to a computer from the diagnoses, which could be simply emailing a determination to another location and thus all features of data processing can all be analog/mental processing of the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The final limitation again is just sending a signal to a computer, and such amounts to computer structure claimed as performing generic computer functions routinely used in computer applications. Even if the steps were performed by a computer at most such would be generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further limitations related to data gathering, and to more details of the exception/additional mathematical concepts and/or mental processes of data processing for the used for the diagnosing (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Avital et al. (Avital, US 2020/0054618) in view of Dabrowska (US 2019/0357832).
Regarding claim 1, Avital teaches a method for diagnosing attention disorder (see at least abstract), comprising:
providing to a user a predetermined continuous background noise (see at least [0066]);
providing to the user, a first audio stimulation comprising a single sound in a first known intensity (see at least [0065]-[0066] pulse alone);
detecting a first startle response (see at least [0065]-[0066]);
providing to the user, a second audio stimulation comprising two sounds, a first sound in a second intensity and a second sound having the first intensity, wherein the second intensity is selected to be higher than the background noise in an amount that allows the first sound to be noticed by the user (see at least [0065]-[0066] pre+pulse);
detecting a second startle response (see at least[0065]- [0066]);
diagnosing an attention disorder by measuring an inhibition value between the second startle response and the first startle response compared to an inhibition value of a healthy population (see at least [0065]-[0066] Figures 2A,C);
however, the limitation of sending a signal comprising the diagnosis to an external computing device is not directly taught.
Transmitting data from one location to another is a well-known process and involves routine skill to one in the art. Such process is known from Dabrowska in paragraph 41 “In some examples, the computer-readable medium could be configured to store the information (e.g., information relating to the discrimination index, therapy, diagnosis, and/or efficacy) and/or transmit the information via the communication interface. Such information may be transmitted to an associated device (e.g., a cellphone or computer), an associated user (e.g., a physician, a patient, a psychologist, or a pharmacist), and/or uploaded to a server or cloud computing platform.”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of sending diagnostic data from one location to another in order to yield predictable results of communicating findings to a monitoring system/person for further storage or analysis of the diagnostic data.
Regarding claim 2, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the single sound of the first audio stimulation and the second sound of the second audio stimulation are provided in a known first duration (see at least [0066]).
Regarding claim 3, the limitations are met by Avital in view of Dabrowska, where Avital teaches the first sound of the second audio stimulation is provided in a second known duration (see at least [0066]).
Regarding claim 4, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the first startle response and the second startle response are detected using electromyography (EMG) electrodes placed on an Orbicularis Oculi muscle of the user (see at least [0065]).
Regarding claim 5, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein detecting each of the first startle response and detecting the second startle response comprises detecting at least one of: the maximum intensity of an EMG signal, the rise in time of the EMG signal intensity and the decay time of the EMG signal intensity(see at least [0066]).
Regarding claim 8, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the first known intensity is between 4-400 dB (see at least [0066]).
Regarding claim 9, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the predetermined continuous background noise is between 40-80 dB (see at least [0066]).
Regarding claim 10, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the second sound is provided 30-600 milliseconds after the first sound (see at least [0066]).
Regarding claim 11, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the first and second audio stimulations are provided to both ears of the user situationally using earphones (see at least [0065], headphones used, but specifics into both ears is not directly taught. However, such amounts to an obvious feature that sound can be provided, as desired, to include stimulation to both ears as opposed to a single ear. Such reasonably falls under obvious to try (left ear, right ear, both ears) and does not amount to patentable feature).
Regarding claim 12, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the duration of the first audio stimulation and the second sound in the second audio stimulation is 10-500 milliseconds (see at least [0066]).
Regarding claim 13, the limitations are met by Avital in view of Dabrowska, where Avital teaches wherein the duration of the second sound is 2-400 milliseconds (see at least [0066]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Avital et al. (Avital, US 2020/0054618) in view of Dabrowska (US 2019/0357832) as applied to claim 1 above, and further in view of Cakmak (US 2020/0100719).
Regarding claim 6, the limitations are met by Avital in view of Dabrowska, except the limitation of wherein the first startle response and the second startle response are detected using stream of images of at least a portion the user's face is not directly taught.
Cakmak teaches a related system for analyzing mental conditions including by monitoring audio stimulation responses (see at least title, abstract, [0059]), including using image data detection of response to stimuli which reasonably teaches wherein the first startle response and the second startle response are detected using stream of images of at least a portion the user's face (see at least [0060], [0063]-[0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using eye image data with or without EMG data to determine startle response in order to calculate PPI of a subject for diagnosis purposes.
Regarding claim 7, the limitations are met by Avital in view of Dabrowska and Cakmak, where Cakmak teaches wherein detecting each of the first startle response and detecting the second startle response comprises detecting a maximum movement of an eyelid of at least one eye detected from the stream of images (see at least [0016], [0069] amplitude of the response).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791