DETAILED ACTION
Applicant' s arguments, filed 11/25/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/07/2022, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 2-3, 7-12, and 14-20 are the current claims hereby under examination.
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 .
Claim Objections
Claims 2-3 are objected to because of the following informalities:
Claim 2 line 15 it appears that “presenting a plurality …” should read “presenting the plurality …”
Claim 2 lines 29-30 it appears that “based upon the physiologic responses” should read “based upon the plurality of objective physiologic responses”
Claim 3 line 6 it appears that “a plurality of objective physiologic responses” should read “the plurality of objective physiologic responses”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 2-3, 7-12, and 14-20 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 2 recites “a head mounted video-oculography (VOG) system comprising a 3d head mounted display system in a goggle unit with integrated eye tracking technology, user input device, headphones for auditory input for instructions or stimulus and/or subject isolation, coupled to a computer” but it is unclear if the user input device or headphones are integrated into the head mounted display system, or if they are separate from the head mounted display system but still part of the VOG system. It is further unclear if the recitation of “coupled to a computer” is intended to convey that the VOG system comprises each of the listed component and the computer or if the VOG system, comprises each of the listed components but not the computer itself and the VOG system is then coupled to a computer. For the purposes of this examination, The VOG system in interpreted as the head mounted display system not requiring the user input or headphones to be integrated into the head mounted display and the VOG system encompassing all the listed component being connected to a computer such that the computer is part of the system.
Claims 3, 7-12, and 14-20 are rejected by virtue of their dependance on claim 2.
Claim 3 recites “a food and Drug Administration approved normative database of physiologic responses” but it is unclear if this limitation is the same as, related to, or different from “a normative database” of claim 2. For the purposes of this examination, these limitations will be interpreted as referring to the same database.
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 2-3, 7-12, and 14-20 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. Claims 2-3, 7-12, and 14-20 are directed to a method of processing neurological response signals using a computational algorithm, which is an abstract idea. Claims 2-3, 7-12, and 14-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 2 is as follows:
Step 1: Claim 2 is drawn to a process
Step 2A – Prong One: Claim 2 recites an abstract idea. In particular, claim 2 recites the following limitations:
[A1] presenting a plurality of oculomotor, vestibular, reaction time, and cognitive tests to the subject including a plurality of i) pursuit, ii) saccade, iii) optokinetic, iv) vergence, v) vestibular ocular reflex, vi) cognitive, and vii) reaction time testing
[B1] obtaining objective physiologic responses of the patient from the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the subject
[C1] using a plurality of the objective physiologic responses of the patient compared to normative databases to assess neurological injuries in the patient, wherein the assessment of the post SARS infection based neurological injuries in the patient includes a categorization of the patient as one of mild, moderate and severe grouping for the patient based upon the physiologic responses thereby providing a quantitative, noninvasive, clinically objective, oculomotor, vestibular, reaction time, and cognitive response assessment protocol neurological injuries
These elements [A1]-[C1] of claim 2 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. In particular, the administration of tests, obtaining of results, and use of the results to assess a neurological condition may be performed in the human mind using nothing more than pen and paper. The process is directed towards an assessment that would otherwise be carried out by a physician to assess neurological health
Step 2A – Prong Two: Claim 2 recites the following limitations that are beyond the judicial exception:
[A2] a head mounted video-oculography (VOG) system comprising a 3d head mounted display system in a goggle unit with integrated eye tracking technology, user input device, headphones for auditory input for instructions or stimulus and/or subject isolation, coupled to a computer
[B2] coupling the VOG system to a patient
These elements [A2]-[B2] of claim 2 do not integrate the exception into a practical application of the exception. In particular, the element [B2] merely adds the words “apply it” (or an equivalent) with the judicial exception. Also, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the limitation of a computer is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “a head mounted video-oculography (VOG) system comprising a 3d head mounted display system in a goggle unit with integrated eye tracking technology, user input device, headphones for auditory input for instructions or stimulus and/or subject isolation, coupled to a computer” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a system comprising a head mounted video-oculography (VOG) system comprising a 3d head mounted display system in a goggle unit with integrated eye tracking technology, a user input device, a headphone unit, and each of these elements being coupled to a computer. Each of the components comprising this system are routine, conventional, or well-known and thus the system as a whole is considered to be routine and conventional since there are no particular recitations or limitations to how each of these elements are combined, structured, or otherwise used in a manner inconsistent with their typical use. These elements are conventional as evidenced by:
U.S. Patent Application Publication No. US 2018/0184002 A1 (Thukral) discloses that conventional eye tracking systems keep a VOG sensor turned on (paragraph 0042 of Thukral);
U.S. Patent Application Publication No. US 2007/0177103 A1 (Migliaccio) discloses that VOG systems are conventional (paragraph 0013 of Migliaccio); and
U.S. Patent Application Publication No. US 2014/0313488 A1 (Kiderman) discloses that video-oculography (VOG) systems became commercially available in the 1980s (paragraph 0131 of Kiderman).
Additionally, Applicant’s own specification evidences that the headphones and user input are well known, routine, and conventional elements as evidenced by the lack of explanation regarding their structure or function such as in paragraph 0019 which recites the use of headphones and paragraphs 0034 and 0036-0037 which recite the use of any desired input device.
Further, the limitation of these elements being connected to a computer does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (that is one of data receipt and processing), (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 3, 7-12, and 14-20 depend from claim 2, and recite the same abstract idea as claim 2. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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.
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.
Claims 1-5, 7-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ashmore US Patent Application Publication Number US 2016/0270711 A1 hereinafter Ashmore in view of Kiderman US Patent Application Publication Number US 2019/0082954 A1 hereinafter Kiderman in view of Edmonds US Patent Application Publication Number US 2023/0238143 A1 hereinafter Edmonds and further in view of Moghimi “The Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection” published by Springer Nature; June 2021, pages 1-17 hereinafter Moghimi.
Regarding claim 2 Ashmore discloses a method of assessing based neurological injuries in a patient to yield quantitative, noninvasive, clinically objective, oculomotor, vestibular, reaction time, and cognitive response assessment protocol neurological injuries (Abstract; Paragraphs 0055 and 0109: a method of assessing traumatic brain injuries, or neurological injuries, using quantitative assessment methods), said method comprising the steps of:
providing a head mounted video-oculography (VOG) system comprising a 3d head mounted display system in a goggle unit with integrated eye tracking technology (Paragraph 0059-0060: the VOG head mounted goggles including eye tracking, VR display of objects using 3-D graphics hardware), user input device (Paragraph 0099-0101: some form of input device), a speaker for auditory input for instructions or stimulus and/or subject isolation (Paragraphs 0101-0102: the audio testing uses a speaker), coupled to a computer (Paragraph 0061: the VOG unit runs tests and records the responses thereto and thus implicitly discloses some form of computational elements in order to carry out the tests, measurements, and processing steps described in paragraphs 0069-0125);
coupling a VOG system to a patient wherein the VOG system is configured to present a plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient (Paragraph 0055: the VOG/VNG unit for presenting a plurality of visual stimuli; Paragraph 0020: the visual stimuli tests may include nystagmus and saccades tests; Paragraph 0109: a battery of vestibular, oculomotor, and reaction time tests);
presenting a plurality of oculomotor, vestibular, reaction time, and cognitive tests to the subject on the VOG system (Paragraph 0055: presenting a plurality of visual stimuli; Paragraph 0020: the visual stimuli tests may include nystagmus and saccades tests; Paragraph 0109: a battery of vestibular, oculomotor, and reaction time tests), including a plurality of i) pursuit, ii) saccade, iii) optokinetic, iv) vergence, v) vestibular ocular reflex, vi) cognitive, and vii) reaction time testing, wherein visual stimuli are presented to the patient virtually on the 3d head mounted display system (Paragraphs 0070-0084: a variety of pursuit, saccade, optokinetic, reaction time, nystagmus or vestibular ocular reflex, tests. These tests collect a variety of parameters and the visual tests are displayed in the VOG unit as described in the description of each test type in paragraphs 0086-0104)
obtaining objective physiologic responses of the patient from the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the subject via the VOG system, including objective physiologic responses of the patient from visual stimuli presented to the patient virtually on the 3d head mounted display system (Paragraph 0055: obtaining objective physiological response; Paragraphs 0086-0104: the visual tests presented in the VOG goggles and the objective responses therefrom); and
using a plurality of the objective physiologic responses of the patient compared to normative databases to assess neurological injuries in the patient, thereby providing a quantitative, noninvasive, clinically objective, oculomotor, vestibular, reaction time, and cognitive response assessment protocol neurological injuries (Paragraphs 0021 0067, 0106: the determining the presence of mTBI involves a comparison to a normative database; Paragraph 0114: the scores are used to determine presence and severity of mild traumatic brain injury).
Ashmore further discloses that the severity of mTBI is determined parametrically by the magnitude of the assessment model output (Paragraph 0114) which appears to suggest that categorizing patients by the severity of the diagnosed mTBI is desirable.
Ashmore fails to further disclose the method wherein the VOG system includes headphones; wherein the assessment of the neurological injuries in the patient includes a categorization of the patient as one of mild, moderate and severe grouping for the patient based upon the physiologic responses; and the method being applied to post SARS infected patients to identify post SARS infection neurological injuries.
Kiderman teaches an objective testing of vergence dysfunction comprising the steps of: providing a head mounted goggle based stimulus generating eye tracking unit to the subject; presenting visual stimulus to the subject, wherein the visual stimulus is in the head mounted goggle based system and forms the optical target stimulus for at least one vergence test; obtaining objective physiologic response of the subject from the head mounted goggle unit based upon each of the visual stimulus presented to the subject in each test; and using the objective physiologic responses to diagnose the presence of vergence dysfunction (Abstract). Thus Kiderman falls within the same field of endeavor as Applicant’s invention.
Kiderman teaches a VOG system comprising a 3D head-mounted display with integrated eye tracking technology, a user input device, and headphones for auditory input for instructions or stimulus and/or subject isolation, coupled to a laptop (Paragraph 0034).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the headphones of Kiderman to use as the speaker of Ashmore because such a change is a simple substitution of one known element for another with no surprising technical effect.
Ashmore in view of Kiderman fails to further disclose the method wherein the assessment of the neurological injuries in the patient includes a categorization of the patient as one of mild, moderate and severe grouping for the patient based upon the physiologic responses; and the method being applied to post SARS infected patients to identify post SARS infection neurological injuries.
Edmonds teaches systems and methods for determining diagnostic and/or prognostic risk of having or developing brain injury related symptoms after a head impact includes a point-of-care assay reader, a PHI smart device application, and a neurocognitive/vestibular smart device application. The diagnosis and prognosis server application includes instructions stored on a non-transitory computer-readable medium executed on the server that receives patient protected health information (PHI) from the PHI smart device application, receives neurocognitive test results from a neurocognitive testing application, and receives assay results from the point-of-care assay reader and generates a diagnostic score and a prognostic risk scores for post-acute traumatic brain injury TBI symptom categories as measures of patient outcomes (Abstract). Thus, Edmonds is reasonably pertinent to the problem at hand.
Edmonds teaches that neurocognitive, vestibular and/or oculomotor function measurements may be used as metrics for brain function and performance and can be used to classify various states of brain injury. Edmonds teaches that these metrics may be used to differentiate patients having no TBI to patients who do have TBI. The patients identified as having TBI may further be classified into three risk strata based on the severity of the TBI (Paragraph 0025). Thus, Edmonds teaches the classification of the severity of TBI into three strata.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the classification of TBI identified patients into one of three categories based on severity as taught by Edmonds into the method of Ashmore because Ashmore already appears to contemplate such a classification in paragraph 0114 where Ashmore contemplates determining the severity of patients identified as having TBI and the categories of Edmonds provides useful bins into which each subject may be placed to provide a more standardized output.
Ashmore in view of Kiderman further in view of Edmonds fails to further disclose the method being applied to post SARS infected patients to identify post SARS infection neurological injuries.
Moghimi teaches that COVID-19 or SARS-CoV-2 infection is a global health challenge and that infection may result in neurological manifestations of post-acute sequelae (neuro-PASC). Moghimi identifies the need of identifying COVID-19 patients suffering from neuro-PASC early to provide the most appropriate and effective treatments (Abstract). Thus, Moghimi is reasonably pertinent to the problem at hand.
Moghimi teaches that COIV-19 patients can suffer from post-acute sequalae of SARS-CoV-2 and that such sequelae may manifest itself as cognitive dysfunction (Introduction; Figs. 1 and 2: neurocognitive effects are a diagnostic criteria).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to adapt the method of Ashmore in view of Edmonds for use on post COVID-19 patients in order to identify neurocognitive dysfunction which may be a symptom of neuro-PASC as taught by Moghimi because known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The cognitive function testing to diagnose TBI of Ashmore in view of Edmonds is readily adapted to any condition where cognitive or neurological testing is desirable and one of ordinary skill in the art would recognize that screening post COVID-19 infection patients for cognitive dysfunction is a desirable adaptation for the method of Ashmore in view of Edmonds based on the teachings of a market need and analogous symptom testing of Moghimi.
Examiners Note: all dependent claims are rejected with the understanding that Ashmore in view of Kiderman in view of Edmonds further in view of Moghimi (hereinafter modified Ashmore) is being applied to post COVID-19 patients as described above.
Regarding claim 3, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of using the plurality of the objective physiologic responses of the patient to assess post SARS infection based neurological injuries in the patient includes a comparison of a plurality of the objective physiologic responses of the patient to a normative database of physiologic responses (Paragraph 0021: the determining the presence of mTBI involves a comparison to a normative database).
Modified Ashmore fails to explicitly disclose the normative database being a Food and Drug Administration (FDA) approved normative database.
An obvious variation of modified Ashmore would be to utilize an FDA approved database for comparison. Such a variation would be obvious because an FDA approved database would be readily available to one of ordinary skill in the art and may enhance the validity of comparisons and conclusions drawn therefrom since the database of normative values has been approved by a regulatory body. Additionally, the substitution of one normative database for another is a simple substitution of one known element for another with no surprising technical effect.
Regarding claim 7, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of obtaining the objective physiologic responses of the patient from the plurality of oculomotor, vestibular, reaction time, and cognitive tests presented to the patient via the VOG system includes physiologic responses of the patient for at least pursuit, saccade, optokinetic, vergence, vestibular ocular reflex, cognitive, and reaction time testing (Paragraphs 0070-0084 a variety of pursuit, saccade, optokinetic, reaction time, nystagmus or vestibular ocular reflex, tests. These tests collect a variety of parameters as described in the description of each test type in paragraphs 0086-0104; Paragraphs 0105 and 0110-0113: the plurality of variables, or physiologic responses collected. As described in the above presented 35 USC 112 rejection, the meets and bounds of each domain is unclear and thus the plurality of variables of Ashmore are considered sufficient to satisfy the physiologic responses including at least the listed domains).
Regarding claim 8, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the VOG system is configured to automatically run a number of preprogrammed neurologic oculomotor, vestibular, reaction time, and cognitive tests and to record the physiologic responses thereto (Paragraph 0061: the VOG/VNG unit automatically runs a number of preprogrammed neurologic tests and records the physiologic responses thereto.).
Regarding claim 9, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes spontaneous nystagmus testing (Paragraphs 0020 and 0066).
Regarding claim 10, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes horizontal gaze testing (Paragraphs 0070-0084: Gaze Horizontal testing).
Regarding claim 11, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes horizontal random saccade and vertical random saccade (Paragraphs 0070-0084: Horizontal and vertical random saccade).
Regarding claim 12, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes predictive saccade testing (Paragraphs 0070-0084: Horizontal predictive saccade).
Regarding claim 14, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes horizontal and vertical smooth pursuit testing (Paragraphs 0070-0084: vertical and horizontal smooth pursuit).
Regarding claim 15, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore fails to further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the subject on the VOG system includes vergence pursuit testing.
Kiderman teaches a method of conducting vergence pursuit testing and that the resultant parameters may be utilized as a factor for identifying mild traumatic brain injury (Paragraphs 0046-0050).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the vergence pursuit testing of Kiderman into the method of modified Ashmore because Kiderman teaches that vergence pursuit testing produces relevant data for identifying mild traumatic brain injuries (Paragraph 0050) and adding this test to the array of tests utilized by modified Ashmore may result in more accurate identification of mild traumatic brain injuries.
Regarding claim 17, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes optokinetic testing (Paragraphs 0070-0084: optokinetic tests; Paragraph 0097).
Regarding claim 18, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes visual and auditory reaction time testing (Paragraphs 0070-0084: visual and auditory reaction time testing; Paragraphs 0101-0102).
Regarding claim 19, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the subject on the VOG system includes light reflex testing (Paragraphs 0070-0084: light reflex testing; Paragraph 0104).
Regarding claim 20, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes subjective visual vertical and horizontal testing (Paragraphs 0070-0084: subjective visual vertical and horizontal testing; Paragraphs 0099-0100).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ashmore US Patent Application Publication Number US 2016/0270711 A1 hereinafter Ashmore in view of Kiderman US Patent Application Publication Number US 2019/0082954 A1 hereinafter Kiderman in view of Edmonds US Patent Application Publication Number US 2023/0238143 A1 hereinafter Edmonds in view of Moghimi “The Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection” published by Springer Nature; June 2021, pages 1-17 hereinafter Moghimi as applied to claim 2 above and further in view of Port US Patent Number US 9895100 B2 hereinafter Port.
Regarding claim 16, modified Ashmore teaches the method of assessing post SARS infection based neurological injuries in a patient having previously been infected with SARS from a coronavirus according to claim 2. Modified Ashmore further teaches the method wherein the step of presenting the plurality of oculomotor, vestibular, reaction time, and cognitive tests to the patient on the VOG system includes saccade reaction time testing (Paragraph 0103: saccade and reaction time testing).
Modified Ashmore fails to further teach the method including self-paced saccade testing.
Port teaches a wearable device for the detection of mild traumatic brain injury, such as concussions, and methods of use thereof. Further disclosed are a method and system for detecting a mild traumatic brain injury (Abstract). Thus, Port falls within the same field of endeavor as Applicant’s invention.
Port teaches a self-paced saccade test for collecting information used to diagnose mild traumatic brain injuries by comparing the results of a subject to a baseline and/or other non-concussed subject results (Col 11 lines 33-48; Table 1; Col 18 lines 7-33).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the self-paced saccade testing of Port into the method of modified Ashmore because Port teaches that self-paced saccade testing produces relevant data for identifying mild traumatic brain injuries (Col 18 lines 7-33) and adding this test to the array of tests utilized by Ashmore may result in more accurate identification of mild traumatic brain injuries.
Response to Arguments
Applicant’s arguments with respect to claim 2 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to Applicant’s arguments directed towards the previously presented 101 rejection, the amended language is insufficient to incorporate the abstract idea into a practical application because the VOG system as a whole is recited at a high level of generality. The claimed method is directed towards an assessment of a neurological conditions involving presenting various tests, recording data from the tests, and using the data to assess a neurological condition. Each of these steps may be practically performed in the human mind using pen and paper such as by a physician performing a neurological evaluation of a patient. The VOG system itself is merely a direction to implement such an abstract idea into a computer and include the various componentry required for carrying out the testing. Each of the various components appear to be routine and conventional as evidenced in the above rejection and there are no particular structural requirements for any of the components. Additionally, each of the components of the system are used in a manner consistent with their well-known usage and there is no indication that a system including each of these well known elements would produce a surprising technical effect. As such, the 101 rejection is maintained as the claim is still directed towards the abstract idea of a physician performing an assessment and implementing such an assessment method onto a computer using well known components.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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 on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791