DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/15/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 01/15/2026, with respect to the rejection of Claims 7-10 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. The rejection of Claims 7-10 under 35 U.S.C. § 112(b) has been withdrawn.
Applicant’s arguments with respect to the rejection of Claims 1-20 under 35 U.S.C. § 103 with regards to the use of Childs as a primary reference have been considered but are moot because the new ground of rejection does not use Childs as a primary reference.
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 1-20 under 35 U.S.C. § 101, the Applicant has argued the claim 1 elements integrate any alleged abstract idea into a practical application through the use of a particular machine (e.g., the oximetry device). Specifically, the applicant cites Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923), found in M.P.E.P. § 2106.05(b), and asserts: “Similar to the Fourdrinier machine in Eibel Process, the oximetry device is configured in a particular way (e.g., portable, non-invasive, and operating within specific time constraints of up to 11 seconds) to achieve the specific result of real-time TBI assessment in field conditions” (page 7 of arguments). However, in the same MPEP section, it is made clear that with claims considered to recite a particular machine, specific structural details are clearly claimed. See Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 40 USPQ 199 (1939) (“The claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged”) and Eibel (“a Fourdrinier machine (which was understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls)”; Emphasis added). None of the critical structural details that make the device portable or non-invasive are in the specification or the claims—rather, the device is described as portable and non-invasive without further explanation. If the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. See MPEP 2106.04(d)(1). Finally, operating within specific time constraints of up to 11 seconds is a functional limitation, not a structural one.
The applicant has also argued the "performing" element of claim 1 is not "mere data gathering" because “(1) a particular type of device (oximetry devices that are portable and non-invasive); (2) a particular anatomical target (the optic nerve or retina); and (3) a specific temporal constraint (within a time period of up to 11 seconds)” (page 8 of arguments). However, the claim language only recites the oximetry device broadly as a data gathering device—generic oximetry devices are routine and conventional, as further explained below. The applicant cites their specification at [0020] to support their argument that "[t]argeting the optic nerve head is difficult, but the oximetry device 100 has been shown to accurately scan with very good reliability and reproducibility", but unlike other notable cases (see CardioNet, LLC v. InfoBionic, Inc., 955 F. 3d 1358), there is no evidence of record supporting the statements in the written description concerning the benefits of the claimed device. For example, there are no graphs, recorded experiments, or quantitative analysis to demonstrate how specific features of the oximetry device increase reliability or reproducibility of optic nerve scans. Finally, as further explained below, the Examiner respectfully disagrees with the Applicant’s argument that the device working with a specific temporal constraint (within a time period of up to 11 seconds) is non-obvious and therefore an improvement in technology.
The applicant has also argued the retinal oximetry device of claim 1 is not a "generic computer" being used as a tool to perform mathematical calculations in real time. However, in the rejection of the claims under 35 U.S.C. § 101, the retinal oximetry device was considered a mere data gathering device, not a generic computer being used as a tool.
The applicant has also argued that the claimed oximetry device is not well-understood, routine, and conventional (WURC). Specifically, the applicant has argued “[L'Esperance] does not establish using oximetry devices for real-time TBI severity assessment [at] the time of filing. The WURC inquiry must focus on the specific application claimed, ( e.g., using oximetry for real time TBI severity assessment and prognosis determination) not the general existence of oximetry technology. Showing that a tool has a general capability does not establish a particular application of that tool was routine or conventional” (page 10 of arguments). However, this argument does not reflect the claim 1 language describing the oximetry devices, which merely recites “performing, using one or more oximetry devices, scans of optic nerve/retinal oximetry of a group of test subjects within a time period of up to 11 seconds, each scan indicating oxygenation levels of an optic nerve or a retina of a test subject, the one or more oximetry devices being portable and non-invasive” (Emphasis added). Under broadest reasonable interpretation, the disclosure in L’Esperance proves this limitation is WURC. Furthermore, determining a change in oxygenation and a prognosis corresponding to a rehabilitation benchmark are abstract ideas; an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. In other words, the improvement in technology cannot come from improvement in the abstract idea.
For these reasons, the rejection of Claims 1-20 under 35 U.S.C. § 101 is maintained.
Regarding the use of Mufti and Liu in the rejection of the claims under 35 U.S.C. § 103, the applicant has argued “Mufti acknowledges the correlation between retinal oxygen saturation and TBI prognosis remains unproven and represents a future research direction, not an established technique for determining rehabilitation-specific prognoses”. However, this very disclosure proves that one of ordinary skill in the art would have had obvious motivation to investigate the correlation between a change in oxygenation of the optic nerve or the retina and the severity of traumatic brain injury and whether the level of hypoxia in the optic nerve or retina indicates the severity of a traumatic brain injury because Mufti directly encourages such questioning.
In response to applicant's argument “one of ordinary skill in the art would not have been motivated to combine Liu's NAD+ biomarker monitoring with the retinal oximetry teachings of Childs and Mufti because Liu does not discuss retinal oximetry or use comparable data”, the examiner notes the field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field. See MPEP 2141.01(a) and Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001, 120 USPQ2d 1593, 1597 (Fed. Cir. 2016). Liu's disclosure is still concerned with the medical issue of TBI (specifically, managing rehabilitation benchmarks from TBI)—regardless of how the TBI was diagnosed. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Claim Objections
Claims 11 and 14-16 are objected to because of the following informalities:
In Claim 11, “wherein performing the scans of optic nerve/retinal oximetry in real-time…” should read “wherein performing the scans of optic nerve/retinal oximetry within the time period…” to match parent Claim 1.
In Claims 14-16, “wherein capturing oxygenation levels of the optic nerve or the retina in real-time” should read “wherein capturing oxygenation levels of the optic nerve or the retina within the time period …” to match parent Claim 1.
Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 1, the claim recites a method for correlating a change in oxygenation of an optic nerve/retina to the severity of a traumatic brain injury. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
determining, based on the scans, (ii) a change in oxygenation of the optic nerve or retina having a direct correlation to a severity of a traumatic brain injury and (ii) a level of hypoxia of the optic nerve or the retina indicating the severity of the traumatic brain injury
determining, based on the change in oxygenation of the optic nerve or the retina and the level of hypoxia of the optic nerve or the retina, a prognosis corresponding to at least one of: (i) a rehabilitation period, (ii) a rehabilitation goal and (iii) a rehabilitation success timeline
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally determining, based on scans, (ii) a change in oxygenation of the optic nerve or the retina having a direct correlation to the severity of a traumatic brain injury and (ii) the level of hypoxia of the optic nerve or the retina indicating the severity of the traumatic brain injury with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally determining, based on the change in oxygenation of the optic nerve or the retina and the level of hypoxia of the optic nerve or the retina, a prognosis corresponding to at least one of: (i) a rehabilitation period, (ii) a rehabilitation goal and (iii) a rehabilitation success timeline with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
performing, using one or more oximetry devices, scans of optic nerve/retinal oximetry of a group of test subjects within a time period of up to 11 seconds, each scan indicating oxygenation levels of an optic nerve or retina of a test subject, the one or more oximetry devices being portable and non-invasive
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
performing, using one or more oximetry devices, scans of optic nerve/retinal oximetry of a group of test subjects within a time period of up to 11 seconds, each scan indicating oxygenation levels of an optic nerve or retina of a test subject, the one or more oximetry devices being portable and non-invasive
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The one or more oximetry devices is/are considered to be well-understood, routine, and conventional based on a statement in L'Esperance, Jr. (US 6494576 B1, hereinafter L'Esperance) (“There is overwhelming evidence supporting the capability of photographic retinal oximetry for detecting desaturation before it is clinically apparent”, 4:55-57).
Dependent Claims 7-8, 14-16, and 18-20 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea. The Examiner notes that Claims 7-8 recite fundamental social activities that have been performed by humans with other humans for hundreds of years, which are considered certain methods of organizing human activity and therefore abstract ideas. Claim 14 recites “showing that there are demographically standardized norms for gender, age, race, ethnicity, and geographical location”. This is a natural phenomenon, which is considered an abstract idea.
Dependent Claims 2-6, 9-17 and 19 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 2-6, 9-17 and 19 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, Claims 1-20 are not patent eligible under 35 U.S.C. § 101.
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 1-6, 11-13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Samec et al (US 11022797 B2, hereinafter Samec) in view of the Non-Patent Literature (NPL) to Mufti et al (“Ocular changes in traumatic brain injury”, hereinafter Mufti) and Liu (US 20170101662 A1, hereinafter Liu).
Regarding Claim 1, Samec discloses a method for measuring oxygenation of an optic nerve/retina (See Fig. 6), comprising:
performing, using one or more oximetry devices (Element 58, Fig. 5), scans of optic nerve/retinal oximetry (“The one or more electromagnetic radiation detectors may be positioned and oriented to receive light reflected after encountering at least one blood vessel of the retina of the eye of the user”, 3:24-27) of a group of test subjects (“ With a configuration as described above, wherein there is one world model that can reside on cloud computing resources and be distributed from there, such world can be “passable” to one or more users in a relatively low bandwidth form preferable to trying to pass around real-time video data or the like”, 5:54-49), each scan indicating oxygenation levels of an optic nerve or a retina of a test subject (“The controller may be configured to calculate a ratio of first wavelength light measurement to second wavelength light measurement, and wherein this ratio is converted to an oxygen saturation reading via a lookup table based at least in part upon the Beer-Lambert law”, 3:40-45), the one or more oximetry devices being portable (“A solution is presented herein which combines the convenience of wearable computing in the form of an AR or VR system with the oxygen saturation monitoring technology of pulse oximetry”, 1:46-50) and non-invasive (See Fig. 2A).
Samec discloses the claimed invention except for expressly disclosing the method further including correlating a change in oxygenation of an optic nerve/retina to the severity of a traumatic brain injury, and comprising:
performing the scans within a time period of up to 11 seconds;
determining, based on the scans, (i) a change in oxygenation of the optic nerve or retina having a direct correlation to a severity of a traumatic brain injury and (ii) a level of hypoxia of the optic nerve or the retina indicating the severity of the traumatic brain injury; and
determining, based on the change in oxygenation of the optic nerve or the retina and the level of hypoxia of the optic nerve or the retina, a prognosis corresponding to at least one of: (i) a rehabilitation period, (ii) a rehabilitation goal, and (iii) a rehabilitation success timeline.
However, Samec teaches a recognized need for performing scans using retinal oximetry devices in a real-time manner (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Samec, to perform scans within a time period of up to 11 seconds, as part of routine experimentation.
Mufti teaches a motivation for determining, based on the scans (“Recent advances in imaging modalities, such as SD-OCT, SD-OCT angiography (SD-OCTA), Heidelberg retinal flowmeter (HRF), and retinal oximetry, allow non-invasive imaging and quantification of retinal thickness, retinal vessel density, blood flow, and oxygen saturation.”, p. 871, col. 1), (i) a change in oxygenation of the optic nerve or retina having a direct correlation to a severity of a traumatic brain injury (“Retinal oximetry may be useful in understanding how TBI affects retinal oxygen delivery and utilization. Specifically, this technique provides insight into oxygen utilization in the retina, and therefore retinal metabolism, by determining the amount of oxyhemoglobin (HbO2) versus deoxyhemoglobin (Hb) in retinal vessels”, p. 870-871) and (ii) a level of hypoxia of the optic nerve or the retina indicating the severity of the traumatic brain injury (“Retinal oximetry may be useful in understanding how TBI affects retinal oxygen delivery and utilization. Specifically, this technique provides insight into oxygen utilization in the retina, and therefore retinal metabolism, by determining the amount of oxyhemoglobin (HbO2) versus deoxyhemoglobin (Hb) in retinal vessels”, p. 870-871). In addition, Samec teaches “there is an opportunity to utilize some of these system components to conduct certain physiologic monitoring tasks relative to the user” (2:7-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to act on the motivation of Mufti and add the step of determining, based on the scans, (i) a change in oxygenation of the optic nerve or retina having a direct correlation to a severity of a traumatic brain injury and (ii) a level of hypoxia of the optic nerve or the retina indicating the severity of the traumatic brain injury to the method of Samec because Mufti teaches that oxygenation of the optic nerve/retina and traumatic brain injury may be related (p. 870-871).
Liu teaches determining, based on a diagnosis of TBI ([0030]), a prognosis corresponding to at least one of: (i) a rehabilitation period, (ii) a rehabilitation goal, and (iii) a rehabilitation success timeline (“…“Monitoring” can include, for example, determination of prognosis, risk-stratification, selection of drug therapy, assessment of ongoing drug therapy, determination of effectiveness of treatment, prediction of outcomes, determination of response to therapy, diagnosis of a disease or disease complication, following of progression of a disease or providing any information relating to a patient's health status over time, selecting patients most likely to benefit from experimental therapies with known molecular mechanisms of action, selecting patients most likely to benefit from approved drugs with known molecular mechanisms where that mechanism may be important in a small subset of a disease for which the medication may not have a label, screening a patient population to help decide on a more invasive/expensive test”, [0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Samec in view of Mufti with the teachings of Liu (i.e. wherein the method comprises determining, based on the change in oxygenation of the optic nerve or the retina and the level of hypoxia of the optic nerve or the retina, which correlate to TBI, a prognosis corresponding to at least one of: (i) a rehabilitation period, (ii) a rehabilitation goal, and (iii) a rehabilitation success timeline) because Liu teaches the advantage of real time monitoring for traumatic brain injuries (“Timely management decisions are critical in optimizing outcomes of TBI. Consequently, the value of real time diagnostic assessment given by point-of care testing of TBI is desirable to expedite appropriate treatment”, [0003]).
Regarding Claim 2, modified Samec discloses the method of claim 1. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing scans includes using the one or more oximetry devices to perform scan sessions on each test subject at primary, 2 weeks, 1 month and 3-month sessions. However, at the time of the invention, there was a recognized need for retinal oximetry testing protocols to understand the correlation between traumatic brain injuries and retinal oxygen levels (“Retinal oximetry may be useful in understanding how TBI affects retinal oxygen delivery and utilization. Specifically, this technique provides insight into oxygen utilization in the retina, and therefore retinal metabolism, by determining the amount of oxyhemoglobin (HbO2) versus deoxyhemoglobin (Hb) in retinal vessels”, p. 870-871 of Mufti; therefore, retinal oximetry scans should be performed on subjects to further understand how TBI affects oxygenation of the retina). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec, wherein performing scans includes using the one or more oximetry devices to perform scan sessions on each test subject at primary, 2 weeks, 1 month and 3-month sessions.
Regarding Claim 3, modified Samec discloses the method of claim 2. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing scans includes using the one or more oximetry devices to scan optic nerve oximetry during time periods ranging between 1 second and 11 seconds while a test subject is at rest. However, Samec teaches a recognized need for performing scans using retinal oximetry devices in a real-time manner (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec, wherein performing scans includes using the one or more oximetry devices to scan optic nerve oximetry during time periods ranging between 1 second and 11 seconds while a test subject is at rest.
Regarding Claim 4, modified Samec discloses the method of claim 3. Modified Samec discloses the claimed invention except for expressly disclosing wherein the time periods are 1, 3, 5, 8, and 10 seconds in duration. However, Samec teaches a recognized need for performing scans using retinal oximetry devices in a real-time manner (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec, wherein the time periods are 1, 3, 5, 8, and 10 seconds in duration.
Regarding Claim 5, modified Samec discloses the method of claim 4. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing scans includes using the one or more oximetry devices to scan optic nerve/retinal oximetry immediately after physical activity. However, Samec teaches a recognized need for performing scans using retinal oximetry devices in a real-time manner (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec, wherein performing scans includes using the one or more oximetry devices to scan optic nerve/retinal oximetry immediately after physical activity, such as the high-altitude hiking disclosed in Samec.
Regarding Claim 6, modified Samec discloses the method of claim 5. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing scans includes using the one or more oximetry devices to scan optic nerve/retinal oximetry after a time period following physical activity. However, Samec teaches a recognized need for performing scans using retinal oximetry devices in a real-time manner (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Childs, wherein performing scans includes using the one or more oximetry devices to scan optic nerve/retinal oximetry after a time period following physical activity.
Regarding Claim 11, modified Samec discloses the method of claim 1, wherein performing the scans of optic nerve/retinal oximetry in real-time includes using an oximetry device of the one or more oximetry devices to capture oxygenation levels of the optic nerve or retina of a test subject (“The controller may be configured to calculate a ratio of first wavelength light measurement to second wavelength light measurement, and wherein this ratio is converted to an oxygen saturation reading via a lookup table based at least in part upon the Beer-Lambert law”, 3:40-45).
Regarding Claim 12, Modified Samec discloses the method of claim 11, wherein using the oximetry device to accurately capture oxygenation levels of the optic nerve or retina includes using the oximetry device to capture scans that are reproducible within seconds, minutes, hours, days, weeks and months with exception to age variances as the test subject progresses in years (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44).
Regarding Claim 13, Modified Samec discloses the method of claim 12. Modified Samec discloses the claimed invention except for expressly disclosing wherein using the oximetry device to accurately capture oxygenation levels of the optic nerve or retina includes using the oximetry device to capture the scans in an optimal scan time-period that falls between 1 second and 11 seconds. However, Samec teaches a recognized need for performing scans using retinal oximetry devices in a real-time manner (“it would be valuable to certain users, such as high-altitude hikers or persons with certain cardiovascular or respiratory problems, to be able to see a convenient display of their own blood oxygen saturation as the move about their day and conduct their activities”, 2:40-44). One of ordinary skill in the art could have pursued any known potential retinal oximetry measurement protocols with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Samec, to capture the scans in an optimal scan time-period that falls between 1 second and 11 seconds, as part of routine experimentation.
Regarding Claim 20, modified Samec discloses the method of claim 1, wherein determining (i) that the change in oxygenation of the optic nerve or retina has the direct correlation to the severity of the traumatic brain injury or (ii) that the level of hypoxia of the optic nerve or retina indicates the severity of traumatic brain injuries (See the modification to Samec by Mufti in Claim 1) includes determining that ocular oxygenation depressions are an indicator of an occurrence and depth of a traumatic brain injury (“Retinal oximetry may be useful in understanding how TBI affects retinal oxygen delivery and utilization. Specifically, this technique provides insight into oxygen utilization in the retina, and therefore retinal metabolism, by determining the amount of oxyhemoglobin (HbO2) versus deoxyhemoglobin (Hb) in retinal vessels”, p. 870-871 of Mufti, which was relied upon in parent Claim 1).
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of in view of Mufti and Liu, and further in view of the Non-Patent Literature (NPL) to Childs et al (“Retinal imaging: a first report of the retinal microvasculature in acute mild traumatic brain injury”, hereinafter Childs).
Regarding Claim 7, modified Samec discloses the method of claim 1. Modified Samec discloses the claimed invention except for expressly disclosing the method further comprising performing a survey of each test subject's demographics(“this is the first preliminary account to suggest that mTBI may be associated with quantifiable changes in the retinal vessels”, p, 389, col. 1), teaches performing a survey of each test subject's demographics comprising gender (The examiner notes this limitation is claimed in the alternative, and only one element in the list must be disclosed in order for the claim to be anticipated), age (“After obtaining ethics institutional review board approval, patients between the ages of 21 and 70 years (Glasgow Coma Scale 13–15) presenting with two or more PCS and warranting overnight hospital observation were eligible”, p. 388, col. 2), race, sport, or competitive season versus off season (The examiner notes these limitations are claimed in the alternative, and only one element in the list must be disclosed in order for the claim to be anticipated). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the survey of Childs to modified Samec, because Mufti encourages investigating the correlation between retinal oxygen saturation and TBI prognosis, and such investigations may provide greater insight when demographics are accounted for.
Regarding Claim 19, modified Samec discloses the method of claim 1. Modified Samec discloses the claimed invention except for expressly disclosing wherein determining (i) that the change in oxygenation of the optic nerve or retina has the direct correlation to the severity of the traumatic brain injury or (ii) that the level of hypoxia of the optic nerve or retina indicates the severity of traumatic brain injuries includes using an oximetry device of the one or more oximetry devices to establish concrete quantitative values that are indicative of a test subject's concussive cascade during and after a traumatic brain injury. However, Childs teaches using an oximetry device of the one or more oximetry devices to establish concrete quantitative values (See Table 1) that are indicative of a test subject's concussive cascade during and after a traumatic brain injury (“All mTBI patients recruited into the study were invited to return to the emergency department (ED) for repeat retinal photography at the 6-month time-point after recruitment”, p. 388, col. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Samec such that determining (i) that the change in oxygenation of the optic nerve or retina has the direct correlation to the severity of the traumatic brain injury or (ii) that the level of hypoxia of the optic nerve or retina indicates the severity of traumatic brain injuries includes using an oximetry device of the one or more oximetry devices to establish concrete quantitative values that are indicative of a test subject's concussive cascade during and after a traumatic brain injury, because said change in oxygenation and/or level of hypoxia may have utility in diagnosing TBI, as taught by Childs (p. 388, col. 1, paragraph 1).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Mufti and Liu, and further in view of Cohen (US 20200060573 A1, hereinafter Cohen).
Regarding Claim 8, modified Samec discloses the method of claim 1. Modified Samec discloses the claimed invention except for expressly disclosing recruiting athletes as a control group comprising a portion of the group of test subject (“To appreciate the appearance and values for retinal vascular parameters (retinal signs) of mTBI patients, data from an existing healthy control group, and age-matched, sex-matched and race-matched to the patients, were compared.”, p. 388, col. 2). However, Cohen teaches recruiting athletes as a control group comprising a portion of the group of test subject (“A total of 65 (20.9±2.3 yr.) players were enrolled in the study. Player screening was undertaken to identify any possible contraindications to participating in the study, and for history of concussion. Tests were performed on a weekly schedule during the rugby club's training time”, [0222]; “To address potential bias, the administrator of the test did not know the condition of the player until after the data was processed”, [0026]; players unaffected by TBI would be a control group under broadest reasonable interpretation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec to include recruiting athletes as a control group comprising a portion of the group of test subjects, because traumatic brain injuries are often experienced in sports specifically, and a reliable assessment of whether the player has sustained mild Traumatic Brain Injury is required in a limited time period in this field (See [0003]-[0004] of Cohen).
Regarding Claim 9, modified Samec discloses the method of claim 8. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing scans includes performing scans on up to 150 athletes per week. However, Cohen teaches wherein performing scans includes performing scans on up to 150 athletes per week (“A total of 65 (20.9±2.3 yr.) players were enrolled in the study. Player screening was undertaken to identify any possible contraindications to participating in the study, and for history of concussion. Tests were performed on a weekly schedule during the rugby club's training time”, [0222]; the Examiner notes the phrase “up to 150 athletes per week” is construed as a maximum of 150 test subjects and a range of 0-150 subjects). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec by performing scans on up to 150 athletes per week, as taught by Cohen, as a matter of routine optimization of test parameters.
Regarding Claim 10, modified Samec discloses the method of claim 9. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing scans includes performing scans during each athlete's pre-season conditioning and through a competitive season as part of an athlete's fitness training. However, Cohen teaches wherein performing scans includes performing scans during each athlete's pre-season conditioning and through a competitive season as part of an athlete's fitness training (“Prior to the competition season, all enrolled players underwent the screening assessment. Once enrolled, all participants underwent the EEG test twice (for test-retest reliability purposes). Throughout the competition season, at training sessions typically two days after a competition game, participants were fitted with the EPOC+ headset and their SSVEP acquired.”, [0226]). would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec by performing scans during each athlete's pre-season conditioning and through a competitive season as part of an athlete's fitness training, as taught by Cohen, as a matter of routine optimization of test parameters.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Mufti and Liu, and further in view of Singhvi (US 20160259890 A1, hereinafter Singhvi).
Regarding Claim 14, Modified Samec discloses the method of claim 12. Modified Samec discloses the claimed invention except for expressly disclosing wherein capturing oxygenation levels of the optic nerve or the retina in real-time includes showing that there are demographically standardized norms for gender, age, race, ethnicity, and geographical location. However, Singhvi teaches there are demographically standardized norms (“Metadata is setup to define the file formats from various data sources and the rules for enrichment and loading. This data is then correlated based on the demographic and geographical attributes and normalized to build a healthcare data warehouse (HDW)”, [0017]) for gender, age, race, ethnicity, and geographical location (“The demographic parameters, for example, could include patient's age, gender, race, ethnicity, geographic location, et cetera, and disease characteristics would include the type and extent of the disease, pre-existing co-morbid conditions, number and type of prior treatment received for disease under investigation, pathological and/or molecular sub-type/ genetic variations of the disease under investigation etc”, [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec with the demographically standardized norms for geographic location of Singhvi, for the advantage of creating a cohort of valid sample population members to serve as a clinical database to support statistical probability analysis (e.g., the presence of traumatic brain injury) and evaluation of treatment metrics (See Abstract of Singhvi).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Mufti and Liu, and further in view of the Non-Patent Literature (NPL) to Schmitz et al (“Effects of high-intensity interval training on optic nerve head and macular perfusion using optical coherence tomography angiography in healthy adults”, hereinafter Schmitz).
Regarding Claim 15, modified Samec discloses the method of claim 12. Modified Samec discloses the claimed invention except for expressly disclosing wherein capturing oxygenation levels of the optic nerve or retina in real-time includes showing that oxygen perfusion of the optic nerve, as indicated in the scans, differs before and after athletic activity. However, Schmitz shows that oxygen perfusion of the optic nerve, as indicated in scans, differs before and after athletic activity (“We found significant differences in retinal macular and [optic nerve head] perfusion in young healthy subjects in response to a four-week HIIT program.”, Section 4.1; since oxygen is transported by blood, changes in oxygen perfusion reflects changes in blood perfusion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Samec wherein capturing oxygenation levels of the optic nerve or retina in real-time includes showing that oxygen perfusion of the optic nerve, as indicated in the scans, differs before and after athletic activity, as suggested by Schmitz, in order for the user to determine which changes in oxygen perfusion come from traumatic brain injury and which come from athletic activity.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Mufti and Liu, and further in view of Cohen.
Regarding Claim 16, modified Samec discloses the method of claim 12. Modified Samec discloses the claimed invention except for expressly disclosing wherein capturing oxygenation levels of the optic nerve or the retina in real-time includes showing that concussed scan values show a reduced deviation from a test subject's values and a deviation from a test subject's group norms. However, Cohen teaches that concussed scan values show a reduced deviation from a test subject's values and a deviation from a test subject's group norms (“FIGS. 10 and 11 show example graphical representations of a Fourier transformation of signals measured by electrodes 1210. The graphs show the frequency response of the electrodes. Typically, in healthy individuals, a high and distinct fundamental frequency will be observed with the frequency matching the frequency of the visual stimulus. FIG. 10 shows a response measured by electrodes in a healthy individual. A high and distinct response is measured at around 15 Hz. FIG. 11 shows a response measured by electrodes in an individual suffering a functional disorder of the brain. The graph of FIG. 11 shows a lower response which is less distinct”, [0147]; changes in brain frequency response include a reduced deviation from a test subject's values and a deviation from a test subject's group norms). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method wherein capturing oxygenation levels of the optic nerve or the retina in real-time includes showing that concussed scan values show a reduced deviation from a test subject's values and a deviation from a test subject's group norms, as taught by Cohen (the examiner notes that both reduced retinal oxygen values and reduced brain frequency values qualify as “concussed scan values”), because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claim 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Mufti and Liu, and further in view of Liu et al (US 20180020922 A1, hereinafter Liu ‘922).
Regarding Claim 17, modified Samec discloses the method of claim 1. Modified Samec discloses the claimed invention except for expressly disclosing wherein performing the scans includes measuring retinal oxygen levels of healthy non-concussed test subjects, with differentiation for any ocular or systemic disease states. However, Liu ‘922 teaches wherein performing scans includes measuring the retinal oxygen levels of healthy non-concussed test subjects (“Certain examples demonstrate the versatile and robust data collection capabilities our hyperspectral retinal imaging system by performing spectra-based retinal oximetry measurements on 10 healthy patients”, [0128]), with differentiation for any ocular or systemic disease states (“To demonstrate the performance capabilities of the system, we recruited 11 healthy volunteers with no known ocular disease for fundus imaging with the HSI system”, [0138]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec, with the measuring of retinal oxygen levels of healthy non-concussed test subjects, as suggested by Liu ‘922, for the advantages of acquiring baseline retinal oxygen levels for comparison with retinal oxygen levels in concussed individuals.
Regarding Claim 18, Modified Samec discloses the method of claim 17. Modified Samec discloses the claimed invention except for expressly disclosing wherein determining that the change in oxygenation of the optic nerve or the retina has the direct correlation to the severity of the traumatic brain injury includes using baseline retinal oxygen values of the healthy non-concussed test subjects to investigate active changes during one or more traumatic brain injuries incidents. However, Mufti teaches retinal oximetry may be useful in understanding how TBI affects retinal oxygen delivery and utilization by providing insight into oxygen utilization in the retina, and therefore retinal metabolism by determining the amount of oxyhemoglobin (HbO2) versus deoxyhemoglobin (Hb) in retinal vessels (p. 870-871). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Samec such that determining that the change in oxygenation of the optic nerve or the retina has the direct correlation to the severity of the traumatic brain injury includes using baseline retinal oxygen values of the healthy non-concussed test subjects to investigate active changes during one or more traumatic brain injuries incidents, as an obvious way to utilize the naturally occurring correlation taught by Mufti.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Faubert et al (US 5919132 A), which discloses performing, using one or more oximetry devices (See Fig. 1), scans of optic nerve/retinal oximetry of a group of test subjects within a time period of up to 11 seconds (“The present invention relates to a method and device for conducting on-line and real-time spectroreflectometry oxygenation measurement in the eye”, 1:8-10), each scan indicating oxygenation levels of an optic nerve (“For example, in the case of glaucoma, the oxygenation measurement can be taken in the region of the optic nerve”, 6:21-22) or a retina of a test subject, the one or more oximetry devices being portable and non-invasive (“the spectroreflectometry oxygenation measuring device comprises a portable fundus camera”, 3:33-34).
See Ramella-Roman et al (WO 2010042264 A1).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791