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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 78-89, in the reply filed on 18 August 2025 is acknowledged.
Claim Objections
Claims 78, 97, 99, 103, 107-109, 113, and 116 are objected to because of the following informalities:
Regarding Claim 78, the limitation "at the onset of, or during, or after" in line 5 of the claim is written in a way that would be more grammatically correct to be written as "at the onset of, during, or after". Additionally, the limitation "the eye motion capture apparatus" in line 7 of the claim should be written as "the portable eye motion capture apparatus" in order to avoid confusion for if "the portable eye motion capture apparatus" is the same or different than "the eye motion capture apparatus". Since these apparatuses are the same, it is best to keep the language consistent.
Regarding Claim 78, limitations that are broken up by splitting lines should include commas or semicolons. Therefore, there should be a semi-colon after the term “imbalance” recited in line 6 of the claim to read as “imbalance;” as well as after the term “imbalance” recited in line 8 of the claim to read as “imbalance;”.
Regarding Claim 97, the limitation "portion of the sensor area" in line 3 of the claim should read as "portion of the overall sensor area" in order to be more obvious that "the overall sensor area" recited in lines 1 and 2 of the claim is the same area recited in line 3 of the claim.
Regarding Claims 99, 103, and 107-109, the claims recite the limitation "centre". The more accepted spelling for this limitation is "center".
Regarding Claim 113, the limitation "at the onset of, or during, or after" in lines 5-6 of the claim is written in a way that would be more grammatically correct to be written as "at the onset of, during, or after". Additionally, the limitation "the eye motion capture apparatus" in line 7 of the claim should be written as "the portable eye motion capture apparatus" in order to avoid confusion for if "the portable eye motion capture apparatus" is the same or different than "the eye motion capture apparatus". Since these apparatuses are the same, it is best to keep the language consistent.
Regarding Claim 113, limitations that are broken up by splitting lines should include commas or semicolons. Therefore, there should be a semi-colon after the term “location” recited in line 13 of the claim to read as “location;”.
Regarding Claim 116, the limitation "the eye motion capture apparatus" in line 7 of the claim should be written as "the portable eye motion capture apparatus" in order to avoid confusion for if "the portable eye motion capture apparatus" is the same or different than "the eye motion capture apparatus". Since these apparatuses are the same, it is best to keep the language consistent.
Appropriate correction is required.
Applicant is advised that should Claim 85 be found allowable, Claim 115 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The same goes for if Claim 89 should be found allowable, Claim 116 will be objected to under 37 CFR 1.75 as being substantially duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 78-89 and 91-116 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 78, the limitation "the onset" in line 5 of the claim lacks proper antecedent basis. This limitation is being interpreted to be "at an onset of". They previously recite “prior to onset”; the “onset” there gives “the onset” proper antecedent basis.
Additionally, the limitation “respective processed, part-processed, or unprocessed eye motion data” in line 12 of the claim is unclear. It is unclear what “respective” is being referred or compared to. This limitation is being interpreted to mean “transmitting the processed or part-processed eye motion data or transmitting unprocessed eye motion data”.
Furthermore, the limitation "the…unprocessed eye motion data" in line 12 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "the respective processed or part-processed eye motion data or transmitting unprocessed eye motion data".
Regarding Claim 78, the limitation “part-processing” in line 9 of the claim is unclear. It is unclear what entails “part-processing”. This limitation is being interpreted to mean “semi-processed for additional processing to still take place”. This limitation means that not all of the data has to be processed onboard the device or remotely.
Additionally, the processing/part-processing and transmitting steps recited in lines 9-16 of the claim is unclear if the recited “remote” location recited in lines 10 and 13 is the same or different between the steps. It is unclear how remotely processed or part-processed data would then be transferred to the same remote location. This limitation is being interpreted to mean that the processed or part-processed data does not have to be processed and transmitted to the same remote location and that there could be more than one remote location.
Regarding Claim 78, the limitation “a portable eye motion capture apparatus” recited in lines 4-6 of the claim is a device instead of a method step. A method claim should recite method steps, therefore the limitation could be written similar to “self-administering a portable eye motion capture apparatus…”
Additionally, the limitation “the eye motion capture apparatus configured for capturing eye motion data” recited in line 7 of the claim is a device instead of a method step. A method claim should recite method steps, therefore the limitation should be written similar to “capturing eye motion data of the user during their episode or event of dizziness or imbalance with the eye motion capture device”.
Furthermore, the method steps recited in lines 4-8 contradict one another. How can an “eye motion capture apparatus” capture eye motion data of the user “during their episode or event” if in the “self-administering” step the user does not cover their eyes until after an episode or event? The limitation is being interpreted to mean that the method step recited in lines 7-8 should recite “during or after their episode or event”.
Regarding Claim 81, the limitation "the nystagmus eye movements" lacks proper antecedent basis. This limitation is being interpreted to mean "nystagmus eye movements".
Regarding Claim 83, the claim has multiple recitations of the limitation "the nystagmus" which lacks proper antecedent basis. Both of these limitations are being interpreted to mean "the nystagmus eye movements".
Regarding Claim 84, the claim has multiple recitations of the limitation "the nystagmus" which all lack proper antecedent basis. Each of these limitations are being interpreted to mean "the nystagmus eye movements".
Additionally, the limitation "analyzing within phase eye kinematics of the nystagmus" is unclear. This verbiage does not make sense what is being analyzed or what "analyzing within phase" is referring to. This limitation is being interpreted to mean "analyzing kinematics of the nystagmus eye movements that occur within different phases".
Furthermore, the limitation "the eye movements" lacks proper antecedent basis. This limitation is being interpreted to mean "the nystagmus eye movements".
Regarding Claim 84, the claim recites the limitation "analyzing between nystagmus". This limitation is incomplete as there is nothing stated in the claim that recites what is being analyzed between nystagmus. Therefore, this claim is unclear what is meant by this limitation and is indefinite. The specification fails to clarify what this limitation is meant to mean and therefore cannot be interpreted.
Regarding Claim 85, the limitation "their episode or event" in line 3 of the claim is unclear. It is unclear if "their episode or event" is the same or different "episode or event" recited in lines 5 and 6 of Claim 78 in which this claim depends on. This limitation is being interpreted to mean "the episode or event of dizziness or imbalance."
Regarding Claim 89, the limitation "the patient" in line 3 of the claim lacks proper antecedent basis as well as is unclear if "the patient" and "the user", previously mentioned in the claims, are referring to the same individual using the eye motion capture apparatus or not. This limitation is being interpreted to mean "the user".
Additionally, the limitation "the recording" in line 4 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a recording".
Furthermore, the limitation "after the data capture" in line 4 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "after the captured eye motion data".
Finally, the limitation "compresses the video data" in line 4 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "compresses video data".
Regarding Claim 91, the limitation "the pupil(s)" in line 2 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a user's pupil(s)".
Regarding Claim 92, the limitation "the pupil(s)" in line 2 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a user's pupil(s)".
Regarding Claim 94, the limitation "displaying time rate of change of the angle of gaze" is unclear. It is unclear how something could display a time rate of change because it is unclear what a "time rate of change" would even entail. Based on the specification in Paragraph [0064], this limitation is interpreted to mean "displaying a rate of change of the angle of gaze with respect to time".
Regarding Claim 96, the limitation recited in lines 3-5 of the claim is unclear. The specification fails to clarify what this limitation is meant to mean and therefore cannot be interpreted.
Regarding Claim 101, the limitation "generally" is a relative term that makes the claim indefinite.
Additionally, the limitation "the image capture means" in line 3 of the claims lacks proper antecedent basis. This limitation is being interpreted to mean "image capture means".
Regarding Claim 102, the limitation "the accuracy of the eye kinematics" lacks proper antecedent basis. This limitation is being interpreted to mean "the accuracy of eye kinematics".
Regarding Claim 103, the limitation "the shape of the pupil image" lacks proper antecedent basis. This limitation is being interpreted to mean "a shape of a pupil image".
Additionally, the limitation "the view of the pupil" lacks proper antecedent basis. This limitation is being interpreted to mean "a view of a pupil".
Regarding Claim 105, the limitation "providing the alert" lacks proper antecedent basis. This limitation is being interpreted to mean "providing an alert".
Regarding Claim 106, it is unclear if iii) is supposed to be considered or not given the fact that the claim recites "following features i) to ii)". It is also unclear what is happening with "at least one of the following features". Is the method of claim 78 supposed to contain one of the following features? This limitation is interpreted to mean "configured to contain at least one of the following features i) to iii)".
Regarding Claim 107, the limitation "the respective pupil or iris" lacks proper antecedent basis. This limitation is interpreted to mean "the respective pupil or a respective iris".
Regarding Claim 110, the limitation "optionally" makes the claim unclear. It is unclear if the "environmental change" has to include one of the elements listed amongst the groups of elements, if the "body metrics" have to include measuring one of the elements listed amongst the group of elements, or if the "body metrics" have to include utilizing a method listed amongst the group of methods recited in the claim.
Regarding Claim 111, the limitation "optionally" makes the claim unclear. It is unclear if anything recited after the term "optionally" is actually a part of the device or not.
Regarding Claim 112, the limitation "optionally" makes the claim unclear. It is unclear if anything recited after the term "optionally" is actually a part of the device or not.
Regarding Claim 113, the limitation "their episode or event" in line 8 of the claim is unclear. It is unclear if "their episode or event" is the same or different "episode or event" recited in lines 5 and 6 of the same claim. This limitation is being interpreted to mean "the episode or event of dizziness or imbalance."
Regarding Claim 115, the limitation "their episode or event" in line 3 of the claim is unclear. It is unclear if "their episode or event" is the same or different "episode or event" recited in lines 5 and 6 of Claim 78 in which this claim depends on. This limitation is being interpreted to mean "the episode or event of dizziness or imbalance."
Regarding Claim 116, the limitation "the recording" in line 3 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a recording".
Additionally, the limitation "the data capture" in line 4 of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "after capture of the eye motion data".
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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 78-89 and 91-116 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 78 follows.
STEP 1
Regarding Claim 78, the claim recites a series of steps or acts, including a self-administered portable eye motion capture apparatus used to cover the eyes of a user; capturing eye motion data of the user during an episode or event of dizziness or imbalance; processing or part-processing captured eye motion data; transmitting eye motion data to a remote location; creating analytics based on the eye motion data to be used by a clinician in order to provide a medical diagnosis, produce a treatment regime, or report on the symptoms. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of creating analytics based on the eye motion data to be used by a clinician in providing a medical diagnosis, producing a treatment regime, or reporting of symptoms sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 78 fails to recite any application of the created analytics in a manner that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on the created analytics, nor does the method use a particular machine to perform the Abstract Idea. It is noted that while the claim recites that the created analytics are “for use by a clinician in providing the medical diagnosis, or producing the treatment regimen, or reporting on the symptoms, for said user”, this limitation is intended use language; the claimed invention does not positively recite a step of providing a medical diagnosis, producing a treatment regimen, or reporting on symptoms of the user based on the created analytics. Furthermore, were the claim amended to positively recite performing one or a combination of the aforementioned steps, each of these steps is also directed to a concept performed in the human mind, making each step drawn to a Mental Process, which is an Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 78 recites additional steps of capturing eye motion data of the user during an episode or event of dizziness or imbalance, processing or part-processing the captured eye motion data, and transmitting the eye motion data to a remote location. The capturing, processing, and transmitting steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea, as well as post-solution activity. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering or processing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the capturing, processing, and transmitting steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Dependent Claims 79-89 and 91-116 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing as well as steps that could be performed by a clinician looking at data and making a mental observation/judgment. Steps that can be performed by a clinician in this manner present steps that can be performed mentally which is an Abstract idea.
The capturing, processing, transmitting, and creating steps recited in the independent claim, Claim 78, maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 78-80, 84-85, 87-88, 95, 106, 112-113, and 115 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paul Lewkowski'034 (WO Patent Publication 2007128034 - cited by applicant).
Regarding Claim 78, Paul Lewkowski’034 discloses a method of capturing and reporting eye motion data of a user for use in a medical diagnosis, or for producing a treatment regime, or for monitoring symptoms, for a user (Page 7 lines 23-25 - provided a method of diagnosing a disease or disorder correlated with eye movement in a subject using a portable device), the method including:
a portable eye motion capture apparatus self-administered by the user to cover their eyes prior to onset of, at an onset of, during, or after, an episode or event of dizziness or imbalance (Page 6 lines 20-21 - applying the device to a subject undergoing treatment for the disorder when changes in eye movement are present; Page 14 lines 13-14 - Preferably the mask 10 is designed to provide a light omitting, tightly fitting cover 16 for the user's eyes 22; Page 19 lines 22-24 - a clinic 100 will provide the mask 10 to a patient 102 under investigation for them to take home or with them where ever they go, that is in an outpatient scenario);
the portable eye motion capture apparatus configured for capturing eye motion data of the user during or after the episode or event of dizziness or imbalance (Page 6 lines 1-3 - applying the device to a subject when changes in eye movement are present; and capturing images of the subject's eyes in digital form);
processing or part-processing the captured eye motion data onboard the portable eye motion capture apparatus or remote from the portable eye motion capture apparatus, or a combination of onboard and remotely (Page 19 lines 4-9 - The images can be transmitted to the medical professional in various forms and in a variety of ways. Thus, the images transmitted may be unprocessed, in which case, processing may occur remote from the subject. Alternatively, the images may be processed by the mask 10 prior to being sent to the medical professional. The level of processing may be varied and will be dictated by the features on the mask 10); and
transmitting the respective processed or part-processed eye motion data or transmitting unprocessed eye motion data to a remote location creating analytics based on the processed, part processed or unprocessed eye motion data for use by a clinician in providing the medical diagnosis, or producing the treatment regime, or reporting on the symptoms, for said user (Page 6 lines 14-15 - Page 19 lines 4-9 - Preferably, the method includes the step of producing a report and transmitting the report to the medical professional; The images can be transmitted to the medical professional in various forms and in a variety of ways. Thus, the images transmitted may be unprocessed, in which case, processing may occur remote from the subject. Alternatively, the images may be processed by the mask 10 prior to being sent to the medical professional. The level of processing may be varied and will be dictated by the features on the mask 10).
Regarding Claim 79, Paul Lewkowski’034 discloses including automatically detecting individual eye movements or patterns of eye movements within the processed and/or unprocessed said captured eye motion data (Page 20 lines 15-17 - The analysis may make use of already existing eye tracking processing software which is able to analyse the eye images for vertical, horizontal or tortional eye movements).
Regarding Claim 80, Paul Lewkowski’034 discloses including detecting nystagmus eye movements or patterns of nystagmus eye movements (Page 23 lines 11-14 - In particular the analysis may involve the identification of nystagmus during the time of a vestibular attack, as well as the intensity and direction of the nystagmus. Analysing eye movements during an attack of dizziness can be a key diagnostic tool in vestibular disorders).
Regarding Claim 84, Paul Lewkowski’034 discloses including analyzing at least one component of the nystagmus eye movements or analyzing kinematics of the nystagmus eye movements that occur within different phases or analyzing at least one component of at least one slow phase of the nystagmus eye movements or analyzing transition(s) of one or more phases of the nystagmus eye movements or analyzing between nystagmus, or analyzing a combination of any two or more thereof to determine drivers of the nystagmus eye movements, origin of the nystagmus eye movements and/or physiological pathways contributing to the nystagmus eye movements (Page 20 lines 13-18 - In the case of nystagmography the analysis concentrates on recorded eye movements during the dizzy attack. The analysis may make use of already existing eye tracking processing software which is able to analyse the eye images for vertical, horizontal or tortional eye movements, pupil diameter and other eye attribute parameters).
Regarding Claim 85, Paul Lewkowski’034 discloses wherein the eye motion data includes or is augmented by eye movement video sequences, 3Dorientation and position of the user's head during the episode or event of dizziness or imbalance, eye kinematics and tracking data, other eye feature information, patient history, questionnaire data, information pertinent to diagnosis, or a combination of any two or more thereof (Page 17 lines 20-23 - allows for increased accuracy in measuring eye movements. It also advantageously allows for the comparison of eye attributes such as pupil diameter, which may be indicative of particular diseases and disorders; Page 23 lines 18-21 - The analysis of the captured images of changes in the eye may also help to diagnose other neurological disorders. Changes in other attributes of the eye such as discolouration, pupil size and iris size may also lead to diagnosis of numerous other medical conditions).
Regarding Claim 87, Paul Lewkowski’034 discloses including instructing the user when and how to self-administer and use the portable eye motion capture apparatus (Page 19 lines 24-26 - The clinic 100 will also be responsible for training the patient or their carer to make themselves safe and to deploy the mask when they experience an attack of dizziness commencing).
Regarding Claim 88, Paul Lewkowski’034 discloses wherein episode capture and/or recording is monitored in real or near real time by at least one clinician following automatic detection and transmission of recorded or direct image data as the episode or event occurs (Page 19 lines 10-17 - The manner in which the images are transmitted to the medical professional will vary depending on the functionality of the mask 10. When the mask 10 includes a removable storage means - such as the CF card 60 - containing the data, the storage means could be sent to the health-care professional. When the mask 10 includes a data transmission means such as the communications port 90 described above, the images, processed or unprocessed, can be transmitted directly to the health care professional. This can be achieved via the Internet or any other suitable mode of data transmission; Page 20 lines 21-23 - Another mode of use for the device is the real-time viewing and recording of eye images. This would be likely in an inpatient situation or in a situation where the data is transmitted wirelessly to a clinician or other health professional).
Regarding Claim 95, Paul Lewkowski’034 discloses including identifying pupil position and/or pupil diameter in a reference region (Page 20 lines 15-18 - The analysis may make use of already existing eye tracking processing software which is able to analyse the eye images for vertical, horizontal or tortional eye movements, pupil diameter and other eye attribute parameters).
Regarding Claim 106, Paul Lewkowski’034 discloses an alert is provided, or the apparatus ceases operating or does not start working, until light external of the apparatus that reaches the user's eyes is removed or falls to an accepted level within the portable eye motion capture apparatus (Page 14 lines 23-28 - The mask 10 may also include a seal indicating means that provides a suitable indication that the mask 10 is properly fitted. This indicating means may take the form of a light detecting electronic sensor that is operable to emit light or sound via a user control interface 70, described in further detail below, to indicate whether the mask 10 is properly fitted (i.e. no light sensed by the light detecting electronic sensor), or otherwise).
Regarding Claim 112, Paul Lewkowski’034 discloses determining general health, personal health, stress, fatigue or illness by detection/measurement of eye state or changes in eye state (Page 23 lines 13-17 - Analysing eye movements during an attack of dizziness can be a key diagnostic tool in vestibular disorders. It may help determine whether the cause of a patient's imbalance problems is vestibular (inner ear) or otherwise, and if vestibular they may point towards a specific diagnosis); and/or
assessing data relating to head movement and eye or pupil motion, optionally the assessing further including assessing data relating to at least one measured body function and/or at least one environmental factor, such as at least one body function includes at least one of heart rate, blood pressure, body temperature, oxygen level, wherein, optionally, the at least one environmental factor includes at least one of ambient temperature, air pressure, humidity, location, gravity; and/or assessing data including determining at least one threshold, safe range, cut-off, optionally the at least one threshold, safe-range or cut-off including determining one or more of a safe threshold for a person conducting an activity, a threshold for time spent in or presence in a particular gravity or change of gravity (Page 5 lines 23-25 - a method of assessing eye movement using a portable device in accordance with an aspect of the present invention as herein described; Page 8 lines 1-3 - comparing said images with a database of eye movement data correlated with a range of disorders and/or conditions to diagnose the disease or disorder; Page 24 lines 5-7 - The portable device of the present invention can be conveniently worn when these stimuli are applied to ensure eye movement data is efficiently captured).
Regarding Claim 113, Paul Lewkowski’034 discloses the user capturing their nystagmus eye motion data at their home, residence, place of work, or place of recreation (Page 19 lines 22-24 - a clinic 100 will provide the mask 10 to a patient 102 under investigation for them to take home or with them where ever they go, that is in an outpatient scenario; Page 23 lines 11-14 - In particular the analysis may involve the identification of nystagmus during the time of a vestibular attack, as well as the intensity and direction of the nystagmus. Analysing eye movements during an attack of dizziness can be a key diagnostic tool in vestibular disorders), the method including:
the user self-administering the apparatus, the apparatus being a portable eye motion capture apparatus, to cover their eyes prior to onset of, at an onset of, during, or after, an episode or event of dizziness or imbalance (Page 6 lines 20-21 - applying the device to a subject undergoing treatment for the disorder when changes in eye movement are present; Page 14 lines 13-14 - Preferably the mask 10 is designed to provide a light omitting, tightly fitting cover 16 for the user's eyes 22; Page 19 lines 22-24 - a clinic 100 will provide the mask 10 to a patient 102 under investigation for them to take home or with them where ever they go, that is in an outpatient scenario);
the portable eye motion capture apparatus configured for capturing eye motion data of the user during the episode or event of dizziness or imbalance (Page 6 lines 1-3 - applying the device to a subject when changes in eye movement are present; and capturing images of the subject's eyes in digital form);
processing or part-processing the captured eye motion data onboard the portable eye motion capture apparatus or remote from the portable eye motion capture apparatus or a combination of onboard and remotely (Page 19 lines 4-9 - The images can be transmitted to the medical professional in various forms and in a variety of ways. Thus, the images transmitted may be unprocessed, in which case, processing may occur remote from the subject. Alternatively, the images may be processed by the mask 10 prior to being sent to the medical professional. The level of processing may be varied and will be dictated by the features on the mask 10); and
transmitting the respective processed or part-processed eye motion data or transmitting unprocessed eye motion data to a remote location creating analytics based on the processed, part processed or unprocessed eye motion data (Page 6 lines 14-15 - Page 19 lines 4-9 - Preferably, the method includes the step of producing a report and transmitting the report to the medical professional; The images can be transmitted to the medical professional in various forms and in a variety of ways. Thus, the images transmitted may be unprocessed, in which case, processing may occur remote from the subject. Alternatively, the images may be processed by the mask 10 prior to being sent to the medical professional. The level of processing may be varied and will be dictated by the features on the mask 10).
Regarding Claim 115, Paul Lewkowski’034 discloses wherein eye motion data includes or is augmented by eye movement video sequences, 3D orientation and position of the user's head during the episode or event of dizziness or imbalance, eye kinematics and tracking data, other eye feature information, patient history, questionnaire data, information pertinent to diagnosis, or a combination of any two or more thereof (Page 17 lines 20-23 - allows for increased accuracy in measuring eye movements. It also advantageously allows for the comparison of eye attributes such as pupil diameter, which may be indicative of particular diseases and disorders; Page 23 lines 18-21 - The analysis of the captured images of changes in the eye may also help to diagnose other neurological disorders. Changes in other attributes of the eye such as discolouration, pupil size and iris size may also lead to diagnosis of numerous other medical conditions).
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.
Claims 81-83 and 114 are rejected under 35 U.S.C. 103 as being unpatentable over Paul Lewkowski’304 (WO Patent Publication 2007128034 – cited by applicant) in view of Phillips et. al.'557 (WO Patent Publication 2019224557).
Regarding Claim 81, Paul Lewkowski’034 discloses the method outlined in Claim 80 above, but fails to disclose including determining speed and direction of nystagmus eye movements and/or determining speed and direction of patterns of the nystagmus eye movements. Phillips et. al.’557 teaches considering the direction and speed of nystagmus to measure eye movement (Page 24 lines 9-15 - Nystagmus is characterised by a periodic motion in which the eyes involuntarily drift slowly in one direction, before moving in the opposite direction at a faster speed. Nystagmus can be horizontal or vertical; left, right, up or down-beating, as defined by the direction of the fast phase of the cycle (shown in Figure 4). The slow phase velocity (SPV), measures the speed of eye movement in degrees per second during the slow component of nystagmus). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include measuring the direction and speed of a nystagmus event in order to help characterize what type of nystagmus event is occurring as seen in Phillips et. al.’557.
The same rationale for Claim 81 applies to Claim 114 as the claims are mere duplicates of one another.
Regarding Claim 82, Paul Lewkowski’034 in view of Phillips et. al.’557 discloses the method outlined in Claim 81 above. Paul Lewkowski’034 also discloses including displaying pattern, speed and/or direction of the nystagmus eye movements or patterns of eye movements as at least one graphic representation and/or on an electronic display (Page 5 lines 5-6 - the user control interface and the visual display are provided integrally such as in a liquid crystal display (LCD) touch screen or the like; Page 6 lines 1-3 - applying the device to a subject when changes in eye movement are present; and capturing images of the subject's eyes in digital form).
Regarding Claim 83, Paul Lewkowski’034 in view of Phillips et. al.’557 discloses the method outlined in Claim 81 above. Paul Lewkowski’034 also discloses including determining at least one driver or origin of the nystagmus eye movements from the pattern speed or direction of the nystagmus eye movements (Page 1 lines 22-26 - The presence of nystagmus (very specific, rapid, involuntary eye movements) during a dizziness attack can suggest to a clinician that there is a vertiginous component to it and the direction of the nystagmus eye movements may provide some evidence to a specialist in the field, of more specific information, such as which ear (or which part of the ear) has the active disease; Page 23 lines 11-17 - In particular the analysis may involve the identification of nystagmus during the time of a vestibular attack, as well as the intensity and direction of the nystagmus. Analysing eye movements during an attack of dizziness can be a key diagnostic tool in vestibular disorders. It may help determine whether the cause of a patient's imbalance problems is vestibular (inner ear) or otherwise, and if vestibular they may point towards a specific diagnosis).
Claims 86, 89, 104-105, and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Paul Lewkowski’304 (WO Patent Publication 2007128034 – cited by applicant) as applied to Claim 78 above, in view of Tsai et. al.'245 (WO Patent Publication 2018213245).
Regarding Claim 86, Paul Lewkowski’034 discloses the method outlined in Claim 78 above, but fails to disclose including identifying severity, timing and location of the episode or event. Tsai et. al.’245 teaches identifying severity, time, and location of neurological conditions (Paragraph [0046] - Device 100 may also, or alternatively, be configured to determine whether the subject suffers from a neurological condition and/or the severity…Device 100 may also, or alternatively, enable the type of neurological condition and/or specific locations or structures of the brain that have been injured to be identified based on differences in the blink reflex and/or blink period between the left and right eye. Over time, device 100 may be configured to track changes in the baseline blink reflex, blink period, and/or brain reflex as a subject ages or is repeatedly exposed to brain or neurological trauma). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include identifying severity, time, and location of an episode or event in order to get a baseline that can be used to compare similar episodes or events over time as well as getting a better understanding of what is occurring as seen in Tsai et. al.’245.
Regarding Claims 89 and 104, Paul Lewkowski’034 discloses the method outlined in Claim 78 above, but fails to disclose wherein the portable eye motion capture apparatus performs on-board processing that occurs during or after video capture of the eye motion data, wherein the on-board processing detects if the user closes their eyes during a recording and/or after the captured eye motion data, compresses video data and/or logs particular eye and head movements. Paul Lewkowski’034 also fails to disclose detecting partial eye closure or full eye closure occurring within a threshold time. Tsai et. al.’245 teaches discarding or ignoring blink-related data wherein an amount of time that a user’s eyes are closed is compared to a threshold amount of time during imaging (Paragraph [0044] - Blink reflex device 100 may also, or alternatively, be configured to detect when the subject exhibits an abnormal blink and may reject, discard, and/or ignore any data associated with a blink reflex measurement of the abnormal blink or other non-reflex closure or movement of the eye. An abnormal blink may occur when the eye of the subject does not fully return to the open state, does not fully close, remains closed for a prolonged time period (e.g., greater than 2 times, 5 times, 10 times, 15 times, etc. of a normal blink period) (sometimes referred to as a “micro-sleep”)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include discarding or ignoring periods of time whenever the user’s eyes are closed for longer than a threshold amount of time in order to discount abnormal data as a way to filter and observed desired data as seen in Tsai et. al.’245.
The same rationale for Claim 89 applies to Claim 116 as the claims are mere duplicates of one another.
Regarding Claim 105, Paul Lewkowski’034 discloses the method outlined in Claim 104 above, but fails to disclose using the threshold time to allow for a user blinking, such as if eye full or partial eye closure is within the threshold time; and/or if eye full or partial closure is beyond the threshold time, providing an alert and/or stop recording and/or apparatus shut down/go into sleep mode occurs. Tsai et. al.’245 teaches applying a threshold amount of time wherein a user’s eyes remain closed (Paragraph [0044] - An abnormal blink may occur when the eye of the subject does not fully return to the open state, does not fully close, remains closed for a prolonged time period (e.g., greater than 2 times, 5 times, 10 times, 15 times, etc. of a normal blink period) (sometimes referred to as a “micro-sleep”)); and providing an alert to the user (Paragraph [0112] - In the event that the received information does not match the stored information, blink reflex may output a notification that alerts the user that a tracking point cannot be identified). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include an alert to a user whose eyes remain closed beyond a threshold amount of time in order to notify the user that the device cannot perform its function as it is supposed to so that a user can make adjustments as needed as seen in Tsai et. al.’245.
Claims 91, 92, and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Paul Lewkowski’304 (WO Patent Publication 2007128034 – cited by applicant) as applied to Claim 78 above, in view of Wesley Krueger'608 (U.S. Patent Application 20160262608 - cited by applicant).
Regarding Claim 91, Paul Lewkowski’034 discloses the method outlined in Claim 78 above, but fails to disclose wherein a starting point and a finishing point of a user’s pupil(s) is used to determine direction and magnitude of eye or pupil movement and/or other eye kinematics. Wesley Krueger'608 teaches determining eye movement based on changes in eye positioning – direction - from an initial position to a different position over a distance - magnitude (Paragraph [0222] - The saccade eye position 1701 changes during this duration 1709 to reach a new position that differs from the initial eye position by a distance that can be defined as a saccade amplitude 1711. FIG. 17B shows the typical relationship between saccade amplitude and saccade duration). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include tracking eye movements based on changes in eye positioning from an initial position to a different position over a distance in order to understand and characterize eye movements as seen in Wesley Krueger’608.
Regarding Claim 92, Paul Lewkowski’034 discloses the method outlined in Claim 78 above, but fails to disclose including capturing rotational motion of the eye(s) and/or pupil(s); and/or determining speed and/or rate of rotation and/or other eye kinematics from time taken for a full or partial rotation. Wesley Krueger'608 teaches capturing torsional eye movement through observing eye rotation (Paragraph [0051] - The most natural definition of a torsional eye movement is as a rotation about the line of sight. The line of sight is the imaginary line that connects the eye with the fixation target. When the eye rotates about this line, the eyes remain fixated on this same target. When the eye makes any horizontal and/or vertical gaze shift, the line of sight and, therefore, the axis of rotation for torsion, shifts as well). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include capturing rotational eye movement in order to identify and understand shifting that occurs in a user’s gaze as seen in Wesley Krueger’608.
Regarding Claim 99, Paul Lewkowski’034 discloses the method outlined in Claim 78 above, but fails to disclose using one or more of pupil center, pupil shape or pupil position relative to a horizontal plane/reference for calibration/position determination; and/or including calibrating or compensating for incorrect position of the portable eye motion capture apparatus or an image capture means of the portable eye motion capture apparatus, such as by frame positioning/windowing, apparatus positioning and/or gaze positioning/pupil position, and/or correcting for misalignment in recordings due to incorrect portable eye motion capture apparatus placement. Wesley Krueger'608 teaches using a center of a user’s pupil relative to a horizontal point as a reference for position determination (Paragraph [0232] - Eye tracking using binocular horizontal and vertical eye position estimates can be derived from the relative positions of multiple corneal reflections and the center of the pupil. By using two eye landmarks (corneal surface reflections and pupil center) whose relative position are invariant under translation, the angular position of the eye independently of lateral motion of the video system relative to the head is able to be estimated). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Paul Lewkowski’304 to include using a center of a user’s pupil relative to a horizontal point in order to be used as a reference for position determination as a way to understand pupil position and movement as seen in Wesley Krueger’608.
Claim 93 is rejected under 35 U.S.C. 103 as being unpatentable over Paul Lewkowski’304 (WO Patent Publication 2007128034 – cited by applicant) as applied to Claim 78 above, in view of Matthew Stack'099 (U.S. Patent Application 20130308099).
Regarding Claim 93, Paul Lewkowski’034 discloses the method outlined in Claim 78 above, but fails to disclose including using at least one of pixel count, pixel size and/or pixel pattern, of a sensor of a camera or each said camera of the portable eye motion capture apparatus to determine angle of gaze of the user, the method including determining angle of gaze from captured image data and/or image data recordings of eye/pupil position/movement, and/or the method including determining and/or displaying a rate of change of the angle of gaze with respect to time. Matthew Stack'099 teaches using pixels to determine a gaze angle of a user (Paragraph [0104] - This measurement of the distance between the centroid and the glint permits calculating the gaze angle which is correlated to the position of the dot as illustrated at 126 start