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 .
Response to Amendment
Claims 1-11 and 32-51 are currently pending. Claims 1, 6, 9, 35-37, 40, 42, 43, 45, and 49 have been amended. Claim 1 has been amended to overcome the claim objection and claims 6, 35-37, 42, and 49 have been amended to overcome the 35 U.S.C. 112(b) rejections set forth in the Non-Final Office Action mailed on 23 March 2026.
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 35 and 36 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.
The term “about” in claims 35 and 36 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the term “about” encompasses. It is unclear what ranges “about 500 milliseconds” (claim 35) and “about 3 Hz” (claim 36) encompasses. Clarification is requested.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 recites “wherein the computing device is configured to acquire and process the first data and second data in order to determine whether an anomaly in the first data is due to an error or is indicative of a said pathological condition.” Because of the “or” language, claim 9 could also be read as “wherein the computing device is configured to acquire and process the first data and second data in order to determine whether an anomaly in the first data is indicative of a said pathological condition,” which, although not verbatim, has been recited in claim 1 and thus does not further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 8, 9, 32, 33, 39, 41, 44, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Komaki ‘897 (US Pub No. 2017/0150897 – previously cited) in view of Siwoff ‘851 (US Pub No. 2020/0029851 – previously cited) further in view of Samec et al. ‘101 (US Pub No. 2017/0365101).
Regarding claim 1, Komaki ‘897 teaches a system for assessing a patient's visual function ([0003]), comprising:
a first plurality of electrodes (Fig. 2 electrodes 152a, 152b and [0031]);
a head-mounted device comprising a frame (Fig. 2 frame 110 and [0050]), a left eye element positioned in the frame (Fig. 2 AXL and [0031]), a right eye element positioned in the frame (Fig. 2 AKR and [0031]), and a bridge connecting portions of the frame containing the left eye element and right eye element (The portion of the frame 110 that goes over the nose bridge is interpreted as a bridge connection portion.), wherein when positioned over the patient's periocular region, the frame is adapted to have a first side facing the patient's eyes and a second side opposing the first side (The bottom side of the frame 110 faces the patient’s eyes and the top side of the frame 110 faces away from the patient’s eyes.);
a first set of one or more light sources positioned within the left eye element or portion of the frame containing the left eye element on the first side (Fig. 2 LEDS M01, M11, M02 and [0051]);
a second set of one or more light sources positioned within the right eye element or portion of the frame containing the right eye element on the first side (Fig. 2 LED M12 and [0051]);
a second plurality of electrodes integrally positioned on the head-mounted device (Fig. 2 electrodes 151a, 151b and [0031]); and
a computing device operably connected to the first plurality of electrodes, the first set of one or more light sources, the second set of one or more light sources, and the second plurality of electrodes (Fig. 19 data processor 11 and [0128]), wherein the computing device is configured to activate at least one of the first set of one or more light sources or second set of one or more light sources to deliver visual stimuli to at least one of the patient's eyes ([0145], [0162]), wherein the computing device is configured simultaneously record the first set of data and the second set of data ([0138]).
Komaki ‘897 teaches all of the elements of the current invention as mentioned above except for wherein the first plurality of electrodes configured to be positioned on the patient's scalp and configured to generate a first set of data comprising visual evoked potential data; the second plurality of electrodes are configured to generate a second set of data comprising electroretinogram.
Siwoff ‘851 teaches EEG technology can be used to measure Visual Evoked Potential (VEP). The electrodes can be placed in a position to detect electrical signals resulting from nervous activity in the brain. Typically, the electrodes are placed on the scalp ([0003]). For Electro-Retinal-Gram (ERG), the electrodes are typically placed on or in vicinity to the eye, in order to measure nervous or electrical activity of the eye evoked in response to visual stimuli displayed to the eye ([0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first plurality of electrodes of Komaki ‘897 to include being positioned on the patient's scalp and configured to generate a first set of data comprising visual evoked potential data and the second plurality of electrodes of Komaki ‘897 to include being configured to generate a second set of data comprising electroretinogram as Siwoff ‘851 teaches that this will aid in obtaining nervous system activity to visual stimuli ([0006]).
Komaki ‘897 in view of Siwoff ‘851 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to process the first set of data and the second set of data to determine whether an anomaly in the visual evoked potential data is indicative of a pathological condition based on said processing.
Samec et al. ‘101 teaches a system that monitors physiological and/or behavioral aspects of the user using ERG and EEG sensors ([0482]). A visual evoked potential (VEP) analysis may be performed to determine optical nerve dysfunctions and to measure the integrity of the visual pathways ([0652]). Fig. 11 and [0653] mentions that a stimulus is presented to a user and electrodes are used to determine electrical potential, which is associated with the user’s reaction. The electrical potentials are processed to determine the presence of a neurological condition associated with the user’s reaction ([0653], [0663]). [0663] mentions that if the reaction to the stimulus is atypical (which the Examiner interprets as “determining whether [there is] an anomaly in the VEP”), the display system may determine that lesions of the optic nerve anterior to the optic chiasm may be present. Monocular and binocular VEP testing may be evaluated to determine optic neuropathy, which refers to damage to the optic nerve, which can be a result of many causes, e.g. ocular disorders. Monocular and Binocular VEP testing may also be evaluated to diagnose photosensitive epilepsy and identify which stimuli, e.g. patterns, cause seizures.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing system of Komaki ‘897 in view of Siwoff ‘851 to include processing the first set of data and the second set of data to determine whether an anomaly in the visual evoked potential data is indicative of a pathological condition based on said processing as Samec et al. ‘101 teaches that this will aid in determining optical nerve dysfunctions and the integrity of the visual pathways.
Regarding claim 2, Komaki ‘897 teaches wherein the head-mounted device is configured as a pair of goggles (Fig. 2 and [0049]).
Regarding claim 3, Komaki ‘897 teaches wherein the first set of one or more light sources and the second set of one or more light sources are light emitting diodes (Fig. 2 four LEDs M01, M02, M11, M12 and [0051]).
Regarding claim 4, Komaki ‘897 teaches wherein when the frame is positioned over the patient's periocular region, the left eye element and the right eye element respectively extend over and cover the patient's left eye and right eye respectively (Fig. 2 shows that AXL is on the left eye and AXR is on the right eye.).
Regarding claim 8, Komaki ‘897 in view of Siwoff ‘851 teaches all of the elements of the current invention as mentioned above except for wherein the first data is indicative of visually evoked potential responses and the second data is indicative of electroretinogram responses.
Siwoff ‘851 teaches measuring and displaying visual evoked potential (VEP), electro retina-gram (ERG) ([0059]) for use in neuro-rehabilitation ([0001]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first data and the second data of Komaki ‘897 in view of Siwoff ‘851 to include being indicative of visually evoked potential responses and electroretinogram responses, respectively, as Siwoff ‘851 teaches that this will aid in measuring how the brain and eye process visual information, which is useful in the field of neuro-rehabilitation ([0065]).
Regarding claim 9, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to acquire and process the first data and second data in order to determine whether an anomaly in the first data is due to an error or is indicative of a pathological condition.
Samec et al. ‘101 teaches a system that monitors physiological and/or behavioral aspects of the user using ERG and EEG sensors ([0482]). A visual evoked potential (VEP) analysis may be performed to determine optical nerve dysfunctions and to measure the integrity of the visual pathways ([0652]). Fig. 11 and [0653] mentions that a stimulus is presented to a user and electrodes are used to determine electrical potential, which is associated with the user’s reaction. The electrical potentials are processed to determine the presence of a neurological condition associated with the user’s reaction ([0653], [0663]). [0663] mentions that if the reaction to the stimulus is atypical (which the Examiner interprets as “determining whether [there is] an anomaly in the VEP”), the display system may determine that lesions of the optic nerve anterior to the optic chiasm may be present. Monocular and binocular VEP testing may be evaluated to determine optic neuropathy, which refers to damage to the optic nerve, which can be a result of many causes, e.g. ocular disorders. Monocular and Binocular VEP testing may also be evaluated to diagnose photosensitive epilepsy and identify which stimuli, e.g. patterns, cause seizures.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being configured to acquire and process the first data and second data in order to determine whether an anomaly in the first data is due to an error or is indicative of a pathological condition as Samec et al. ‘101 teaches that this will aid in determining optical nerve dysfunctions and the integrity of the visual pathways.
Regarding claim 32, Komaki ‘897 in view of Siwoff ‘851 teaches all of the elements of the current invention as mentioned above except for wherein the first plurality of electrodes comprises a ground reference electrode positioned on the patient's earlobe.
Siwoff ‘851 teaches that commonly used ground electrodes include the forehead, vertex (Cz), mastoid, earlobe (A1 or A2) or linked earlobes ([0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first plurality of electrodes of Komaki ‘897 in view of Siwoff ‘851 to include a ground reference electrode positioned on the patient's earlobe as Siwoff ‘851 teaches that this is commonly used for ground electrodes.
Regarding claim 33, Komaki ‘897 in view of Siwoff ‘851 teaches all of the elements of the current invention as mentioned above except for an amplifier operably connected between the computing device and the first and the second pluralities of electrodes.
Siwoff ‘851 teaches sampling bot the EEG or ERG data typically after being processed by an amplifier ([0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Komaki ‘897 in view of Siwoff ‘851 to include an amplifier operably connected between the computing device and the first and the second pluralities of electrodes as Siwoff ‘851 teaches that an amplifier is typical in EEG systems ([0075]).
Regarding claim 39, Komaki ‘897 teaches wherein at least one of the left eye element and the right eye element houses a printed circuit board supporting the at least one of the first set of one or more light sources and the second set of one or more light sources (Because Fig. 2 shows that the LEDs M01, M11, M02, M12 are on the same structure, frame 110, one of ordinary skill would understand that these LEDs are on the same circuit board.).
Regarding claim 41, Komaki ‘897 teaches a fastener comprising at least one of tape, straps, clasps, and elastic bands for securing the head-mounted device to the patient ([0166]).
Regarding claim 44, Komaki ‘897 in view of Siwoff ‘851 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to display the first set of data and the second set of data on a display screen.
Siwoff ‘851 teaches displaying visual stimuli on at least one display ([0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 to include being configured to display the first set of data and the second set of data on a display screen as Siwoff ‘851 teaches that this will aid in displaying the visual stimuli.
Regarding claim 45, Komaki ‘897 in view of Siwoff ‘851 teaches all of the elements of the current invention as mentioned above except for wherein the displayed first set of data and second set of data comprise waveform maps corresponding to the visual evoked potentials and the electroretinograms.
Siwoff ‘851 teaches displaying VEP and ERG responses (Figs. 8, 9 and [0059], [0104]-[0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the displayed first set of data and second set of data of Komaki ‘897 in view of Siwoff ‘851 to include being waveform maps corresponding to the visual evoked potentials and the electroretinograms as Siwoff ‘851 teaches that this will aid in conducting VEPs and ERGs on a plethora of difference devices having display screens ([0081]).
Claims 5-7, 10, 11, 40, 42, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Mowery et al. ‘116 (US Pub No. 2019/0143116 – previously cited).
Regarding claim 5, Komaki ‘897 teaches wherein on the first side of the frame each of the left eye element and the right eye element houses the first set of one or more light sources (Fig. 2 LEDS M01m M11, M02) and the second set of one or more light sources (Fig. 2 LED M12) respectively.
Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein on the second side of the frame each of the left eye element and the right eye element comprises an opaque covering or a semi-opaque covering.
Mowery et al. ‘116 teaches a translucent or opaque covering is provided in order to encourage the patient to minimize eye movement so that the frequency of therapy stimulation pulses continue to stimulate the desired tissue volumes throughout the therapy session ([0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second side of the frame each of the left eye element and the right eye element of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include an opaque covering or a semi-opaque covering as Mowery et al. ‘116 teaches that this will aid in encouraging the patient to minimize eye movement so that the frequency of therapy stimulation pulses continue to stimulate the desired tissue volumes throughout the therapy session.
Regarding claim 6, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein each of the left eye element and the right eye element is surrounded by a material, and wherein the second plurality of electrodes are integrated in the material.
Mowery et al. ‘116 teaches an eye-goggle-frame 560 with a flexible compressible elastic extension 531 that allows each eye-encircling s trip 511 to better conform to the patient’s face. Each eye-encircling strip 511 includes a double-sided pressure-sensitive-adhesive-coated foam layer 518, adhered on one of its faces to a hypo-allergenic substrate 517 on which are deposited a plurality of electrodes 111 each individually electrically connected by a conductor (also deposited on substrate 517) to a separate corresponding contact on electrical connector 541 (Fig. 5A and [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the left eye element and the right eye element of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being surrounded by a material, and wherein the second plurality of electrodes are integrated in the material as Mowery et al. ‘116 teaches that this will aid in better conforming to the patient’s face.
Regarding claim 7, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein each of the second plurality of electrodes is a pre-gelled surface electrode.
Mowery et al. ‘116 teaches a plurality of individually activatable electrodes that are coated with an electrically conductive gel and surrounded by an electrically insulating adhesive, in order that when an electrical signal is applied to a first selected electrode 111, the current goes into the tissue of the patient 99 only under that first electrode (and, in some embodiments, one or more other electrodes 111) when the signal from treatment-control apparatus 190 is active to the first electrode ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the second plurality of electrodes of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being a pre-gelled surface electrode and Mowery et al. ‘116 teaches that this will aid in the current going into the tissue of the patient only under that electrode when an electrical signal is applied.
Regarding claim 10, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the second plurality of electrodes includes a first electrode positioned at a first corner of the left eye element, a second electrode positioned at a second corner of the left eye element, a third electrode positioned at a third corner of the right eye element and a fourth electrode positioned at a fourth corner of the right eye element.
Mowery et al. ‘116 teaches electrodes 111 that are at a first corner and second corner of the left eye element and at a third corner and further corner of the right eye element (Fig. 1A and [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second plurality of electrodes of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include a first electrode positioned at a first corner of the left eye element, a second electrode positioned at a second corner of the left eye element, a third electrode positioned at a third corner of the right eye element and a fourth electrode positioned at a fourth corner of the right eye element as Mowery et al. ‘116 teaches that this will aid in ensuring that the current of the electrical signal applied goes into the tissue of the patient only under the electrodes ([0061]).
Regarding claim 11, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Mowery et al. ‘116 teaches all of the elements of the current invention as mentioned above except for wherein upon positioning the frame over the patient's periocular region, the first electrode and second electrode correspond to two corners of the patient's left eye whereas the third and fourth electrodes correspond to two corners of the patient's right eye.
Mowery et al. ‘116 teaches electrodes 111 that are at a first corner and second corner of the left eye element and at a third corner and further corner of the right eye element (Fig. 1A and [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first electrode and second electrode of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Mowery et al. ‘116 to include corresponding to two corners of the patient's left eye whereas the third and fourth electrodes correspond to two corners of the patient's right eye as Mowery et al. ‘116 teaches that this will aid in ensuring that the current of the electrical signal applied goes into the tissue of the patient only under the electrodes ([0061]).
Regarding claim 40, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101, as modified by Mowery et al. ‘116, teaches wherein the material comprises foam padding configured to contact the patient’s periocular region (Fig. 2 of Komaki ‘897 shows that the frame 110 contacts the periocular region of the patient.).
Regarding claim 42, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein each of the second plurality of electrodes comprises a spherical electrode having a diameter of 5 millimeters.
Mowery et al. ‘116 teaches the area of tissue under each one of a plurality of electrodes is between about 1 mm.sup.2 and about 50 mm.sup.2 (e.g., each electrode having electrical contact to skin in a square of about 1 mm by 1 mm to a square of about 7 mm by 7 mm, or a circle having a diameter of about 1.125 mm to about 8 mm) ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second plurality of electrodes of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include having a spherical electrode having a diameter of 5 millimeters as Mowery et al. ‘116 teaches that this is choosing from a finite number of identified, predictable solutions with a reasonable expectation of success as [0061] of Mowery et al. ‘116 mentions different sizing and dimensions of the electrodes.
Regarding claim 43, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101, as modified by Mowery et al. ‘116, teaches wherein each of the second plurality of electrodes is positioned on a surface of the material facing the patient's eye (Fig. 2 of Komaki ‘897 shows electrodes 151a and 151b are facing the patient’s eye.).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Klistorner et al. ‘245 (US Pub No. 2010/0091245 – previously cited).
Regarding claim 34, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the first plurality of electrodes is positioned over each of the patient's occipital, parietal, and central brain regions.
Klistorner et al. ‘245 teaches at least one recording electrode 110 is placed on the scalp of a subject (Fig. 1 and [0064]). It is noted that the dots that are on the scalp of the subject in Fig. 1 show electrodes on the occipital, parietal, and central brain regions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first plurality of electrodes of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being positioned over each of the patient's occipital, parietal, and central brain regions as Klistorner et al. ‘245 teaches that this will aid in detecting VEP signals from the subject ([0064]).
Claims 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Davis et al. ‘495 (US Pub No. 2015/0342495 – previously cited).
Regarding claim 35, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to trigger the first set of one or more light sources and the second set of one or more light sources to deliver flash stimuli having durations between 10 milliseconds and about 500 milliseconds.
Davis et al. ‘495 teaches a controller 110 may also modulate a light emission from the infrared light emitter 103 to create infrared flashes of light having durations less than 40 ms and an infrared flash frequency greater than 1 Hz ([0086]). Controlling the timing between the stimulus frequency and the infrared flash frequency can be advantageous so that, for example, the lighting created by the light stimulus interacts in a consistent manner with the infrared flashes. Other potential advantages of controlling the timing between the two frequencies include reduced peak power, better contrast with less chromatic aberration and less changes to lighting levels in embodiments using a camera sensitive to visible and IR light ([0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include triggering the first set of one or more light sources and the second set of one or more light sources to deliver flash stimuli having durations between 10 milliseconds and about 500 milliseconds as Davis et al. ‘495 teaches that this will aid in the light stimulus interacts in a consistent manner with the infrared flashes.
Regarding claim 36, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Davis et al. ‘495 teaches all of the elements of the current invention as mentioned above except for wherein the flash stimuli are delivered at a frequency between 1 Hz and about 3 Hz.
Davis et al. ‘495 teaches a controller 110 may also modulate a light emission from the infrared light emitter 103 to create infrared flashes of light having durations less than 40 ms and an infrared flash frequency greater than 1 Hz ([0086]). Controlling the timing between the stimulus frequency and the infrared flash frequency can be advantageous so that, for example, the lighting created by the light stimulus interacts in a consistent manner with the infrared flashes. Other potential advantages of controlling the timing between the two frequencies include reduced peak power, better contrast with less chromatic aberration and less changes to lighting levels in embodiments using a camera sensitive to visible and IR light ([0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flash stimuli of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Davis et al. ‘495 to include being delivered at a frequency between 1 Hz and about 3 Hz as Davis et al. ‘495 teaches that this will aid in the light stimulus interacts in a consistent manner with the infrared flashes.
Regarding claim 37, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein at least one of the first set of one or more light sources and the second set of one or more light sources comprise light emitting diodes having a homogeneous wavelength.
Davis et al. ‘495 teaches a first light emitter may have a first visible emission spectrum and may emit, for example, green, red, orange, blue, amber, or yellow light ([0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least one of the first set of one or more light sources and the second set of one or more light sources of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include light emitting diodes having a homogeneous wavelength as Davis et al. ‘495 teaches that this will aid in improving the measurements by making the stimulation more consistent, improving the data collection, and/or checking the error of conditions ([0043]).
Regarding claim 38, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein at least one of the first set of one or more light sources and the second set of one or more light sources comprise light emitting diodes having heterogeneous wavelengths.
Davis et al. ‘495 teaches a first light emitter may have a first visible emission spectrum and may emit, for example, green, red, orange, blue, amber, or yellow light. The first light emitter may be a LED. Optionally, other (2, 3, 4, 5 or more) visible light emitters may be present with distinct spectra. For example, some embodiments may use 4 LEDs that each have red, green, and blue emitters ([0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least one of the first set of one or more light sources and the second set of one or more light sources of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include light emitting diodes having heterogeneous wavelengths as Davis et al. ‘495 teaches that this will aid in improving the measurements by making the stimulation more consistent, improving the data collection, and/or checking the error of conditions ([0043]).
Claims 46, 47, 50, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 further in view of Malov ‘255 (US Pub No. 2003/0156255 – previously cited).
Regarding claim 46, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to determine a latency shift in a visual evoked potential waveform.
Malov ‘255 teaches that disease states such as glaucoma or optic nerve disorders that cause blind spots in the vision (e.g., optic neuritis in multiple sclerosis) can the detected and mapped. Both amplitudes and latencies of the signals can be compared to normal reference values or compared between the two eyes of a subject ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being configured to determine a latency shift in a visual evoked potential waveform as Malov ‘255 teaches that this will aid in detecting glaucoma or optic nerve disorders.
Regarding claim 47, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to determine an amplitude reduction in a visual evoked potential waveform.
Malov ‘255 teaches a VEP trace array from left and right eyes. It shows normal amplitude signals throughout the field of the right eye, but reduced VEP amplitudes in parts of the left visual field. FIGS. 7b(i) and (ii) show the corresponding subjective Humphrey visual field printouts from the right and left eyes respectively. Subjective losses of visual sensitivity are seen as gray areas on the upper right diagram and as black squares (representing high probability of abnormality compared to normals) on the total deviation and pattern deviation plots. The areas of defective vision seen in this subjective test are in the same area of the left visual field as they were in the objective VEP trace array. This confirms that the technique is capable of detecting visual defects in glaucoma (Figs. 7a, 7b and [0098]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include determining an amplitude reduction in a visual evoked potential waveform as Malov ‘255 teaches that this will aid in detecting visual defects in glaucoma.
Regarding claim 50, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to compare the first set of data and the second set of data to distinguish between pathological impairment of an optic pathway and insufficient retinal stimulation.
Malov ‘255 teaches that disease states such as glaucoma or optic nerve disorders that cause blind spots in the vision (e.g., optic neuritis in multiple sclerosis) can the detected and mapped. Both amplitudes and latencies of the signals can be compared to normal reference values or compared between the two eyes of a subject ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being configured to compare the first set of data and the second set of data to distinguish between pathological impairment of an optic pathway and insufficient retinal stimulation as Malov ‘255 teaches that this will aid in detecting glaucoma or optic nerve disorders.
Regarding claim 51, Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 teaches all of the elements of the current invention as mentioned above except for wherein the computing device is configured to classify a change in the first set of data as a technical anomaly when a corresponding change is detected in the second set of data.
Malov ‘255 teaches that disease states such as glaucoma or optic nerve disorders that cause blind spots in the vision (e.g., optic neuritis in multiple sclerosis) can the detected and mapped. Both amplitudes and latencies of the signals can be compared to normal reference values or compared between the two eyes of a subject ([0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing device of Komaki ‘897 in view of Siwoff ‘851 further in view of Samec et al. ‘101 to include being configured to classify a change in the first set of data as a technical anomaly when a corresponding change is detected in the second set of data as Malov ‘255 teaches that this will aid in detecting glaucoma or optic nerve disorders.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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