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 .
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 does not contain a period at the end of the sentence. Appropriate correction is required.
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 1-3, 5-8, 10-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hamrah (US 20210393957) and further in view of Yao (WO2009089509).
Regarding claims 1 and 14, Hamrah discloses a method (Abstract – “Disclosed are apparatus, systems, devices, methods”) comprising: [claim 1]
a system (Abstract – “Disclosed are apparatus, systems, devices, methods”) comprising: [claim 14]
a mechanism configured to ([0007] – “a lens worn by the patient that includes circuitry to interface with the sensors”)
performing an […] method on a cornea of a patient for a time period to detect transient […] changes in one or more nerves of the cornea corresponding to […] generation of action potentials by the one or more nerves of the cornea ([0052] – “Disclosed are devices, apparatus, methods and other implementations, to study and/or measure corneal nerve function”, [0059] – “at least one of the sensors 130 a-e is configured to sense the electrical activity produced by the nerve tissue (e.g., such as ophthalmic nerve). More particularly, the at least one of the sensors 130 a-e is configured, in some embodiments, to measure activity by assessing nerve firing patterns”);
a computing device comprising a memory storing instructions and a processor to execute the instructions (Fig. 3 - device 300 comprises a processor 310 and memory 314, [0102] – “The device 300 additionally includes a controller 310, […] that provide processing functions, as well as other computations and control functionality. The controller 310 may also include memory 314 for storing data and software instructions for executing programmed functionality within the device”), [claim 14]
receiving, by a computing device comprising a processor, a record of the […] action potentials of the one or more nerves of the cornea and analyzing […] the action potentials generated by the one or more nerves of the cornea (Fig. 3 - device 300 comprises a processor 310, [0075] – “at least some of the processing applied to the sensed data (which includes the electrical activity signals sensed by at least one of the system's sensors) may be assigned to a remote processor, such as the computing device 150 a or 150 b”, [0052] – “study and/or measure corneal nerve function”), the analyzing comprising:
quantifying a property […] of the action potentials generated by the one or more nerves of the cornea for the time period ([0034] – “The electrical activity signals may be representative of measured electrical activity waveforms generated due to nerve firing by at least one nerve”, [0052] – “study and/or measure corneal nerve function”); and
comparing the property […] of the action potentials generated by the one or more nerves of the cornea for the time period to a baseline […] property ([0076] – “compare the measured electrical activity waveforms to a pre-stored baseline data representative of normal electrical activity waveforms”),
wherein a health property of the cornea is determined based on the comparison ([0077] – “an abnormality exists in the received electrical activity waveforms (e.g., the deviation of a sensed electrical activity signal, as determined by comparisons of samples of the measured signals to one or more of the baseline signals, or as determined from comparison of signal characteristics of the sensed waveform and one or more of the baseline waveforms, exceeds some pre-determined threshold)”), [0080] – “nerve firing patterns and changes in thresholds may be observed and profiled for different diseases and conditions. This can be used to identify, based on sensed waveforms, whether a patient may be suffering from some particular condition or disease”).
Conversely Hamrah does not teach performing an optical method on a […eye] of a patient for a time period to detect transient optical changes in one or more nerves of the cornea corresponding to Fast Optical Signals (FOS) provided with generation of action potentials by the one or more nerves […];
receiving, by a computing device comprising a processor, a record of the FOS of the action potentials of the one or more nerves […] and analyzing the FOS of the action potentials generated by the one or more nerves, quantifying a property of the FOS of the action potentials, comparing the property of the FOS of the action potentials generated by the one or more nerves […] for the time period to a baseline FOS property.
However Yao discloses performing an optical method on a […eye] of a patient for a time period to detect transient optical changes in one or more nerves of the cornea corresponding to Fast Optical Signals (FOS) provided with generation of action potentials by the one or more nerves […] (Abstract – “Disclosed is a method for detecting a physiological change in one or more retinal neurons using fast intrinsic optical signals created by a response to visible light”, pg. 2 line 19 – “transient intrinsic optical responses (lORs)”, pg. 2 line 23 – “fast IOR (FIOR)”, pg. 2 lines 32-33 – “FIORs closely associated with action potentials and postsynaptic potentials were also observed”);
receiving, by a computing device comprising a processor, a record of the FOS of the action potentials of the one or more nerves […] and analyzing the FOS of the action potentials generated by the one or more nerves (pg. 24 lines 26-29 – “advanced computer processing, concurrent spatially registered near infrared (probe light) and visible (stimulus light) microlens array illumination/imaging can provide accurate stimulation control and reliable recording of transient intrinsic optical responses”), quantifying a property of the FOS of the action potentials (Fig. 4, pg. 18 lines 16-18 – “(e) - (h) are temporal changes of averaged FIORs over the stimulus covered (black traces), stimulus uncovered (red traces) areas, and ERG responses (grey traces)”), comparing the property of the FOS of the action potentials generated by the one or more nerves […] for the time period to a baseline FOS property (Yao does not explicitly teach comparing the property of the FOS of the action potentials to a baseline FOS property however as cited above Hamrah teaches comparing the electrical activity waveforms to baseline electrical activity waveforms, therefore one with ordinary skill in the art would find it obvious to compare the detected FOS signals of Yao which are associated with action potentials to baseline FOS signals).
Yao is an analogous art considering it is in the field of a detecting nerve function in the eye.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hamrah to incorporate the detection of Fast Optical Signals of Yao to achieve the same results. One would have motivation to combine because “Optical imaging of transient intrinsic optical responses (lORs) in activated neural tissues can eliminate the requirement of exogenous dyes or indicators” (Yao – pg. 2 lines 18-20).
Regarding claim 2, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Hamrah further discloses further comprising stimulating the cornea of a patient with a stimulus that is configured to trigger one or more nerves of the cornea to generate the action potentials ([0058] – “a stimulator/transmitter (in a form of an integrated circuit, or chip) that can be embedded inside the lens or disposed on one of the surfaces of the lens to maintain close proximity to the corneal surface for adequate nerve stimulation (e.g., of corneal nerves)”), [0054] – “adjust the stimulation to be applied based on continually measured electrical activity of the nerves being monitored or sensed”).
Regarding claim 3, Hamrah and Yao disclose all the elements of the claimed invention as cited in claims 1 and 2.
Hamrah further discloses wherein the stimulus is at least one of a mechanical stimulus ([0069] – “the stimulus produced by the stimulator is mechanical”), a chemical stimulus ([0065] – “at least one chemical stimulator 140 c”), or thermal stimulus ([0069] – “Other examples of possible stimuli generated by the one or more stimulators of the system 100 include thermal stimuli”).
Regarding claim 5, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hamrah does not teach wherein the transient optical changes correspond to phase shifts from neuron membrane motion, expansion and contraction, refractive index, scattering, and/or birefringence.
However Yao discloses wherein the transient optical changes correspond to phase shifts from neuron membrane motion, expansion and contraction, refractive index (pg. 20 lines 32-33 – “refractive index change of neural tissues (Stepnoski et al., 1991), to produce transient optical changes”), scattering (pg. 2 lines 28-32 – “Fast light scattering responses have been observed in intact and isolated photoreceptors (Harary 1978; Kahlert 1990; Pepperberg 1988) through fast photodiode recording. Those signals might be specifically associated with the fast phototransduction process, and may provide useful information for functional assessment of the photoreceptors”), and/or birefringence.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hamrah to incorporate the detection of Fast Optical Signals of Yao to achieve the same results. One would have motivation to combine because “Optical imaging of transient intrinsic optical responses (lORs) in activated neural tissues can eliminate the requirement of exogenous dyes or indicators” (Yao – pg. 2 lines 18-20).
Regarding claim 6, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Hamrah further discloses further comprising: determining whether the patient has corneal nerve dysfunction ([0077] – “an abnormality exists in the received electrical activity waveforms (e.g., the deviation of a sensed electrical activity signal, as determined by comparisons of samples of the measured signals to one or more of the baseline signals, or as determined from comparison of signal characteristics of the sensed waveform and one or more of the baseline waveforms, exceeds some pre-determined threshold)”), [0080] – “nerve firing patterns and changes in thresholds may be observed and profiled for different diseases and conditions.” [0052] – “study and/or measure corneal nerve function and simultaneously or separately modulate stimulation applied to tissue (e.g., corneal nerves) to treat, for example, corneal nerve dysfunction”), corneal neuropathies, mild neurotrophic keratopathy, and/or neuropathic dry eye syndrome based on the health property ([0078] – “establish a baseline and profile different firing patterns to assess the influence of those nociceptors (including polymodal, thermal and mechanical receptors) in ocular diseases associated with corneal pain, including DED, NCP and post-herpetic neuralgia, as well as systemic corneal neuropathies”, [0052] – “dry eye disease (DED)”).
Regarding claim 7, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Hamrah further discloses further comprising tracking progress of a disease over time based on the health property ([0054] – “The resultant stimulation control signal may be such that the resulting stimulation (e.g., electrical stimulation) causes reduction of the abnormality. Thus, the feedback mechanisms of some of the embodiments described herein can continually adjust the stimulation to be applied based on continually measured electrical activity of the nerves being monitored or sensed. Some conditions or ailments that may be treated using a lens-based feedback implementation include (as a representative, non-exhaustive examples), dry eye condition, post-herpetic neuralgia, and other diseases and conditions as discussed herein”).
Regarding claim 8, Hamrah and Yao disclose all the elements of the claimed invention as cited in claims 1 and 7.
Hamrah further discloses wherein the disease is diabetic neuropathy, neuropathy related to a neuropathic pain syndrome, neuropathy related to radiation therapy, and/or neuropathy related to herpes simplex or herpes zoster infection ([0054] – “Some conditions or ailments that may be treated using a lens-based feedback implementation include (as a representative, non-exhaustive examples), dry eye condition, post-herpetic neuralgia, and other diseases and conditions as discussed herein”, [0052] – “treat or alleviate symptom in such diseases and conditions that include, but are not limited to: […] 2) neuropathic corneal pain (NCP) (including etiology related to post-surgical NCP, e.g. post-cataract surgery, post-LASIK surgery), […] herpetic keratitis, […] 8) diabetic neuropathy, and/or 9) other systemic diseases”).
Regarding claim 10, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
As sited above Yao teaches FOS.
Hamrah further discloses wherein the baseline […] is determined from a population of people, from a population of people with a similar condition, and/or from historical data from the patient ([0061] – “a baseline (of nerve firing profiles for healthy individuals as well as for individuals suffering from various diseases or conditions)”).
Regarding claim 11, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Hamrah further discloses wherein the one or more nerves comprise an individual nerve tract or a larger nerve bundle ([0059] – “sensors 130 a-e is configured to sense the electrical activity produced by the nerve tissue (e.g., such as ophthalmic nerve)”).
Regarding claim 12, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Hamrah further discloses wherein the health property of the cornea is linked to pain, depression, neuropathies of peripheral nerves and/or the central nervous system, and/or overall patient wellness ([0052] – “diseases and conditions that include, but are not limited to: 1) dry eye disease (DED), 2) neuropathic corneal pain (NCP) (including etiology related to post-surgical NCP, e.g. post-cataract surgery, post-LASIK surgery), psychiatric disease, neurological disease, autoimmune disease etc., 3) contact lens discomfort, 4) contact lens intolerance, 5) herpetic keratitis, 6) shingles, 7) other ocular diseases such as allergic keratitis, open-angle glaucoma, atopic keratoconjunctivitis, Fuchs' dystrophy etc., 8) diabetic neuropathy, and/or 9) other systemic diseases and conditions”).
Regarding claim 13, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hamrah does not teach wherein optical method comprises optical coherence tomography (OCT).
However Yao discloses wherein optical method comprises optical coherence tomography (OCT) (pg. 10 lines 22-24 – “The current disclosure describes a digital camera based optical coherent tomography (OCT) imager, with high spatial (sub-cellular) and temporal (millisecond) resolution”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hamrah to incorporate the optical coherence tomography of Yao to achieve the same results. One would have motivation to combine because “NIR light imaging of fast IORs allows a new methodology for high resolution evaluation of retinal neural function, while concurrently providing high resolution imaging of morphological structure” (Yao – pg. 10 lines 19-22).
Regarding claim 15, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 14.
Hamrah further discloses further comprising a stimulation mechanism configured to apply a mechanical stimulus ([0069] – “the stimulus produced by the stimulator is mechanical”), a chemical stimulus ([0065] – “at least one chemical stimulator 140 c”), or a thermal stimulation ([0069] – “Other examples of possible stimuli generated by the one or more stimulators of the system 100 include thermal stimuli”) to at least a portion of the cornea of the patient to trigger action potentials to be generated by the one or more nerves of the cornea of the patient ([0058] – “a stimulator/transmitter (in a form of an integrated circuit, or chip) that can be embedded inside the lens or disposed on one of the surfaces of the lens to maintain close proximity to the corneal surface for adequate nerve stimulation (e.g., of corneal nerves)”), [0054] – “adjust the stimulation to be applied based on continually measured electrical activity of the nerves being monitored or sensed”).
Regarding claim 16, Hamrah and Yao disclose all the elements of the claimed invention as cited in claims 14 and 15.
Hamrah further discloses wherein the processor averages responses to the mechanical stimulus, the chemical stimulus, or the thermal stimulation to measure signaling of the one or more nerves of the cornea of the patient ([0089] – “comparing statistical features of the waveform (e.g., average amplitude), general shape, frequency, and other characteristics of the measured waveform, to the corresponding features of the baseline waveforms”).
Regarding claim 17, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 14.
Conversely Hamrah does not teach wherein the mechanism configured to perform the optical method is configured for optical coherence tomography (OCT).
However Yao discloses wherein the mechanism configured to perform the optical method is configured for optical coherence tomography (OCT) (pg. 10 lines 22-24 – “The current disclosure describes a digital camera based optical coherent tomography (OCT) imager, with high spatial (sub-cellular) and temporal (millisecond) resolution”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamrah to incorporate the optical coherence tomography of Yao to achieve the same results. One would have motivation to combine because “NIR light imaging of fast IORs allows a new methodology for high resolution evaluation of retinal neural function, while concurrently providing high resolution imaging of morphological structure” (Yao – pg. 10 lines 19-22).
Regarding claim 18, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 14.
As cited above Yao teaches FOS.
Hamrah further discloses wherein the baseline […] is based on data from a population of people, data from a population of people with a similar condition, and/or from historical data from the patient ([0061] – “a baseline (of nerve firing profiles for healthy individuals as well as for individuals suffering from various diseases or conditions)”).
Regarding claim 20, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 14.
As cited above Hamrah teaches detection of the action potentials fired from the one or more nerves of the cornea of the patient.
Conversely Hamrah does not teach wherein the mechanism configured to perform the optical method […] is configured to detect the FOS of the action potentials fired […] based on at least one of phase changes from neuron membrane motion, expansion and contraction, refractive index, scattering, and/or birefringence.
However Yao discloses wherein the mechanism configured to perform the optical method […] is configured to detect the FOS of the action potentials fired […] based on at least one of phase changes from neuron membrane motion, expansion and contraction, refractive index (pg. 20 lines 32-33 – “refractive index change of neural tissues (Stepnoski et al., 1991), to produce transient optical changes”), scattering (pg. 2 lines 28-32 – “Fast light scattering responses have been observed in intact and isolated photoreceptors (Harary 1978; Kahlert 1990; Pepperberg 1988) through fast photodiode recording. Those signals might be specifically associated with the fast phototransduction process, and may provide useful information for functional assessment of the photoreceptors”), and/or birefringence.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamrah to incorporate the detection of Fast Optical Signals of Yao to achieve the same results. One would have motivation to combine because “Optical imaging of transient intrinsic optical responses (lORs) in activated neural tissues can eliminate the requirement of exogenous dyes or indicators” (Yao – pg. 2 lines 18-20).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hamrah (US 20210393957) and Yao (WO2009089509) as applied to claim 2 above, and further in view of Ehrmann (US 20190099071).
Regarding claim 4, Hamrah and Yao disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Hamrah does not teach wherein the stimulus is a mechanical stimulus provided by at least one of an aesthesiometer or a tonometer.
However Ehrmann discloses wherein the stimulus is a mechanical stimulus provided by at least one of an aesthesiometer or a tonometer ([0103] – “FIG. 1 is an exemplary embodiment of a liquid jet aesthesiometer capable of supplying a stimulus in the form of a liquid droplet to the cornea of a subject”).
Ehrmann is an analogous art considering it is in the field of providing mechanical stimulation to the cornea.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hamrah to incorporate the mechanical stimulus provided by an aesthesiometer of Ehrmann to achieve the same results. One would have motivation to combine because “the device may be configured to apply the stimulus to a precise, predetermined location on the ocular surface of the subject's eye” (Ehrmann – [0095]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hamrah (US 20210393957) and Yao (WO2009089509) as applied to claim 1 above, and further in view of Gore (US 20210275497).
Regarding claim 9, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hamrah does not teach further comprising tracking an efficacy of a therapy affecting the health property, wherein the therapy is at least one of nerve growth factors applied to the cornea of the patient, anti-inflammatories, anti-depressants, anticonvulsants, and/or ocular surgery.
However Gore discloses further comprising tracking an efficacy of a therapy affecting the health property, wherein the therapy is at least one of nerve growth factors applied to the cornea of the patient, anti-inflammatories, anti-depressants, anticonvulsants, and/or ocular surgery ([0378] – “50 subjects age 18 to 40 who received corneal surgery…Corneal sensitivity is measured using the Cochet-Bonnet aesthesiometer (CBA) (Luneau, Paris, France) at the center of the cornea, where the cornea is most sensitive, at two, four, six, and eight weeks post-surgery…Corneal nerve bundles are monitored by white light, tandem, slit scanning confocal microscopy prior to surgery and two, four, six, and eight weeks post-surgery”).
Gore is an analogous art considering it is in the field of monitoring nerves of the cornea.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hamrah to incorporate the tracking of efficacy of an ocular surgery of Gore to achieve the same results. One would have motivation to combine because it would allow one to determine if the eye is improving after the surgical procedure or if another therapeutic procedure is necessary.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hamrah (US 20210393957) and Yao (WO2009089509) as applied to claim 14 above, and further in view of Liu (CN102306301A).
Regarding claim 19, Hamrah and Yao disclose all the elements of the claimed invention as cited in claim 14.
As cited above Hamrah teaches detection […] of the action potentials fired from the one or more nerves of the cornea of the patient
Conversely Hamrah does not teach wherein the mechanism configured to perform the optical method on […] the patient is configured to motion register neuron membrane motion and detect transient optical changes to detect the FOS of the action potentials fired from the one or more nerves […] of the patient.
However Yao discloses wherein the mechanism configured to perform the optical method on […] the patient is configured […] detect transient optical changes to detect the FOS of the action potentials fired from the one or more nerves […] of the patient (Abstract – “Disclosed is a method for detecting a physiological change in one or more retinal neurons using fast intrinsic optical signals created by a response to visible light”, pg. 2 line 19 – “transient intrinsic optical responses (lORs)”, pg. 2 line 23 – “fast IOR (FIOR)”, pg. 2 lines 32-33 – “FIORs closely associated with action potentials and postsynaptic potentials were also observed”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamrah to incorporate the detection of Fast Optical Signals of Yao to achieve the same results. One would have motivation to combine because “Optical imaging of transient intrinsic optical responses (lORs) in activated neural tissues can eliminate the requirement of exogenous dyes or indicators” (Yao – pg. 2 lines 18-20).
Conversely Hamrah and Yao do not teach wherein the mechanism configured to perform the optical method on […] the patient is configured to motion register neuron membrane motion and detect transient optical changes to detect the FOS of the action potentials fired from the one or more nerves […] of the patient.
However Liu discloses wherein the mechanism configured to perform the optical method on […] the patient is configured to motion register neuron membrane motion and detect transient optical changes to detect the FOS of the action potentials fired from the one or more nerves […] of the patient (Abstract – “The invention provides motion identification system…a video image is processed to obtain motion information being sensitive to a motion speed and a direction… the obtained motion information is converted into a pulse train responded by the neuron; thirdly, a motion feature vector is extracted according to an average firing rate and a behavior feature of the pulse train and identification is carried out on the motion in the video image”).
Liu is an analogous art considering it is in the field of detecting action potentials of a nerve.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hamrah to incorporate the detection of neuron membrane motion of Liu to achieve the same results. One would have motivation to combine because “the system not only improves the accuracy of actions, but also significantly speeds up the recognition rate” (Liu – [0009]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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