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 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.
Claim(s) 1-9, 11, 13, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable by Towne(US 20160030765 A1) in view of Wells(US 20110172725 A1) and further in view of Witten(AU 2011323235 A1).
Regarding claim 1, Towne discloses a method for stimulating neural tissue, the tissue including one or more neurons genetically modified to express a light-sensitive protein, the method comprising: applying a light stimulus to the neural tissue; wherein the light stimulus comprises light in the visible spectrum and is configured to activate the light-sensitive protein(Referring again to FIG. 4C, an LED (or alternatively, “ILED”, to denote the distinction between this inorganic system and Organic LEDs) typically is a semiconductor light source, and versions are available with emissions across the visible, ultraviolet, and infrared wavelengths, with relatively high brightness. When a light-emitting diode is forward-biased (switched on), electrons are able to recombine with electron holes within the device, releasing energy in the form of photons[0079]); and applying a respective electrical stimulus to the neural tissue at the same time as, or at a predetermined delay time after, the start if applying of each pulse of the light stimulus, wherein each electrical stimulus comprises a pulse train(Furthermore, the combined electrical stimulation and optical stimulation described herein may also be used for intraoperative tests of inhibition in which an electrical stimulation is delivered and inhibited by the application of light to confirm proper functioning of the implant and optogenetic inhibition[0238]. Nerve stimulation, such as electrical stimulation (“e-stim”), causes bidirectional impulses in a neuron, antidromic and orthodromic stimulation[0234]); membrane depolarization in at least one of the neurons(One embodiment is directed to a system for controllably managing pain in the afferent nervous system of a patient having a targeted tissue structure that has been genetically modified to have light sensitive protein,[0018]is occurs when the depolarization results in a depolarized membrane potential such that sodium channels are inactivated and no action potential of spikes can be generated[0015]. The control of the output pulse train, or burst, may be managed locally by a state-machine, as shown in this non-limiting example, with parameters passed from the microprocessor[0182]).
Towne fails to explicitly state wherein the combination of the applying of the light stimulus and the applying of the electrical stimulus triggers membrane depolarization in at least one of the neurons. However, Wells teaches “An apparatus and method for stimulating animal tissue (for example to trigger a nerve action potential (NAP) signal in a human patient) by application of both electrical and optical signals for treatment and diagnosis purposes. The application of an electrical signal before or simultaneously to the application of a NAP-triggering optical signal allows the use of a lower amount of optical power or energy than would otherwise be needed if an optical signal alone was used for the same purpose and effectiveness[abstract]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a both optical and the electrical stimulation of the tissue at either the same or different times to maximize patient stimulation.
Towne further fails to explicitly state wherein the light stimulus is applied as a series of pulses. However, Witten teaches “The optical light source may be capable of providing continuous light and/or pulsed light, and may be programmable to provide light in pre-determined pulse sequences”(see attached copy, page 27 paragraph 1).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the optogenetic control system of Witten. Doing so would specify that the light/optical stimulation occurs in pulses that can be programmed with specific timing.
Regarding claim 2, Towne in view of Wells and Witten teaches the method of claim 1, wherein the membrane depolarization comprises an action potential(For example, optogenetic technologies and techniques recently have been utilized in laboratory settings to change the membrane voltage potentials of excitable cells, such as neurons, and to study the behavior of such neurons before and after exposure to light of various wavelengths. In neurons, membrane depolarization leads to the activation of transient electrical signals (also called action potentials or “spikes”), which are the basis of neuronal communication[0011]).
Regarding claim 3, Towne in view of Wells and Witten teaches the method of claim 1, but Towne fails to specify wherein a light power level of the light stimulus is below a threshold light power level to trigger an action potential in the at least one neuron in the absence of the electrical stimulus.
However, Wells teaches a depolarizing electrical signal 603 that is below threshold will cause a slightly depolarized response 613 that does not trigger a NAP. An optical signal 623 that is below threshold will also cause a depolarized response 643 (similar to the response 613 to a sub-threshold electrical signal 603) that also does not trigger a NAP(nerve action potential) [0080].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a threshold for the light stimulus power level that would serve as a trigger for an action potential based on if the threshold is met or not.
Regarding claim 4, Towne in view of Wells and Witten teaches the method claim 1, but Towne fails to disclose wherein an electrical power level of the electrical stimulus is below a threshold electrical power level to trigger an action potential in the at least one neuron in the absence of the light stimulus.
However, Wells teaches a depolarizing electrical signal 603 that is below threshold will cause a slightly depolarized response 613 that does not trigger a NAP. An optical signal 623 that is below threshold will also cause a depolarized response 643 (similar to the response 613 to a sub-threshold electrical signal 603) that also does not trigger a NAP(nerve action potential)[0080]. In other embodiments, the optical pulse is applied starting before the electrical pulse. In some such embodiments, the optical pulse continues for the duration of the electrical pulse. In other embodiments, the optical pulse ends before or as the electrical pulse starts. In other embodiments, the optical pulse ends as or after the electrical pulse ends. In some embodiments, the main optical pulse is of such long duration and is applied sufficiently early relative to the electrical pulse as to essentially act as a DC optical preconditioning voltage[0083].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to occur and end beforehand.
Regarding claim 5, Towne in view of Wells and Witten teaches the method of claim 1, but Towne fails to specify wherein the applying of the electrical stimulus starts at a predetermined delay time after the start of the applying of the light stimulus. However, Wells teaches of one or more pulses, duration of the optical pulse, temporal shape of the optical pulse, the wavelength(s) of the optical pulse, the amount of ambient light, electrical voltage or current magnitudes, temporal shape of the electrical pulse, time delay between the start of the electrical pulse and the start of the optical pulse, the frequency of pulses, pulse repetition rate of pulses, or time interval between pulses of the stimulation, and other parameters[0214].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to affect the tissue.
Regarding claim 6, Towne in view of Wells and Witten teaches the method of claim 5, but Towne fails to disclose wherein the predetermined delay time is greater than a duration of the light stimulus, such that the applying of the electrical stimulus starts after cessation of the applying of the light stimulus.
However, Wells teaches in other embodiments, the optical pulse is applied starting before the electrical pulse. In some such embodiments, the optical pulse continues for the duration of the electrical pulse. In other embodiments, the optical pulse ends before or as the electrical pulse starts. In other embodiments, the optical pulse ends as or after the electrical pulse ends. In some embodiments, the main optical pulse is of such long duration and is applied sufficiently early relative to the electrical pulse as to essentially act as a DC optical preconditioning voltage[0083]. In some embodiments, the apparatus further includes a digital-delay generator configured to trigger the optical-stimulation device to apply the pulse of optical energy after a predetermined time delay (from the start of the electrical pulse) determined by the digital-delay generator[0227].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to affect the tissue.
Regarding claim 7, Towne in view of Wells and Witten teaches the method of claim 5, but Towne fails to disclose wherein the predetermined delay time is less than a duration of the light stimulus, such that the applying of the electrical stimulus starts before cessation of the applying of the light stimulus. However, Wells teaches in other embodiments, the optical pulse is applied starting before the electrical pulse. In some such embodiments, the optical pulse continues for the duration of the electrical pulse. In other embodiments, the optical pulse ends before or as the electrical pulse starts. In other embodiments, the optical pulse ends as or after the electrical pulse ends. In some embodiments, the main optical pulse is of such long duration and is applied sufficiently early relative to the electrical pulse as to essentially act as a DC optical preconditioning voltage[0083]. In some embodiments, the apparatus further includes a digital-delay generator configured to trigger the optical-stimulation device to apply the pulse of optical energy after a predetermined time delay (from the start of the electrical pulse) determined by the digital-delay generator[0227].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to affect the tissue.
Regarding claim 8, Towne in view of Wells and Witten teaches the method of claim 6, but Towne fails to teach wherein the predetermined delay time is between 0.1 ms and 30 ms. However, Wells teaches the pulse of optical energy stimulation is applied starting at a time delay of about 1 msec after the start of the electrical pulse having the sub-threshold-for-stimulation amount electrical current[0227].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to affect the tissue.
Regarding claim 9, Towne in view of Wells and Witten teaches the method of claim 1, but Towne fails to disclose wherein a duration of the light stimulus is between 0.1 ms and 20 ms. However, and the duration (as an FWHM measurement) of the electrical pulse is in a range of 0.005 msec to 0.01 msec, of 0.01 msec to 0.02 msec, of 0.02 msec to 0.04 msec, of 0.04 msec to 0.08 msec, of 0.08 msec to 0.1 msec, or of 0.1 msec to 0.2 msec (i.e., subranges of the range 0.005 msec to 0.20 msec)[0121].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to affect the tissue.
Regarding claim 11, Towne in view of Wells and Witten teaches the method of claim 6, but Towne fails to disclose wherein the applying of the electrical stimulus starts between 0.1 ms and 60 ms, after cessation of the applying of the light stimulus, or wherein the applying of the electrical stimulus starts 0.1 ms, 0.2 ms, 0.5 ms, 1 ms, 5 ms, 10 ms, 15 ms, 20 ms, 25 ms, 30 ms, 40 ms, 50 ms, 60 ms, 0.1 s, 0.2 s, 0.3 s, 0.4 s, 0.5 s, 0.6 s, 0.8s, 1 s, 2s,3s,4s,5s,10s,15 s, 20 s, 30 s,45s, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, or 30 minutes, after the cessation of the applying of the light stimulus.
However, Wells teaches the delay (as a measurement between the time of the falling-edge half maximum value of the optical pulse and the time of the leading-edge half maximum value of the electrical pulse) between the end of the optical pulse and the start of the electrical pulse is in a range of 0.001 msec to 0.01 inclusive, a range of 0.01 msec to 0.02 msec inclusive, a range of 0.02 msec to 0.04 msec inclusive, a range of 0.04 msec to 0.1 msec inclusive, 0.1 msec to 0.2 msec inclusive, of 0.2 msec to 0.4 msec inclusive, of 0.4 msec to 1 msec inclusive, of 1 msec to 2 msec inclusive, of 2 msec to 4 msec inclusive, or of 4 msec to 10 msec inclusive[0121].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the system and method for optogenetic therapy of Towne with the apparatus and method for stimulating tissue of Wells. Doing so would specify a time delay for the electrical stimulation so there is adequate time for the light stimulus to affect the tissue.
Regarding claim 13, Towne in view of Wells and Witten teaches the method of claim 1, wherein the light stimulus comprises light having a wavelength of between 380 nm and 740nm(The light source may be configured to emit light having a wavelength that is within a wavelength range that is selected from the group consisting of: 440 nm to 490 nm, 491 nm to 540 nm, 541 nm to 600 nm, 601 nm to 650 nm, and 651 nm to 700 nm[0018]).
Regarding claim 15, Towne in view of Wells and Witten teaches the method of claim 1, wherein the light stimulus comprises light having a wavelength of between 450 nm and 600 nm, or wherein the light stimulus comprises light having a wavelength of less than 700 nm(The light source may be configured to emit light having a wavelength that is within a wavelength range that is selected from the group consisting of: 440 nm to 490 nm, 491 nm to 540 nm, 541 nm to 600 nm, 601 nm to 650 nm, and 651 nm to 700 nm[0018]).
Regarding claim 19, Towne in view of Wells and Witten teaches the method of claim 1, wherein the pulse train has a pulse frequency of between: 5 Hz to 5 kHz; or 500 Hz to 2 kHz; or 5 Hz to 100 Hz(Furthermore, the pulse repetition frequency (PRF) may be configured from between 0.1 Hz and 200 Hz, with a PRF of 1 Hz being typically effective for inhibitory channels[0317]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11, 13, 15, and 19 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. Applicant argues that the references fail to teach “triggering, or increasing the potential for, an action potential by using a combination of a pulsed, visible light stimulus and a pulse-train electrical stimulation”. However, incorporated art Wells teaches “In some embodiments of the present invention that uses both electrical and optical signals for stimulation, the electrical signal is pulsed. In some embodiments, the pulsed electrical signal is applied simultaneously with an optical pulse of substantially the same duration[0081]. Thus, recently, very specific optical-stimulation waveforms and wavelengths have been used to stimulate a nerve to trigger a NAP(nerve action potential) signal[0017]”. Wells can be combined with Witten, and Towne to disclose all claimed material. Therefore the 103 rejections for all claims stands.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796