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 .
For the purpose of examination, all references to as-filed specification have been made using the USPGPub. version of the instant application.
Status of Claims
Claims 1-14 are currently pending and under consideration.
Claim Objections
Claims 3-5, 7, 11, and 14 are objected to under 37 CFR 1.75(c) as being in improper form because multiple dependent claims should refer to other claims in the alternative only and/or cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim 3-5, 7, 11, and 14 not been further treated on the merits.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "electrical stimulator configured to apply electrical stimulation…the electrical stimulation " in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Paragraphs [0125], [0126], and [0128] of the specification provides corresponding structure for “electrical stimulator” that includes electrodes, channels, etc.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edgerton et. al, (US 20180280693, published 10/04/20218, hereinafter known as Edgerton).
Regarding claim 1, Edgerton teaches a method of neuromodulating the central nervous system of a subject, the method comprising applying electrical stimulation to the spinal cord of a subject [0005] in a manner sufficient to maintain voluntary control of physical activity during ((“stepping ability was assessed while the subject walked in the EKSO with and without stimulation at T11 and/or Co1 in both a passive and an active mode” in [0238]): when electrical stimulation is actively delivered [0238]; wherein in the absence of electrical stimulation the subject is capable of maintaining voluntary control of physical activity due to the neuroplasticity induced in the brain and spinal cord by the neuromodulation (“Based on the effort applied by the subject, the onboard computer will provide the necessary assistance to complete the step cycle. The EKSO has several tilt and position sensors that maintain the position of various joints within a fixed trajectory. We hypothesized that tonic transcutaneous electrical spinal cord stimulation can be used to re-engage the spinal circuitry to facilitate stepping in the EKSO and to progressively recover voluntary control of specific joint movements after complete paralysis in [0234]).
Regarding claim 2, Edgerton teaches applying the electrical stimulation is sufficient to integrate and reconnect the brain to the spinal cord [0009].
Regarding claim 3, Edgerton teaches applying electrical stimulation to the spinal cord of the subject is sufficient to excite neurons in the brain and spinal cord (“locomotion can be improved, in some embodiments substantially, when locomotor and postural spinal neuronal circuitries are stimulated simultaneously” in [0206]).
Regarding claim 12, Edgerton teaches the system comprising an electrical stimulator configured to apply electrical stimulation to the spinal cord of a subject in a manner sufficient to maintain voluntary control of physical activity during the electrical stimulation (“As the subject is in a vertical position, combination partial weight bearing and activation of spinal neural networks via stimulation greatly enhances locomotor as well as autonomic functions“ in [0244]).
Regarding claim 14, Edgerton teaches the electrical stimulator is integrated into a wearable device [0053].
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Edgerton in view of Simon et. al, (US 20140257437, published 09/11/2014, hereinafter known as Simon).
Regarding claim 4, Edgerton teaches the method of neuromodulating the central nervous system as described in claim 1.
However, Edgerton does not teach applying electrical stimulation to the spinal cord of the subject is sufficient to inhibit neurons in the brain and spinal cord.
Simon teaches Devices, systems and methods are disclosed for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain (Abstract). The non-invasive method involves performing electrical stimulation at that location, using surface stimulators that are similar to those used for peripheral nerve and muscle stimulation for treatment of pain (transdermal electrical nerve stimulation), muscle training (electrical muscle stimulation) and electroacupuncture of defined meridian points [0217], which would read on “inhibition of excitatory neurons in the brain and spinal cord.” .
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the inhibition of excitatory neurons in the brain and spinal cord of Simon with the method of neuromodulating the central nervous system of Edgerton in order to treat variety of conditions including pain.
Claims 5, 7, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Edgerton in view of Johnson et. al, (US 20070299895 A1, published 12/27/2007, hereinafter known as Johnson).
Regarding claims 5 and 13, Edgerton teaches the method of neuromodulating the central nervous system as described in claims 1 and 12.
However, Edgerton does not teach the electrical stimulation comprises applying at least one waveform selected from the group consisting of: one or more of a trapezoidal monophasic waveform and a trapezoidal biphasic waveform; one or more of a triangular monophasic waveform and triangular biphasic waveform; an asymmetrical biphasic waveform; a double monophasic waveform; and a monophasic waveform.
Johnson teaches an apparatus and method of generating electrical stimulation waveforms using Direct Digital Synthesis (DDS) [Abstract]. A triangular wave stimulation may be more comfortable for a patient; the ramping up of current by the trapezoidal wave may also be more comfortable for a patient [0037], a wave emerged from filtering stage as a monophasic waveform (uni-directional); the amplification stage of the wave in which a negative and positive power source amplifies the signal and converts it to a biphasic waveform (bi-directional) [0053], and finally, that asymmetrical waveforms have been investigated [0003].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the electrical stimulation containing various waveforms of Johnson with the method of neuromodulating the central nervous system of Edgerton because these waveforms may allow the patient to acclimate to the therapeutic current (Johnson, [0037]).
Regarding claim 7, Edgerton and Johnson teach the method of neuromodulating the central nervous system as described in claim 5.
However, Edgerton does not teach wherein each waveform comprises a high frequency component and a low frequency component and wherein the high frequency component provides an analgesic effect on the skin and the low frequency component tunes the spinal cord neurons to achieve the required functional goals.
In the modified device of Johnson, Johnson teaches that the high-frequency wave passes through the skin tissues more easily because as frequency increases, the skin impedance decreases [0039], and the low frequency wave constitutes the signal recognized as affecting cellular functions [0038].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of waveforms with both high frequency and low frequency components of Johnson with the method of neuromodulating the central nervous system of Edgerton because a combination of the low-frequency wave and the high-frequency wave overcomes the frequency-dependent skin-impedance limitations of low-frequency waveforms (Johnson, [0040]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Edgerton and Johnson as applied to claim 5 above, and in further view of Murphy et. al, (Brain Stimulation, Volume 13, Issue 5, 2020, pages 1370-1380, hereinafter known as Murphy).
Regarding claim 6, Edgerton and Johnson teach the method of neuromodulating the central nervous system as described in claim 5.
However, Edgerton and Johnson do not teach wherein the one or more applied waveforms further comprises a DC offset.
Murphy teaches that transcranial random noise stimulation (tRNS), may induce more pronounced and reliable neuromodulatory effects by delivering a randomly fluctuating electrical field which prevents activation of homeostatic mechanisms (Murphy, Brain Stimulation, Volume 13, Issue 5, 2020, pages 1370-1380). tRNS can also be delivered with a direct current offset (DC-offset), (Murphy, Brain Stimulation, Volume 13, Issue 5, 2020, pages 1370-1380).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of a DC-offset of Murphy with the method of neuromodulating the central nervous system of Edgerton and Johnson because tRNS + DC-offset may prove more effective as a means to enhance cognitive performance (Murphy, Brain Stimulation, Volume 13, Issue 5, 2020, pages 1370-1380).
Claim 8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Edgerton in view of Gerasimenko et. al, (US 9993642 B2, published 06/12/2018, hereinafter known as Gerasimenko).
Regarding claim 8, Edgerton teaches a method of neuromodulation in a subject having delayed or abnormal brain development [0008].
However, Edgerton does not teach the method comprising applying electrical stimulation to the spinal cord of the subject in a manner sufficient to induce neuroplasticity of the brain and spinal cord neural network of the subject.
Gerasimenko teaches the methods enable the spinal cord circuitry to utilize sensory input as well as newly established functional connections from the brain to circuits below the spinal lesion as a source of control signals (Col. 11, lines 7-10).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the establishment of connections between the brain and spinal cord of Gerasimenko with the method of neuromodulating the central nervous system of Edgerton because these methods can also serve as building blocks for future recovery strategies (Gerasimenko, Col. 10, lines 42-43).
Regarding claim 10, Edgerton teaches voluntary muscle control comprises one or more of: activating one or more muscle groups (“This method enabled the activation of all leg muscles in a coordinated manner to aid in the performance of stepping in the EKSO as well as when performing voluntary tasks.” In [0244]); inhibiting activity by one or more muscle groups [0017]; and having no impact on one or more muscle groups (“Little activation was observed in the proximal muscles.” In [0242]).
Regarding claim 11, Edgerton teaches the neuromodulation comprises applying the electrical stimulation in a manner sufficient to enable and learn a non-patterned, non-repetitive, stochastic motor response by the subject [0206].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Edgerton and Gerasimenko as applied to claim 8 above, and in further view of Zholudeva et. al, (Trends in Neurosicences, Sept. 2018, Vol. 41, No. 9, pp625-639, hereinafter known as Zholudeva).
Regarding claim 9, Edgerton and Gerasimenko teach the method of neuromodulating the central nervous system as described in claim 8, wherein the neuromodulation comprises applying the electrical stimulation at a frequency and amplitude sufficient to: activate one or more of the sensory neurons (Gerasimenko, Col. 8, lines 31-34) of the spinal cord neural network; and not directly activate the motor neurons of the spinal cord neural network (Gerasimenko, Col. 8, lines 49-52).
However, Edgerton and Gerasimenko do not teach the activation of the interneurons of the spinal cord neural network.
Zholudeva The adult mammalian spinal cord comprises four main neuronal types: lower (or spinal) motoneurons, preganglionic neurons, ascending projection neurons, and spinal interneurons (SpINs) (p625, Spinal Interneurons: An Essential Element for Neuroplasticity section). Zholudeva further highlight some of the recent progress that elucidates the importance of SpINs in circuits affected by spinal cord injury (SCI), especially those within respiratory networks and potential ways that spinal neuroplasticity can be therapeutically harnessed for recovery (Abstract). One of the strategies targeting neurons and circuitry spared by injury can include activity-based therapies that stimulate activity and afferent feedback to the spinal cord (Fig. 3)
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to target non-invasive electrical therapy of Edgerton and Gerasimenko to the spinal interneurons as taught by Zholudeva in order to non-invasively treat spinal interneurons involved in neuroplasticity in the injured spinal cord.
Conclusion
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792