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 10 is objected to because of the following informalities: line 5 states “configured provide”, this should state “configured to provide”.
Claim 14 is objected to because of the following informalities: line 6 states “a subject” this should be “the subject”. Appropriate correction is required.
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 5, 7-10, and 15 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 “approx.” in claims 5, 8, and 9, is a relative term which renders the claim indefinite. The term “approx..” 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. Therefore, it is unclear what the objective standard is in order to allow the public to determine the scope of the claim.
Regarding claim 7, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Dependent claims 8-10 inherit the same deficiencies.
Claim 15 requires “the one or more controller devices”; and “the one or more communicator devices”; it is unclear if this is referring to the structures of claim 13 or the ones established in claim 14.
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.
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.
Claim(s) 1-12 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonizzato et al (BONIZZATO, M. et al., "Multi-pronged neuromodulation intervention engages the residual motor circuitry to facilitate walking in a rat model of spinal cord injury," Nature Communications, Vol. 12, No. 1925, March 26, 2021, 14 pages; copy included as part of IDS dated 10/30/2024) in view of Bloch et al (US Publication 2017/0354819).
Referring to Claim 1, Bonizzato et al teaches a combined neuromodulation/neurostimulation system for mitigating locomotor deficits of/or neuronal disorders, especially at least one of Parkinson's disease, epilepsy, chronic pain, depression, Alzheimer's disease, obsessive compulsive disorders, obesity, and/or other locomotor deficits and/or neuronal disorders after spinal cord injury (SCI), stroke, and/or other neurological disorders (e.g. abstract, page 2 left column last paragraph to page 2 right column ), said system comprising: at least one Deep Brain Stimulation (DBS) System for providing Deep Brain Stimulation to brain tissue of a subject (e.g. Page 2 right column first full paragraph discloses applying EES and DBS and Page 4 right column states discloses delivery of EES and DBS led to significant improvements of locomotor performance), at least one control unit, configured and adapted to provide stimulation data (e.g. page 3 left column paragraph starting “We then asked whether EES and DBS” discloses delivery of EES at 40Hz; therefore a control unit for controlling the output of the pulse generator), at least one stimulation unit, operatively connected to the at least one control unit, the at least one stimulation unit being configured and adapted to deliver epidural electrical stimulation (EES) to the dorsal side of the spinal cord of said subject (e.g. page 2 “functional impact of serotonin agonists, EES, DBS and their combination” paragraph discloses implanted electrodes over the dorsal aspect of the spinal segments to deliver EES), and at least one pulse generator wherein the at least one stimulation unit includes one or more electrodes configured to be implanted epidurally, the one or more electrodes being operatively connected to the at least one pulse generator (e.g. page 2 “functional impact of serotonin agonists, EES, DBS and their combination” paragraph discloses implanted electrodes over the dorsal aspect of the spinal segments to deliver EES and page 3 left column paragraph starting “We then asked whether EES and DBS” discloses delivery of EES at 40Hz). However, Bonizzato et al does not explicitly disclose at least one implantable pulse generator (IPG).
Bloch et al (US Publication 2017/0354819) teaches that it is known to use a control unit (e.g. Figure 11, Element 150) configured and adapted to provide stimulation data with at least one stimulation unit (e.g. Figure 11, Element 111) operatively connected to the at least one control unit, the at least one stimulation unit adapted to deliver epidural electrical stimulation (EES) to the dorsal side of the spinal cord to said subject and at least one implantable pulse generator (IPG) (e.g. Figure 11, Element 119 and Paragraph [0123] to provide improved locomotion of the patient by having the device implanted with reduced risk of the device being disconnected or damaged. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bonizzato et al, with a control unit (e.g. Figure 11, Element 150) configured and adapted to provide stimulation data with at least one stimulation unit (e.g. Figure 11, Element 111) operatively connected to the at least one control unit, the at least one stimulation unit adapted to deliver epidural electrical stimulation (EES) to the dorsal side of the spinal cord to said subject and at least one implantable pulse generator as taught by Bloch et al, since such a modification would provide the predictable results of improved locomotion of the patient by having the device implanted with reduced risk of the device being disconnected or damaged.
Referring to Claim 2, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 1, wherein the at least one stimulation unit is configured and adapted to deliver EES to the lumbosacral region of the spinal cord (e.g. Figure 7 caption and page 11 right column “surgical procedures and post-surgical care” paragraph discloses electrode over L2 and S1).
Referring to Claim 3, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 1, wherein the at least one DBS System is configured to provide low frequency stimulation to the brain tissue in a range between 0-150 Hz (e.g. page 2 right column 1st “results” paragraph discloses DBS 40Hz).
Referring to Claim 4, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 1, wherein the at least one DBS System is configured to provide low frequency stimulation to the brain tissue by means of charge balanced biphasic stimulation pulses (e.g. page 2 right column 1st “results” paragraph discloses biphasic pulses).
Referring to Claim 5, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 1, wherein the at least one DBS System is configured to provide stimulation pulses with a pulse width of approx. 90 μs (e.g. page 2 right column 1st “results” paragraph discloses DBS 200µs).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bonizzato et al with a pulse width of approx. 90 μs, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 6, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 1, wherein the at least one DBS System is configured to provide stimulation to the subthalamic nucleus (STN) (e.g. page 2 right column 1st “results” paragraph discloses PPN which means the device is capable of being to provide stimulation to the STN).
Referring to Claim 7, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 3, wherein the at least one stimulation unit is configured provide stimulation to spinal cord tissue and/or tissue of the spinal cord dorsal roots, for example in the range between 0-150 Hz (e.g. page 3 left column paragraph starting “We then asked whether EES and DBS” discloses delivery of EES at 40Hz).
Referring to Claim 8, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 7, wherein the at least one stimulation unit is configured provide stimulation to spinal cord tissue and/or tissue of the spinal cord dorsal roots at currents in the range of approx. 0.4-1.7 mA (e.g. page 3 left column paragraph starting “We then asked whether EES and DBS” discloses delivery of EES at 100-300 µA).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bonizzato et al with currents in the range of approx. 0.4-1.7 mA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 9, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 7, wherein the at least one stimulation unit is configured provide stimulation to spinal cord tissue and/or tissue of the spinal cord dorsal roots with a pulse width of approx. 200-300 μs (e.g. page 3 left column paragraph starting “We then asked whether EES and DBS” discloses delivery of EES at 300 μs).
Referring to Claim 10, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 7, wherein the at least one stimulation unit comprises at least a lead paddle with an electrode array and is configured provide stimulation to spinal cord tissue and/or tissue of the spinal cord dorsal roots with electrodes of the lead paddle, where at least one cathode is provided by the electrodes of the lead paddle and/or at least one anode is provided at least partially by either the electrodes of the lead paddle or the IPG case (e.g. Page 11 right column “surgical procedures and post-surgical care” discloses electrode arrays and page 12 “evaluation and characterization of midbrain stimulation” discloses biphasic pulses).
Referring to Claim 11, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 3, wherein the combined neuromodulation/neurostimulation system further comprises at least one module for administering a pharmacological agent to the subject (e.g. page 3 left column first paragraph discloses administration of serotonergic receptors and Figure 7 illustrates 5HT agonists being applied).
Referring to Claim 12, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 3, wherein the combined neuromodulation/neurostimulation system further comprises a Brain Spinal Interface (BSI) with microelectrode arrays, which are configured to be placed at the left and right leg primary motor cortex (e.g. page 11 right column “surgical procedures and post-surgical care” paragraph discloses a microelectrode array was inserted into the right motor cortex).
Referring to Claim 16, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 2, wherein the at least one stimulation unit is configured and adapted to deliver EES to the lumbosacral region of the spinal cord at spinal cord segments from L2 to S1 (e.g. Figure 7 caption and page 11 right column “surgical procedures and post-surgical care” paragraph discloses electrode over L2 and S1).
Referring to Claim 17, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 3, wherein the at least one DBS System is configured to provide low frequency stimulation to the brain tissue in a range of 20-100 Hz (e.g. page 2 right column 1st “results” paragraph discloses DBS 40Hz).
Referring to Claim 18, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 7, wherein the stimulation unit is configured provide stimulation to spinal cord tissue and/or the tissue of the spinal cord dorsal roots in a range of 20-100 Hz (e.g. page 3 left column paragraph starting “We then asked whether EES and DBS” discloses delivery of EES at 40Hz).
Referring to Claim 19, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 11, wherein said pharmacological includes Levodopa (e.g. page 3 left column first paragraph discloses administration of serotonergic receptors and Figure 7 illustrates 5HT agonists being applied).
Claim(s) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonizzato et al (BONIZZATO, M. et al., "Multi-pronged neuromodulation intervention engages the residual motor circuitry to facilitate walking in a rat model of spinal cord injury," Nature Communications, Vol. 12, No. 1925, March 26, 2021, 14 pages; copy included as part of IDS dated 10/30/2024) in view of Bloch et al (US Publication 2017/0354819), as applied above, and further in view of Capogrosso et al (CAPOGROSSO, M. et al., "A brain-spine interface alleviating gait deficits after spinal cord injury in primates," Nature, Vol. 589, November 9, 2016, 23 pages; copy included as part of IDS dated 10/30/2024).
Referring to Claim 13, Bonizzato et al in view of Bloch et al teaches the combined neuromodulation/neurostimulation system according to claim 12, wherein the Brain Spinal Interface (BSI) further includes one or more sensors (e.g. page 12 left column “cortex-midbrain interface” discloses Intracortical voltage signals were pre-amplified, digitalized and sampled). However, Bonizzato et al does not disclose one or more controller devices, configured and adapted to receive signals from the one or more sensors, process the received signals to determine one or more parameters regarding movement intentions of the subject, and generate one or more stimulation parameters based on the determined one or more movement intentions parameters, and one or more communicator devices, configured and adapted to communicate the generated one or more stimulation parameters to the at least one IPG. Capogrosso et al teaches that it is known to use Brain Spinal Interface (BSI) further includes intracortical arrays, wireless modules, and pulse generator which links cortical activity with spatiotemporal neuromodulation therapies (e.g. page 286 right column last paragraph to 287 left column 1st full paragraph) to provide improved movement and/or cortical dynamics and predict the probability of events, such as foot-strike and foot-off without prior training. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the [system/method] as taught by Bonizzato et al, with wherein the Brain Spinal Interface (BSI) further includes one or more sensors; one or more controller devices, configured and adapted to receive signals from the one or more sensors, process the received signals to determine one or more parameters regarding movement intentions of the subject, and generate one or more stimulation parameters based on the determined one or more movement intentions parameters, and one or more communicator devices, configured and adapted to communicate the generated one or more stimulation parameters to the at least one IPG as taught by Capogrosso et al, since such a modification would provide the predictable results of improved movement and/or cortical dynamics and predict the probability of events, such as foot-strike and foot-off without prior training.
Referring to Claim 20, Bonizzato et al in view of Bloch et al and Capogrosso et al teaches the combined neuromodulation/neurostimulation system according to claim 13, wherein said one or more sensors include one or more among a cortical neurosensor for recording a cortical activity of a subject, a motion sensor, a haptic sensor, and/or a physiological sensor (e.g. page 11 right column “surgical procedures and post-surgical care” paragraph discloses a microelectrode array was inserted into the right motor cortex; and Capogrosso et al page 286 right column last paragraph to 287 left column 1st full paragraph).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonizzato et al (BONIZZATO, M. et al., "Multi-pronged neuromodulation intervention engages the residual motor circuitry to facilitate walking in a rat model of spinal cord injury," Nature Communications, Vol. 12, No. 1925, March 26, 2021, 14 pages; copy included as part of IDS dated 10/30/2024) in view of Bloch et al (US Publication 2017/0354819) and Capogrosso et al (CAPOGROSSO, M. et al., "A brain-spine interface alleviating gait deficits after spinal cord injury in primates," Nature, Vol. 589, November 9, 2016, 23 pages; copy included as part of IDS dated 10/30/2024), as applied above, and further in view of Bonizzato et al (US Publication 2022/0266017), hereby referred to as “Bonizzato ‘017”.
Referring to Claims 14-15, Bonizzato et al in view of Bloch et al and Capogrosso et al teaches the combined neuromodulation/neurostimulation system according to claim 13, wherein the combined neuromodulation/neurostimulation system further includes one or more muscle activity sensors and/or one or more behavioral sensors for recording muscle activity and/or a behavior of a subject; one or more controller devices, configured and adapted to receive signals from the one or more muscle activity sensors and/or one or more behavioral sensors, process the received signals to determine one or more parameters regarding movement intentions of the subject, and generate one or more stimulation parameters based on the one or more determined movement intentions parameters, and one or more communicator devices, configured and adapted to communicate the generated stimulation parameters to the at least one IPG; wherein the one or more muscle activity sensors and/or one or more behavioral sensors, the one or more controller devices and/or the one or more communicator devices are integrated in a single unit.
Bonizzato ‘017 teaches that it is known to use one or more muscle activity sensors and/or one or more behavioral sensors for recording muscle activity and/or a behavior of a subject; one or more controller devices, configured and adapted to receive signals from the one or more muscle activity sensors and/or one or more behavioral sensors, process the received signals to determine one or more parameters regarding movement intentions of the subject, and generate one or more stimulation parameters based on the one or more determined movement intentions parameters, and one or more communicator devices, configured and adapted to communicate the generated stimulation parameters to the at least one IPG; wherein the one or more muscle activity sensors and/or one or more behavioral sensors, the one or more controller devices and/or the one or more communicator devices are integrated in a single unit as set forth in Figure 8A and Paragraphs [0174], [0179], and [0198] to provide improved gait event synchronization. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bonizzato et al, with one or more muscle activity sensors and/or one or more behavioral sensors for recording muscle activity and/or a behavior of a subject; one or more controller devices, configured and adapted to receive signals from the one or more muscle activity sensors and/or one or more behavioral sensors, process the received signals to determine one or more parameters regarding movement intentions of the subject, and generate one or more stimulation parameters based on the one or more determined movement intentions parameters, and one or more communicator devices, configured and adapted to communicate the generated stimulation parameters to the at least one IPG; wherein the one or more muscle activity sensors and/or one or more behavioral sensors, the one or more controller devices and/or the one or more communicator devices are integrated in a single unit as taught by Bonizzato ‘017, since such a modification would provide the predictable results of improved gait event synchronization.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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