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 § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 11-14, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carbunaru et al. (US 2011/0106214).
In re claim 1, Carbunaru discloses a method [0002] for programming [0040] a stimulator device (fig. 3: 14) comprising a plurality of electrode nodes (fig. 2: plurality of electrodes E1 and E16 on leads 12(1) and 12(2)), each electrode node configured to be coupled to one of a plurality of electrodes (fig. 2; [0038]) configured to contact a patient’s tissue [0068], the method comprising:
programming the stimulator device to provide first (fig. 9b: first pulses are each first stimulation phase per electrode during a bi-phasic pulse; [0069]) and second pulses (fig. 9b: second pulses are each a charge recovery phase per electrode during a bi-phasic pulse; [0069]) at at least two of the electrode nodes to create via the first and second pulses a stimulation current through the patient’s tissue ([0039]: electrodes in array 26 provide stimulation; [0009, 0049] fig. 2),
wherein, at a first electrode node of the at least two electrode nodes, each first pulse comprises
a first monophasic pulse [0006] of a first polarity ([0069]: stimulation phase include a first polarity) and
a first passive charge recovery pulse ([0069]: passive charge recovery phase may be used) of a second polarity opposite the first polarity ([0069]: second phase includes a second opposite polarity),
the first passive charge recovery pulse being configured to recover charge stored during the first monophasic pulse ([0069]: first passive charge recovery pulse recharges charge; [0006]), and
wherein, at the first electrode node, each second pulse comprises a second monophasic pulse of the second polarity ([0080]: electrodes operated in a bipolar manner, resulting in the second pulse have a second monophasic pulse of the second polarity; [0069]: each phase results in opposite polarity being generated due to a recharge period [0006]) and a second passive charge recovery pulse of the first polarity [0069, 0080],
the second passive charge recovery pulse being configured to recover charge stored during the second monophasic pulse [0006, 0069],
wherein an amplitude [0077], pulse width, or both, of the first and second monophasic pulses is the same ([0077]: amplitude during first and second phases are the same).
In re claim 2, Carbunaru discloses wherein the first and second monophasic pulses are charge balanced at the first electrode node [0080].
In re claim 5, Carbunaru discloses
wherein the first passive recovery pulse follows immediately after the first monophasic pulse in the first pulse at the first electrode node (fig. 9b: charge recovery phase follows right after the first stimulation phase; [0069]), and
wherein the second passive recovery pulse follows immediately after the second monophasic pulse in the second pulse at the first electrode node (fig. 9b; [0069]).
In re claim 6, Carbunaru discloses wherein the amplitude of the first and second monophasic pulses comprise constant current amplitudes [0045].
In re claim 11, Carbunaru discloses wherein the second pulses are centered in time with the first pulses at the first electrode node (fig. 9b: first and second phase are centered between a time between them).
In re claim 12, Carbunaru discloses wherein the first and second pulses do not overlap at the first electrode (fig. 9b)
In re claim 13, Carbunaru discloses
wherein, at a second electrode node (fig. 2: 12(2)) of the at least two electrode nodes (fig. 2), each first pulse comprises
a third monophasic pulse [0006] of the second polarity ([0080]: electrodes operated in a bipolar manner, resulting in the first pulse having a third monophasic pulse of the second polarity; [0069]: each phase results in opposite polarity being generated due to a recharge period [0006]) and
a third passive charge recovery pulse of the first polarity [0069, 0080],
the third passive charge recovery pulse being configured to recover charge stored during the third monophasic pulse ([0069]: each passive charge recovery pulse recharges charge; [0006]),
wherein, at the second electrode node, each second pulse comprises
a fourth monophasic pulse of the first polarity ([0069]: stimulation phase may include a first polarity and the second electrode node would have its own third and fourth monophasic pulse and third and fourth passive charge recovery pulse) and
a fourth passive charge recovery pulse of the second polarity ([0069]: passive charge recovery pulse may include a second opposite polarity; [0069]: each phase results in opposite polarity being generated due to a recharge period [0006]),
the fourth passive charge recovery pulse being configured to recover charge stored during the fourth monophasic pulse ([0069]: each passive charge recovery pulse recharges charge; [0006]),
wherein the first and third monophasic pulses are coincident in time (fig. 9b),
wherein the second and fourth monophasic pulses are coincident in time (fig. 9b),
wherein the first and third passive charge recovery pulses are coincident in time (fig. 9b), and
wherein the second and fourth passive charge recovery pulses are coincident in time (fig. 9b).
In re claim 14, Carbunaru discloses wherein an interphase period (fig. 9b: interphase) during which no stimulation current flows intervenes between
(i) the first monophasic pulse and the first passive charge recovery pulse in each first pulse (fig. 9b: no stimulation during the interphase period), and
(ii) the second monophasic pulse and the second passive charge recovery pulse in each second pulse (fig. 9b).
In re claim 17, Carbunaru discloses,
wherein the stimulator device comprises at least one implantable lead (fig. 2: leads 12(1) and 12(2); [0004 ,0037]),
wherein at least some of the electrodes are located on the at least one implantable lead (fig. 2),
wherein the first electrode node comprises an electrode node coupled to an electrode located on the at least one implantable lead (fig. 2: electrode node 12(1) contains an electrode node i.e. the part of the lead which is coupled to electrodes E1-E8).
In re claim 19, regarding the limitations, “a stimulator device, comprising:
a plurality of electrode nodes, each electrode node configured to be coupled to one of a plurality of electrodes configured to contact a patient’s tissue; and
stimulation circuitry configured by stimulation parameters to provide first and second pulses at at least two of the electrode nodes to create via the first and second pulses a stimulation current through the patient’s tissue,
wherein, at a first electrode node of the at least two electrode nodes, each first pulse comprises a first monophasic pulse of a first polarity and a first passive charge recovery pulse of a second polarity opposite the first polarity,
the first passive charge recovery pulse being configured to recover charge stored during the first monophasic pulse, and
wherein, at the first electrode node, each second pulse comprises a second monophasic pulse of the second polarity and a second passive charge recovery pulse of the first polarity,
the second passive charge recovery pulse being configured to recover charge stored during the second monophasic pulse,
wherein an amplitude, pulse width, or both, of the first and second monophasic pulses is the same”,
see in re claim 1 above.
In re claim 20, Carbunaru discloses a non-transitory computer readable medium [0005, 0016] comprising instructions for programming a stimulator device [0016] comprising a plurality of electrode nodes [0016-0018], each electrode node configured to be coupled to one of a plurality of electrodes configured to contact a patient’s tissue (see in re claim 1 above).
Regarding the limitations, “wherein the instructions when executed are configured perform the following method:
programming stimulation circuitry in the stimulator device to provide first and second pulses at at least two of the electrode nodes to create via the first and second pulses a stimulation current through the patient’s tissue,
wherein, at a first electrode node of the at least two electrode nodes, each first pulse comprises a first monophasic pulse of a first polarity and a first passive charge recovery pulse of a second polarity opposite the first polarity,
the first passive charge recovery pulse being configured to recover charge stored during the first monophasic pulse, and
wherein, at the first electrode node, each second pulse comprises a second monophasic pulse of the second polarity and a second passive charge recovery pulse of the first polarity,
the second passive charge recovery pulse being configured to recover charge stored during the second monophasic pulse,
wherein an amplitude, pulse width, or both, of the first and second monophasic pulses is the same”,
see in re claim 1 above.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru et al. (US 2011/0106214) in view of Libbus et al. (US 2009/0076561).
In re claim 3, Carbunaru fails to disclose wherein both the amplitude and the pulse width of the first and second monophasic pulses are the same.
Libbus teaches a stimulation device (fig. 1: 100) comprising of a series of first and second monophasic pulses ([0062]: series of monophasic pulse trains) having alternating polarities [0062], wherein both the amplitude [0062] and the pulse width [0062] of the first and second monophasic pulses are the same [0062].
Libbus further teaches that the amplitude and pulse width may be the same or different [0062].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device taught by the Carbunaru, to provide wherein both the amplitude and the pulse width of the first and second monophasic pulses are the same, as taught by Libbus, because the amplitude and pulse width may be either the same or different.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru et al. (US 2011/0106214) in view of Johanek (US 2018/0369593).
In re claim 4, Carbunaru fails to disclose wherein the stimulator device is programmed to provide a repeating sequence of the first and second pulses interleaved at the at least two of the electrode nodes.
Johanek teaches a stimulation device (fig. 2: 14) and teaches wherein the stimulator device is programmed to provide a repeating sequence of first and second pulses interleaved at least two electrode nodes (electrode nodes 24 and 26; [0088]: processing circuitry 30 controls stimulation to alternate delivery of pulses 62 between leads 16A and 16B; fig. 2).
Johanek further teaches that any suitable order of pulses between electrode combinations may be provided as desired [0061, 0088].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device taught by the Carbunaru, to provide wherein the stimulator device is programmed to provide a repeating sequence of the first and second pulses interleaved at the at least two of the electrode nodes, as taught by Johanek, because any suitable order of pulses between electrode combinations may be provided as desired.
Claims 7-10, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru et al. (US 2011/0106214) in view of Feldman et al. (US 2018/0140831).
In re claim 7, Carbunaru fails to disclose wherein the stimulator device comprises stimulation circuitry comprising one or more Digital-to-Analog converters (DACs) configured to actively drive the first and second monophasic pulses at the first electrode node.
Feldman teaches improved current generation [0002] for an implantable pulse generator [0002] and teaches comprising one or more Digital-to-Analog converters (DACs) (fig. 6A: 172; [0017]) configured to actively drive first and second monophasic pulses ([0020]: includes first and second pulses 94a and 94b; [0042-0043]: pulses are monophasic and repeat; fig. 4A: 94a) at a first electrode node (fig. 2A: any one of electrode nodes 61a; [0017, 0042-0043]).
Feldman further teaches that the digital-to-analog convertor receives a stimulation program for the electrodes [0017] and allows for optimal stimulation current to be provided [0012].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device taught by the Carbunaru, to provide wherein the stimulator device comprises stimulation circuitry comprising one or more Digital-to-Analog converters (DACs) configured to actively drive the first and second monophasic pulses at the first electrode node, as taught by Feldman, because the digital-to-analog convertor receives a stimulation program for the electrodes and allows for optimal stimulation current to be provided.
In re claim 8, the proposed combination fails to yield
wherein the stimulation circuitry comprises a plurality of passive recovery switches each coupled between one of the electrode nodes and a reference potential,
wherein the first and second passive charge recovery pulses are formed by closing the passive recovery switch coupled to the first electrode node.
Feldman teaches
wherein stimulation circuitry (fig. 2B: 170) comprises a plurality of passive recovery switches (fig. 3A: plurality of passive recovery switches 96(x); [0021-0022]) each coupled between one of the electrode nodes and a reference potential (fig. 3A: 96(2) is between electrode node 61a and Vbat i.e. a reference potential; [0021-0023]),
wherein the first and second passive charge recovery pulses are formed by closing the passive recovery switch coupled to the first electrode node [0021-0023].
Feldman further teaches that closing the passive recovery switches is beneficial because they will recover built up charge [0045].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device yielded by the proposed combination, to provide wherein the stimulation circuitry comprises a plurality of passive recovery switches each coupled between one of the electrode nodes and a reference potential and wherein the first and second passive charge recovery pulses are formed by closing the passive recovery switch coupled to the first electrode node, as taught by Feldman, because closing the passive recovery switches recovers built up charge.
In re claim 9, the proposed combination fails to yield wherein the one or more DACs are not configured to actively drive the first and second passive charge recovery pulses.
Feldman teaches wherein the one or more DACs are not configured to actively drive the first and second passive charge recovery pulses ([0021]: passive charge recovery does not use active currents provided by the DAC).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device yielded by the proposed combination, to provide wherein the one or more DACs are not configured to actively drive the first and second passive charge recovery pulses, as taught by Feldman, for substantially the same reasons as discussed above.
In re claim 10, the proposed combination fails to yield
wherein the one or more DACs comprise one or more positive DACs (PDACs) configured to source a current and one or more negative DACs (NDACs) designed to sink a current,
wherein the first monophasic pulses are actively driven at the first electrode node by at least one of the one or more PDACs, and
wherein the second monophasic pulses are actively driven at the first electrode node by at least one of the one or more NDACs.
Feldman teaches
wherein the one or more DACs comprise one or more positive DACs (PDACs) (fig. 3A: 172p; [0017, 0051]) configured to source a current [0051] and one or more negative DACs (NDACs) (172n; [0051]) designed to sink a current [0051],
wherein the first monophasic pulses are actively driven at the first electrode node by at least one of the one or more PDACs [0017, 0051], and
wherein the second monophasic pulses are actively driven at the first electrode node by at least one of the one or more NDACs [0017, 0051].
Feldman further teaches that the PDAC and NDAC are used to prevent charge from building in tissues [0017].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device yielded by the proposed combination, to provide wherein the one or more DACs comprise one or more positive DACs (PDACs) configured to source a current and one or more negative DACs (NDACs) designed to sink a current, wherein the first monophasic pulses are actively driven at the first electrode node by at least one of the one or more PDACs, and wherein the second monophasic pulses are actively driven at the first electrode node by at least one of the one or more NDACs, as taught by Feldman, because the PDAC and NDAC are used to prevent charge from building in tissues.
In re claim 15, Carbunaru fails to disclose
wherein the first pulses are issued at a first frequency at the first electrode node and
wherein the second pulses are issued at the first frequency at the first electrode node.
Feldman teaches
wherein first pulses are issued at a first frequency at a first electrode node [0036 0042],
wherein second pulses are issued at the first frequency at the first electrode node (‘T=1/f’ and f i.e. the frequency is the same; [0036, 0042, 0059]).
Feldman further teaches that the first frequency may be adjusted depending on a desired duration of each passive charge recovery phase [0036].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device taught by the Carbunaru, to provide wherein the first pulses are issued at a first frequency at the first electrode node and wherein the second pulses are issued at the first frequency at the first electrode node, as taught by Feldman, because the first frequency may be adjusted depending on a desired duration of each passive charge recovery phase.
In re claim 18, Carbunaru fails to disclose wherein each electrode node is coupled to its associated electrode through a DC-blocking capacitor.
Feldman teaches wherein each electrode node is coupled to its associated electrode through a DC-blocking capacitor (fig. 2B: DC-blocking capacitor 55 is in between the electrodes at each the electrode node; [0022]).
Feldman further teaches that DC-blocking capacitors provide safety [0009] and ensure that DC current isn’t injected into tissue during a failure [0009].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device taught by the Carbunaru, to provide wherein each electrode node is coupled to its associated electrode through a DC-blocking capacitor, as taught by Feldman, because DC-blocking capacitors provide safety and ensure that DC current isn’t injected into tissue during a failure.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru et al. (US 2011/0106214) in view of Feldman et al. (US 2018/0140831) in view of Boggs et al. (US 2018/0056066).
In re claim 16, the proposed combination fails to yield wherein the first frequency is less than 200 Hz.
Boggs teaches an implanted pulse generator [0114] that provides passive charge recovery [0114], wherein a first frequency is less than 200 Hz [0097].
Boggs further teaches that the frequency may be adjusted as desired [0097] between various ranges [0097].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for programming a stimulator device yielded by the proposed combination, to provide wherein the first frequency is less than 200 Hz, as taught by Boggs, because the frequency may be adjusted as desired between various range.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the first frequency is less than 200 Hz, 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
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Vallejo (US 2018/0353758) discloses spinal cord stimulation (abstract) wherein a polarity of a first phase (abstract) may be either polarity (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796