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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 20-38 and Species 1B, 2B, 3B, and 4A in the reply filed on 06/04/2024 is acknowledged.
Claims 26 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/04/2024.
Claims 20-25, 27, 29-38 are considered in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/04/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 117, 118, and 119. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0069], the first diode is referred to both as reference number 226 and 224. The phrase “a first diode 226, and a first resistor 224 in parallel with the first diode 224” should read “a first diode 226, and a first resistor 224 in parallel with the first diode 226”
In paragraphs [0051, 0052, 0090], the reference number t2 is used for both first time and second time. The phrase “ends after the first time t2” should read “ends after the second time t2”.
Appropriate correction is required.
Claim Objections
In re claim 31, the limitation “wherein a characteristic of the offset component applied by the current generator and a characteristic of the alternating current component applied by the current generator based on the first input and the second input” should read “wherein a characteristic of the offset component applied by the current generator and a characteristic of the alternating current component applied by the current generator are based on the first input and the second input”.
Claim Interpretation
In re claim 23, the limitation “for a duration of the alternating current component” is understood under broadest reasonable interpretation in light of the spec to mean any duration of time during the application of the alternating current component up to, and including, the entire application of the alternating current component.
In re claim 24, the limitation “component for a subset of the duration of the alternating current component” is understood under broadest reasonable interpretation in light of the specification to mean any duration of time during the application of the alternating current up to, but excluding, the entire application of the alternating current.
In re claim 25, the limitation “to apply the offset component before the alternating current component” is understood under broadest reasonable interpretation in light of the specification to mean that the application of the offset component is started before the application of the alternating current component, wherein the offset component and alternating current component can overlap once the alternating current commences.
In re claim 38, the limitation “wherein the burst of transcutaneous stimulation is asymmetrical with respect to an amplitude of the burst based on the offset component” is understood under broadest reasonable interpretation in light of the specification to mean that the amplitude of the burst of transcutaneous stimulation is asymmetrical as a result of the offset component of the burst of transcutaneous current.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 20-25, 27, 29-38 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In re claim 20, the limitations “one or more implantable device implanted beneath the skin”, “the burst of transcutaneous current delivers a first electrical charge to tissue”, and “the burst of transcutaneous current delivers a second electrical charge different than the first electrical charge to tissue” are directed to non-statutory subject matter. Specifically, “implanted beneath the skin” and delivering a charge to a tissue implies that the subject, skin, and tissue are a part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean "one or more implantable device configured to be implanted beneath the skin”, “the burst of transcutaneous current is configured to deliver a first electrical charge to tissue”, and “the burst of transcutaneous current is configured to deliver a second electrical charge different than the first electrical charge to tissue”.
In re claim 21, the limitations “the first electrical charge activates the tissue” and “the second electrical charge does not activate the tissue” are directed to non-statutory subject matter. Specifically, activating or not activating the tissue implies that the tissue is a part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean "the first electrical charge is configured to activate the tissue” and “the second electrical charge is configured to not activate the tissue”.
In re claim 22, the limitations “the first electrical charge activates the tissue” and “the second electrical charge activates the tissue” are directed to non-statutory subject matter. Specifically, activating the tissue implies that the tissue is a part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean "the first electrical charge is configured to activate the tissue” and “the second electrical charge is configured to activate the tissue”.
In re claim 31, the limitations “the second burst of transcutaneous current delivers a third electrical charge to the tissue” and “the second burst of transcutaneous current delivers a fourth electrical charge to the tissue” are directed to non-statutory subject matter. Specifically, delivering an electrical charge to the tissue implies that the tissue is a part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean “the second burst of transcutaneous current is configured to deliver a third electrical charge to the tissue” and “the second burst of transcutaneous current is configured to deliver a fourth electrical charge to the tissue”.
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.
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 20, 23, 27, 29-30, 33-35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Gillbe (US 20090326611) in view of Moore (US 20130197609).
In re claim 20, Gillbe discloses an external generator (Fig. 17: “EXTERNAL POWER UNIT” dashed box), comprising:
a current generator (Fig. 17: 03, 06; [0124-0126]: “The capacitor supplies the pulse current for the output”);
a first skin electrode (10) coupled to the current generator (10 connected to 03, 06); and
a second skin electrode (11) coupled to the current generator (10 connected to 03, 06),
wherein
the current generator is configured to apply a burst of transcutaneous current [0019, 0126-0127] between the first skin electrode and the second skin electrode to a skin of a subject [0127, 0133-0134],
the burst of transcutaneous current comprising an alternating current component (Fig. 2; [0022, 0071, 0123]: “alternating in polarity”) and an offset component [0022, 0127]: “imposing a D.C. component or a sinusoidal or square waveform so that the minimum current is non-zero but sufficiently small that the peripheral nerves are unaffected”,
a portion of the burst of transcutaneous current passes through one or more implantable device implanted beneath the skin of the subject (Fig. 17: current passes from 10 and 11 to 20; [0132-0135]),
the one or more implantable device (Fig. 17: “IMPLANTED DEVICE” dashed box) including a first channel (Fig. 17: from 20 to end of “implanted electrodes or sensors”),
the first channel of the implantable device comprises a rectifier (15; [0135, 0138]: “The received signal is rectified”) allowing positive (note: bridge rectifier outputs a positive current) current to pass through the first channel (Fig. 7: apparent flow from 20 to end of “implanted electrodes or sensors”; [0021, 0076]),
the burst of transcutaneous current delivers a first electrical charge to tissue at an output electrode of the first channel based on the offset component (Fig. 7: apparent flow from 20 to end of “implanted electrodes or sensors”; [0034-0035, 0076]).
Gillbe lacks:
a portion of the burst of transcutaneous current passes through one or more implantable device implanted beneath the skin of the subject,
the one or more implantable device including a first channel and a second channel,
the second channel comprises a rectifier allowing negative current to pass through the second channel,
the burst of transcutaneous current delivers a second electrical charge different than the first electrical charge to tissue at an output electrode of the second channel based on the offset component.
Moore discloses an implantable receiver-stimulator device [0012-0013] that, like the implantable device disclosed in the external generator of Gillbe, comprises a rectifier (Fig. 6A: upper 121) and an anode (113; i.e. output electrode) to deliver a positive current to a tissue ([0056, 0066]: “the positive output of the rectifiers”; [0064-0065]: “the electrical output of the rectifiers 121 is used to directly stimulate tissue”). In addition, Moore discloses wherein the implantable stimulator delivers an electrical charge to stimulate tissue [0064-0065] and comprises another rectifier (lower 121) with a negative output (i.e. a second channel comprising a rectifier allowing negative current to pass through the second channel) which stimulates tissue through cathode (113), thus providing a positive charge to the anode and a negative charge to the cathode (i.e. delivering a second electrical charge different than a first electrical charge to tissue at an output electrode of the second channel), and wherein the positive and negative output are input to processing circuitry [0064-0065].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the stimulation device disclosed by Gillbe by providing a second channel comprising a rectifier which allows negative current to pass through the second channel and wherein a burst of current delivers a second electrical charge different than a first electrical charge to tissue at an output electrode of the second channel and wherein the positive and negative output are input to processing circuitry as taught by Moore because it would allow for the external generator to provide the stimulation therapy of Moore which would be able to treat cardiac, nerve brain, voluntary muscle, gastric, and bone stimulation, as well as pain amelioration [0011, 0064].
In re claim 23, Gillbe discloses, wherein the current generator is configured to apply the offset component for a duration of the alternating current component ([0022, 0033]: “imposing a D.C. component; note: apparent that imposing a D.C. component would provide that component for a duration of the alternating current component of an interrupted waveform).
In re claim 27, Gillbe lacks:
wherein one implantable device comprises a first stimulation channel and a second stimulation channel.
Moore discloses wherein an implantable device comprises a first stimulation channel and a second stimulation channel (see 35 U.S.C. 103 Rejection, In re claim 20; the first channel and second channel in claim 1 are used for stimulation, as disclosed by Moore).
In re claim 29, Gillbe discloses a controller ([0036, 0134-0139]: “control unit”; Fig. 17: microprocessor) configured to:
receive a first input corresponding to a first current level for the first channel ([0137]; Fig. 17: 17 receives pulse from 15); and
receive a second input corresponding to a second current level for the second channel ([0137]; Fig. 17: 17 receives pulse from 15 to be input to the lower implanted electrodes),
wherein a characteristic of the offset component applied by the current generator and a characteristic of the alternating current component applied by the current generator based on the first input and the second input (inherent; [0136-0137]: determines the amplitude of the stimulation pulse).
Gillbe lacks:
receive a second input corresponding to a second current level for the second channel.
Moore discloses a second channel with a second charge and wherein processing circuitry ([0064]; i.e. controller) receives the output of the rectifier of the second channel [0064] (see above 35 U.S.C. 103 Rejection, In re claim 20).
In re claim 30, Gillbe discloses wherein
the characteristic of the alternating current component is an amplitude of the alternating current component (inherent; [0136-0137]: determines the amplitude of the stimulation pulse) and
the characteristic of the offset component is an amplitude, a shape, or a duration of the offset component (inherent; [0136-0137]: determines the amplitude of the stimulation pulse; note: this would include the imposed DC component).
In re claim 33, Gillbe discloses:
wherein the current generator is further configured to apply a balancing current to the skin of the subject [0072--73],
wherein the balancing current is charge balanced with the offset component ([0022-0024, 0072-0073]: the balancing pulse is to balance the charge of the forward pulse, including the DC component).
In re claim 34, Gillbe discloses wherein the current generator does not apply the balancing current during the burst of transcutaneous current ([0024, 0072]: applies the balancing pulse during inter-pulse spacing).
In re claim 35, Gillbe discloses wherein the balancing current has a longer duration than the offset component ([0072-0073]: “the balancing pulse may also be a very low amplitude pulse of long duration”; note: this is in contrast to the duration of the forward pulse, which would include the DC component).
In re claim 38, Gillbe discloses wherein the burst of transcutaneous stimulation is asymmetrical with respect to an amplitude of the burst based on the offset component ([0022]: imposing a D.C. component which would prevent the pulsed waveform from having a minimum amplitude of zero; note: D.C. component with AC would result in an asymmetrical amplitude).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Gillbe (US 20090326611) in view of Moore (US 20130197609) in further view of Glukhovsky (US 20140172053).
In re claim 21, Gillbe discloses the first electrical charge activates the tissue at the output electrode of the first channel [0068].
The proposed system lacks:
the second electrical charge does not activate the tissue at the output electrode of the second channel.
Glukhovsky discloses implant system for electrical stimulation that, like the external generator of Gillbe, comprises an external stimulator (Fig. 12C: 50; i.e. current generator), a surface cathodic electrode (20; i.e. first skin electrode), and a second surface electrode (22; i.e. second skin electrode) that delivers an electrical current (i.e. transcutaneous current) through the skin (10) to receiving electrodes of a lead (24; i.e. implantable device) and stimulates tissue through stimulating electrodes (e1-e3) on the lead. In addition, Glukhovsky discloses wherein a pick-up electrode (p2) is insulated and resultingly, a corresponding stimulating electrode (e2; i.e. output electrode) does not activate tissue ([0160]; no arrow towards nerve and surface electrode 22) while other stimulating electrodes of respective corresponding pick-up electrodes (Fig. 10B; i.e. first/other channels) activate the tissue [0162; 0156-0158].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein an electrical charge does not activate the tissue at the output electrode of a second channel as taught by Glukhovsky because it would allow for the selection of different pick up or stimulating electrodes during or after implantation which would be beneficial if the stimulating end or target issue have migrated within the body and the selected stimulating electrode is no longer in the vicinity of the target tissue or if any wires have become damaged (Glukhovsky: [0156]). Such a combination would yield wherein the first electrical charge activates the tissue at the output electrode of the first channel and the second electrical charge does not activate the tissue at the output electrode of the second channel.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gillbe (US 20090326611) in view of Moore (US 20130197609) in further view of Block (US 20200376272).
In re claim 22, Gillbe discloses:
wherein the first electrical charge activates the tissue at the output electrode of the first channel [0068],
Gillbe lacks:
wherein the second electrical charge activates the tissue at the output electrode of the second channel, and
wherein an activation level of the tissue at the output electrode of the first channel is different than an activation level of the tissue at the output electrode of the second channel.
Moore discloses wherein the second electrical charge stimulates (i.e. activates) the tissue at the output electrode of the second channel (see above 35 U.S.C. 103 Rejection, In re claim 20).
The proposed system lacks:
wherein an activation level of the tissue at the output electrode of the first channel is different than an activation level of the tissue at the output electrode of the second channel.
Block discloses a neuromodulation stimulation system (Fig. 2, [0065-0066]) that, like the external generator and associated implantable medical device disclosed by Gillbe, concerns implantable and external elements [0066] including an implantable neuromodulation device (Fig. 2: 212) with stimulating electrodes (211) to stimulate neural targets (i.e. tissue; [0065]). In addition, Block discloses wherein electrodes at different locations corresponding to a neural targets (i.e. tissue at different output electrode locations; Fig. 22A and 22C) have a difference in activation thresholds (i.e. activation level; Fig. 22B and 22C; [0138-0139, 0151]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein an activation level of the tissue at the output electrode is different than an activation level of the tissue at the output electrode as taught by Block because it would allow the implantable device to improve the efficacy of the stimulation for pain therapy, or other stimulation applications, as well as the device functionality such as energy utilization (Block: [0139]). Such a combination would yield wherein the first electrical charge activates the tissue at the output electrode of the first channel, wherein the second electrical charge activates the tissue at the output electrode of the second channel , and wherein an activation level of the tissue at the output electrode of the first channel is different than an activation level of the tissue at the output electrode of the second channel.
Claims 24, 31, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Gillbe (US 20090326611) in view of Moore (US 20130197609) further in view of Zhang (US 20190184180).
In re claim 24, Gillbe lacks:
wherein the current generator is configured to apply the offset component for a subset of the duration of the alternating current component.
Zhang discloses an implantable stimulator that, like the external generator disclosed by Gillbe, delivers a therapeutic stimulation current comprising a biphasic current of opposite polarity (i.e. alternating current) and an imbalance (i.e. offset component; note: the imbalance shifts the current of the stimulation current so that it is net positive or negative functioning as an offset component (Instant Specification: [0090])) (Fig. 15, [0025, 0028]), and additionally discloses electrodes of opposite net polarity (Fig. 6). In addition, Zhang discloses wherein the imbalance occurs for a portion of the therapeutic stimulation (Fig. 15: includes a period of “No Imbalance”; [0099, 0101]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the imbalance (i.e. offset component) is applied for a subset of the duration of the alternating current as taught by Zhang because extended DC application may exceed DC current density limits which can corrode electrodes or cause tissue damage [0099, 0114].
In re claim 31, Gillbe lacks wherein the current generator is further configured to apply a second burst of transcutaneous current to the skin of the subject, the second burst of transcutaneous current comprising
a second alternating current component and
a second offset component,
wherein:
the second burst of transcutaneous current delivers a third electrical charge to the tissue at the output electrode of the first channel based on the second offset component,
the second burst of transcutaneous current delivers a fourth electrical charge to the tissue at the output electrode of the second channel based on the second offset component,
the first electrical charge is greater than the second electrical charge, and
the fourth electrical charge is greater than the third electrical charge.
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Zhang discloses an implantable stimulator (abstract) that, like the external generator disclosed by Gillbe, delivers a therapeutic stimulation current comprising a biphasic current of opposite polarity (i.e. alternating current, [0014]) and an imbalance (i.e. offset component; note: the imbalance shifts the current of the stimulation current so that it is net positive or negative functioning as an offset component (Instant Specification: [0090])) (Fig. 15, [0025, 0028]), and additionally discloses electrodes of opposite net polarity (Fig. 6). In addition, Zhang discloses wherein the imbalance changes net polarity (i.e. the offset component changes from negative to positive or from positive to negative; Fig. 15d) in alternating periods, wherein the user can select if the polarity oscillates (selected in Fig. 14: 134; [0104]). Specifically, Zhang discloses a positive first electrical charge (Examiner’s Figure 15D: a) and a negative second electrical charge (b) in a stimulation burst followed by a second stimulation burst with a positive third electrical charge (c) and a negative fourth electrical charge (d) each based on the imbalance; wherein the first electrical charge is greater than the second electrical charge (a has a greater amplitude than b) and the fourth electrical charge is greater than the third electrical charge (d has a greater amplitude than c). Additionally, Zhang discloses a DC offset period that negatively mirrors the imbalance of an initial DC onset period which allows the stimulation to switch from a period of imbalance to no imbalance, the imbalance of the DC offset and DC onset are equal and opposite (Fig. 15c; [0102]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the imbalance (i.e. offset component) alternates in polarity, with a first electric charge greater than a second electrical charge and a third electrical charge greater than a fourth electrical charge and wherein an equal and opposite imbalance is applied in a later stimulation current as taught by Zhang because it would allow the direction of the stimulation current to change during alternating periods as desired by the user to match with the needs of the user’s tissue (for example, if the required activation level or desired polarity has changed over time) and to switch between a period with an offset component and a period without an offset component (Zhang: [0102]).
Further, as Zhang teachers altering the polarity of the imbalance (i.e. offset) as desired by the user, it would be obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to be able to adjust the therapy signal of Gillbe which would allow for the selection of stimulation parameters yielding wherein the current generator is further configured to apply a second burst of transcutaneous current to the skin of the subject, the second burst of transcutaneous current comprising a second alternating current component and a second offset component, wherein: the second burst of transcutaneous current delivers a third electrical charge to the tissue at the output electrode of the first channel based on the second offset component, the second burst of transcutaneous current delivers a fourth electrical charge to the tissue at the output electrode of the second channel based on the second offset component, the first electrical charge is greater than the second electrical
In re claim 36, Gillbe discloses a controller configured to receive an input (see above 35. U.S.C. 103, In re claim 20).
Gillbe lacks:
a controller configured to receive an input from a user interface or a sensor,
wherein a characteristic of the offset component is based on the input.
Zhang discloses an implantable stimulator (abstract) that, like the external generator disclosed by Gillbe, delivers a therapeutic stimulation current comprising a biphasic current of opposite polarity (i.e. alternating current, [0014]) and an imbalance (i.e. offset component; note: the imbalance shifts the current of the stimulation current so that it is net positive or negative functioning as an offset component (Instant Specification: [0090])) (Fig. 15, [0025, 0028]), and additionally discloses electrodes of opposite net polarity (Fig. 6). In addition, Zhang discloses a graphical user interface (Fig. 14: 100) wherein a user can set a charge imbalance (characteristic of the offset component) between a positive and negative electrode [0031-0032], wherein the charge imbalance parameter can be a difference in amplitude, pulse width, or charge between the two electrodes [0032], and determining pseudo-constant DC current, DC voltage, or DC current density based on the input charge imbalance ([0032; 0034]; i.e. a characteristic is an amplitude, a timing, or duration of the offset component).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein the imbalance (i.e. offset component) is applied for a subset of the duration of the alternating current as taught by Zhang because it would allow for the user to determine the relationship between the two electrodes depending on their own physical needs such as their pain level.
In re claim 37, Gillbe discloses wherein the characteristic is an amplitude, a shape, a timing, or a duration of the offset component (see above 35 U.S.C. 103 Rejection, In re claim 36).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Gillbe (US 20090326611) in view of Moore (US 20130197609) in further view of Keenan (US 20240252820).
In re claim 25, Gillbe lacks:
wherein the current generator is configured to apply the offset component before the alternating current component.
Keenan discloses a neuromodulation system that stimulates tissue of a patient (abstract) that, like the external generator of Gillbe, provides transcutaneous stimulation comprising a biphasic balanced waveform (i.e. alternating current component; [0050]; Fig. 9d: pulse with highest positive and negative amplitudes) and a subthreshold pre-pulse (i.e. offset component; [0050]: “sub-threshold depolarizing pre-pulse”; Fig. 9d: first pulse). In addition, Keenan discloses a sub-threshold pre-pulse (i.e. offset component applied before the alternating current component; [0050]: “The pre-pulse is delivered immediately prior to the stimulation waveform”; Fig. 9d).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the proposed system by providing wherein a sub-threshold pre-pulse (i.e. offset component) is applied before a biphasic stimulation pulse (i.e. alternating current) as taught by Keenan because it provides depolarization and has been shown to enhance stimuli response, altering the characteristics of action potential and motor point thresholds (Keenan: [0050]).
Allowable Subject Matter
If Claim 32 were rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, claim 32 would be objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In re claim 32, John (US 20060149337) is considered the closest prior art. John discloses a system for tissue stimulation in medical treatment that an alternating current and a DC offset (i.e. offset component, [0059]), additionally comprising a net positive lead and a net negative lead [0059]. In addition, John discloses wherein a positive and negative DC offset are alternated from time to time so that a positive offset results in a signal #1 (i.e. a first burst of current; Fig. 4a: Signal #1) and a negative DC offset results in a signal #2 (i.e. a second burst of current; Fig. 4a: corresponding Signal #2); each signal comprising an offset component and an alternating current component ([0059]: “alternating the DC offset of the two partial signals, from time to time”).
Examiner asserts it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed system of an external generator to provide wherein the offset component and second offset component are charge balanced.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E 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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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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