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 § 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 1-5, 8-18 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.
Claims 1 and 8 recite “at least 50khz” however it is unclear what the metes and bounds of the claim are. “At least” defines a bottom bound but the maximum is unbounded, thus it isn’t clearly defined. For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims depending from these claims share this issue, except for claims 6-7 and 19-20 which do not have this issue as they recite a top bound as a further limitation.
Claim 9 recites “regulating the voltage outputted to the wound” it is unclear what the scope of this is. Does it mean merely adjusting parameters for later stimulations or does it require actively outputting adjusted additional stimulation. The claim does not clearly define the metes and bounds therefore it is indefinite. Examiner thinks an interview after the non-final may be beneficial to further prosecution with regards to this rejection.
Claim 17 recites “according to claim 8, . . . prior to regulating the voltage output, a short period of no voltage output is held.” However, there is no reference to “regulating the voltage output” earlier in the claim or in the claim from which claim 17 depends, thus it is unclear what the regulating the voltage is referring to. For the above reasons the claim does not clearly define the metes and bounds and the claim is indefinite.
Claim 17 recites “short period” however the term “short” in claim 17 is a relative term which renders the claim indefinite. The term “short” 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. The reference does not disclose a time frame, the specification even recites this “short period” can be “any period deemed suitable for the course of treatment” which does not provide a standard for determining requisite degree. For the above reasons the claim does not clearly define the metes and bounds and the claim is indefinite.
Claim Rejections - 35 USC § 102/103
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 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.
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.
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, 5, 8 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by US 20190240475 to Lawson et al. (hereinafter Lawson) or, in the alternative, under 35 U.S.C. 103 as obvious over Lawson.
Regarding Claim 1, an interpretation of Lawson discloses a device for electro-therapy (abstract, [0047], [0051], [0107] see also [0031]; applies electrical stimulation to the body), the device comprising
a controlled voltage source ([0046] including “control unit 12, which is powered by a battery or other source of current/voltage”, [0047] see also [0031], [0051], [0107]) connected to at least two stimuli electrodes ([0046]-[0047] see also [0031], [0051], [0107]), the stimuli electrodes being configured to be electrically in contact with skin surrounding a wound ([0044] including “two or more electrodes 11 for attaching to a person's limb at or near the damaged skin to apply electrical stimulation”, [0046]-[0047] see also [0031], [0051], [0107]; to the extent the claimed element(s) are intended use of the device the device recited by the prior art is structurally capable of performing the intended use) and the controlled voltage source being configured to output a pulsed direct current with a frequency of at least 50 kHz ([0051] including “in the range of 50-500 kHz”, [0123] see also [0031], [0107]; to the extent the claimed element(s) are intended use of the device the device recited by the prior art is structurally capable of performing the intended use), and wherein the pulsed direct current has a duty cycle in the range of 1-10% ([0051] including “a duty cycle 1% to 100% (pulsed-to-continuous on-time)”, [0070] including “control unit 12 may stop or adjust one or more characteristics of the electrical stimulation, such as the wave form, including amplitude, duration, and pulse width based on input (sensor signals or user input).” see also [0031], [0107]; The device is configured to provide stimulation in the range. to the extent the claimed element(s) are intended use of the device, the device recited by the prior art is structurally capable of performing the intended use).
In the alternative, if Applicant disagrees that Lawson anticipates the duty cycle, then in the alternative the 1-10% duty cycle is a routine optimization under MPEP 2144.05(II) as the reference recites the element as a results effective variable, parameters defining the waveforms are changed in order to achieve the desired result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lawson by limiting the duty cycle to the 1-10% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 5, an interpretation of Lawson further discloses wherein the current is a monophasic pulsed direct current ([0123]).
Regarding Claim 8, an interpretation of Lawson discloses electro-therapeutic method for healing a wound (abstract, [0047], [0051], [0107] see also [0031]), the method comprising the steps of:
providing at least two stimuli electrodes ([0046]-[0047] see also [0031], [0051], [0107]);
bringing each of the at least two stimuli electrodes into electrical contact with a discrete part of the skin surrounding the wound ([0044] including “two or more electrodes 11 for attaching to a person's limb at or near the damaged skin to apply electrical stimulation”, [0046]-[0047] see also [0031], [0051], [0107]);
applying a pulsed direct current ([0051] including “in the range of 50-500 kHz”, [0123] see also [0031], [0107]) with a frequency of at least 50 kHz ([0051] including “in the range of 50-500 kHz”, [0123] see also [0031], [0107]) and a duty cycle in the range of 1-10% ([0051] including “a duty cycle 1% to 100% (pulsed-to-continuous on-time)”, [0070] including “control unit 12 may stop or adjust one or more characteristics of the electrical stimulation” see also [0031], [0107]) to the wound through the at least two stimuli electrodes ([0044] including “two or more electrodes 11 for attaching to a person's limb at or near the damaged skin to apply electrical stimulation”, [0046]-[0047], [0051], [0123] see also [0031], [0107]).
In the alternative, if Applicant disagrees that Lawson anticipates the duty cycle, then in the alternative the 1-10% duty cycle is a routine optimization under MPEP 2144.05(II) as the reference recites the element as a results effective variable, parameters defining the waveforms are changed in order to achieve the desired result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lawson by limiting the duty cycle to the 1-10% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim Rejections - 35 USC § 103
Claim(s) 1-3, 6-14, 15-16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080161884 to Chandler et al. (hereinafter Chandler) in view of Lawson EP 2127694 to Koninklijke Philips Electronics N.V. (hereinafter Konin) in further view of US 20170224990 to Goldwasser et al. (hereinafter Goldwasser).
Regarding Claim 1, an interpretation of Chandler discloses a device for electro-therapy (abstract, [0055]), the device comprising a controlled voltage source ([0056], [0060]-[0061]) connected to at least two stimuli electrodes ([0055]-[0056], Figs. 1-2), the stimuli electrodes being configured to be electrically in contact with skin surrounding a wound ([0031], [0070], Fig. 4; to the extent the claim element is an intended use the device recited by the prior art is structurally capable of performing the intended use) and the controlled voltage source being configured to output a pulsed direct current ([0009], [0016] see also [0076]).
An interpretation of Chandler may not explicitly disclose the pulsed direct current with a frequency of at least 50khz.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the controlled voltage source is configured to output DC pulses having a frequency in the range of 50 to 500 kHz ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 50-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
An interpretation of Chandler may not explicitly disclose wherein the pulsed direct current has a duty cycle in the range of 1-10%.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches a similar wound healing system ([1185]), wherein the voltage outputted from the controlled voltage source has a duty cycle in the range of 1-10% ([0094], [0765], [1256] see also [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin to include a 1-10% duty cycle because Goldwasser teaches a varied waveform with off times may minimize pain and irritation ([1019]).
Regarding Claim 2, an interpretation of chandler may not explicitly disclose wherein the average current outputted from the controlled voltage source is limited to the range of .1 to 10 mA.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches wherein the average current outputted from the controlled voltage source is limited to the range of 1 to 10 mA ([0094] see also [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin to use a current in this range because Goldwasser teaches particular advantageous stimulation protocols fall within this range with little skin irritation and discomfort ([0653]).
Regarding Claim 3, an interpretation of Chandler further discloses wherein the average peak voltage outputted from the controlled voltage source is limited to the range of 0.1 to 20 V.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the average peak voltage outputted from the controlled voltage source is limited to the range of 0.1 to 20 V ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 50-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
Regarding Claim 6, an interpretation of Chandler may not explicitly disclose wherein the controlled voltage source is configured to output a pulsed direct current with a frequency in the range of 50 to 500 kHz.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the controlled voltage source is configured to output DC pulses having a frequency in the range of 50 to 500 kHz ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 50-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
Regarding Claim 7, an interpretation of Chandler may not explicitly disclose wherein the controlled voltage source is configured to output a pulsed direct current with a frequency in the range of 100 to 500 kHz.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the controlled voltage source is configured to output DC pulses having a frequency in the range of 100 to 500 kHz ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 100-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
Regarding Claim 8, an interpretation of Chandler discloses a electro-therapeutic method for healing a wound (abstract, [0055]), the method comprising the steps of:
providing at least two stimuli electrodes ([0055]-[0056], Figs. 1-2, 4);
bringing each of the at least two stimuli electrodes into electrical contact with a discrete part of the skin surrounding the wound ([0031], [0070], Fig. 4);
applying a pulsed direct current to the wound through the at least two stimuli electrodes ([0009], [0016] see also [0076]).
An interpretation of Chandler may not explicitly disclose the pulsed direct current with a frequency of at least 50khz.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the controlled voltage source is configured to output DC pulses having a frequency in the range of 50 to 500 kHz ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 50-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
An interpretation of Chandler may not explicitly disclose wherein the pulsed direct current has a duty cycle in the range of 1-10%.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches a similar wound healing system ([1185]), wherein the voltage outputted from the controlled voltage source has a duty cycle in the range of 1-10% ([0094], [0765], [1256] see also [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin to include a 1-10% duty cycle because Goldwasser teaches a varied waveform with off times may minimize pain and irritation ([1019]).
Regarding Claim 9, an interpretation of chandler discloses the above including a plurality of discrete electrode pads which may be any known in the art ([0127]-[0128], [0058] including “when the device 10 detects high resistance between the individual electrodes of the electrode pair 50”; based on the ability to be used to both be used to “detect” high resistance and provide stimulation the electrodes are both sensors and stimulators).
An interpretation of Chandler may not explicitly disclose wherein the method further comprises the steps of: providing at least two sense electrodes; arranging the sense electrodes on discrete parts of the skin surrounding the wound; measuring one or more voltage drops over the wound via the sense electrodes; regulating the voltage outputted to the wound via the stimuli electrodes based on at least one measured voltage drop measurement.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the method further comprises the steps of:
providing at least two sense electrodes ([0037], Figs. 1-2);
arranging the sense electrodes on parts of the skin surrounding the wound ([0037], Figs. 1-2);
measuring one or more voltage drops over the wound via the sense electrodes ([0016], [0037]-[0039]);
regulating the voltage outputted to the wound via the stimuli electrodes based on at least one measured voltage drop measurement ([0032], [0039] see also [0014]-[0015]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the electrotherapy device of Chandler and include sense electrodes measuring voltage drops across the wound and adjusting the output based on the voltage drops because Konin teaches it allows a controlled response to the actual status of the wound’s healing (see [0032]).
Regarding Claim 10, an interpretation of Chandler may not explicitly disclose wherein the method further comprises the step of: - measuring the current running between the stimuli electrodes; and wherein the regulation of the voltage outputted to the wound via the stimuli electrodes is based on at least one measured voltage drop measurement and at least one current measurement.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the method further comprises the step of:
measuring the current running between the stimuli electrodes ([0015], [0029]); and
wherein the regulation of the voltage outputted to the wound via the stimuli electrodes is based on at least one measured voltage drop measurement and at least one current measurement ([0015], [0028]-[0029]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the electrotherapy device of Chandler to measure the current between electrodes as recited by Konin in order to avoid irritation and burning of the skin ([0029]).
Regarding Claim 11, an intereptation of Chandler discusses a distance of electrodes from the wound ([0070]).
an interpretation of Chandler may not explicitly disclose wherein the stimuli electrodes and the sense electrodes are arranged such that they form pairs comprising at least one sense electrode and at least one stimuli electrode.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein at least one of the stimuli electrodes and at least one of the sense electrodes are attached to each supporting structure ([0021]; they are paired together).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the electrotherapy device of Chandler to pair the sense electrodes with the stimuli electrodes on the substrate because Konin teaches it allows for the condition of the wound to be measured alongside the treatment ([0022]).
An interpretation of Chandler may not explicitly disclose wherein at least one sense electrode and at least one stimuli electrode being arranged on the skin such that they are in the range of 5 to 50 mm within one another.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches a pair of at least one of the stimuli electrodes has at least one sense electrode located within 5 to 50 mm of it ([0077], [0746] see also [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the electrotherapy device of Chandler in view of Konin to include the recited spacing between electrodes from Goldwasser because the distance has been found to be sufficient to both allow electrical isolation when connecting to the active regions while also providing sufficient mechanical support ([0077]).
Regarding Claim 12, an interpretation of Chandler may not explicitly disclose wherein the voltage is regulated such that the measured voltage drop is in the range of 50-350 mV per mm distance of the wound.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches wherein the voltage is regulated such that the measured voltage drop is in the range of 50-350 mV per mm distance ([0979] see also [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the electrotherapy device of Chandler in view of Konin to include the voltage drops as recited by Goldwasser teaches it as an appropriate working range ([0979]).
Regarding Claim 13, an interpretation of Chandler may not explicitly disclose wherein an impedance value is calculated from one or more measured voltage drops and one or more measured current levels, and wherein the voltage is regulated such that one or more measured voltage drops are in the range of 0.05V to 1V per numerical Ohm of the calculated impedance.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein an impedance value is calculated from one or more measured voltage drops and one or more measured current levels, and wherein the voltage is regulated such that one or more measured voltage drops are in the range of 0.05V to 1V per numerical Ohm of the calculated impedance ([0016]-[0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the electrotherapy device of Chandler to calculate an impedance between sense electrodes because Konin teaches it helps determine the presence and location of the wound and/or its perimeter ([0016]).
Regarding Claim 15, and interpretation of Chandler may not explicitly disclose the step of increasing the peak voltage outputted to the wound via the stimuli electrodes from a first peak voltage level to a second peak voltage level.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches the step of increasing the peak voltage outputted to the wound via the stimuli electrodes from a first peak voltage level to a second peak voltage level ([0249] including ”ramping up at beginning”, [0250] including “ramping may refer to the transition between a previous predetermined set of waveform properties (including transitioning from or to no waveform properties or zero-value properties at the start and end of a neurostimulation, respectively), and a new predetermined set of waveform properties that occurs over time (ramping time).”, [0977]-[0978] see also [0245], [0252], [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the electrotherapy device of Chandler in view of Konin to include the ramping parameters as recited by Goldwasser teaches because ramping/gradually changing the stimulation over time may reduce pain and irritation ([1020]).
Regarding Claim 16, and interpretation of Chandler may not explicitly disclose the step of increasing the peak voltage outputted to the wound via the stimuli electrodes gradually and/or stepwise from a first peak voltage level to a second peak voltage level.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches the step of increasing the peak voltage outputted to the wound via the stimuli electrodes gradually and/or stepwise from a first peak voltage level to a second peak voltage level ([0249] including ”ramping up at beginning”, [0250] including “ramping may refer to the transition between a previous predetermined set of waveform properties (including transitioning from or to no waveform properties or zero-value properties at the start and end of a neurostimulation, respectively), and a new predetermined set of waveform properties that occurs over time (ramping time).”, [0977]-[0978] see also [0245], [0252], [1020], [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the electrotherapy device of Chandler in view of Konin to include the ramping parameters as recited by Goldwasser teaches because ramping/gradually changing the stimulation over time may reduce pain and irritation ([1020]).
Regarding Claim 18, an interpretation of Chandler may not explicitly disclose wherein the average current applied to the wound through the stimuli electrodes is in the range of approximately 1-10 mA.
However, in the same field of endeavor (medical electrical stimulation devices), Goldwasser teaches wherein the average current applied to the wound through the stimuli electrodes is in the range of approximately 1-10 mA ([0094] see also [1258]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin to use a current in this range because Goldwasser teaches particular advantageous stimulation protocols fall within this range with little skin irritation and discomfort ([0653]).
Regarding Claim 19, an interpretation of Chandler may not explicitly disclose wherein the pulsed direct current applied to the wound through the stimuli electrodes is with a frequency in the range of 50 to 500 kHz.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the pulsed direct current applied to the wound through the stimuli electrodes is with a frequency in the range of 50 to 500 kHz ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 50-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
Regarding Claim 20, an interpretation of Chandler may not explicitly disclose wherein the pulsed direct current applied to the wound through the stimuli electrodes is with a frequency in the range of 100 to 500 kHz.
However, in the same field of endeavor (medical electrical stimulation devices), Konin teaches wherein the pulsed direct current applied to the wound through the stimuli electrodes is with a frequency in the range of 100 to 500 kHz ([0017]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the pulsed current of Chandler and include a frequency of 100-500kHz because Konin teaches helps stimulate the movement of cells towards the wound ([0017]).
Claim Rejections - 35 USC § 103
Claim(s) 4-5, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over chandler in view of Konin in further view of Goldwasser in further view of Luther Kloth. Electrical Stimulation Technologies for Wound Healing. Adv Wound Care (New Rochelle). 2014 Feb 1;3(2):81-90. doi: 10.1089/wound.2013.0459 (hereinafter Kloth).
Regarding Claim 4, an interpretation of Chandler may not explicitly disclose wherein the pulsed direct current has a duty cycle in the range of 1-4%.
However, in the same field of endeavor (medical electrical stimulation devices), Kloth teaches a similar wound healing system (MATERIALS AND METHODS: BACKGROUND section Pg. 81-82 discussing an overview of electrical stim; ES devices: low- and high-voltage PC Pg 86 discussing different devices at the time), wherein the voltage outputted from the controlled voltage source has a duty cycle in the range of 1-4% (Pulsed current section discussing the monophasic and biphasic pulsed direct current, Pg. 84-85, Fig. 2; Fig. 4 the bottom example shows a signal with a 1.784% duty cycle).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin in further view of Goldwasser to include a duty cycle as shown by Kloth because it is merely combining a system with a known particular parameter setting for duty cycle according to known method (setting parameters) to yield a predictable result of a stimulation with the specific parameter.
Regarding Claim 5, an interpretation of chandler may not explicitly disclose wherein the current is a monophasic pulsed direct current.
However, in the same field of endeavor (medical electrical stimulation devices), Kloth teaches wherein the current is a monophasic pulsed direct current (Pulsed current section discussing the monophasic and biphasic pulsed direct current Pg. 84-85, Fig. 2).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin in further view of Goldwasser to include it more specifically being monophasic pulsed current as shown by Kloth because it is merely combining a system with a pulsed direct current and combining it with the more specific teaching of being a monophasic pulsed direct current as recited by Kloth which is merely combining prior art elements according to known method (setting parameters to achieve the type of waveform) to yield a predictable result of a stimulation with the particular waveform.
Regarding Claim 14, an interpretation of Chandler may not explicitly disclose wherein the pulsed direct current has a duty cycle in the range of 1-4%.
However, in the same field of endeavor (medical electrical stimulation devices), Kloth teaches a similar wound healing system (MATERIALS AND METHODS: BACKGROUND section Pg. 81-82 discussing an overview of electrical stim; ES devices: low- and high-voltage PC Pg 86 discussing different devices at the time), wherein the voltage outputted from the controlled voltage source has a duty cycle in the range of 1-4% (Pulsed current section discussing the monophasic and biphasic pulsed direct current, Pg. 84-85, Fig. 2; Fig. 4 the bottom example shows a signal with a 1.784% duty cycle).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pulsed current of Chandler in view of Konin in further view of Goldwasser to include a duty cycle as shown by Kloth because it is merely combining a system with a known particular parameter setting for duty cycle according to known method (setting parameters) to yield a predictable result of a stimulation with the specific parameter.
Claim Rejections - 35 USC § 103
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over chandler in view of Konin in further view of Goldwasser in further view of Lawson.
Regarding Claim 17, an interpretation of Chandler discloses wherein prior to the next pulse, a short period of no voltage output is held ([0009], [0016] see also [0076]; discloses pulsed stimulation which has pauses between each of the pulses).
An interpretation of Chandler does not disclose regulating the voltage output.
However, in the same field of endeavor (medical electrical stimulation devices), Lawson teaches a period of no voltage before prior to regulating the voltage output ([0060], [0070]-[0071], [0073], [0100], [0108], [0138] see also [0031]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to modify the electrotherapy device of Chandler in view of Konin in further view of Goldwasser further to include the step of having a pause followed by “regulating” as recited by Lawson as Lawson teaches changing stimulation based on feedback following a period of stimulation to optimize the wound healing ([0138]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 17923219 in view of Lawson. Claim 5 of ‘219 discloses two stimulation electrodes and two sensing electrodes, sensing of applied current by the sensing electrodes to provide modification of stimulation and the application of current with a duty cycle of 1-10%. an interpretation of ‘219 may not explicitly disclose the application of the stimulation to have a pulsed direct current of 50-500khz. Lawson discloses wherein the controlled voltage source is configured to output DC pulses having a frequency in the range of 50 to 500 kHz ([0051] see also [0031], [0107]). It would have been obvious to one of ordinary skill in the art at the time of the invention to apply a frequency of 50-500kHz because Lawson teaches these parameters monitor and treat wounds in at home-setting in a way which is cost effective manner that can prevent amputation of untreated wounds ([0005]-[0006]).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jerome Hunckler et al. A current affair: electrotherapy in wound healing. J Multidiscip Healthc. 2017 Apr 20;10:179-194. doi: 10.2147/JMDH.S127207.
Henry Lukaski et al. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. doi: 10.1177/193229681200600126. – Fig. 1 with four (two stim and two sense) electrodes sensing the voltage drop across the wound at 50khz
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James Moss/Examiner, Art Unit 3792
Prosecution Insights