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 .
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Regarding the 112(b), Applicant argues that “about” is understood to mean “very close to” the respective value. The intent is that infinitesimal accuracy is not required and that reasonable accuracy to the stated reference value is sufficient. The examiner appreciates this statement however, the question is what is “very close to” the respective value encompass. MPEP 2173.05(b) discloses in determining the range encompassed by the term “about,” one must consider the context of the term as it is used in the specification and claims of the application. The disclosure or claim does not provide a standard deviation or explains component tolerances. Therefore, “about” is a subjective term, is a deviation of 10% encompassed by the claim? Would 25% or more be encompassed by the claim? Or is reasonable accuracy limited to 0.001%? The court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). Based on the record there is not an objective standard for determining the range encompassed by the term “about”. Instead the claim appears to depend solely on an unrestrained opinion of the limits of “about”. Therefore, as an example, it is unclear in claim 22 if “about 15Hz” encompasses 14.9-15.1Hz; 10-20Hz, or 0-30Hz?
Regarding the prior art rejection, Applicant argues the combination renders the modified primary reference unsuitable for its intended purpose and does not disclose every feature of the claims. Applicant argues the claims are directed to migraine treatment and Claude is a handheld sinus treatment device. The Applicant argues the present claims requires a constant peak stimulation current between 15 and 32 milliamps. While Claude discloses microcurrent which Applicant alleges is multiple orders of magnitude lower. Applicant questions why a person having ordinary skill in the art would modify Claude sinus treatment device to use much higher current and to output a completely different type of treatment. The examiner respectfully disagrees as Covalin does not preclude the use of 15-32mA. While the Applicant argues Claude discloses microcurrents in Paragraph [0039] and another embodiment with 1000microamps in Paragraph [0084] this does not prohibit larger currents. Claude discloses in Paragraph [0002] the handheld device includes a current output circuit and does not make any attempt to limit current to microcurrents. The examiner notes for a reference to be considered to teach away from a proposed modification such reference must criticize, discredit, or otherwise discourage the proposed combination. In re Fulton, 73 USPQ2d 1141 (Fed. Cir. 2004). The applicant is further advised that disclosed examples and/or preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments, even if such nonpreferred embodiments are described as somewhat inferior. See In re Susi, 169 USPQ 423 (CCPA 1971), and In re Gurley, 31 USPQ2d 1130 (Fed. Cir. 1994).
Furthermore, the examiner notes the modification does not replace the features of Claude but adds the additional features of Covalin to include a migraine treatment. Claude provides a handheld treatment device to treat sinus pain and Covalin discloses a handheld device that treats migraines. By integrating the teachings of Covalin with the ability to apply current up to 30mA suprajacent the occipital or auricular nerve for treatment of headaches and migraines provides a single instrument that has the functioning of Claude for treating sinus pain and Covalin for treating migraines. Modifying the features of Covalin into Claude would provide a single instrument to treat different pains and increase the versatility of the device.
Applicant argues neither Claude not Covalin discloses keeping a peak stimulation current constant between 15 and 32 milliamps by adjusting a stimulation voltage. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Claude in Paragraph [0083] discloses maintaining a constant treatment stimulation current corresponds to causing the peaks of the treatment stimulation current to have substantially the same magnitudes. This is modified by Covalin which teaches the use of applying current up to 30mA (e.g. Paragraph [0080]) suprajacent the occipital or auricular nerve for the treatment of headaches and migraines. To elaborate the caregiver or the patient can apply the device at varying levels of pressure to vary the contact area between the tip and the skin, which may change the impedance between the electrode and the therapy site and thereby change the amount of current delivered to the therapy site. As the pressure is subsequently increased to press the tip into the skin, indenting it somewhat and thereby increasing the surface area of the skin that contacts the electrode. This increased contact area between the tip and the patient reduces the electrical impedance between the electrode and the therapy site, and inversely and proportionally increases the stimulation current provided to the patient without otherwise adjusting parameters of the stimulation. Therefore, Claude in view of Covalin teaches in Paragraph [0080] that when using the modified device to treat migraines the peak stimulation current is constant at 30mA. The modification provides an even delivery of current when treating migraines. This modification reduces cost by providing a single device where the peak current can be adjusted to treat various pains. Instead of having to purchase Claude for sinus pain and Covalin or Baschinski et al (US Publication 2013/0085551) for migraine treatment. For these reasons the arguments are not persuasive.
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 22, 27, 30, and 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claims 22, 27, 30, and 46 is a relative term which renders the claim indefinite. The term “about” 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 disclosure does not provide any indication into the deviation that would fall within the scope of the claim. This leaves the exact metes and bounds unclear as to what amount of variance would be considered “about”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-9, 12, 15, 20-22, 26-28, 30, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claude et al (US Publication 2019/0217094) in view of Covalin (US Publication 2010/0030299).
Referring to Claim 1, Claude et al teaches a method of operating a treatment microcurrent device, the method comprising: detecting, with the microcurrent treatment device and while a treatment electrode of the microcurrent treatment device is held in contact with a first skin surface location of a user and a return electrode of the microcurrent device is in contact with one of the user's hands, an impedance between the treatment electrode and the return electrode (e.g. Paragraphs [0026] and [0041]); applying a stimulation voltage between the treatment electrode and the return electrode; adjust the stimulation voltage between as the detected impedance between the treatment electrode and the return electrode changes (e.g. Paragraph [0083] discloses adjust the stimulation voltage between the conductive tip 108 and the return electrode 110 to maintain a constant treatment stimulation current). However, Claude et al does not disclose a migraine treatment, a first skin surface location of a user superjacent one or more of a trigeminal nerve, an auricular nerve, an occipital nerve or a cervical nerve; and adjusting a stimulation voltage to maintain a constant peak stimulation current of between 15 and 32 milliamps. Covalin teaches that it is known to use apply current stimulation of up to 30mA superjacent the occipital or auricular nerve for the treatment of headaches and migraines as set forth in paragraphs [0003-0004], table 1 (migraine as primary headache in paragraph [0005] and paragraphs [0016] (treatment of primary headaches via transcutaneous stimulation), [0080] and [0128] to provide reduced medical costs by enabling the patient to treat and/or prevent headache pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Claude et al, with a migraine treatment, a first skin surface location of a user superjacent one or more of a trigeminal nerve, an auricular nerve, an occipital nerve or a cervical nerve; and adjusting a stimulation voltage to maintain a constant peak stimulation current of between 15 and 32 milliamps as taught by Covalin, since such a modification would provide the predictable results of reduced medical costs by enabling the patient to treat and/or prevent headache pain.
Referring to Claim 3, Claude et al in view of Covalin teaches the method of claim 1, wherein adjusting the stimulation voltage comprises adjusting the stimulation voltage according to a treatment model saved to a memory of the microcurrent device (e.g. Paragraph [0052] discloses memory including treatment length, stimulation strengths, and frequencies of treatment).
Referring to Claim 4, Claude et al in view of Covalin teaches the method of claim 1, further comprising applying an initial stimulation voltage between the treatment electrode and the return electrode (e.g. Paragraphs [0052] and [0069]).
Referring to Claim 5, Claude et al in view of Covalin teaches the method of claim 4, wherein applying the initial stimulation voltage comprises applying a personal stimulation voltage saved to a therapy profile in a memory of the microcurrent device, and wherein the personal stimulation voltage is based on a most recent stimulation voltage used by the microcurrent device (e.g. Paragraph [0052]).
Referring to Claim 6, Claude et al in view of Covalin teaches the method of claim 4, wherein applying the initial stimulation voltage includes applying a user selected stimulation voltage received from a user input of the microcurrent device (e.g. Figure 5 and Paragraph [0051]).
Referring to Claim 7, Claude et al in view of Covalin teaches the method of claim 1, wherein detecting the impedance includes measuring the stimulation current between the treatment electrode and the return electrode (e.g. Paragraphs [0086-0087]).
Referring to Claim 8, Claude et al in view of Covalin teaches the method of claim 1, further comprising initiating a treatment mode of the microcurrent device by initiating a user interface notification, when the impedance drops below a threshold, that the treatment electrode is at a treatment location (e.g. Paragraph [0041]).
Referring to Claim 9, Claude et al in view of Covalin teaches the method of claim 8, wherein initiating a user interface notification includes at least one of: initiating a haptic feedback of the microcurrent device and illuminating a light emitting diode of the microcurrent device (e.g. Paragraphs [0042] and [0056]).
Referring to Claim 12, Claude et al in view of Covalin teaches the method of claim 1, further comprising turning off the microcurrent device when the impedance between the treatment electrode and the return electrode is greater than a pre-determined threshold for a pre-determined time period (e.g. Paragraph [0046] discloses terminating (turning off) the treatment when detecting an impedance increase above the threshold).
Referring to Claim 15, Claude et al in view of Covalin teaches the method of claim 1, further comprising applying the stimulation voltage between the treatment electrode and the return electrode, including driving voltage pulses across the treatment electrode and the return electrode (e.g. Paragraph [0045] discloses controls the stimulation voltage (across the treatment electrode 208 and return electrode 210)).
Referring to Claim 20, Claude et al in view of Covalin teaches the method of claim 1, wherein the stimulation current is an alternating polarity having a frequency of less than 100 Hertz (e.g. Paragraph [0085] discloses frequency between 1 and 100 Hz).
Referring to Claim 21, Claude et al in view of Covalin teaches the method of claim 20, wherein the stimulation current has a frequency between 10 Hertz and 30 Hertz (e.g. Paragraph [0085]).
Referring to Claim 22, Claude et al in view of Covalin teaches the method of claim 21, wherein the stimulation current has a frequency of about 15 Hertz (e.g. Paragraph [0085]).
Referring to Claim 26, Claude et al in view of Covalin teaches the method of claim 20, wherein the stimulation current waveform has a duty cycle of less than 5% (e.g. Paragraph [0085] discloses less than 3%).
Referring to Claim 27, Claude et al in view of Covalin teaches the method of claim 26, wherein the stimulation current waveform has a duty cycle of about 2% (e.g. Paragraph [0085]).
Referring to Claim 28, Claude et al in view of Covalin teaches the method of claim 20, wherein the stimulation current has a time-averaged current of between 300 and 480 microamps (e.g. Paragraph [0084] discloses average current less than 600 microamps). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Claude et al with a time-averaged current of between 300 and 480 microamps, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 30, Claude et al in view of Covalin teaches the method of claim 28, wherein the stimulation has a time-averaged current of about 360 microamps (e.g. Paragraph [0084]).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Claude et al with a time-averaged current of about 360 microamps, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 36, Claude et al in view of Covalin teaches the method of claim 1, further comprising: entering a treatment mode when the detected impedance is below a dynamically adjusted impedance threshold (e.g. Paragraphs [0041] and [0043]); wherein the applying a stimulation voltage between the treatment electrode and the return electrode includes applying the stimulation voltage while in the treatment mode (e.g. Paragraph [0042]).
Referring to Claim 37, Claude et al in view of Covalin teaches the method for treating human migraine symptoms of claim 36, wherein entering the treatment mode includes outputting a signal, via a user interface, indicating that a treatment electrode is at a location for applying the microcurrent treatment (e.g. Paragraphs [0042] and [0045]).
Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claude et al (US Publication 2019/0217094) in view of Covalin (US Publication 2010/0030299), as applied above, and further in view of Schepis et al (US Publication 2017/0224989).
Referring to Claim 31, Claude et al in view of Covalin teaches the method of claim 20, except wherein the stimulation has a peak current density of between 150 and 450 milliamps per square centimeter where the treatment electrode contacts the skin surface location.
Schepis et al teaches that it is known to use generate high density current at the tip of 140mA/cm2 to about 1000mA/cm2 to the skin as set forth in Paragraph [0082] and [0097] to provide selective blocking of nerve fibers to reduce the patient’s sensations of pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Claude et al, with the stimulation has a peak current density of between 150 and 450 milliamps per square centimeter where the treatment electrode contacts the skin surface location as taught by Schepis et al, since such a modification would provide the predictable results of selective blocking of nerve fibers to reduce the patient’s sensations of pain.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Claude et al with a peak current density of between 150 and 450 milliamps per square centimeter, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 33, Claude et al in view of Covalin and Schepis et al teaches the method of claim 31, except wherein the stimulation has a peak current density of about 300 milliamps per square centimeter where the treatment electrode contacts the skin surface location.
Schepis et al teaches that it is known to use generate high density current at the tip of 140mA/cm2 to about 1000mA/cm2 to the skin as set forth in Paragraph [0082] and [0097] to provide selective blocking of nerve fibers to reduce the patient’s sensations of pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Claude et al, with the stimulation has a peak current density of about 300 milliamps per square centimeter where the treatment electrode contacts the skin surface location as taught by Schepis et al, since such a modification would provide the predictable results of selective blocking of nerve fibers to reduce the patient’s sensations of pain.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Claude et al with a peak current density of about 300 milliamps per square centimeter, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 45-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Claude et al (US Publication 2019/0217093) (hereby referred to as Claude 2) in view of Covalin (US Publication 2010/0030299).
Referring to Claim 45, Claude 2 teaches a microcurrent device, comprising: a treatment electrode (e.g. Figure 2B, electrode 218); a return electrode operatively coupled to a device body of the microcurrent device (e.g. Figure 2B, electrode 210 and Paragraph [0025]); a stimulation driver stage coupled to apply a stimulation voltage between the treatment electrode and the return electrode (e.g. Paragraphs [0069], [0070] and [0076]); a peak detector coupled to generate a peak stimulation current signal in response to receiving a stimulation signal from the treatment electrode (e.g. Paragraphs [0069, [0074], [0076], [0078], and [0079]); a microcontroller coupled to receive the peak stimulation current signal from the peak detector and coupled to the stimulation driver stage and configured to adjust the stimulation voltage in response to the peak stimulation current signal to keep the peak stimulation current signal at a constant value (e.g. Paragraph [0083]). However, Claude et al does not disclose a migraine treatment, adjusting a stimulation voltage to maintain a constant peak stimulation current of between 15 and 24 milliamps. Covalin teaches that it is known to use apply current stimulation of up to 30mA for the treatment of headaches and migraines as set forth in paragraphs [0003-0004], table 1 (migraine as primary headache in paragraph [0005] and paragraphs [0016] (treatment of primary headaches via transcutaneous stimulation), [0080] and [0128] to provide reduced medical costs by enabling the patient to treat and/or prevent headache pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Claude et al, with a migraine treatment and adjusting a stimulation voltage to maintain a constant peak stimulation current of between 15 and 24 milliamps as taught by Covalin, since such a modification would provide the predictable results of reduced medical costs by enabling the patient to treat and/or prevent headache pain.
Referring to Claim 46, Claude 2 in view of Covalin teaches the migraine treatment microcurrent device of claim 45, except wherein the microcontroller is configured to maintain the peak stimulation current at about 18 milliamps.
Covalin teaches that it is known to use apply current stimulation of up to 20mA for the treatment of headaches and migraines as set forth in paragraphs [0003-0004], table 1 (migraine as primary headache in paragraph [0005] and paragraphs [0016] (treatment of primary headaches via transcutaneous stimulation), [0080] and [0128] to provide reduced medical costs by enabling the patient to treat and/or prevent headache pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Claude et al, with a migraine treatment and adjusting a stimulation voltage to maintain a constant peak stimulation current of about 18 milliamps as taught by Covalin, since such a modification would provide the predictable results of reduced medical costs by enabling the patient to treat and/or prevent headache pain
Referring to Claim 47, Claude 2 in view of Covalin teaches the microcurrent device of claim 45, wherein the stimulation driver stage includes: a digital-to-analog converter (DAC) coupled to generate an analog voltage in response to a digital instruction from the microcontroller (e.g. Paragraph [0070] discloses the stimulation driver stage includes a digital-to-analog converter (DAC)); an amplifier coupled to generate an amplified analog voltage in response to receiving the analog voltage from the DAC (e.g. Paragraph [0070] discloses the stimulation driver stage includes an amplifier); a transformer, wherein the treatment electrode is coupled to a secondary side of the transformer (e.g. Paragraphs [0070] and [0072] discloses the stimulation driver stage includes a transformer); a capacitor coupled between the amplifier and a primary side of the transformer to block the DC (direct current) portions of the amplified analog signal (e.g. Paragraphs [0070] and [0073] discloses the stimulation driver stage includes a capacitor).
Referring to Claim 48, Claude 2 in view of Covalin teaches the microcurrent device of claim 45, wherein the peak detector includes: a diode element (e.g. Paragraph [0074]); a buffer circuit coupled to output the peak stimulation current signal (e.g. Paragraph [0074]); a sample and hold circuit coupled between the diode element and the buffer circuit, wherein the diode element is coupled between a secondary side of the transformer and the sample and hold circuit (e.g. Paragraphs [0074] and [0075]).
Referring to Claim 49, Claude 2 in view of Covalin teaches the microcurrent device of claim 48, wherein the microcontroller includes an analog-to-digital converter (ADC) coupled to sample the peak stimulation current signal and drive the digital instruction to the DAC to keep the peak stimulation current signal at the constant value (e.g. Paragraph [0076]).
Referring to Claim 50, Claude 2 in view of Covalin teaches the migraine treatment device of claim 45, wherein: the device body includes a housing configured to be held in a hand of a user; the return electrode is positioned on the housing such that when the user holds the housing the hand of the user is in contact with the return electrode (e.g. Figure 2B and Paragraph [0025]).
Referring to Claim 51, Claude 2 in view of Covalin teaches the migraine treatment device of claim 45 wherein the stimulation current flows in an alternating polarity waveform between the treatment electrode and the return electrode (e.g. Paragraph [0052]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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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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/William J Levicky/Primary Examiner, Art Unit 3796