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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/22/2024 is being considered by the examiner.
Status of Claims
Claims 1-20 are currently pending and under examination.
Priority
The instant application (filed on 10/16/2023) is a non-provisional application filed under 35 USC 111(a). Acknowledgment is made of applicant's claim for domestic priority based on provisional application 63/380,303 filed on 10/20/2022. Instant claims 1-7, 9-18, and 20 are sufficiently described in the provisional application to receive an effective filing date of 10/20/2022.
The specification or figures in provisional application 63/380,303 do not fully disclose the ranges in claims 8 and 19 (“the electrical stimuli having a frequency comprising 1 Hz to 100 Hz, an amplitude comprising 10 to 50 milliamps, a duration comprising 1 minute to 1 hour and a pulse width comprising 25 to 500 microseconds”). The provisional application discloses “an example, the applied frequency of the stimulation Pulses 1410 is in the range of 2 Hertz to 150 Hertz, and the current applied is up to 10 milliamps. An example, Pulses 1410 singly or in Bursts 1430 have Pulse High Times 1420 in the range of 100 to 500 microseconds, and Pulse Low Times 1422 in the range of 100 to 500 microseconds, and with Burst Frequency and Pulse Frequency for single pulses in the range of 2 Hertz to 50 Hertz, and the current applied is up to 10 milliamps” ([63-64]). The frequency, amplitude, and pulse widths above do not match the full extent of the ranges in instant claims 8 and 19. The provisional application does not mention the duration of stimulation either. Additionally, these ranges are not disclosed in 15/912,058 (which was incorporated by reference in the provisional application). Therefore, instant claims 8 and 19 receive an effective filing date of 10/16/2023.
Claim Objections
The following claims are objected to because of the following informalities:
• Claims 6 and 17: The limitation “adjusting the treatment session in response the sensing” would be better understood as something along the lines of “adjusting the treatment session in response to the sensing.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-2 and 12-13 are rejected under U.S.C 103 as being unpatentable over Toong (US 2020/0338333, see “Notice of References Cited) in view of Rigaux (US 2018/0333576, see “Notice of References Cited).
Regarding Claim 1, Toong discloses a method of treating pain ([0002]), the method comprising:
• affixing a patch externally on a dermis of a user ([0020]) on a body location (Fig. 1, [0077] - example being given of application to a heel or foot) of the user adjacent to one or more targeted nerves ([0020]), the patch comprising a flexible substrate ([0022] – “Patch 100 in one example can include a flexible substrate”), a processor directly coupled to the substrate ([0022] – “electronic circuitry (as disclosed herein) embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is directly contacting the flexible substrate”; [0021] – “a processor/controller and instructions that are executed by the processor … and associated electrical circuitry”), and electrodes directly coupled to the substrate ([0022] – “one or more electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and directly contacting the flexible substrate”); and
• activating the patch to initiate a treatment session, the activating comprising generating electrical stimuli ([0021]) to the targeted nerves via the electrodes ([0020]).
However, Toong does not disclose the application of a patch to the head to treat a headache.
Rigaux, in the same field of endeavor of an electrode used to stimulate nerves ([0002]), teaches a self-adhesive patch attached to the forehead to stimulate particular nerves ([0046] – “FIG. 2D shows the positioning on a forehead of a bipolar self-adhesive skin electrode (6) comprising two metallic contact areas (11). As before, the bipolar self-adhesive skin electrode and its positioning are thereby adapted for stimulation of the trigeminal nerve, and preferably for stimulation of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve”). The forehead electrode is intended to relieve pain from migraine headaches ([0032]), where migraine headaches are described as “Migraine is a common neurobiological disorder characterized by recurrent episodes of headache accompanied by sensory hypersensitivity, which can significantly impair quality of life” ([0003]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s method for applying an electrode patch for pain relief by incorporating the application of the patch to the head for pain relief of migraine headaches in Rigaux. This would have been obvious because both Toong and Rigaux discuss use of an electrode within a patch to stimulate nerves for pain relief and Rigaux provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the head. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Toong by incorporating the application of the patch to the head for pain relief of migraine headaches in Rigaux.
Therefore, Claim 1 is obvious over Toong in view of Rigaux.
Regarding Claim 2, the method of treating a headache according to Claim 1 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong discloses a method of applying a patch over the dermis to stimulate nerves ([0020]) for pain relief ([0002]). However, Toong does not disclose the patch affixed on a forehead of the user, the one or more targeted nerves comprises bilateral supraorbital nerves or supratrochlear nerves.
Rigaux, in the same field of endeavor of an electrode used to stimulate nerves ([0002]), teaches a self-adhesive patch attached to the forehead to stimulate particular nerves, including the supraorbital nerves or supratrochlear nerves ([0046] – “FIG. 2D shows the positioning on a forehead of a bipolar self-adhesive skin electrode (6) comprising two metallic contact areas (11). As before, the bipolar self-adhesive skin electrode and its positioning are thereby adapted for stimulation of the trigeminal nerve, and preferably for stimulation of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve”). Both sides of the nerves are meant to be covered and stimulated by the device ([0071]). The forehead electrode is intended to relieve pain from migraine headaches ([0032]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s method for applying an electrode patch for pain relief by incorporating the application of the patch to the forehead for pain relief of migraine headaches in Rigaux. This would have been obvious because both Toong and Rigaux discuss use of an electrode within a patch to stimulate nerves for pain relief and Rigaux provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the forehead. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Toong by incorporating the application of the patch to the forehead for pain relief of migraine headaches in Rigaux.
Therefore, Claim 2 is obvious over Toong in view of Rigaux.
Regarding Claim 12, Toong discloses a pain treatment system ([0002]) comprising:
• a patch adapted to be externally affixed on a dermis of a user ([0020]) on a body location (Fig. 1, [0077] - example being given of application to a heel or foot) of the user adjacent to one or more targeted nerves ([0020]), the patch comprising a flexible substrate ([0022] – “Patch 100 in one example can include a flexible substrate”), a processor directly coupled to the substrate ([0022] – “electronic circuitry (as disclosed herein) embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is directly contacting the flexible substrate”; [0021] – “a processor/controller and instructions that are executed by the processor … and associated electrical circuitry”), and electrodes directly coupled to the substrate ([0022] – “one or more electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and directly contacting the flexible substrate”); and
• the processor adapted to activate the patch to initiate a treatment session, the activating comprising generating electrical stimuli ([0021]) to the targeted nerves via the electrodes ([0020]).
Rigaux, in the same field of endeavor of an electrode used to stimulate nerves ([0002]), teaches a self-adhesive patch attached to the forehead to stimulate particular nerves ([0046] – “FIG. 2D shows the positioning on a forehead of a bipolar self-adhesive skin electrode (6) comprising two metallic contact areas (11). As before, the bipolar self-adhesive skin electrode and its positioning are thereby adapted for stimulation of the trigeminal nerve, and preferably for stimulation of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve”). The forehead electrode is intended to relieve pain from migraine headaches ([0032]), where migraine headaches are described as “Migraine is a common neurobiological disorder characterized by recurrent episodes of headache accompanied by sensory hypersensitivity, which can significantly impair quality of life” ([0003]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s electrode patch for pain relief by incorporating the application of the patch to the head for pain relief of migraine headaches in Rigaux. This would have been obvious because both Toong and Rigaux discuss an electrode within a patch to stimulate nerves for pain relief and Rigaux provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the head. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Toong by incorporating the application of the patch to the head for pain relief of migraine headaches in Rigaux.
Therefore, Claim 12 is obvious over Toong in view of Rigaux.
Regarding Claim 13, the headache treatment system according to Claim 12 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong discloses a patch placed over the dermis to stimulate nerves ([0020]) for pain relief ([0002]). However, Toong does not disclose the patch adapted to be affixed on a forehead of the user, the one or more targeted nerves comprises bilateral supraorbital nerves or supratrochlear nerves.
Rigaux, in the same field of endeavor of an electrode used to stimulate nerves ([0002]), teaches a self-adhesive patch attached to the forehead to stimulate particular nerves, including the supraorbital nerves or supratrochlear nerves ([0046] – “FIG. 2D shows the positioning on a forehead of a bipolar self-adhesive skin electrode (6) comprising two metallic contact areas (11). As before, the bipolar self-adhesive skin electrode and its positioning are thereby adapted for stimulation of the trigeminal nerve, and preferably for stimulation of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve”). Both sides of the nerves are meant to be covered and stimulated by the device ([0071]). The forehead electrode is intended to relieve pain from migraine headaches ([0032]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s electrode patch for pain relief by incorporating the application of the patch to the forehead for pain relief of migraine headaches in Rigaux. This would have been obvious because both Toong and Rigaux discuss use of an electrode within a patch to stimulate nerves for pain relief and Rigaux provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the forehead. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Toong by incorporating the application of the patch to the forehead for pain relief of migraine headaches in Rigaux.
Therefore, Claim 13 is obvious over Toong in view of Rigaux.
Claims 3-11 and 14-20 are rejected under U.S.C 103 as being unpatentable over Toong (US 2020/0338333, see “Notice of References Cited) in view of Rigaux (US 2018/0333576, see “Notice of References Cited) and Page (US PG Pub 2020/0269046, see “Notice of References Cited).
Regarding Claim 3, the method of treating a headache according to Claim 1 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong discloses a method of applying a patch over the dermis to stimulate nerves ([0020]) for pain relief ([0002]). However, Toong does not disclose the patch affixed on a back of the head, the one or more targeted nerves comprises bilateral occipital nerves.
Page, in the same field of endeavor of an electrode used to stimulate nerves ([0009]), teaches a stimulation device placed on the back of the head to target the occipital nerves (Fig. 7, [0178] – “Fig. 7 illustrates an example stimulation device 100 positioned on the back of the patient's head for targeting at least one of the greater occipital nerve, lesser occipital nerve, and least occipital nerve (i.e. 3rd occipital nerve)”). The electrode housing placed on the back of the head ([0178] – “The electrode 120 is located within the housing such that the electrical stimulation is projected toward the contact surface of the housing … The electrode 120 and/or housing is sized and configured for placement adjacent an outer surface of the patient's skin”) is interpreted as equivalent to a patch. The left and right occipital nerves can be stimulated ([0054]). The stimulation is meant to relieve pain from headaches via inhibition of nervous signaling ([0003] – “The inhibition of nervous signaling via a non-invasive means is important as it would allow for patients to self-administer inhibition of nervous signaling outside the medical office on an as-needed basis and/or for the acute treatment of a condition (e.g. for abortion of a migraine episode)”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s method for applying an electrode patch for pain relief by incorporating the application of the patch to the back of the head for pain relief of migraines in Page. This would have been obvious because both Toong and Page discuss use of an electrode within a patch to stimulate nerves for pain relief and Page provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the back of the head. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Toong by incorporating the application of the patch to the back of the head for pain relief of migraines in Page.
Therefore, Claim 3 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 4, the method of treating a headache according to Claim 1 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong further discloses the patch comprising one or more sensors directly coupled to the substrate ([0022] - “electronic circuitry (as disclosed herein) embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is directly contacting the flexible substrate the electronic circuitry integrated as a system on a chip and including … a nerve stimulation sensor that provides feedback in response to a stimulation of one or more nerves”), the sensors detecting a parameter ([0026]). However, Toong does not disclose the sensors detecting a degree of headache.
Page, in the same field of endeavor of an electrode used to stimulate nerves ([0009]), teaches
a stimulation feedback provided by sensors which measure biometrics associated with headache pain ([00286] – “In its simplest form, the method may rely on a patient's feedback regarding their perception of pain after delivery of nerve blocking electrical stimulation to assess the effectiveness of the temporary and selective nerve signaling inhibition … the method may rely on feedback collected by a recording electrode, such as an ECG, galvanic skin response, skin conductance meter, skin pH meter, transdermal water loss sensor, blood flow meter, skin or body temperature, and/or electromyogram signals to assess the effectiveness of the nerve signal inhibition, since the stimulation may occur before, during, or immediately after a surgical procedure or at a time when the patient is suffering severe acute head-and-face pain and is unable to provide meaningful feedback”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s method for applying an electrode patch for pain relief by incorporating the application of a patch with sensors to measure pain for stimulation feedback and control in Page. This would have been obvious because both Toong and Page discuss use of an electrode within a patch to stimulate nerves for pain relief and Page provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the back of the head. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Toong by incorporating the application of a patch with sensors to measure pain for stimulation feedback and control in Page.
Therefore, Claim 4 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 5, the method of treating a headache according to Claim 4 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses the sensors sensing one or more of chemical, thermal, electrical field, magnetic field, audio or motion ([0026] – a variety of sensor types can be used: “Patch 100 receives sensory signals from the tissue and translates them to a data stream that is recognized by control unit 1002. Sensory signals can include electrical, mechanical, acoustic, optical and chemical signals”).
Therefore, Claim 5 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 6, the method of treating a headache according to Claim 5 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses comprising adjusting the treatment session in response the sensing ([0089] – “Various arrays of electrodes as disclosed above can be controlled to generate optimized stimulation. The stimulation can be adaptive based on feedback from sensors as disclosed above”; [0126] – “Further, in example inventions, patch 100 selects the one or more sensor electrodes 1240 by activating sensing mode switch 1242 to connect the sensor to processor 1216. Processor 1216 uses one or more of hardware or software or firmware to analyze the measurement procured from sensor electrode 1240, using the analyzed measurement to inform the selection of positive electrodes 1212”).
Therefore, Claim 6 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 7, the method of treating a headache according to Claim 6 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses the electrical stimuli comprising a series of pulses with a pattern comprising an intensity and a duration, the adjusting comprising adjusting the intensity or the duration of the pattern ([0049] – “A treatment is performed by a sequence of periodic pulses, which deliver charge into the body through electrodes 320. Some of the parameters of the treatment are fixed and some are user adjustable. The strength, duration and frequency may be user adjustable. The user may adjust these parameters as necessary for comfort and efficacy”).
Therefore, Claim 7 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 8, the method of treating a headache according to Claim 1 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong further discloses the electrical stimuli having a frequency comprising 1 Hz to 100 Hz ([0089] – “a pulse repetition rate of between 50 and 200 Hz”), an amplitude ([0089] – “the Gate Theory type treatment, square waves having an amplitude between 10
and 100 volts”), a duration ([0065-0066] – 1000+ pulses) and a pulse width comprising 25 to 500 microseconds ([0089] – “pulse widths between 100 and 500 microseconds”). According to MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for pulse width or frequency. Note Toong discloses the capability of producing amplitudes of 2-20 mA, but these amplitudes are associated with different pulse width and frequency settings ([0089] – “For the KES type treatment, the stimulation in would be in the form of square waves having an amplitude between 2 and 20 mA, pulse widths between 10 and 50 microseconds, and a pulse repetition rate of between 20 and 40 KHz”). Therefore, Toong does not disclose the electrical stimuli having an amplitude of 10 to 50 milliamps or duration comprising 1 minute to 1 hour.
Page, in the same field of endeavor of an electrode used to stimulate nerves ([0009]), teaches a stimulation waveform for treating migraine headaches using a current amplitude of 1-200 mA ([0219]) or voltage amplitude of 1-2000 V ([0219]) and frequency 0.01-50 Hz ([0220]). Page teaches a duration of up to 8 hours, but preferably from 1-30 min ([0221]). According to MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for amplitude, frequency, or duration.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s method for using an electrode patch for pain relief by incorporating the stimulator settings used to treat migraines in Page. This would have been obvious because both Toong and Page discuss use of an electrode within a patch to stimulate nerves for pain relief and Page provides a solution/improvement with settings (capable of being reproduced using the apparatus in Toong) which can be used to treat a migraine condition and improve patient quality of life. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Toong by incorporating the stimulator settings used to treat migraines in Page.
Therefore, Claim 8 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 9, the method of treating a headache according to Claim 5 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses further comprising:
• determining a target charge level (Claim 8 – Line 2) for the treatment based at least in part on the sensing by the sensors ([0053] – charge is measured via sensors to assess adaptive charge);;
• outputting a series of pulses from the electrodes (Claim 8 – Line 3);
• for each pulse outputted, measuring a charge value of the pulse and compare the charge value to the target charge level (Claim 8 – Lines 4-6);
• if the charge value is greater than the target charge level, reducing a strength level of a subsequent outputted pulse (Claim 8 – Lines 7-9);
• if the charge value is less than the target charge level, increasing the strength level of a subsequent outputted pulse (Claim 8 – Lines 10-12); and
• repeating the determining, outputting and measuring ([0058] – this process can be repeated for any number of pulses).
Therefore, Claim 9 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 10, the method of treating a headache according to Claim 9 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses the determining the target charge level Qtarget comprises generating an acquisition series of pulses and
Q
t
a
r
g
e
t
=
∑
i
=
1
T
x
f
Q
p
u
l
s
e
(
i
)
, where T is a duration of the acquisition series of pulses, f is a count of pulses for one treatment acquisition series of pulses and Qpulse(i) is a measured charge of each of the acquisition series of pulses ([0053]).
Therefore, Claim 10 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 11, the method of treating a headache according to Claim 9 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses the patch further comprising electronic circuitry directly coupled to the substrate ([0022] – “electronic circuitry (as disclosed herein) embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is directly contacting the flexible substrate”) and comprising a differential integrator (700 - Differential Integrator circuit), the charge value of the pulse based on an output of the differential integrator ([0053] – “Differential Integrator circuit 700 of FIG. 6 is an example of a circuit used to integrate current measured over time and quantify the delivered charge and therefore determine the charge output over a treatment pulse”).
Therefore, Claim 11 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 14, the headache treatment system according to Claim 12 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong discloses a patch placed over the dermis to stimulate nerves ([0020]) for pain relief ([0002]). However, Toong does not disclose the patch affixed on a back of the head, the one or more targeted nerves comprises bilateral occipital nerves.
Page, in the same field of endeavor of an electrode used to stimulate nerves ([0009]), teaches a stimulation device placed on the back of the head to target the occipital nerves (Fig. 7, [0178] – “Fig. 7 illustrates an example stimulation device 100 positioned on the back of the patient's head for targeting at least one of the greater occipital nerve, lesser occipital nerve, and least occipital nerve (i.e. 3rd occipital nerve)”). The electrode housing placed on the back of the head ([0178] – “The electrode 120 is located within the housing such that the electrical stimulation is projected toward the contact surface of the housing … The electrode 120 and/or housing is sized and configured for placement adjacent an outer surface of the patient's skin”) is interpreted as equivalent to a patch. The left and right occipital nerves can be stimulated ([0054]). The stimulation is meant to relieve pain from headaches via inhibition of nervous signaling ([0003] – “The inhibition of nervous signaling via a non-invasive means is important as it would allow for patients to self-administer inhibition of nervous signaling outside the medical office on an as-needed basis and/or for the acute treatment of a condition (e.g. for abortion of a migraine episode)”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s electrode patch for pain relief by incorporating the application of the patch to the back of the head for pain relief of migraines in Page. This would have been obvious because both Toong and Page discuss use of an electrode within a patch to stimulate nerves for pain relief and Page provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the back of the head. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Toong by incorporating the application of the patch to the back of the head for pain relief of migraines in Page.
Therefore, Claim 14 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 15, the headache treatment system according to Claim 12 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong further discloses the patch comprising one or more sensors directly coupled to the substrate ([0022] - “electronic circuitry (as disclosed herein) embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is directly contacting the flexible substrate the electronic circuitry integrated as a system on a chip and including … a nerve stimulation sensor that provides feedback in response to a stimulation of one or more nerves”), the sensors detecting a parameter ([0026]). However, Toong does not disclose the sensors detecting a degree of headache.
Page, in the same field of endeavor of an electrode used to stimulate nerves ([0009]), teaches a stimulation feedback provided by sensors which measure biometrics associated with headache pain ([00286] – “In its simplest form, the method may rely on a patient's feedback regarding their perception of pain after delivery of nerve blocking electrical stimulation to assess the effectiveness of the temporary and selective nerve signaling inhibition … the method may rely on feedback collected by a recording electrode, such as an ECG, galvanic skin response, skin conductance meter, skin pH meter, transdermal water loss sensor, blood flow meter, skin or body temperature, and/or electromyogram signals to assess the effectiveness of the nerve signal inhibition, since the stimulation may occur before, during, or immediately after a surgical procedure or at a time when the patient is suffering severe acute head-and-face pain and is unable to provide meaningful feedback”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s electrode patch for pain relief by incorporating the application of a patch with sensors to measure pain for stimulation feedback and control in Page. This would have been obvious because both Toong and Page discuss use of an electrode within a patch to stimulate nerves for pain relief and Page provides a solution/improvement to improve quality of life by reducing pain from migraines via a patch applied to the back of the head. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Toong by incorporating the application of a patch with sensors to measure pain for stimulation feedback and control in Page.
Therefore, Claim 15 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 16, the headache treatment system according to Claim 15 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong further discloses the sensors sensing one or more of chemical, thermal, electrical field, magnetic field, audio or motion ([0026] – a variety of sensor types can be used: “Patch 100 receives sensory signals from the tissue and translates them to a data stream that is recognized by control unit 1002. Sensory signals can include electrical, mechanical, acoustic, optical and chemical signals”).
Therefore, Claim 16 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 17, the headache treatment system according to Claim 16 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses the processor further adapted to adjusting the treatment session in response the sensing ([0089] – “Various arrays of electrodes as disclosed above can be controlled to generate optimized stimulation. The stimulation can be adaptive based on feedback from sensors as disclosed above”; [0126] – “Further, in example inventions, patch 100 selects the one or more sensor electrodes 1240 by activating sensing mode switch 1242 to connect the sensor to processor 1216. Processor 1216 uses one or more of hardware or software or firmware to analyze the measurement procured from sensor electrode 1240, using the analyzed measurement to inform the selection of positive electrodes 1212”).
Therefore, Claim 17 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 18, the headache treatment system according to Claim 17 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses electrical stimuli comprising a series of pulses with a pattern comprising an intensity and a duration, the adjusting comprising adjusting the intensity or the duration of the pattern ([0049] – “A treatment is performed by a sequence of periodic pulses, which deliver charge into the body through electrodes 320. Some of the parameters of the treatment are fixed and some are user adjustable. The strength, duration and frequency may be user adjustable. The user may adjust these parameters as necessary for comfort and efficacy”).
Therefore, Claim 18 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 19, the headache treatment system according to Claim 12 is obvious over Toong in view of Rigaux, as indicated hereinabove. Toong further discloses the electrical stimuli having a frequency comprising 1 Hz to 100 Hz ([0089] – “a pulse repetition rate of between 50 and 200 Hz”), an amplitude ([0089] – “the Gate Theory type treatment, square waves having an amplitude between 10 and 100 volts”), a duration ([0065-0066] – 1000+ pulses) and a pulse width comprising 25 to 500 microseconds ([0089] – “pulse widths between 100 and 500 microseconds”). According to MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for pulse width or frequency. Note Toong discloses the capability of producing amplitudes of 2-20 mA, but these amplitudes are associated with different pulse width and frequency settings ([0089] – “For the KES type treatment, the stimulation in would be in the form of square waves having an amplitude between 2 and 20 mA, pulse widths between 10 and 50 microseconds, and a pulse repetition rate of between 20 and 40 KHz”). Therefore, Toong does not disclose the electrical stimuli having an amplitude of 10 to 50 milliamps or duration comprising 1 minute to 1 hour.
Page, in the same field of endeavor of an electrode used to stimulate nerves ([0009]), teaches a stimulation waveform for treating migraine headaches using a current amplitude of 1-200 mA ([0219]) or voltage amplitude of 1-2000 V ([0219]) and frequency 0.01-50 Hz ([0220]). Page teaches a duration of up to 8 hours, but preferably from 1-30 min ([0221]). According to MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for amplitude, frequency, or duration.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Toong’s electrode patch for pain relief by incorporating the stimulator settings used to treat migraines in Page. This would have been obvious because both Toong and Page discuss use of an electrode within a patch to stimulate nerves for pain relief and Page provides a solution/improvement with settings (capable of being reproduced using the apparatus in Toong) which can be used to treat a migraine condition and improve patient quality of life. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Toong by incorporating the stimulator settings used to treat migraines in Page.
Therefore, Claim 19 is obvious over Toong in view of Rigaux and Page.
Regarding Claim 20, the headache treatment system according to Claim 16 is obvious over Toong in view of Rigaux and Page, as indicated hereinabove. Toong further discloses the processor further adapted to:
• determining a target charge level (Claim 8 – Line 2) for the treatment based at least in part on the sensing by the sensors ([0053] – charge is measured via sensors to assess adaptive charge);
• outputting a series of pulses from the electrodes (Claim 8 – Line 3);
• for each pulse outputted, measuring a charge value of the pulse and compare the charge value to the target charge level (Claim 8 – Lines 4-6);
• if the charge value is greater than the target charge level, reducing a strength level of a subsequent outputted pulse (Claim 8 – Lines 7-9);
• if the charge value is less than the target charge level, increasing the strength level of a subsequent outputted pulse (Claim 8 – Lines 10-12); and
• repeating the determining, outputting and measuring ([0058] – this process can be repeated for any number of pulses).
Therefore, Claim 20 is obvious over Toong in view of Rigaux and Page.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796