DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 May 2025 has been entered.
Status of Claims
Claims 1-22 are pending and currently under consideration for patentability; claims 1, 11, and 18 have been amended.
Response to Arguments
Applicant’s arguments dated 04 April 2025 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claims to recite the use of an alternating current, such that the pulses alternate between positive and negative voltages. Applicant argues that the previously presented references do not disclose or suggest the use of alternating current waveforms. The Examiner has addressed the amended limitations in the updated text of the rejection below and offers the following response to Applicant’s arguments.
Applicant argues that Palermo describes an electrical stimulation device for transcranial direct current stimulation. Although the Examiner agrees that Palermo is generally directed to devices that provide transcranial direct current stimulation, the Examiner respectfully submits that Palermo is not limited to only direct current stimulation devices. For example, Palermo describes that “examples of the types of electrical stimulation that may be used include[s]…electroacupuncture, which may use alternating or modulated alternating current waveforms” ([0074]). Later in the Specification, when describing the electronic control unit, Palermo states that “one skilled in the art will understand that a variety of different circuit configurations may be used to generate the direct current” ([0135]), and further that “a variety of different transcranial direct current electrical stimulation devices may be used and/or adapted for use in accordance with the present invention” ([0136]). The Examiner does not dispute that these previous two statements are in relation to direct current stimulation. However, Palermo also accounts for a different stimulation mode, when stating, later in the same paragraph, that “of course, other types of electrical stimulation devices could also be used, which are generally available in the industry” ([0136]). Palermo does not limit the “other types of electrical stimulation devices” to direct current devices, nor does Palermo state that other types of “direct current” electrical stimulation devices could also be used. To the contrary, by contrasting the “other types of electrical stimulation devices” with the “variety of different transcranial direct current electrical stimulation devices” described earlier in the paragraph, Palermo seems to indicate that the “other types of electrical stimulation devices” are not necessarily direct current electrical stimulation devices.
Therefore, although the Examiner does not dispute that Palermo describes a transcranial direct current stimulation device, nor does the Examiner dispute Palermo’s definition of “direct current” as summarized by Applicant, the Examiner respectfully submits that Palermo is not limited to only direct current devices.
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.
Claims 1-5 and 9-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Palermo et al. (US 2008/0208287 A1) in view of Libbus et al. (US 2007/0288070 A1).
Regarding claims 1 and 11, Palermo describes a device for treating a disorder, in particular Parkinson’s disease, in a patient ([0079], [0143]), the device comprising
a stimulator comprising an electrode configured for contacting an outer skin surface of a neck of the patient ([0134])
an energy source coupled to the electrode and configured to transmit, via the electrode, an electric current transcutaneously and non-invasively ([0130] describes the use of a transcranial stimulation device; [0073] - [0074] describe wherein “electrical stimulation” includes nerve activation/stimulation and wherein transcutaneous electrical nerve stimulation may be used to carry out the described methods) through the outer skin surface of the neck of the patient to generate an electrical impulse ([0130], [0135] describes “generating a series of electrical pulses in accordance with a procedure for treating a neurological disorder”)
wherein the electrical impulse comprises an alternating current ([0074], [0136], stimulation devices other than direct current electrical stimulation devices may be used, thereby suggesting the use of alternating current) comprising bursts of pulses ([0018], figures 2F-2H, for example), with each of the bursts comprising a frequency from about 15 Hz to about 50 Hz (figures 2F-2H and their corresponding descriptions in [0125] - [0127]), wherein each of the bursts has a constant period and a burst period (figures 2A and 2C, for example; [0018] - [0019], [0105] - [0106])
Palermo does not explicitly disclose wherein the electrical impulse is generated “at or near a vagus nerve,” and Palermo does not explicitly disclose wherein the bursts contain 2 to 20 pulses, with each of the pulses comprising a duration from about 20 microseconds to about 1000 microseconds and alternating between positive and negative voltages, such that the duration of the burst period is about 40 microseconds to about 20,000 microseconds.
Regarding generating the electrical impulse at or near a vagus nerve, the Examiner respectfully directs the Applicant to the Libbus reference. Libbus also describes a method of treating a disorder in a patient ([0052]) including the use of a transcutaneous stimulation of the vagus nerve ([0023]: “Various embodiments provide an external neural stimulator to transcutaneously provide the neural stimulation and/or inhibition...Examples of a neural targets to provide parasympathetic inhibition include vagus, aortic and carotid nerves and branches thereof...These neural target examples are not intended to be an exhaustive list of all possible neural targets”). In this, the Examiner respectfully submits that Libbus describes the use of transcutaneous stimulation of the vagus nerve. Since the stimulation is “transcutaneous,” or through the skin, the Examiner respectfully submits that, by describing transcutaneous stimulation of the vagus nerve, Libbus thereby describes stimulation through the skin, such that a stimulation source would be placed on the “outer skin surface” and stimulation would be delivered through the skin to the vagus nerve. Based on Libbus’s teachings, the Examiner respectfully submits that, in order to position “an external neural stimulator to transcutaneously provide the neural stimulation” to a “neural target” such as the “vagus” nerve and “branches thereof” (quotations taken from Libbus’s [0023]), it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide stimulation at or near the vagus nerve via electrodes on the outer skin surface of the neck, as doing so advantageously allows the stimulator to properly reach its neural target.
Regarding the bursts containing 2 to 20 pulses, the embodiments provided by Palermo include a number of pulses within each burst (figures 2F-2H), though it is not immediately discernable exactly how many pulses are within each burst. Palermo does, however, describe wherein the stimulation therapy can be varied as necessary in order to best treat the underlying condition ([0124] gives one example of this when stating “preferably, the different burst frequencies are selected so as to selectively generate the production of endorphin, dynorphin, and enkephalin/serotonin during each of the respective sequences, which is believed to have beneficial effects in the treatment of the neurological disorders of the present invention”). Therefore, the Examiner respectfully submits that Palermo recognizes this parameter as a result-effective variable which achieves a recognized result.
Regarding each of the pulses comprising a duration from about 20 microseconds to about 1000 microseconds, the embodiments provided by Palermo include a pulse duration range of 30 microseconds to 400 microseconds ([0102]), and Palermo describes multiple ranges for the duration of the individual pulses (for example, 50-70 microseconds in [0170], [0183], [0196]; 200 microseconds in [0395], [0415]; 50-200 microseconds in [0465], [0496]; 50-100 microseconds in [0479], [0528]). Palermo further describes an overall range of 0.5 microseconds to 10 minutes (claim 86), and an even larger range of 0.5 microseconds to 60 minutes ([0146]). Based on these embodiments, the Examiner respectfully submits that Palermo recognizes this parameter as a result-effective variable which achieves a recognized result.
Regarding the pulses alternating between positive and negative voltages, the Examiner respectfully submits that alternating between positive and negative values is a known and obvious feature of an alternating current device.
Based on the above analysis, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was made to adjust the number of pulses within each burst and the pulse duration, for example arriving at a range of 2 to 20 pulses per burst and a range of 20 to 1000 microseconds per pulse, as doing so would be a matter of optimizing the prior art conditions through routine experimentation in order to optimize patient treatment (please see MPEP 2144.05). Making such modifications also advantageously allows the resulting treatment to be tailored to a specific patient, a specific disorder, and/or a specific part of the body. The Examiner respectfully submits that, when modified in accordance with the guidance above, the resulting system would have a burst period of about 40 microseconds (for example, 2 pulses at 20 microseconds per pulse) to about 20,000 microseconds (for example, 20 pulses at 1000 microseconds per pulse) as recited.
Regarding claims 2 and 12, Palermo describes wherein the method further comprises transmitting zero pulses during each constant period (figures 2A and 2C, delay as shown).
Regarding claims 3 and 13, Palermo describes wherein the electrical impulse alternates between a positive voltage and a negative voltage during the burst periods ([0098]).
Regarding claim 4, Palermo describes wherein the electrical impulses is sufficient to inhibit an inflammation in the patient ([0079] describes that the neurological disorder to be treated refers to inflammation and inflammatory myopathies, [0086] describes wherein treatment includes “preventing, ameliorating, suppressing, or alleviating” a symptom of the neurological disorder; the Examiner respectfully submits that “preventing, ameliorating, suppressing, or alleviating” are analogous to “inhibit[ing]”).
Regarding claim 5, Palermo describes wherein the disorder is Parkinson’s disease ([0079], [0143]).
Regarding claim 9, Palermo describes wherein the pulses have a duration of about 200 microseconds ([0395], [0415]).
Regarding claim 10, although Palermo does not explicitly disclose wherein the electrical impulse has a pulsed on-time of about 100 microseconds to about 300 microseconds, the Examiner respectfully submits that, by adjusting the result effective variables as described by Palermo (please see discussion of claim 1 above), the skilled artisan would arrive at an electrical impulse with a pulsed on-time of 100 microseconds to 300 microseconds. For example, a pattern of 10 pulses of 20 microseconds each would result in a pulsed on-time of 200 microseconds.
Claims 6-8, 15, and 17-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Palermo in view of Libbus, further in view of Huston et al. (US 2009/0143831 A1).
Regarding claims 6 and 15, Palermo in view of Libbus suggests the device of claim 1 and the method of claim 11, including wherein the electrical impulse effects the inflammatory cascade (Palermo: [0079]; Libbus: [0056], [0061]), but Palermo and Libbus do not explicitly disclose wherein the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine. However, Huston also describes a method for treating a disorder in a patient ([0015]), including wherein an electrical impulse is sufficient to inhibit release of a pro-inflammatory cytokine ([0008], [0012]). As Huston is also directed towards treating a disorder in a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to incorporate modulating a pro-inflammatory cytokine, similar to that described by Huston, when using the when using the device and method described by Palermo and Libbus, as doing so advantageously allows the resulting method to better target key mediators in the inflammatory cascade.
Regarding claim 7, Huston further describes wherein the pro-inflammatory cytokine is tumor necrosis factor alpha ([0005]).
Regarding claims 8 and 17, Huston further describes wherein the electrical impulse is sufficient to increase activity of an anti-inflammatory cytokine in the patient ([0014]).
Regarding claim 18, Palermo describes a method for treating a disorder in a patient ([0079], [0143]), the method comprising
positioning an electrode in contact with an outer skin surface of a neck of the patient ([0134])
transmitting, via the electrode, an electric current transcutaneously and non-invasively ([0130] describes the use of a transcranial stimulation device; [0073] - [0074] describe wherein “electrical stimulation” includes nerve activation/stimulation and wherein transcutaneous electrical nerve stimulation may be used to carry out the described methods) through the outer skin surface of the neck of the patient to generate an electrical impulse ([0130], [0135] describes “generating a series of electrical pulses in accordance with a procedure for treating a neurological disorder”)
wherein the electrical impulse comprises an alternating current ([0074], [0136], stimulation devices other than direct current electrical stimulation devices may be used, thereby suggesting the use of alternating current) comprising bursts of pulses ([0018], figures 2F-2H, for example), with each of the bursts comprising a frequency from about 15 Hz to about 50 Hz (figures 2F-2H and their corresponding descriptions in [0125] - [0127]), wherein each of the bursts has a constant period and a burst period (figures 2A and 2C, for example; [0018] - [0019], [0105] - [0106])
Palermo does not explicitly disclose wherein the method is used for treating rheumatoid arthritis, wherein the electrical impulse is generated “at or near a vagus nerve,” and wherein the bursts contain 2 to 20 pulses, with each of the pulses comprising a duration from about 20 microseconds to about 1000 microseconds and alternating between positive and negative voltages, such that the duration of the burst period is about 40 microseconds to about 20,000 microseconds.
Regarding generating the electrical impulse at or near a vagus nerve, the Examiner respectfully directs the Applicant to the Libbus reference. Libbus also describes a method of treating a disorder in a patient ([0052]) including the use of a transcutaneous stimulation of the vagus nerve ([0023]: “Various embodiments provide an external neural stimulator to transcutaneously provide the neural stimulation and/or inhibition...Examples of a neural targets to provide parasympathetic inhibition include vagus, aortic and carotid nerves and branches thereof... These neural target examples are not intended to be an exhaustive list of all possible neural targets”). In this, the Examiner respectfully submits that Libbus describes the use of transcutaneous stimulation of the vagus nerve. Since the stimulation is “transcutaneous,” or through the skin, the Examiner respectfully submits that, by describing transcutaneous stimulation of the vagus nerve, Libbus thereby describes stimulation through the skin, such that a stimulation source would be placed on the “outer skin surface” and stimulation would be delivered through the skin to the vagus nerve. Based on Libbus’s teachings, the Examiner respectfully submits that, in order to position “an external neural stimulator to transcutaneously provide the neural stimulation” to a “neural target” such as the “vagus” nerve and “branches thereof” (quotations taken from Libbus’s [0023]), it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide stimulation at or near the vagus nerve via electrodes on the outer skin surface of the neck, as doing so advantageously allows the stimulator to properly reach its neural target.
Regarding using the method to treat rheumatoid arthritis, the Examiner respectfully directs the Applicant to the Huston reference. Huston also describes a method of treating a disorder in a patient ([0021]), including via stimulation of the vagus nerve ([0016]), and further that the disorder to be treated may be rheumatoid arthritis ([0021]). As Huston is also directed towards treating a disorder in a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to incorporate treating rheumatoid arthritis, as described by Huston, when using the when using the method described by Palermo and Libbus, as doing so advantageously allows the resulting method to target a larger number of disorders.
Regarding the bursts containing 2 to 20 pulses, the embodiments provided by Palermo include a number of pulses within each burst (figures 2F-2H), though it is not immediately discernable exactly how many pulses are within each burst. Palermo does, however, describe wherein the stimulation therapy can be varied as necessary in order to best treat the underlying condition ([0124] gives one example of this when stating “preferably, the different burst frequencies are selected so as to selectively generate the production of endorphin, dynorphin, and enkephalin/serotonin during each of the respective sequences, which is believed to have beneficial effects in the treatment of the neurological disorders of the present invention”). Therefore, the Examiner respectfully submits that Palermo recognizes this parameter as a result-effective variable which achieves a recognized result.
Regarding each of the pulses comprising a duration from about 20 microseconds to about 1000 microseconds, the embodiments provided by Palermo include a pulse duration range of 30 microseconds to 400 microseconds ([0102]), and Palermo describes multiple ranges for the duration of the individual pulses (for example, 50-70 microseconds in [0170], [0183], [0196]; 200 microseconds in [0395], [0415]; 50-200 microseconds in [0465], [0496]; 50-100 microseconds in [0479], [0528]). Palermo further describes an overall range of 0.5 microseconds to 10 minutes (claim 86), and an even larger range of 0.5 microseconds to 60 minutes ([0146]). Based on these embodiments, the Examiner respectfully submits that Palermo recognizes this parameter as a result-effective variable which achieves a recognized result.
Regarding the pulses alternating between positive and negative voltages, the Examiner respectfully submits that alternating between positive and negative values is a known and obvious feature of an alternating current device.
Based on the above analysis, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was made to adjust the number of pulses within each burst and the pulse duration, for example arriving at a range of 2 to 20 pulses per burst and a range of 20 to 1000 microseconds per pulse, as doing so would be a matter of optimizing the prior art conditions through routine experimentation in order to optimize patient treatment (please see MPEP 2144.05). Making such modifications also advantageously allows the resulting treatment to be tailored to a specific patient, a specific disorder, and/or a specific part of the body. The Examiner respectfully submits that, when modified in accordance with the guidance above, the resulting system would have a burst period of about 40 microseconds (for example, 2 pulses at 20 microseconds per pulse) to about 20,000 microseconds (for example, 20 pulses at 1000 microseconds per pulse) as recited.
Regarding claim 19, Palermo describes wherein ethe method further comprises transmitting zero pulses during each constant period (figures 2A and 2C, delay as shown).
Regarding claim 20, Palermo describes wherein the electrical impulse alternates between a positive voltage and a negative voltage during the burst periods ([0098]).
Regarding claim 21, Huston describes wherein the electrical impulse is sufficient to suppress a release of pro-inflammatory cytokines ([0008], [0012]).
Regarding claim 22, Huston describes wherein the electrical impulse is sufficient to increase a release of anti-inflammatory cytokines ([0014]).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Palermo in view of Libbus, further in view of Erfan (US 2005/0165460 A1).
Regarding claim 14, Palermo in view of Libbus suggests the method of claim 11, but neither Palermo nor Libbus explicitly disclose wherein the electrical impulse is sufficient to increase dopamine levels in the brain. However, Erfan also describes a method for treating neurologic conditions, including the use of transcutaneous delivery ([0017]) of stimulation pulses sufficient to increase dopamine levels in the brain ([0008]). As Erfan is also directed towards patient treatment and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a method similar to that described by Palermo and Libbus to increase dopamine levels, in a manner similar to that described by Erfan, as doing so advantageously allows the resulting method to treat certain conditions more effectively, as described by Erfan ([0008]).
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 16, the prior art of record does not disclose or suggest wherein the electrical impulse is sufficient to increase a release of retinoic acid.
Statement on Communication via Internet
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“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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