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 combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 1-10 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Huston et al. (US 2009/0143831; hereinafter “Huston”) in view of Faul (US 2005/0075678; hereinafter “Faul”), further in view of Goodall et al. (US 2018/0168905; hereinafter “Goodall”), further in view of Rezai et al. (US 2014/0067021).
Regarding claims 1 and 18, Huston discloses a device for treating a patient, the device comprising: a transcutaneous stimulation element placed at an outer skin surface of the patient and comprising one or more electrodes (e.g. ¶¶ 16, 20, etc.); and an energy source coupled to the electrodes (e.g. ¶¶ 46-48, etc.), wherein the energy source comprises a signal generator (e.g. ¶¶ 50 – driver #18) configured to generate at least one electrical impulse to the electrodes such that the electrodes transmit the electrical impulse transcutaneously through the outer skin surface of the patient to a selected nerve in the patient (e.g. ¶¶ 13-14, 16, 20, etc.) according to a stimulation protocol that includes a plurality of doses, with at least one doses administered each day for a plurality of days, wherein the dose has a duration of about sixty seconds to about 5 minutes (e.g. ¶¶ 15-20); a storage medium storing a content (e.g. ¶¶ 48 – where if the controller can be programmed, it necessarily employs some sort of storage medium with content including the programmed stimulation parameters); and a controller coupled to the signal generator to limit transmission of the electrical impulse to a specific intensity based on the content in the storage medium (e.g. ¶¶ 48 – “controller 16 may also limit the stimulation, so that it does not exceed a maximum level for intensity (e.g., voltage) or frequency (including on and/or off time, etc.”, ¶¶ 95, etc.).
Huston fails to expressly disclose limiting transmission of the electrical impulse to a specific number of the plurality of doses as claimed. In the same field of endeavor, Faul teaches the transcutaneous stimulation where the treatment limits transmission of the electrical impulse to a specific number of the doses (e.g. ¶¶ 29 – “two separate treatment sessions”; e.g. ¶¶ 31 – “number of treatment sessions per day may vary”; and further e.g. ¶¶ 41 – where the number of treatment sessions is refined and set based on the response of the patient to different stimulus) in order to ensure the stimulation therapy is effective. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of limiting electrical impulses to a specific number of the plurality of doses, as taught by Faul, to the programmed therapy stimulation regimen of Huston, to improve the device by ensuring the appropriate stimulation doses are applied to the patient for the appropriate therapeutic response.
Huston fails to expressly disclose that the transcutaneous stimulation element is a patch having an adhesive surface for adhering to an outer skin surface as claimed. In the same field of endeavor, Goodall discloses transcutaneous stimulation to cranial nerves including the vagus nerve via an adhesive patch at the neck of an individual in order to provide effective non invasive stimulation (e.g. ¶¶ 62-63). In addition, Faul also teaches the use of adhesive skin electrodes for different nerve stimulation including vagal stimulation (e.g. ¶¶ 33). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of using an adhesive patch for vagal stimulation, as it would have simply been “obvious to try” – choosing from a finite number of identified and predictable solutions for transcutaneous vagal stimulation as discussed in Goodall to yield the predictable results of providing an effective stimulation.
Huston fails to expressly disclose an energy source wirelessly coupled to the electrodes configured to wirelessly transmit at least one electrical impulse to the electrodes. In the same field of endeavor, Rezai discloses an embodiment where an energy source wirelessly coupled to the electrodes is configured to wirelessly transmit at least one electrical impulse to the electrodes (e.g. ¶¶ 39, 50 – “It will be appreciated that the electrode(s) 12 can alternatively be powered by a wireless power source”) in order to delivery a particular signal to a particular region as necessary. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention to use the known technique of wirelessly transmitting an electrical impulse to an electrode from a wirelessly coupled energy source as taught by Rezai, to improve the similar device of Huston by allowing targeted stimulation in specific regions as needed.
Regarding claim 2, Huston discloses the selected nerve is a vagus nerve (e.g. ¶¶ 13).
Regarding claim 3, Huston discloses the patch is configured for attachment to the outer skin surface of a neck of the patient (e.g. ¶¶ 16, 20, etc.)
Regarding claim 4, Huston discloses a controller coupled to the energy source and configured to transmit parameters for the stimulation protocol to the energy source (e.g. ¶¶ 48).
Regarding claim 5, Huston discloses the stimulation protocol includes at least two doses administered each day (e.g. ¶¶ 15 – off time of 2 hours)
Regarding claim 6, Huston discloses each of the doses are separated by a time frame of about 1 hour to about 12 hour (e.g. ¶¶ 15-20).
Regarding claim 7, Huston discloses the stimulation protocol comprises 2 to 12 treatments/day (e.g. ¶¶ 15-20).
Regarding claim 8, Huston discloses the electrical impulse is sufficient to modify post- operative symptoms of a patient (e.g. ¶¶ 78).
Regarding claim 9, Huston discloses at least one of the doses is administered to the patient prior to a surgery (e.g. ¶¶ 79).
Regarding claim 10, Huston discloses at least of the doses is administered to the patient after the surgery (e.g. ¶¶ 79).
Regarding claim 14, Huston discloses the electrical impulse is sufficient to reduce intraperitoneal or retroperitoneal inflammation (e.g. ¶¶ 77-79).
Regarding claim 15, Huston discloses the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine (e.g. ¶¶ 71-73).
Regarding claim 16, Huston discloses the electrical impulse is sufficient to reduce post- operative pain (e.g. ¶¶ 78-79).
Regarding claim 17, Huston discloses the electrical impulse is sufficient to modify the vagus nerve such that the symptoms of post-operative ileus are reduced (e.g. ¶¶ 78-79).
Regarding claims 19-20, Huston discloses the energy source is housed within the mobile device (e.g. ¶¶ 46-48)
Regarding claim 20, Huston discloses the energy source is remote from, and coupled to, the mobile device (e.g. ¶¶ 48-52).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Huston, in view of Faul, further in view of Goodall, further in view of Rezai, further in view of Simon et al. (US 2011/0152967).
Regarding claim 11, Huston does indicate a plurality of frequencies (e.g. 30 Hz) which may be adjusted (e.g. ¶¶ 15-20), but fails to expressly disclose the electrical impulse comprises pulses having a frequency of 1 - 20 kHz. In the same field of endeavor, Simon discloses vagal stimulation at the outer skin surface of a neck of a patient at a frequency within the claimed 1-20 kHz range (e.g. ¶¶ 35) in order to provide an effective electrical impulse. It would have been obvious to apply the same stimulation parameters as taught by Simon within the claimed 1-20 Khz range, to treat patients suffering from different disorders, because the teaching, suggestion, or motivation in the prior art of Simon would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the frequency to a higher frequency between 1-20kHz, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 12-13, Huston fails to expressly disclose the electrical impulse comprises bursts of pulses, with each burst having a frequency of about 2 to 20 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration (e.g. ¶¶ 15-20). In the same field of endeavor, Simon teaches the electrical impulse comprises bursts of about 2-20 pulses (e.g. ¶¶ 34 – “1 to 20 pulses per burst”) and each of the pulses has a duration of about 50 to 100 microseconds (e.g. ¶¶ 35 – “duration of 10-1000 microseconds”) in order to provide an effective electrical impulse. It would have been obvious to apply the same stimulation parameters as taught by Simon with a plurality of 2-20 pulse bursts with a duration of about 50 to 100 microseconds, to treat patients suffering from different disorders, because the teaching, suggestion, or motivation in the prior art of Simon would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the parameters to have a plurality of 2-20 pulse bursts with a duration of about 50 to 100 microseconds, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
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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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796