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 and amendments, see Pages 8-13, filed 12/22/2025, with respect to the rejection(s) of claim(s) 1-20 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Napadow (US 2020/0139126 A1) in view of Simon (US 9403001 B2).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-11, and 13, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Napadow (US 2020/0139126 A1) in view of Simon (US 9403001 B2).
Regarding claims 1, 9, and 17, Napadow discloses A method of providing electrical stimulation to a patient to treat a functional gastrointestinal disorder (FGID) condition of the patient (eg. Para. 9, 26) said method comprising: automatically detecting a normal respiration cycle of the patient with a sensor (eg. Para. 37-57, 64, 67, 71-74), the sensor fitted and worn around a lower aspect or trunk of the patient and the sensor detecting physical expansions and contractions of the lower aspect or trunk and generating an electrical signal representing the expansions and contractions of the lower aspect or trunk to provide the automatically detected normal respiration cycle (eg. Para. 37-57, 64, 67, 71-74, Fig. 7, respiratory belt 719); processing the detected normal respiration cycle to identify one or more points-of-interest (POI) within the normal respiration cycle (Eg. Para. 9, 13, 64, 92, 111, Fig. 6, 8, 10); and repeatedly administering an electrical stimulation to a target site of the patient, the electrical stimulation applied to the target site while the patient inhales and exhales with the normal respiration cycle (eg. Para. 9 26-30, 34-37, 49-51, 66, 74-75 Fig. 5), and the electrical stimulation applied to the target site without interrupting the normal respiration cycle and without interrupting a normal breath of the patient during the normal respiration cycle (eg. Para. 9 26-30, 34-37, 49-51, 66, 74-75 Fig. 5, synchronize to particular point of interest in the waveform without having the waveform being interrupted before, during, and after stimulation delivery); wherein the target site is one or more of a vagal nerve of the patient, a spinal cord of the patient, a sacral nerve of the patient, a peripheral nerve of the patient, a segment of a gut of the patient, a liver of the patient, a pancreas of the patient, a bladder of the patient and a kidney of the patient (eg. Para. 26-28, RAVANS system which targets the vagal nerve), and the repeated administration of said electrical stimulation is automatically synchronized with the normal respiration cycle of the patient detected by said sensor (Para. 9 26-30, 34-37, 49-51, 66, 74-75, Fig. 5), and the electrical stimulation is timed with reference to the one or more POI to treat the FGID condition of the patient (Para. 9 26-30, 34-37, 49-51, 66, 74-75, Fig. 5).
Napadow discloses gastrointestinal disorders but does not explicitly recite FGID.
Simon teaches the use of vagal nerve stimulation to treat FGID disorders such as IBS, gastroparesis, and functional dyspepsia (eg. Abstract, Col. 3, Ln. 24-40, Col. 67, Ln. 35 – Col. 68, Ln. 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Napadow with the treatment of FGIDs as taught by Simon since both are directed to electrical stimulation of vagus nerve stimulation. By applying Napadow’s respiratory synchronization stimulation, one of ordinary skill could predictably improve the therapeutic efficacy of treating FGIDs, given that both references target the same neural pathway.
Regarding claim 2, the combined invention of Napadow and Simon discloses obtaining patient data during a period in which a prior electrical stimulation had been administered; determining an effectiveness of the prior electrical stimulation administered during the period based on the obtained patient data; and adjusting a parameter of a future administered electrical stimulation in response to the determined effectiveness (eg. Napadow, Para. 13 and 29, recording and identifying points of interest before applying stimulation, Simon, Col. 38, Ln. 51 – Col. 40, Ln. 45).
Regarding claim 3, the combined invention of Napadow and Simon discloses the parameter is one of a shape of a waveform of the electrical stimulation, an amplitude of a current of the electrical stimulation, an amplitude of a voltage of the electrical stimulation, a frequency of the electrical stimulation, a pulse width of the electrical stimulation and a duration of the electrical stimulation (eg. Simon, Col. 38, Ln. 51 – Col. 40, Ln. 45).
Regarding claim 5, the combined invention of Napadow and Simon discloses administering the electrical stimulation comprises: providing electrical signals to an electrode positioned with respect to the target site of the patient such that the electrical stimulation is administered to the target site (eg. Napadow, Para. 29 and 33).
Regarding claims 6, 13, and 18, the combined invention of Napadow and Simon discloses the electrode is one of a transcutaneous pad positioned on the patient's skin, a percutaneous needle inserted through the patient's skin, and a lead implanted within the patient (eg. Napadow, Para. 29 and 33).
Regarding claims 7, 15, and 19, the combined invention of Napadow and Simon discloses a symptom of the disorder is ameliorated by repeated administration of the electrical stimulation automatically synchronized with the normal respiration cycle of the patient detected by said sensor (eg. Napadow, Para. 9, 26-29, 33, Abstract, Col. 3, Ln. 24-40, Col. 67, Ln. 35 – Col. 68, Ln. 2).
Regarding claims 8, 16, and 20 the combined invention of Napadow and Simon discloses applying an electrode to the patient, said administering being delivered through said electrode (eg. Napadow, Para. 26-29 and 33).
Regarding claim 10, the combined invention of Napadow and Simon discloses controller in operative communication with said sensor, said controller controlling said electric power supply in response to the normal respiration cycle detected by said sensor (eg. Napadow, Para. 11-12, 34, 43).
Regarding claim 11, the combined invention of Napadow and Simon discloses a feedback module comprising at least one processor and at least one memory including computer program code configured to, with the at least one processor, cause the feedback module to at least; obtain patient data during a period in which a prior electrical stimulation had been administered in accordance with a stimulation parameter, said stimulation parameter being one of a shape of a waveform of the electrical stimulation, an amplitude of a current of the electrical stimulation, an amplitude of a voltage of the electrical stimulation, a frequency of the electrical stimulation, a pulse width of the electrical stimulation and a duration of the electrical stimulation;determine an effectiveness of the prior electrical stimulation administered during the period based on the obtained patient data; and change the stimulation parameter for a future administered electrical stimulation in response to the determined effectiveness (eg. Napadow, Para. 13 and 29, recording and identifying points of interest before applying stimulation, Simon, Col. 38, Ln. 51 – Col. 40, Ln. 45).
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 MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached 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 (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J LAU/Examiner, Art Unit 3796
Prosecution Insights