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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/7/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 11/7/2025 with respect to claims 2, 4-5, and 22 have been considered but are moot in view of the new ground(s) of rejection as necessitated by the applicant’s claim amendments. In particular, the examiner is now citing Southwell for the newly added treatment step in independent claims 2 and 22 and for dependent claims 4 and 5. All arguments for these claims are now moot as Southwell has been substituted for Gerber.
Regarding the arguments directed towards the Hathorn reference and dependent claims 3, 6, 14, and 15, the examiner is not persuaded. Hathorn is only being cited to teach external compression (claim 3), mechanical stimulation (claim 6), and the particulars of the external compression tension device (claims 14 and 15). Devanaboyina and Southwell teach automatically applying an external electrical stimulation to an abdomen of the user that provokes an abdominal reflex in response to the detection of the at least one of the abdominal wall relaxation or the abdominal wall contraction that indicates the bloating or the distention as illustrated in the rejection for claims 2 and 22 above.
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.
Claim(s) 2, 4-5, 7-9, 12-13, 16, and 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devanaboyina (Pub. No.: US 2013/0046150 A1), in view of Southwell et al. (Pub. No.: US 2012/0221073 A1); hereinafter referred to as “Southwell”.
Regarding claims 2 and 22, Devanaboyina discloses a system (e.g. see figure 1 element 100) comprising: memory (e.g. see figure 2 element 224); and at least one processor (e.g. see figure 2 element 222) coupled to the memory and configured, based at least in part on information stored in the memory, to: receive a first set of data from one or more biosensors configured to measure physiological data of a user (e.g. see figure 4 element 102…N, [0048], [0055]); detect at least one of an abdominal wall relaxation or an abdominal wall contraction that indicates bloating or distention based on second data from the one or more biosensors (e.g. see figures 5-6, [0053]-[0057]).
Devanaboyina discloses sensing abdominal wall relaxation/contraction (e.g. see [0053]-[0057]) and a stimulator (e.g. see figure 7, “stimulator”, [0079]) that automatically applies the stimulation according to biofeedback from sensors (e.g. [0079]) but is silent as to applying to an external abdominal location of the user an external electrical stimulation to induce muscle relaxation or muscle contraction in a bowel of the user. Southwell teaches that it is known to use such a modification as set forth in [0035], [0041], [0124], [0126] to provide long-term benefits in some patients with continued improvement after the period of treatment by the non-invasive electrical stimulation (e.g. see [0011]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use external abdominal electrical stimulation for GI treatment as taught by Southwell in the system/method of Devanaboyina, since said modification would provide the predictable results of long-term benefits in some patients with continued improvement after the period of treatment by the non-invasive electrical stimulation.
Regarding claims 4 and 5, Devanaboyina discloses sensing abdominal wall relaxation/contraction (e.g. see [0053]-[0057]) and a stimulator (e.g. see figure 7, “stimulator”, [0079]) that automatically applies the stimulation according to biofeedback from sensors (e.g. [0079]) but is silent as to automatically applying the external electrical stimulation to provoke the muscle contraction/relaxation in an abdomen in response to the abdominal wall relaxation and/or contraction. Southwell teaches that it is known to use such a modification as set forth in [0035], [0041], [0124], [0126] to provide long-term benefits in some patients with continued improvement after the period of treatment by the non-invasive electrical stimulation (e.g. see [0011]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use external abdominal electrical stimulation for GI treatment as taught by Southwell in the system/method of Devanaboyina, since said modification would provide the predictable results of long-term benefits in some patients with continued improvement after the period of treatment by the non-invasive electrical stimulation.
Regarding claim 7, Devanaboyina discloses the at least one processor is configured to detect the abdominal wall relaxation that indicates the bloating or the distension based on an increase in abdominal circumference (e.g. see figure 4 element 102…N, [0048], [0053], [0055]).
Regarding claim 8, Devanaboyina discloses determine a pattern based on the physiological data from the one or more biosensors (e.g. see figures 5-6, [0056]-[0057]), sensing abdominal wall relaxation/contraction (e.g. see [0053]-[0057]) and a stimulator (e.g. see figure 7, “stimulator”, [0079]) that automatically applies the stimulation according to biofeedback from sensors (e.g. [0079]) but is silent as to automatically applying the external electrical stimulation to provoke the muscle contraction/relaxation in an abdomen in response to the abdominal wall relaxation and/or contraction. Southwell teaches that it is known to use such a modification as set forth in [0035], [0041], [0124], [0126] to provide long-term benefits in some patients with continued improvement after the period of treatment by the non-invasive electrical stimulation (e.g. see [0011]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use external abdominal electrical stimulation for GI treatment as taught by Southwell in the system/method of Devanaboyina, since said modification would provide the predictable results of long-term benefits in some patients with continued improvement after the period of treatment by the non-invasive electrical stimulation.
Regarding claim 9, Devanaboyina discloses the at least one processor is further configured to: receive user input regarding at least one selected from a group consisting of thoughts, feelings, and records of meals; and correlate the user input to the physiological data from the one or more biosensors (e.g. see [0033], [0045], [0055], [0073]).
Regarding claim 12, Devanaboyina discloses the one or more biosensors (e.g. see figure 4 element 102…N, [0048], [0055]).
Regarding claim 13, Devanaboyina discloses the one or more biosensors are non-invasive (e.g. see figure 4 element 102…N, [0048], [0055]).
Regarding claim 16, Devanaboyina discloses the first set of data received from the one or more biosensors further includes at least one or heart rate, perspiration, or bowel movements (e.g. see figures 5-6, [0056]-[0057]).
Regarding claim 18, Devanaboyina discloses the at least one processor is further configured to provide biofeedback in response to receiving the physiological data (e.g. see figures 7, 8, elements 700, 800).
Regarding claim 19, Devanaboyina discloses the at least one processor is further configured to wirelessly transmit information about the physiological data to a display device (e.g. see figures 4 and 7 elements 103, 104).
Regarding claim 20, Devanaboyina discloses the at least one processor is configured to detect the abdominal wall relaxation indicating the bloating or the distention based on the second data from the one or more biosensors (e.g. see figures 5-6, [0053]-[0057]); and to provide the alert to the user in response to the detection of the abdominal wall relaxation that indicates the bloating or the distention (e.g. see figure 2 element 210, [0045], [0067]).
Regarding claim 21, Devanaboyina discloses the at least one processor is configured to detect the abdominal wall contraction indicating the bloating or the distention based on the second data from the one or more biosensors (e.g. see figures 5-6, [0056]-[0057]); and to provide the alert to the user in response to detection of the the abdominal wall contraction that indicates the bloating or the distention (e.g. see figure 2 element 210, [0045], [0067]).
Regarding claim 23, Devanaboyina discloses providing an alert to the user in response to the detection of the at least one of the abdominal wall relaxation or the abdominal wall contraction indicating the bloating or the distention (e.g. see figure 2 element 210, [0045], [0067]).
Claim(s) 3, 6, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devanaboyina and Southwell in view of Hathorn (Pub. No.: US 2013/0178893 A1).
Regarding claim 3, Devanaboyina and Southwell disclose automatically adjusting a level of treatment in response to the detection of the at least one of the abdominal wall relaxation or the abdominal wall contraction that indicates the bloating or the distention (e.g. see the rejection for claims 2 and 22 above) but are silent as to adjusting a level of compression. Hathorn teaches it is known to use such a modification as set forth in elements 14, 16, 18, and 20 to provide a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region (e.g. see [0009]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system/method as taught by Devanaboyina and Southwell, with adjusting a level of compression as taught by Hathorn, since such a modification would provide a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region.
Regarding claim 6, Devanaboyina and Southwell disclose automatically applying an external electrical stimulation to an abdomen of the user that provokes an abdominal reflex in response to the detection of the at least one of the abdominal wall relaxation or the abdominal wall contraction that indicates the bloating or the distention (e.g. see the rejection for claims 2 and 22 above) but are silent as to the external stimulation being mechanical. Hathorn teaches it is known to use such a modification as set forth in elements 14, 16, 18, and 20 to provide a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region (e.g. see [0009]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system/method as taught by Devanaboyina and Southwell, with using mechanical external stimulation as taught by Hathorn, since such a modification would provide a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region.
Regarding claims 14 and 15, Devanaboyina and Southwell disclose the invention (see the rejection for claims 2 and 22 above) but are silent as to an apparatus for treating symptoms of Irritable Bowel Syndrome (IBS), including: a base material comprising a material that fits to a body of the user; an elastic portion capable of applying compression across an abdomen of the user; and a portion comprising the one or more biosensors, wherein the apparatus further includes a tension adjusting mechanism for adjusting the compression applied to the abdomen in order to treat the symptoms of the IBS. Hathorn teaches it is known to use such a modification as set forth in elements 14, 16, 18, and 20 to provide a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region (e.g. see [0009]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system/method as taught by Devanaboyina and Southwell, with the particular elastic external tension device as taught by Hathorn, since such a modification would provide a non-invasive, external tensile colonoscopy compression device that when applied to a patient, generates tension and exerts pressure upon and provides support to a patient's abdomen region.
Claims 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devanaboyina and Southwell in view of Spiegel et al. (WO 2014/039404 A1); hereinafter referred to as “Spiegel”.
Regarding claims 10 and 11, Devanaboyina and Southwell disclose the claimed invention except for the physiological data from the one or more biosensors further includes measurement information for electrical conductance of skin of the user from a galvanic skin response sensor and the galvanic skin response sensor. Spiegel teaches that it is known to use such a modification as set forth in pages 5-6, lines 29-3, page 13, lines 29-33 to provide more discerning means to monitor the patient’s gastric function. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system/method as taught by Devanaboyina and Southwell, with such a modification as taught by Spiegel, since such a modification would provide the predictable results of more discerning means to monitor the patient’s gastric function.
Conclusion
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/P.C.E/Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792