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 filed 6/2/2026 have been fully considered but they are not persuasive.
Applicant argues on page 9: “Stimuli in Devanaboyina "to distract the patient" is not "in response to the detection" as in claim 2. Devanaboyina does not disclose or suggest that such stimuli to "distract[] the patient," is automatically applied "in response to the detection, based on the second data from the one or more biosensors, of the at least one of the abdominal wall relaxation or the abdominal wall contraction that indicates the bloating or the distention," in combination with the other aspects of claim 2 (emphasis added)”.
The examiner is not persuaded. Devanaboyina states “[0076] In one embodiment, the device of the present invention may be used to provide biofeedback training to treat the condition of bloat in a patient in a similar manner as described earlier for constipation. For the purpose of biofeedback training, the person acquires electroencephalography, electromyography, skin conductivity, and gastrointestinal tract electrical/contractility and abdominal distention signals, or some combination of the foregoing, and records symptoms and events as mentioned earlier. When the user notices symptoms related to bloating, the user can monitor the changes in electroencephalography, skin conductivity or electromyography of diaphragm and abdominal muscles, or a combination of the foregoing. If the changes are determined to be related to electroencephalography or autonomic system changes, but not completely related to gastrointestinal tract, then the person can practice meditation or mindfulness or other behavioral modification techniques to get relief. The user may make use of audio visual instructions or distraction tools included to achieve the same purpose. Alarm systems included in the device of the present invention may alert the patient about the bloating condition, if certain patterns related to bloating are detected, thereby further helping the user to reinforce the user on the biofeedback treatment”.
The underlined portions of [0076] clearly indicated the stimulation in [0076], [0077], [0079] and figure 7 are “in response to” the sensed relaxation/contraction signals indicative of bloating/distension. Additionally, the “Alarm systems” disclosed in the last sentence of [0076] will “automatically” alert the patient. This alert is a precursor of the stimulation of [0076], [0077], [0079] and figure 7. Thus, the stimulation is “automatically” applied in Devanaboyina.
Applicant argues on page 9: “Southwell fails to cure the deficiency in Devanaboyina. The Office Action cites Southwell to cure the deficiency in Devanaboyina. However, the "electrical stimulation" in Southwell is configured to apply "sessions" of stimulation that are wholly unrelated to "detection, based on the second data from the one or more biosensors, of the at least one of the abdominal wall relaxation or the abdominal wall contraction that indicates the bloating or the distention," as in claim 2”.
The examiner agrees with the applicant’s assessment that Southwell does not administer the stimulation “in response to” the sensed abdominal signals. As illustrated above in [0076], Devanaboyina clearly addresses this limitation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues on page 10: “Lack of a Motivation to Combine. As Southwell is configured to provide a "treatment regime" that includes "sessions" set by a therapist, it is a different type of therapy delivery device that delivers a different type of therapy than Devanaboyina. A modification of Devanaboyina based on the "treatment regime" of Southwell to "automatically apply, to an external abdominal location of the user, at least one of an adjusted level of compression, an external electrical stimulation, an external magnetic stimulation, or an external sonic stimulation to induce muscle relaxation or muscle contraction in a bowel of the user in response to the detection, based on the second data from the one or more biosensors, of the at least one of the abdominal wall relaxation or the abdominal wall contraction that indicates the bloating or the distention," as in claim 2 would require an impermissible hindsight reconstruction based on information gleaned solely from Applicant's specification”.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the current application, the primary reference, Devanaboyina, teaches stimulation in [0076], [0077], [0079] and figure 7 “in response to” the sensed relaxation/contraction signals indicative of bloating/distension as disclosed in [0076], figures 5-6, [0053]-[0057] (especially [0053]). However, Devanaboyina 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]). Thus, Southwell provides the knowledge which was within the level of ordinary skill at the time the claimed invention was made (external, non-invasive abdominal stimulation to improve bowel function disorders). Additionally, Southwell provides a clear motivation to combine (e.g. see [0011]). The examiner is merely switching the stimulation means of the primary reference for the secondary reference.
In response to applicant's argument that it would not have been obvious to substitute the external, non-invasive abdominal stimulation of Southwell for the distraction stimulation disclosed in Devanaboyina, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The combined teachings of the references (feedback sensing of Devanaboyina and the therapeutic, non-invasive stimulation of Southwell) would have suggested to those of ordinary skill in the art that the combination would more robustly (direct abdominal stimulation of Southwell) and more precisely (feedback sensing of Devanaboyina) address bowel function disorders.
Applicant argues on page 11: “The Office Action has not shown how the manual application of the colonoscopy compression device by a technician discloses "automatically adjust a level of the compression 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 in dependent claim 3 (emphasis added).
The examiner is not persuaded. Per the rejection below, the Hathorn reference was cited only to illustrate that external compression of the abdominal region to treat bowel disfunction is already known in the art as evidenced by Hathorn. The automatic adjustment of stimulation is taught by Devanaboyina and Southwell in the rejections of claims 2 and 22. The “Alarm systems” disclosed in the last sentence of [0076] will “automatically” alert the patient. This alert is a precursor of the stimulation of [0076], [0077], [0079] and figure 7. Thus, the stimulation is “automatically” applied in Devanaboyina.
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]. Note: [0053] states “N may be mounted on stretchable belt, such as belt 402 discussed above, that extends around the torso of the patient and can be connected to a piezo actuator, strain gauge or similar mechanism to measure changes in diameter of the chest and/or the abdomen so as to monitor the distension associated with abdominal bloating”).
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. [0076]) 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. [0076]) 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. [0076]) 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
THIS ACTION IS MADE FINAL. 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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 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, Unsu Jung can be reached on 571-272-8506. 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.
/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights