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 Amendment
The response filed on 5/2/2026 is not in conformance with the Office's rules and regulations regarding claim amendments. In particular, claims 3-4 should be have the status identifiers “Withdrawn” since these claims were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. In an effort to continue prosecution, the amendments have been entered, but the Applicant should be mindful of the proper format for making amendments.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities:
in claim 1, line 10: “the” should be inserted before “fecal matter”;
in claim 10, line 7: “the” should be inserted before “fecal matter”;
in claim 10, line 9: “the” should be inserted before “fecal matter”;
in claim 10, line 12: “the” should be inserted before “presence”; and
in claim 10, line 12: “the” should be inserted before “fecal matter”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites: “transmitting the first set of bioimpedance data and the second set of bioimpedance data to an external device; and alerting the user of the potential discharge event due to presence of fecal matter based on the first set of bioimpedance data and the second set of bioimpedance data” in lines 10-13, but the relationship between the transmitting and alerting steps is not clear. How does the transmission of the first and second sets leads to the alert? There appears to be one or more intermediate steps that are missing. That is, the alert is recited to be generated with no recited relationship to the transmission that comes before it. The missing step(s) creates confusion as to the scope of the claim since the connection between the recited steps is left ambiguous.
Claim 11 is rejected by virtue of its dependence from claim 10.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0202503 (Nakanishi), in view of WO 2016/065082 (Gregersen)(previously cited), and in view of WO 2006/085087 (Cooper)(previously cited).
Nakanishi teaches the use of an ultrasonic sensor to measure the width of the rectum so as to predict a bowel movement timing of a subject (paragraph 0018 of Nakanishi). Immediately before a bowel movement, fecal matter is accumulated in the rectum so that the rectum has a large width. That is, the width of the rectum indicates whether fecal matter is present in the rectum or not. A determiner 52 determines a bowel movement timing from the width of the rectum based on an output of the ultrasonic sensor 1. For example, it can be determined that bowel movement will arrive soon if the width of the rectum exceeds a predetermined determination threshold (paragraph 0042 of Nakanishi). Nakanishi also teaches that any sensor that measures the width of the rectum may be used (paragraph 0051 of Nakanishi).
Gregersen teaches an insertion device comprising an outer shell configured for placement into an anus (the housing shown in FIGS. 2A, 2B, 2C, 2D, 3, 4, 5A, 5B, 6A, 6B, 7A, 7B, 8A, and 8B of Gregersen); a bioimpedance sensor (the impedance sensor of Gregersen; paragraphs 0039, 0041, 0045, 0053, 0057, and 0061 of Gregersen); and a transmitter in the capsule (paragraphs 0014, 0016, 0039-0044, and 0050 of Gregersen) for transmission to an outside unit. The impedance measurements are used to determine the cross-sectional areas of the rectum (paragraphs 0008-0009, 0021, 0039, 0041, 0045, 0053, and 0056 of Gregersen). Also, Gregersen teaches that real-time monitoring is contemplated (paragraph 0059 and 0062 of Gregersen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the impedance sensor in the outer shell of Gregersen that also has a transmitter for transmitting of the impedance readings to the device body 2 of Nakanishi since it is a simple substitution of one known element for another to obtain predictable results, it permits review of real-time data while in the patient, and/or Nakanishi teaches that any type of sensor that measures the width of the rectum may be used and Gregersen teaches one such sensor.
The combination teaches the use of a transmitter in the capsule for transmitting data to the device body 2 of Nakanishi (paragraphs 0014, 0016, 0039-0044, and 0050 of Gregersen). Copper teaches that a two-way communication link is a suitable substitute for a one-way communication link (pages 29-30 of Cooper). Such a two-way link provides the ability for data and/or instructions to be sent to the capsule from the outside unit. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the two-way communication link of Cooper since it is a simple substitution of one known element for another to obtain predictable results and/or it provide the operator real-time control of the measuring capsule via the outside unit.
With respect to timing of the measurements relative to the presence/absence of feces, measurements occurring before the presence of feces and after the presence of feces would have been obvious since real-time monitoring is contemplated (paragraph 0059 and 0062 of Gregersen) and the prediction of a bowel movement (i.e., the feces presence/absence) is the purpose of the monitoring (paragraphs 0018 and 0042 of Nakanishi). Nakanishi teaches the use of a haptic or visual notifier (paragraph 0055 of Nakanishi). Gregersen discloses the display of data on the outside unit (paragraph 0040 of Gregersen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to display the prediction of a bowel movement (i.e., the feces presence/absence) of Nakanishi on the display of Gregersen since it informs the user of the parameters of interest of Nakanishi and/or it provides the user with information about the digestive condition of the patient.
With respect to claim 1, the combination teaches or suggests an alert system, comprising:
an insertion device comprising an outer shell configured for placement into an anus (the housing shown in FIGS. 2A, 2B, 2C, 2D, 3, 4, 5A, 5B, 6A, 6B, 7A, 7B, 8A, and 8B of Gregersen); and a bioimpedance sensor (the impedance sensor of Gregersen) configured to obtain conductance data from anorectal tissue as well as to obtain conductance data from fecal matter (the measurements of the impedance sensor would have conductance data from the tissue inside the anorectal tissue as well fecal matter); and
an external device (the device body 2 of Nakanishi), whereby said insertion device and said external device can communicate bidirectionally (the two-way link of Cooper).
wherein the insertion device is configured to send a signal to the external device when the conductance data obtained by the bioimpedance sensor indicates a presence of fecal matter (the 103 analysis; the impedance sensor of Gregersen transmitting to the device body 2 of Nakanishi); and
wherein the external device is configured to alert a user of a potential discharge event in response to receiving said signal (the device body 2 of Nakanishi displaying the prediction of a bowel movement (i.e., the feces presence/absence) of Nakanishi on the display of Gregersen).
With respect to claim 10, the combination teaches or suggests a method of alerting a user of a potential discharge event, comprising the steps of:
inserting an insertion device into an anus of a patient (inserting the housing shown in FIGS. 2A, 2B, 2C, 2D, 3, 4, 5A, 5B, 6A, 6B, 7A, 7B, 8A, and 8B of Gregersen into the anus), the insertion device configured to obtain bioimpedance data from anorectal tissue and from fecal matter present within the anus (the impedance sensor of Gregersen is configured to obtain bioimpedance data);
collecting a first set of bioimpedance data, wherein the first set of bioimpedance data is indicative of an absence of fecal matter (the continuous monitoring of Gregersen would mean that there is bioimpedance data during each of the times when there is an absence, a buildup, and a presence of fecal matter in the rectum, respectively, since the purpose is to monitor the patient continuously so as to be notified when a bowel movement is predicted. Thus, the multiple sets of bioimpedance data during these three conditions would have been inherent, implicit, or obvious);
collecting a second set of bioimpedance data wherein the second set of bioimpedance data is indicative of a presence of fecal matter (the continuous monitoring of Gregersen would mean that there is bioimpedance data during each of the times when there is an absence, a buildup, and a presence of fecal matter in the rectum, respectively, since the purpose is to monitor the patient continuously so as to be notified when a bowel movement is predicted. Thus, the multiple sets of bioimpedance data during these three conditions would have been inherent, implicit, or obvious);
transmitting the first set of bioimpedance data and the second set of bioimpedance data to an external device (the transmission from the housing shown in FIGS. 2A, 2B, 2C, 2D, 3, 4, 5A, 5B, 6A, 6B, 7A, 7B, 8A, and 8B of Gregersen to the device body 2 of Nakanishi); and
alerting the user of the potential discharge event due to presence of fecal matter based on the first set of bioimpedance data and the second set of bioimpedance data (the display of the prediction of a bowel movement (i.e., the feces presence/absence) of Nakanishi on the display of Gregersen).
With respect to claim 11, the values of the impedance measurements relative to the presence/absence of feces are results-effective variables that would depend upon the physical conditions in which the measurements are taken. As such, the values of the measurements relative to the presence/absence of feces are results-effective variables that would have been optimized through routine experimentation based on the physical conditions in which the measurements are taken. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for “wherein the second set of bioimpedance data comprises an impedance reading lower than an impedance reading of the first set of bioimpedance data” of claim 11 since the measurements are subject to the physical conditions in which the measurements are taken.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0164221 (Singh)(previously cited), in view of U.S. Patent Application Publication No. 2004/0176685 (Takizawa)(previously cited), and further in view of EP 0286374 (Marzolf)(previously cited).
Singh teaches an osmotic valve mechanism 300 that is incorporated into an ingestible device in order to obtain samples (paragraph 1020 of Singh). The osmotic valve mechanism 300 includes an absorptive material 310 including any suitable sponge material that is inside the sampling chamber 304 (paragraph 1024 of Singh). The device is configured to detect the analyte at a location within the gastrointestinal (GI) tract of a subject including the small intestine, the large intestine, the rectum, the anus, the sphincter, the duodenum, the jejunum, the ileum, and the colon (paragraph 0217 of Singh). Also, the device includes the ability to analyze the sample from the GI tract while in the GI tract of the subject (paragraphs 0458, 0996, 1006, 1062, 1301, and 1307 of Singh) using a plurality of sensors (the analyte sensors of Singh; paragraphs 1006 and 1062 of Singh),
Takizawa teaches that impedance measurements may be used to determine the presence or absence of feces (paragraph 0163 of Takizawa). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use impedance sensors in the absorptive material 310 of the sampling chamber 304 of Singh so as to detect the presence or absence of feces since it would provide a better picture of the environment to which the capsule is currently situated in.
With respect to timing of the measurements relative to the presence/absence of feces, measurements occurring before the presence of feces and after the presence of feces would have been obvious since real-time monitoring is contemplated (paragraphs 0006 and 1325 of Singh) and the determining feces presence/absence is one of the purposes of the monitoring (paragraph 0163 of Takizawa). Singh discloses the display of data (paragraphs 1316 and 1318 of Singh). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to display the feces presence/absence of Takizawa since Singh teaches that data can be displayed and the feces presence/absence of Takizawa is such data and/or it provides the user with information about the digestive condition of the patient.
Singh teaches a base station of Singh that communicates bidirectionally with the device 200 (the wireless transmission of Singh; paragraphs 0035, 0049, 0060, 0220, 0244, 1388, 1406, 1426, and 1545 of Singh). Marzolf teaches that an audible alarm or visual display may be used to inform the patient of an impending bowel movement due to the presence of feces (abstract; col. 1, lines 15-30; col. 7, line 24 to col. 8, line 2 of Marzolf). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate an audible alarm or visual display of an impending bowel movement due to the presence of feces at the base station of Singh since it will inform the patient or practitioner of the digestive condition of the patient.
With respect to claim 1, the combination teaches or suggests a method of alerting a user of a potential discharge event, comprising the steps of:
an insertion device comprising an outer shell configured for placement into an anus (the device 200 of Singh), and a bioimpedance sensor configured to obtain conductance data from anorectal tissue as well as to obtain conductance data from fecal matter (the impedance sensors of combination used to detect the presence or absence of feces and the conductance data/information of anorectal tissue; paragraph 0163 of Takizawa);
an external device (the base station of Singh), whereby said insertion device and said external device can communicate bidirectionally (the wireless transmission of Singh; paragraphs 0035, 0049, 0060, 0220, 0244, 1388, 1406, 1426, and 1545 of Singh),
wherein the insertion device is configured to send a signal to the external device when the conductance data obtained by the bioimpedance sensor indicates a presence of fecal matter (the wireless transmission of the data to the base station of Singh);
collecting a second set of bioimpedance data wherein the second set of bioimpedance data is indicative of a presence of fecal matter (measurements occurring after the presence of feces); and
wherein the external device is configured to alert a user of a potential discharge event in response to receiving said signal (the audible alarm or visual display of an impending bowel movement due to the presence of feces of Marzolf at the base station of Singh).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/145913 (Jimenez)(previously cited), in view of WO 2016/065082 (Gregersen)(previously cited), and in view of WO 2006/085087 (Cooper)(previously cited).
Jimenez teaches the use of a pressure sensor implanted in relation to the bowel or lower rectum or anus to detect filing and imminent bowel movement (paragraph 0052 of Jiminez). The filling of the bowel may be detected by a change in a pressure signal from the pressure sensor that is detected in the operating algorithm of a control unit (paragraph 0098 of Jiminez). Gregersen teaches an insertion device comprising an outer shell configured for placement into an anus (the housing shown in FIGS. 2A, 2B, 2C, 2D, 3, 4, 5A, 5B, 6A, 6B, 7A, 7B, 8A, and 8B of Gregersen); a pressure sensor (the pressure sensor of Gregersen; paragraphs 0044, 0050, 0052-0053, 0055, 0058, and 0060 of Gregersen); and a transmitter in the capsule (paragraphs 0014, 0016, 0039-0044, and 0050 of Gregersen) for transmission to an outside unit. Also, Gregersen teaches that real-time monitoring is contemplated (paragraph 0059 and 0062 of Gregersen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the pressure sensor of Jimenez in an outer shell that is inserted into the anus that also has a transmitter for transmitting of the pressure readings to an outside unit, as disclosed by Gregersen, since it is a simple substitution of one known element for another to obtain predictable results and/or it permits review of real-time data while in the patient.
The combination teaches the use of a transmitter in the capsule for transmitting data to an outside unit (paragraphs 0014, 0016, 0039-0044, and 0050 of Gregersen). Copper teaches that a two-way communication link is a suitable substitute for a one-way communication link (pages 29-30 of Cooper). Such a two-way link provides the ability for data and/or instructions to be sent to the capsule from the outside unit. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the two-way communication link of Cooper since it is a simple substitution of one known element for another to obtain predictable results and/or it provide the operator real-time control of the measuring capsule via the outside unit.
With respect to timing of the measurements relative to the presence/absence of feces, measurements occurring before the presence of feces and after the presence of feces would have been obvious since real-time monitoring is contemplated (paragraph 0059 and 0062 of Gregersen) and the determinations of the filling of fecal matter (i.e., the feces presence/absence) and imminent bowel movement are the purposes of the monitoring (paragraph 0052 of Jimenez). Gregersen discloses the display of data on the outside unit (paragraph 0040 of Gregersen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to display the filling of fecal matter (i.e., the feces presence/absence) and the determination of imminent bowel movement of Jimenez on the display of Gregersen since it informs the user of the parameters of interest of Jimenez and/or it provides the user with information about the digestive condition of the patient.
With respect to claim 5, the combination teaches or suggests an alert system, comprising:
an insertion device comprising an outer shell configured for placement into an anus (the housing shown in FIGS. 2A, 2B, 2C, 2D, 3, 4, 5A, 5B, 6A, 6B, 7A, 7B, 8A, and 8B of Gregersen); and a pressure sensor (the pressure sensor of Jimenez) configured to determine a change in pressure within an anal cavity when the insertion device is positioned therein; and
an external device (the outside unit of Gregersen), whereby said insertion device and said external device can communicate bidirectionally (the two-way link of Cooper).
wherein the insertion device is configured to send a signal to the external device when the pressure sensor determines the change in pressure which indicates a presence of fecal matter (the 103 analysis; the pressure sensor of Jimenez transmitting to the outside unit of Gregersen); and
wherein the external device is configured to alert a user of a potential discharge event in response to receiving said signal (the outside unit displaying the filling of fecal matter (i.e., the feces presence/absence) and the determination of imminent bowel movement of Jimenez on the display of Gregersen).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0164221 (Singh)(previously cited), in view of U.S. Patent Application Publication No. 2004/0176685 (Takizawa)(previously cited), and further in view of EP 0286374 (Marzolf)(previously cited), and further in view of CN 103249348 (Schentag)(previously cited). Citations to Schentag will refer to the machine English translation that accompanied the Office Action mailed on 4/20/2026.
Singh teaches an osmotic valve mechanism 300 that is incorporated into an ingestible device in order to obtain samples (paragraph 1020 of Singh). The osmotic valve mechanism 300 includes an absorptive material 310 including any suitable sponge material that is inside the sampling chamber 304 (paragraph 1024 of Singh). The device is configured to detect the analyte at a location within the gastrointestinal (GI) tract of a subject including the small intestine, the large intestine, the rectum, the anus, the sphincter, the duodenum, the jejunum, the ileum, and the colon (paragraph 0217 of Singh). Also, the device includes the ability to analyze the sample from the GI tract while in the GI tract of the subject (paragraphs 0458, 0996, 1006, 1062, 1301, and 1307 of Singh) using a plurality of sensors (the analyte sensors of Singh; paragraphs 1006 and 1062 of Singh),
Takizawa teaches that impedance measurements may be used to determine the presence or absence of feces (paragraph 0163 of Takizawa). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use impedance sensors in the absorptive material 310 of the sampling chamber 304 of Singh so as to detect the presence or absence of feces since it would provide a better picture of the environment to which the capsule is currently situated in.
With respect to timing of the measurements relative to the presence/absence of feces, measurements occurring before the presence of feces and after the presence of feces would have been obvious since real-time monitoring is contemplated (paragraphs 0006 and 1325 of Singh) and the determining feces presence/absence is one of the purposes of the monitoring (paragraph 0163 of Takizawa). Singh discloses the display of data (paragraphs 1316 and 1318 of Singh). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to display the feces presence/absence of Takizawa since Singh teaches that data can be displayed and the feces presence/absence of Takizawa is such data and/or it provides the user with information about the digestive condition of the patient.
Marzolf teaches that an audible alarm or visual display may be used to inform the patient of an impending bowel movement due to the presence of feces (abstract; col. 1, lines 15-30; col. 7, line 24 to col. 8, line 2 of Marzolf). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate an audible alarm or visual display of an impending bowel movement due to the presence of feces since it will inform the patient or practitioner of the digestive condition of the patient.
Schentag teaches that a device may be implanted into the anus directly (paragraph 0033 of Schentag). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the device of Singh directly into the anus since it provides a direct route to the target tissue.
With respect to claim 10, the combination teaches or suggests a method of alerting a user of a potential discharge event, comprising the steps of:
inserting an insertion device into an anus of a patient (the device is inserted into the anus so as to obtain impedance measurements), the insertion device configured to obtain bioimpedance data from anorectal tissue and from fecal matter present within the anus (the impedance sensors of combination used to detect the presence or absence of feces and the conductance data/information of anorectal tissue; paragraph 0163 of Takizawa);
collecting a first set of bioimpedance data, wherein the first set of bioimpedance data is indicative of an absence of fecal matter (measurements occurring before the presence of feces);
collecting a second set of bioimpedance data wherein the second set of bioimpedance data is indicative of a presence of fecal matter (measurements occurring after the presence of feces); and
transmitting the first set of bioimpedance data and the second set of bioimpedance data to an external device (the wireless transmission of Singh; paragraphs 0035, 0049, 0060, 1322, 1388, 1406, 1455, and 1545 of Singh); and
alerting the user of the potential discharge event due to presence of fecal matter based on the first set of bioimpedance data and the second set of bioimpedance data (an audible alarm or visual display of Marzolf).
With respect to claim 11, the values of the impedance measurements relative to the presence/absence of feces are results-effective variables that would depend upon the physical conditions in which the measurements are taken. As such, the values of the measurements relative to the presence/absence of feces are results-effective variables that would have been optimized through routine experimentation based on the physical conditions in which the measurements are taken. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for “wherein the second set of bioimpedance data comprises an impedance reading lower than an impedance reading of the first set of bioimpedance data” of claim 11 since the measurements are subject to the physical conditions in which the measurements are taken.
Response to Arguments
The Applicant's arguments filed on 5/2/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 5/2/2026, the previous claims objections are withdrawn. There are new claim objections that were necessitated by the claim amendments filed on 5/2/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 5/2/2026, the previous claims rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn with the exception of the Applicant’s amendment to claim 10 that did not fully address the indefiniteness issue with respect to the recitation “transmitting the first set of bioimpedance data and the second set of bioimpedance data to an external device; and alerting the user of the potential discharge event due to presence of fecal matter based on the first set of bioimpedance data and the second set of bioimpedance data” in claim 10, lines 10-13. In particular, it is not clear how the transmission of the first and second sets leads to subsequent the alert. That is, the alert merely requires the first and second sets of bioimpedance data that was collected in lines 6-9, but how the transmission fits into this process is not clear. The missing step(s) creates confusion as to the scope of the claim since the connection between the recited steps is left ambiguous.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
In view of the claim amendments filed on 5/2/2026, the previous claims rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, are withdrawn.
Prior art rejections
The Applicant’s arguments with respect to claims 1, 5, and 10-11 have been considered but are 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. That is, there are new grounds of rejection that were necessitated by the claim amendments filed on 5/2/2026.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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