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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant's submission filed on 9/3/2026 has been entered.
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 10-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the insertion device is configured to determine a presence of fecal matter based on a comparison between the conductance data obtained from the anorectal tissue and the conductance data obtained from the fecal matter and to send a signal to the external device when the comparison indicates a presence of fecal matter” in lines 7-11 which is not supported by the specification as originally filed.
Though the Applicant cites to paragraphs [0032], [0033], and [0035]1 for supporting these features of claim 1. These paragraphs do not support the claimed subject matter. First, there is no disclosure of an actual determination of a presence of fecal matter. The Examiner notes the following passages:
[0032]: “Bioimpedance sensors or elements 120 of the present disclosure are configured to obtain conductance data/information of/from anorectal tissue as well as to obtain conductance data/information of/from fecal matter, noting that fecal matter can have 3-4 times the conductance of rectal tissue.”
[0032]: “Bioimpedance sensors or elements 120 of the present disclosure are therefore configured to determine a conductance difference between rectal tissue and fecal matter.”
[0033]: “…that defecation may be soon or imminent due to changes in conductance and/or pressure, with said changes due the presence of fecal matter adjacent to device 100 within the rectal cavity.”
[0035]: “If the impedance/conductance data and/or pressure data changes to a level indicative of the presence of feces, consistent with the description referenced herein, data can be transmitted to the external device 250 to alert the user of device 100 that the user needs to go to the restroom to defecate (so to avoid involuntary defecation).”
None of these passages, and nowhere else in the specification, is there disclosure of a determination of the presence of fecal matter, but only the determination of impedance changes that are indicative of the presence of fecal material, which is not the same thing.
Second, none of these passages, and nowhere else in the specification, is there disclosure of a comparison between the conductance data obtained from the anorectal tissue and the conductance data obtained from the fecal matter. Rather, as indicated by the above passages, impedance changes are determined, not a comparison between two impedance measurements.
In view of the above, there is no written description support for the subject matter of lines 7-11 of claim 1.
Claim 10 recites “in response to a comparison between the first set of bioimpedance data and the second set of bioimpedance data indicating a presence of fecal matter” in lines 13-14 which is not supported by the specification as originally filed. Though the Applicant cites to paragraphs [0032], [0033], and [0035] for supporting these features of claim 10. These paragraphs do not support the claimed subject matter. In particular, none of these passages cited above from paragraphs [0032], [0033], and [0035], and nowhere else in the specification, is there disclosure of a comparison between the first set of bioimpedance data and the second set of bioimpedance data indicating a presence of fecal matter. Rather, as indicated by the above passages, impedance changes are determined, not a comparison between two impedance measurements.
In view of the above, there is no written description support for the subject matter of lines 13-14 of claim 10.
Claim 11 is rejected by virtue of its dependence from claim 10.
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 1 and 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 1 recites “a presence of fecal matter” in lines 10-11, but it is not clear if this recitation is the same as, related to, or different from “a presence of fecal matter” in line 7. If they are the same, “a presence of fecal matter” in lines 10-11 should be “the presence of the fecal matter”. If they are different, their relationship should be made clear; they should be distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation should make it clear which recitation is being referred to.
Related to the above, it is not clear if “fecal matter” in line 7 and “fecal matter” in line 11 are the same as, related to, or different from each other and/or “fecal matter” in line 4. If they are the same, “fecal matter” in line 7 and “fecal matter” line 11 should be “the fecal matter”. If they are different, their relationship should be made clear; they should be distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation should make it clear which recitation is being referred to.
Claim 10 recites “presence of fecal matter” in lines 11-12 and “a presence of fecal matter” in line 14, but it is not clear if these recitations are the same as, related to, or different from “a presence of fecal matter” in line 8. If they are the same, “presence of fecal matter” in lines 11-12 and “a presence of fecal matter” in line 14 should be “the presence of the fecal matter”. If they are different, their relationship should be made clear; they should be distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation should make it clear which recitation is being referred to.
Related to the above, it is not clear if “fecal matter” in line 6, “fecal matter” in line 8, “fecal matter” in line 12, and “fecal matter” in line 14 are the same as, related to, or different from each other and/or “fecal matter” in line 3. If they are the same, “fecal matter” in line 6, “fecal matter” in line 8, “fecal matter” in line 12, and “fecal matter” in line 14 should be “the fecal matter”. If they are different, their relationship should be made clear; they should be distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation should make it clear which recitation is being referred to.
Claim 10 recites “a first set of bioimpedance data” in line 5 and “a second set of bioimpedance data” in line 7, but it is not clear if either of these recitations is the same as, related to, or different from “bioimpedance data” in line 3. The relationship among these recitations should be made clear.
Claim 11 is rejected by virtue of its dependence from claim 10.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP H05309133 (Masato). Citations to Masato will refer to the machine English translation that accompanies this Office Action.
With respect to claim 10, Masato teaches 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 (insertion of the crushing insert 1 of Masato; pages 2-3 of Masato), the insertion device configured to obtain bioimpedance data from anorectal tissue and from fecal matter present within the anus (the sensor mechanism that obtains acoustic impedance; pages 3-4 of Masato);
collecting a first set of bioimpedance data, wherein the first set of bioimpedance data is indicative of an absence of fecal matter (the fecal detection circuit 10 obtains a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal);
collecting a second set of bioimpedance data wherein the second set of bioimpedance data is indicative of a presence of fecal matter (the fecal detection circuit 10 obtains a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal);
transmitting the first set of bioimpedance data and the second set of bioimpedance data to an external device (the fecal detection circuit 10 obtains a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that the data from the sensor mechanism is transmitted to the fecal detection circuit 10); and
alerting, by the external device, the user of the potential discharge event due to presence of fecal matter (the fecal detection circuit issues warnings if feces are detected and the process of discharge is carried out; pages 1 and 5 of Masato) in response to a comparison between the first set of bioimpedance data and the second set of bioimpedance data indicating a presence of fecal matter (the fecal detection circuit 10 obtains a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal; and the fecal detection circuit determines that feces are detected from the difference signal (page 5 of Masao)).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over JP H05309133 (Masato), in view of U.S. Patent Application Publication No. 2017/0202503 (Nakanishi)(previously cited). Citations to Masato will refer to the machine English translation that accompanies this Office Action.
With respect to claim 1, Masato teaches an alert system, comprising:
an insertion device (the crushing insert 1, the fecal detection circuit 10, and the cable 5 of Masato) comprising an outer shell (the protective cover 3 of Masato) configured for placement into an anus, and a bioimpedance sensor configured to obtain conductance data from anorectal tissue as well as to obtain conductance data from fecal matter (the sensor mechanism that obtains acoustic impedance; pages 3-4 of Masato); and
an external device (the components of FIG. 2 of Masato other than the crushing insert 1, the fecal detection circuit 10, and the cable 5 of Masato), whereby said insertion device and said external device can communicate bidirectionally (see the bidirectional communication lines in FIG. 2 of Masato between the crushing insert 1, the fecal detection circuit 10, and the cable 5 and the other components of FIG. 2 of Masato; pages 3-6 of Masato),
wherein the insertion device is configured to determine a presence of fecal matter based on a comparison between the conductance data obtained from the anorectal tissue and the conductance data obtained from the fecal matter and to send a signal to the external device when the comparison indicates a presence of fecal matter (the sensing function utilizes the acoustic impedance of the distal end (page 3 of Masato); the fecal detection circuit 10 obtains a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal; and the fecal detection circuit determines that feces are detected from the difference signal (page 5 of Masato)).
Masato teaches that the warnings are issued if feces are detected and the process of discharge is carried out (pages 1 and 5 of Masato). Nakanishi teaches that a notifier 7 in the form of an alarm or lamp is a suitable warning mechanism (paragraph 0055 of Nakanishi). 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 alarm notifier 7 of Nakanishi as the warning mechanism of Masato since it is a simple substitution of one known element for another to obtain predictable results and/or a type of warning mechanism is required and Nakanishi is one type of warning mechanism. Thus, the combination teaches or suggest that the external device is configured to alert a user of a potential discharge event in response to receiving said signal (the warnings are issued via the notifier of Nakanishi if feces are detected and the process of discharge is carried out; pages 1 and 5 of Masato).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over JP H05309133 (Masato). Citations to Masato will refer to the machine English translation that accompanies this Office Action.
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 JP H05309133 (Masato), and further in view of EP 0286374 (Marzolf)(previously cited). Citations to Masato will refer to the machine English translation that accompanies this Office Action.
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. Also, Masato teaches that the detection of feces based on impedance measurements can be achieved by obtaining a difference signal of impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato). To obtain a difference signal, Masato is connoting that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference between the two. Masato also teaches that feces are detected from the difference signal (page 5 of Masato). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain impedance signals of the rectal tissue, obtain impedance signals of the feces, take a difference of these two impedance signals, and determine that feces are detected by this difference signal since a regime for detecting the presence of feces is required and Masato teaches one such regime.
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 an alert system, comprising:
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 determine a presence of fecal matter based on a comparison between the conductance data obtained from the anorectal tissue and the conductance data obtained from the fecal matter and to send a signal to the external device when the comparison indicates a presence of fecal matter (the functions of obtainment a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal; and the determination that feces are detected from the difference signal (page 5 of Masato), 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).
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 JP H05309133 (Masato), 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. Citations to Masato will refer to the machine English translation that accompanies this Office Action.
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. Also, Masato teaches that the detection of feces based on impedance measurements can be achieved by obtaining a difference signal of impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato). To obtain a difference signal, Masato is connoting that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference between the two. Masato also teaches that feces are detected from the difference signal (page 5 of Masato). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain impedance signals of the rectal tissue, obtain impedance signals of the feces, take a difference of these two impedance signals, and determine that feces are detected by this difference signal since a regime for detecting the presence of feces is required and Masato teaches one such regime.
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; obtainment a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal);
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; obtainment a difference signal of acoustic impedance so as to discriminate between the rectal wall and the feces (page 2 of Masato), which means that one signal for the rectal wall and another signal for the feces are obtained so as to obtain the difference signal); 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, by the external device, the user of the potential discharge event due to presence of fecal matter in response to a comparison between the first set of bioimpedance data and the second set of bioimpedance data indicating a presence of fecal matter (an audible alarm or visual display of Marzolf; the determination that feces are detected from the difference signal (page 5 of Masato)).
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 9/3/2026 have been fully considered.
Claim objections
In view of the Applicant’s arguments presented on 9/3/2026, the claim objection of claim 1 related to “fecal matter” in line 10 (now claim 11) was converted into a rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Similarly, in view of the Applicant’s arguments presented on 9/3/2026, the claim objection of claim 10 related to “fecal matter” in line 7 (now line 6), in line 9 (now line 8), and in line 12 was converted into a rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 9/3/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
In response to the claim objection related to “fecal matter” in claim 1, line 10 (now claim 11), the Applicant states:
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This explanation casts the meaning of “fecal matter” into confusion with respect to claim 1. First, according to the Applicant, the term “fecal matter” is intended to refer to both “a stated type” of material and specifically identified material (e.g., see the term “the fecal matter” in claim 1, line 9). The use of the same expression to mean two different things creates confusion as to which meaning is intended in each instance. Second, it runs contrary to the idea that particular fecal material is being identified by the expression “determine a presence of fecal matter” in line 7 when, according to one interpretation, it appears the same presence of the same fecal matter is being alluded to in lines 10-11. This contradiction renders claim 1 indefinite.
The Applicant’s response was also applicable to the claim objections related to “fecal matter” in claim 10, line 7 (now line 6), in claim 10, line 9 (now line 8), and in claim 10, line 12. Again, the Applicant’s explanation casts the meaning of “fecal matter” into confusion with respect to claim 10. First, even if the term “fecal matter” is intended to refer to “a stated type” of material, it appears to be that the same type of material is being referred to such that the definite article “the” is appropriate. Second, it runs contrary to the idea that particular fecal material is being identified by the expression “a presence of fecal matter” in line 8 when, according to one interpretation, it appears the same presence of the same fecal matter is being alluded to in lines 11-12 and again in line 14. This contradiction renders claim 10 indefinite.
Prior art rejections
The Applicant’s arguments with respect to claims 1 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.
With respect to the rejection of claim 1 based on Singh, Takizawa, Masato, and Marzolf, the Applicant’s comments that an ingestible device is not a device for placement in the anus is not persuasive. As correctly pointed out, the device will enter the anus eventually thus ensuring the placement in the anus. As a result, the outer shell is configured for placement in the anus. Claim 1 does not require anything further.
With respect to the rejection of claim 1 based on Singh, Takizawa, Masato, and Marzolf, the Applicant’s argument that Singh requires that the measurements are taken at different GI locations is not persuasive since Singh explicitly teaches that a single location of measurement is contemplated with the teaching of paragraph 0217 of Singh (“In some embodiments, the device is configured to detect the analyte at a location within the gastrointestinal (GI) tract of a subject. In some embodiments, the location within the GI tract of the subject comprises a member selected from the group consisting of the mouth, the throat, the esophagus, the stomach, the small intestine, the large intestine, the rectum, the anus, the sphincter, the duodenum, the jejunum, the ileum, and the colon”). Thus, Singh contemplates only measurement in the anus. Thus, the operating context of the teachings of Singh has not changed.
With respect to the rejection of claim 10 based on Singh, Takizawa, Masato, Marzolf, and Schentag, the Applicant’s argument that Singh requires that the measurements are taken at different GI locations is not persuasive since Singh explicitly teaches that a single location of measurement is contemplated with the teaching of paragraph 0217 of Singh (“In some embodiments, the device is configured to detect the analyte at a location within the gastrointestinal (GI) tract of a subject. In some embodiments, the location within the GI tract of the subject comprises a member selected from the group consisting of the mouth, the throat, the esophagus, the stomach, the small intestine, the large intestine, the rectum, the anus, the sphincter, the duodenum, the jejunum, the ileum, and the colon”). Thus, Singh contemplates only measurement in the anus. Thus, the operating context of the teachings of Singh has not changed.
With respect to the rejection of 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. In other words, the impedance measurements follow what the impedance values are for the respective structures (impedance for feces versus impedance for rectal tissue). That is, these material properties of the feces and rectal tissue are what they are and cannot be “designed” by the user. 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.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 The Applicant actually cites to the U.S Application Publication. For sake of consistency, the Examiner will also cite to the Application Publication.
