DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 05/12/2026.
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 .
Status of Claims
Claims 49-68 are pending in the application.
Claims 49-68 are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 05/12/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments/remarks filed on 05/12/2026 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Seres does not disclose “processing the sensor data to identify a change in an electrical property of the detection sensor as compared to the reference sensor” and instead teaches only an evaluation of temperature. The arguments are not found persuasive. Seres discloses using a change in electrical property to determine the change in temperature. The temperature sensors of Seres are thermistors. As a result, the electrical resistance of the thermistors changes when the temperature changes and a processor within the hub 122 can compare the resistances to determine if they are different (¶0214, 0247 and 0251-0252). Thus, Seres discloses “processing the sensor data to identify a change in an electrical property of the detection sensor as compared to the reference sensor”.
With respect to the drawing objection(s), Applicant’s argument(s) is/are found persuasive. Therefore, the drawing objection(s) is/are withdrawn.
With respect to the claim rejection(s) under 35 U.S.C. § 112(b), Applicant’s amendment(s) to the claim(s) has/have overcome the claim rejection(s).
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/12/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 49-68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a system comprising a processor and “memory storing instructions”. The claim is directed to a non-transitory forms of signal transmission or memory such as a propagating signal. Examiner recommends Applicant to change the claims to indicate that the memory is non-transitory. See MPEP § 2106.03.
Claim Rejections - 35 USC § 102
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 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 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(s) 49-51, 54-59, and 62-68 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seres (US PGPUB 20190133810).
Regarding claim 49, Seres discloses a control unit of an ostomy system (¶0216 and Fig. 1B), the control unit (Fig. 1B) comprising:
a connector configured to releasably connect to a control unit interface of an ostomy appliance (Since ostomy appliance 104 and ostomy bag sensors 124 can be connected to a hub 122 via wires: ¶0229; thus, wires of Seres reads on the claimed connector and a hub 122 reads on the claimed control unite interface; In addition, since the hub 122 can be removed from an ostomy bag 120 and replaced with a new ostomy bag and Seres also suggests that a hub removability can save money for a user: ¶0232; Seres implicitly discloses that the connector configured to releasably connect to a control unit interface 122), the control unit interface (the hub 122) comprising:
a housing for releasably connecting with the connector of the control unit (since Seres suggested that sensors can be mounted on a side of the hub 122: ¶0233; thus, Seres implicitly discloses that the hub 122 has a housing; and since the connector configured to releasably connect to the hub 122, the housing of the hub 122 is configured to releasably connect with the connector;
a plurality of electrode terminals disposed within the housing (a plurality of electrode terminals should be disposed within the housing to allow wires/connector of sensors to connect to the hub 122: ¶0229 and 0233) that, when the connector of the control unit is releasably connected to the ostomy appliance, electrically couple the control unit to a detection sensor and reference sensor of the ostomy appliance (a detection sensor 202 and a reference sensor 204; and the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes and a processor within the hub 122 can compare the resistances to determine if they are different: ¶0214, 0242-0243, 0247, 0267, and Fig. 2);
a processor (a hardware processor: ¶0229) operably coupled to the connector (¶0229: the ostomy appliance 104 and the control unit 122 are electrically connected via wires to process sensor data and transmit sensor data; A person having ordinary skill in the art would have understood/recognized that there is a connector between 104 and 122 for processing and transmitting data); and
a memory storing instructions that, when executed by the processor, cause the control unit to perform a set of operations (¶0229, 0425, and 0430), the set of operations comprising:
obtaining, via the connector, sensor data corresponding to the reference sensor and the detection sensor of the ostomy appliance (¶0003, 0229, and 0243);
processing the sensor data to identify a change in an electrical property of the detection sensor as compared to the reference sensor (the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes and a processor within the hub 122 can compare the resistances to determine if they are different: ¶0214, 0247 and 0251-0252); and
based on identifying the change in the electrical property, generating a warning corresponding to the ostomy appliance (based on the changes in temperature to generate a warning: ¶0170, 0214, 0239, and 0252).
Regarding claim 50, Seres further discloses sensor data of the detection sensor corresponds to a first region of the ostomy appliance at a first radial distance from a center of the ostomy appliance (a first detection sensor 202 are positioned at a first radial distance from a center 210: ¶0007-0009, 0242, and Fig. 2); and sensor data of the reference sensor corresponds to a second region of the ostomy appliance at a second radial distance from the center that is greater than the first radial distance (a reference sensor 204 is positioned in a peripheral region of a body 212 or a neck 214 having a second radial distance from the center 210 greater than the first radial distance: ¶0243 and see annotated Fig. 2 below), thereby enabling detection of fluid at the first region before propagation to the second region (¶0243).
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Regarding claim 51, Seres further discloses the first region and the second region are each arranged annularly around the center of the ostomy appliance (¶0243 and Fig. 2).
Regarding claim 54, Seres further discloses the set of operations further comprises providing an indication of the generated warning to a remote computing device of a user (providing warning to a patient via user device 130 such as a smartphone or tablet: ¶0174, 0215, and 0328).
Regarding claim 55, Seres further discloses the change in the electrical property comprises a change in resistance in an adhesive layer of the ostomy appliance (an adhesive layer is coupled to a sensor layer, the sensor layer comprises temperature sensors, and the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes: ¶0003, 0170, 0214, 0247, and claim 1; thus, the change in the electrical property comprises a change in resistance in an adhesive layer of the ostomy appliance).
Regarding claim 56, Seres further discloses the ostomy appliance is one of a base plate or sensor assembly part (ostomy wafer 104 with sensors: ¶0221 and Fig. 1B).
Regarding claim 57, Seres discloses a control unit of an ostomy system (¶0216 and Fig. 1B), the control unit (Fig. 1B) comprising:
a connector configured to releasably connect to a control unit interface of an ostomy appliance (Since ostomy appliance 104 and ostomy bag sensors 124 can be connected to a hub 122 via wires: ¶0229; thus, wires of Seres reads on the claimed connector and a hub 122 reads on the claimed control unite interface; In addition, since the hub 122 can be removed from an ostomy bag 120 and replaced with a new ostomy bag and Seres also suggests that a hub removability can save money for a user: ¶0232; Seres implicitly discloses that the connector configured to releasably connect to a control unit interface 122), the control unit interface (the hub 122) comprising:
a housing for releasably connecting with the connector of the control unit (since Seres suggested that sensors can be mounted on a side of the hub 122: ¶0233; thus, Seres implicitly discloses that the hub 122 has a housing; and since the connector configured to releasably connect to the hub 122, the housing of the hub 122 is configured to releasably connect with the connector;
a plurality of electrode terminals disposed within the housing (a plurality of electrode terminals should be disposed within the housing to allow wires/connector of sensors to connect to the hub 122: ¶0229 and 0233) that, when the connector of the control unit is releasably connected to the ostomy appliance, electrically couple the control unit to a plurality of sensors of the ostomy appliance (a detection sensor 202 and a reference sensor 204; and the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes and a processor within the hub 122 can compare the resistances to determine if they are different: ¶0214, 0242-0243, 0247, 0267, and Fig. 2);
a processor (a hardware processor: ¶0229) operably coupled to the connector (¶0229: the ostomy appliance 104 and the control unit 122 are electrically connected via wires to process sensor data and transmit sensor data; A person having ordinary skill in the art would have understood/recognized that there is a connector between 104 and 122 for processing and transmitting data); and
a memory storing instructions that, when executed by the processor, cause the control unit to perform a set of operations (¶0229, 0425, and 0430), the set of operations comprising:
obtaining, via the connector, sensor data corresponding to the plurality of sensors of the ostomy appliance (¶0003, 0229, and 0243);
processing the sensor data to identify a change in an electrical property of a first sensor of the plurality of sensors as compared to a second sensor detecting changes in temperature by comparing data from a first/detection sensor 202 and a second/reference sensor 204 and the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes and a processor within the hub 122 can compare the resistances to determine if they are different: ¶0214, 0247 and 0251-0252); and
based on identifying the change in the electrical property, generating a warning corresponding to the ostomy appliance (based on the changes in temperature to generate a warning: ¶0170, 0214, 0239, and 0252).
Regarding claim 58, Seres further discloses sensor data of the first sensor corresponds to a first region of the ostomy appliance (a first/detection sensor 202 are positioned at a first region of the ostomy appliance: ¶0007-0009, 0242, and Fig. 2); and sensor data of the second sensor corresponds to a second region of the ostomy appliance (a second/reference sensor 204 is positioned in a peripheral region of a body 212 or a neck 214 or a second region of the ostomy appliance: ¶0243 and see annotated Fig. 2 above).
Regarding claim 59, Seres further discloses the first region is at a first radial distance from a center of the ostomy appliance (the first/detection sensor 202 are positioned at a first radial distance from a center 210: ¶0007-0009, 0242, and Fig. 2); and the second region is at a second radial distance from the center that is greater than the first radial distance (a reference sensor 204 is positioned in a peripheral region of a body 212 or a neck 214 having a second radial distance from the center 210 greater than the first radial distance: ¶0243 and see annotated Fig. 2 above), thereby enabling detection of fluid at the first region before propagation to the second region (¶0243).
Regarding claim 62, Seres further discloses the set of operations further comprises providing an indication of the generated warning to a remote computing device of a user (providing warning to a patient via user device 130 such as a smartphone or tablet: ¶0174, 0215, and 0328).
Regarding claim 63, Seres further discloses the change in the electrical property comprises a change in resistance (¶0214, 0247, 0267, and 0280).
Regarding claim 64, Seres discloses an ostomy system (an ostomy device 102: ¶0216 and Fig. 1B) comprising:
an ostomy appliance (an ostomy wafer 104: ¶0217-0218 and Fig. 1B), comprising:
a control unit interface (the hub 122) comprising:
a housing for releasably connecting with the connector of the control unit (since Seres suggested that sensors can be mounted on a side of the hub 122: ¶0233; thus, Seres implicitly discloses that the hub 122 has a housing; and since the connector configured to releasably connect to the hub 122, the housing of the hub 122 is configured to releasably connect with the connector;
a plurality of electrode terminals disposed within the housing (a plurality of electrode terminals should be disposed within the housing to allow wires/connector of sensors to connect to the hub 122: ¶0229 and 0233);
an adhesive layer for attachment to a skin surface of a user (¶0003 and 0218); and
a plurality of sensors (sensors 202/204: ¶0241-0243 and Fig. 2), comprising:
a detection sensor for a first region of the ostomy appliance at a first radial distance from a center of the ostomy appliance (a detection sensor 202 are positioned at a first radial distance from a center 210: ¶0007-0009, 0242, and see annotated Fig. 2 above); and
a reference sensor for a first region of the ostomy appliance at a second radial distance from the center that is greater than the first radial distance (a reference sensor 204 is positioned in a peripheral region of a body 212 or a neck 214 having a second radial distance from the center 210 greater than the first radial distance: ¶0243 and see annotated Fig. 2 below); and
a backing layer (a flexible sensor layer: ¶0003), wherein at least a part of each of the plurality of sensors is between the adhesive layer and a proximal surface of the backing layer (¶0003-0004); and
a control unit configured for connection with the ostomy appliance via the control unit interface (¶0216 and Fig. 1B), the control unit (Fig. 1B) comprising:
a connector configured to releasably connect to a control unit interface of an ostomy appliance (Since ostomy appliance 104 and ostomy bag sensors 124 can be connected to a hub 122 via wires: ¶0229; thus, wires of Seres reads on the claimed connector and a hub 122 reads on the claimed control unite interface; In addition, since the hub 122 can be removed from an ostomy bag 120 and replaced with a new ostomy bag and Seres also suggests that a hub removability can save money for a user: ¶0232; Seres implicitly discloses that the connector configured to releasably connect to a control unit interface 122), thereby electrically coupling, when the connector of the control unit is releasably connected to the ostomy appliance, the control unit to the plurality of sensors of the ostomy appliance (the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes and a processor within the hub 122 can compare the resistances to determine if they are different: ¶0214, 0242-0243, 0247, 0267, and Fig. 2);
a processor (a hardware processor: ¶0229) operably coupled to the connector (¶0229: the ostomy appliance 104 and the control unit 122 are electrically connected via wires to process sensor data and transmit sensor data; A person having ordinary skill in the art would have understood/recognized that there is a connector between 104 and 122 for processing and transmitting data); and
a memory storing instructions that, when executed by the processor, cause the control unit to perform a set of operations (¶0229, 0425, and 0430), the set of operations comprising:
obtaining, via the connector, sensor data corresponding to the reference sensor and the detection sensor of the ostomy appliance (¶0003, 0229, and 0243); and
processing the sensor data to identify a change in an electrical property of the detection sensor as compared to the reference sensor (detecting changes in temperature by comparing data from the detection sensor and reference sensor: ¶0214, 0247 and 0251-0252).
Regarding claim 65, Seres further discloses the first region and the second region are each arranged annularly around the center of the ostomy appliance (¶0243 and Fig. 2).
Regarding claim 66, Seres further discloses the set of operations further comprises providing an indication of the generated warning to a remote computing device of a user (providing warning to a patient via user device 130 such as a smartphone or tablet: ¶0174, 0215, and 0328).
Regarding claim 67, Seres further discloses the change in the electrical property comprises a change in resistance in an adhesive layer of the ostomy appliance (an adhesive layer is coupled to a sensor layer, the sensor layer comprises temperature sensors, and the electrical resistance of the thermistors of sensors changes when the temperature of the thermistors changes: ¶0003, 0170, 0214, 0247, and claim 1; thus, the change in the electrical property comprises a change in resistance in an adhesive layer of the ostomy appliance).
Regarding claim 68, Seres further discloses the ostomy appliance is one of a base plate or a sensor assembly part (ostomy wafer 104 with sensors: ¶0221 and Fig. 1B.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 52-53 and 60-61 is/are rejected under 35 U.S.C 103 as being unpatentable over Seres (US PGPUB 20190133810).
Regarding claim 52, Seres further discloses the detection sensor is a first detection sensor (¶0242 and Fig. 2) and the connector further couples the control unit (see rejection of claim 49 above).
Seres in the embodiment of Fig. 2 does not disclose a second detection sensor of the ostomy appliance that corresponds to a third region of the ostomy appliance and processing the sensor data further comprises comparing an electrical property of the second detection sensor with an electrical property of the reference sensor; however, Seres in another embodiment discloses/suggests to have more sensors disposed in a roughly circular distribution concentric with the center 210 (¶0242) for the benefits of facilitating detecting leaks or irritation in different directions or any direction, increasing a granularity of measurement, potentially more accurately predicting which direction a leak or irritation occurs (¶0242).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the ostomy appliance of Seres by having a second detection sensor corresponds to a third region of the ostomy appliance, in order to facilitate detecting leaks or irritation in different directions or any direction, increase a granularity of measurement, potentially more accurately predict which direction a leak or irritation occurs, as suggested in ¶0242 of Seres. Since the connector couples the control unit 122 (see rejection of claim 49 above), the control unit is capable of comparing an electrical property of the second detection sensor with an electrical property of the reference sensor.
Regarding claim 53, Seres in the embodiment of Fig. 2 does not disclose the third region is at a third radial distance from the center of the ostomy appliance that is between the first radial distance and the second radial distance, thereby enabling detection of fluid propagation between the first region and the third region by detecting a change in an electrical property of both the first detection sensor and the second detection sensor as compared to the reference sensor.
Seres in another embodiment discloses/suggests to have more sensors disposed in a roughly circular distribution concentric with the center 210 (¶0242) for the benefits of facilitating detecting leaks or irritation in different directions or any direction, increasing a granularity of measurement, potentially more accurately predicting which direction a leak or irritation occurs (¶0242). From these teachings, a person having ordinary skill in the art would have recognized/deduced that positioning the second detection sensor at a third radial distance or a third region such that the third radial distance in between the first radial distance and the second radial distance yields the predictable result of facilitating detecting leaks or irritation in different directions or any direction, increasing a granularity of measurement, potentially more accurately predicting which direction a leak or irritation occurs.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the ostomy appliance of Seres by positioning the second detection sensor at a third radial distance and having the third radial distance in between the first radial distance and the second radial distance, in order to facilitate detecting leaks or irritation in different directions or any direction, increase a granularity of measurement, potentially more accurately predict which direction a leak or irritation occurs, as suggested in ¶0242 of Seres. Since the connector couples the control unit 122 (see rejection of claim 49 above), the control unit is capable of detecting a change in an electrical property of both the first detection sensor and the second detection sensor as compared to the reference sensor.
Regarding claim 60, Seres in the embodiment of Fig. 2 does not disclose the plurality of sensors further comprises a third sensor; sensor data of the third sensor corresponds to a third region of the ostomy appliance; and processing the sensor data further comprises comparing an electrical property of the third sensor with an electrical property of the second sensor; however, Seres in another embodiment discloses/suggests to have more sensors disposed in a roughly circular distribution concentric with the center 210 (¶0242) for the benefits of facilitating detecting leaks or irritation in different directions or any direction, increasing a granularity of measurement, potentially more accurately predicting which direction a leak or irritation occurs (¶0242).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the ostomy appliance of Seres by incorporating a third sensor corresponds to a third region of the ostomy appliance, in order to facilitate detecting leaks or irritation in different directions or any direction, increase a granularity of measurement, potentially more accurately predict which direction a leak or irritation occurs, as suggested in ¶0242 of Seres. Since the connector couples the control unit 122 (see rejection of claim 57 above), the control unit is capable of comparing an electrical property of the third sensor with an electrical property of the second sensor.
Regarding claim 61, Seres in the embodiment of Fig. 2 does not disclose the third region is at a third radial distance from the center of the ostomy appliance that is between the first radial distance and the second radial distance, thereby enabling detection of fluid propagation between the first region and the third region by detecting a change in an electrical property of both the first sensor and the third sensor as compared to the second sensor.
Seres in another embodiment discloses/suggests to have more sensors disposed in a roughly circular distribution concentric with the center 210 (¶0242) for the benefits of facilitating detecting leaks or irritation in different directions or any direction, increasing a granularity of measurement, potentially more accurately predicting which direction a leak or irritation occurs (¶0242). From these teachings, a person having ordinary skill in the art would have recognized/deduced that positioning the third sensor at a third radial distance or a third region such that the third radial distance in between the first radial distance and the second radial distance yields the predictable result of facilitating detecting leaks or irritation in different directions or any direction, increasing a granularity of measurement, potentially more accurately predicting which direction a leak or irritation occurs.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the ostomy appliance of Seres by positioning the third sensor at a third radial distance and having the third radial distance in between the first radial distance and the second radial distance, in order to facilitate detecting leaks or irritation in different directions or any direction, increase a granularity of measurement, potentially more accurately predict which direction a leak or irritation occurs, as suggested in ¶0242 of Seres. Since the connector couples the control unit 122 (see rejection of claim 57 above), the control unit is capable of detecting a change in an electrical property of both the first sensor and the third sensor as compared to the second sensor.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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