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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 3, 2025 has been entered.
Response to Amendment
Applicant amended claims 1, 9, 11, 17, and 19, canceled claim 10, and added claim 21. Claims 1-9 and 11-21 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 8-9 of Applicant’s Remarks, filed 09/03/25, with respect to the rejection of claim 1 under 35 U.S.C. 101 as being directed to an abstract idea without significantly more has been fully considered and are persuasive in light of the amendment to claim 1. Accordingly, the rejection has been withdrawn.
Applicant’s arguments, see pages 10-12 of Applicant’s Remarks, with respect to the rejections of claims 1, 9, and 19 under 35 U.S.C. 103 as being unpatentable over Angelides in view of Krystek and in further view of Carlson have been fully considered and are not persuasive.
Applicant argues that the combination of Angelides, Krystek, and Carlson does not teach or suggest the server device being configured to receive a request for a base plate adaptation parameter, process the accessory data to determine a user type, determine a base plate adaptation parameter based on the user type, and transmit, in response to the request from the accessory device, the base plate adaptation parameter to the accessory device to instruct or cause the accessory device to adapt and present operating state of the base plate.
As noted below there does not appear to be a written description of the processors of the server being configured to receive requests from the accessory device, or of the processors of the accessory device being configured to send a request to the server device, nor has applicant pointed out where these limitations are supported in the specification.
Additionally, in the claims as written, the “request” for a base plate adaptation parameter sent from the accessory device to the server device comprises the accessory data, but does not include any characteristics which would distinguish it from a transmission of accessory data from the accessory device to the server device. Therefore, as discussed below, because Angelides describes the transmission of accessory data from the accessory device to the server device, Angelides discloses that the server device is configured to receive a request for a base plate adaptation parameter. Furthermore, as discussed below, because Angelides describes using sensor data from the accessory device to estimate the remaining wear time of the ostomy appliance and transmitting that estimate to the accessory device, Angelides discloses transmitting a base plate adaptation parameter to the accessory device in response to the request.
Furthermore, as discussed below, Krystek renders it obvious to process the accessory data to determine a user type, determine a base plate adaptation parameter based on the user type, and to adapt and present an operating state of the base plate to the suer.
Claim Interpretation
The claims recite a “base plate adaptation parameter”. The specification does not explicitly define what a “base plate adaptation parameter” is. However, as claimed, a “base plate adaptation parameter” is used to adapt an “operating state” of the base plate. Page 23, line 22 – page 26, line 24 of the present specification discusses the operating state of the base plate, which is indicative of the dynamic internal state of the base plate related to adhesive performance and may comprise wear time metrics, among other things. In particular, page 26, lines 4-24 discusses that determining the operating state may comprise determining an estimate of remaining wear time, based in part on a base plate parameter, and further that determining an estimate of remaining wear time may comprise determining a change, increase, or decrease in the estimate of remaining wear time based in part on a current estimate of remaining wear time. Page 29, lines 1-13 defines a variety of base plate parameters, including wear time metrics such as remaining wear time. Therefore, the present specification discloses that a “base plate parameter” is used to change, or in other words adapt, an “operating state” of the base plate in a similar manner to the claimed “base plate adaptation parameter”. Therefore, the claimed “base plate adaptation parameter” was interpreted to be the same as the “base plate parameter” discussed in the present specification.
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, 9, and 19 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.
Claims 1 and 19 were amended to recite that the processors of the server are configured to “receive, from an accessory device … a request for a base plate adaptation parameter, the request comprising accessory data from the accessory device”. Claim 9 was amended to recite that the processor of the accessory device is configured to “request, from a server appliance, … one or more base plate adaptation parameters”. There does not appear to be a written description of the processors of the server being configured to receive requests from the accessory device, or of the processors of the accessory device being configured to send a request to the server device, nor has applicant pointed out where these limitations are supported.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Angelides (US 2017/0140103 A1) in view of Krystek et al. (US 2013/0324952 A1) and in further view of Carlson et al. (AU 2007/342523 B2).
Regarding claim 1, Angelides discloses a server device (Figs. 1-2, feats. 200, 220, and 240; ¶0044 and 0073-0075 – platform 200 includes knowledge module 230 and portal 240, which may be implemented as data modules running on a server) for an ostomy system of a user (Fig. 1, feat. 100; ¶0044), the server device comprising: a memory (¶0075); one or more processors (¶0075); and an interface coupled to the processors and configured to communicate with an accessory device (¶0079), wherein the one or more processors are configured to: receive, from an accessory device associated with an ostomy appliance of a user (Figs. 1-2, feats. 110 and 210 and Figs. 4A-4D, feats. 410; ¶0043, 0046, and 0071: mobile device 210 may be the patient’s and associated with ostomy appliances 110/410), a request for a base plate adaptation parameter, the request comprising accessory data from the accessory device (Figs. 1-2, feats. 200 and 210; ¶0071-0073 and 0079-0086: accessory device 210 sends data to the platform 200 on the server, and the server may send information such as a wear time estimation to the accessory device); determine a base plate adaptation parameter corresponding to accessory data (¶0080-0083 – the knowledge module 230 of the platform 200 incorporates data, which includes sensor data from the appliance 110 and data entered into a portal 240 on the accessory device 210, received from the accessory device 210 into determinations of the remaining wear time for base plate 420); and transmit, in response to the request from the accessory device (¶0073 and 0079-0086), the base plate adaptation parameter to the accessory device of the user (¶0083, 0085 and 0086 – the knowledge module 230 of the server 200 may send messages to a portal 240 running on the accessory device 210 regarding the remaining wear time of a medical appliance.)
Angelides discloses that the system comprises a single accessory device, and that the server comprises an interface configured to communicate with a single accessory device, wherein accessory data is obtained from a single accessory device, in contrast to the claimed plurality of accessory devices. Furthermore, Angelides does not disclose that the one or more processors of the server device are configured to process the accessory data to determine, for the user, a user type from a set of user types, wherein each user type of the set of user types corresponds to a subset of devices from the plurality of accessory devices, that the base plate adaptation parameter corresponds to the accessory data of the respective subset of devices for the plurality of accessory devices corresponding to the user type and is determined using the user type for the user, or that the accessory device is instructed to adapt an operating state of the base plate according to the determined base plate adaptation parameter and present the adapted operating state to the user.
Krystek teaches an ostomy appliance wear time prediction system (Figs. 1, 1a, and 4; ¶0031-0034) comprising an ostomy bag (200), base plate (202), sensor pack (101), and an accessory device (400), which receives the sensor data from the sensor pack. The accessory device may be a smart phone or other computing device associated with a patient for presenting data to the patient (¶0034-0035). Krystek teaches that data is collected from the sensors in the sensor pack in order to form a history of events occurring to the ostomy appliance, and that sensor data is compared to historical sensor data in order to predict reductions in wear time (¶0005) in order to optimize the cost effectiveness of each bag before it needs to be replaced (¶0017 and 0029). Krystek further teaches that the accessory device (400) may process received sensor data, determine the wear and fill level, and predict when the bag should be replaced, or in other words the estimated remaining wear time (¶0034). Krystek teaches that events which may shorten wear time include high physical activity, which may lead to a lot of trunk movement and sweating, high ambient temperature, high moisture, the presence of liquid in the bag, overpressure in the bag, bag load over time, physical contact, and patient orientation (¶0019-0028). Krystek teaches that these factors should be considered in order to accurately predict wear time for patients with different patterns of behavior, and to alert patients and/or their caregivers when the bag may need to be restocked (¶0036-0039). Because the behavior patterns of patients affects the predicted wear time of the appliance, patients with different behavior patterns, such as high or low activity levels, are different types of patients, or users, with respect to wear time. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the server device disclosed by Angelides so that it is configured to process the accessory data to determine, for the user, a user type from a set of user types, to determine a base adaptation plate parameter using the user type for the user, and so that the accessory device is instructed to adapt an operating state of the base plate according to the determined base plate adaptation parameter and present the adapted operating state to the user in order to accurately account for different patient’s behavior patterns when predicting wear time as taught by Krystek.
Angelides in view of Krystek does not suggest a plurality of accessory devices, that each user type of the set of user types corresponds to a subset of the plurality of accessory devices, or that the base plate adaptation parameter corresponds to the accessory data of the respective subset of the plurality of accessory devices corresponding to the user type.
Carlson teaches a medical system (Fig. 1; Page 9, lines 15-28) comprising a medical device or appliance (102) in communication with an external transceiver or accessory device, which is associated with a given patient (104; Page 9, line 29 – Page 10, line 25), which is in further communication with a remote server system (108) via a network (110). Carlson teaches that the system may employ both within-patient diagnostic techniques to detect short-term changes in a given patient’s condition (Page 13, lines 10-16) and between-patient diagnostic techniques for a more complete and long-term analysis of the patient’s condition (Page 30, lines 15-33; Page 38, lines 16-23). Patient reference groups, or user types, may be based on a variety of factors, including using the same type of device or implant, behaviors, such as similar physical activity levels or medication use, environments, such as geography or clinic, and physical attributes, such as physiological values, age, or co-morbidities (Page 31, line 1 – Page 32, line 29). Carlson teaches that the comparison between a given patient and a reference group, or user type, is performed by comparing data from the given patient, such as physical activity level obtained by an internal or external device, to the same data for each of the patients in the reference group (Page 34, lines 32 – Page 35, line 13). Carlson further teaches that the comparison between a given patient and a reference group, or user type, may be used to estimate, or predict, the health outcomes for the given patient within a particular amount of time, relative to the reference group (Page 36, line 1 – Page 37, line 5). Furthermore, as discussed above, the systems disclosed by Angelides (¶0043 and 0071), taught by Krystek (¶0034-0035), and taught by Carlson (Page 9, line 29 – Page 10, line 25) include accessory devices which are associated with each patient as interfaces between an ostomy device, in the case of Angelides and Krystek, or implanted device, in the case of Carlson, and the rest of the network. Because the patient reference groups, or user types, of Carlson comprises a pool of patients which are similar to the given patient, and each patient has an accessory device, the patient reference group, or user type, corresponds to the subset of accessory devices associated with the patients in the reference group. Furthermore, because estimations or predictions of health outcomes for the given patient are relative to the reference group, the estimations or predictions would also correspond to the data of the subset of accessory devices associated with the patients in the reference group. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Angelides in view of Krystek so that it comprises a plurality of accessory devices, so that the server device interface is configured to communicate with a plurality of accessory devices, so that each user type of the set of user types corresponds to a subset of devices from the plurality of the accessory devices, determine a user type based on accessory data obtained from the plurality of accessory devices, and so that the base plate adaptation parameter corresponds to the accessory data of the respective subset of the plurality of accessory devices corresponding to the user type in order to perform between-patient analysis and improve the predictions with respect to a given patient as taught by Carlson.
Regarding claim 2, Angelides in view of Krystek and in further view of Carlson suggests the server device according to claim 1. Angelides further discloses that the accessory device (Figs. 1-2, feat. 210) receives data from the monitor device (Figs. 1, feat. 130; Figs. 5A-6E, feat. 520; ¶0044 and 0067-0070) associated with the ostomy bag (Fig. 1, feat. 110; Figs. 4A-4D, feat. 410) and its base plate (Figs. 4A-4D, feat. 420), which includes data from sensors (Fig. 1, feat. 120; Fig. 5B, feat. 510; ¶0044, 0050, and 0067), and further sends it to the server device (¶0071-0072). Additionally, as discussed above, Krystek teaches that sensor data from the appliance that captures the patient’s behavior patterns is incorporated into the wear time prediction (¶0036-0039). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the accessory data comprises monitor data from a monitor device associated with the base plate and the user type is determined based on the monitor data.
Regarding claims 3-5, Angelides in view of Krystek and in further view of Carlson suggests the server device according to claim 2. Angelides further discloses that one type of sensor connected to the monitor device is a moisture and/or leakage sensor attached to the base plate comprising electrodes which change resistance as they get wet (¶0061). As discussed above, Krystek teaches that sensor data from the appliance that captures the patient’s behavior patterns is incorporated into the wear time prediction (¶0036-0039). In particular, Krystek teaches that moisture due to sweating, which may be from physical activity, may lead to decreased wear time (¶0019-0029). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the monitor data comprises ostomy data obtained from electrodes of the base plate and the user type is determined based on the ostomy data, with respect to claim 3. Angelides further discloses that the raw sensor data from the sensors, such as the electrodes, may be further processed before being sent to the accessory device (Fig. 1, feat. 150; ¶0069). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the monitor data comprises parameter data based on ostomy data from the electrodes of the base plate and the user type is determined based on the parameter data, with respect to claim 4. Angelides further discloses many other types of sensors which produce data that is sent to the accessory device (Angelides: ¶0055-0065) and Krystek also further teaches a variety of sensors (Krystek: ¶0036) that produce data which may be incorporated into wear time prediction based on behavior patterns (Krystek: ¶0036-0039). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the monitor data comprises sensor data of one or more sensors of the monitor device and the user type is determined based on the sensor data.
Regarding claims 6-8, Angelides in view of Krystek and in further view of Carlson suggests the server device of claim 1. Krystek further teaches that several factors affect the wear time of the appliance and should be included into the wear time prediction system, including the climate data, which is related to the user’s location (¶0019-0029, especially ¶0023), appliance data, such as the make, model, and historical user data for the appliance (¶0034), and patient data such as body mass index or activity level (¶0080-0086). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the accessory data comprises location data from the accessory device and the user type is determined based on the location data, with respect to claim 6, that the accessory data comprises appliance data of the ostomy appliance and the user type is determined based on the appliance data, with respect to claim 7, and that the one or more processors are configured to obtain user data of the user and the user type is determined from the set of user types based on the user data, with respect to claim 8.
Regarding claim 9, Angelides discloses an accessory device (Figs. 1-2, feat. 210; ¶0071-0072) for an ostomy system (Fig. 1, feat. 100; ¶0044) comprising a monitor device (Fig. 1, feat. 130; Figs. 5A-6E, feat. 530; ¶0044 and 0067-0070) and an ostomy appliance (Fig. 1, feat. 110; ¶0044-0047), the ostomy appliance comprising a base plate (Figs. 4A-4D, feat. 420; ¶0046), the accessory device comprising: a memory; a processor (¶0071 – accessory device 210 may be a smart phone or tablet computer, which are known to comprise memory and processors); and an interface coupled to the processor and configured to communicate with the monitor device (¶0072), wherein the interface comprises a display (¶0071 – the mobile device 210 comprises a display for depicting a visual representation of data from the monitor device) and is configured to obtain monitor data from the monitor device coupled to the ostomy appliance (¶0071-0072), wherein the processor is configured to: obtain accessory data (Figs. 1-2; ¶0071-0075 and 0079 – platform 200 may run in part on a mobile device like a smart phone or tablet computer, and the platform 200 receives data from the accessory device 210); request, from a server device associated with the ostomy appliance, one or more base plate adaptation parameters based on the accessory data (Figs. 1-2, feats. 200 and 210; ¶0071-0073 and 0079-0086: accessory device 210 sends data to the platform 200 on the server, and the server may send information such as a wear time estimation to the accessory device), receive, from the server device, the one or more base plate adaptation parameters including a first base plate adaptation parameter (¶0080-0086 – the knowledge module 230 of the platform 200 incorporates data, which includes sensor data from the appliance 110 and data entered into a portal 240 on the accessory device 210, received from the accessory device 210 into determinations of the remaining wear time, and the knowledge module 230 of the server 200 may send messages to a portal 240 running on the accessory device 210 regarding the remaining wear time of a medical appliance).
Angelides does not disclose that the first base plate adaptation parameter is associated with a user type of a set of user types, wherein users assigned to the user type have one or more similar properties including at least one of: behavior, environment, or physical attribute, that the first base plate adaptation parameter corresponds to a plurality of accessory devices each associated with the same user type, that the accessory device processes the accessory data using the received one or more base plate adaptation parameters associated with the user type of the user, thereby generating an adapted operating state for the base plate, or that the accessory device displays, on the display, a first user interface object representing the adapted operating state of the base plate.
As discussed above, Krystek teaches an ostomy appliance wear time prediction system (Figs. 1, 1a, and 4; ¶0031-0034) comprising an ostomy bag (200), base plate (202), sensor pack (101), and an accessory device (400), which receives the sensor data from the sensor pack. The accessory device may be a smart phone or other computing device associated with a patient for presenting data to the patient (¶0034-0035). Krystek teaches that data is collected from the sensors in the sensor pack in order to form a history of events occurring to the ostomy appliance, and that sensor data is compared to historical sensor data in order to predict reductions in wear time (¶0005) in order to optimize the cost effectiveness of each bag before it needs to be replaced (¶0017 and 0029). Krystek further teaches that the accessory device (400) may process received sensor data, determine the wear and fill level, and predict when the bag should be replaced, or in other words the estimated remaining wear time (¶0034). Krystek teaches that events which may shorten wear time include high physical activity, which may lead to a lot of trunk movement and sweating, high ambient temperature, high moisture, the presence of liquid in the bag, overpressure in the bag, bag load over time, physical contact, and patient orientation (¶0019-0028). Krystek teaches that these factors should be considered in order to accurately predict wear time for patients with different patterns of behavior, and to alert patients and/or their caregivers when the bag may need to be restocked (¶0036-0039). Because the behavior patterns of patients affects the predicted wear time of the appliance, patients with different behavior patterns, such as high or low activity levels, are different types of patients, or users, with respect to wear time. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the accessory device disclosed by Angelides so that the first base plate adaptation parameter is associated with a user type and so that that the accessory device processes the accessory data using the received one or more base plate adaptation parameters associated with the user type of the user, thereby generating an adapted operating state for the base plate, and that the accessory device displays, on the display, a first user interface object representing the adapted operating state of the base plate in order to accurately account for different patient’s behavior patterns when predicting wear time as taught by Krystek.
Angelides in view of Krystek does not suggest that the user type is from a set of user types, wherein users assigned to the user type have similar properties in at least one of behavior, environment, or physical attribute and so that the first base plate adaptation parameter corresponds to a plurality of accessory devices each associated with the same user type
As discussed above, Carlson teaches a medical system (Fig. 1; Page 9, lines 15-28) comprising a medical device or appliance (102) in communication with an external transceiver or accessory device, which is associated with a given patient (104; Page 9, line 29 – Page 10, line 25), which is in further communication with a remote server system (108) via a network (110). Carlson teaches that the system may employ both within-patient diagnostic techniques to detect short-term changes in a given patient’s condition (Page 13, lines 10-16) and between-patient diagnostic techniques for a more complete and long-term analysis of the patient’s condition (Page 30, lines 15-33; Page 38, lines 16-23). Patient reference groups, or user types, may be based on a variety of factors, including using the same type of device or implant, behaviors, such as similar physical activity levels or medication use, environments, such as geography or clinic, and physical attributes, such as physiological values, age, or co-morbidities (Page 31, line 1 – Page 32, line 29). Carlson teaches that the comparison between a given patient and a reference group, or user type, is performed by comparing data from the given patient, such as physical activity level obtained by an internal or external device, to the same data for each of the patients in the reference group (Page 34, lines 32 – Page 35, line 13). Carlson further teaches that the comparison between a given patient and a reference group, or user type, may be used to estimate, or predict, the health outcomes for the given patient within a particular amount of time, relative to the reference group (Page 36, line 1 – Page 37, line 5). Because estimations or predictions of health outcomes for the given patient are relative to the reference group, the estimations or predictions would also correspond to the data of the subset of accessory devices associated with the patients in the reference group. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the accessory suggested by Angelides in view of Krystek so that the user type is from a set of user types, wherein users assigned to the user type have similar properties in at least one of behavior, environment, or physical attribute and so that the first base plate adaptation parameter corresponds to a plurality of accessory devices each associated with the same user type in order to perform between-patient analysis and improve the predictions with respect to a given patient or user as taught by Carlson.
Regarding claim 11, Angelides in view of Krystek and in further view of Carlson suggests the accessory device according to claim 9. Angelides further discloses that the accessory data comprises monitor data from the monitor device (Figs. 1, feat. 130; Figs. 5A-6E, feat. 520; ¶0044 and 0067-0072 – the monitor device 130 sends measurement data to the accessory device 210, which further sends the data to the platform 200), and wherein the one or more base plate adaptation parameters of the base plate is based on the monitor data (¶0080-0083 and 0086: the knowledge module 230 of the platform incorporates the measurement data into the remaining wear time estimation).
Regarding claims 12-14, Angelides in view of Krystek and in further view of Carlson suggests the accessory device according to claim 11. Angelides further discloses that the monitor data comprises ostomy data obtained from electrodes of the base plate (¶0044, 0061, and 0067 – the measurement data that the monitor 130 sends to the accessory device 210 may include data recorded from electrodes in the base plate 420), with respect to claim 12, that the monitor data comprises parameter data based on ostomy data from electrodes of the base plate (¶0044, 0061, 0067, 0069 – the measurement data that the monitor 130 sends to the accessory device 210 may include processed data recorded from electrodes in the base plate 420), with respect to claim 13, and that the monitor data comprises sensor data of one or more sensors of the monitor device (¶0055-0069: the monitor device 130 may send data from a variety of sensors to the accessory device 210), with respect to claim 14.
Regarding claims 15-16 and 19, Angelides in view of Krystek and in further view of Carlson suggests the server device of claim 9. Krystek further teaches that several factors affect the wear time of the appliance and should be included into the wear time prediction system, including the climate data, which is related to the user’s location (¶0019-0029, especially ¶0023), appliance data, such as the make, model, and historical user data for the appliance (¶0034), and patient data such as body mass index or activity level (¶0080-0086). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the accessory data comprises location data from the accessory device, with respect to claim 15, that the accessory data comprises appliance data of the ostomy appliance, with respect to claim 16, and that the accessory data comprises user data of a user with the ostomy appliance, with respect to claim 18.
Regarding claim 17, Angelides in view of Krystek and in further view of Carlson discloses the accessory device according to claim 9. Angelides further discloses determining the estimated remaining wear time of the based plate (¶0083 and 0086) and displaying a user interface object representing the estimated remaining wear time (Figs. 7A-7C; ¶0083-0086 and 0103-112). As discussed above, Krystek teaches that the accessory device incorporates information about the behavior of the user into predictions of estimated remaining wear time (¶0034-0039). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that processing the accessory data using the one or more base plate adaptation parameters comprises estimating a remaining wear time of the base plate based on the first base plate adaptation parameter associated with the user type of the user and wherein the first user interface object represents the estimate of remaining wear time of the base plate.
Regarding claim 19, Angelides discloses an ostomy system (Figs. 1-2, feats. 100 and 200; ¶0044), comprising: a server device (Figs. 1-2, feats. 200, 220, and 240; ¶0044 and 0073-0075 – platform 200 includes knowledge module 230 and portal 240, which may be implemented as data modules running on a server) including: a memory (¶0075); one or more processors (¶0075); and an interface coupled to the processors and configured to communicate with the accessory device (¶0079), wherein the one or more processors are configured to: receive, from an accessory device associated with an ostomy appliance of a user (Figs. 1-2, feats. 110 and 210 and Figs. 4A-4D, feats. 410; ¶0043, 0046, and 0071: mobile device 210 may be the patient’s and associated with ostomy appliances 110/410), a request for a base plate adaptation parameter, the request comprising accessory data from the accessory device (Figs. 1-2, feats. 200 and 210; ¶0071-0073 and 0079-0086: accessory device 210 sends data to the platform 200 on the server, and the server may send information such as a wear time estimation to the accessory device); determine a base plate adaptation parameter corresponding to accessory data (¶0080-0083 – the knowledge module 230 of the platform 200 incorporates data, which includes sensor data from the appliance 110 and data entered into a portal 240 on the accessory device 210, received from the accessory device 210 into determinations of the remaining wear time for base plate 420); and transmit, in response to the request from the accessory device (¶0073 and 0079-0086), the base plate adaptation parameter to the accessory device of the user (¶0083, 0085 and 0086 – the knowledge module 230 of the server 200 may send messages to a portal 240 running on the accessory device 210 regarding the remaining wear time of a medical appliance); and an accessory device (Figs. 1-2, feat. 210; ¶0071-0072) including a memory; a processor (¶0071 – accessory device 210 may be a smart phone or tablet computer, which are known to comprise memory and processors); and an interface coupled to the processor of the accessory device and configured to communicate with the monitor device (¶0072), wherein the interface comprises a display (¶0071 – the mobile device 210 comprises a display for depicting a visual representation of data from the monitor device) and is configured to obtain monitor data from the monitor device coupled to the ostomy appliance (¶0071-0072), wherein the processor of the accessory is configured to: obtain accessory data (Figs. 1-2; ¶0071-0075 and 0079 – platform 200 may run in part on a mobile device like a smart phone or tablet computer, and the platform 200 receives data from the accessory device 210) from the ostomy appliance (Fig. 1, feat. 110), the base plate adaptation parameter (¶0080-0083 – the knowledge module 230 of the platform 200 incorporates data, which includes sensor data from the appliance 110 and data entered into a portal 240 on the accessory device 210, received from the accessory device 210 into determinations of the remaining wear time); display, on the display, a first user interface comprising a first user interface object representing the estimate of remaining wear time for the base plate (Figs. 7A-7C; ¶0103-0112).
Angelides discloses that the system comprises a single accessory device, and that the server comprises an interface configured to communicate with a single accessory device, wherein accessory data is obtained from a single accessory device, in contrast to the claimed plurality of accessory devices. Furthermore, Angelides does not disclose that the one or more processors of the server device are configured to process the accessory data to determine, for the user, a user type from a set of user types, wherein each user type of the set of user types corresponds to a subset of devices from the plurality of accessory devices, that the base plate adaptation parameter corresponds to the accessory data of the respective subset of devices for the plurality of accessory devices corresponding to the user type and is determined using the user type, or that the accessory device is caused to adapt the operating state of the base plate according to the determined base plate adaptation parameter. Furthermore, Angelides does not disclose that the accessory device processes the accessory data using the received base plate adaptation parameter, thereby generating an estimate of remaining wear time for the base plate.
As discussed above, Krystek teaches an ostomy appliance wear time prediction system (Figs. 1, 1a, and 4; ¶0031-0034) comprising an ostomy bag (200), base plate (202), sensor pack (101), and an accessory device (400), which receives the sensor data from the sensor pack. The accessory device may be a smart phone or other computing device associated with a patient for presenting data to the patient (¶0034-0035). Krystek teaches that data is collected from the sensors in the sensor pack in order to form a history of events occurring to the ostomy appliance, and that sensor data is compared to historical sensor data in order to predict reductions in wear time (¶0005) in order to optimize the cost effectiveness of each bag before it needs to be replaced (¶0017 and 0029). Krystek further teaches that the accessory device (400) may process received sensor data, determine the wear and fill level, and predict when the bag should be replaced, or in other words the estimated remaining wear time (¶0034). Krystek teaches that events which may shorten wear time include high physical activity, which may lead to a lot of trunk movement and sweating, high ambient temperature, high moisture, the presence of liquid in the bag, overpressure in the bag, bag load over time, physical contact, and patient orientation (¶0019-0028). Krystek teaches that these factors should be considered in order to accurately predict wear time for patients with different patterns of behavior, and to alert patients and/or their caregivers when the bag may need to be restocked (¶0036-0039). Because the behavior patterns of patients affects the predicted wear time of the appliance, patients with different behavior patterns, such as high or low activity levels, are different types of patients, or users, with respect to wear time. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Angelides so that the server is configured to process the accessory data to determine, for the user, a user type from a set of user types, to determine a base adaptation plate parameter using the user type, so that the accessory device is caused to adapt the operating state of the base plate according to the determined base plate adaptation parameter corresponding to the user type, so that that the accessory device processes the accessory data using the received base plate adaptation parameter, thereby generating an estimate of remaining wear time for the base plate in order to accurately account for different patient’s behavior patterns when predicting wear time as taught by Krystek.
As discussed above, Angelides in view of Krystek does not suggest a plurality of accessory devices, that each user type from a set of user types corresponds to a subset of devices from the plurality of accessory devices, or that the base plate adaptation parameter corresponds to the accessory data of the respective subset of devices for the plurality of accessory devices corresponding to the user type.
As discussed above, Carlson teaches a medical system (Fig. 1; Page 9, lines 15-28) comprising a medical device or appliance (102) in communication with an external transceiver or accessory device, which is associated with a given patient (104; Page 9, line 29 – Page 10, line 25), which is in further communication with a remote server system (108) via a network (110). Carlson teaches that the system may employ both within-patient diagnostic techniques to detect short-term changes in a given patient’s condition (Page 13, lines 10-16) and between-patient diagnostic techniques for a more complete and long-term analysis of the patient’s condition (Page 30, lines 15-33; Page 38, lines 16-23). Patient reference groups, or user types, may be based on a variety of factors, including using the same type of device or implant, behaviors, such as similar physical activity levels or medication use, environments, such as geography or clinic, and physical attributes, such as physiological values, age, or co-morbidities (Page 31, line 1 – Page 32, line 29). Carlson teaches that the comparison between a given patient and a reference group, or user type, is performed by comparing data from the given patient, such as physical activity level obtained by an internal or external device, to the same data for each of the patients in the reference group (Page 34, lines 32 – Page 35, line 13). Carlson further teaches that the comparison between a given patient and a reference group, or user type, may be used to estimate, or predict, the health outcomes for the given patient within a particular amount of time, relative to the reference group (Page 36, line 1 – Page 37, line 5). Furthermore, as discussed above, the systems disclosed by Angelides (¶0043 and 0071), taught by Krystek (¶0034-0035), and taught by Carlson (Page 9, line 29 – Page 10, line 25) include accessory devices which are associated with each patient as interfaces between an ostomy device, in the case of Angelides and Krystek, or implanted device, in the case of Carlson, and the rest of the network. Because the patient reference groups, or user types, of Carlson comprises a pool of patients which are similar to the given patient, and each patient has an accessory device, the patient reference group, or user type, corresponds to the subset of accessory devices associated with the patients in the reference group. Furthermore, because estimations or predictions of health outcomes for the given patient are relative to the reference group, the estimations or predictions would also correspond to the data of the subset of accessory devices associated with the patients in the reference group. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Angelides in view of Krystek so that it comprises a plurality of accessory devices, so that the server device interface is configured to communicate with a plurality of accessory devices, so that each user type of the set of user types corresponds to a subset of the plurality of the accessory devices from the plurality of accessory devices, and so that the base plate adaptation parameter corresponds to the accessory data of the respective subset of devices for the plurality of accessory devices corresponding to the user type in order to perform between-patient analysis and improve the predictions with respect to a given patient as taught by Carlson.
Regarding claim 20, Angelides in view of Krystek and in further view of Carlson suggests the server device according to claim 1. As discussed above, Carlson teaches that each patient reference group comprises a pool of similar patients (Page 31, line 1 – Page 32, line 29; Page 34, line 32 – Page 35, line 13), and therefore teaches that multiple patients interact with and are analyzed by the system. Furthermore, as discussed above, Carlson teaches that patient reference groups, or user types, may be based on a variety of factors, including using the same type of device or implant, behaviors, such as similar physical activity levels or medication use, environments, such as geography or clinic, and physical attributes, such as physiological values, age, or co-morbidities (Page 31, line 1 – Page 32, line 29), and that the patient reference group for each patient should be constructed based on which patients are similar to the given patient in order to increase the quality or accuracy of predictive calculations (Page 34, line 32 – Page 35, line 13), which could result in different patients having different reference groups. Furthermore, as discussed above, the systems disclosed by Angelides (¶0043 and 0071), taught by Krystek (¶0034-0035), and taught by Carlson (Page 9, line 29 – Page 10, line 25) include accessory devices which are associated with each patient as interfaces between an ostomy device, in the case of Angelides and Krystek, or implanted device, in the case of Carlson, and the rest of the network, which results in different patients having different accessory devices, which would produce different instances of accessory data. Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the accessory data is a first instance of accessory data, the accessory device is a first accessory device, the user type is a first user type, the base plate adaptation parameter is a first base plate adaptation parameter, and the one or more processors are further configured to: obtain a second instance of accessory data from a second accessory device of the plurality of accessory devices, determine, based on the second instance of accessory data, a second user type from a second set of user types, wherein the second user type is different than the first user type, and transmit a second base plate adaptation parameter to the second accessory device, wherein the second base plate adaptation parameter is different than the first base plate parameter and is associated with the second user type.
Regarding claim 21, Angelides in view of Krystek and in further view of Carlson suggests the server device of claim 1. As discussed above with respect to claim 9, Krystek teaches that the accessory device may be a smart phone or other computing device associated with a patient for presenting data to the patient, including wear time estimates (¶0034-0035). Therefore, Angelides in view of Krystek and in further view of Carlson further suggests that the accessory device is configured to display, based on the base plate adaptation parameter, a user interface comprising a user interface object representing the adapted operating state of the base plate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781