DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant amended claims 1-2, 6, 9, 13-14, and 19, canceled claims 7, 11-12, and 16, and added claims 22-25. Claims 1-6, 8-9, 13-15, and 17-25.
Response to Arguments
Applicant’s arguments, see page 8 of Applicant’s Remarks, filed 03/30/26, with respect to the rejection of claims 1, 9, and 19 under 35 U.S.C. 112(a) as lacking a written description have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see pages 8-11, with respect to the rejections of claims 1-9 and 11-21 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. In light of the amendments to independent claims 1 and 19 to require that the accessory data from the accessory device is “at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type”, new grounds of rejection have been made of claims 1, 19, and their corresponding dependent claims, as indicated below.
With respect to applicant’s argument, see page 9, that Angelides in view of Krystek and in further view of Carlson does not disclose or render obvious receiving a request comprising accessory data that is at least one of an accessory type, a base plate identifier, a base plate type, or an adhesive type, processing the accessory data to determine a user type, and determining a base plate adaptation parameter using the user type, new reference Casado renders the consideration of the type of adhesive of the ostomy appliance into the wear time calculation to be obvious, and therefore renders it obvious to include data regarding the type of adhesive into the accessory data, which contributes to the base plate adaptation parameter as represented by an estimated remaining wear time.
Additionally, please note the rejection of independent claims 1 and 19 under 35 U.S.C. 112(a) as lacking a written description of the accessory data being “an accessory type”.
Applicant further argues, see pages 9-10, that the cited references estimate the remaining wear time on the server and not the accessory device. However, as discussed below, Krystek teaches that sensor data may be processed on the accessory device, and that the accessory device may further predict when the bag should be replaced, or in other words the estimated remaining wear time (¶0034), and therefore Krystek teaches that the “adapted operating state”, as represented by the estimated remaining wear time, may be determined on the accessory device.
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 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, among other things, that “the request comprises accessory data from the accessory device that is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type” (emphasis added by the examiner). There does not appear to be a written description of the accessory data including an accessory type, nor has applicant pointed out where these limitations are supported. The present specification does not appear to include the term “accessory type” or any synonyms, as best understood by the examiner. The present specification does indicate that the accessory data may include appliance data, which may comprise one or more of “an appliance type, a base plate identifier, a base plate type, and an adhesive type” (¶0124 and 0142 of the pre-grant publication). Therefore, the present specification does not appear to include a written description of the accessory data include an accessory type.
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 1-6, 8, and 19-21 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), in further view of Casado et al. (US 2014/0236111 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 receive, from an accessory device, a request for a base plate adaptation parameter comprising accessory data that is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type, process at least 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 monitor data of the accessory device and 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. Furthermore, as discussed above, Angelides further discloses that the accessory device (Angelides: Figs. 1-2, feat. 210) receives sensor data from a monitor device (Angelides: Fig. 1, feat. 130; Figs. 5A-6E, feat. 520; ¶0044 and 0067-0070) associated with the ostomy bag (Angelides: Fig. 1, feat. 110; Figs. 4A-4D, feat. 410) and its base plate (Angelides: Figs. 4A-4D, feat. 420), and further sends it to the server device (Angelides: ¶0071-0072), and Krystek further teaches that sensor data from the appliance, and therefore monitor data, that captures the patient’s behavior patterns should be incorporated into the wear time prediction (Krystek: ¶0036-0039). 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 at least 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 monitor data of the accessory device and 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 that the accessory data in the request is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type, or that the system includes 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.
Casado teaches systems and methods for managing ostomy care (¶0052-0059). Casado teaches that known ostomy management options (¶0074-0076 and Tables 1-10) include the type of adhesive skin barrier used for attaching the ostomy appliance to the patient (Table 2: 4-5). Casado teaches that the type of adhesive skin barrier impacts the wear time of the ostomy appliance (Table 2: 4-5). 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 the accessory data in the request is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type in order to account for the impact of the type of adhesive on the estimated remaining wear time.
Angelides in view of Krystek and in further view of Casado 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 and in further view of Casado 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, in further view of Casado, 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, in further view of Casado, and in further view of Carlson further suggests that the request further comprises the monitor data from a monitor device associated with the base plate and the user type is determined further based on the monitor data.
Regarding claims 3-5, Angelides in view of Krystek, in further view of Casado, 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, in further view of Casado, 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, in further view of Casado, 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, in further view of Casado, 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 and 8, Angelides in view of Krystek, in further view of Casado, 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, in further view of Casado, 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, 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 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 receive, from an accessory device, a request for a base plate adaptation parameter comprising accessory data that is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type, process at least 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 monitor data of the accessory device and the determined base plate adaptation parameter. Furthermore, Angelides does not disclose that the accessory device processes the monitor 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. Furthermore, as discussed above, Angelides further discloses that the accessory device (Angelides: Figs. 1-2, feat. 210) receives sensor data from a monitor device (Angelides: Fig. 1, feat. 130; Figs. 5A-6E, feat. 520; ¶0044 and 0067-0070) associated with the ostomy bag (Angelides: Fig. 1, feat. 110; Figs. 4A-4D, feat. 410) and its base plate (Angelides: Figs. 4A-4D, feat. 420), and further sends it to the server device (Angelides: ¶0071-0072), and Krystek further teaches that sensor data from the appliance, and therefore monitor data, that captures the patient’s behavior patterns should be incorporated into the wear time prediction (Krystek: ¶0036-0039). Furthermore, as discussed above, Angelides disclose that measurement data from electrodes in the base plate may be transmitted through the system and constitute monitor data (Angelides: ¶0044, 0061, and 0067), and Krystek teaches that the accessory device may process received sensor data (¶0034). 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 monitor data of the accessory device and the determined base plate adaptation parameter corresponding to the user type, so that that the accessory device processes the monitor 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 that the accessory data in the request is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type, or that the system includes 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, Casado teaches systems and methods for managing ostomy care (¶0052-0059). Casado teaches that known ostomy management options (¶0074-0076 and Tables 1-10) include the type of adhesive skin barrier used for attaching the ostomy appliance to the patient (Table 2: 4-5). Casado teaches that the type of adhesive skin barrier impacts the wear time of the ostomy appliance (Table 2: 4-5). 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 the accessory data in the request is at least one of: an accessory type, a base plate identifier, a base plate type, or an adhesive type in order to account for the impact of the type of adhesive on the estimated remaining wear time.
Angelides in view of Krystek and in further view of Casado 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 and in further view of Casado 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, in further view of Casado, 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, in further view of Casado, 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, in further view of Casado, 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, in further view of Casado, 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.
Regarding claim 22, Angelides in view of Krystek, in further view of Casado, and in further view of Carlson suggests the system of claim 19. As discussed above, 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, in further view of Casado, and in further view of Carlson further suggests that the request further comprises the monitor data and the user type is determined further based on the monitor data.
Regarding claim 23, Angelides in view of Krystek, in further view of Casado, and in further view of Carlson suggests the server device according to claim 2. , As discussed above, 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, in further view of Casado, 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.
Regarding claims 24-25, Angelides in view of Krystek, in further view of Casado, and in further view of Carlson suggests the server device of claim 19. 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, in further view of Casado, 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 24, and that the user type is determined from the set of user types based on the user data, with respect to claim 25.
Claims 9, 13-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Angelides in view of Krystek, and in further view of Carlson.
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, via the interface, 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) and monitor data (¶0072), wherein the monitor data comprises ostomy data obtained from one or more 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); 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 monitor 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 based on the monitor data, 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. Furthermore, as discussed above, Angelides disclose that measurement data from electrodes in the base plate may be transmitted through the system and constitute monitor data (Angelides: ¶0044, 0061, and 0067), and Krystek teaches that the accessory device may process received sensor data (¶0034). 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 monitor 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 based on the monitor data 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 claims 13-14, Angelides in view of Krystek and in further view of Carlson suggests the accessory device according to claim 11. Angelides further discloses that 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 and 18, 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.
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.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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