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 .
In light of the amendments to the claims filed 04/07/2026 in which claims 21-23, 33-35, and 40 were amended and claim 41 was added, claims 21-41 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a continuation of 17/846535 filed 06/22/2022 and 16/955039 filed 06/18/2020 which is a 371 of PCT/DK2018/050385 filed 12/20/2018 which claims priority to DKPA/2017/70985 filed on 12/22/20217.
Claims 21-41 receive priority to the prior-filed application, filed on 12/22/2017.
Response to Arguments
Objections to the Specification
The objections to the specification are withdrawn in view of the amendments to the specification filed 04/07/2026.
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 04/07/2026.
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding independent claims 21, 33, and 40 and dependent claim 41, the applicant asserts on pg. 10-13 that the prior art to Angelides and Cronin fail to disclose the newly added limitations: the ostomy appliance including a base plate and an ostomy bag coupled to the base plate, collecting data via a data collection controller, and at least one of the data collection schemes monitoring a status of an adhesive material of the base plate.
In response to the applicant’s arguments, the examiner respectfully disagrees and notes that the prior art to Angelides and Cronin were not used in the previous Office Action filed 01/07/2026 to read on the newly added limitations. Applicant asserts that Angelides is only directed to a sensor system associated with a collection bag to measure features of the collection bag. As noted in the previous rejection filed 01/07/2026, Angelides discloses that the sensors can be attached to or embedded within a flange (para. 0050) and that the types of sensors can be volume, turbidity, odor-olfaction, temperature, liquid flow, leakage, and activity sensors at least (para. 0055-0065). Further, applicant asserts that Cronin appears to disclose the processor performing all claimed functions instead of in conjunction with a separate data collector. As explained below, Cronin discloses the processor sending signals to an intermediate component for querying of the sensor system (para. 0062).
The amendments to the claims have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-32 and 41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the data collector" in ln. 14 and 16. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, the examiner is treating the claim as though the data collector is the data collection controller.
Claims 22-32 and 41 are rejected for depending upon a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-26, 31, 33-37, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over US/2017/0140103 A1 to Angelides and WO/2016/151479 A1 to Cronin.
Regarding claims 21-23, Angelides discloses (Claim 21) a monitor device for an ostomy system having a base plate and an ostomy bag coupled to the base plate (para. 0046, flange 420 attached mechanically or with adhesive to the ostomy bag; para. 0050, sensors 510 may be attached to or embedded within flange 420; Fig. 6C, sensor device 120/600; Abstract), the monitor device comprising:
at least one processor (Fig. 6C, data processor having control board 606; para. 0013, a measurement communicator and a data processor); and
a memory (Fig. 6C; para. 0069) storing instructions that, when executed by the at least one processor, cause the monitor device to perform a set of operations, the set of operations comprising:
determining to collect data from a base plate of the ostomy system according to a data collection scheme (para. 0067-0069); and
collecting, via a connector of the monitor device, data from the base plate of the ostomy system, wherein the connector is configured to electrically couple with a first electrode of the base plate and a second electrode of the base plate from which the data is collected (Fig. 6E, communication conduits 632/634 connecting sensors 510 to data processors 152/154; para. 0050, sensors 510 may be attached to or embedded within flange 420; para. 0055-0065, types of sensors; para. 0067-0069).
Angelides differs from the instantly claimed invention in that Angelides fails to disclose (Claim 21) a data collection controller operably coupled to the processor, and the set of operations comprising: determining to collect data from the base plate of the ostomy system based on a control signal received by the processor and according to a data collection scheme selected from a set of data collection schemes comprising: a first data collection scheme; and a second data collection scheme different from the first data collection scheme; and collecting, via the data collection controller, data from the base plate of the ostomy system according to the selected data collection scheme based on the control signal, wherein the data collection controller is configured to electrically couple with a first electrode and a second electrode of the base plate from which the data is collected;
(Claim 22) wherein a sampling rate of the first data collection scheme is different than a sampling rate of the second data collection scheme; and
(Claim 23) wherein collecting the data from the base plate according to the selected data collection scheme comprises: providing a control signal indicative of the selected data collection scheme to the data collection controller, thereby causing the data collection controller to obtain the data according to the selected data collection scheme.
Cronin teaches (Claim 21) a wearable sensor system (Fig. 1, wearable device 10) comprising:
at least one processor (Fig. 1, processor 52; Fig. 6, processor 604; para. 0090-0091);
a data collection controller operably coupled to the processor (para. 0024-0025; para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; intermediate component can be considered data collection controller in that it receives a signal and performs a function, querying sensors and passing on sensor data, in response);
a memory (Fig. 1, memory 24) storing instructions that, when executed by the at least one processor (Fig. 1, processor 52), cause the wearable sensor system to perform a set of operations, the set of operations comprising:
determining to collect data from the sensor system based on a control signal received by the processor and according to a data collection scheme selected from a set of data collection schemes (para. 0062; para. 00133-00141; Fig. 14) comprising:
a first data collection scheme (first frequency); and
a second data collection scheme different from the first data collection scheme (second frequency); and
collecting, via the data collection controller, data from the wearable sensor system according to the selected data collection scheme based on the control signal (para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; para. 0090-0091, processor 604 connected via communication buses or signal lines to peripheral interface 606 comprising sensors; para. 00133-00141; Fig. 14), wherein the data collection controller is configured to electrically couple with sensors from which the data is collected (para. 0024-0025; para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; intermediate component can be considered data collection controller in that it receives a signal and performs a function, querying sensors and passing on sensor data, in response; para. 0062; para. 00133-00141);
(Claim 22) wherein a sampling rate of the first data collection scheme is different than a sampling rate of the second data collection scheme (para. 00133-00141);
(Claim 23) wherein collecting the data according to the selected data collection scheme comprises:
providing a control signal indicative of the selected data collection scheme to the data collection controller (para. 0062), thereby causing the data collection controller to obtain the data according to the selected data collection scheme (para. 0024-0025; para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; intermediate component can be considered data collection controller in that it receives a signal and performs a function, querying sensors and passing on sensor data, in response; para. 0062; para. 00133-00141); and
wherein the system of this invention preserves battery power of the monitor device by changing from a first data collection scheme when values are below a threshold and less important to a second data collection scheme with a higher frequency only when needed (para. 00139).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Angelides to collect data via two different data collection schemes as taught by Cronin, because Angelides teaches the system of their invention setting off a warning alarm when a sensor measurement is at a threshold value below a predetermined critical value (para. 0116), and Cronin teaches that the system of their invention preserves battery power of the monitor device by changing from a first data collection scheme when values are below a threshold and less important to a second data collection scheme with a higher frequency only when needed (para. 00139).
Regarding claim 24, the cited prior art suggests the invention of claim 21. Angelides further discloses wherein the data collection scheme is selected from the set of data collection schemes based on an operating state of the ostomy appliance (para. 0055-0065, leakage sensors).
Regarding claim 25, the cited prior art suggests the invention of claim 21. Angelides further discloses wherein the data collection scheme is selected from the set of data collection schemes based on an orientation of a user (para. 0055-0065, activity sensors).
Regarding claim 26, the cited prior art suggests the invention of claim 21. Angelides further discloses wherein the data collection scheme is selected from the set of data collection schemes based on an activity level of a user (para. 0055-0065, activity sensors).
Regarding claim 31, the cited prior art suggests the invention of claim 21; however, the prior art fails to disclose wherein the data collection scheme is selected from the set of data collection schemes based on a preference of a user of the ostomy appliance.
Cronin teaches wherein the data collection scheme is based on user-provided threshold levels (para. 0058-0059; para. 0073).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on user-provided threshold levels as taught by Cronin, because Cronin teaches that this allows a user to set up the device according to preset settings that fit their lifestyle more accurately (para. 0058-0058; para. 0073).
Regarding claims 33-35, Angelides discloses (Claim 33) a method for data collection from an ostomy appliance, the ostomy appliance including a base plate and an ostomy bag coupled to the base plate (para. 0046, flange 420 attached mechanically or with adhesive to the ostomy bag; para. 0050, sensors 510 may be attached to or embedded within flange 420; Fig. 6C, sensor device 120/600; Abstract; para. 0067-0069), the method comprising:
determining, by a control signal of a processor of a monitor device of the ostomy appliance, to collect data from a base plate of the ostomy system according to a data collection scheme (Fig. 6C, sensor device 120/600 and data processor having control board 606; Abstract; para. 0013, a measurement communicator and a data processor; para. 0067-0069); and
collecting, via a connector of the monitor device that electrically couples with a plurality of electrodes of the base plate, data from the plurality of electrodes of the base plate (Fig. 6E, communication conduits 632/634 connecting sensors 510 to data processors 152/154; para. 0050, sensors 510 may be attached to or embedded within flange 420; para. 0055-0065, types of sensors; para. 0067-0069).
Angelides differs from the instantly claimed invention in that Angelides fails to disclose
(Claim 33) determining, by a control signal of a processor of a monitor device of the ostomy appliance, to collect data from the base plate according to a data collection scheme selected from a set of data collection schemes comprising: a first data collection scheme; and a second data collection scheme different from the first data collection scheme; and collecting via a data collection controller of the monitor device that electrically couples with a plurality of electrodes of the base plate, data from the plurality of electrodes according to the selected data collection scheme based on the control signal;
(Claim 34) wherein a sampling rate of the first data collection scheme is different than a sampling rate of the second data collection scheme; and
(Claim 35) wherein collecting the data from the base plate according to the selected data collection scheme comprises: providing a control signal indicative of the selected data collection scheme to the data collection controller, thereby causing the data collection controller to obtain the data according to the selected data collection scheme.
Cronin teaches (Claim 33) a wearable sensor system (Fig. 1, wearable device 10) and a method of using said system (para. 00133-00141; Fig. 14) comprising:
determining, by a control signal of a processor of a monitor device, to collect data from the sensor system according to a data collection scheme selected from a set of data collection schemes (para. 0062; para. 00133-00141; Fig. 14) comprising:
a first data collection scheme (first frequency); and
a second data collection scheme different from the first data collection scheme (second frequency); and
collecting, via a data collection controller of the monitor device that electrically couples with sensors, data from the sensor system according to the selected data collection scheme based on the control signal (para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; para. 0090-0091, processor 604 connected via communication buses or signal lines to peripheral interface 606 comprising sensors; para. 00133-00141; Fig. 14);
(Claim 34) wherein a sampling rate of the first data collection scheme is different than a sampling rate of the second data collection scheme (para. 00133-00141);
(Claim 35) wherein collecting the data according to the selected data collection scheme comprises:
providing a control signal indicative of the selected data collection scheme to the data collection controller (para. 0062), thereby causing the data collection controller to obtain the data according to the selected data collection scheme (para. 0024-0025; para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; intermediate component can be considered data collection controller in that it receives a signal and performs a function, querying sensors and passing on sensor data, in response; para. 0062; para. 00133-00141); and
wherein the system of this invention preserves battery power of the monitor device by changing from a first data collection scheme when values are below a threshold and less important to a second data collection scheme with a higher frequency only when needed (para. 00139).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Angelides to collect data via two different data collection schemes as taught by Cronin, because Angelides teaches the system of their invention setting off a warning alarm when a sensor measurement is at a threshold value below a predetermined critical value (para. 0116), and Cronin teaches that the system of their invention preserves battery power of the monitor device by changing from a first data collection scheme when values are below a threshold and less important to a second data collection scheme with a higher frequency only when needed (para. 00139).
Regarding claim 36, the cited prior art suggests the invention of claim 33. Angelides further discloses wherein the data collection scheme is selected from the set of data collection schemes based on an operating state of the ostomy appliance (para. 0055-0065, leakage sensors).
Regarding claim 37, the cited prior art suggests the invention of claim 33. Angelides further discloses wherein the data collection scheme is selected from the set of data collection schemes based on an activity level of a user (para. 0055-0065, activity sensors).
Regarding claim 40, Angelides discloses an ostomy system (para. 0046; para. 0049-0050), comprising:
a base plate comprising a first electrode and a second electrode, the base plate configured to be coupled with an ostomy bag (para. 0046, flange 420 attached mechanically or with adhesive to the ostomy bag; para. 0050, sensors 510 may be attached to or embedded within flange 420; para. 0055-0065, types of sensors); and
a monitor device operably coupled to the base plate (Fig. 6C, sensor device 120/600; Fig. 6E, communication conduits 632/634 connecting sensors 510 to data processors 152/154; para. 0050, sensors 510 may be attached to or embedded within flange 420; Abstract), comprising:
a monitor interface configured to electrically couple with the first electrode and the second electrode of the base plate (Fig. 6E, communication conduits 632/634 connecting sensors 510 to data processors 152/154; para. 0050, sensors 510 may be attached to or embedded within flange 420; para. 0055-0065, types of sensors; para. 0067-0069);
at least one processor (Fig. 6C, data processor having control board 606; para. 0013, a measurement communicator and a data processor); and
a memory (Fig. 6C; para. 0069) storing instructions that, when executed by the at least one processor, cause the monitor device to perform a set of operations, the set of operations comprising:
determining to collect data from the base plate according to a data collection scheme (Fig. 6C, sensor device 120/600; Abstract; para. 0067-0069); and
collecting, via the monitor interface, data from the base plate (Fig. 6E, communication conduits 632/634 connecting sensors 510 to data processors 152/154; para. 0050, sensors 510 may be attached to or embedded within flange 420; para. 0055-0065, types of sensors; para. 0067-0069).
Angelides differs from the instantly claimed invention in that Angelides fails to disclose a data collection controller operably coupled to the processor, and the set of operations comprising: determining to collect data from the base plate of the ostomy system based on a control signal received by the processor and according to a data collection scheme selected from a set of data collection schemes comprising: a first data collection scheme; and a second data collection scheme different from the first data collection scheme; and collecting, via the data collection controller, data from the base plate of the ostomy system according to the selected data collection scheme based on the control signal.
Cronin teaches a wearable sensor system (Fig. 1, wearable device 10) and a method of using said system (para. 00133-00141; Fig. 14) comprising:
at least one processor (Fig. 1, processor 52; Fig. 6, processor 604; para. 0090-0091);
a data collection controller operably coupled to the processor (para. 0024-0025; para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; intermediate component can be considered data collection controller in that it receives a signal and performs a function, querying sensors and passing on sensor data, in response);
a memory (Fig. 1, memory 24) storing instructions that, when executed by the at least one processor (Fig. 1, processor 52), cause the wearable sensor system to perform a set of operations, the set of operations comprising:
determining to collect data from the sensor system based on a control signal received by the processor and according to a data collection scheme selected from a set of data collection schemes (para. 0062; para. 00133-00141; Fig. 14) comprising:
a first data collection scheme (first frequency); and
a second data collection scheme different from the first data collection scheme (second frequency); and
collecting, via the data collection controller, data from the wearable sensor system according to the selected data collection scheme based on the control signal (para. 0062, processor 52 may instruct an intermediate component to query sensor 12 at a particular sampling frequency; para. 0090-0091, processor 604 connected via communication buses or signal lines to peripheral interface 606 comprising sensors; para. 00133-00141; Fig. 14),
wherein the system of this invention preserves battery power of the monitor device by changing from a first data collection scheme when values are below a threshold and less important to a second data collection scheme with a higher frequency only when needed (para. 00139).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Angelides to collect data via two different data collection schemes as taught by Cronin, because Angelides teaches the system of their invention setting off a warning alarm when a sensor measurement is at a threshold value below a predetermined critical value (para. 0116), and Cronin teaches that the system of their invention preserves battery power of the monitor device by changing from a first data collection scheme when values are below a threshold and less important to a second data collection scheme with a higher frequency only when needed (para. 00139).
Regarding claim 41, the cited prior art suggests the invention of claim 21. Angelides further discloses: wherein at least one of the first data collection scheme and the second data collection scheme monitor a status of an adhesive material of the base plate (para. 0055-0065, leakage sensors, specifically para. 0061; para. 0067-0069).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over the cited prior art as applied above, and further in view of US/2017/0181628 A1 to Burnette.
Regarding claim 27, the cited prior art suggests the invention of claim 21. Angelides further discloses: an accessory device (Fig. 7A, mobile device 710).
The prior art differs from the instantly claimed invention in that the prior art fail to disclose wherein the data collection scheme is selected from the set of data collection schemes based on a distance between the monitor device and an accessory device.
Burnette teaches a wearable sensor system wherein data from the sensors is able to be queried based on the display device with which the sensor electronics device is communicating (para. 0039), and a mode of transmitting said data based on a range of the sensor electronics device from the display device (para. 0128), wherein this mode of operation conserves battery power (para. 0128).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on the distance between the sensor electronics device and an accessory device as taught by Burnette, because Burnette teaches that this mode of operation conserves battery power (para. 0128).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over the cited prior art as applied above, and further in view of US/2018/0113498 A1 to Cronin (hereinafter referred to as Cronin ‘498).
Regarding claim 28, the cited prior art suggests the invention of claim 21.
The prior art differs from the instantly claimed invention in that the prior art fail to disclose wherein the data collection scheme is selected from the set of data collection schemes based on a power capacity of a power unit of the monitor device.
Cronin ‘498 teaches a wearable sensor comprising a data collection scheme based on a power capacity of a power unit of a monitor device (para. 0057; Fig. 1, wearable device 102; Fig. 11), wherein automatically adjusting sampling frequency based on power consumption can allow for the battery to sustain operation (para. 0057).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on the power capacity of a power unit of the device as taught by Cronin ‘498, because Cronin ‘498 teaches that automatically adjusting sampling frequency of data based on power consumption can allow for the battery to sustain operation until a scheduled or estimated charging time (para. 0057).
Claims 32 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over the cited prior art as applied above, and further in view of US/2004/0078219 A1 to Kaylor.
Regarding claim 32, the cited prior art suggests the invention of claim 21.
The prior art differs from the instantly claimed invention in that the prior art fail to disclose wherein the data collection scheme is selected from the set of data collection schemes based on a geographic location of a user of the ostomy appliance.
Kaylor teaches a wearable sensor device configured to determine geographic location as well as physiological measurements (para. 0001-0002; para. 0268) which is especially useful for children, explorers or hikers, or soldiers (para. 0268).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on sensor data directed to geographic location as well as physiological measurements as taught by Kaylor, because Kaylor teaches that GPS data monitored along with physiological measurements would be especially useful for children, explorers or hikers, or soldiers (para. 0268).
Regarding claim 39, the cited prior art suggests the invention of claim 33.
The prior art differs from the instantly claimed invention in that the prior art fail to disclose wherein the data collection scheme is selected from the set of data collection schemes based on a geographic location of a user of the ostomy appliance.
Kaylor teaches a wearable sensor device configured to determine geographic location as well as physiological measurements (para. 0001-0002; para. 0268) which is especially useful for children, explorers or hikers, or soldiers (para. 0268).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on sensor data directed to geographic location as well as physiological measurements as taught by Kaylor, because Kaylor teaches that GPS data monitored along with physiological measurements would be especially useful for children, explorers or hikers, or soldiers (para. 0268).
Claims 29, 30, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over the cited prior art as applied above, and further in view of WO/2011/139499 to Tsai.
Regarding claims 29-30, the cited prior art suggests the invention of claim 21.
The prior art differs from the instantly claimed invention in that the prior art fail to disclose
(Claim 29) wherein the data collection scheme is selected from the set of data collection schemes based on a model type of the ostomy appliance; and
(Claim 30) wherein the data collection scheme is selected from the set of data collection schemes based on a wear time of the ostomy appliance.
Tsai teaches a wearable sensor system configured to recognize a unique identifier of an appliance and determine the wear time of the appliance based on said unique identifier (pg. 5 ln. 20-24; pg. 9 ln. 23-34 and pg. 10 ln. 1-14), wherein this allows the system to generate an alert based on a comparison of the wear-time to a recommended wear-time (pg. 5 ln. 20-24; pg. 9 ln. 23-34 and pg. 10 ln. 1-14).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on sensor data directed to model type or wear time as taught by Tsai, because Tsai teaches that their system monitors wear-time of an apparatus compared to a recommended wear-time, such that when the wear time reaches a maximum threshold, the system generates an alert (pg. 5 ln. 20-24; pg. 9 ln. 23-34 and pg. 10 ln. 1-14).
Regarding claim 38, the cited prior art suggests the invention of claim 33; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the data collection scheme is selected from the set of data collection schemes based on a wear time of the ostomy appliance.
Tsai teaches a wearable sensor system configured to recognize a unique identifier of an appliance and determine the wear time of the appliance based on said unique identifier and a sensor determining wear time (pg. 5 ln. 20-24; pg. 9 ln. 23-34 and pg. 10 ln. 1-14), wherein this allows the system to generate an alert based on a comparison of the wear-time to a recommended wear-time (pg. 5 ln. 20-24; pg. 9 ln. 23-34 and pg. 10 ln. 1-14).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the data collection scheme of the cited prior art to be based on sensor data directed to model type or wear time as taught by Tsai, because Tsai teaches that their system monitors wear-time of an apparatus compared to a recommended wear-time, such that when the wear time reaches a maximum threshold, the system generates an alert (pg. 5 ln. 20-24; pg. 9 ln. 23-34 and pg. 10 ln. 1-14).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 11 June 2026
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