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 preliminary amendments to the claims filed 11/20/2024, claims 21-40 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 21-40 receive priority to the prior-filed application, filed on 12/22/2017.
Election/Restrictions
Applicant’s election with traverse of Species I in the reply filed 11/12/2025 is acknowledged. The traversal is on the ground(s) that the species II-IX are generic to species I as disclosed in the specification. This is found persuasive.
The election requirement filed 09/11/2025 has been withdrawn in view of the applicant’s arguments.
Specification
The abstract of the disclosure is objected to because the abstract contains phrases which could be implied (e.g. “Embodiments of the present disclosure”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: The fifth terminal is referred to by an incorrect reference number (pg. 50 ln. 16).
Appropriate correction is required.
Claim Objections
Claims 22 and 34 are objected to because of the following informalities:
Claim 22 recites the limitation “the primary data collection scheme is different than a sampling rate of the secondary data collection scheme” in ln. 1-3. Primary and secondary data collection schemes are not previously claimed; however, it is clear that the primary scheme is the first scheme and the secondary scheme is the second scheme.
Claim 34 recites a similar limitation to claim 22 and has a similar issue.
Appropriate correction is required.
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 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 (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) the set of operations comprising: determining to collect data from a base plate of the ostomy system 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 connector of the monitor device, data from the base plate of the ostomy system according to the selected data collection scheme;
(Claim 22) wherein a sampling rate of the primary data collection scheme is different than a sampling rate of the secondary 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 a data collection controller of the monitor device, 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:
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 according to a data collection scheme selected from a set of data collection schemes (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 connector of the monitor device, data from the wearable sensor system according to the selected data collection scheme (para. 00133-00141; Fig. 14);
(Claim 22) wherein a sampling rate of the primary data collection scheme is different than a sampling rate of the secondary data collection scheme (para. 00133-00141); and
(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 a data collection controller of the monitor device (para. 0062), thereby causing the data collection controller to obtain the data according to the selected data collection scheme (Fig. 1, sensor data database 28/32; para. 0059; para. 00107-00108; para. 00133-00141).
Cronin is considered to be analogous to the instantly claimed invention in that Cronin discloses a wearable sensor device for physiological measurements. 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 a base plate of an ostomy appliance (Fig. 6C, sensor device 120/600; Abstract; para. 0067-0069), the method comprising:
determining, by 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; Abstract; para. 0067-0069); and
collecting, via a connector of the monitor device that electrically couples with a 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 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 data from the plurality of electrodes according to the selected data collection scheme;
(Claim 34) wherein a sampling rate of the primary data collection scheme is different than a sampling rate of the secondary 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 a data collection controller of the monitor device, 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 to collect data from the sensor system according to a data collection scheme selected from a set of data collection schemes (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 data from the sensor system according to the selected data collection scheme (para. 00133-00141; Fig. 14);
(Claim 34) wherein a sampling rate of the primary data collection scheme is different than a sampling rate of the secondary data collection scheme (para. 00133-00141); and
(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 a data collection controller of the monitor device (para. 0062), thereby causing the data collection controller to obtain the data according to the selected data collection scheme (Fig. 1, sensor data database 28/32; para. 0059; para. 00107-00108; para. 00133-00141).
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 (para. 0050, sensors 510 may be attached to or embedded within flange 420; para. 0055-0065, types of sensors); and
a monitor device (Fig. 6C, sensor device 120/600; 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 determining 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 data from the base plate according to the selected data collection scheme.
Cronin teaches a wearable sensor system (Fig. 1, wearable device 10) and a method of using said system (para. 00133-00141; Fig. 14) comprising:
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 according to a data collection scheme selected from a set of data collection schemes (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 connector of the monitor device, data from the wearable sensor system according to the selected data collection scheme (para. 00133-00141; Fig. 14).
Cronin is considered to be analogous to the instantly claimed invention in that Cronin discloses a wearable sensor device for physiological measurements. 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).
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); however, 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).
Burnette is considered to be analogous to the instantly claimed invention in that Burnette discloses a wearable sensor device for physiological measurements. 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; however, 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).
Cronin ‘498 is considered to be analogous to the instantly claimed invention in that Cronin ‘498 discloses a wearable sensor device for physiological measurements. 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; however, 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).
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; however, 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).
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; however, 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).
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).
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2020/00188161 A1 to Seres discloses an ostomy monitoring system that collects data at varying lengths of intervals. US/2020/0246176 A1 to Hansen discloses an ostomy monitoring system that changes the sampling rate based on the settings of the monitor device.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781