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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8, 9, 10, 11, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen et al. US 2020/0330260 A1 (hereinafter Hansen).
Regarding claim 1, Hansen discloses an ostomy wafer 4 (Fig. 3 – base plate 4) configured to couple an ostomy bag (Par. 166 – “The base plate 4 is adapted to support an ostomy pouch (not shown)”) to a user (Par. 174 – “The base plate 4 comprises… a proximal surface… adheres to the user's skin in the peristomal area”), the wafer 4 (Fig. 3) including:
a sensor layer 204 (Fig. 3 – electrode assembly 204) comprising a plurality of leak sensors 216 (Fig. 3 – plurality of electrodes 216) surrounding a stoma opening 18 (Fig. 1 – central opening 18) of the wafer 4 (Fig. 3), wherein the plurality of leak sensors 216 (Fig. 3) are generally an equal distance away from a center of the stoma opening 18 (Fig. 3 – the plurality of electrodes are a predetermined distance away from the center of central opening 18, marked as X in Fig. 3);
an adhesive layer 200 (Fig. 3 – adhesive layer 200) configured to be between the sensor layer 204 (Fig. 3) and skin of the user (Fig. 3, and Par. 174 – “During use, a proximal surface of the first adhesive layer 200 adheres to the user's skin in the peristomal area”), the adhesive layer 200 (Fig. 3) comprising a single opening 259 (Fig. 3 – opening 259) through a thickness of the adhesive layer 200 (Fig. 3), the single opening 259 (Fig. 3) configured to overlap with one or more of the leak sensors 216 (Fig. 3, and Par. 214 – “each of the plurality of sensor points 270 is defined by one of the first plurality of openings 259 (FIG. 8) of the first adhesive layer 200… to expose a portion of one of the plurality of electrodes 216”); and
a hardware processor 101 (Fig. 2 – processor 101), the hardware processor 101 (Fig. 2) configured to detect leakage of effluent based at least in part on signals from one or more of the plurality of leak sensors 216 (Fig. 2, Fig. 3, Par. 195 – “accurately measure moisture content at the one or more sensing zones 251 (see FIG. 11) by the plurality of electrodes 216”, and Par. 209 – “the ostomy system 1 may further be configured to detect the leakage of output, such as one or more indications of the leakage of output, at each of the one or more sensing zones 251 based on the resistance measured“), the leak sensors 216 (Fig. 6, Fig. 8-9) being in an open-circuit configuration (Par. 121 – “The first adhesive layer may have a plurality of sensor point openings”, which is when there is no leaked fluid connecting the sensor points), wherein contact with moisture or liquid is configured to complete a leak detection circuit (Par. 120 – “The base plate and/or the sensor assembly part may be configured to detect the leakage of output, such as the one or more indications of leakage of output, by way of detecting short-circuit events via the plurality of electrodes... e.g. when the leakage of output connects the first leakage electrode and the second leakage electrode at a first sensor point and a second sensor point of the plurality of sensor points”, and Par. 214 – “The aligned first and second plurality of openings 253, 259 together define a plurality of conduits, such as sensor point openings, 272 (e.g. open channels from the skin to the plurality of electrodes 216) configured for the leakage of output to enter and contact the exposed parts of the plurality of electrodes 216. Thereby, the skin is unlikely to contact the electrodes, whereas output or other liquid may propagate through the sensor point openings 272 and provide a sensor reading through a short-circuiting event”).
Regarding claim 2, Hansen discloses the invention of claim 1. Hansen further discloses wherein the hardware processor 101 (Fig. 2) is configured to determine a location of a leak based at least in part on a location of at least one leak sensor 216 (Fig. 3) that is in a closed circuit (Par. 152 – “A leakage signal may comprise at least one of leakage location... The leakage location may comprise the sensing zones where short-circuit events have been detected”).
Regarding claim 8, Hansen discloses the invention of claim 1. Hansen further discloses further comprising an accelerometer (Par. 105 – “The monitor device may comprise a sensor unit with one or more sensors... The sensor unit may comprise an accelerometer”).
Regarding claim 9, Hansen discloses the invention of claim 8. Hansen further discloses wherein the hardware processor 101 (Fig. 1) is further configured to determine a location and/or direction of a leak based on at least one signal from at least one of the leak sensors 216 (Fig. 3, and Par. 152 – “A leakage signal may comprise at least one of leakage location, leakage propagating direction,…”) and data from the accelerometer (Par. 105 – “The sensor unit may comprise an accelerometer for sensing acceleration and provision of acceleration data to the processor”; Examiner notes that acceleration is a vector quantity).
Regarding claim 10, Hansen discloses the invention of claim 1. Hansen further discloses herein the single opening 259 (Fig. 3) overlaps at least substantially with the leak sensors 216 (Fig. 8, and Par. 214 – “each of the plurality of sensor points 270 is defined by one of the first plurality of openings 259 (FIG. 8) of the first adhesive layer 200 aligning with one of the second plurality of openings 253 (FIG. 7) of the masking element 218 to expose a portion of one of the plurality of electrodes 216”) when the ostomy wafer 4 (Fig. 8) is assembled (Fig. 8).
Regarding claim 11, Hansen discloses the invention of claim 1. Hansen further discloses wherein each leak sensor 216 (Fig. 6) comprises a ground electrode 234, 236, 238, 240 (Fig. 6 – ground electrode 222 branches into electrode parts 234, 236, 238, 240) and a sensing electrode 224, 226 ,228 ,230, 232 (Fig. 6 – first, second, third, fourth, and fifth electrode 224, 226, 228, 230, 232).
Regarding claim 17, Hansen discloses the invention of claim 1. Hansen further discloses wherein the single opening 259 (Fig. 3) comprises a channel (Fig. 3 – a ring formed by opening 259) extending around a central stoma opening 18 (Fig. 3, and Par. 214 – “plurality of openings 253… together define a plurality of conduits”) of the ostomy wafer 4 (Fig. 3).
Regarding claim 18, Hansen discloses the invention of claim 17. Hansen further discloses wherein the channel (Fig. 3) extends entirely circumferentially around the central stoma opening 18 (Fig. 3 and Fig. 9 – ring formed by opening 259 around the central opening 18) such that the channel separates the adhesive layer 200 (Fig. 3) into a first outer part (Fig. 3 – the circumferential area outside of ring formed by opening 259) and a second inner part (Fig. 3 – the circumferential area inside of ring formed by opening 259).
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.
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 3, 5, 6, 7, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen.
Regarding claim 3, Hansen discloses the invention of claim 1. However, Hansen does not explicitly disclose wherein the hardware processor is configured to receive a voltage value of one or more leak sensors so as to determine whether any leak sensor or any group of leak sensors is in a closed circuit.
Hansen currently discloses that wherein the hardware processor is configured to receive a resistance value of one or more leak sensors so as to determine whether any leak sensor or any group of leak sensors is in a closed circuit (Par. 119 – “The monitor device may be configured to measure one or more resistances between the plurality of electrodes, and detect the leakage of output, such as the one or more indications of leakage of output based on the measured one or more resistances”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have reasonably and mathematically deduced a voltage value from the measured resistance of the leak sensors of Hansen to determine a leakage caused by a closed circuit, since one of ordinary skill in the art would have had the technological capability to recognize the well-known relationship between voltage, resistance, and current. Therefore, using another electrical parameter derived from the resistance value of Hansen, in this instant case – a voltage value, would have been obvious and within the skill of an artisan.
Regarding claim 5, Hansen discloses the invention of claim 3. Hansen further discloses wherein the hardware processor 101 (Fig. 2) is further configured to determine a rate of change of the voltage value so as to determine whether any leak sensor 216 (Fig. 3) or any group of leak sensors is in a closed circuit (Par. 229 – “In reference to FIG. 14, the first derivative (slope) of the resistance drop as a function of time, e.g. the rate of change of the resistance, may be correlated to the influx of moisture in the respective sensing zones. Additionally, the slope may provide information as to the quantity of moisture entering the corresponding sensing zone. Furthermore, the rate of change may be indicative of whether the underlying cause of the detected increased moisture content. For example, a big rate of change may be indicative of output causing the moisture increase”).
Once the modification is made as discussed in claim 3, the system of Hansen is able to utilize the voltage value for leak determination, since it is established above that the voltage value can be reasonably derived from Hansen’s measured resistance value. Similarly, the rate of change of the voltage value can also be derived from the rate of change of the resistance value (Par. 229 and Fig. 14 of Hansen). Thus, the limitation is met.
Regarding claim 6, Hansen discloses the invention of claim 3. Hansen further discloses wherein the hardware processor 101 (Fig. 2) is further configured to differentiate moisture due to the user's sweating or leakage of effluent (Par. 229 -“a big rate of change may be indicative of output causing the moisture increase, while a smaller rate of change may be indicative of sweat causing the moisture increase”).
Regarding claim 7, Hansen discloses the invention of claim 3. Hansen further discloses wherein the plurality of leak sensors 216 (Fig. 6) are configured to be separated into four groups (Fig. 6 – four major rings seen in Fig. 6).
Regarding claim 20, Hansen discloses the invention of claim 17. However, Hansen does not disclose in which the channel has a width of about 1 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made width of Hansen’s channel to be about 1 mm, in order to fit the particular procedure being done since this claimed dimension of the channel does not change the channel ability to allow fluid flow therethrough to reach the sensors. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 172 of Applicant’s PG-PUB), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Patel et al. US 2016/0310329 A1 (hereinafter Patel).
Regarding claim 4, Hansen discloses the invention of claim 3. However, Hansen does not explicitly disclose in which the hardware processor is configured to normalize the voltage value by a battery voltage value.
Patel, in the same field of endeavor of collecting urine with a monitoring system (Abstract and Par. 2), teaches a battery voltage value (Par. 78 – voltage source 34), and the system is configured to normalize the voltage value (Par. 77 – “Without a current path between first electrically conductive pathway 36 and second electrically conductive pathway 38, current supplied by voltage source 34 may not flow through resistor 40, which may cause the voltage drop across resistor 40 to be approximately zero. Where the voltage drop across resistor 40 is approximately zero, processors 22 may determine that the impedance state of electrical circuit 32 is open” and Par. 78 – “With such a current path between first electrically conductive pathway 36 and second electrically conductive pathway 38, current supplied by voltage source 34 may flow through resistor 40, which may cause the voltage drop across resistor 40 to be greater than zero. Where the voltage drop across resistor 40 is greater than zero, processors 22 may determine that the impedance state of electrical circuit 32 is closed”; thus detecting leakage by interpreting values between 0V and greater than 0V).
While Patel does not explicitly teach normalizing the voltage value by the battery voltage value, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hardware processor of Hansen such that the voltage value is normalized by the battery voltage value, in order to provide ease and efficient determination between an open circuit and a closed circuit (Par. 77-78 of Patel) in the presence of fluid.
Claims 12, 13, 14, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Seres et al. US 2019/0133811 A1 (hereinafter Seres).
Regarding claim 12, Hansen discloses the invention of claim 11. Hansen further discloses wherein the ground electrode 234, 236, 238, 240 (Fig. 6 – ground electrode 222 branches into electrode parts 234, 236, 238, 240) and the sensing electrode 224, 226 ,228, 230, 232 (Fig. 6 – first, second, third, fourth, and fifth electrode 224, 226, 228, 230, 232) are on alternating inwardly (Fig. 6 – each ground electrode part and each sensing electrode alternates radially inwardly) of the sensor layer 204 (Fig. 3).
However, Hansen does not disclose pointing fingers of the sensor layer.
Seres, in the same field of endeavor of ostomy monitoring system (Title), teaches pointing fingers (see annotated Fig. 5 below, and Par. 258 – “The sensor layer 500 can include a plurality of partial rings”) of the sensor layer 500 (Fig. 5 – sensor layer 500).
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Annotated Fig. 5 of Seres
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor layer of Hansen to arrange the alternating ground electrode and sensing electrode on inwardly pointing fingers as taught by Seres, in order to allow customization of a stoma size hole since the fingers can act as guides to resize the stoma hole (Par. 258 of Seres).
Regarding claim 13, Hansen in view of Seres discloses the invention of claim 12. However, the combination currently does not disclose wherein a portion of the inwardly pointing fingers further comprised a temperature sensor.
Seres, in the same field of endeavor of ostomy monitoring system (Title), teaches wherein a portion of the inwardly pointing fingers (see annotated Fig. 5 above) further comprised a temperature sensor 502 (Fig. 5 – sensor 502, and Par. 257 – “the sensor layer 500 includes sensors 502, which may be thermistors”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified pointing finger of the combination to further include a thermistor as taught by Seres, in order to detect skin irritation and leakage in the peristomal region (Par. 212 of Seres).
Regarding claim 14, Hansen discloses the invention of claim 1. However, Hansen does not disclose wherein the sensor layer further comprises outer fingers extending radially outwardly from the main body.
Seres, in the same field of endeavor of ostomy monitoring system (Title), teaches wherein the sensor layer 500 (Fig. 5) further comprises outer fingers (see annotated Fig. 5 above) extending radially outwardly from the main body 512 (Fig. 5 – body 512).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor layer of Hansen to further include outer fingers as taught by Seres, in order to allow customization of a stoma size hole since the fingers can act as guides to resize the stoma hole (Par. 258 of Seres).
Regarding claim 15, Hansen in view of Seres discloses the invention of claim 14. However, the combination currently does not disclose further comprising a plurality of temperature sensors located on the outer fingers.
Seres, in the same field of endeavor of ostomy monitoring system (Title), teaches further comprising a plurality of temperature sensors 502 (Fig. 5 – sensors 502, and Par. 257 – “the sensor layer 500 includes sensors 502, which may be thermistors”) located on the outer fingers (see annotated Fig. 5 above).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified pointing fingers of the combination to further include a thermistor as taught by Seres, in order to detect skin irritation and leakage in the peristomal region (Par. 212 of Seres).
Regarding claim 19, Hansen discloses the invention of claim 17. However, Hansen does not disclose wherein the channel extends partially around the central stoma opening.
Seres, in the same field of endeavor of ostomy monitoring system (Title), teaches wherein the channel 506 (Fig. 5 – cutout section 506) extends partially around the central stoma opening 210 (Fig. 5 – stoma hole 210).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the channel of Hansen to extend partially around the central stoma opening as taught by Seres, in order to provide a gap between the portions of the sensor layer and allow customization of a stoma size hole since the fingers can act as guides to resize the stoma hole (Par. 258 of Seres).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Seres as applied to claim 15 above, and further in view of Carlsson et al. US 2021/0386368 A1 (hereinafter Carlsson).
Regarding claim 16, Hansen in view of Seres discloses the invention of claim 15. The combination further discloses wherein the hardware processor 101 (Fig. 1 of Hansen) is configured to detect peeling of the wafer 4 (Fig. 3) from the user's body based at least in part on signals from the plurality of sensors 216 (Fig. 6, and Par. 183 – “the ostomy system may further provide information regarding whether the first adhesive layer 200 has detached from the skin of the patient”) on the outer fingers (see annotated Fig. 5 of Seres above; see modification of claim 14-15 above).
However, the combination does not disclose detect peeling based at least in part on signals from the plurality of temperature sensors.
Carlsson, in the same field of endeavor of ostomy appliance comprising thermal sensor (Title), teaches detect peeling based at least in part on signals from the plurality of temperature sensors (Par. 18 – “the controller may be configured to determine a condition of the ostomy appliance based on the at least one thermal property detected at the at least one thermal sensor... the controller may determine… an ostomy appliance detachment condition based on a change in a temperature of the barrier material due to detachment of the barrier material from a user”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further utilize on the signals from the temperature sensors as taught by Carlsson, in order to determine detachment of the barrier material form a user (Par. 18 of Carlsson). This also enhances the monitoring function of the device to ensure that the ostomy appliance remains attached and sealed for a wearer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Berduque et al. US 2022/0146449 A1 teaches electrochemical sensors with annular electrodes.
Khosravi et al. US 11,255,805 B2 teaches a sensor system with radial symmetry electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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