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
This office action is responsive to the amendment filed on 27 May 2025. As directed by the amendment: claims 1, 6, 7, 17, 19, and 22 have been amended. Claim 25 is newly added. Thus, claims 1-4, 6-15, 16-20 and 22-25 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 27 May 2025 have been fully considered but they are not persuasive for the following reasons:
The Applicant argues the amendment of “obtaining, from the monitor device and via the communication interface, monitor data for a plurality of sensors within an adhesive layer of the base plate, wherein the monitor data is indicative of an electrical property for each respective sensor of the plurality of sensors that corresponds to adhesiveness of the adhesive layer, and wherein the adhesive layer is configured to be placed on the skin surface of the user; and generating, by an ostomy user application installed on the accessory device and for presentation to a user of the accessory device via a display of the accessory device, a graphical user interface comprising a user interface object that represents the determined future operating state.” While the amended claims recite additional structural components such as the sensors and application, said components are still recited at a high degree of generality and do not appear to amount to significantly more than the judicial exception.
This judicial exception is not integrated into a practical application because the additional elements as recited are only generally linking the use of the judicial exception to a particular technological environment or field of use - see MPEP 2106.05(h). Regarding the "improvements" consideration; The claims as currently presented do not clearly incorporate the steps/features of the invention which provide the disclosed improvement. Specifically, the improvement appears to stem from at least the combination of the determination of the moisture state, and conveying/performing an action as result of such determination outside of mere generating using UI. Therefore, the claimed invention fails the "improvements" consideration. See MPEP 2106.05(a).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are well understood, routine, and conventional aspects of ostomy sensors and indication of the operating condition by a device using visual means.
Therefore, the claims are not patent eligible and are rejected under 35 U.S.C 101.
See below for detailed rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea—mental processes—which are concepts performed in the human mind.
Claim 1 is rejected under 35 USC 101 because:
1. (Currently Amended) A method, performed in an accessory device of an ostomy system, wherein the accessory device comprises a communication interface configured to communicate with one or more devices of the ostomy system, wherein the ostomy system comprises a monitor device, and/or an ostomy appliance configured to be placed on a skin surface of a user, and wherein the ostomy appliance comprises a base plate, the method comprising:
- obtaining, from the monitor device and via the communication interface, monitor data for a plurality of sensors within an adhesive layer of the base plate, wherein the monitor data is indicative of an electrical property for each respective sensor of the plurality of sensors that corresponds to adhesiveness of the adhesive layer, - extra- solution activity in the form of mere data gathering
and wherein the adhesive layer is configured to be placed on the skin surface of the user; Additional element as these elements merely describe the context/device to which the mental process is intended to be applied.
obtaining context data indicative of a context in which the ostomy appliance is operating; - a mental process of making an observation, evaluation, and/or judgement.
determining, based on the monitor data and the context data, a future moisture estimate for the adhesive layer of the base plate;
- a mental process of making an observation, evaluation, and/or judgement.
determining, based on the future moisture estimate and a relationship between moisture content and adhesiveness of the adhesive layer, a future operating state of the ostomy appliance that is indicative of a remaining wear time of the base plate of the ostomy appliance, - a mental process of making an observation, evaluation, and/or judgement.
and
generating, by an ostomy user application installed on the accessory device and for presentation to a user of the accessory device via a display of the accessory device, a graphical user interface comprising a user interface object that represents the determined future operating state. -additional element not amounting to significantly more than the exception as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea
Claim 2 is rejected under 35 USC 101 because:
2. (Previously Presented) The method according to claim 1, wherein the future operating state further comprises at least one of: a quality of adhesion, and a moisture pattern representation. - a mental process of making an observation, evaluation, and/or judgement.
Claim 3 is rejected under 35 USC 101 because:
3. (Previously Presented) The method according to claim 1, the method comprising determining a current operating state based on the monitor data and/or the context data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 4 is rejected under 35 USC 101 because:
4. (Previously Presented) The method according to claim 3, wherein the current operating state comprises at least one of: a wear time, a quality of adhesion, and a moisture pattern representation.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 6 is rejected under 35 USC 101 because:
6. (Currently Amended) The method according to claim 1, wherein obtaining the context data comprises obtaining the context data from another application different from the ostomy user application.
- extra- solution activity in the form of mere data gathering
Claim 7 is rejected under 35 USC 101 because:
7. (Currently Amended) The method according to claim 1, wherein obtaining the context data comprises:
displaying a user interface field configured to accept discourse input,
detecting a first user input on the user interface field, and
determining the context data based on the detected first user input.
additional element not amounting to significantly more than the exception as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 8 is rejected under 35 USC 101 because:
8. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining calendar data from a calendar application installed on the accessory device.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 9 is rejected under 35 USC 101 because:
9. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining location data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 10 is rejected under 35 USC 101 because:
10. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining environment data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 11 is rejected under 35 USC 101 because:
11. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining nutritional data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 12 is rejected under 35 USC 101 because:
12. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining medicine intake data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 13 is rejected under 35 USC 101 because:
13. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining health data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 14 is rejected under 35 USC 101 because:
14. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining activity data.
- a mental process of making an observation, evaluation, and/or judgement.
Claim 15 is rejected under 35 USC 101 because:
15. (Previously Presented) The method according to claim 1, wherein obtaining the context data comprises obtaining the context data over a time period and wherein a processor of the accessory device is configured to store the context data received over the time period in a memory of the accessory device or remotely on a storage server.
- Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 17 is rejected under 35 USC 101 because:
17. (Currently Amended) The method according to claim 1, wherein the graphical user interface comprises a notification that comprises the user interface object representing the determined future operating state.
- Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 18 is rejected under 35 USC 101 because:
18. (Previously Presented) The method according to claim 1, wherein the user interface object is a first user interface object and the graphical user interface further comprises a second user interface object prompting the user to provide an indicator as to whether a trend in the determined future operating state is incorrect.
- Additional element as these elements merely describe the context/device to which the mental process is intended to be applied.
Claim 19 is rejected under 35 USC 101 because:
19. (Currently Amended) The method according to claim 17, the method comprising:- detecting a user input to the notification; and- in response to detecting the user input, opening the ostomy user application installed on the accessory device.
- Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 20 is rejected under 35 USC 101 because:
20. (Previously Presented) The method according to claim 19, the method comprising:- in response to opening the ostomy user application, displaying another user interface object representing the current operating state of the ostomy appliance.
- Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 22 is rejected under 35 USC 101 because:
22. (Previously Presented) An ostomy system, comprising an accessory device and one or more devices, wherein the one or more devices comprises a monitor device and an ostomy appliance configured to be placed on a skin surface of a user, wherein the ostomy appliance comprises a base plate, and wherein the accessory device comprises:
a memory; - Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
a processor operatively connected to an interface, a display, and to the memory, the interface being configured to communicate with the one or more devices of the ostomy system; - Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
wherein the interface communicatively couples the accessory device and the ostomy appliance, thereby enabling the accessory device to obtain monitor data from a plurality of sensors of an adhesive layer of the baseplate, wherein the monitor data is indicative of an electrical property for each respective sensor of the plurality of sensors that corresponds to adhesiveness of the adhesive layer, - extra- solution activity in the form of mere data gathering
and wherein the adhesive layer is configured to be placed on the skin surface of the user, Additional element as these elements merely describe the context/device to which the mental process is intended to be applied.
and
wherein the processor is configured to:
obtain, via the interface, context data indicative of a context in which the ostomy appliance is operating; - a mental process of making an observation, evaluation, and/or judgement.
determine, based on the monitor data and the context data, a future moisture estimate for the adhesive layer of the base plate; - a mental process of making an observation, evaluation, and/or judgement.
determine, based on the future moisture estimate and a relationship between moisture content and adhesiveness of the adhesive layer, a future operating state of the ostomy appliance that is indicative of a remaining wear time of the base plate of the ostomy appliance; - a mental process of making an observation, evaluation, and/or judgement.
and
generate, for presentation to a user of the accessory device by an ostomy user application installed on the accessory device and via the display of the accessory device, a graphical user interface comprising a user interface object that represents the determined future operating state.
-additional element not amounting to significantly more than the exception as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea
Claim 23 is rejected under 35 USC 101 because:
23. (Previously Presented) The ostomy system of claim 22, wherein the monitor device further comprises a second interface configured to removably couple the monitor device and the ostomy appliance, thereby establishing electrical communication between the monitor device and the ostomy appliance.
-Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 24 is rejected under 35 USC 101 because:
24. (Previously Presented) The ostomy system of claim 23, wherein the accessory device is communicatively coupled to the ostomy appliance via the monitor device.
Additional element as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea.
Claim 25 is rejected under 35 USC 101 because:
25. (New) The ostomy system of claim 22, wherein the user interface object is representative of a moisture pattern type and comprises a plurality of regions that each has an associated sensor of the plurality of sensors, thereby transforming the monitor data for the plurality of sensors into a graphical representation of the ostomy appliance according to the determined future operating state.
-additional element not amounting to significantly more than the exception as conveying or displaying the results of an abstract idea is well-known and further has no bearing on the actual determination made by the abstract idea
This judicial exception is not integrated into a practical application because the additional elements as recited are only generally linking the use of the judicial exception to a particular technological environment or field of use - see MPEP 2106.05(h). Regarding the "improvements" consideration; The claims as currently presented do not clearly incorporate the steps/features of the invention which provide the disclosed improvement. Specifically, the improvement appears to stem from at least the combination of the determination of the moisture state, and conveying/performing an action as result of such determination outside of mere generating using UI. Therefore, the claimed invention fails the "improvements" consideration. See MPEP 2106.05(a).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 22 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1 and 22 (and their dependent claims) amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 and 22 (and their dependent claims) are not patent eligible and rejected under 35 U.S.C. 101.
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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