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 Objections
Claim 51 is objected to because of the following informalities: Claim 51 is dependent on canceled claim 21. Appropriate correction is required. In the interest of compact prosecution, the claim is being interpreted as dependent on independent claim 26.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive. Applicant argues that Seres does not teach the newly amended limitation. However, as set forth in the rejection below, the hub 122 of Seres Fig 1B ¶[0216][0220][0229][0232] may couple to the sensors wirelessly or with wires and may be disposed in various positions of the device 102. When sensors are disposed on both opposing planar sides of the wafer, the hub may couple to both sides via wires. The wired connection of hub 122 to the sensors is in communication with the processor of the hub 122 itself, user device 130, network 140, third party systems 150, clinician device 160, backend system 170 and patient data storage 180, all of which may be considered a monitor device connected to the monitor interface. Thus the rejection of claim 26 is maintained over Seres as set forth in the rejection below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 26, 37, 40, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seres (US 20190133810 A1).
Regarding Claim 26, Seres discloses a sensor patch for attachment to an adhesive surface of a base plate for a skin surface appliance (Figure 13 shows an ostomy bag with sensor layers connected to an ostomy wafer; Figure 8 shows sensor layers on an ostomy bag, that is a skin surface appliance),
the sensor patch having a first side and a second side, wherein the adhesive surface of the base plate is adapted for attachment of the base plate to a skin surface of a user (adhesive layer of the ostomy wafer adheres to the skin, ¶[0003]),
the sensor patch being adapted to form a stomal opening with a centre point (wafer can sit in the stoma which sits in the stoma hole in the wafer,¶[0178]),
the stomal opening being configured to allow passage of output through the stomal opening and into a pouch attached to the base plate (the ostomy bag can receive output from the stoma, ¶[0216]), the sensor patch (the bag can include multiple sensor layers, ¶[0219]) comprising:
a sensor assembly comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor (sensors can be located on the same or different sides of a single layer, ¶[0219]; Figure 3 shows a second electrode at the inner region of the sensor layer, Element 304, and a first electrode at the other region of the sensor layer, Element 308),
the sensor assembly having a first sensor side and a second sensor side, and at least a first part of the plurality of electrodes being exposed on the first sensor side and at least a second part of the plurality of electrodes being exposed on the second sensor side (sensors can be located on the same or different sides of a single layer, ¶[0219]; Figure 3 shows a second electrode at the inner region of the sensor layer, Element 304, and a first electrode at the other region of the sensor layer, Element 308. While Fig 3 shows different electrodes on an inner and outer region of the sensor layer, Seres also envisions that different electrodes may be on opposing planar sides of a sensor layer ¶[0219]),
a first adhesive sensor layer forming the first side of the sensor patch, wherein a primary first side of the first adhesive sensor layer is adapted for attachment to the skin surface of the user when the sensor patch is used in a first configuration (the wafer including the sensor layers have adhesive layers on a patient contact side, ¶[0262]),
and wherein the primary first side of the first adhesive sensor layer is adapted for attachment to the adhesive surface of the base plate when the sensor patch is used in a second configuration (the wafer including the sensor layers have adhesive layers on the ostomy bag contact side, ¶[0262]), and
a second adhesive sensor layer forming the second side of the sensor patch, wherein a primary second side of the second adhesive sensor layer is adapted for attachment to the skin surface of the user when the sensor patch is used in the second configuration (the wafer including the sensor layers have adhesive layers on the ostomy bag contact side, ¶[0262]),
and wherein the primary second side of the second adhesive sensor layer is adapted for attachment to the adhesive surface of the base plate when the sensor patch is used in the first configuration (the wafer including the sensor layers have adhesive layers on a patient contact side, ¶[0262]), and
a monitor interface coupled to both the first part of the plurality of electrodes exposed on the first sensor side and the second part of the plurality of electrodes exposed on the second sensor side (Fig 1B ¶[0216][0229][0232] hub 122 may couple to the sensors wirelessly or with wires and may be disposed in various positions of the device 102. When sensors are disposed on both opposing planar sides of the wafer, the hub may couple to both sides via wires), thereby enabling a monitor device connected thereto to measure the plurality of electrodes on both sensor sides (Fig 1B ¶[0216][0220] the wired connection of hub 122 to the sensors is in communication with the processor of the hub 122 itself, user device 130, network 140, third party systems 150, clinician device 160, backend system 170 and patient data storage 180, all of which may be considered a monitor device connected to the monitor interface).
Regarding Claim 37, Seres discloses that the first adhesive sensor layer and/or the second adhesive sensor layer comprises hydrocolloids (¶[0226][0256][0262-0263] hydrocolloid adhesives act as the adhesive layer for either sensor side).
Regarding Claim 40, Seres discloses that the first electrode forms a first loop surrounding the centre point (Fig 3 ¶[0248] 308 comprises conductive wiring in a loop surrounding center point 210) and the second electrode forms a second loop surrounding the centre point (Fig 3 ¶[0248] 304 comprises conductive wiring in a loop surrounding center point 210), and wherein a radial distance from the centre point to the second loop is less than the radial distance from the centre point to the first loop (Fig 3, loop comprising 308 is at a greater radial distance from 210 than the loop comprising 304).
Regarding Claim 51, Seres discloses that the monitor interface is configured to mechanically coupled with the monitor device at the second side of the sensor patch when the sensor patch is used in the first configuration (Fig 1B ¶[0216][0220][0229][0232] hub 122 may couple to the sensors wirelessly or with wires and may be disposed in various positions of the device 102. When sensors are disposed on both opposing planar sides of the wafer, the hub may couple to both sides via wires. The wired connection of hub 122 to the sensors is mechanically coupled with the processor of the hub 122 itself); and the monitor interface is configured to mechanically couple with the monitor device at the first side of the sensor patch when in the second configuration (Fig 1B ¶[0216][0220][0229][0232] hub 122 may couple to the sensors wirelessly or with wires and may be disposed in various positions of the device 102. When sensors are disposed on both opposing planar sides of the wafer, the hub may couple to both sides via wires. The wired connection of hub 122 to the sensors is mechanically coupled with the processor of the hub 122 itself).
Claim Rejections - 35 USC § 103
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 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Seres (US 20190133810 A1) in view of Bernard (US 20180164357 A1).
Regarding Claim 27, Seres is silent whether a primary first sensor part of the first electrode is exposed on the first sensor side and a secondary first sensor part of the first electrode is exposed on the second sensor side, and wherein a primary second sensor part of the second electrode is exposed on the first sensor side and a secondary second sensor part of the second electrode is exposed on the second sensor side.
However, Bernard teaches a sensor device using electrodes that may be worn by a person (¶[0040]), thus from the same field of endeavor, wherein a primary first sensor part of the first electrode is exposed on the first sensor side and a secondary first sensor part of the first electrode is exposed on the second sensor side (Fig 15 ¶[0038] undulating conductor 22 comprises an upper exposed portion (primary first sensor part) exposed on the upper surface of sheet 30 (first sensor side) and a lower exposed part exposed on the lower surface of sheet 30 (second sensor side)), and wherein a primary second sensor part of the second electrode is exposed on the first sensor side and a secondary second sensor part of the second electrode is exposed on the second sensor side ((Fig 15 ¶[0038] undulating conductor 23 comprises an upper exposed portion (primary first sensor part) exposed on the upper surface of sheet 30 (first sensor side) and a lower exposed part exposed on the lower surface of sheet 30 (second sensor side)) to allow sensors to be incorporated into fabrics or other materials worn by humans or placed on structures to be monitored (¶[0040]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres so that a primary first sensor part of the first electrode is exposed on the first sensor side and a secondary first sensor part of the first electrode is exposed on the second sensor side, and wherein a primary second sensor part of the second electrode is exposed on the first sensor side and a secondary second sensor part of the second electrode is exposed on the second sensor side, as taught by Bernard to allow sensors to be incorporated into fabrics or other materials worn by humans or placed on structures to be monitored (as motivated by Bernard ¶[0040]).
Regarding Claim 28, Seres is silent whether the sensor assembly comprises a support layer, and wherein the first electrode and the second electrode extend from the first sensor side of the sensor assembly to the second sensor side of the sensor assembly through the support layer.
However, Bernard teaches a sensor device using electrodes that may be worn by a person (¶[0040]), thus from the same field of endeavor, wherein the sensor assembly (Fig 15, wireless sensor) comprises a support layer (Fig 15 ¶[0038] sheet 30), and wherein the first electrode and the second electrode extend from the first sensor side of the sensor assembly to the second sensor side of the sensor assembly through the support layer (Fig 15 ¶[0038] each of 22 and 23 extend through sheet 30 from a first upper side to a second lower side) to allow sensors to be incorporated into fabrics or other materials worn by humans or placed on structures to be monitored (¶[0040]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres so that the sensor assembly comprises a support layer, and wherein the first electrode and the second electrode extend from the first sensor side of the sensor assembly to the second sensor side of the sensor assembly through the support layer, as taught by Bernard to allow sensors to be incorporated into fabrics or other materials worn by humans or placed on structures to be monitored (as motivated by Bernard ¶[0040]).
Regarding Claims 29 and 30, Seres is silent whether the first electrode comprises one or more electrically conductive first threads sewn on the support layer, wherein the support layer is a textile fabric.
However, Bernard teaches a sensor device using electrodes that may be worn by a person (¶[0040]), thus from the same field of endeavor, wherein the first electrode comprises one or more electrically conductive first threads sewn on the support layer (Fig 15 ¶[0026] undulating conductor 22 is an electrically conductive trace, wire, thread, or filament sewn into sheet 30) wherein the support layer is a textile fabric (Fig 15 ¶[0032]sheet 30 may be formed from cotton, natural material fabrics, polyester or other man made fabrics), to allow sensors to be incorporated into fabrics or other materials worn by humans or placed on structures to be monitored (¶[0040]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres so that the first electrode comprises one or more electrically conductive first threads sewn on the support layer, wherein the support layer is a textile fabric, as taught by Bernard to allow sensors to be incorporated into fabrics or other materials worn by humans or placed on structures to be monitored (¶[0040]).
Claims 38-39 and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Seres (US 20190133810 A1) in view of Carlsson (US 20220304844 A1 with provisional application 62/861,508 filed 06/14/2019).
Regarding Claim 38, Seres is silent regarding a first sensor release liner arranged to protect the primary first surface of the first adhesive sensor layer and configured to be peeled off by the user.
However, Carlsson teaches leakage detection for an ostomy appliance, thus from the same field of endeavor, including a first sensor release liner arranged to protect the primary first surface of the first adhesive sensor layer and configured to be peeled off by the user (Fig 4, 5A-6 (¶[0065] release liner 120 covers skin barrier 112 and thus protects top layer 130 of leakage detection device 114 and includes a tab to facilitate removal) in order to cover the skin barrier adhesive prior to use (¶[0065]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres to include a first sensor release liner arranged to protect the primary first surface of the first adhesive sensor layer and configured to be peeled off by the user, as taught by Carlsson in order to cover the first adhesive sensor layer prior to use (as motivated by Carlsson ¶[0065]).
Regarding Claim 39, Seres is silent regarding a second sensor release liner arranged to protect the primary second surface of the second adhesive sensor layer and configured to be peeled off by the user.
However, Carlsson teaches leakage detection for an ostomy appliance, thus from the same field of endeavor, including a second sensor release liner arranged to protect the primary second surface of the second adhesive sensor layer and configured to be peeled off by the user (Fig 4, 5A-6 (¶[0065] release liner 121 covers backing layer 118 and thus protects bottom layer 132 of leakage detection device 114 and includes a tab to facilitate removal) in order to cover the backing layer adhesive prior to use (¶[0065]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres to include a second sensor release liner arranged to protect the primary second surface of the second adhesive sensor layer and configured to be peeled off by the user, as taught by Carlsson in order to cover the second adhesive sensor layer prior to use (as motivated by Carlsson ¶[0065]).
Regarding Claim 41, Seres is silent whether the first adhesive sensor layer comprises a plurality of first sensor point openings, each of the plurality of first sensor point openings overlapping a part of one of the plurality of electrodes to form a sensor point.
However, Carlsson teaches leakage detection for an ostomy appliance, thus from the same field of endeavor, wherein the first adhesive sensor layer comprises a plurality of first sensor point openings, each of the plurality of first sensor point openings overlapping a part of one of the plurality of electrodes to form a sensor point (Fig 4 ¶[0074], skin barrier 112 comprises cut outs 113 which cover a corresponding sensor) to facilitate consistent and reliable signal generation by leak detection sensors (¶[0075]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres so that the first adhesive sensor layer comprises a plurality of first sensor point openings, each of the plurality of first sensor point openings overlapping a part of one of the plurality of electrodes to form a sensor point, as taught by Carlsson to facilitate consistent and reliable signal generation by the sensors (as motivated by Carlsson ¶[0075]).
Regarding Claim 42, Seres is silent whether the second adhesive sensor layer comprises a plurality of second sensor point openings, each of the plurality of second sensor point openings overlapping a part of one of the plurality of electrodes to form a sensor point.
However, Carlsson teaches leakage detection for an ostomy appliance, thus from the same field of endeavor, wherein the second adhesive sensor layer comprises a plurality of second sensor point openings, each of the plurality of second sensor point openings overlapping a part of one of the plurality of electrodes to form a sensor point (Fig 4 ¶[0074], skin barrier 112 comprises cut outs 113 which cover a corresponding sensor) to facilitate consistent and reliable signal generation by leak detection sensors (¶[0075]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Seres so that the second adhesive sensor layer comprises a plurality of second sensor point openings, each of the plurality of second sensor point openings overlapping a part of one of the plurality of electrodes to form a sensor point, as taught by Carlsson to facilitate consistent and reliable signal generation by the sensors (as motivated by Carlsson ¶[0075]). Since Seres discloses sensors on opposite planar sides of a sensor layer, one of ordinary skill would recognize the benefit of having sensor point openings on the second adhesive sensor layer because otherwise the sensing capability of the second adhesive sensor layer would be impeded.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Millot (US 6171289 B1) discloses ostomy appliance sensors where the electrodes are embedded in a support layer.
THIS ACTION IS MADE FINAL. 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 TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 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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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781