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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/05/2026 has been entered.
An amendment was filed on 02/09/2026. Claims 30, 46, 56-58 have been amended, claim 45 has been canceled, and new claim 59 has been added. Currently, claims 30-44 and 46-59 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 30 and 56-58 have been considered but are not persuasive.
In response to the applicant’s arguments with respect to the independent claims adding claim limitations that were similar to claim 45 which previously contained allowable subject material, the examiner notes that previous claim 45 importantly cited a secondary reference electrode with a secondary sensing part. As claimed, however, the secondary sensing part can be interpreted more broadly to include aspects that don’t require a secondary reference electrode, including but not limited to respective wiring.
Moreover, the double patenting rejection has been updated below.
Further, the rejection under 35 U.S.C. 112 is rendered moot due to the amendments and/or canceling of claims 45-46.
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.
Claims 30-44 and 47-59 are rejected under 35 U.S.C. 103 as being unpatentable over Seres (US 20190133812).
Regarding claim 30, the closest prior art of record, Seres (US 20190133812), discloses an electrode assembly for a base plate of a skin surface appliance, the electrode assembly comprising:
a support layer, the support layer having an opening with a center point (fig. 3, hole 210 at the center on the body); and
a plurality of electrodes including a first set of electrodes (fig. 3 notes a plurality of thermistors indicated and numbers A1-D10, paragraph 0248, notably looking at concentric ring 306 for the first set of electrodes), the first set of electrodes each cooperating with a first primary reference electrode (fig. 3 shows an outer ring of electrodes in ring 308, wherein paragraph 0322 notes that the out edge sensors may be used as a reference sensor, thus the ring of electrodes serves as a first primary reference electrode. Alternatively, fig. 3 also has a neck 214 with a sensor 204 to act as a reference electrode, paragraph 0241) to define:
a first primary sensing zone arranged in a first primary angle space from the center point and comprising a first primary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at top right form first set), and
a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode (fig. 3, when outer ring 308 is considered a reference sensor/electrode, comprises primary sensing part at top right corner in the primary angle space as defined)
a first secondary sensing zone arranged in the first secondary angle spaced from the center point and comprising a first secondary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at bottom right form second set), and a secondary sensing part to cooperate with the first secondary electrode (fig. 3, secondary sensing part may be interpreted as wiring in between the electrodes that lead up to the neck, see annotated fig. 3 below)
a first tertiary sensing zone arranged in a first tertiary angle space form the center point and comprising a first tertiary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 bottom left form third set)
wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone (paragraph 0240), the sensor data comprising:
first sensor data for the first primary sensing zone (paragraph 0240, “more accurately predict which direction a leak or irritation occurs”, thus describing distinct sensor data from each of the zones)
second sensor data for the first secondary sensing zone (paragraph 0240), and
third sensor data for the first tertiary sensing zone (paragraph 0240).
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Seres appears to teach wherein the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space (fig. 3, zones such as those defined by the A and B electrodes appear to span a 45 degree space).
However, if this is not clearly envisioned by the applicant, 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 disclosed in Seres such that the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 33, Seres discloses wherein the first set of electrodes is configured to detect presence of fluid in a first quaternary sensing zone, the first quaternary sensing zone arranged in a first quaternary angle space from the center point of the support layer (fig. 3 shows a quaternary sensing zone either as the thermistors at the top left of ring 306, or alternatively as thermistors C4 and D4 on the top right of ring 306, said sensors being at a distinct angle space from thermistors A4 and B4 in the first sensing zone), the electrodes generating fourth sensor data for detecting presence of fluid in a first quaternary sensing zone (paragraph 0242 describes detecting at different directions, thus granting a separate piece of data).
Regarding claim 34, Seres discloses wherein the first set of electrodes is configured to detect presence of fluid in a first quinary sensing zone (fig. 3, the first quinary sensing zone may be defined as the C and D thermistors on the bottom right of ring 306), the first quinary sensing zone arranged in a first quinary angle space from the center point of the support layer (the noted sensors would be at a distinct angle space from the A and B thermistors in the bottom right corner of ring 306), wherein the electrodes generate fifth sensor data for detecting presence of fluid in a first quinary sensing zone (paragraph 0240, paragraph 0262).
Regarding claim 35, Seres discloses wherein the first set of electrodes is configured to detect presence of fluid in a first senary sensing zone, the first senary sensing zone arranged in a first senary angle space from the center point of the support layer (fig. 3, senary zone can be defined by the C and D electrodes in the bottom left corner or ring 306), the electrodes generating sixth sensor data for detecting presence of fluid in a first senary zone (paragraph 0240, paragraph 0262).
Regarding claim 36, Seres discloses wherein the first primary reference electrode comprises a primary sensing part, wherein the primary sensing part is arranged in the first primary angle space (fig. 3, when outer ring 308 is considered a reference sensor/electrode, comprises primary sensing part at top right corner in the primary angle space as defined)
Regarding claim 37, Seres discloses the first primary reference electrode (308) comprises a secondary sensing part arranged in the first secondary angle space (fig. 3, secondary sensing part can include thermistors in the bottom right corner of ring 308).
Regarding claim 38, Seres discloses wherein the first primary reference electrode comprises a tertiary sensing part arranged in the first tertiary angle space (fig. 3, tertiary sensing part can include thermistors in bottom left corner of ring 308).
Regarding claim 39, Seres discloses wherein the first primary electrode comprises a primary sensing part arranged in the first primary angle space (fig. 3, sensing parts in the top right angle space of ring 306 can include any of the thermistors in that area) .
Regarding claim 40, Seres discloses wherein the first primary electrode comprises a quaternary sensing part arranged in the first quaternary angle space (fig. 3, quaternary sensing part can be thermistor C4 or D4 in the quaternary angle space).
Regarding claim 41, Seres discloses wherein the first secondary electrode comprises a secondary sensing part arranged in the first secondary angle space (fig. 3, first secondary electrode has a secondary sensing part at thermistor A in its respective area and angle space).
Regarding claim 42, Seres discloses wherein the first secondary electrode comprises a quinary sensing part arranged in the first quinary angle space (fig. 3, quinary sensing part can be thermistor C or D in its respective area in a quinary space distinct from the secondary angle space with thermistor A).
Regarding claim 43, Seres discloses wherein the first tertiary electrode comprises a tertiary sensing part arranged in the first tertiary angle space (fig. 3, tertiary electrode with a sensing part with thermistor A or B in the respective area acting in the tertiary angle space).
Regarding claim 44, Seres discloses wherein the first tertiary electrode comprises a senary sensing part arranged in the first senary angle space (fig. 3, tertiary electrode with a sensing part with thermistor C or D in the respective area in a senary angle space).
Regarding claim 46, Seres discloses the assembly further comprising a tertiary sensing part arranged in the first tertiary angle space to cooperate with the first tertiary electrode (fig. 3, tertiary sensing part may be interpreted as wiring leading to neck, see annotated fig. 3 above)
Regarding claim 47, Seres discloses wherein the plurality of electrodes comprises a second set of electrodes (fig. 3 shows a ring of electrodes 304), the second set of electrodes comprising a second primary electrode (fig. 3, ring 304 with a thermistor, for instance A7, can be used as a second primary electrode, or the ring 304 may be the second primary electrode), and wherein the second primary electrode is configured to detect presence of fluid at a second primary distance from the center point of the support layer (fig. 3, ring 304 to detect fluid at a different distance than the thermistors on ring 306)
Regarding claim 48, Seres discloses wherein the electrode assembly comprises a masking layer arranged on a proximal side of the support layer (fig. 4 shows encapsulation sheet 404 acting as masking layer, paragraph 0253 discloses wherein the encapsulation sheet is used with support sheet 401), the masking layer covering at least parts of electrodes of the electrode assembly for forming conductor parts of electrodes (paragraphs 0223 and 0253 describe encapsulation as a protective plastic).
Regarding claim 49, Seres is silent to wherein the first primary angle space spans a first primary angle in the range from 45 degrees to 315 degrees.
However, 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 disclosed in Seres such that the first primary angle space spans a first primary angle in the range from 45 degrees to 315 degrees, for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 50, Seres is silent to wherein the first secondary angle space spans a first secondary angle in the range from 45 degrees to 315 degrees.
However, 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 disclosed in Seres such that the first secondary angle space spans a first secondary angle in the range from 45 degrees to 315 degrees, for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 51, Seres is silent to wherein the first tertiary angle space spans a first tertiary angle in the range from 45 degrees to 180 degrees.
However, 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 disclosed in Seres such that the first tertiary angle space spans a first tertiary angle in the range from 45 degrees to 180 degrees, for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 52, Seres discloses wherein the first primary sensing zone and the first secondary sensing zone are separate sensing zones (fig. 3, first primary sensing zone in a top right angle and first secondary sensing zone at bottom right angle are separate sensing zones).
Regarding claim 53, Seres discloses wherein the first primary electrode comprises a plurality of primary sensing parts arranged in the first primary sensing zone (fig. 3, primary electrode has thermistors A and B in the first primary sensing zone).
Regarding claim 54, Seres discloses wherein the first secondary electrode comprises a plurality of secondary sensing parts arranged in the first secondary sensing zone (fig. 3, plurality of sensing parts involves the A and B thermistors in the relevant area).
Regarding claim 55, Seres discloses wherein the first tertiary electrode comprises a plurality of tertiary sensing parts arranged in the tertiary sensing zone (fig. 3, plurality of sensing parts involves the A and B thermistors in the relevant area).
Regarding claim 56, Seres discloses a base plate for a skin surface appliance (abstract), wherein the base plate comprises:
an electrode assembly (fig. 3, sensor layer 300), the electrode assembly comprising:
a support layer, the support layer having an opening with a center point (fig. 3, hole 210 at the center on the body supporting the electrodes); and
a plurality of electrodes including a first set of electrodes (fig. 3 notes a plurality of thermistors indicated and numbers A1-D10, paragraph 0248, notably looking at concentric ring 306 for the first set of electrodes), the first set of electrodes each cooperating with a first primary reference electrode (fig. 3 shows an outer ring of electrodes in ring 308, wherein paragraph 0322 notes that the out edge sensors may be used as a reference sensor, thus the ring of electrodes serves as a first primary reference electrode. Alternatively, fig. 3 also has a neck 214 with a sensor 204 to act as a reference electrode, paragraph 0241) to define:
a first primary sensing zone arranged in a first primary angle space from the center point and comprising
a first primary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at top right form first set),
a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode (fig. 3, when outer ring 308 is considered a reference sensor/electrode, comprises primary sensing part at top right corner in the primary angle space as defined)
a first secondary sensing zone arranged in the first secondary angle spaced from the center
a first secondary sensing zone arranged in the first secondary angle spaced from the center point and comprising a first secondary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at bottom right form second set), ), and a secondary sensing part to cooperate with the first secondary electrode (fig. 3, secondary sensing part may be interpreted as wiring in between the electrodes that lead up to the neck, see annotated fig. 3 below)
and
a first tertiary sensing zone arranged in a first tertiary angle space form the center point and comprising a first tertiary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 bottom left form third set)
wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone (paragraph 0240), the sensor data comprising:
first sensor data for the first primary sensing zone (paragraph 0240, “more accurately predict which direction a leak or irritation occurs”, thus describing distinct sensor data from each of the zones)
second sensor data for the first secondary sensing zone (paragraph 0240), and
third sensor data for the first tertiary sensing zone (paragraph 0240).
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Seres appears to teach wherein the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space (fig. 3, zones such as those defined by the A and B electrodes appear to span a 45 degree space).
However, if this is not clearly envisioned by the applicant, 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 disclosed in Seres such that the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 57, Seres discloses a skin surface appliance (abstract) comprising:
an electrode assembly (fig. 3, sensor layer 300), the electrode assembly comprising:
a support layer, the support layer having an opening with a center point (fig. 3, hole 210 at the center on the body); and
a plurality of electrodes including a first set of electrodes (fig. 3 notes a plurality of thermistors indicated and numbers A1-D10, paragraph 0248, notably looking at concentric ring 306 for the first set of electrodes), the first set of electrodes each cooperating with a first primary reference electrode (fig. 3 shows an outer ring of electrodes in ring 308, wherein paragraph 0322 notes that the out edge sensors may be used as a reference sensor, thus the ring of electrodes serves as a first primary reference electrode. Alternatively, fig. 3 also has a neck 214 with a sensor 204 to act as a reference electrode, paragraph 0241) to define:
a first primary sensing zone arranged in a first primary angle space from the center point and comprising
a first primary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at top right form first set),
a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode (fig. 3, when outer ring 308 is considered a reference sensor/electrode, comprises primary sensing part at top right corner in the primary angle space as defined)
a first secondary sensing zone arranged in the first secondary angle spaced from the center point and comprising a first secondary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at bottom right form second set), and a secondary sensing part to cooperate with the first secondary electrode (fig. 3, secondary sensing part may be interpreted as wiring in between the electrodes that lead up to the neck, see annotated fig. 3 below)
and
a first tertiary sensing zone arranged in a first tertiary angle space form the center point and comprising a first tertiary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 bottom left form third set)
wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone (paragraph 0240), the sensor data comprising:
first sensor data for the first primary sensing zone (paragraph 0240, “more accurately predict which direction a leak or irritation occurs”, thus describing distinct sensor data from each of the zones)
second sensor data for the first secondary sensing zone (paragraph 0240), and
third sensor data for the first tertiary sensing zone (paragraph 0240).
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Seres appears to teach wherein the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space (fig. 3, zones such as those defined by the A and B electrodes appear to span a 45 degree space).
However, if this is not clearly envisioned by the applicant, 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 disclosed in Seres such that the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 58, Seres discloses a skin surface system comprising:
a skin surface appliance (fig. 4, wafer 400 with an adhesive layer 406 to contact the skin), and
an electrode assembly (fig. 3, sensor layer 300), the electrode assembly comprising:
a support layer, the support layer having an opening with a center point (fig. 3, hole 210 at the center on the body); and
a plurality of electrodes including a first set of electrodes (fig. 3 notes a plurality of thermistors indicated and numbers A1-D10, paragraph 0248, notably looking at concentric ring 306 for the first set of electrodes), the first set of electrodes each cooperating with a first primary reference electrode (fig. 3 shows an outer ring of electrodes in ring 308, wherein paragraph 0322 notes that the out edge sensors may be used as a reference sensor, thus the ring of electrodes serves as a first primary reference electrode. Alternatively, fig. 3 also has a neck 214 with a sensor 204 to act as a reference electrode, paragraph 0241) to define:
a first primary sensing zone arranged in a first primary angle space from the center point and comprising a first primary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at top right form first set)
a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode (fig. 3, when outer ring 308 is considered a reference sensor/electrode, comprises primary sensing part at top right corner in the primary angle space as defined),
a first secondary sensing zone arranged in the first secondary angle spaced from the center point and comprising a first secondary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at bottom right form second set), and a secondary sensing part to cooperate with the first secondary electrode (fig. 3, secondary sensing part may be interpreted as wiring in between the electrodes that lead up to the neck, see annotated fig. 3 below)
and
a first tertiary sensing zone arranged in a first tertiary angle space form the center point and comprising a first tertiary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 bottom left form third set)
wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone (paragraph 0240), the sensor data comprising:
first sensor data for the first primary sensing zone (paragraph 0240, “more accurately predict which direction a leak or irritation occurs”, thus describing distinct sensor data from each of the zones)
second sensor data for the first secondary sensing zone (paragraph 0240), and
third sensor data for the first tertiary sensing zone (paragraph 0240).
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Seres appears to teach wherein the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space (fig. 3, zones such as those defined by the A and B electrodes appear to span a 45 degree space).
However, if this is not clearly envisioned by the applicant, 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 disclosed in Seres such that the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 59, Seres discloses the base plate further comprising a tertiary sensing part arranged in the first tertiary angle space to cooperate with the first tertiary electrode (fig. 3, tertiary sensing part may be interpreted as wiring leading to neck, see annotated fig. 3 above)
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Seres in view of Gibbons (US 20200000624).
Regarding claim 31, Seres discloses a neck (214) that is resiliently deformable in response to movement (paragraph 0241) with the entire layer including the neck being a flexible sensor layer (paragraph 0004 recites a flexible sensor layer, with paragraph 0239 reciting the sensor layer 200 with neck 214), thus being tiltable, but does not teach a support member comprising a base part and a coupling part tiltably attached to the base part via a joint.
However, Gibbons teaches an ostomy leakage alert system (abstract) that utilizes a support member that comprises a base part (38) and a coupling part (30) attached to the base part via a joint (fig. 2, lead 30 coupling the sensor pad 14 to the alarm assembly 40 shown in fig. 1, coupled to the male connector 38 via a joint [in this instance, the change in area between the lead 30 and the male connector 38]).
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 disclosed in Seres such that the assembly comprises a support member comprising a base part and a coupling part attached to the base part via a joint, as taught by Gibbons, for the purpose of providing a suitable structure that grants a male connector and female port electric connection between the electrodes and a processor (see Gibbons, paragraph 0007).
Moreover, because Seres teaches the neck, a similar structure to the lead in Gibbons, to be flexible and resiliently deformable, one of ordinary skill in the art would have also found it obvious to make the lead resiliently deformable and flexible to make the lead tiltably attached to the male connector for the purpose of maintaining the benefits of the neck in Seres for adapting to patient movement.
Regarding claim 32, Seres, as modified by Gibbons, is silent to wherein the coupling part is angled at least 15 degrees with respect to the base part.
However, because the patient would likely have a wide range of motion, 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 disclosed in Seres such that the coupling part is configured to be angled at least 15 degrees with respect to the base part for the purpose of allowing the device to be more capable of conforming to patient movement (see Seres, paragraph 0241).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30 and 56-58 are rejected on the ground of nonstatuatory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11717433 in view of Seres, and 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3, respectively of U.S. Patent No. US 11717433 in view of Seres
Instant claims
Patent
Claim 30: An electrode assembly for a base plate of a skin surface appliance, the electrode assembly comprising: a support layer, the support layer having an opening with a centre point; and a plurality of electrodes including a first set of electrodes, the first set of electrodes each cooperating with a first primary reference electrode to define: a first primary sensing zone arranged in a first primary angle space from the centre point and comprising a first primary electrode of the first set of electrodes and a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode; a first secondary sensing zone arranged in a first secondary angle space from the centre point and comprising a first secondary electrode of the first set of electrodes; and a secondary sensing part to cooperate with the first secondary electrode, and a first tertiary sensing zone arranged in a first tertiary angle space from the centre point and comprising a first tertiary electrode of the first set of electrodes, wherein the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45-degree angle space, and wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone, the sensor data comprising: first sensor data for the first primary sensing zone: second sensor data for the first secondary sensing zone, and third sensor data for the first tertiary sensing zone.
Claim 1: A base plate for an ostomy appliance, the base plate comprising: a first adhesive layer with a proximal side configured for attachment of the base plate to the skin surface of a user, the first adhesive layer having a stomal opening with a center point; a primary angular sensing zone between a first direction and a second direction from the center point, the primary sensing zone having a first leakage electrode of a plurality of electrodes to enable detection of liquid between the first direction and the second direction; and a secondary angular sensing zone separate from the primary angular sensing zone and between the second direction and a third direction from the center point, the secondary sensing zone having a second leakage electrode of the plurality of electrodes to enable detection of liquid between the second direction and the third direction.
Claim 56: A base plate for a skin surface appliance, wherein the base plate comprises: an electrode assembly, the electrode assembly comprising: a support layer, the support layer having an opening with a centre point; and a plurality of electrodes including a first set of electrodes, the first set of electrodes each cooperating with a first primary reference electrode to define: a first primary sensing zone arranged in a first primary angle space from the centre point and comprising a first primary electrode of the first set of electrodes; and a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode, a secondary sensing zone arranged in a first secondary angle space from the centre point and comprising a first secondary electrode of the first set of electrodes; and a secondary sensing part to cooperate with the first secondary electrode, and
a first tertiary sensing zone arranged in a first tertiary angle space from the centre point and comprising a first tertiary electrode of the first set of electrodes, wherein the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45-degree angle space, and wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone, the sensor data comprising: first sensor data for the first primary sensing zone, second sensor data for the first secondary sensing zone, and third sensor data for the first tertiary sensing zone.
Claim 57: A skin surface appliance comprising: an electrode assembly, the electrode assembly comprising: a support layer, the support layer having an opening with a centre point; and a plurality of electrodes including a first set of electrodes, the first set of electrodes each cooperating with a first primary reference electrode to define: a first primary sensing zone arranged in a first primary angle space from the centre point and comprising a first primary electrode of the first set of electrodes; and a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode, a first secondary sensing zone arranged in a first secondary angle space from the centre point and comprising a first secondary electrode of the first set of electrodes; and a secondary sensing part to cooperate with the first secondary electrode, and a first tertiary sensing zone arranged in a first tertiary angle space from the centre point and comprising a first tertiary electrode of the first set of electrodes, wherein the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45-degree angle space, and wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone, the sensor data comprising: first sensor data for the first primary sensing zone, second sensor data for the first secondary sensing zone, and third sensor data for the first tertiary sensing zone.
Claim 58: A skin surface system comprising: a skin surface appliance; and an electrode assembly, the electrode assembly comprising: a support layer, the support layer having an opening with a centre point; and a plurality of electrodes including a first set of electrodes, the first set of electrodes each cooperating with a first primary reference electrode to define: a first primary sensing zone arranged in a first primary angle space from the centre point and comprising a first primary electrode of the first set of electrodes; and a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode, a first secondary sensing zone arranged in a first secondary angle space from the centre point and comprising a first secondary electrode of the first set of electrodes; and a secondary sensing part to cooperate with the first secondary electrode, and
a first tertiary sensing zone arranged in a first tertiary angle space from the centre point and comprising a first tertiary electrode of the first set of electrodes, wherein the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45-degree angle space, and wherein the plurality of electrodes is configured to generate sensor data for detecting presence of fluid in the first primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone, the sensor data comprising: first sensor data for the first primary sensing zone, second sensor data for the first secondary sensing zone, and third sensor data for the first tertiary sensing zone.
Regarding claims 30 and 56-58, it is clear all the elements of claims 30 and 56-58 are to be found in ‘433. The difference between claims 30 and 56-58 of the instant application and claim 1 of the patent is the first set of electrodes each cooperating with the first primary reference electrode to define a first primary sensing zone arranged in a first primary angle space from the center point and comprising the first primary electrode of the first set of electrodes, a first secondary sensing zone arranged in a first secondary angle space from the centre point and comprising the first secondary electrode of the first set of electrodes, and a first tertiary sensing zone arranged in a first tertiary angle space from the centre point and comprising the first tertiary electrode of the first set of electrodes, wherein each of the sensing zones each span at least a 45-degree angle space.
However, Seres teaches the use of reference sensors (paragraph 0241 discusses how a reference sensor determines a temperature difference that is used to detect the presence of a leak or irritation, paragraph 0322, “Using the outer edge sensors that are already part of the device as a reference sensor may be a way to save costs instead of implanting a separate sensor on the neck), ), the first set of electrodes each cooperating with a first primary reference electrode (fig. 3 shows an outer ring of electrodes in ring 308, wherein paragraph 0322 notes that the out edge sensors may be used as a reference sensor, thus the ring of electrodes serves as a first primary reference electrode. Alternatively, fig. 3 also has a neck 214 with a sensor 204 to act as a reference electrode, paragraph 0241) to define:
a first primary sensing zone arranged in a first primary angle space from the center point and comprising a first primary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at top right form first set), and a primary sensing part of the first primary reference electrode to cooperate with the first primary electrode (fig. 3, when outer ring 308 is considered a reference sensor/electrode, comprises primary sensing part at top right corner in the primary angle space as defined)
a first secondary sensing zone arranged in the first secondary angle spaced from the center point and comprising a first secondary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 at bottom right form second set), and a secondary sensing part to cooperate with the first secondary electrode (fig. 3, secondary sensing part may be interpreted as wiring in between the electrodes that lead up to the neck, see annotated fig. 3 below), and
a first tertiary sensing zone arranged in a first tertiary angle space form the center point and comprising a first tertiary electrode of the first set of electrodes (fig. 3, electrodes in ring 306 bottom left form third set)
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 disclosed in the patent to include the above missing limitations, as suggested by Seres, for the purpose of providing a suitable structure that grants a baseline that allows a sensor to detect a presence of a leak based on a difference from the baseline (see Seres, paragraph 0241).
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Seres appears to teach wherein the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space (fig. 3, zones such as those defined by the A and B electrodes appear to span a 45 degree space).
However, if this is not clearly envisioned by the applicant, 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 disclosed in Seres such that the primary sensing zone, the first secondary sensing zone, and the first tertiary sensing zone each span at least a 45 degree angle space for the purpose of providing a suitable structure that grants more granularity for measurement for more accurate predictions on which direction a leak occurs (paragraph 0240).
Regarding claim 49, ‘433 discloses wherein the first primary angle space spans a first primary angle in the range from 45 degrees to 315 degrees (claim 2)
Regarding claim 50, ‘433 discloses wherein the first secondary angle space spans a first secondary angle in the range of 45 degrees to 315 degrees (claim 3)
Conclusion
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/Brandon W. Levy/Examiner, Art Unit 3781