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 .
DETAILED ACTION
Claims 29-48 are presented for examination.
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.
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Claims 29-41 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 13, 17, 24-25, and 28 of U.S. Patent No. 12029582. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim the same invention of monitoring a base plate of an ostomy appliance via an accessory device and the current application claims the invention broadly. Comparison between the independent claim 1 of the US Patent 12029582 independent claim 29 of the current application with the independent claim 29 of the current application is provided below for an example.
US Patent 12029582
Current Application 18/673358
Claim 1. A method, performed in an accessory device, for a base plate of an ostomy appliance, wherein the accessory device comprises an interface configured to communicate with one or more devices of an ostomy system, the interface comprising a display, wherein the ostomy system comprises a monitor device, and/or the ostomy appliance configured to be placed on a skin surface of a user, wherein the ostomy appliance comprises the base plate, the method comprising:
obtaining monitor data from the monitor device;
determining a current operating state of the base plate based on the monitor data, the current operating state indicative of current adhesive performance of the base plate;
determining a future operating state of the base plate based on the monitor data and/or the current operating state, the future operating state indicative of future adhesive performance of the base plate; and
displaying, on the display, a first user interface screen comprising a first primary user interface object representing the current operating state and/or a first secondary user interface object representing the future operating state.
Claim 29. A method, performed in an accessory device, for a base plate of an ostomy appliance, the method comprising:
obtaining, from a monitor device coupled to the base plate, monitor data;
generating a future operating state of the base plate based on the monitor data; and
displaying, on a display of the accessory device, a user interface screen comprising an indication of the determined future operating state of the base plate.
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 29-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angelides (US Pub. 2017/01401031).
As per claim 1, Angelides discloses a method, performed in an accessory device [Fig. 7A; para 0103; a mobile device 710], for a base plate of an ostomy appliance [Abstract; Fig. 7A; para 0103; an ostomy bag 110; Fig. 4B, 4C; para 0046; the flange ring 420 called a flange, wafer or baseplate as well as the bag], the method comprising:
obtaining, from a monitor device coupled to the base plate, monitor data [para 0050; parameter sensor(s) are typically attached to or embedded withing the flange 420 (i.e., the baseplate); “The parameter sensors 510 may be mounted in any desired position for monitoring as long as the parameter sensors are in communication with the measurement communicator 530.”; para 0067];
generating a future operating state of the base plate based on the monitor data [para 0067, 0071-0073, 0089, 0108-0109; a knowledge module 230 analyzes the data received and a user sub-portal is configured to provide real-time information; the constant monitoring and predicting the fill rates; making a prediction of when the current bag will be filled up]; and
displaying, on a display of the accessory device, a user interface screen comprising an indication of the determined future operating state of the base plate [Fig. 9; para 0071, 0101, 0110; a visual representation of the fill levels; “An exemplary display is shown in fig. 9.”; “As shown in Fig. 7C, the measurement of fluid levels can be visually represented on the mobile device 710.”; para 0099; user portal 320D].
As per claim 43, Angelides discloses an accessory device [Fig. 7A; para 0103; a mobile device 710], comprising:
at least one processor [Fig. 7A; para 0103; a mobile device 710 and inherent to the mobile device 710 to have at least one processor]; and
a memory storing instructions that, when executed by the at least one processor, causes the accessory device to perform a set of operations [Fig. 7A; para 0103; a mobile device 710 and inherent to the mobile device 710 to have a memory], the set of operations comprising:
obtaining, from a monitor device coupled to a base plate of an ostomy system, monitor data for the base plate [para 0050; parameter sensor(s) are typically attached to or embedded withing the flange 420 (i.e., the baseplate); “The parameter sensors 510 may be mounted in any desired position for monitoring as long as the parameter sensors are in communication with the measurement communicator 530.”; para 0067];
determining a future operating state of the base plate based on the monitor data [para 0067, 0071-0073, 0089, 0108-0109; a knowledge module 230 analyzes the data received and a user sub-portal is configured to provide real-time information; the constant monitoring and predicting the fill rates; making a prediction of when the current bag will be filled up]; and
displaying a user interface screen comprising a graphical representation of the determined future operating state [Fig. 9; para 0071, 0101, 0110; a visual representation of the fill levels; “An exemplary display is shown in fig. 9.”; “As shown in Fig. 7C, the measurement of fluid levels can be visually represented on the mobile device 710.”; para 0099; user portal 320D].
As per claims 30 and 44, Angelides discloses further comprising: detecting user actuation of the indication [para 0099; user portal 320D]; and in response to detecting the user actuation, opening an ostomy user application on the accessory device [para 0071; an interactive platform for stoma care management 200; the stoma care management software; mobile application].
As per claim 31, Angelides discloses wherein the user interface screen is a first user interface screen and the method further comprises: in response to opening the ostomy user application, displaying a second user interface screen comprising a graphical representation of the future operating state [Abstract; para 0016, 0071, 0084, 0099; an interactive wireless stoma care management platform; one or more interfaces; user portal is an interactive portal].
As per claims 32 and 45, Angelides discloses wherein obtaining the monitor data comprises obtaining a first instance of monitor data and a second instance of monitor data corresponding to a time period later than the first instance of monitor data [para 0065, 0114; measurements are taken at predetermined set time intervals].
As per claims 33 and 46, Angelides discloses wherein the future operating state of the base plate is determined based on the first instance of monitor data and the second instance of monitor data [para 0067, 0071-0073, 0089, 0108-0109; inherent to the system as obtaining/receiving monitoring data periodically].
As per claim 34, Angelides discloses wherein the future operating state of the base plate is determined based on at least one of a current operating state or a previous operating state of the base plate [para 0067, 0071-0073, 0089, 0108-0109; obviously it is inherent to the process of analyzing the data received].
As per claim 35, Angelides discloses wherein the method further comprises determining the current operating state based on the monitor data [para 0067, 0071-0073, 0089, 0108-0109; real-time information].
As per claim 36, Angelides discloses further comprising: displaying, in the second user interface screen, an indication of at least one of a previous operating state or a current operating state, in addition to the graphical representation of the future operating state [Abstract; para 0016, 0071, 0084, 0099; an interactive wireless stoma care management platform; one or more interfaces; user portal is an interactive portal].
As per claim 37, Angelides discloses wherein the second user interface screen further comprises an elapsed time prior to a current time [para 0008, 0065, 0107; length of time; set time intervals; time interval between two measurements].
As per claim 38, Angelides discloses wherein the monitor data is a first instance of monitor data and the method further comprises: detecting, based on a second instance of monitor data, removal of the monitor device from the base plate, and generating an indication of a lack of connection between the monitor device and the base plate [para 0067, 0071-0073, 0089, 0108-0109; inherent to any such critical appliance to detect an error or malfunction or connection problem; para 0080; problem areas with the bag; para 0083, 0089; providing alerts].
As per claim 39, Angelides discloses further comprising: detecting, based on a third instance of monitor data, attachment of the monitor device to the base plate, and generating an indication of an established connection between the monitor device and the base plate [para 0056, 0067, 0071-0073, 0089, 0108-0109; inherent to any such critical appliance to detect a new connection and alert the user].
As per claims 40 and 48, Angelides discloses wherein the user interface screen comprises at least one of a lock screen of the accessory device or a home screen of the accessory device [para 0074; authorized credential screen usually is a lock screen and a lock screen in case of a mobile device is well known and inherent].
As per claim 41, Angelides discloses wherein displaying the user interface screen comprises displaying a notification [para 0104-0105; notifications].
As per claim 42, Angelides discloses wherein: the method further comprises determining whether a current operating state of the base plate satisfies a change criterion [para 0016, 0116; a predefined threshold level; a predefined warning threshold]; and the user interface screen comprising the indication of the determined future operating state is displayed in response to determining the current operating state satisfies the change criterion [para 0071, 0084, 0101, 0111; a visual representation displaying on a display screen; “An exemplary display is shown in FIG 9.”].
As per claim 47, Angelides discloses wherein the monitor data is a first instance of monitor data and the set of operations further comprises: detecting, based on a second instance of monitor data, removal of the monitor device from the base plate, and generating an indication of a lack of connection between the monitor device and the base plate [para 0067, 0071-0073, 0089, 0108-0109; inherent to any such critical appliance to detect an error or malfunction or connection problem; para 0080; problem areas with the bag; para 0083, 0089; providing alerts].
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
N. WO-2018028756 discloses an ostomy appliance comprising a leakage warning signal generator provided on a distal surface of the base plate, i.e. on the side of the base plate facing away from the user's skin surface, thereby facing away from the surface of the base plate where leakage normally occurs.
O. WO-2017041807 discloses an ostomy appliance comprising a collection bag and an adaptable ostomy base plate where the collection bag is detachable from the base plate.
P. WO-2014117778 discloses that base plates are used in ostomy appliances to attach ostomy bags to the skin of a user having a stoma, the user also being referred to as an ostomist.
Q. WO-2012079592 discloses an ostomy appliance comprising a base plate with an adhesive wafer and a convex supporting device.
R. WO-2004070548 discloses a system and method for verifying operational parameters of medical devices.
S. EP-3203945 discloses an ostomy device can be a one-piece appliance comprising a) a base plate (also referred to as a body-side member or face plate) attachable around the stomal opening; and comprising b) attached to the base plate a collection bag.
T. DE-102008056761 discloses single or multipart ostomy appliance holding fluid or pasty bowel from stoma, comprises base plate, collection bag, gas filter, and integrated filter protection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURESH K SURYAWANSHI whose telephone number is (571)272-3668. The examiner can normally be reached M-F 8:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kenneth M Lo can be reached at 5712729774. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SURESH SURYAWANSHI/Primary Examiner, Art Unit 2116
1 Prior art cited by applicant in submitted information discloser statement.
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