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 .
Status of Claims
As directed by the amendment filed on 20 March 2025: claim(s) 1-20 have been cancelled, claim(s) 21-40 have been added. Thus, claims 21-40 are presently pending.
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.
Claim(s) 21-24, 26-36, and 38-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angelides (US 20170140103 A1).
Regarding Claim 21, Angelides discloses a monitor device for an ostomy system (see Abstract), the monitor device comprising:
at least one processor ("data processor 150" [0044]; FIG. 1);
an interface ("sensor or sensing device 120" [0044]) operably coupled to the at least one processor (see FIG. 1), the interface comprising a plurality of terminals for obtaining data from a base plate of the ostomy system ("sensor paper is placed at the site of bag attachment to the stoma with the sensor paper surrounding the stoma or attached to the flange 420" [0061]; FIGs. 4A-4D); and
memory storing instructions that, when executed by the at least one processor, cause the monitor device to perform a set of operations ("knowledge module 230 may further include computer program instructions for analyzing the formatted measurement data from the stoma care management software application and data received from external database 310" [0094]),
the set of operations comprising:
determining a processing scheme from a set of processing schemes ("periodically advise the patient of needed actions as well as to provide reminders, advice and coaching" [0043]) based on a control parameter of the ostomy system ("one or more parameters of an effluent received in the bag"; [0043]), the set of processing schemes comprising a first processing scheme and a second processing scheme different from the first processing scheme ("reminders, advice and coaching" [0043]); and
processing the ostomy data according to the determined processing scheme ("computer that maintains a patient related database, correlates the measurement data, information on external data sources and patient responses to queries in order to develop a health metric for the stoma patient, and periodically advises the patient of needed actions as well as to provide reminders, advice and coaching" [0044]).
Regarding Claims 22 & 34, Angelides discloses the control parameter is indicative of the operating state of the ostomy appliance and comprises an indication of a risk of leakage by the ostomy appliance ("parameter sensor that uses ink jet electrodes printed on paper can be used to measure leakage" [0061]).
Regarding Claims 23 & 35, Angelides discloses the control parameter is indicative of a data collection scheme of the monitor device ("fill levels can be measured at predetermined time intervals" [0114]).
Regarding Claims 24 & 36, Angelides discloses the control parameter is indicative of a data transmission scheme of the monitor device ("data may be transmitted with a predefined delay" [0105]).
Regarding Claims 26 & 38, Angelides discloses the control parameter is indicative of a preference of a user of the base plate ("patient preferences"; [0085]).
Regarding Claims 27 & 39, Angelides discloses the control parameter is indicative of a location of a user of the base plate ("direction/orientation of the patient's bodys"; [0062]).
Regarding Claims 28 & 40, Angelides discloses the control parameter is indicative of an activity level of a user of the base plate ("activity level" [0062], [0080] & [0118]).
Regarding Claim 29, Angelides discloses the control parameter is indicative of connectivity between the monitor device and an accessory device ("When the measurement communicator 530 is powered, it goes into an advertising mode and looks for a suitable mobile device to pair with"; [0104]).
Regarding Claim 30, Angelides discloses the first processing scheme comprises a first set of threshold values ("measurements" [0116]); the second processing scheme comprises a second set of threshold values ("patient's records stored in a database" [0116]) different from the first set of threshold values ("measurements are equal to or greater than a predetermined critical value" [0116]).
Regarding Claim 31, Angelides discloses the first processing scheme comprises a set of criteria comprising one or more criteria to be applied in the first processing scheme ("adjustments to their diet, exercise, posture, etc. 1190" [0116]).
Regarding Claim 32, Angelides discloses the first processing scheme comprises a data configuration indicative of data to be used in the first processing scheme ("read in hexadecimal format and compared against the values provided in the dictionary to determine that the collection bag 710 is empty or full" [0112]).
Regarding Claim 33, Angelides discloses a method of monitoring an ostomy appliance ("methods for providing comprehensive care for stoma patients" Abstract), the method comprising:
obtaining, via an interface ("sensor or sensing device 120" [0044]) that operably couples to a base plate of the ostomy appliance ("parameter sensor(s) 510 are typically attached to or embedded within the collection bag 110 or the flange 420" [0050]), data from the base plate ("measurement data point" [0013-0014]);
determining a processing scheme from a set of processing schemes ("periodically advise the patient of needed actions as well as to provide reminders, advice and coaching" [0043]) based on a control parameter of the ostomy appliance ("one or more parameters of an effluent received in the bag"; [0043]), the set of processing schemes comprising a first processing scheme and a second processing scheme different from the first processing scheme ("reminders, advice and coaching" [0043]); and
processing the ostomy data according to the determined processing scheme ("computer that maintains a patient related database, correlates the measurement data, information on external data sources and patient responses to queries in order to develop a health metric for the stoma patient, and periodically advises the patient of needed actions as well as to provide reminders, advice and coaching" [0044]).
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.
Claim(s) 25 & 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Angelides in view of Krystek et al. (US 20130324952 A1).
Regarding Claims 25 & 37, Angelides fails to specify the control parameter is indicative of a wear time of the base plate. However, Krystek teaches “Use of and performance of ostomy appliances are enhanced by providing one or more sensors to an ostomy pouch” ([0005]) wherein the control parameter is indicative of a wear time of the base plate ([0037]-[0038]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Angelides to incorporate the teachings of Krystek to provide “proper attention and maintenance to the appliance” ([0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. 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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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
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