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 the Claims
Claims 21-40 are pending in the application.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claims 21-40 are considered allowable over the prior art of record, subject to the Double Patenting rejections presented below.
The closest prior art of record is: Thirstrup (US 2017/0340474 A1); and Millot (US 6171289 B1).
As to independent claims 21, 28, and 35, Thirstrup teaches an ostomy monitor device; ostomy system; and/or method of monitoring an ostomy appliance (Fig. 7A-8B; [0144]-[0152]; as at least reader unit 85,109; [0144],ll.4) for an ostomy appliance (ostomy system/appliance 83; [0144], ll.3-4 with a base plate 84; Fig.7A, [0144],ll.4-9), comprising:
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an ostomy base plate (ostomy base plate 84 Fig.7A, [0144],ll.4-9);
at least one processor and/or memory with: memory storing instructions that, when executed by the processor as processing, cause the device to determine a leak in the adhesive (micro-controller necessarily including memory to function [0144], ll.16-19, wherein a processing scheme [0144];[0077] processes leakage data of the adhesive of the base plate [0144];[0146];[0149]; also including signals corresponding to the adhesive being soaked with liquid [0056]); the leaking determination comprising:; obtaining, (claim 21) from the electrode pair (via interface of wire terminals 73, 74; and electrode pair 80,82 Fig.7A, [0144],ll.4-9) connected to the processor and memory ([0144], ll.4-9, 16-19); (claims 21, 28, 35) leaking electrical signal between the electrode pair 80,82 (where processor configured for collecting the electrical signal change from the lead in the adhesive from the electrode pairs , the data comprising first data from a first electrode pair 80,82 (ring electrode pair 80,82 provided in electrically conductive pattern of pattern Fig.7A, [0144],ll.4-9)of the base plate 84 (Fig.7A); processing the leaking signals to determine a leaking state of the ostomy base plate indicating a progression of liquid within the adhesive (micro-controller necessarily including memory to function [0144], ll.16-19, wherein a processing scheme [0144];[0077] processes leakage data of the adhesive of the base plate [0144];[0146];[0149]; also including data corresponding to the adhesive being soaked with liquid [0056]); transmitting a leak signal indicative of liquid flowing within the adhesive between the electrodes of the plurality of electrode (as wireless transceiver unit to transmit a signal, e.g., but not limited to the processor and/or an event-handling device 103; [0144]; [0146]; [0149]; wherein processor collects data comprising the leaking signal from the electrode pair 80,82 within adhesive of the base plate 84 Fig.7A, [0144],ll.4-9 of the base plate 84 Fig.7A).
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As to independent claims 21, 28, and 35, Millot teaches an ostomy base plate monitor device; an ostomy system; and/or method of monitoring an ostomy appliance [ostomy seal 5 Fig.2-3;Col.3,ll.21-38 for an ostomy appliance, Fig.1 Col.3,ll.19-22],
the method or device 5 comprising:
a processor and/or memory with memory storing instructions that, when executed by the processor, cause the device to process signals/data from an electrode pair 17,18 provided in a top channels of the adhesive layer of ostomy base plate Col.6,ll.16-21); [providing] a plurality of electrode sets 17,18 [at least one set of one or more sets of electrodes 17,18 Fig.2-3 Col.3,ll.41]; in order to provide an electronic circuit capable of measuring the degree of hydration of a hydrocolloid adhesive baseplate and activate an alarm when the degree of hydration is above a predetermined threshold that indicates lack of satisfactory securing and sealing of the ostomy device to the patient (Col.2, lines 38-46).
However, as to claim 21, Thirstrup and/or Millot fails to teach or suggest the combination of: wherein the processor determines parameter data indicating an operating state from a plurality of operating states, and transmitting a signal indicative the determined operating state of the base plate.
However, as to claim 28, Thirstrup and/or Millot fails to teach or suggest the combination of wherein the monitor device is configured to: obtain data from a plurality of electrodes of the ostomy base plate; process the obtained to determine an operating state of the ostomy base plate from a set of operating states; and; transmit a signal to the determined operating state for the ostomy base plate to an accessory device of a user of the ostomy system.
However, as to claim 35, Thirstrup and/or Millot fails to teach or suggest a method of monitoring an ostomy appliance, the method comprising the combination of: processing the parameter data to determine an operating state from a plurality of operating states; transmitting a signal corresponding to the determined first operating state for the ostomy base plate.
It would not have been obvious to one of ordinary skill in the art at the time of the invention to modify Thirstrup and/or Millot to provide the above combination of elements and features. One of skill would not have been motivated to modify the teachings of Thirstrup and/or Millot to provide the above combination elements and features, where Thirstrup and/or Millot fails to teach or fairly suggest providing these elements and features, and do not provide any motivation to do so. Thirstrup’s and/or Millot’s device and method is only configured to transmit an "alarm corresponding to a leak" or to a "propagating leak" (both of which is not indicative of a set or operations or a dynamic internal state of the base plate) and an "alarm corresponding to a soaked adhesive". Only when it is detected that the adhesive of the base plate is soaked, is the alarm or leak notice transmitted the first monitor signal. Starting from Thirstrup and/or Millot, which is consistently directed to detecting a leak in the adhesive and/or the detachment of a base plate from the skin, the skilled person would therefore have no motivation to modify this known monitor device in order to take into account a plurality of operating states indicative of a dynamic internal state of the base plate.
Accordingly, Thirstrup and/or Millot fails to teach or fairly suggest the above combinations and fails to provide any motivation to do so.
Dependent claims 22-27, 29-34, and 36-40 are allowable as dependent upon an allowable base claim.
Thus, claims 21-40 are considered allowable over the prior art of record.
Double Patenting
Non Statutory Obviousness Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-40 are rejected on the ground of nonstatutory double patenting over claims 1-4, 6, 10-11, 14, 18 and 19 of US Patent No. 12,208,030 B2 (‘030) (issued from parent application 18/252890).
As to Claims 21-40, claims 1-4, 6, 10-11, 14, 18 and 19 of ‘030 teach or suggest the claimed sensor device, as follows:
Claim
21
22
23
24
25
26
27
28
29
30
31
‘030
1
3 (/1)
6 (/4, /2, /1)
19 (/18)
11 (/1)
14
2 (/1)
14
3 (/1)
6 (/4, /2, /1)
14
Claim
32
33
34
35
36
37
38
39
40
‘030
11 (/1)
14
2 (/1)
18
3 (/1)
6 (/4, /2, /1)
10 (/1)
11 (/1)
18
The differences between present claims and the claims of ‘030 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘030 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘030 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘030 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Claims 21-40 are rejected on the ground of nonstatutory double patenting over claims 1, 2, 4, 7, 10-11, 15, and 18 of US Patent No. 11,872,154 B2 (‘154) (issued from parent application 18/082600).
As to Claims 21-40, claims 1, 2, 4, 7, 10-11, 15, and 18 of ‘154 teach or suggest the claimed sensor device, as follows:
Claim
21
22
23
24
25
26
27
28
29
30
31
‘154
1,
18
2 (/1)
7 (/4, /2, /1)
10 (/1)
11 (/1)
2 (/1)
1
15
2 (/1)
7 (/4, /2, /1)
10 (/1)
Claim
32
33
34
35
36
37
38
39
40
‘154
11 (/1)
2 (/1)
2 (/1)
18
2 (/1)
7 (/4, /2, /1)
10 (/1)
11 (/1)
2 (/1)
The differences between present claims and the claims of ‘154 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘154 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘154 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘154 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Claims 21-25 and 27 are rejected on the ground of nonstatutory double patenting over claims 1-4, 8-9, 12-14, and 19-20 of US Patent No. 11,559,423 B2 (‘423) (issued from parent application 16/954521).
As to Claims 21-40, claims 1-4, 8-9, 12-14, and 19-20 of ‘423 teach or suggest the claimed sensor device, as follows:
Claim
21
22
23
24
25
26
27
28
29
30
31
‘423
1,20
14 (/4; /2, /1); 20
13 (/12, /2, /1)
8 (/1)
9 (/1)
1, 3 (/1)
1
19 (/1)
14 (/4; /2, /1); 20
13 (/12, /2, /1)
8 (/1)
Claim
32
33
34
35
36
37
38
39
40
‘423
9 (/1)
1, 3 (/1)
1
20
14 (/4; /2, /1); 20
13 (/12, /2, /1)
8 (/1)
9 (/1)
1, 3 (/1)
The differences between present claims and the claims of ‘423 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘423 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘423 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘423 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
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 Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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