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 .
Information Disclosure Statements
The seven information disclosure statement(s) (IDSs) submitted on 1/8/25 and 12/3/25 was/were filed before the mailing date of a first Office Action on the merits. The submission(s) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have being considered and entered by the examiner.
Status of the Claims
Claims 1-15 are pending in the application.
Reasons for Allowable Subject Matter
Claims 1-15 are considered allowable over the prior art of record, subject to the 101 and Obviousness Type Double Patenting rejections presented below. The following is an examiner’s statement of reasons for allowable subject matter: The prior art fails to teach or fairly suggest the present claims of Applicant. The closest prior art of record is Millot (US 6171289 B1).
As to independent claim 1, Millot teaches a method of monitoring performance of an ostomy device (Abstract; Fig.2-3;Col.2,ll.21 to Col.3,ll.61), the method comprising: providing an ostomy appliance 1 (ostomy device 1; Fig.2-3; comprising at least sensor 17/18; and base plate 5; Abstract; Fig.2-3;Col.3,ll.19-38;43-45;57-61), comprising: a sensor 17/18 (sensor as combination of: electrode 18 adjacent first electrode 17 provided in tracks 15,16 carved out of the top of ring adhesive 11 Fig.2-3 to form a sensor to detect a change in voltage Col.3,ll.53-59 representing detection of liquid in an adhesive 11; Fig.2-3; Abstract; Fig.2-3;Col.3,ll.19-38;43-45;53-61); and a base plate 5 (ostomy seal 5 Fig.2-3 Col.3, lines 21-38); wherein the base plate 5 is attachable to skin of a user by an adhesive 11 disposed on a proximal side of the base plate 5 and the sensor 17/18 is distal of the adhesive 11 (Fig.2-3; Col.2,ll.21-24;Col.3,ll.31-38); providing a monitor device 20/23/24/25/26 (electronic part of detector comprising power source 20, current generator 23, signaling means 24, circuits 25,26 (Fig.4;Col.4,ll.49-59) electrically attachable to the sensor 17/18 of the ostomy appliance (Fig.2-3;Col.3,ll.56-60) (where sensor as combination of: electrode 18 adjacent first electrode 17 provided in tracks 15,16 carved out of the top of ring adhesive 11 Fig.2-3 to form a sensor to detect a change in voltage Col.3,ll.53-59 representing detection of liquid on the distal side of an adhesive 11; Fig.2-3; Abstract; Fig.2-3;Col.3,ll.19-38;43-45;53-61));
However, as to claim 1, Millot fails to teach or suggest the combination of: monitoring, with the sensor, moisture information sensed between the skin of the user and the adhesive on the proximal side of the ostomy appliance;
collecting the moisture information with the monitor device; and
transferring, with the monitor device, the moisture information to an accessory device.
Applicants define the moisture information as detecting fluid, such as stoma output, between the adhesive layer and the skin of the user to determine the risk of leakage (e.g., p.21,ll.13-15). Accordingly, Millot teaches detecting with the sensor/electrodes 17/18 on the distal or top surface of the adhesive layer 11 opposite the skin facing side of the adhesive layer 11 (Fig.3), and thus teaches away from detecting fluid between the adhesive layer and the skin.
It would not have been obvious to one of ordinary skill in the art at the time of the invention to modify the ostomy monitoring method of Millot to provide the above combination of elements and features. One of skill would not have been motivated to modify the teachings of Millot to provide the above combination elements and features, where Millot fails to teach or fairly suggest providing the combination of these elements, and does not provide any motivation to do so, as teaching away from detecting moisture on the skin facing surface of the adhesive.
Accordingly, Millot fails to teach or fairly suggest the above combination and fails to provide any motivation to do so.
Dependent claims 2-15 are allowable as dependent upon allowable base claim 1.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-15 of US Patent No. 12,161,581 B2 (‘581) (issued from parent application 18/541136). The claims are provisionally rejected based on the following 35 USC 101 Double Patenting rejection presented below, wherein amendments to the claims to overcome the 101 double patenting rejection may likely result in the claims being obvious over the claims of US 12,161,581.
As to claims 1-15, claims 1-15 of ‘581 teach or suggest the claimed delivery and fluid storage bridge, as follows:
Claim
1
2
3
4
5
6
7
8
9
10
11
‘581
1
2
3
4
5
6
7
8
9
10
11
Claim
12
13
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15
‘581
12
13
14
15
The present claims and the claims of ‘581 claims currently, identically, recite each element of current claims, as presented above.
The ‘581 claims teach each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘581 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 ‘581 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.
Double Patenting Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-15 of US Patent 12,161,581 (issued from parent application No. 18/541136).
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-15 are rejected under 35 USC 101 as claiming the same invention as claims 1-15 of US patent 12,161,581. This is a statutory Double Patenting Rejection.
See MPEP §§ 804; 804(I)(A); 804 (II)(A).
No Obviousness Type Double Patenting
It is noted that the claims of issued patents US 11,974,938 B2 and US 11,865,029 B2 (issued from parent applications 17/975626 and 16/954527, respectively) fail to teach or fairly suggest the present claims of applicants, e.g., where the claims fail to teach or fairly suggest the combination of elements as presented above for the prior art. Thus, the claims of these patents do not render obvious the present claims under Obviousness-Type Double Patenting.
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
Prosecution Insights