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 Statement
The information disclosure statement(s) (IDSs) submitted on 12/11/24; 12/11/24, 5/1/25, 6/20/25, and 1/6/26 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Status of the Claims
Claims 1-21 are pending in the application.
Reasons for Allowable Subject Matter
Claims 1-21 are considered allowable over the prior art of record, subject to the Non-Statutory Double Patenting rejection 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 Seres (US 2019/0133812 A1).
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As to independent claim 1, Seres discloses an ostomy device 400 Fig.4 ([0251]-[0254];[0003]) comprising:
a proximal side 408 [of adhesive layer] configured for attachment to a user (peristomal skin contacting side of adhesive layer 406 Fig.4; [0252],ll.2);
a distal side opposite to the proximal side 408 (Fig.4,14A multiple layers of the device; [0251],ll.1-3;[0003]-[0005] (proximal side 408 Fig.4)
a leakage detection sensor 200 (sensor layer 200; Fig.4; [0251],ll.1-2) comprising electrically conductive circuitry 202 (sensors 202; Fig.4; [0253],ll.6) supported on a support layer 404 (encapsulation sheets 404 [0253]), wherein the leakage detection sensor 200 is configured to detect ostomy effluent by detecting a change in resistance in the electrically conductive circuitry ([0057]; [0212]); wherein the ostomy device is an ostomy accessory configured to be attached to an ostomy appliance Fig.4 ([0251]-[0254];[0003]).
However, Seres fails to teach or fairly suggest the combination of wherein: the ostomy device as ostomy accessory includes an adhesive barrier; wherein the distal side [of the ostomy device] is attached to a proximal side of the adhesive barrier.
It would have not have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the ostomy device of Seres to further include the ostomy device as ostomy accessory includes an adhesive barrier; wherein the distal side [of the ostomy device] is attached to a proximal side of the adhesive barrier, and one of skill would not have been motivated to do so, where Seres fails to teach or fairly suggest these elements, and does not provide any motivation to do so.
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 1-21 are rejected on the ground of nonstatutory double patenting over claims 1-20 of US Patent No. 12,161,578 B2 (‘578) (Issued from parent application 17/616950).
As to Claims 1-21, claims 1-20 of ‘578 teach or suggest the claimed delivery and fluid storage bridge, as follows (with claim dependencies shown in paratheses, e.g., 3(/2/1) as claim 3 incorporating claims 1 and 2):
Claim
1
2
3
4
5
6
7
8
9
10
11
12
‘578
1, 2 (/1)
1
2
(/1)
2
(/1)
3
(/2 /1)
4
(/2 /1)
5
(/4 /2 /1)
6
(/5 /4 /2 /1)
7
(/3 /2 /1)
8
(/3 /2 /1)
1
9
(/1)
Claim
13
14
15
16
17
18
19
20
21
‘578
10
(/9 /1)
11
(/10 /9 /1)
14
(/1)
and 11 (/10 /9 /1)
5
(/4 /2 /1) and 6
(/5 /4 /2 /1)
2
(/1)
1
1
1
1
The differences between present claims and the claims of ‘578 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 ‘578 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘578 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 ‘578 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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