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 3/27/25 and 4/9/25 was/were filed after before 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.
Reasons for Allowable Subject Matter
Claims 2-21 are considered allowable over the prior art of record, subject to the Obviousness 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 Suzuki (US 2012/0253303 A1); and Newton (US 2017/0348139 A1).
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As to independent claims 1, 20, and 21, Suzuki discloses [claims 2 and 20] a fluid collection device/system 102 , and [claim 21] method of using (fluid/urine collection device/system as urine absorption member 102 being positioned and secured adjacent female or male urethral opening of a wearer and receiving fluid therefrom Fig.1-2 [0048] as separately usable with underpants such as for incontinence [0048],ll.20-21,17-21), the fluid collection device comprising:
[claim 20] a fluid storage container 112 configured to hold fluid (Fig.3;[0050],ll.7-8); |
a fluid collection device in fluid communication with the fluid storage container 112 (Fig.3-4); the fluid collection device including: a fluid collection member 136/102a/132, including: a fluid impermeable barrier 136a-d including a proximal end region a distal end region (leakage barrier 136 Fig.3-4 [0062]), at least defining: a chamber 102a (as at least container section 102a formed within barrier 136 Fig.3; [0049],ll.4-5); at least one opening (as longitudinal, top, opening defined by inner edges of members 136b Fig.3) extending therethrough ([0062],ll.9-17) and configured to be [claims positioned adjacent and secured near a female urethra or a male urethra positioned therethrough to receive fluid in the chamber 102a with porous material 132 therein (in contact with and covering skin area of female or male urethra [0048],ll.7-21, as further claimed below); and an outlet 114 at the proximal end region [claim 21] for removing fluid from the chamber 102a (outlet as drainage port 114 of fluid impermeable barrier at end of chamber 102a; Fig.4; [0050],ll.5-8); at least one porous material 132 (filter 132 as porous absorbent material Fig.3-4 [0053],ll.12-13;), at least partially disposed within the chamber 102a (within 102 Fig.3); and (claim 20) a vacuum source in fluid communication with the one or more of the fluid storage container or the fluid collection device, the vacuum source configured to draw fluid from the fluid collection device([0048],ll.5-7;[0049],ll.10-13).
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Newton teaches a fluid collection device/system [claims 1, 20] (urine collection device [0034],ll.1-2; insertable into underwear, etc.), and [claim 21] method of using being positioned and secured adjacent female or male urethral opening of a wearer and receiving fluid therefrom (Abstract); the device; comprising: a fluid collection device 10 (container 10 Fig.1-2 [0014]) comprising: a fluid impermeable barrier 12 (shell 12; Fig.1-2; [0014],ll.2-5) comprising: a chamber 18 therein Fig.1-2,[0014],ll.2-3,12-13; an opening 20 (window 20 Fig.2 [0014],ll.4-5); and a porous material 24 (wicking material 24) disposed within the chamber 18 (24 within chamber 18 Fig.1-2,5 [0015]; [10018],ll.10-14).
However, as to independent claim(s) 1, 20, and 21, Suzuki and/or Newton fail(s) to teach or fairly suggest the combination of: at least one flange, the at least one flange including a flange body and an adhesive member disposed on the flange body, the flange body attached to and extending outwardly from the fluid collection member, the at least one flange spaced from the proximal end region and the distal region.
It would not have been obvious to one of ordinary skill in the art at the time of the invention to modify the device/system of Suzuki and/or Newton to provide combination of flange and arrangement, and one of skill would not have been motivated to do so, where Suzuki and/or Newton fail to teach or fairly suggest providing the combination of these elements and features, and do 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 2-21 are rejected on the ground of nonstatutory double patenting over at least claims 1-3, 5, 6, 9, 11, 15, 17, and 18 of US Patent No. 11,938,053 B2 (‘053) (Issued from grandparent application 17/051554)).
As to claims 2-21, claims 1-3, 5, 6, 9, 11, 15, 17, and 18 of ‘053 teach or suggest the claimed delivery and fluid storage bridge, as follows (with claim dependency shown, e.g., 3 (/2/1) claim 3 depending from claim 2 depending from claim 1):
Claim
2
3
4
5
6
7
8
9
10
11
12
13
‘053
1
6 (/5 /1)
1
1
1, 18
2 (/1)
1
1
3 (/1)
2 (/1)
1
3 (/1)
Claim
14
15
16
17
18
19
20
21
‘053
9
11 (/9)
1
1
1
17 (/15)
9
15
The differences between present claims and the claims of ‘053 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 ‘053 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘053 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 ‘053 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 2-21 are rejected on the ground of nonstatutory double patenting over at least claims 1, 2, 5, 6, 10, 12, 15, 16, 18, 19, 20, 22, 23 of US Patent No. 12,285,352 B2 (‘352) (Issued from parent application 18/415080).
As to Claims 2-21, at least claims 1, 2, 5, 6, 10, 12, 15, 16, 18, 19, 20, 22, 23 of ‘352 teach or suggest the claimed delivery and fluid storage bridge, as follows (with claim dependency shown, e.g., 3 (/2/1) claim 3 depending from claim 2 depending from claim 1):
Claim
2
3
4
5
6
7
8
9
10
11
12
‘352
1
6 (/5 /1)
19 (/16)
19 (/16)
19 (/16)
22 (/1)
19 (/16)
19 (/16)
18 (/16)
2 (/1)
23 (/22 /1)
Claim
13
14
15
16
17
18
19
20
21
‘352
12 (/10)
15 (/10)
1
10
1
10
10
10
16, 20 (/16), 10
The differences between present claims and the claims of ‘352 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 ‘352 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘352 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 ‘352 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.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 EST. 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 571-272-5879. 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
