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 statements (IDSs) submitted on 9/9/24 and 2/3/25 was filed before the mailing of a Non-Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 2-21 are pending in the application.
Allowable Subject Matter
Claims 7-9, 16, and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims..
Claims 2-6, 10-15, 17, and 20-21 are considered allowable over the prior art of record, subject to the Non-Statutory Double Patent 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 Newton (US 2017/0348139 A1).
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As to independent claim 2, Newton teaches a fluid collection assembly for capturing one or more bodily fluids (urine collection device 10 insertable into underwear, etc., [0014]; [0034],ll.1-2), comprising: a fluid impermeable barrier 12 (impermeable shell 12; Fig.1-2; [0014],ll.2-5) defining at least one opening 20 (window 20 Fig.2 [0014],ll.4-5), a chamber 18 in fluid communication with the at least one opening 20 (Fig.1-2; [0014],ll.4), and at least one fluid outlet 14 (port 14;Fig.1; [0014],ll.3,12), the fluid impermeable barrier 12 defining a back wall opposite the at least one opening 20 (Fig.1), the fluid impermeable barrier defining two inner longitudinal edges (as edges at longitudinal sides of opening 20; Fig.1,2); at least one porous material 24 disposed in the chamber, the at least one porous material 24 extending across the at least one opening 20, a portion of the porous material 24 extending across the opening 20 extending outwardly from the two inner longitudinal edges of the fluid permeable barrier (porous material as fabric layer 24 as wicking/absorbing material 24 within chamber 18 and opening 20 of barrier 12 Fig.1-2,5 [0014]); and at least one conduit (tubing) extending through at least one fluid outlet 14 and into the chamber 18 ([0015],ll.7,1-13).
Newton does not teach or fairly suggest the combination of wherein at least a portion of the back wall is generally planar; and wherein the at least one conduit extends adjacent to the back wall. It would not have been obvious to one of ordinary skill in the art at the time of the invention to modify the walls and conduit inlets of Newton to provide the combination of wherein at least a portion of the back wall is generally planar; and wherein the at least one conduit extends adjacent to the back wall. One of skill would not have been motivated to modify the teachings of Newton to provide the above combination of elements and arrangement, where Newton fail to teach or fairly suggest providing these elements and features, and do not provide any motivation to do so.
As to independent claim 18, Newton teaches a fluid collection assembly for capturing one or more bodily fluids (urine collection device 10 insertable into underwear, etc; [0014]; [0034],ll.1-2), comprising: a fluid impermeable barrier 12 (impermeable shell 12; Fig.1-2; [0014],ll.2-5) defining at least one opening 20 (window 20 Fig.2 [0014],ll.4-5), a chamber 18 in fluid communication with the at least one opening 20 (Fig.1-2; [0014],ll.4), and at least one fluid outlet 14 (port 14;Fig.1; [0014],ll.3,12), the fluid impermeable barrier 12 defining a back wall opposite the at least one opening 20 (Fig.1); at least one porous material 24 disposed in the chamber, the at least one porous material 24 extending across the at least one opening 20 (porous material as fabric layer 24 as wicking/absorbing material 24 within chamber 18 and opening 20 of barrier 12 Fig.1-2,5 [0014]); and at least one conduit (tubing) extending through at least one fluid outlet 14 and into the chamber 18 ([0015],ll.7,1-13).
Newton does not teach or fairly suggest the combination of wherein the back wall including a bulge extending away from the at least one opening, the back wall including two generally planar portions, the two generally planar portions on opposing sides of the bulge.. It would not have been obvious to one of ordinary skill in the art at the time of the invention to modify the walls and conduit inlets of Newton to provide the combination of wherein the back wall including a bulge extending away from the at least one opening, the back wall including two generally planar portions, the two generally planar portions on opposing sides of the bulge. One of skill would not have been motivated to modify the teachings of Newton to provide the above combination of elements and arrangement, where Newton fail to teach or fairly suggest providing these elements and features, and do not provide any motivation to do so.
As to independent claim 20, Newton teaches a fluid collection assembly for capturing one or more bodily fluids (urine collection device 10 insertable into underwear, etc; [0014]; [0034],ll.1-2), comprising: a fluid impermeable barrier 12 (impermeable shell 12; Fig.1-2; [0014],ll.2-5) defining at least one opening 20 (window 20 Fig.2 [0014],ll.4-5), a chamber 18 in fluid communication with the at least one opening 20 (Fig.1-2; [0014],ll.4), and at least one fluid outlet 14 (port 14;Fig.1; [0014],ll.3,12), the fluid impermeable barrier 12 defining a back wall opposite the at least one opening 20 (Fig.1); at least one porous material 24 disposed in the chamber, the at least one porous material 24 extending across the at least one opening 20 (porous material as fabric layer 24 as wicking/absorbing material 24 within chamber 18 and opening 20 of barrier 12 Fig.1-2,5 [0014]); and at least one conduit (tubing) extending through at least one fluid outlet 14 and into the chamber 18 ([0015],ll.7,1-13).
Newton does not teach or fairly suggest the combination of wherein the fluid collection assembly is configured to be bent into a selected shape responsive to an external physical force being applied to the fluid collection assembly, the fluid collection assembly configured to maintain the selected shape when the external physical force is removed. It would not have been obvious to one of ordinary skill in the art at the time of the invention to modify the walls and conduit inlets of Newton to provide the combination of wherein the fluid collection assembly is configured to be bent into a selected shape responsive to an external physical force being applied to the fluid collection assembly, the fluid collection assembly configured to maintain the selected shape when the external physical force is removed. One of skill would not have been motivated to modify the teachings of Newton to provide the above combination of elements and arrangement, where Newton fail to teach or fairly suggest providing 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 2-6 and 10-14 are rejected on the ground of nonstatutory double patenting over claims 1-2, 5-6, 10 and 15 of US Patent No. 12,138,195 B2 (‘195) (Issued from parent application 17/662700).
As to claims 2-6 and 10-14, claims 1-2, 5-6, 10 and 15 of ‘195 teach or suggest the claimed delivery and fluid storage bridge, as follows:
Claim
2
3
4
5
6
10
11
12
‘195
1
2 (/1)
1
1
5 (/4, /1)
5 (/4, /1)
6 (/1)
6 (/1)
Claim
13
14
‘195
10 (/1)
15
The differences between present claims and the claims of ‘195 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 ‘195 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘195 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 ‘195 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 2-6, 10-15, 17, and 20-21 are provisionally rejected on the ground of nonstatutory double patenting over claims 1, 4, 6, 8, and 15 of US Patent Application No. 17/759587 (‘587). This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
As to Claims 2-6, 10-15, 17, and 20-21, claims 1, 4, 6, 8, and 15 of ‘587 disclose or suggest the claimed delivery and fluid storage bridge, as follows (wherein claim dependency in the cited claims are indicated where cited claim 3, dependent on claim 2, dependent on claim 1, is designated “3(/2/1)”, etc.):
Claim
2
3
4
5
6
7
8
9
10
11
12
‘587
1, 8, 15
6 (/1), 8, 16
6, 8, 16
1, 8, 16
4(/1)
1, 8, 15
1, 8, 15
1, 8, 15
Claim
13
14
15
16
17
18
19
20
21
‘587
1, 8, 15
8, 15
8, 15
8, 15
8, 15
8, 15
The differences between present claims and the claims of ‘587 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 ‘587 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘587 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 ‘587 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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