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 .
Claim Status
Claims 1-5, 8-12, and 15-18 are currently pending and under consideration. Claims 1, 8, and 15 have been amended. Claims 6-7,13-14, and 19-20 have been cancelled.
Response to Arguments
Applicant's arguments filed November 17th, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Locke does not disclose or contemplate each and every feature of the amended independent claim 1, examiner disagrees as Locke is seen to teach all of the features of amended independent claim 1 as detailed in the rejection below. Applicant has not provided any further reasoning other than restating the claim limitations and providing a general argument that Locke does not disclose these limitations without particularly pointing out what limitations are not disclosed and as such the examiner does not find this argument persuasive in light of the examiners finding in the below rejection that Locke does disclose all the claim limitations as presented in claim 1.
Regarding applicant’s argument pertaining to claims 3 and 4, this argument relies solely on the argument presented for claim 1 and as such has been addressed above.
Regarding applicant’s argument pertaining to independent claims 8 and 15 that Watson in view of Locke does not disclose or contemplate each and every feature of the amended independent claim 8 and 15, the applicant has provided the same argument as pertaining to independent claim 1. As the examiner is still relying on Locke to teach these features, this argument is seen to have been addressed by the above argument. Applicant has not provided any further reasoning other than restating the claim limitations and providing a general argument that Locke does not disclose or contemplate these limitations without particularly pointing out what limitations are not disclosed and as such the examiner does not find this argument persuasive in light of the examiners finding in the below rejection that Watson in view of Locke suggest all the claim limitations as presented in claims 8 and 15.
Claim Interpretation
The claim term of “adjacent” is being interpreted under its broadest reasonable interpretation of “not distant: nearby” as defined by the Meriam Webster dictionary (https://www.merriam-webster.com/dictionary/adjacent) as the applicant has not provided a special definition of this term. Furthermore, the applicant’s specification appears to use the term in accordance with this definition through the use of the term “immediately adjacent” which appears to delineate a difference between the terms “adjacent” and “immediately adjacent” suggesting that the term “adjacent” does not necessitate the adjacent object to be “immediately” next to or neighboring the adjacent object.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) a as being unpatentable over Locke et al. (U.S. Publication 2014/0276499).
Regarding claim 1, Locke discloses a storage unit 121 for a bodily fluid collection (Abstract), comprising:
a body 103;
an inlet port 104 coupled to the body;
an outlet port 105 coupled to the body;
a first porous layer (see illustrative diagram below) disposed within the body and adjacent the inlet port (adjacent to end of inlet 128);
an absorbent layer 132 disposed within the body and adjacent the first porous layer, wherein the first porous layer is between the inlet port and the absorbent layer (see illustrative diagram of Fig. 2 below); and
a second porous layer (134 in pairs ¶0028 located on each side of absorptive layers, second porous layer would be opposite layer to first porous layer of pair to either side of absorptive layer) disposed within the body and adjacent the absorbent layer and the outlet port (adjacent to absorptive layer on one face and adjacent to outlet port 105 on other face), wherein the second porous layer is between the absorbent layer and the outlet port (see illustrative diagram below, wherein the absorbent layer is between the first porous layer and the second porous layer (¶0028 one wicking layer disposed proximate each side of one of the absorptive layers, below illustrative diagram of Fig. 2 shows first and second porous layers disposed to either side such that the absorptive layer is disposed between them), and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer (absorbent layer 132 placed between pairs of porous wicking layer 134 and as such is located between both wicking layers with the wicking layers being located on either laterally adjacent side of the absorbent layer 132, see below illustrative diagram of Fig. 2 below).
PNG
media_image1.png
692
511
media_image1.png
Greyscale
Illustrative diagram of Fig. 2 of Locke.
Locke does not expressly disclose the storage unit being for a urinary relief system, however, the limitations of “for a urinary relief system” is considered functional language (describes function of acting to collect urine from a subject when subject reliefs themselves). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Locke discloses all the structure as claimed, and is further used to collect bodily fluids from a subject (Abstract). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a urinary relief system).
Regarding claim 2, Locke discloses the storage unit of claim 1. Locke further discloses the body being configured to be collapsible (¶0023 container 103 comprises a flexible bag having walls that are elastic and expandable, collapsible in the empty state and expandable to the full state).
Regarding claim 5, Locke discloses the storage unit of claim 1. Locke further discloses the body being made from a plastic (¶0023 thermoplastic material such as polyurethane).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (U.S. Publication 2014/0276499) in view of Watson (U.S. Publication 2023/0091118).
Regarding claims 3 and 4, Locke discloses the storage unit of claim 1. Locke does not expressly disclose a flow restrictor configured to prevent liquid from exiting the storage unit (claim 3) disposed with the body (claim 4).
However, Watson, in the same field of endeavor of flexible fluid storage units, teaches incorporating a fluid flow restrictor 132 that prevents liquid from exiting the storage unit through an outlet port 128 for the purpose of preventing fluid from traversing the vacuum connector while still allowing air to pass through (¶0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet port 105 of Locke to have included a fluid flow restrictor, as taught by Watson for the purpose of preventing fluid from traversing the vacuum connector and into the vacuum line while still allowing air to pass through, which would have the expected benefit of keeping the suction source and line free of fluid that could potentially damage the vacuum or contaminate the line/pump thus reducing the need for cleaning this portion of the device, while also maintaining all fluid in the intended collection container.
Claim(s) 8-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson (U.S. Publication 2023/0091118) in view of Locke et al. (U.S. Publication 2014/0276499).
Regarding claim 8, Watson discloses a urinary relief system 100 comprising:
a human interface device 112;
a control unit 116; and
a storage device 120 coupled to the human interface device and the control unit (coupled through lines 114 and 126), the storage device including:
an inlet port 124 coupled to the human interface device (124 coupled to 114 coupled to 112);
an outlet port 128 coupled to the control unit (128 coupled to 126 coupled to 116);
a first porous layer and
a second porous layer disposed within the body (foam structure 140 removably positionable in interior region of flexible bladder in discrete segments ¶0038, Fig. 3B).
Watson does not expressly disclose an absorbent layer disposed within the body or the position of the layers with respect to the inlet and outlet ports.
However, Locke, in the same field of endeavor of fluid collection devices, teaches a storage unit 121 for a bodily fluid collection (Abstract), comprising: a body 103;
an inlet port 104 coupled to the body; an outlet port 105 coupled to the body; a first porous layer 134 disposed within the body and adjacent the inlet port (adjacent to end of inlet 128); an absorbent layer 132 disposed within the body and adjacent the first porous layer, wherein the first porous layer is between the inlet port and the absorbent layer (see illustrative diagram of Fig. 2 below); and
a second porous layer (134 in pairs ¶0028 located on each side of absorptive layers, second porous layer would be opposite layer to first porous layer of pair to either side of absorptive layer) disposed within the body and adjacent the absorbent layer and the outlet port (adjacent to absorptive layer on one face and adjacent to outlet port 105 on other face), wherein the second porous layer is between the absorbent layer and the outlet port (see illustrative diagram below, wherein the absorbent layer is between the first porous layer and the second porous layer (¶0028 one wicking layer disposed proximate each side of one of the absorptive layers, below illustrative diagram of Fig. 2 shows first and second porous layers disposed to either side such that the absorptive layer is disposed between them), and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer (absorbent layer 132 placed between pairs of porous wicking layer 134 and as such is located between both wicking layers with the wicking layers being located on either laterally adjacent side of the absorbent layer 132, see below illustrative diagram of Fig. 2 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the internal baffling 140 of Watson that performs the function of preventing sloshing and splashing of urine held in the flexible bladder as the bladder is moved as well as causing urine to flow in a tortuous path (¶0037) for the baffling 130 of Locke since these elements perform the same function of Providing a tortuous path of flow for collected liquid and preventing sloshing and splashing of fluid collected as the baffling of Locke absorbs and maintains the fluid in place. Simply substituting one fluid flow controlling means for another would yield the predictable result of allowing a(n) flexible fluid container to provide a tortuous pathway and fluid movement control. See MPEP 2143.
Furthermore one of ordinary skill in the art before the effective filing date would have found it obvious to have modified the device of Watson to have included an absorbent layer disposed within the body with the first porous layer disposed adjacent the inlet port, the absorbent layer disposed adjacent the first porous layer, and the second porous layer disposed adjacent the absorbent layer and the outlet port, as taught by Locke for the purpose of storing fluid captured by the container such that movement of the fluid was limited by the absorptive layer and enhancing the distribution of bodily fluid to the absorptive layers throughout the entire chamber of the container to enhance the fluid storage capability of the absorptive lamination (¶0028 of Locke).
Regarding claim 9, Watson in view of Locke suggest the urinary relief system of claim 8. Watson further discloses the storage device being configured to be collapsible (¶0023 expandable pouch, expansion inherently requires a collapsed state).
Regarding claim 10, Watson in view of Locke suggest the urinary relief system of claim 9. Watson further discloses the storage device further comprising: a body 121 disposed around the first porous layer, the absorbent layer, and the second porous layer, the body being made for plastic (¶0028 thermoplastic elastomers).
Regarding claim 11, Watson in view of Locke suggest the urinary relief system of claim 8. Watson further discloses a flow restrictor 132 configured to prevent a liquid from reaching the control unit (¶0033 configured to prevent fluid from traversing the vacuum connector).
Regarding claim 12, Watson in view of Locke suggest the urinary relief system of claim 11. Watson further discloses the flow restrictor being disposed between the second porous layer and the outlet port (Fig. 2b shows flow restrictor 132 placed at bottom of outlet port 128 and therefore would inherently be between the outlet port and anything placed inside the volume of 120).
Regarding claim 13, Watson in view of Locke suggest the urinary relief system of claim 8. Watson does not teach the absorbent layer being between the first porous layer and the second porous layer, and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer. However, Locke further teaches the absorbent layer being between the first porous layer and the second porous layer, and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer (Locke teaches absorbent layer 132 placed between pairs of porous wicking layer 134 and as such is located between and laterally adjacent to both wicking layers) for the purpose of enhancing the distribution of bodily fluid to the absorptive layers throughout the entire chamber of the container to enhance the fluid storage capability of the absorptive lamination (¶0028 of Locke).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the position of the absorbent and porous layers of Watson as modified by Locke to have the absorbent layer between the porous layers and laterally adjacent the first porous layer and the second porous layer as further taught by Locke, for the purpose of enhancing the distribution of bodily fluid to the absorptive layers throughout the entire chamber of the container to enhance the fluid storage capability of the absorptive lamination (¶0028 of Locke) as the positioning of the porous layers to either side of the absorbent layer provides the benefit of enhancing distribution to the absorptive layers throughout the entire chamber of the container (¶0028 of Locke),
Regarding claim 14, Watson in view of Locke suggest the urinary relief system of claim 8. Watson in view of Locke further suggest the absorbent layer being above (on top of with respect to fluid flow) the first porous layer (Locke teaches layer of pair of 134 underneath absorbent layer 132) and below the second porous layer (layer of pair of 134 above absorbent layer 132).
Regarding claim 15, Watson discloses a urinary relief system 100 comprising: a human interface device 112; a control unit 116; a flow restrictor 132; and a storage device 120 coupled to the human interface device by a first tube 114 and the control unit by a second tube 126, wherein the flow restrictor is between the control unit and the storage device along the second tube (between the fluid compartment of 120 and the control unit 116 at opening of outlet 128) the storage device including: an inlet port 124 coupled to the human interface device (124 coupled to 114 coupled to 112); an outlet port 128 coupled to the control unit (128 coupled to 126 coupled to 116); a first porous layer and a second porous layer disposed within the body (foam structure 140 removably positionable in interior region of flexible bladder in discrete segments ¶0038, Fig. 3B).
Watson does not expressly disclose an absorbent layer disposed within the body or the position of the layers with respect to the inlet and outlet ports.
However, Locke, in the same field of endeavor of fluid collection devices, teaches a storage unit 121 for a bodily fluid collection (Abstract), comprising: a body 103; an inlet port 104 coupled to the body; an outlet port 105 coupled to the body; a first porous layer 134 disposed within the body and adjacent the inlet port (adjacent to end of inlet 128); an absorbent layer 132 disposed within the body and adjacent the first porous layer, wherein the first porous layer is between the inlet port and the absorbent layer (see illustrative diagram of Fig. 2 below); and
a second porous layer (134 in pairs ¶0028 located on each side of absorptive layers, second porous layer would be opposite layer to first porous layer of pair to either side of absorptive layer) disposed within the body and adjacent the absorbent layer and the outlet port (adjacent to absorptive layer on one face and adjacent to outlet port 105 on other face), wherein the second porous layer is between the absorbent layer and the outlet port (see illustrative diagram below, wherein the absorbent layer is between the first porous layer and the second porous layer (¶0028 one wicking layer disposed proximate each side of one of the absorptive layers, below illustrative diagram of Fig. 2 shows first and second porous layers disposed to either side such that the absorptive layer is disposed between them), and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer (absorbent layer 132 placed between pairs of porous wicking layer 134 and as such is located between both wicking layers with the wicking layers being located on either laterally adjacent side of the absorbent layer 132, see below illustrative diagram of Fig. 2 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the internal baffling 140 of Watson that performs the function of preventing sloshing and splashing of urine held in the flexible bladder as the bladder is moved as well as causing urine to flow in a tortuous path (¶0037) for the baffling 130 of Locke since these elements perform the same function of Providing a tortuous path of flow for collected liquid and preventing sloshing and splashing of fluid collected as the baffling of Locke absorbs and maintains the fluid in place. Simply substituting one fluid flow controlling means for another would yield the predictable result of allowing a(n) flexible fluid container to provide a tortuous pathway and fluid movement control. See MPEP 2143.
Furthermore one of ordinary skill in the art before the effective filing date would have found it obvious to have modified the device of Watson to have included an absorbent layer disposed within the body with the first porous layer disposed adjacent the inlet port, the absorbent layer disposed adjacent the first porous layer, and the second porous layer disposed adjacent the absorbent layer and the outlet port, as taught by Locke for the purpose of storing fluid captured by the container such that movement of the fluid was limited by the absorptive layer and enhancing the distribution of bodily fluid to the absorptive layers throughout the entire chamber of the container to enhance the fluid storage capability of the absorptive lamination (¶0028 of Locke).
Regarding claim 16, Watson in view of Locke suggest the urinary relief system of claim 15. Watson further discloses the storage device being configured to be collapsible (¶0023 expandable pouch, expansion inherently requires a collapsed state).
Regarding claim 17, Watson in view of Locke suggest the urinary relief system of claim 15. Watson further discloses the storage device further comprising: a body 121 disposed around the first porous layer, the absorbent layer, and the second porous layer, the body being made for plastic (¶0028 thermoplastic elastomers).
Regarding claim 18, Watson in view of Locke suggest the urinary relief system of claim 15. Watson further discloses the flow restrictor preventing a liquid from reaching the control unit (¶0033 prevents fluid from traversing the vacuum connector).
Regarding claim 19, Watson in view of Locke suggest the urinary relief system of claim 15. Watson does not teach the absorbent layer being between the first porous layer and the second porous layer, and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer However, Locke further teaches the absorbent layer being between the first porous layer and the second porous layer, and wherein the absorbent layer is laterally adjacent the first porous layer and the second porous layer (Locke teaches absorbent layer 132 placed between pairs of porous wicking layer 134 and as such is located between and laterally adjacent to both wicking layers) for the purpose of enhancing the distribution of bodily fluid to the absorptive layers throughout the entire chamber of the container to enhance the fluid storage capability of the absorptive lamination (¶0028 of Locke).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the position of the absorbent and porous layers of Watson as modified by Locke to have the absorbent layer between the porous layers and laterally adjacent the first porous layer and the second porous layer as further taught by Locke, for the purpose of enhancing the distribution of bodily fluid to the absorptive layers throughout the entire chamber of the container to enhance the fluid storage capability of the absorptive lamination (¶0028 of Locke) as the positioning of the porous layers to either side of the absorbent layer provides the benefit of enhancing distribution to the absorptive layers throughout the entire chamber of the container (¶0028 of Locke),
Regarding claim 20, Watson in view of Locke suggest the urinary relief system of claim 15. Watson in view of Locke further suggest the absorbent layer being above (on top of with respect to fluid flow) the first porous layer (Locke teaches layer of pair of 134 underneath absorbent layer 132) and below the second porous layer (layer of pair of 134 above absorbent layer 132).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781