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 .
Status of the Claims
Claims 1-4, 6-23, and 64 are pending in the application.
Claim Objections
Claim 15 recites that the fluid impermeable barrier defines a chamber. However, dependent claims 16-17 and 19 recite that the fluid impermeable barrier defines a reservoir. Appropriated correction is suggested.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6, 7, 9-13, 15-17, 20-23, and 26 rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Cheng (US 2004/0176731 A1).
As to claims 1 and 15, Cheng teaches:
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(claim 15) a fluid collection system 10/20 (urine conveyance tube 10 Fig.4B; [0095],ll.3-4, integral with female urine collector 20; [0116] ; Fig.4A-E; 5A-B at least [0095] to [0124]), comprising: a fluid collection assembly (of female urine collector 20 ; Fig.4A-E;5A-B; [0116]) including:
a fluid impermeable barrier (water impermeable layer 213; Fig.4A-E,5A-C; [0116],ll.11-15) defining: at least (claim 1) a chamber OR (claim 15) a reservoir (as chamber/reservoir within 213 as liquid containment Fig.4B;5B; [0116],ll.11-15), at least one opening (as opening of flexible structure 21 with skin contact surface 210 to collect urine from wearer Fig.4A,5B; [0116],ll.2-3,5-10), and a fluid outlet (as outlet of 213 adjacent spacer 226 of extension 22 to conduct urine from chamber of barrier 213 to collector/connector 290 of urine collection tube 10 Fig.4B,5B; [0116],ll.2-5,);
at least one assembly porous material 211 (wicking materials 211; Fig.5B;[0116],ll.7-11) disposed in the chamber (of fluid impermeable barrier 213; Fig.5B; [0116],ll.7-11); and (claims 1,15): a conduit 10/22 (conveyance tube 10 Fig.4B;/ extension 22 [0120],ll.1-3) (claim 1) for use in a fluid collection system for collecting one or more bodily fluids (urine management system; [0116],ll.3-5) or (claim 15) in fluid communication with the chamber (within 213) (connected to adjacent space 226 of extension 22 of conveyance tube 10 Fig.4B; [0016],ll.3-5;11-15), the conduit 10/22 comprising:
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at least one wall 104/224 (waterproof film layers 104 and/or 224; Fig.4B; [0120],ll.1-3) at least partially defining at least:
an inlet (as opening at top of conduit 10/22 adjacent spacer 226; Fig.4B-c; [0116],ll.3-5);
an outlet (as opening in bottom of conduit 10/22 connected via connection 60 to urine storage collection device 30 Fig.4c; [0095],ll.8-10); and
a passageway (conveying urine to a urine storage device 30; Fig.4C-D; [0095] from outlet ) extending from the inlet to the outlet (Fig.4C; as presented above); and
at least one conduit porous material 106/226 (conveyance tube wicking spacer 106/226 of extension 22 of conduit 10; Fig.5B; [0123] as wicking material [0116],ll.3-5) (claim 15) distinct from the at least one assembly porous material 211 (as presented above), (claims 1, 15) [the at least one conduit porous material 106/226] disposed in at least a portion of the passageway Fig.5B, the at least one conduit porous material 106/226 substantially occupying a cross-sectional area of the passageway and extending at least from or near the inlet to or near the outlet (Fig.5B).
As to claim 3, Cheng teaches wherein the at least one wall is formed from a film (tube film layers [0120]).
As to claims 4 and 12-13, Cheng teaches wherein: (claim 4) the at least one conduit porous material includes spun nylon (woven and/or mesh mats or fiber pads of nylon, necessarily including spun nylon. [0123],ll.24,27-30).
(claim 12) at least a portion of the at least one conduit porous material includes a rolled sheet (spans continuously along length; [0123],ll.1-3); (claim 13) at least a portion of the at least one conduit porous material 106/226 exhibits a generally circular cross-sectional shape (as within generally circular cross sectional shape of porous material within conduit Fig.4B;5B; 10/22/106/226 (as further presented above for claim 1)).
As to claim 6, Cheng teaches wherein the at least one conduit porous material 106/226 is only disposed in the passageway (as within 22 outside of urine collector 20, as shown in Fig.5B; [0016],ll.3-5);
As to claims 7 and 9, Cheng teaches wherein (claim 7) the at least one conduit porous material 104/226 Fig.5B,14 includes a first portion and a second portion, at least a portion of the first portion is not disposed in the passageway and at least a portion of the second portion is disposed in the passageway (as shown in Fig.14, where top of 226 as porous material not disposed in passageway; 226 below urine collector 20 disposed in passageway [0118];[0145]); and (claim 9) the first portion (top of 226 Fig.14) exhibits a maximum lateral dimension that is greater than a maximum lateral dimension of the at least one wall 22/104/224 ([0120]; as shown in Fig.14,5B).
As to claim 10, Cheng teaches wherein the first portion (226 within 20 Fig.14) includes a plurality of regions that form different and distinct flow paths for the one or more bodily fluids to flow through (Fig.14; [0116]-[0118]; [0145]).
As to claim 11, Cheng teaches wherein the at least one wall (22/104/224 of conveyance tube 10 with porous material 226 within conduit 10/22/226 Fig.5B,14;[0120]) includes a primary branch and one or more secondary branches (Fig.14; [0145],ll.4), the passageway of the primary branch (within 10/22 below 20 Fig.5B,14) including at least a portion of the second portion (below 20 Fig.14) of the at least one conduit porous material 226 disposed therein (Fig.14), the passageway of the one or more secondary branches including a portion of one or more regions of the first portion of the at least one conduit porous material disposed therein (Fig.14; [0145]).
[claims 12-13 rejected with claim 4 above]
As to claims 16-17, Cheng teaches wherein: (claim 16) the fluid impermeable barrier 213 defines a reservoir (as within 213 as liquid containment Fig.4B;5B; [0116],ll.11-15), the inlet (as opening at top of conduit 10/22 adjacent spacer 226; Fig.4B-c; [0116],ll.3-5) of the conduit 10/22 is positioned adjacent to the reservoir (as protruding within 213; Fig.5B), and the conduit 10/22 extends through the fluid outlet (as outlet of 213 adjacent spacer 226 of extension 22 to conduct urine from chamber of barrier 213 to collector/connector 290 of urine collection tube 10 Fig.4B,5B; [0116],ll.2-5,); and
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(claim 17) the fluid impermeable barrier 310/320/311 (Fig.11: urine collection/distributor comprising front wall 310/ back wall 320/ sealed peripheral edges 311 [0126],ll.5-9) includes: a distal end region (top Fig.11) and a proximal end region (bottom Fig.11) opposite the distal end region (Fig.11), the reservoir (within 310/320; Fig.5B) is at least partially defined by the distal end region (bottom Fig.11) of the fluid impermeable barrier 310/320 and the fluid outlet (opening adjacent connector 60 Fig.11) is: (claim 17) at or near the distal end region (top) of the fluid impermeable barrier 310/320 Fig.11; and ; [and where any disclosed aspects of the one embodiment can be incorporated into other embodiments as disclosed [0150]].
As to claim 20, Cheng teaches wherein the fluid impermeable barrier 213 extends along a longitudinal axis (Fig.5B) and the conduit 10/22 extends from the fluid outlet so that it is generally parallel to the longitudinal axis (where conduit 10/22 made of materials that can easily conform to varied and changing contours and shapes [0120],ll.2-4; [0041], such that the conduit 10/22 can be made to be generally parallel to the longitudinal axis of barrier 213).
As to claim 21, Cheng teaches wherein the fluid impermeable barrier 213 extends along a longitudinal axis (Fig.5B) and the conduit 10/22 extends from the fluid outlet (of 213) at an angle that is generally non-parallel to the longitudinal axis (as shown in Fig.5A-C).
As to claim 22, Cheng teaches wherein the fluid impermeable barrier 213 of the fluid collection assembly 20 forms at least a portion of the at least one wall of the conduit ([0114]).
As to claim 23, Cheng teaches wherein the conduit 10/22 extends along at least one lateral surface (e.g., bottom surface of 213 where conduit enters 213 Fig.5B) of the fluid impermeable barrier 213 (where conduit 10/22 made of materials that can easily conform to varied and changing contours and shapes [0120],ll.2-4;[0041], such that the conduit 10/22 can be made to extend laterially along bottom surface of 213 as lateral surface, e.g., if female patient is lying down).
As to claim 26, Cheng teaches wherein the fluid collection system further comprising an adaptor 224 (Fig.5B), the adaptor including a conduit portion attached to the inlet (top adjacent opening in 213 for 10/22) of the conduit (Fig.5B; [0120]) .
Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng.
As to claim 8, Cheng does not specifically teach wherein the first portion (top of 226 within urine collector 20) exhibits a generally semi-spherical shape or a bulb-like shape However, Cheng teaches that the porous spacer 226 serves to prevent the extension/tube 22 with 226 from collapsing that would block flow of urine [0119],ll.2-4; and that the tube 10/extension 22 is made of film layers 224 and 104 that can easily conform to varied and changing shapes ([0120];[0041]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shape of the flexible and conformable spacer 226 within the tube/extension 10/22 to have a semi-spherical or bulb like shape, and one of skill would have been motivated to do so, in order to provide wherein a semi-spherical or bulb like shape would improve the lack of collapsing; and where the tube/extension 10/22 with the spacer 226 within would be capable of forming such a shape.
As to claim 14, Cheng does not teach wherein the conduit may exhibit a bend therein exhibiting an average radius of curvature of about 2 cm without kinking.
However, Cheng teaches that the porous spacer 226 serves to prevent the extension/tube 22 with 226 from kinking/collapsing that would block flow of urine [0119],ll.2-4; and that the tube 10/extension 22 is made of film layers 224 and 104 that can easily conform to varied and changing shapes ([0120];[0041]).
It would have been obvious to one of skill before the effective filing date to provide wherein the conduit may exhibit a bend therein exhibiting an average radius of curvature of about 2 cm without kinking, and one of skill would have been motivated to do so, where the conduit 10/22 is capable of having an average curvature of about 2 cm would additionally help to further prevent the extension/tube 22 with 226 from kinking/collapsing that would block flow of urine..
Claims 2 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Sanchez (WO 2017/210524 A1).
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As to claim 2, Cheng teaches that the wall 104/225 ([0120]) [of the ] can be made of single or multiple layers, such as thin plastic films ([0041]).| Cheng does not teach wherein the at least one wall includes polyvinyl chloride.
However, Sanchez teaches a conduit 1621 (tube 1621; Fig.32) for use in a fluid collection system comprising a urine collection assembly 1602 for collecting one or more bodily fluids (urine collection assembly 1602; Abstract; [0133]), the conduit 1621 comprising: at least one wall (wall of tube 1621) at least partially defining at least: an inlet (adjacent 1610 Fig.32); an outlet (opposite outlet end adjacent 1620 Fig.32); and a passageway (within 1620) extending from the inlet to the outlet (Fig.32; [0133]);
wherein the at least one wall includes polyvinyl chloride ([0067],ll.7); in order to include suitable biocompatible materials as polymers [0067],ll.2-3.
It would have been obvious to one of skill in the art before the effective filing date to modify the conduit materials of Cheng to include PVC according to Sanchez, and one of skill would have been motivated to do so, in order to include suitable biocompatible materials as polymers.
As to claim 18, Cheng does not teach wherein the conduit 1621 occupies substantially all of the chamber that is not occupied by the at least one assembly porous material. However, Sanchez teaches wherein the conduit (tube 1621 Fig.11) occupies substantially all of the chamber (reservoir/chamber 1610 (Fig.11; [0133],ll.5) that is not occupied by the at least one assembly porous material 1640 (permeable support 1640 Fig.32; [0133],ll.6, where Fig.11 shows that the conduit 1621 substantially occupies all of the reservoir/chamber 1610 that is not occupied by the porous material 1640); in order to provide a urine collection assembly 1602 including materials of the conduit/tube 1621 and porous material 1640 that can be pliable and/or flexible, and which fill the chamber/reservoir 1610, such that the assembly 1602 can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly that can include a tube 1621 associated with the outlet 1620, such that fluid in the reservoir 1610 can be removed through tube 1621 and out of the outlet 1720 via a vacuum source [0133],ll.11-15. It would have been obvious to one of skill in the art before the effective filing date to modify the arrangement of the reservoir/chamber and conduit of Cheng to include where all of the chamber/reservoir is occupied by the conduit and the porous material according to Sanchez, and one of skill would have been motivated to do so, in order to provide a urine collection assembly 1602 including materials of the conduit/tube 1621 and porous material 1640 that can be pliable and/or flexible, and which fill the chamber/reservoir 1610, such that the assembly 1602 can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly that can include a tube 1621 associated with the outlet 1620, such that fluid in the reservoir 1610 can be removed through tube 1621 and out of the outlet 1720 via a vacuum source.
As to claim 19, Cheng does not teach wherein the fluid impermeable barrier defines a reservoir, the fluid impermeable barrier includes a distal end region and a proximal end region opposite the distal end region, the reservoir is at least partially defined by the distal end region of the fluid impermeable barrier and the fluid outlet is at the proximal end region of the fluid impermeable barrier. However, Sanchez teaches wherein the fluid impermeable barrier 1604 (urine collection assembly 1602 comprising impermeable casing 1604 Fig.11; [0133]) defines a reservoir/chamber 1610 (Fig.11; [0133],ll.5), the fluid impermeable barrier 1602 includes a distal end region (L Fig.11) and a proximal end region (R Fig.11) opposite the distal end region (L Fig.11), the reservoir 1610 is at least partially defined by the distal end region of the fluid impermeable barrier 1604 and the fluid outlet 1620 is at the proximal end region (L Fig.11) of the fluid impermeable barrier 1604 (Fig.11; [0133]); in order to provide a urine collection assembly 1602 that can be pliable and/or flexible such that the assembly 1602 can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly that can include a tube 1621 associated with the outlet 1620, such that fluid in the reservoir 1610 can be removed through tube 1621 and out of the outlet 1720 via a vacuum source [0133],ll.11-15. It would have been obvious to one of skill in the art before the effective filing date to modify the arrangement of the reservoir/end regions/outlet of Cheng to include the fluid outlet in the proximal end region of the fluid impermeable barrier according to Sanchez, and one of skill would have been motivated to do so, in order to provide a urine collection assembly 1602 that can be pliable and/or flexible such that the assembly 1602 can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly that can include a tube 1621 associated with the outlet 1620, such that fluid in the reservoir 1610 can be removed through tube 1621 and out of the outlet 1720 via a vacuum source.
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, NICHOLAS WEISS, can be reached on 571-270-1775. 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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