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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/19/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 09/19/2025 has been entered. Claims 1, 12, and 13 have been amended; claims 3, 5, 7, 11, 17, 20, 23, 24, 28, 31, 35, and 40 have been cancelled. Accordingly, 1-2, 4, 6, 8-10, 12-16, 18-19, 21-22, 25-27, 29-30, 32-34, and 36-39 are pending and under consideration, with claims 34 and 36-39 being withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 1 is now rejected Kuntz US 4,747,166 A (previously cited), as cited in the IDS, and further in view of Weaver US 2003/0132352 A1 (newly cited). See rejection of claims below.
Applicant’s arguments with respect to claim 13 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 13 is now rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Sanchez in view of Brunner US 8,839,792 B2 (newly cited). See rejection of claims below.
Applicant's arguments filed have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating the criticality of the opening’s lateral width via Par. 18 and Par. 32 of Applicant’s PG-Pub, Examiner acknowledged the remarks, but respectfully disagrees. The cited Par. 18 of Applicant’s PG-Pub does not describe in details the opening’s dimension; rather, it describes the dimension of the fluid collection device as a whole. Thus, the substantially flat and wider fluid collection device does not necessarily translate into a substantially flat and wide opening. Furthermore, the cited Par. 32 of Applicant’s PG-Pub does not sufficiently prove the criticality of the claimed opening’s dimension, as the statement “A fluid collection device having at least one of a greater lateral width BD.sub.1 of the fluid impermeable barrier 102 or a greater lateral width OD1 of the opening 106 than conventional fluid collection devices allows for easier positioning and securement of the fluid collection device 100 on thinner patients” is considered merely conclusory. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (MPEP 716.02(d)).
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 (i.e., changing from AIA to pre-AIA ) 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, 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 for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz US 4,747,166 A (previously cited, hereinafter Kuntz), as cited in the IDS, and further in view of Weaver US 2003/0132352 A1 (newly cited, hereinafter Weaver).
Regarding claim 1, Kuntz discloses a fluid collection device 10 (Fig. 1 – fluid aspiration system 10), comprising:
a fluid impermeable barrier 36a (Fig. 2 – backing layer 36a, and Col. 2, line 29 – “a lower, backing layer of impermeable material”; Examiner notes that Fig. 2 is a cross-sectional view variation of the device in Fig. 1) having a first region R1 (see annotated Fig. 2 below) and a second region R2 (see annotated Fig. 2 below) opposite to the first region R1 (see annotated Fig. 2 below), the fluid impermeable barrier at least partially defining a chamber “C” (see annotated Fig. 2 below – a chamber defined by the inner surface of the backing layer 36a; Examiner notes that if core 34 is removed, there will be a chamber “C” as annotated), an aperture 24/24a (Fig. 1-2 – opening 24/24a) between the first region R1 (see annotated Fig. 2 below) and the second region R2 (see annotated Fig. below) configured to receive a conduit 18/18a therethrough (Fig. 1-2 – tube 18/18a), and an opening “O” (see annotated Fig. 1 below – opening “O”) defined by the first region R1 (see annotated Fig. 1 and Fig. 2 below – opening O defined in the first region R1) of the fluid impermeable barrier 36a (see annotated Fig. 2 below); and
a fluid permeable body 34 (Fig. 2 – pad core 34) having a first surface 28a (Fig. 2 – upper facing layer 28a) and a second surface “S2” (see annotated Fig. 2 below – second surface “S2” is the bottom surface of the pad core 34 that is adjacent the backing layer 36a) opposite to the first surface 28a (see annotated Fig. 2 below – second surface “S2” is on the bottom, while the first surface 28a is at the top of the pad core 34), the fluid permeable body 34 (Fig. 2) being positioned at least partially within the chamber “C” (see annotated Fig. 2 below – the pad core 34 is disposed within the space of chamber “C” formed by the backing layer 36a) such that the first surface 28a (Fig. 2) extends across at least a portion of the opening “O” (see annotated Fig. 1-2 below – the first surface 28a of pad core 34 spans across the opening “O”) and is configured to wick fluid away from the opening “O” (Col. 3, line 45-52 – “The cushioning ring 26 is intended to make direct contact with the patient's body surrounding the urethral opening and facilitates the positioning of the pad to the body surface so that all urine that is expelled by the patient is passed into and absorbed by the pad”; in other words, urine will be collected into the space/opening “O” formed by ring 26 and onto the top of pad core 34 which is the first surface 28a), and the second surface “S2” (see annotated Fig. 2 below) is positioned substantially opposite to the opening “O” (see annotated Fig. 2 below – second surface “S2” faces away from the annotated opening “O”) and oriented towards the second region R2 (see annotated Fig. 2 below – second surface S2 faces the second region R2 of barrier 36a) of the fluid impermeable barrier 36a (Fig. 2),
wherein the first surface 28a and second surface “S2” (see annotated Fig. 2 of Kuntz below – first and second surfaces 28a and “S2” lay flat horizontally) are substantially planar and the fluid permeable body 34 (Fig. 2) includes a slot 22/22a (Fig. 1-2 – central bore 22/22a) extending longitudinally through the fluid permeable body 34 (Fig. 2 and Col. 3, line 42-44 – “The pad 12 is formed with a central bore 22 extending longitudinally of the pad…”) when the first surface 28a and the second surface “S2” is substantially planar (see annotated Fig. 2 below – when the first and second surface 28a and “S2” lay flat horizontally, the central 22/22a extends substantially parallel to said surfaces), the slot 22/22a (Fig. 1-2) being configured at least partially receive a conduit 18/18a therein (Fig. 2 – tube 18a with an extended portion 30 is inserted into the bore 22a, and Col. 3, line 61-64 – “…the tube 18a is provided with an extended perforated end portion 30 which may be inserted within pad 12a to occupy substantially the entire extent of the hollow bore 22a of such pad”),
the slot 22/22a (Fig. 1-2) extending inward into the fluid permeable body 34 (Fig. 2 – the central bore 22/22a is within the core pad 34) to a predetermined depth within the fluid permeable body 34 (Fig. 2 – the central bore 22/22a spans radially from the central longitudinal axis of the system 10 to a certain depth to form a cylindrical bore).
PNG
media_image1.png
733
1244
media_image1.png
Greyscale
PNG
media_image2.png
606
1459
media_image2.png
Greyscale
Annotated Fig. 2 of Kuntz
However, Kuntz does not disclose the slot extending inward into the fluid permeable body from at least a portion of the second surface of the fluid permeable body to a predetermined depth within the fluid permeable body such that the slot is oriented towards the second region of the fluid impermeable barrier.
Weaver, in the same field of endeavor of medical appliances used in the care of a patient (Par. 2) and tube organizer (Title), teaches the slot 12a (Fig. 1-2 – thin slot 12a) extending inward into the body 10 (Fig. 1-2 – block 10) from at least a portion of the second surface (see annotated Fig. 2 below) of the body 10 (Fig. 2) to a predetermined depth within the body 10 (see annotated Fig. 2 below – the slot extending from a second surface and into block 10 to a predetermined depth).
PNG
media_image3.png
258
624
media_image3.png
Greyscale
Annotated Fig. 2 of Weaver
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kuntz’s configuration of the slot to have the shape as taught by Weaver, in order to provide a slot with sufficient depth to hold the item in use (Par. 6 of Weaver). The body with said slot allows the insertion of medical patient care tubular units therewithin (Par. 6 of Weaver). Further, it is a matter of engineering design to arrange the slot in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Furthermore, since the body/block 10 of Weaver has two major surfaces as identified in the annotated Fig. 2 of Weaver above, one of ordinary skill in the art would have had the technological capability to recognize that the slot 22/22a of Kuntz, when modified by Weaver, will be arranged in two identified, predictable solutions, i.e. to position the slot 12a (Fig. 2 of Weaver) with the slit facing the first region R1 of Kuntz’s impermeable barrier 36a (see annotated Fig. 2 above), or with the slit facing the second region R2 of Kuntz’s impermeable barrier 36a (see annotated Fig. 2 above). Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int' l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007). Thus, the limitation of “the slot is oriented towards the second region of the fluid impermeable barrier” is read upon the modification of Weaver.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weaver as applied to claim 1 above, and further in view of Washington US 4,886,508 A (previously cited, hereinafter Washington), as cited in the IDS.
Regarding claim 2, Kuntz in view of Weaver suggests the invention of claim 1. The combination further discloses the opening “O” (see annotated Fig. 1-2 above of Kuntz) includes a longitudinal length “L1” (see annotated Fig. 1 above of Kuntz – longitudinal length “L1”) and a lateral width “W1” (see annotated Fig. 1 above of Kuntz – lateral width “W1”), the aperture 24/24a (Fig. 1-2 of Kuntz) being positioned on an axis “L” (see annotated Fig. 1 above of Kuntz – axis “L”) that is substantially centered on the lateral width “W1” of the opening “O” (see annotated Fig. 1 above of Kuntz – axis “L” being centered on the width “W1” of opening “O”).
However, the combination does not disclose the opening includes a longitudinal length of at least about 4 cm and a lateral width substantially equal to or greater than the longitudinal length.
Washington, in the same field of endeavor of urine collection device (Col. 1, line 20), teaches the opening 24 (Fig. 1 – top opening 24) includes a longitudinal length (Col. 12, line 1-2) of at least about 4 cm (Col. 12, line 1-2 – “The top opening 24 is about… 3
1
4
inch (8.3 cm) long…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the longitudinal length of the opening of the combination to be of at least 4 cm as taught by Washington, in order to provide ease of inserting or removing the insert/permeable body (Col. 12, line 4-5 of Washington). One of ordinary skill in the art would also have been motivated to modify the dimension of the opening so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Similarly, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the lateral width of the combination to be substantially equal to or greater than the longitudinal length, so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the lateral width of the combined device to be equal to or greater than the longitudinal width to provide sufficient surface area for urine collection and comfort for wearers as the opening exposes the permeable body to the wearer’s skin. Thus, the limitation “a lateral width substantially equal to or greater than the longitudinal length” is met.
Regarding claim 4, Kuntz in view of Weaver in view of Washington suggests the invention of claim 2. However, the combination does not disclose wherein the lateral width is at least 1.5 times greater than the longitudinal length and the lateral width is about 5 cm to about 7.5 cm.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the lateral width of the combination to be at least 1.5 times greater than the longitudinal length and the lateral width to be about 5 cm to about 7.5 cm, so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the lateral width of the combined device to the claimed dimension so as to provide sufficient surface area for urine collection and comfort for wearers as the opening exposes the permeable body to the wearer’s skin. Thus, the limitation “wherein the lateral width is at least 1.5 times greater than the longitudinal length and the lateral width is about 5 cm to about 7.5 cm” is met.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weaver as applied to claim 1 above, and further in view of Sanchez et al. US 2016/0374848 A1 (previously cited, hereinafter Sanchez), as cited in the IDS.
Regarding claim 6, Kuntz in view of Weaver suggests the invention of claim 1. The combination further discloses further comprising a reservoir “R” (see annotated Fig. 2 of Kuntz above – reservoir “R” is at the bottom-most end of central bore 22a), the reservoir “R” (see annotated Fig. 2 of Kuntz above) being positioned distal to the aperture 24/24a (Fig. 2 of Kuntz – reservoir “R” is positioned on the other end of device 10, away from aperture 24/24a), wherein the reservoir “R” (see annotated Fig. 2 of Kuntz above) is aligned on the axis “L” (see annotated Fig. 1 of Kuntz above) that is substantially centered on the lateral width “W1” (see annotated Fig. 1 of Kuntz above) of the opening “O” (see annotated Fig. 1 of Kuntz above – the bottom end of central bore 22/22a is positioned on the axis “L”).
However, the combination does not currently disclose comprising a reservoir defined at least partially by the fluid permeable body and the fluid impermeable barrier. Examiner notes that the reservoir of Kuntz in view of Sanchez is currently being defined only by the fluid permeable body 34 (Fig. 2 of Kuntz).
Sanchez, in the same field of endeavor of systems and apparatus for collecting and transporting urine away from the body of a person (Par. 5), teaches comprising a reservoir 1610 (Fig. 32 – reservoir 1610) defined at least partially by the fluid permeable body 1630 (Fig. 32 – permeable membrane 1630) and the fluid impermeable barrier 1650 (Fig. 32 – impermeable backing 1650 – reservoir 1610 is formed from the bottom end of permeable membrane sleeve 1630 and the wall of the backing 1650).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of the combination to have a reservoir defined at least partially by the fluid permeable body and the fluid impermeable barrier as taught by Sanchez, in order to have the received urine withdrawn from the reservoir via the tube and out of the fluid discharge end of the tube (Par. 50 of Sanchez). This construct of the reservoir as taught by Sanchez can also reduce/prevent fluid from exiting the device assembly (Par. 55 of Sanchez) by holding a small/large amount of urine as may be released during incontinence/voiding of a full bladder (Par. 59 of Sanchez).
Once the combination is made as discussed, the reservoir “R” of the combination will be modified similarly to the construct as taught by Sanchez, that is, the impermeable barrier 36a of Kuntz will extend to a certain degree to the right, and the slot 22/22a will now extend throughout the longitudinal length of the permeable body 34, while the permeable body 34 of Kuntz maintain its longitudinal length to accommodate a space assigned as the reservoir. Said modified reservoir “R” of the combination will be able to hold an amount of urine released by the user prior to or during removal of fluid by the conduit.
Regarding claim 10, Kuntz in view of Weaver in view of Sanchez suggests the invention of claim 6. The combination further discloses further comprising a conduit 18/18a (Fig. 1-2 of Kuntz) including an inlet “IN” (see annotated Fig. 2 of Kuntz above – inlet “IN” is the perforation on the end portion 30) and an outlet “OUT” (see annotated Fig. 2 of Kuntz above), wherein at least a portion 30 (Fig. 2 of Kuntz – extended perforated end portion 30) of the conduit 18/18a (Fig. 1-2 of Kuntz) extends through the aperture 24/24a (Fig. 1-2 of Kuntz – end portion 30 of tube 18/18a enters the opening 24/24a) and is positioned within the slot 22/22a (Fig. 1-2) of the fluid permeable body 34 (Fig. 2 – end portion 30 enters the opening 24/24a and is positioned within the central bore 22/22a of core pad 34) to position the inlet “IN” (see annotated Fig. 2 of Kuntz above) fluid communication with the reservoir “R”/1610 (see annotated Fig. 2 of Kuntz above – the inlet “IN” receives fluid from central bore 22/22a which connects to the reservoir “R”; Examiner also notes that Fig. 32 of Sanchez shows the end of tube 1621 probing into the reservoir 1610; therefore, the inlet of tube 18/18a of Kuntz is in fluid communication with the reservoir 1610 upon the modification as established in claim 6 above).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weaver in view of Sanchez as applied to claim 6 above, and further in view of Heki US 2003/0120178 A1 (previously cited, Heki, hereinafter Heki), as cited in the IDS.
Regarding claim 8, Kuntz in view of Weaver in view of Sanchez suggests the invention of claim 6. The combination further discloses wherein the fluid impermeable barrier 36a (Fig. 2 of Kuntz) includes:
a first lateral side “S1” (see annotated Fig. 1 of Kuntz above) defining the aperture 24/24a (see annotated Fig. 1-2 of Kuntz above – opening 24/24a is disposed on the first lateral side “S1”);
a second lateral side “S2” (see annotated Fig. 1 of Kuntz above) distal to the first lateral side “S1” (see annotated Fig. 1 of Kuntz above – lateral side “S1” and lateral side “S2” are opposite to each other).
However, the combination does not disclose a protrusion extending from the second lateral side, the reservoir being positioned within the protrusion.
Heki, in the same field of endeavor of interlabial device (Title), teaches a protrusion (see annotated Fig. 9 below – protrusion) extending from the second lateral side (see annotated Fig. 9 below – second lateral side; the protrusion extending past the flange 410 and the annotated second lateral side), the reservoir 420 (Fig. 9 – pouch 420) being positioned within the protrusion (see annotated Fig. 9 below, and Par. 70 – “…collect discharged body fluids and a pouch 420 to store discharged body fluids as shown in FIG. 9”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second lateral side of the combination to further have a protrusion extending therefrom and to have the reservoir be within said protrusion as taught by Heki, in order to provide a flexible receptacle for the containment of discharged body fluids (Par. 71 of Heki). Heki also discusses that said particular elongated protrusion with reservoir which is principally tubular or rectangular is typically utilized by bedridden patients and elderly incontinence sufferer (Par. 71 of Heki). Thus, once the modification is made as discussed, the reservoir as taught by Sanchez as discussed in claim 6 will now be disposed within a protrusion as taught by Heki. This extended space/reservoir further improves the holding capacity of bodily fluid.
PNG
media_image4.png
322
663
media_image4.png
Greyscale
Annotated Fig. 9 of Heki
Regarding claim 9, Kuntz in view of Weaver in view of Sanchez in view of Heki discloses the invention of claim 8. The combination further discloses wherein the fluid impermeable barrier 36a (Fig. 2 of Kuntz) includes two longitudinal sides “LS” (see annotated Fig. 1 of Kuntz above – two longitudinal side “LS”) extending between the first lateral side “S1” and the second lateral side “S2” (see annotated Fig. 1 of Kuntz above – two longitudinal sides “LS” are between lateral side “S1” and lateral side “S2”), and wherein the opening “O” (see annotated Fig. 1 of Kuntz above) is substantially rectangular (see annotated Fig. 1 of Kuntz above – opening “O” is substantially rectangular in the sense that the overall shape is rectangular with rounded bevel edges).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Weaver as applied to claim 1 above, and further in view of Holsten US 2019/0059938 A1 (previously cited, hereinafter Holsten).
Regarding claim 12, Kuntz in view of Weaver suggests the invention of claim 1. The combination further discloses such that the second surface (see annotated Fig. 2 of Weaver above) of the permeable body 34/10 (Fig. 2 of Kuntz after modification by Weaver) is substantially continuous over the slot 12a (see annotated Fig. 2 of Weaver above – second surface of block 10 is substantially continuous over the slit 12a).
However, the combination does not disclose wherein the slot is substantially T-shaped or L-shaped and the fluid permeable body includes one or more covers covering the slot.
Holsten, considered to be analogous art since the invention employs a body with a slot and covers encircling a medical instrument (Par. 5 and Fig. 3), teaches wherein the slot 130+132 (Fig. 3 – guard aperture 130 and radial slots 132) is substantially T-shaped (Fig. 3 – radial slots 132 form a substantial T-shaped with angled segments) and the body 126 (Fig. 3 – guard member 126) includes one or more covers “C” (see annotated Fig. 3 below) covering the slot 130+132 (Fig. 3 – covers “C” in its relaxed state is covering the actual surface area that aperture 130 can radially stretch/expand thanks to the radial slots 132).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the permeable body’s slot of the combination to have a substantial T-shape and covers as taught by Holsten, in order to provide sufficient flexibility to not interfere with passage of the object (Par. 22 of Holsten), such as the passage/insertion of conduit 18 of the combination. In other words, the T-shape/covers formed by radial slots 132 as taught by Holsten when combined with the slot 22/22a of the combination allow the conduit to move within the permeable body 34 without great restriction; In the absence of room for flexibility, the whole fluid collection device 10 can be dragged around when the conduit is external portion of the conduit 18 is moving.
Also, it is well known in the art that the slots can have a variety of shapes of configurations, including T-shaped as taught by Holsten. The change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, it is a matter of engineering design to configure the slot in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the slot shape of the combination to include a shape as taught by Holsten, without any new and unexpected results since the new slot shape can still receive the conduit and permit flow through the conduit. Therefore, the limitation “wherein the slot is substantially T-shaped or L-shaped” is met.
PNG
media_image5.png
284
552
media_image5.png
Greyscale
Annotated Fig. 3 of Holsten
Claims 13, 14, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Sanchez in view of Brunner US 8,839,792 B2 (newly cited, hereinafter Brunner).
Regarding claim 13, Kuntz discloses a fluid collection device 10 (Fig. 1 – fluid aspiration system 10), comprising:
a fluid impermeable barrier 36a (Fig. 2 – backing layer 36a, and Col. 2, line 29 – “a lower, backing layer of impermeable material”; Examiner notes that Fig. 2 is a cross-sectional view variation of the device in Fig. 1) having a first lateral side “S1” (see annotated Fig. 1 above) defining an aperture 24/24a (Fig. 1-2 – opening 24/24a; opening 24/24a is disposed on the first lateral side “S1”) configured to receive a conduit 18/18a therethrough (Fig. 1-2 – tube 18/18a), a second lateral side “S2” (see annotated Fig. 1 below) distal to the first lateral side “S1” (see annotated Fig. 1 above – lateral side “S1” and lateral side “S2” are opposite to each other), and the fluid impermeable barrier 36a (Fig. 2) also defining a chamber “C” (see annotated Fig. 2 above – a chamber defined by the inner surface of the backing layer 36a; Examiner notes that if core 34 is removed, there will be a chamber “C” as annotated), and an opening “O” (see annotated Fig. 1 above – opening “O” defined by the space in which the cushioning ring 26 creates) disposed on the fluid collection device 10 to be positioned adjacent to skin of a female over a urethra of the female (Fig. 1, Col. 3, line 48-50 – “The cushioning ring 26 is intended to make direct contact with the patient's body surrounding the urethral opening…”, and Col. 3, line 50-51 – “…facilitates the positioning of the pad to the body surface…”); and
a fluid permeable body 34 (Fig. 2 – pad core 34) positioned at least partially within the chamber “C” (see annotated Fig. 2 below – the pad core 34 is disposed within the space of chamber “C” formed by the backing layer 36a) to extend across at least a portion of the opening “O” (see annotated Fig. 1-2 above – pad core 34 spans across the opening “O” below the ring 26) and to at least partially define a reservoir “R” (see annotated Fig. 2 of Kuntz above – pad core 34 forms a reservoir “R” which is at the bottom-most end of central bore 22a), the fluid permeable body 34 (Fig. 2) being configured to wick fluid away from the opening “O” (Col. 3, line 45-52 – “The cushioning ring 26 is intended to make direct contact with the patient's body surrounding the urethral opening and facilitates the positioning of the pad to the body surface so that all urine that is expelled by the patient is passed into and absorbed by the pad”; in other words, urine will be collected into the space/opening “O” formed by ring 26) positioned adjacent to the skin of the female over the urethra of the female (Col. 3, line 48-51 – “The cushioning ring 26 is intended to make direct contact with the patient's body surrounding the urethral opening and facilitates the positioning of the pad to the body surface so that all urine that is expelled by the patient is passed into and absorbed by the pad”) to the reservoir “R” (Col. 6, line 56 – “…urine reaches the chamber (bore) 22a…”).
However, Kuntz does not disclose a protrusion extending from the second lateral side and being more narrow than the second lateral side; a fluid permeable body to at least partially define, with the fluid impermeable barrier, a reservoir that is positioned in the protrusion of the fluid impermeable barrier.
Sanchez, in the same field of endeavor of systems and apparatus for collecting and transporting urine away from the body of a person (Par. 5), teaches a fluid permeable body 1630 (Fig. 32 – permeable membrane 1630) to at least partially define, with the fluid impermeable barrier 1650 (Fig. 32 – impermeable backing 1650, a reservoir 1610 (Fig. 32 – reservoir 1610; reservoir 1610 is formed from the bottom end of permeable membrane sleeve 1630 and the wall of the backing 1650).
Brunner, in the same field of endeavor of fluid collection device (Col. 5, line 54-55), teaches a protrusion 40 (Fig. 1 – reservoir 40) extending from the second lateral side (see annotated Fig. 1 below) and being more narrow than the second lateral side (see annotated Fig. 1 below – the width of reservoir 40 is smaller than the annotated second lateral side).
PNG
media_image6.png
373
924
media_image6.png
Greyscale
Annotated Fig. 1 of Brunner
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of Kuntz to have a reservoir defined at least partially by the fluid permeable body and the fluid impermeable barrier as taught by Sanchez, in order to have the received urine withdrawn from the reservoir via the tube and out of the fluid discharge end of the tube (Par. 50 of Sanchez). This construct of the reservoir as taught by Sanchez can also reduce/prevent fluid from exiting the device assembly (Par. 55 of Sanchez) by holding a small/large amount of urine as may be released during incontinence/voiding of a full bladder (Par. 59 of Sanchez).
Once the combination is made as discussed, the reservoir “R” of Kuntz in view of Sanchez will be modified similarly to the construct as taught by Sanchez, that is, the impermeable barrier 36a of Kuntz will extend to a certain degree to the right, and the slot 22/22a will now extend throughout the longitudinal length of the permeable body 34, while the permeable body 34 of Kuntz maintain its longitudinal length to accommodate a space assigned as the reservoir. Said modified reservoir “R” of Kuntz in view of Sanchez will be able to hold an amount of urine released by the user prior to or during removal of fluid by the conduit.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second lateral side of the Kuntz in view of Sanchez to further have a narrower protrusion extending therefrom and to have the reservoir be within said protrusion as taught by Brunner, in order to provide a tip where fluid can collect (Col. 5, line 54-55 of Brunner). Thus, once the modification is made as discussed, the reservoir as taught by Sanchez as discussed in claim 13 will now be disposed within a protrusion as taught by Brunner. This extended space/reservoir further improves the holding capacity of bodily fluid.
Regarding claim 14, Kuntz in view of Sanchez in view of Brunner suggests the invention of claim 13. The combination further discloses wherein the opening “O” (see annotated Fig. 1 of Kuntz above) includes a lateral width “W1” (see annotated Fig. 1 of Kuntz above– lateral width “W1”) and a longitudinal length “L1” (see annotated Fig. 1 above of Kuntz – longitudinal length “L1”), and the aperture 24/24a (Fig. 1-2 of Kuntz) and the protrusion 40 (Fig. 1 of Brunner) are positioned on an axis “L” (see annotated Fig. 1 of Kuntz above) that is substantially centered on the lateral width “W1” of the opening “O” (see annotated Fig. 1 above of Kuntz – axis “L” being centered on the width “W1” of opening “O”; Fig. 1 of Brunner also demonstrates that the reservoir 40 is laterally centered).
Examiner notes that once the combination is made as discussed in claim 13, the protrusion as taught by Brunner will be created in alignment with the longitudinal direction of the conduit 18/18a for drainage/suction; also as seen in Fig. 1 of Brunner, the annotated protrusion is symmetrical about the center point/axis of the device. Furthermore, since conduit 18/18a is positioned in alignment with the axis “L” that is centered on the lateral width “W1” of the opening “O” (see annotated Fig. 1 of Kuntz above), the modified protrusion will be positioned on said axis. Thus, the limitation “…the protrusion are positioned on an axis that is substantially centered on the lateral width of the opening” is met.
Regarding claim 18, Kuntz in view of Sanchez in view of Brunner suggests the invention of claim 13. The combination further discloses wherein:
the fluid impermeable barrier 36a (Fig. 2 of Kuntz) includes two longitudinal sides “LS” (see annotated Fig. 1 of Kuntz above – two longitudinal side “LS”) extending between the first lateral side “S1” and the second lateral side “S2” (see annotated Fig. 1 of Kuntz above – two longitudinal sides “LS” are between lateral side “S1” and lateral side “S2”); and
the opening “O” (see annotated Fig. 1 of Kuntz above) is substantially rectangular (see annotated Fig. 1 of Kuntz above – opening “O” is substantially rectangular in the sense that the overall shape is rectangular with rounded bevel edges).
Regarding claim 19, Kuntz in view of Sanchez in view of Brunner suggests the invention of claim 13. The combination further discloses comprising a conduit 18/18a (Fig. 1-2 of Kuntz) including an inlet “IN” (see annotated Fig. 2 of Kuntz above – inlet “IN” is the perforation on the end portion 30) and an outlet “OUT” (see annotated Fig. 2 of Kuntz above), wherein at least a portion 30 (Fig. 2 of Kuntz – extended perforated end portion 30) of the conduit 18/18a (Fig. 1-2 of Kuntz) extends through the aperture 24/24a (Fig. 1-2 of Kuntz – end portion 30 of tube 18/18a enters the opening 24/24a) and the fluid permeable body 34 (Fig. 2 of Kuntz – end portion 30 is inserted into the core pad 34 via central bore 22/22a) to position the inlet “IN” (see annotated Fig. 2 of Kuntz above) in fluid communication with the reservoir “R”/1610 (see annotated Fig. 2 of Kuntz above – the inlet “IN” receives fluid from central bore 22/22a which connects to the reservoir “R”; Examiner also notes that Fig. 32 of Sanchez shows the end of tube 1621 probing into the reservoir 1610; therefore, the inlet of tube 18/18a of Kuntz is in fluid communication with the reservoir 1610 upon the modification as established in claim 13 above)
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Sanchez in view of Brunner as applied to claim 14 above, and further in view of Washington.
Regarding claim 15, Kuntz in view of Sanchez in view of Brunner suggests the invention of claim 14. However, the combination does not disclose wherein the longitudinal length is at least about 4 cm and the lateral width is substantially equal to or greater than the longitudinal length.
Washington, in the same field of endeavor of urine collection device (Col. 1, line 20), teaches wherein the longitudinal length (Col. 12, line 1-2) is at least about 4 cm (Col. 12, line 1-2 – “The top opening 24 is about… 3
1
4
inch (8.3 cm) long…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the longitudinal length of the opening of the combination to be of at least 4 cm as taught by Washington, in order to provide ease of inserting or removing the insert/permeable body (Col. 12, line 4-5 of Washington). One of ordinary skill in the art would also have been motivated to modify the dimension of the opening so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Similarly, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the lateral width of the combination to be substantially equal to or greater than the longitudinal length, so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the lateral width of the combined device to be equal to or greater than the longitudinal width to provide sufficient surface area for urine collection and comfort for wearers as the opening exposes the permeable body to the wearer’s skin. Thus, the limitation “the lateral width is substantially equal to or greater than the longitudinal length” is met.
Regarding claim 16, Kuntz in view of Sanchez in view of Brunner in view of Washington suggests the invention of claim 15. However, the combination does not disclose wherein the lateral width is about 5 cm to about 7.5 cm.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the lateral width of the combination to be about 5 cm to about 7.5 cm, so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the lateral width of the combined device to the claimed dimension so as to provide sufficient surface area for urine collection and comfort for wearers as the opening exposes the permeable body to the wearer’s skin. Thus, the limitation “wherein the lateral width is about 5 cm to about 7.5 cm” is met.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Sanchez in view of Brunner as applied to claim 19 above, and further in view of Weaver.
Regarding claim 21, Kuntz in view of Sanchez in view of Brunner suggests the invention of claim 19. The combination further discloses wherein:
the fluid permeable body 34 (Fig. 2 of Kuntz – pad core 34) includes a first surface 28a (Fig. 2 – upper facing layer 28a) extending across at least a portion of the opening “O” (see annotated Fig. 1-2 of Kuntz above – the first surface 28a of pad core 34 spans across the opening “O” below the ring 26), a second surface “S2” (see annotated Fig. 2 of Kuntz above – second surface “S2” is the bottom surface of the pad core 34 that is adjacent the backing layer 36a) opposite to the first surface 28a (see annotated Fig. 2 of Kuntz above – second surface “S2” is on the bottom while the first surface 28a is at the top of the pad core 34), and
a slot 22/22a (Fig. 1-2 of Kuntz – central bore 22/22a) extending longitudinally through the fluid permeable body 34 (Fig. 2 of Kuntz and Col. 3, line 42-44 of Kuntz – “The pad 12 is formed with a central bore 22 extending longitudinally of the pad…”) and extending inward into the fluid permeable body 34 (Fig. 2 of Kuntz – the central bore 22/22a is within the core pad 34) to a predetermined depth within the fluid permeable body 34 (Fig. 2 of Kuntz – the central bore 22/22a spans radially from the central longitudinal axis of the system 10 to a certain depth to form a cylindrical bore); and
the conduit 18/18a (Fig. 1-2 of Kuntz) is positioned at least partially within the slot 22/22a (Fig. 2 of Kuntz – tube 18a with an extended portion 30 is inserted into the bore 22a, and Col. 3, line 61-64 of Kuntz – “…the tube 18a is provided with an extended perforated end portion 30 which may be inserted within pad 12a to occupy substantially the entire extent of the hollow bore 22a of such pad”).
However, the combination does not disclose a slot extending inward into the fluid permeable body from at least a portion of the second surface of the fluid permeable body to a predetermined depth within the fluid permeable body.
Weaver, in the same field of endeavor of medical appliances used in the care of a patient (Par. 2) and tube organizer (Title), teaches a slot 12a (Fig. 1-2 – thin slot 12a) extending inward into the body 10 (Fig. 1-2 – block 10) from at least a portion of the second surface (see annotated Fig. 2 above) of the body 10 (Fig. 2) to a predetermined depth within the body 10 (see annotated Fig. 2 above – the slot extending from a second surface and into block 10 to a predetermined depth).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kuntz’s configuration of the slot to have the shape as taught by Weaver, in order to provide a slot with sufficient depth to hold the item in use (Par. 6 of Weaver). The body with said slot allows the insertion of medical patient care tubular units therewithin (Par. 6 of Weaver). Further, it is a matter of engineering design to arrange the slot in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Sanchez in view of Brunner in view of Weaver as applied to claim 21 above, and further in view of Holsten.
Regarding claim 22, Kuntz in view of Sanchez in view of Brunner in view of Weaver suggests the invention of claim 21. However, the combination does not disclose wherein the fluid permeable body includes one or more covers covering at least a portion of the slot when the conduit is at least partially positioned within the slot.
Holsten, considered to be analogous art since the invention employs a body with a slot and covers encircling a medical instrument (Par. 5 and Fig. 3), teaches wherein the body 126 (Fig. 3 – guard member 126) includes one or more covers “C” (see annotated Fig. 3 above) covering at least a portion of the slot 130+132 (Fig. 3 – covers “C” in its relaxed state is covering the actual surface area that aperture 130 can radially stretch/expand thanks to the radial slots 132).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the permeable body’s slot of the combination to have covers as taught by Holsten, in order to provide sufficient flexibility to not interfere with passage of the object (Par. 22 of Holsten), such as the passage/insertion of conduit 18 of Kuntz. In other words, the covers formed by radial slots 132 as taught by Holsten when combined with the slot 22/22a of the combination allow the conduit to move within the permeable body 34 without great restriction; In the absence of room for flexibility, the whole fluid collection device 10 can be dragged around when the conduit is external portion of the conduit 18 is moving. Once the combination is made as discussed, when the conduit 18 is inserted and positioned within the slot 22/22a, the covers “C” as taught by Holsten will be pushed along the direction of insertion of conduit 18 and open to a certain degree due to the diameter of the conduit 18 while still maintaining coverage of the slot. Thus, the limitation “…covering at least a portion of the slot when the conduit is at least partially positioned within the slot” is met.
Claims 25, 27, 29, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Washington and Sanchez.
Regarding claim 25, Kuntz discloses a fluid collection device 10 (Fig. 1 – fluid aspiration system 10), comprising:
a fluid impermeable barrier 36a (Fig. 2 – backing layer 36a, and Col. 2, line 29 – “a lower, backing layer of impermeable material”; Examiner notes that Fig. 2 is a cross-sectional view variation of the device in Fig. 1) having a first lateral side “S1” (see annotated Fig. 1 below) defining an aperture 24/24a (Fig. 1-2 – opening 24/24a; opening 24/24a is disposed on the first lateral side “S1”) configured to receive a conduit 18/18a therethrough (Fig. 1-2 – tube 18/18a) and a second lateral side “S2” (see annotated Fig. 1 below) distal to the first lateral side “S1” (see annotated Fig. 1 above – lateral side “S1” and lateral side “S2” are opposite to each other), the fluid impermeable barrier 36a (Fig. 2) also defining a chamber “C” (see annotated Fig. 2 above – a chamber defined by the inner surface of the backing layer 36a; Examiner notes that if core 34 is removed, there will be a chamber “C” as annotated) and an opening “O” (see annotated Fig. 1 above – opening “O” defined by the space in which the cushioning ring 26 creates), the opening “O” (see annotated Fig. 1 above) including a longitudinal length “L1” (see annotated Fig. 1 above of Kuntz – longitudinal length “L1”) and a lateral width “W1” (see annotated Fig. 1 above of Kuntz – lateral width “W1”); and
a fluid permeable body 34 (Fig. 2 – pad core 34) positioned at least partially within the chamber “C” (see annotated Fig. 2 below – the pad core 34 is disposed within the space of chamber “C” formed by the backing layer 36a) such that a substantially planar portion (Fig. 2 – the top surface of pad core 34, which is a flat surface) of the fluid permeable body 34 (Fig. 2) extends across at least a portion of the opening “O” (see annotated Fig. 1-2 above – top surface of pad core 34 spans across the opening “O” below the ring 26), the fluid permeable body 34 (Fig. 2) being configured to wick fluid away from the opening “O” (Col. 3, line 45-52 – “The cushioning ring 26 is intended to make direct contact with the patient's body surrounding the urethral opening and facilitates the positioning of the pad to the body surface so that all urine that is expelled by the patient is passed into and absorbed by the pad”; in other words, urine will be collected into the space/opening “O” formed by ring 26) to the reservoir “R” (Examiner contends that fluid has to collect at the bottom of central bore 22/22a in order for the conduit 18/18a to effectively drain said fluid).
However, Kuntz does not disclose a longitudinal length of at least about 4 cm and a lateral width that is substantially equal to or greater than the longitudinal length; a fluid permeable body to at least partially define, with the fluid impermeable barrier, a reservoir that is positioned in a protrusion of the fluid impermeable barrier.
Washington, in the same field of endeavor of urine collection device (Col. 1, line 20), teaches wherein the longitudinal length (Col. 12, line 1-2) is at least about 4 cm (Col. 12, line 1-2 – “The top opening 24 is about… 3
1
4
inch (8.3 cm) long…”).
Sanchez, in the same field of endeavor of systems and apparatus for collecting and transporting urine away from the body of a person (Par. 5), teaches a fluid permeable body 1630 (Fig. 32 – permeable membrane 1630) to at least partially define, with the fluid impermeable barrier 1650 (Fig. 32 – impermeable backing 1650), a reservoir 1610 (Fig. 32 – reservoir 1610; reservoir 1610 is formed from the bottom end of permeable membrane sleeve 1630 and the wall of the backing 1650) that is positioned in a protrusion (see annotated Fig. 32 below – protrusion is the dome at the end of the backing 1650; the dome/protrusion houses the reservoir 1610) of the fluid impermeable barrier 1650 (Fig. 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the longitudinal length of the opening of Kuntz to be of at least 4 cm as taught by Washington, in order to provide ease of inserting or removing the insert/permeable body (Col. 12, line 4-5 of Washington). One of ordinary skill in the art would also have been motivated to modify the dimension of the opening so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Similarly, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the lateral width of Kuntz in view of Washington to be substantially equal to or greater than the longitudinal length, so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the lateral width of the combined device to be equal to or greater than the longitudinal width to provide sufficient surface area for urine collection and comfort for wearers as the opening exposes the permeable body to the wearer’s skin. Thus, the limitation “the lateral width is substantially equal to or greater than the longitudinal length” is met.
Next, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of Kuntz in view of Washington to have a reservoir defined at least partially by the fluid permeable body and the fluid impermeable barrier and positioned within a protrusion as taught by Sanchez, in order to have the received urine withdrawn from the reservoir via the tube and out of the fluid discharge end of the tube (Par. 50 of Sanchez). This construct of the reservoir as taught by Sanchez can also reduce/prevent fluid from exiting the device assembly (Par. 55 of Sanchez) by holding a small/large amount of urine within the protrusion as may be released during incontinence/voiding of a full bladder (Par. 59 of Sanchez). Once the combination is made as discussed, the reservoir “R” of Kuntz in view of Washington will be modified similarly to the construct as taught by Sanchez, that is, the impermeable barrier 36a of Kuntz will extend to a certain degree to the right, and the slot 22/22a will now extend throughout the longitudinal length of the permeable body 34, while the permeable body 34 of Kuntz maintain its longitudinal length to accommodate a space assigned as the reservoir. Said modified reservoir “R” within a protrusion of Kuntz in view of Washington in view of Sanchez will be able to hold an amount of urine released by the user prior to or during removal of fluid by the conduit.
Regarding claim 27, Kuntz in view of Washington in view of Sanchez suggests the invention of claim 25. However, the combination currently does not disclose wherein the lateral width is about 5 cm to about 7.5 cm and the lateral width is at least 1.5 times greater than the longitudinal length.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the lateral width of the combination to be at least 1.5 times greater than the longitudinal length and the lateral width to be about 5 cm to about 7.5 cm, so as to fit the particular procedure being done since this claimed dimension of the opening does not change the its ability to receive and collect waste fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29-30 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the lateral width of the combined device to the claimed dimension so as to provide sufficient surface area for urine collection and comfort for wearers as the opening exposes the permeable body to the wearer’s skin. Thus, the limitation “wherein the lateral width is about 5 cm to about 7.5 cm and the lateral width is at least 1.5 times greater than the longitudinal length” is met.
Regarding claim 29, Kuntz in view of Washington in view of Sanchez suggests the invention of claim 25. The combination further discloses wherein:
the fluid impermeable barrier 36a (Fig. 2 of Kuntz) includes two longitudinal sides “LS” (see annotated Fig. 1 of Kuntz above – two longitudinal side “LS”) extending between the first lateral side “S1” and the second lateral side “S2” (see annotated Fig. 1 of Kuntz above – two longitudinal sides “LS” are between lateral side “S1” and lateral side “S2”); and
the opening “O” (see annotated Fig. 1 of Kuntz above) is substantially rectangular (see annotated Fig. 1 of Kuntz above – opening “O” is substantially rectangular in the sense that the overall shape is rectangular with rounded bevel edges).
Regarding claim 30, Kuntz in view of Washington in view of Sanchez suggests the invention of claim 25. The combination further discloses a conduit 18/18a (Fig. 1-2 of Kuntz) including an inlet “IN” (see annotated Fig. 2 of Kuntz above – inlet “IN” is the perforation on the end portion 30) and an outlet “OUT” (see annotated Fig. 2 of Kuntz above), wherein at least a portion 30 (Fig. 2 of Kuntz – extended perforated end portion 30) of the conduit 18/18a (Fig. 1-2 of Kuntz) extends through the aperture 24/24a (Fig. 1-2 of Kuntz – end portion 30 of tube 18/18a enters the opening 24/24a) and the fluid permeable body 34 (Fig. 2 of Kuntz – end portion 30 is inserted into the core pad 34 via central bore 22/22a) to position the inlet “IN” (see annotated Fig. 2 of Kuntz above) in fluid communication with the reservoir “R” (see annotated Fig. 2 of Kuntz above – the inlet “IN” receives fluid from central bore 22/22a which connects to the reservoir “R”).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Washington in view of Sanchez as applied to claim 25 above, and further in view of Brunner.
Regarding claim 26, Kuntz in view of Washington in view of Sanchez discloses the invention of claim 25. The combination of Kuntz, Washington, and Sanchez further discloses wherein the fluid impermeable barrier 36a (Fig. 2 of Kuntz) includes a protrusion (see annotated Fig. 32 of Sanchez; Examiner notes that once the combination is made as discussed, the reservoir/protrusion of Sanchez will be incorporated into the backing layer 36a of Kuntz; thus, the limitation is met), and the aperture 24/24a (Fig. 1-2 of Kuntz) are positioned on an axis “L” (see annotated Fig. 1 of Kuntz above) that is substantially centered on the lateral width “W1” of the opening “O” (see annotated Fig. 1 above of Kuntz – axis “L” being centered on the width “W1” of opening “O”).
However, the combination does not disclose the fluid impermeable barrier includes the protrusion extending from the second lateral side, the protrusion are positioned on an axis that is substantially centered on the lateral width of the opening.
Brunner, in the same field of endeavor of fluid collection device (Col. 5, line 54-55), teaches the fluid impermeable barrier 15 (Fig. 1 – tubular portion 15, and Col. 5, line 51-52 – “The condom should be made of a flexible, non-permeable material such as, for example, latex, polyisoprene, polyurethane, etc.”) includes a protrusion 40 (Fig. 1 – reservoir 40) extending from the second lateral side (see annotated Fig. 1 above), the protrusion 40 (Fig. 1) positioned on an axis that is substantially centered on the lateral width (see annotated Fig. 1 above – reservoir 40 is substantially laterally centered).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second lateral side of the Kuntz in view of Sanchez to further have a protrusion extending therefrom and to have the reservoir be within said protrusion as taught by Brunner, in order to provide a tip where fluid can collect (Col. 5, line 54-55 of Brunner).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Washington in view of Sanchez as applied to claim 30 above, and further in view of Weaver.
Regarding claim 32, Kuntz in view of Washington in view of Sanchez suggests the invention of claim 30. The combination further discloses wherein:
the fluid permeable body 34 (Fig. 2 of Kuntz – pad core 34) includes a first surface 28a (Fig. 2 – upper facing layer 28a) extending across at least a portion of the opening “O” (see annotated Fig. 1-2 of Kuntz above – the first surface 28a of pad core 34 spans across the opening “O” below the ring 26), a second surface “S2” (see annotated Fig. 2 of Kuntz above – second surface “S2” is the bottom surface of the pad core 34 that is adjacent the backing layer 36a) opposite to the first surface 28a (see annotated Fig. 2 of Kuntz above – second surface “S2” is on the bottom while the first surface 28a is at the top of the pad core 34), and
a slot 22/22a (Fig. 1-2 of Kuntz – central bore 22/22a) extending longitudinally through the fluid permeable body 34 (Fig. 2 of Kuntz and Col. 3, line 42-44 of Kuntz – “The pad 12 is formed with a central bore 22 extending longitudinally of the pad…”) and extending inward into the fluid permeable body 34 (Fig. 2 of Kuntz – the central bore 22/22a is within the core pad 34) to a predetermined depth within the fluid permeable body 34 (Fig. 2 – the central bore 22/22a spans radially from the central longitudinal axis of the system 10 to a certain depth to form a cylindrical bore); and
the conduit 18/18a (Fig. 1-2 of Kuntz) is positioned at least partially within the slot 22/22a (Fig. 2 of Kuntz – tube 18a with an extended portion 30 is inserted into the bore 22a, and Col. 3, line 61-64 of Kuntz – “…the tube 18a is provided with an extended perforated end portion 30 which may be inserted within pad 12a to occupy substantially the entire extent of the hollow bore 22a of such pad”).
However, the combination does not currently disclose a slot extending inward into the fluid permeable body from at least a portion of the second surface of the fluid permeable body to a predetermined depth within the fluid permeable body.
Weaver, the same field of endeavor of medical appliances used in the care of a patient (Par. 2) and tube organizer (Title), teaches a slot 12a (Fig. 1-2 – thin slot 12a) extending inward into the body 10 (Fig. 1-2 – block 10) from at least a portion of the second surface (see annotated Fig. 2 above) of the body 10 (Fig. 2) to a predetermined depth within the body 10 (see annotated Fig. 2 above – the slot extending from a second surface and into block 10 to a predetermined depth).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kuntz’s configuration of the slot to have the shape as taught by Weaver, in order to provide a slot with sufficient depth to hold the item in use (Par. 6 of Weaver). The body with said slot allows the insertion of medical patient care tubular units therewithin (Par. 6 of Weaver). Further, it is a matter of engineering design to arrange the slot in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Washington in view of Sanchez in view of Weaver as applied to claim 32 above, and further in view of Holsten.
Regarding claim 33, Kuntz in view of Washington in view of Sanchez in view of Weaver suggests the invention of claim 32. However, the combination does not disclose wherein the fluid permeable body includes one or more covers covering at least a portion of the slot when the conduit is at least partially positioned within the slot.
Holsten, considered to be analogous art since the invention employs a body with a slot and covers encircling a medical instrument (Par. 5 and Fig. 3), teaches wherein the body 126 (Fig. 3 – guard member 126) includes one or more covers “C” (see annotated Fig. 3 above) covering at least a portion of the slot 130+132 (Fig. 3 – covers “C” in its relaxed state is covering the actual surface area that aperture 130 can radially stretch/expand thanks to the radial slots 132).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the permeable body’s slot of the combination to have covers as taught by Holsten, in order to provide sufficient flexibility to not interfere with passage of the object (Par. 22 of Holsten), such as the passage/insertion of conduit 18 of the combined device. In other words, the covers formed by radial slots 132 as taught by Holsten when combined with the slot 22/22a of the combination allow the conduit to move within the permeable body 34 without great restriction; In the absence of room for flexibility, the whole fluid collection device 10 can be dragged around when the conduit is external portion of the conduit 18 is moving. Once the combination is made as discussed, when the conduit 18 is inserted and positioned within the slot 22/22a, the covers “C” as taught by Holsten will be pushed along the direction of insertion of conduit 18 and open to a certain degree due to the diameter of the conduit 18 while still maintaining coverage of the slot. Thus, the limitation “…covering at least a portion of the slot when the conduit is at least partially positioned within the slot” is met.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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.
/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781