DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The claims contain minor informalities.
In claim 1, the language “… wherein said fiber element abuts the drain element … wherein said valve is attached to said vent.” should be changed for clarity.
Claims 6, 12 and 18 contain similar language and should be revised similarly.
In claim 6, the language “… a border such that said border is configured for a sealed attachment …” should be revised for proper grammar.
In claim 14, the language “… wherein said elasticity [[enables]] configures said body to [[contour]] conform to a [[plurality]] range of …” should be changed for clarity.
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 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.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Martin; Adam et al. (WO 2021211568 A1).
Regarding claim 1, Martin discloses an external catheter (¶ [0047] FIGS. 2A-2D show a fluid collection device 200; ¶ [0057] FIGS. 4A-4D show fluid collection device 400; ¶ [0062] Turning specifically to FIG. 5A, which illustrates a front isometric view of a fluid collection device 500; ¶ [0072] FIGS. 7A-7B illustrate rear isometric and front isometric views, respectively, of a fluid collection device 700);
comprising: a body, wherein said body is a hollow concave shape (¶ [0072] FIGS. 7A-7B; ¶ [0073], The fluid collection device 700 may include a fluid impermeable pouch 702 or cup having a hard or soft plastic/elastomer cup or other collection device);
a lip, wherein said lip is attached around perimeter of said body (¶ [0051], The securement element 220 also may include a flange 228 at least partially surrounding the opening 206 and/or the one-way material 218; ¶ [0060], a border 424 surrounding and/or secured to a periphery of the fluid impermeable pouch 402; ¶ [0063], For example, the fluid collection device 500 may include a lip 522 or border at the proximal end region of the fluid impermeable pouch 502 and two opposing wings 520 may extend from the lip 522; ¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps);
a silicone layer, wherein said silicone layer is a single layer of said body (¶ [0087] Pouches, cups, securement elements, and/or fluid impermeable barriers described herein may include any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone … a polycarbonate, etc.) … Example fluid impermeable barriers may include … Silpuran 6000/05 A/B silicone);
a drain element, wherein said drain element is configured for standing and prone urine drainage (¶ [0050] The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer … a portion of the securement element 220 may include shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element to a desired angle that is retained by the securement element 220; ¶ [0073], A tube 708 may feed urine collected with the fluid collection device 700 to an external collection bag via gravity and/or a vacuum. The tube 708 may include an adapter 716 or connector configured to connect to an additional tube (not shown); ¶ [0084] Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position);
an outlet, wherein said outlet covers said drain element (¶ [0073], aperture 712);
a fiber element, wherein said fiber element is attached to said body, wherein said fiber element abuts drain element (¶ [0074] The fluid collection device 700 may further include a fluid permeable portion 710 positioned at least partially inside the chamber 704. The fluid permeable portion 710 may be configured to wick or transport urine to the aperture 712 and/or the tube 708 that provides fluid communication between the chamber 704 and a collection container or bag (not shown));
a collection region, wherein said collection region abuts said fiber element (Fig. 7B, fluid permeable portion 710 is configured to wick or transport urine to the aperture 712 and therefore includes a collection region);
a vent, wherein said vent abuts said body; and a valve, wherein said valve is attached said vent (¶ [0038], The fluid collection device may be vented with a hydrophobic vent to prevent leakage; ¶ [0074], An additional material 714 may extend across the opening on the back side of the fluid collection device 700. For example, the additional material may include an additional fluid impermeable barrier and/or a one-way material that allows air into the chamber 704 but prevents fluid from leaving the chamber 704; ¶ [0075] FIG. 8 shows a fluid collection device 800 … The fluid collection device 800 also may include a vent hole 814 and cap distal to the aperture 812. The cap may be secured or securable to the vent 814).
Martin teaches the invention substantially as claimed by Applicant but does not teach all the claimed features in a single embodiment. This rejection combines features from Martin’s embodiments in Figs. 2, 4, 5, 7 and 8. A skilled artisan would have been able to combine these features by constructing the body of Fig. 7 from silicone material and configuring element # 720 as a lip, according to one of the other embodiments. One would be motivated to modify Martin’s embodiments since Martin lists silicone as a suitable material and also calls for integrating the device 700 of Fig. 7 in underwear (¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps). Configuring element # 720 as a lip will enable the body to attach to an opening in customized underwear.
Regarding claim 6, Martin discloses an external catheter according to claim 1 as discussed above. Martin further discloses an adhesive element, wherein said adhesive element is attached to said lip, wherein said lip and said adhesive element form a border such that said border configured for a sealed attachment to a human body (¶ [0050], The base 222 may include one or more features to secure the base to the surface of the user (bed, seat, etc.), such as but not limited to adhesive, suction cups, rubber feet; ¶ [0053] FIGS. 3A-3D … The fluid collection device 300 may be configured to secure to a user 50 with an adhesive 320 on the fluid collection device 300, with the adhesive 320 being positioned on the fluid collection device 300 to generally be outside of the hairline of the user 50; ¶ [0056] The fluid collection device 300 may be secured to the user with an adhesive. For example, the fluid collection device may include a sheet 322, such as absorbent fabric layer or other material, which includes an adhesive 320 on one or more portions of the layer; ¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps).
Regarding the rationale and motivation to combine features from Martin’s various embodiments, see the discussion of claim 1 above.
Regarding claim 12, Martin discloses an external catheter according to claim 1 as discussed above. Martin’s drain element constitutes a drain tube (¶ [0073], A tube 708 may feed urine collected with the fluid collection device 700 to an external collection bag via gravity and/or a vacuum. The tube 708 may include an adapter 716 or connector configured to connect to an additional tube (not shown)).
Martin’s fiber element comprises cotton (¶ [0091], The fluid permeable membrane can include any material that can wick the fluid. For example, the fluid permeable membrane can include fabric, such as a gauze (e.g., a silk … or cotton gauze)).
Martin further discloses an attachment element, wherein said attachment element is configured to hold said body, wherein said attachment element is adjustable (¶ [0050], The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer. Accordingly, the fluid collection device 200 may include an elbow or bendable portion between the base 222 and the handle 226 that angles the fluid collection device 200 to the desired position; ¶ [0057] FIGS. 4A-4D … The fluid collection device 400 may be sized to fit substantially all users, as the fluid collection device 400 may include adjustable straps 420 to fit a large range of sizes of users; ¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps);
wherein said attachment element is configured for standing and prone urine drainage (¶ [0050] The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer … a portion of the securement element 220 may include shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element to a desired angle that is retained by the securement element 220; ¶ [0084] Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position).
Regarding the rationale and motivation to combine features from Martin’s various embodiments, see the discussion of claim 1 above.
Regarding claim 18, Martin discloses an external catheter according to claim 1 as discussed above. Martin’s drain element constitutes a drain tube (¶ [0073], tube 708).
Martin’s fiber element comprises cotton (¶ [0091], The fluid permeable membrane can include … a gauze (e.g., a silk … or cotton gauze)).
Martin further discloses an attachment element, wherein said attachment element is configured to hold said body, wherein said attachment element is adjustable (¶ [0050], The user also may move … requiring the fluid collection device 200 to be adjusted … Accordingly, the fluid collection device 200 may include an elbow or bendable portion between the base 222 and the handle 226 that angles the fluid collection device 200 to the desired position; ¶ [0057] FIGS. 4A-4D … the fluid collection device 400 may include adjustable straps 420 to fit a large range of sizes of users; ¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps); and
an underwear, wherein said underwear is configured with said attachment element to hold said body (¶ [0059], The fluid collection devices shown in FIGS. 5A-6C may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps; ¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps);
wherein said underwear is unisex (¶ [0072], The fluid collection device 700 may be shaped and dimensioned for use with either a male or female user. For example, the fluid collection device 700 may be sized to position over the vulva of a female user or over at least the penis (e.g., the penis and the scrotum) of a male);
wherein said underwear is configured for standing and prone urine drainage (¶ [0050] The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer … a portion of the securement element 220 may include shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element to a desired angle that is retained by the securement element 220; ¶ [0084] Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position).
Regarding the rationale and motivation to combine features from Martin’s various embodiments, see the discussion of claim 1 above.
Regarding claims 2-5, 7-11, 13-17 and 19-22, Martin discloses an external catheter wherein said external catheter is unisex (¶ [0072], The fluid collection device 700 may be shaped and dimensioned for use with either a male or female user. For example, the fluid collection device 700 may be sized to position over the vulva of a female user or over at least the penis (e.g., the penis and the scrotum) of a male);
wherein said silicone layer enables said body to be elastic, wherein said elasticity configures said body to conform to a range of differently shaped human bodies (¶ [[0087] Pouches, cups, securement elements, and/or fluid impermeable barriers described herein may include any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone … etc.); ¶ [0055], The fluid impermeable pouch 302 or cup also may conform to anatomy of the user; ¶ [0059], The fluid impermeable pouch 402 also may conform to anatomy of the user; ¶ [0072], The fluid collection device 700 may be shaped and dimensioned for use with either a male or female user);
wherein said fiber element guides a stream of urine to said drain element, wherein said stream of urine is collected for disposal (¶ [0074], The fluid permeable portion 710 may be configured to wick or transport urine to the aperture 712 and/or the tube 708 that provides fluid communication between the chamber 704 and a collection container or bag (not shown));
wherein said valve is configured to allow air inside said body, wherein said valve does not allow liquid outside said body (¶ [0074], An additional material 714 … the additional material may include an additional fluid impermeable barrier and/or a one-way material that allows air into the chamber 704 but prevents fluid from leaving the chamber 704);
10. The adhesive element of claim 6, wherein said adhesive element prevents urine from leaking outside said body during urination (¶ [0053] FIGS. 3A-3D … The fluid collection device 300 may be configured to secure to a user 50 with an adhesive 320 on the fluid collection device 300, with the adhesive 320 being positioned on the fluid collection device 300 to generally be outside of the hairline of the user 50);
wherein said cotton material is placed inside said outlet (¶ [0074], The fluid permeable portion 710 may be configured to wick or transport urine to the aperture 712 and/or the tube 708 that provides fluid communication between the chamber 704 and a collection container or bag (not shown)).
Response to Arguments
The objections to the drawings are withdrawn in view of the amendments filed 06 July 2025. The amended drawings and specification properly describe vent 111 and valve 113.
The objections to claims 1 and 18 for minor informalities, the rejections of claims 3, 6-11, 14 and 19 under 35 USC 101 and the rejections of claims 3, 8, 14 and 18-22 under 35 USC 112 are withdrawn in view of the amendments filed 06 July 2025. However, the amended claims introduce further informalities as noted above.
Applicant’s arguments filed 06 July 2025 regarding the rejection of claims 1-22 as amended, under 35 USC § 103 over Martin, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant submits that in the Patent Owner's disclosure, the geometric design and the location of the drain element (106) allows for either prone or standing urine drainage (remarks p. 3). Applicant reasons that prior art (Martin) does not teach this invention in the standing position (in each embodiment, the subject in the prior art is laying down, NOT standing up) (remarks p. 3).
Examiner responds that Martin describes how the body is capable of being used when the user is in a seated, supine or laying-down orientation (¶ [0050] The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer … a portion of the securement element 220 may include shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element to a desired angle that is retained by the securement element 220; ¶ [0084] Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position);
Martin further discloses that the catheter may connect to an external vacuum source (¶ [0073], A tube 708 may feed urine collected with the fluid collection device 700 to an external collection bag via gravity and/or a vacuum. The tube 708 may include an adapter 716 or connector configured to connect to an additional tube (not shown). Connecting a vacuum source to the body will actively remove fluid from the body, and enable it to drain fluid while the user or body is positioned in any orientation.
The ability to operate in standing and prone positions relates to the angle between the wearer’s legs and torso, in other words the user’s pelvis tilt angle. The ability to operate in multiple orientations is also enabled by applying vacuum or negative pressure to the catheter’s body.
The following references each describe an external catheter comprising a body and drain element. These references disclose that the body and catheter are capable of collecting urine while the user is positioned in multiple orientations.
Piette; Francois et al. (US 20100010459 A1) describes a urine collection system and body configured to operate in multiple orientations (¶ [0027] The undergarment of the invention can allow the user to move about in a lying position, or when sitting in an armchair, or when standing, and to change position comfortably and easily).
Kicos; John (US 20130237964 A1) discloses an external catheter and body configured to operate in multiple orientations (¶ [0037] The urine directional device 100 shown in FIG. 7 is configured such that the user can void in a sitting position in addition to a standing position. This sitting position is particularly useful for a male user as the device 100 provides an alternative to invasive catheters. In one configuration in accordance with the principles of the disclosure, the urine directional device 100, as shown in FIG. 7, is configured to be utilized when a user is in a sitting position, raising one leg slightly during a voiding to further ensure against leakage).
Miskie, Mark (US 20050131361 A1) describes a receptacle or body configured to operate in multiple orientations (¶ [0049] When in a normal standing position, the receptacle 10 is generally oriented inside the undergarment as shown in FIG. 8 … Alternatively, for hospital patients or other individuals confined to a bed or wheelchair … When seated or in a supine position, the receptacle 10 is generally oriented in a more horizontal position. In this position, shown in FIG. 9, some amount of urine "U" may flow through the drain holes 41 in the tongue 35 and backwardly towards the user).
Sharma; Amit Kumar et al. (US 20230020563 A1) demonstrates an external catheter and body that apply vacuum and are configured to operate in multiple orientations (¶ [0090], In certain embodiments where suction is capable of being applied to the one or more outlet conduit member(s) 24 … negative pressure is created within the second fluid compartment 104, and consequently in the first fluid compartment 102, and air is drawn into the pouch through the one or more air exchangers 30 for as long as suction/negative pressure is applied; ¶ [0155] The devices described in embodiments herein provide for urine removal devices that may be used by patients or other users in the prone position, lying sideways, or sitting because the designs are effective at containing urine without leaking and evacuating urine quickly away from the anatomy).
Applicant asserts that B. The prior art (Martin) will leak if the user stands when using the catheter device and therefore Martin teaches away from Patent Owner's Patent Application (remarks p. 3). Examiner acknowledges that Martin operates the catheter when the wearer is seated or laying down (¶ [0050] The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer … a portion of the securement element 220 may include shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element to a desired angle that is retained by the securement element 220; ¶ [0084] Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position).
However, Martin further discloses that the catheter includes a vacuum supply which actively removes fluid from the body (¶ [0041], The fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17; ¶ [0044], the portable vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member; ¶ [0051], The tube 208 may feed urine collected with the fluid collection device 200 to an external collection bag via gravity and/or a vacuum source; ¶ [0053], A tube 308 may feed urine collected with the fluid collection device 300 to an external collection bag via gravity and/or a vacuum; ¶ [0057], A tube 408 may feed urine collected with the fluid collection device 400 to an external collection bag via gravity and/or a vacuum). Applying vacuum to the body enables it to operate in any orientation.
Applicant contends that because the device is held in place by the body shape of the user, when the user stands up, the device is not secure and may dislodge or lose contact with the user causing leakage from the device (remarks p. 4-5). Applicant reasons that similar to the argument made above, the embodiments shown in Figures 3A-3D also have leakage issues when the user stands up (remarks p. 5).
Examiner replies that Martin’s vacuum-enabled body is capable of operating in any orientation because it actively removes fluid with vacuum. In addition to removing fluid from the body, the vacuum will push the body closer to the user by its adhesive force.
Applicant submits that as can be seen in the Exhibit table shown in the next page, these differences include: the prior art does not have a vent and valve system for airflow, it is not known whether the prior art is gender specific, and no mention of a fiber/cotton element to guide urine to drain (remarks p. 7-8). Examiner responds that Martin explicitly discloses all the features of claims 1-22 or implies that the catheter is capable of performing the claimed functions.
Claimed feature
Martin’s explicitly disclosed feature
Unisex design
¶ [0072], The fluid collection device 700 may be shaped and dimensioned for use with either a male or female user. For example, the fluid collection device 700 may be sized to position over the vulva of a female user or over at least the penis (e.g., the penis and the scrotum) of a male
Non-invasive use, hollow concave body
¶ [0040] In general, the fluid collection device includes an external collection vessel, such as a cup, pouch, and the like
Elastic silicone body
¶ [0087] Pouches, cups, securement elements, and/or fluid impermeable barriers described herein may include any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone, polypropylene … etc.), polyurethane films … Silpuran 6000/05 A/B silicone.
Adhesive sealing element
¶ [0050], The base 222 may include … adhesive, suction cups, rubber feet; ¶ [0053] FIGS. 3A-3D … The fluid collection device 300 may be configured to secure to a user 50 with an adhesive 320 on the fluid collection device 300; ¶ [0063], In some embodiments, the wings 520 may include an adhesive and/or microtexturing configured to inhibit slipping of the wings 520 on the skin of the user; ¶ [0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps
Absorbent fiber or cotton guiding material
¶ [0091] The fluid permeable membrane and the fluid permeable support also can wick and/or allow transport of the fluid generally towards an interior of the chamber and/or the tube … the fluid permeable membrane can include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze)
Secure attachment for mobility (e.g., underwear or belt)
¶ [0066], A securement element such as an adhesive, one or more straps, or an undergarment may be secured or securable to the fluid impermeable pouch 602 and configured to retain the fluid impermeable pouch 602 over the vulva
Vent and valve system for airflow (no liquid escape)
¶ [0038], The fluid collection device may be vented with a hydrophobic vent to prevent leakage; ¶ [0074], An additional material 714 … may include an additional fluid impermeable barrier and/or a one-way material that allows air into the chamber 704 but prevents fluid from leaving the chamber 704; ¶ [0075] FIG. 8 shows a fluid collection device 800 … The fluid collection device 800 also may include a vent hole 814 and cap distal to the aperture 812
Claimed feature
Martin’s implied feature
Standing or prone urine drainage
¶ [0050] The user also may move between a seated and a supine position … shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element; ¶ [0073], A tube 708 may feed urine collected with the fluid collection device 700 to an external collection bag via gravity and/or a vacuum. The tube 708 may include an adapter 716 or connector configured to connect to an additional tube (not shown); ¶ [0084] Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position
Outlet securing drain element
Fig. 7A, ¶ [0073], aperture 712
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781