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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 March 2026 has been entered.
Claim Objections
The claims contain minor informalities.
In claim 6, the language “… wherein said lip is attached around a perimeter of said body …” should be changed for clarity.
In claim 12, the language “… wherein said collection region abuts [[to]] said cotton material …” 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 1-15, 17-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Jamison; Aron (US 20210220162 A1) in view of Martin; Adam et al. (WO 2021211568 A1).
Regarding claim 1, Jamison discloses an external catheter (¶ [0010] This disclosure is directed to an external urine evacuation device; ¶ [0011] In FIG. 1, a urine evacuation device 100);
comprising: a body, wherein said body is a hollow concave shape (¶ [0011], device 100 may include an outer shell 102 that is impermeable to liquids; ¶ [0014] As depicted in FIG. 2, a peripheral shape of outer shell 102 of device 100 may be similar to an upside-down pear shape);
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a lip, wherein said lip is attached around a perimeter of said body (¶ [0013], it is desirable for outer shell 102 to have curved or rounded edges);
a silicone layer, wherein said silicone layer is a single layer of said body (¶ [0012], Materials having properties akin to silicone are contemplated for outer shell 102; ¶ [0013], materials such as silicone may be used to form outer shell 102);
a drain element (¶ [0011], Device 100 further includes a tube 104);
wherein said drain element is configured to follow the contour of said concave shape of said body (Figs. 3, 5, tube 104 follows the contour of outer shell 102);
an outlet, wherein said outlet covers said drain element (¶ [0013], Moreover, it is noted that port 106 may be molded directly in outer shell 102 or may be punched out after molding outer shell 102);
wherein said outlet is configured to follow the contour of said concave shape of said body (Figs. 3, 5, port 106 follows the contour of outer shell 102);
a fiber element, wherein said fiber element is attached to said body, wherein said fiber element is placed inside said outlet, wherein said fiber element abuts said drain element (¶ [0016], In an embodiment, permeable layer 400 may be formed of a liquid wicking material to draw away moisture from the body. In an embodiment, permeable layer 400 may be an open-cell foam, such as a polyurethane foam, for example);
a collection region, wherein said concave shape of said body directs a flow of urine downwards to said collection region through gravity, wherein said collection region abuts said fiber element (annotated Fig. 5 shows a collection region near the bottom of shell 100, where gravity will direct urine); and
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a vent, wherein said vent abuts said body (¶ [0011], Additionally, one or more ventilation ducts 108 may be included as holes, for example, at an upper end of device 100).
Jamison does not explicitly disclose that the drain element is configured for standing and prone urine drainage. However, Jamison configures the body to operate in at least a standing position (¶ [0015], the portion of tube 104 that is inserted is fixed in a vertically extending position … This orientation may be beneficial to conform more easily with clothing worn by or coverings over the user).
Jamison’s device also appears capable of funneling urine towards the collection region when the user is in a prone position. Annotated Fig. 5 shows how Jamison’s device will be oriented when a user is in a prone position. In this position, the low point will also accumulate urine and permit the drain element (tube 104) to remove the urine.
Regarding the fiber element that is placed inside the outlet and abuts the drain element and collection region, Jamison fills the shell 102 with an open-cell polyurethane foam, wicking material or membrane (¶ [0016], permeable layer 400), and shows that the permeable layer 400 extends through the entire inner volume of shell 102 (Fig. 5).
Jamison lacks a valve. 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 (¶ [0072] FIGS. 7A-7B; ¶ [0073], The fluid collection device 700 may include a fluid impermeable pouch 702);
a lip (¶ [0051], flange 228; ¶ [0060], border 424; ¶ [0063], lip 522 or border);
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 (¶ [0073], aperture 712);
a fiber element (¶ [0074], fluid permeable portion 710);
a collection region (Fig. 7B, fluid permeable portion 710 is configured to wick or transport urine to the aperture 712 and therefore includes a collection region); and
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 prevents leaks through a vent by limiting flow in one direction (¶ [0038]). One would be motivated to modify Jamison with Martin’s valve to prevent leaks through Jamison’s vent, which likewise communicates with the external environment. Therefore, it would have been obvious to modify Jamison with Martin’s valve in order to avoid leaks.
Regarding claim 6, Jamison and Martin teach substantially all features of the claimed invention. Jamison lacks an adhesive element.
Martin 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 is 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).
Martin more securely holds an external collection catheter to a user with a combination of straps and adhesive (¶ [0040], The external collection vessel may be pushed against the anatomy of the female and/or secured to the anatomy of the female via one or more of straps, adhesives, securement element, or some combination thereof). One would be motivated to modify Jamison with Martin’s adhesive element to more securely fasten the catheter and prevent leaks. A skilled artisan would have been able to modify Jamison with Martin’s adhesive element by placing adhesive around Jamison’s perimeter. Therefore, it would have been obvious to modify Jamison with Martin’s adhesive element in order to prevent leaks at the perimeter or lip.
Regarding claim 12, Jamison and Martin teach substantially all features of the claimed invention. Jamison lacks a cotton material and adjustable attachment element.
Martin further discloses a fiber element comprising 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)); and
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).
Martin selects a widely available wicking material and also secures the catheter with elements that in combination prevent leaks (¶ [0040]). Regarding the rationale and motivation to modify Jamison with Martin’s multiple fasteners, see the discussion of claims 1 and 6 above.
Regarding claim 18, Jamison and Martin teach substantially all features of the claimed invention. Jamison lacks a cotton material, an adjustable attachment element and underwear.
Martin further discloses a fiber element comprising cotton (¶ [0091], The fluid permeable membrane can include … a gauze (e.g., a silk … or cotton gauze));
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).
Martin selects a commonly known wicking material and also prevents leaks by securing the external catheter with multiple securement elements. Regarding the rationale and motivation to modify Jamison with Martin’s cotton material and various attachment elements, see the discussion of claims 1, 6 and 12 above.
Regarding claims 2-4, 7-9, 13-15 and 19-20, Jamison discloses an external catheter wherein said external catheter is unisex (¶ [0010], a urine evacuation device may be shaped as depicted in FIGS. 1-5, and such a shape may be particularly beneficial for use evacuating urine from male genitalia. It is contemplated, however, that other shapes not shown herein may be satisfactory as well for male genitalia, and that yet the same or other shapes may be similarly or more accommodating for female genitalia);
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 (¶ [0012], Materials having properties akin to silicone are contemplated for outer shell 102. Silicone rubber is contemplated for use due to the flexibility, compressibility, durability … elasticity and deformability, moldability, inert nature with respect to human skin, and soft, rubbery feel against flesh);
wherein said fiber element guides a stream of urine to said drain element, wherein said stream of urine is collected for disposal (¶ [0016], the permeable layer 400 may allow urine to pass through to be evacuated via tube 104 and prevent urine from remaining in large quantities against the skin of the user/patient; ¶ [0018] In an embodiment, one or more moisture sensors 500 may be embedded in outer shell 102 to detect moisture and communicate with an associated vacuum pump (not shown) to activate the suction).
Regarding claims 5, 11, 17 and 22, Jamison lacks a valve. Martin discloses a valve that 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).
Martin blocks liquids against exiting the vent. One would be motivated to modify Jamison with Martin’s valve since Jamison discloses vents which communicate with the external environment, but do not otherwise retain liquids inside body (¶ [0016], one or more ventilation ducts 108). Therefore, it would have been obvious to modify Jamison with Martin’s valve in order to prevent liquids from leaking out through the vent.
Regarding claim 10, Jamison lacks an adhesive element. Martin discloses an adhesive element that 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).
Martin secures an external catheter with fastening elements that reinforce and cooperate with each other (¶ [0040]). Regarding the rationale and motivation to modify Jamison with Martin’s adhesive element, see the discussion of claim 1 above.
Response to Arguments
The objections to claims 1, 6, 12, 14 and 18 for minor informalities are withdrawn in view of the amendments filed 26 March 2026.
Applicant’s arguments filed 26 March 2026 regarding the rejection of claims 1-15, 17-20 and 22 as amended, under 35 USC § 103 over Martin, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Jamison and Martin (see above).
Examiner acknowledges Applicant’s interview summary for the interview conducted 02 February 2026.
Applicant submits that motivation to combine, Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so (remarks p. 5). Examiner responds that amended claims 1-15, 17-20 and 22 are rejected on new grounds over Jamison and Martin. The current rejection modifies Jamison by adding Martin’s valve, adhesive element, cotton material, attachment element or underwear according to independent claims 1, 6, 12 and 18.
Applicant asserts that in the Patent Owner's disclosure, the absorbent fiber element (108) or cotton material of the patent owner's design is incorporated differently than in the prior art (Martin) (remarks p. 5). Applicant reasons that structurally, this is different from the various embodiments of the prior art (Martin) wherein the fiber wicking element is incorporated throughout the body of the external catheter device, placed directly against the user, and can extend through the drain element to the drainage tube (remarks p. 6). Examiner notes that Jamison is cited in the new grounds of rejection as teaching a fiber element (¶ [0016], [0017], permeable layer 400). Also, none of the pending claims specify that the fiber element (108) or cotton material is located solely between the collection region (112) of the catheter device and the drain element (106) within the outlet (110). Instead, the claims describe “a fiber element … wherein said fiber element is placed inside said outlet, wherein said fiber element abuts said drain element …” This language does not preclude the fiber element against extending to other regions of the external catheter.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the fiber element (108) or cotton material does not enter the drain element (106) itself, only abutting to it (106) … the fiber element (108) of the patent owner's device only participates in one step of the drainage process) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant contends that in the patent owner's device, the outlet and drain elements follow along the contour of the concave body, as is shown in Figures 2, 3, 4, and 6 (remarks p. 7). Examiner replies that Jamison is cited in the new grounds of rejection as teaching a drain element and outlet that follow the body’s contour (Figs. 3, 5). Jamison depicts in Fig. 5 a cross-section profile of the external catheter which shows its drain element curving generally parallel to the body’s contour.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Van Den Heuvel; Eleanor et al. US 20080287894 A1
Eckert; Kathryne Rose US 20200315838 A1
Kriscovich; Hannah Rose et al. US 20220313474 A1
Hughett, Sr.; James David US 20230190512 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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