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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 July 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 10 July 2026. As directed by the amendment: claims 14, 32, and 33 have been amended, claims 1-13 and 28-29 have been or remain canceled. Thus claims 14-27 and 30-33 are presently pending in this application and claims 25-27 remain withdrawn.
Response to Arguments
Applicant's arguments filed 10 July 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Daneshvar does not disclose the retention device itself being configured to receive a slide valve and to prevent operation of that slide valve because Daneshvar repeatedly describes a compartment configured to accommodate specific catheter components including an H-piece, a three-way stopcock, and inflation for and associated tubing, and no slide valve is disclosed, the Examiner respectfully disagrees. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The claims are directed to the structural elements of a retention device. The urinary catheter with the specifically described tubing and valve arrangement is only functionally recited. A urinary catheter with the specifics described does not need to be found for the claim to be taught by the prior art. The retention device of Daneshvar could retain a hypothetical urinary catheter with the recited structures as claimed, as such it teaches the claims. If Applicant believes there are structural components of Daneshvar that would prevent its use as claimed, then those should be pointed out.
Applicant argues the anti-opening wall claimed is not taught by Daneshvar because Daneshvar contains no disclosure that the wall mapped in the rejection interacts with a slide valve, prevents valve actuation, maintains a catheter valve in a closed position, or functions as a stop for a valve actuator and the examiners analyses relies on what the wall could do if a different component were inserted into Daneshvar rather than what Daneshvar actually teaches.
The Examiner respectfully disagrees. The differences argued are again functional so. Daneshvar does not need to teach the function, only the structure required by the function. The wall of Daneshvar, by its nature as a wall, would prevent contact and actuation of a valve on the inside of the retention device. This is the same as the way the anti-opening wall of the instant application works, if the only difference between the anti-opening wall of the instant application and that of Daneshvar is intended use then it is not patentably different, any structural differences should be claimed.
Applicant argues that claim 14 now recites the structure of the slide valve. The examiner agrees that Daneshvar does not teach the slide valve with the recited limitations, however, the slide valve is still only claimed functionally (“A retention device made and arranged to retain a urinary catheter”) as opposed to positively recited. Language such as “A retention device with a urinary catheter retained therein” would positively recite the catheter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14-18, 21, 23-24, 28-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daneshvar (US 5,460,606 A).
Regarding claim 14, Daneshvar discloses a retention device (Fig 4) made and arranged to retain a urinary catheter (79 Fig 4), in an element (71 Fig 4) external to a user's body, wherein the urinary catheter includes a tube having at one end an introduction section for introducing the tube through a urethra into a urinary bladder of a patient, and having at an opposite end a connection section for connecting connection elements, wherein fluid can be evacuated from the urethra through the introduction section into the connection section, and a valve arranged between the introduction section and the connection section such that the fluid is prevented from leaving the connection section when the valve is closed, wherein the valve is configured as a slide valve comprising an elongated movable valve member configured to slide longitudinally within a complementary valve body, said slide valve having three switching positions, the slide valve being closed in a closed position, the valve being air- permeable in a central position, and the valve being open in a release position (The slide valve is not positively recited, the retainer is fully capable of retaining a urinary catheter with a slide valve with the recited structures), the retention device comprising: - a first portion (the portion including 9a Fig 4) extending in a longitudinal direction "X" (down as shown in Fig 4) and comprising an inner recess (9a Fig 4, Col 3 lines 46-48 “spaces like cradles that allow the components of the lower end of the catheter to be positioned and held inside it.”) extending along the longitudinal direction "X", wherein the first portion is closed at an end by a stop portion (56 Fig 4 Col 3 lines 49-50 “a piece 56 with a cover that will close the lower end opening”) comprising an anti-leakage element (Col 11 lines 52-55 “The surface of the plastic 56 may also be designed to close the tip of the lower end of the catheter after the tip of the lower tube is removed, to prevent dripping of urine.”); a second portion (the portion including 11a in Fig 4) extending in a second direction "Y" (left as shown in Fig 4), transverse to the longitudinal direction "X", wherein the second portion comprises an inner recess (11a Fig 4) extending along the second direction "Y", and wherein the second portion is open at one end (the opening is where the catheter 79 splits off to the lower part 11, the right end of the cradle defined by 11a Fig 4) and comprises an anti-opening wall (see the wall at the left most end of the cradle defined by 11a Fig 4) at another end opposite to said one end (the opening is opposite the wall as shown in Fig 4); and a fastening element (straps 77 and 78 Fig 4) configured to releasably fasten the retention device to the element external (Col 3 lines 58-60 “The plastic compartment 80 and its supportive straps 77, 78 can be removed” the straps removably fasten the device 80 relative to the tube end 20 Fig 4), wherein the inner recess (11a Fig 4) of the second portion is configured to receive and accommodate at least a part of a slide valve of the catheter (the inner recess is fully capable of receiving and accommodating at least a part of a slide valve, the catheter and slide valve are not positively recited, slide valves and catheters are constructed in many sizes and shapes and the recess 11a in Fig 4 is able to accommodate at least part of one as it is a recess), wherein the open end of the second portion is made and arranged to allow a part of the slide valve to protrude where an activation button of the slide valve is located (The slide valve is not positively recited, the opening into 11a Fig 4 is fully capable of enabling a part of the slide valve to protrude from the opening by its nature as an opening that allows things through itself), and wherein the anti-opening wall is made and arranged to block movement of the actuator button of the slide valve when a force is applied on it to prevent the slide valve from being opened so as to keep the slide valve in the closed position whenever it is inserted in the retention device (the anti-opening wall (the wall at the left most end of the cradle defined by 11a Fig 4) is fully capable of preventing a slide valve from being opened by its nature as a wall preventing movement of the components inside).
Regarding claim 15, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the fastening element is arranged in the first portion (the straps 77 and 78 are arranged under the majority of the device body 80, including under the first portion 9a as shown in Fig 4).
Regarding claim 16, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the fastening element is integrated in the first portion (As shown in Fig 4, the straps are attached to 80 under the first portion, joining and therefore integrating the components).
Regarding claim 17, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the fastening element comprises a tab (the straps 77 and 78 Fig 4 can be interpreted and defined as tabs, they are flat elements that can be grasped) having an upper end (the bottom edge of the straps 77 and 78 Fig 4) that emerges from a rear face of the retention device (As shown in Fig 4, the straps 77 and 78 extend from the rear face of 80).
Regarding claim 18, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the first portion (the portion defined by wall 9a Fig 4) has an elongated body (the portion 9a is elongate, extending along tubing section 9 Fig 4) in the form of a half-barrel (the tight-fitting wall 9a cradles the section of tubing 9, see the half barrel shape of the cradle 314 shown in the embodiment of Fig 10, and the shape of the cradle 244 in the embodiment of Fig 12).
Regarding claim 21, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the second portion (the portion including 11a in Fig 4) has an elongated half-barrel-shaped body (the portion 11a is elongate, extending along tubing section 11 Fig 4) in the form of a half-barrel (the tight-fitting wall 11a cradles the section of tubing 11, see the half barrel shape of the cradle 314 shown in the embodiment of Fig 10, and the shape of the cradle 244 in the embodiment of Fig 12), the inner recess being created to receive inside and accommodate, in a tight manner, at least a part of the slide valve (Col 11 lines 22-28 “The molding inside this plastic compartment has surfaces, open spaces, and shapes to accept and hold the connected parts of the lower end of the Safe Catheter and tip of the lower tube and their related pieces such as the H. piece, the three-way stopcock and the tip of the inflation port of the balloon, etc., tight inside itself”, the slide valve is functionally claimed, not positively recited, and the inner recess of Daneshvar is fully capable of accommodating, in a tight manner, a slide valve, for example, a catheter having a slide valve with proportions to fit into the inner recess).
Regarding claim 23, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the second portion comprises an opening in the form of a "C" in a central part and a lower part of the second portion, wherein the opening is aligned with the longitudinal axis "X" of the first portion (the opening into the second portion 11a shown in Fig 4 would be C shaped as it is an opening in the half barrel cradle as depicted by opening 252 in Fig 12).
Regarding claim 24, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the retention device is formed as a monobloc body (80 Fig 4 includes a compartment made of molded hard plastic, Col 10 lines 36-45).
Regarding claim 28, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the catheter comprises a urinary catheter (the catheter is not positively recited, the claims currently require a retention device that is fully capable of use with a urinary catheter, and further what structure constitutes a urinary catheter is broad, nonetheless the catheter 79 of Daneshvar is described as a urinary catheter, Col 3 lines 45-46, Claims: “A urinary catheter”).
Regarding claim 29, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the catheter comprises a feeding catheter (the catheter is not positively recited, the claims currently require a retention device that is fully capable of use with a feeding catheter, and further what structure constitutes a feeding catheter is broad, the retention device of Daneshvar is fully capable of use with a feeding catheter as it can be used with a tube that food can pass through).
Regarding claim 30, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the fastening element (straps 77 and 78 Fig 4) is configured to attach to a strap (84 Fig 4) or a user's underwear.
Regarding claim 31, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the open end of the second portion comprises an opening configured to enable the part of the slide valve to protrude from the opening (The slide valve is not positively recited, the opening into 11a Fig 4 is fully capable of enabling a part of the slide valve to protrude from the opening by its nature as an opening that allows things through itself).
Regarding claim 32, Daneshvar discloses the retention device according to claim 31. Daneshvar further discloses wherein the protruding part of the slide valve includes the activation button (The slide valve is not positively recited, the slide valve the opening can accommodate can include any construction, including a slide valve including an activation button).
Regarding claim 33, Daneshvar discloses the retention device according to claim 14. Daneshvar further discloses wherein the anti-opening wall is configured to act as a stop during installation of the slide valve in the second portion and, after the slide valve is installed, to keep the slide valve in the closed position (The slide valve is not positively recited, the anti-opening wall, the left most wall of 11a Fig 4, is fully capable of acting as a stop as claimed by its nature as a solid closed surface. If a slide valve were installed, the wall would prevent access to it and prevent the valve from being opened).
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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Daneshvar (US 5,460,606 A) in view of Barnett (US 9,199,060 B1).
Regarding claim 19, Daneshvar discloses the retention device according to claim 14.
However, Daneshvar fails to disclose wherein the anti-leakage element is configured by a protruding element on an inner part of the first portion, and wherein the anti-leakage element is configured to fit inside an open end of the catheter or a catheter connection tube.
Barnett teaches an anti-leakage element (17 Fig 4) is configured by a protruding element (See the element semi-spherical element of 19 protruding in Fig 3) on an inner part of the first portion (the protrusion is on the inner part of the element that caps the tubing), and wherein the anti-leakage element is configured to fit inside an open end of the catheter or a catheter connection tube (Col 5 lines 63-65 “the stopper cap 19 to form an impermeable seal with the drainage port 16 when engaged.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the anti-leakage element of Daneshvar to be configured as taught by Barnett to “form an impermeable seal with the drainage port 16 when engaged.” (Col 5 lines 63-65)
Regarding claim 20, Daneshvar discloses the retention device according to claim 14.
However, Daneshvar fails to disclose wherein the anti-leakage element is a semi-spherical protrusion.
Barnett teaches an anti-leakage element (17 Fig 4) is a semi-spherical protrusion (See the element semi-spherical element of 19 protruding in Fig 3). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the anti-leakage element of Daneshvar to be a semi-spherical protrusion as taught by Barnett to “form an impermeable seal with the drainage port 16 when engaged.” (Col 5 lines 63-65)
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Daneshvar (US 5,460,606 A) in view of Roberts et al. (US 2018/0154117 A1).
Regarding claim 22, Daneshvar discloses the retention device for a catheter, according to claim 14.
However, Daneshvar fails to disclose wherein the anti-opening wall comprises an opening.
Roberts et al. teaches a non-opening wall comprises an opening (120, 124 Fig 4). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the non-opening wall of Daneshvar to include an opening as taught by Roberts et al. to “improve the breathability of the securement device assembly” ([0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 4:00 PM-9:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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