DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed September 29, 2025.
Election/Restrictions
1. Applicant’s election without traverse of Group II, claims 11-17, in the reply filed on September 29, 2025 is acknowledged. Claims 1-10 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
2. Claims 11-17 are pending and currently under consideration for patentability.
Priority
3. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on March 6, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
5. Claim(s) 11 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US PGPUB 2012/0302955) in view of Kay (US PGPUB 2011/0230851).
6. With regard to claims 11 and 15, Liu discloses a catheter cover for a urinary catheter (scaffold-balloon catheter assembly, 2; Fig. 1; abstract; [0038]), comprising: a cover sheath (protecting sheath, 20), the cover sheath (20) including a longitudinal slit (cut, 26) extending from a first end (proximal end, 20a) of the sheath (20) to a second end (distal end, 20b) of the sheath (Figs. 2A-2D; [0046]); and a raised end portion (24) extending radially outward from the cover sheath (20) and located at the first end (20a) of the catheter cover (Fig. 1A; [0044]; [0047]).
However, Liu fails to explicitly disclose a body engagement portion extending radially outward from the cover sheath and located at the first end of the catheter cover; wherein the body engagement portion is modular relative to the cover sheath.
Kay discloses a male external incontinence device (abstract; Figs. 3 and 5-8) comprising: a cover sheath (housing, 2) for connection to an inlet of a urine collection bag (60; [0029]); a body engagement portion (parameatal barrier body, 3) extending radially outward from the cover sheath (2) and located at the first end of the cover sheath (2), wherein the body engagement portion (3) is modular relative to the cover sheath (“parameatal barrier body 3 attached to lower surface of housing 2”; Fig. 6; [0024-0027]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the raised first end of the catheter cover disclosed by Liu to include a modular body engagement portion similar to that disclosed by Kay, in order to provide the catheter cover with a parameatal barrier seal against the glans penis, reducing the risk of urine leakage, during use, as suggested by Kay in at least paragraph [0012].
7. With regard to claim 13, Liu further discloses at least one friction protrusion (raised end 22, Figs. 1, 4a; or 222, Figs. 5A, 5B) located at the second end of the cover sheath (20), the at least one friction protrusion (22, 222) configured to contact an outer diameter surface of the urinary catheter (catheter shaft, 4 and mandrel, 8) when the cover sheath (20) is in a closed state ([0045]; [0060-0063]; [0065-0066]).
8. With regard to claim 14, Liu, as modified by Kay above, discloses the body engagement portion of claim 11. Liu discloses a collar (24) secured to the cover sheath (20), wherein the collar (24) includes a collar slit (forming upper and lower separable halves, 28, 29) that is coextensive with the slit (26) of the cover sheath (20; Fig. 2D, 3B, 4C; [0046]).
Additionally, Kay discloses that the body engagement portion (3) includes a collar (central portion, 13) securing the body engagement portion to the cover sheath (2; [0025]), and wherein the collar (13) includes a collar slit (plurality of perforations, 21; Fig. 3; [0025]; [0030]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the body engagement portion disclosed by Liu to include a collar with a slit coextensive with the cover sheath slit, similar to that disclosed by Liu, in order to allow the sheath to be easily removed from the catheter with minimal disruption to the structural integrity of the catheter, as suggested by Liu in paragraph [0046] and suggested by Kay in paragraph [0025].
9. With regard to claims 16 and 17, Liu, as modified by Kay above, discloses the body engagement portion of claim 11. Kay discloses that the body engagement portion (3) is adapted for an anatomy of a male patient (title; abstract; [0005]; [0008-0009]) and includes a funnel-like structure (Figs. 1, 7, 8).
While Kay discloses that the body engagement portion (3) includes a set of panels (plurality of leaves or petals, 8; Fig. 1; [0024]) and appears fully capable of use with the anatomy of a female patient, Liu and Kay fail to explicitly disclose that the body engagement portion is adapted for an anatomy of a female patient.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the set of panels disclosed by Liu in view of Kay to take the shape of the female anatomy, in order to allow for the leakage prevention cover to be used by female patients in addition to male patients – creating a wider userbase. Additionally, Kay already teaches the use of a body engagement portion having a set of panels which are fully capable of being placed around the urethra a female patient – and it has been held that a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
10. Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Kay, as applied to claim 11 above, and further in view of Urie (WO 2004/045696 A1).
11. With regard to claim 12, Liu further discloses a spring (constraining sheath, 30) mechanically coupled to the cover sheath (20), wherein the spring (30) includes an elongated tube ([0042]).
However, Liu and Kay are silent in regard to the spring including a spring slit that is coextensive with the slit of the cover sheath
Urie discloses a urinary drainage catheter (abstract; Figs. 1, 2, 5, 6) comprising: an inner sleeve (20); an outer sleeve (10); and a spring (circlip or spring clip, 51) mechanically coupled to the inner sheath (20), wherein the spring (51) includes a tube having a spring slit that is coextensive with the slit of the inner sheath (20; Figs. 5, 6; page 8, line 24 – page 9, line 4; page 9, lines 22-25).
Therefore, , it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the elongated tubular constraining sheath disclosed by Liu in view of Kay to be a spring clip with a spring slit, similar to that disclosed by Urie, in order to utilize alternative well-known retention means similar to circlips which provide easy placement, removal and full reversibility, as suggested by Urie on page 9, line 22-25. Additionally, these are applicant admitted well-known alternatives which can be used interchangeably, as seen in paragraphs [0023-0024] of the Specification, as originally filed, where compression bands and elongated spring clips are contemplated.
Conclusion
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Montes de Oca et al. (US PGPUB 2022/0288350) discloses a ready-to-use urinary catheter.
Foley et al. (US PGPUB 2015/0320970) discloses an intermittent catheter assembly.
Klug (US 5,078,707) discloses an external urinary collection device.
Ostfeld (US PGPUB 2013/0310769) discloses an indwelling device.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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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.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781