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 .
Election/Restrictions
Claims 10-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 June 2026.
Claims 1-9 and 13-20 are examined herein on the merits.
Claim Rejections - 35 USC § 102
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 1, 2, 4, 7, 9, 13-17 and 19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2018/156589 to McMenamin et al.
In the specification and figures, McMenamin discloses the apparatus as claimed by Applicant. With regard to claims 1, 9, 13-16, 19, McMenamin discloses a medical device assembly comprising a case 1 with a generally cylindrical or rectangular hollow
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tubular body 26 a with a closed first end 28 and an open collar end 36 with a hinged 42 cap 14 and a varying outer diameter (see FIG 1 and accompanying text). The interior surface comprises a chamber with ribs 19 and 20, as well as a removable hydrophilic catheter 22 with a funnel 24, drainage member and a tube (see FIGS 7, 12, and accompanying text, ¶00101, 00116). Because the catheter 22 with its drainage slot is within the case, it is in fluid communication with the area between the ribs. McMenamin further discloses that the apparatus may comprise a hydration liner 16, which carries hydrating liquid such as water (see ¶00100, 00116).
With regard to claims 2, 4, 7, McMenamin discloses that the case insert may have a radially extending foot that engages a flange of the drainage funnel insert (see ¶0019).
With regard to claim 17, McMenamin discloses that the case may flare outwardly (see ¶00170).
Claim Rejections - 35 USC § 103
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.
Claims 3, 5, 6, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over 2018156589 to McMenamin et al.
In the specification and figures, McMenamin teaches the apparatus substantially as claimed by Applicant (see rejections above). With regard to claim 3, McMenamin illustrates only a single slot on catheter 22. However, It has been held that the mere duplication of the parts of an apparatus found in the prior art is not patentably significant unless a new and unexpected result is produced. See MPEP § 2144.04 (VI)(B). In the instant case, providing multiple drainage slots would not produce an unexpected result.
With regard to claim 5, McMenamin discloses a plug, which Applicant discloses is equivalent to the instantly claimed grommet, teaching the limitations of the claims (see Specification at ¶0037).
With regard to claims 6 and 20, McMenamin discloses that the interior of the case comprises threads, flanges, lips, groves, seals, and the like are hidden under both one of the sleeve and the cap to accommodate the catheter and the various other components within the case, suggesting the limitations of the claim.
With regard to claim 18, McMenamin discloses that ribs 19 and 21 extend from the bottom of the neck of the interior of the case to the top end of the collar (see ¶00107), teaching that the ribs taper towards an interior surface as the ribs extend in a proximal direction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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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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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 30 June 2026
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