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 .
Status of Claims
As directed by the amendment filed on 2 September 2025: claim(s) 3-5, 7-10, 12, 14-15, and 17 have been amended.
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.
Claim(s) 1-5, 8, 10-12, 14, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kendrick et al. (WO 2021214477 A1).
Regarding Claim 1, Kendrick discloses a catheter assembly (see Abstract) comprising:
a catheter ("catheter 10" Detailed Description of the Invention; FIG. 1) comprising a proximal end for insertion into the body ("configured for insertion into a male patient’s bladder") and a distal end (see FIG. 1),
a sleeve ("sleeve 18"; FIG. 1) configured to enclose the catheter ("enclosing the catheter tube 12 therebetween"; FIG. 1), and a wetting mechanism arranged at the proximal end of the catheter ("wetting mechanism 20 provided at a tip end 13 (proximal end) of the catheter tube 12"), wherein the wetting mechanism comprises a base ("stopper in the form of a plug 26"; FIG. 1) and a body ("housing 16"; FIG. 1), the body comprises a fluid reservoir ("holding chamber" Summary of the Invention; FIG. 1), the base and body are rotatable with respect to one another to define a first configuration and a second configuration of the wetting mechanism ("stopper (e.g. the plug 26, 126, 326) may alternatively be rotatable between first and second positions/configurations"), wherein in the second configuration the wetting mechanism permits release of fluid from the fluid reservoir into the sleeve to wet the catheter ("rotation of the plug 26, 126, 326 (rather than linear movement) may unblock the inlet 43, 143, 243 of the wetting chamber 23, 123, 223, and optionally may align an opening in the stopper unblock an opening 127, 227 or valve in the housing 116, 316 allowing for the release of the wetting fluid into the wetting chamber").
Regarding Claim 2, Kendrick discloses the catheter is an intermittent male urinary catheter ("male urinary catheter … intermittent urinary catheter" Summary of the Invention").
Regarding Claim 3, Kendrick discloses the body is longer than the base (see FIG. 2A).
Regarding Claim 4, Kendrick discloses in the first configuration the wetting mechanism inhibits release of fluid from the fluid reservoir into the sleeve to wet the catheter ("in the first position, the stopper prevents release of fluid from the holding chamber" Summary of the Invention).
Regarding Claim 5, Kendrick discloses the body and base each comprise a major axis and a minor axis (see Annotated FIG. 2A), and the major axes of the body and base are aligned when in the first configuration and second configuration (see FIGs. 2A-2B).
Annotated FIG. 2A
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Regarding Claim 8, Kendrick discloses the base defines a part of an outer peripheral shape of the wetting mechanism between the body and the sleeve (see FIG. 2A).
Regarding Claim 10, Kendrick discloses the fluid reservoir comprises an opening ("inlet 43"; FIG. 2B) to allow wetting fluid to be released from the fluid reservoir ("allow for fluid contained within the wetting chamber 23 to flow through the inlet 43 and into the sleeve 18") and a sealing element configured to provide a seal between the opening and the base when the wetting mechanism is in the first configuration ("cantilevered end portions 39 are provided in contact with surfaces 41 on the housing 16 at the inlet 43. The surfaces 41 are sloped so as to urge the cantilevered portions 39 inwards towards one another to partially block the inlet 43. This is herein referred to as a first position or first configuration of the plug 26"; FIG. 2A).
Regarding Claim 11, Kendrick discloses the fluid reservoir comprises a retainer configured to restrict movement of the sealing element with respect to the opening ("surfaces 41 are sloped so as to urge the cantilevered portions 39 inwards towards one another to partially block the inlet 43").
Regarding Claim 12, Kendrick discloses the base comprises an outlet opening configured to provide a fluid connection between the base and the fluid reservoir when the wetting mechanism is in the second configuration (see FIG. 2B).
Regarding Claim 14, Kendrick discloses in the first configuration, the wetting mechanism prevents passage of the proximal end of the catheter therethrough ("first position or first configuration of the plug 26, corresponding to a position wherein the catheter tube 12 is prevented from being introduced into the wetting chamber 23 through the inlet 43"; FIG. 2A), and wherein in the second configuration the wetting mechanism permits passage of the proximal end of the catheter therethrough ("inlet 43 is unblocked, and the catheter tube 12 is able to be moved through a channel defined through the plug 26"; FIG. 2B), and wherein the wetting mechanism comprises a third configuration between the first and second configurations in which the fluid reservoir is configured to release fluid into the sleeve to wet the catheter and the wetting mechanism prevents passage of the proximal end of the catheter therethrough (see FIGs. 2A-2B; there are infinite number of configurations between FIG. 2A and FIG. 2B and at least one of them consists of the claimed feature).
Regarding Claim 17, Kendrick discloses the wetting mechanism is configured to provide audible/tactile feedback as the wetting mechanism enters the second configuration ("plug 26 may “snap” or “click” in overcoming said abutment to provide tactile and/or audible feedback for the user" Detailed Description of the Invention).
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.
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.
Claim(s) 6-7, 9, 13, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kendrick in view of Fletter (US 20190151610 A1).
Regarding Claims 6-7, 9, 13, and 16, Kendrick fails to specify the wetting mechanism comprises a third configuration between the first and second configurations, and in the third configuration, the major axes of the body and base are not be aligned; an outer peripheral shape of the body may not match an outer peripheral shape of the base when at a point of rotation between the first and second configurations; the body is attached to the sleeve via the base; the outlet opening extends through an arc equivalent to an angle of up to 160 degrees around the axis of rotation of the body and base with respect to each other; and the wetting mechanism has an elliptical cross-section defining the outer peripheral shape. However, Fletter teaches “a urinary catheter includes a shaft” ([0010]) wherein “the twisting motion of the handle valve may alternatively break a frangible seal or otherwise open a sealing member that seals the fluid path or passage(s) through the grip members” ([0037]), wherein the wetting mechanism comprises a third configuration between the first and second configurations, and in the third configuration, the major axes of the body and base are not be aligned ([0038-0042]; FIG. 9B); wherein an outer peripheral shape of the body may not match an outer peripheral shape of the base when at a point of rotation between the first and second configurations (see FIG. 9B); wherein the body is attached to the sleeve via the base ("end portions of the sleeve 34 that define the end opening of the sleeve are secured and sealed to the distal grip member 28 of the handle" [0030]); wherein the outlet opening extends through an arc equivalent to an angle of up to 160 degrees around the axis of rotation of the body and base with respect to each other ("grip member requires less than 180° or pivoting or rotation to place the handle valve in the open configuration" [0042]); wherein the wetting mechanism has an elliptical cross-section defining the outer peripheral shape (see FIG. 3). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Kendrick as taught by Fletter to arrive at the claimed invention to provide more twisting leverage ([0040]) such that the twisting motion open a sealing member that seals the fluid path or passage(s) through the grip members ([0037]).
Regarding Claim 15, Kendrick discloses the wetting mechanism is tubular ("housing may comprise a conical profile" Summary of the Invention) and has an outer peripheral shape in a plane perpendicular to the axis of the wetting mechanism that is the same in the first and second configurations (see FIGs. 2A-2B) but fails to specify the outer peripheral shape has rotational symmetry of order 2. However, Fletter teaches the outer peripheral shape has rotational symmetry of order 2 (see FIGs. 3 & 9B). Therefore, it would have been obvious to modify Kendrick to suitably provide more twisting leverage ([0040]) to break the seal ([0037]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
