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 .
Response to Arguments
Applicant’s arguments, filed 13 October 2025, with respect to the 35 USC 102 rejection have been fully considered and are persuasive. The 35 USC 102 rejection has been withdrawn. Claims 1-3, 5-6, 13-16, 24-27, 29-30, 36, 38-39, 41-42 are pending. Accordingly, this action is second Non-Final.
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.
Claim(s) 1-3, 5-6, 13-16, 24, 29, 36, 38-39, 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (US 2016/0038717) in view of O’Brien (US 2019/0126004).
Regarding claim 1, Murray discloses a catheter assembly having a longitudinal axis (axis lengthwise shown in figures 5A-5C), the catheter assembly comprising:
a catheter (20); a wetting agent storage chamber (48 inside 22, figure 2); and, an external housing (14), wherein the storage chamber comprises a movable insert (18 which has the catheter 20 attached to and extending into the storage chamber) configured to move axially along the longitudinal axis in relation to the external housing when the movable insert is rotated ([0064]-[0066]).
Murray does not disclose the external housing in which the catheter and storage chamber are housed.
O’Brien discloses a catheter housing wherein an external housing (40 and 12) houses both the catheter and storage chamber having an insert (figure 4-5).
O’Brien provides the external housing that houses and encapsulates the catheter and insert in order to provide further sterilization and prevents contamination ([0040]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Murray with the further exterior housing in order to provide further means to prevent contamination.
Regarding claim 2, Murray discloses wherein the movable insert is movable between a sealed configuration (figure 5A, 18 and 19 are sealed together) and a primed configuration (figure 5B, where the catheter is lubed and taken out).
Regarding claim 3, Murray discloses wherein the storage chamber comprises a chamber wall (wall of 19, figure 2), wherein the movable insert and chamber wall sealably engage to seal the storage chamber via a chamber seal (28, [0064]).
Regarding claim 5, Murray discloses wherein the chamber seal comprises a seal element (28) retained by the movable insert or the chamber wall, and an opposing sealing surface provided by the other of the movable insert and chamber wall ([0064]).
Regarding claim 6, Murray discloses wherein the seal element is configured to align with the sealing surface when in the sealed configuration (figure 5A); and wherein the seal element is configured to be axially misaligned with the sealing surface when in a primed configuration (gripper member is taken out and is misaligned when taken out).
Regarding claim 13, Murray discloses wherein at least one of the movable insert and the chamber wall comprises a divergent portion (32) over which the seal element passes when transitioning between a sealed configuration and a primed configuration such that the distance between the chamber wall and movable insert at the axial location of the seal element is increased when in the primed configuration (when the catheter is pulled out, the distance between the divergent portion 32 and the rest of the external housing that includes 14 is increased, figure 5B).
Regarding claim 14, Murray discloses wherein the divergent portion comprises a step (32 is a step) or chamfer adjacent to the sealing surface (figure 5A).
Regarding claim 15, Murray discloses wherein the sealing surface is a primary sealing surface and the catheter assembly further comprises a secondary sealing surface (the inner surface of 26, figure 5B), wherein the seal element seals against the secondary sealing surface when in the primed configuration (figure 5B).
Regarding claim 16, Murray discloses wherein the chamber wall or movable insert comprises one or more axially and circumferentially extending drive surface (28 on 19), and the other of the chamber wall and movable insert comprises a driving element (corresponding surface on 18) which engages with the drive surface to provide the axial movement of the movable insert upon relative rotation of the movable insert and chamber wall ([0064]).
Regarding claim 24, Murray discloses wherein the movable insert is movable between the primed configuration and a wetted configuration (figures 5A-5B).
Regarding claim 29, Murray discloses wherein the movable insert is configured to axially reciprocate along the longitudinal axis ([0064]); and wherein the movable insert is configured to reciprocate whilst being rotated in a continuous common direction (rotating in one direction of the threaded neck).
Regarding claim 36, Murray discloses a movable insert rotation limiter (32) configured to limit the rotation of the movable insert to less than a predetermined amount ([0065], limits the further rotation since it abuts the main housing).
Regarding claim 38, Murray discloses wherein the drive surface comprises a track (luers of 28 form tracks) but does not teach wherein the track is cosine shaped.
However, it has been held that a shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Therefore, in this case the cosine shape is not found to be significant.
Regarding claim 39, Murray discloses wherein the drive surface comprises a track which extends between a first end point (proximal point of the track), a second end point (distal point of the track) and having a mid-point (middle between the proximal and distal points) therebetween, but does not teach wherein the first end point and second end point are axially distal relative to the mid-point.
However, it has been held that a shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Therefore, in this case the first end point and second end point distal relative to mid-point dictates a particular shape and is not found to be significant.
Regarding claim 41, Murray discloses wherein the track extends circumferentially through at least 180 degrees and less than 360 degrees (the luer extends around the housing).
Regarding claim 42, Murray discloses wherein, with the movable insert in the primed configuration, a wetting agent is moved into the wetting agent storage chamber (catheter moving the wetting agent in and out when the catheter is inserted/removed from the chamber).
Allowable Subject Matter
Claims 25-27 and 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 25, the prior art fails to teach wherein the external housing comprises a main body and a cap, wherein the cap is rotatably engaged with the movable insert such that rotation of the cap rotates the movable insert to provide the axial movement. The combined device of Murray and O’Brien does not teach wherein the cap is rotatably engaged with the movable insert such that rotation of the cap rotates the movable insert to provide the axial movement. O’Brien fails to teach and cannot be modified to have the cap is rotatably engaged with the movable insert such that rotation of the cap rotates the movable insert to provide the axial movement since the exterior cap cannot be rotated in a way that moves the movable insert. For these reasons, claims 25-27 and 30 are objected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Van Groningen (US 2012/0110951) discloses a package for catheter.
Bruun (US 2006/0196783) discloses a wetting package for catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca 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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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/ Primary Examiner, Art Unit 3781