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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/03/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/03/2026. As directed by the amendment: claims 7, 16, and 22 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 7-26 are presently pending in this application, with 22-26 being withdrawn from consideration.
Response to Arguments
Applicant’s arguments on p.6-7 of “Remarks”, filed on 04/26/2026, with respect to claim(s) 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see p.7-8 of “Remarks”, filed 04/26/2026, with respect to 103 rejection of claim 16 have been fully considered and are persuasive. The 103 rejection of 03/06/2026 has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the phrase “wherein the attachable slidable collar is initially bound to the molded hub so that an external force must be applied to the attachable slidable collar to move the attachable slidable collar proximally away from molded hub” in lines 1-4 renders the claim indefinite because it is unclear. It is unclear whether the collar is require to be bound to the molded hub or merely configured to be bound to the molded hub. Examiner is interpreting it as the latter with respect to the specification para. 0053.
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) 7, 9-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Loesener (U.S Patent Pub. No. 20160129222 A1) in view of O’Neil (U.S Patent No. 5364377) in view of Mogensen et al. (U.S Patent Pub. No. 20060074380 A1, “Mogensen”).
Regarding claim 7, Loesener discloses (Claim 7) a catheter assembly (see Fig. 1A-2) for organizing a catheter system (10 in Fig. 1A-2) comprising:
a molded hub (16 in Fig. 1A-2) including at least a pair of hub lumens (24 and 32 in Fig. 2, see para. 0018 and 0020-0022 – the hub 16 may be molded over the cannulae 30 such that it is a molded hub and comprises a pair of hub lumens interpreted as each passageway 24 and cannula lumen 32 together);
a catheter tube (12 in Fig. 1A-2) coupled to a distal end of the molded hub (see Fig. 2 and para. 0023 – catheter tube 12 proximal end is seated against distal end of hub 16), the catheter tube (12) including:
at least a pair of catheter tube lumens (14 in Fig. 2 and para. 0017-0018); and
a distal tip (12B in Fig. 1A) configured for insertion into a patient at a percutaneous insertion site (see para. 0016-0017);
a plurality of extension legs (18 in Fig. 1A) each including a proximal and a distal end (see para. 0018), wherein the distal end of each extension leg (18) is coupled to a proximal end of the molded hub (see Fig. 2 and para. 0018), wherein a fluid pathway is formed between the plurality of extension legs (18) and the catheter tube (12) through the pair of hub lumens (24, 32, see Fig. 2 and para. 0018 and 0020).
However, Loesener fails to disclose the limitations of (Claim 7) a securing mechanism configured to secure the plurality of extension legs together, wherein the securing mechanism includes a slidable collar,
wherein:
the slidable collar includes:
a proximal opening at a proximal end thereof and a distal opening at a distal end thereof, the proximal opening and the distal opening defining the same shape;
a perimeter wall (i) extending between the proximal end and the distal end and (ii) continuously surrounding both the proximal opening and the distal opening, and
the plurality of extension legs pass through the proximal opening and the distal opening.
O’Neil discloses a catheter system (40 in Fig. 4) comprising a plurality of extension legs (44, 46, 48) for supplying several intravenous fluids to a patient through a single cannula that is coupled to said extension legs through a connector (42, see Col.4, lines 14-41), wherein O’Neil teaches the limitations (Claim 7) a securing mechanism configured to secure the plurality of extension legs (44, 46, and 48 in Fig. 4) together (see Fig. 4 and Col.4, lines 35-41 – the proximal sections of tubes 44, 46, and 48 are secured together through movable collar 56), wherein the securing mechanism includes a slidable collar (56 in Fig. 4, see Col.4, lines 35-41 – movable collar 56 can slide over the proximal section of tubes 44, 46, and 48).
Since Loesener discloses a catheter system having a plurality of extension legs and O’Neil discloses a catheter system having a plurality of analogous extension legs, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system of Loesener to have the slidable collar of O’Neil configured to secure the plurality of extension legs together. O’Neil provides that the movable collar (56) can be slid along the extension legs to selectively vary the length of the tubing and to selectively vary the potential maximum mutual separation of the proximal connectors of the extension legs to suit the locations of the fluid sources (see Col.4, lines 35-41).
While O’Neil discloses a slidable collar, O’Neil fails to disclose the limitations of (Claim 7) wherein: the slidable collar includes: a proximal opening at a proximal end thereof the slidable collar and a distal opening at a distal end of the slidable collar, the proximal opening and the distal opening defining the same shape; and a perimeter wall (i) extending between the proximal end and the distal end and (ii) continuously surrounding both the proximal opening and the distal opening, and the plurality of extension legs pass through the proximal opening and the distal opening.
Mogensen discloses attachable and adjustable holder devices arranged over a plurality of tubes to secure them in a desired configuration. Mogensen teaches (Claim 7) wherein: the slidable collar (10) includes: a proximal opening at a proximal end thereof and a distal opening at a distal end thereof, the proximal opening and the distal opening defining the same shape; and a perimeter wall (i) extending between the proximal end and the distal end and (ii) continuously surrounding both the proximal opening and the distal opening, and the plurality of extension legs (14, 24, 34) pass through the proximal opening and the distal opening (see annotated Mogensen drawing 1 below, Fig. 4a-4c, and para. 0020-0021 – holder device 10 may be used for providing a desired configuration with the three courses 14, 24, and 34 of tubing that extending therethrough, the holder 10 as annotated below comprises proximal and distal ends defining a group of openings interpreted as a whole as the proximal and distal openings, wherein the group of openings on each end have the same shape, a perimeter wall extends between the two ends and continuously around the openings when the holder 10 is in the closed position, the courses 14, 24, and 34 pass through the openings of the holder 10). Examiner notes the holder 10 is used to secure together courses of the same tubing that is folded, however the securing mechanism of the holder is still used to secure together multiple lengths of tubing which is pertinent to the securing mechanism
PNG
media_image1.png
507
760
media_image1.png
Greyscale
of securing together multiple lengths of extension legs in the claimed invention.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the slidable collar taught by modified Loesener with the slidable holder taught by Mogensen. The motivation for this modification is that Mogensen teaches a holding device with bores therethrough defining guides for the tubing to provide a certain protection of the tubing in these areas and which can be axially split into two sections such that it can be mounted to any existing tubing system (see para. 0009 and 0022).
Regarding claim 9, modified Loesener discloses the catheter assembly of claim 7, as discussed above. In modified Loesener, Mogensen discloses (Claim 9) wherein the slidable collar is an attachable slidable collar (10, see Fig. 4a-4c and para. 0020-0021).
Regarding claim 10, modified Loesener discloses the catheter assembly of claim 9, as discussed above. In modified Loesener, Loesener discloses the molded hub (16 in Fig. 1A-2).
In modified Loesener, O’Neil discloses the slidable collar (56 in Fig. 4).
In modified Loesener, Mogensen discloses the attachable slidable collar (10).
In combination, the attachable slidable collar of modified Loesener would be capable of being configured to be initially bound to the molded hub (16) of Loesener and configured such that an external force must be applied to said attachable slidable collar to move it proximally away from the molded hub (16).
Mogensen teaches (Claim 10) wherein the attachable slidable collar (10 in Fig. 6a-6b) is initially bound to the molded hub (5 in Fig. 1) so that an external force must be applied to the attachable slidable collar (10) to move the attachable slidable collar (10) proximally away from the molded hub (5, see para. 0025 – collar 10 is initially releasably locked to the molded hub 5 such that an external force must be applied to release the locking of collar 10 such that it can move proximally away from the hub 5).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachable slidable collar taught by modified Loesener to have the attachable slidable collar be initially bound to the molded hub and requires an application of external force to move the attachable slidable collar proximally away from the molded hub as taught by Mogensen. This modification is motivated as having the collar be releasably locked to the molded hub prevents incidental or inadvertent movement of the collar during handling, and as provided by Mogensen allows for the collar to be selectively moved to adjust the organization of the extension tubing (see para. 0025).
Regarding claim 11, modified Loesener discloses the catheter assembly of claim 9, as discussed above. In modified Loesener, O’Neil discloses (Claim 11) wherein the slidable collar (56) is positioned over the plurality of extension legs (44, 46, 48, see Fig. 4).
In modified Loesener, Mogensen discloses (Claim 11) the attachable slidable collar (10, see para. 0020-0021).
Regarding claim 12, modified Loesener discloses the catheter assembly of claim 9, as discussed above. In modified Loesener, Mogensen discloses (Claim 12) wherein the attachable slidable collar (10) comprises a length, a width, a height, a longitudinal midpoint, a longitudinal endpoint, an outer surface, and an inner surface (see annotated Mogensen drawing 2 below).
PNG
media_image2.png
506
802
media_image2.png
Greyscale
Regarding claim 13, modified Loesener discloses the catheter assembly of claim 12, as discussed above. In modified Loesener, Mogensen discloses (Claim 13) wherein the length is greater than or equal to the width, and the width is greater than or equal to the height (see annotated Mogensen drawing 2 above).
Regarding claim 15, modified Loesener discloses the catheter assembly of claim 12, as discussed above. In modified Loesener, Mogensen discloses (Claim 15) wherein the inner surface is configured to create friction with an exterior of the plurality of extension legs (14, 24, 34), wherein the friction resists movement of the securing mechanism in an absence of an external force applied to the attachable slidable collar (10, see para. 0021 – the inner surface of the holder 10 is defined by the guides 11 and 12 which are adapted to have a desired minimum friction with the exterior of the tubing 14, 24, and 24, indicating that the holder 10 creates some manner of friction which would resist movement of the holder 10 when an external pulling force is not applied to the holder 10).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Loesener in view of O’Neil in view of Mogensen as applied to claim 12 above, and further in view of Conway et al (U.S Patent Pub. No. 20120239005 A1, “Conway”).
Regarding claim 14, modified Loesener discloses the catheter assembly of claim 12, as discussed above.
However, modified Loesener fails to disclose (Claim 14) wherein the outer surface sloped towards the inner surface at the longitudinal endpoint, then slopes away from the inner surface towards the longitudinal endpoint.
Conway discloses a slidable, catheter gripping apparatus configured to surround a catheter shaft (see Fig. 1 and Fig. 4 and para. 0016), wherein Conway teaches (Claim 14) a slidable collar (1) wherein the outer surface slopes towards the inner surface at the longitudinal midpoint (9), then slopes away from the inner surface towards the longitudinal endpoint (11 and 13, see Fig 1. and para. 0021).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the slidable collar taught by modified Loesener have the shape of the gripper as taught by Conway. Conway teaches a catheter grip with a configuration that is flared towards both ends with a smaller diameter in the middle which aids in positioning the user’s fingers toward the middle for better grip (see para. 0015).
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Loesener in view of O’Neil in view of Mogensen as applied to claim 12 above, and further in view of Wright et al. (U.S Patent Pub. No. 20160008577 A1, “Wright”).
Regarding claim 17, modified Loesener discloses the catheter assembly of claim 12, as discussed above. In modified Loesener, Mogensen discloses (Claim 17) wherein the securing mechanism can be separated axially into two separate sections (see Fig. 4a-4b and para. 0020-0021 –holder 10 may be split axially into two separate parts 10’ and 10’’ as seen in Fig. 4b).
However, modified Loesener fails to disclose (Claim 17) the two separate sections are detached from each other.
Wright discloses a securing mechanism (420 in Fig. 51-53) for a catheter (30 in Fig. 2 and para. 0058), wherein Wright teaches (Claim 17) the securing mechanism (420) can be separated axially into two separate pieces (426, 427 in Fig. 51), and the two separate sections (426, 427) are detached from each other (see Fig. 51 and para. 0048 – the two sections 426 and 427 may be temporarily coupled together such that they can be separated axially and detached from each other).
Since Mogensen discloses a securing mechanism (10 in Fig. 4a-4b) that can be separated axially into two separate sections (10’, 10’’) but remains attached at a hinge (see Fig. 4b), and Wright discloses a securing mechanism (420) with two separate pieces (426, 427) that have a hinge-like coupling that can either be permanent or temporary such that the two sections (426, 427) can be detached from one another (see para. 0084-0085), it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the permanent hinge coupling taught by modified Loesener with the temporary hinge-like coupling of Wright such that the two separate sections could be detached from one another. One of ordinary skill could have substituted a known permanent hinge coupling for a known temporary hinge coupling, and the results of the substitution would have been predictable as Wright teaches a securing mechanism with a hinge-like coupling that can either be temporary or permanent (see para. 0084-0085).
Regarding claim 18, modified Loesener discloses the catheter assembly of claim 17, as discussed above. In modified Loesener, Mogensen discloses (Claim 18) wherein the securing mechanism is joined at the longitudinal midpoint (see annotated Mogensen drawing 2 above and para. 0022 – the sections 10’ and 10’’ of holder 10 are joined by snap lock 15 which is aligned with the annotated longitudinal midpoint of holder 10).
Regarding claim 19, modified Loesener discloses the catheter assembly of claim 18, as discussed above. In modified Loesener, Mogensen discloses (Claim 19) wherein the securing mechanism is joined together by a clasping mechanism (see Fig. 4b-4c and para. 0022 – sections 10’ and 10’’ of holder 10 are joined by snap lock shown as a snap hook 15 on section 10’ and a groove on section 10’’).
Regarding claim 20, modified Loesener discloses the catheter assembly of claim 18, as discussed above. In modified Loesener, Mogensen discloses (Claim 20) wherein the clasping mechanism includes a clasp having a snap hook (15) disposed on a first section (10’) of the two separate sections and a groove on a second section (10’’) of the two separate sections (see annotated Mogensen drawing 3 below for groove), wherein the groove is configured to receive the snap hook (15, see Fig. 4b-4c and para. 0022 – sections 10’ and 10’’ of holder 10 are joined by snap lock shown as a snap hook 15 on section 10’ and a groove on section 10’’).
PNG
media_image3.png
448
693
media_image3.png
Greyscale
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Loesener in view of O’Neil in view of Mogensen in view of Wright as applied to claim 18 above, and further in view of Huitema (U.S Patent Pub. No. 20160306393 A1).
Regarding claim 21, modified Loesener discloses the catheter assembly according to claim 18, as discussed above.
However, modified Loesener fails to disclose (Claim 21) wherein the securing mechanism is joined together by a first pair of magnets and a second pair of magnets, opposite the first pair of magnets.
Huitema teaches (Claim 21) wherein the securing mechanism is joined together by a first pair of magnets (22A and 22B) and a second pair of magnets (24A and 24B), opposite the first pair of magnets (22A and 22B, see Fig. 3-4 and para. 0068 – clasp 10 comprises first pair of magnets 22A and 22B on the first end 14 and a second pair of magnets 24A and 24B on the opposite end 14 which form an attachment mechanism). It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the clasping mechanism taught by modified Loesener to comprise a first pair of magnets on the first component and a second pair of magnets opposite the first pair of magnets on the second component as taught by Huitema. Huitema teaches that instead of using clasps, an improved connection structure may be in the form of magnets to enable the first and second components of Mogensen to be connected in various different positions with respect to one another (see Huitema, para. 0068).
Allowable Subject Matter
Claim 16 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Bierman et al. (U.S Patent Pub. No. 20040199122 A1, “Bierman”).
Bierman discloses a securing mechanism for securing a plurality of catheter tube, wherein the securing mechanism is in the form of a collar (20 in Fig. 1) which has a proximal opening (62 in Fig. 5) and a distal opening (64 in Fig. 5), wherein the proximal opening (62) has an oval-shape (see para. 0072 and 0074), and thus the collar (20) defines a single oval-shaped lumen (60 in Fig. 8) extending from the proximal opening (see para. 0072 and 0074). However, Biermann fails to disclose that the single oval shaped lumen has a uniform shape extending from the proximal opening to the distal opening. Rather, Biermann discloses a retaining structure (73 in Fig. 4) that protrudes within the lumen (60) at its distal opening (64, see Fig. 5 and para. 0089). Said retaining structure (73) is essential when used with a bifurcating catheter to inhibit axial movement of the catheter in the distal direction (see para. 0089). Thus, Biermann explicitly teaches away from a single oval-shaped lumen having a uniform structure extending from the proximal opening to the distal opening.
There is no other reference that teaches or discloses a collar structure having said shape as disclosed in claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights