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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/26/2025. As directed by the amendment: claims 7, 9-12, 16-17, and 22 have been amended, claims 1-6 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 Thus, claims 7-26 are presently pending in this application, with 22-26 being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Rejection mailed on 08/27/2025.
Response to Arguments
Applicant’s arguments, see p.2-3 of “Remarks”, filed 11/26/2025, with respect to the rejection(s) of claim(s) 7, respectively, under 103 have been fully considered and are not persuasive.
In response to applicant’s argument that O’Neil fails to teach a catheter tube that includes “a distal tip configured for insertion into a patient”, this argument was not found persuasive. Applicant argues that “O’Neil does not teach that the male Luer connector half 42 includes a distal tip configured for insertion into a patient,” and the examiner respectfully disagrees. Examiner notes that the claim limitation only requires that the distal tip be functionally capable of insertion into the patient but is not specific on the location of insertion. Thus, O’Neil anticipates the claim limitation as O’Neil discloses the male Luer connector 42 having a distal tip 43 which is capable of being configured for insertion into the patient such as into their mouth or other orifice. Examiner suggests applicant amend to more clearly define the function limitation as a specific location for insertion of the distal tip.
Applicant’s arguments with respect to claim(s) 10 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.3-4 of “Remarks”, filed 11/26/2025, with respect to the rejection(s) of claim(s) 16, respectively, under 103 have been fully considered and are not persuasive.
In response to the applicant’s argument that Biermann fails to disclose or teach “the attachable slidable collar defines a single oval shaped lumen extending from the proximal opening to the distal opening”, the examiner respectfully disagrees. The applicant argues Biermann teaches “a channel 60 that is divided into two channels at one end by the retaining structure 73… the channel 60 does not define a single lumen that extends all the way across the unitary device [collar] 20”. This argument is not persuasive because the examiner is of the opinion that applicant’s interpretation of the structure of a lumen is too narrow. Examiner is interpreting a lumen using the definition from Merriam Webster that states “the bore of a tube”. Thus, in Bierman, the channel (60) that is formed by the grooves (30 and 36) is interpreted as the single lumen that extends the entire length of the collar (20). Examiner notes that a protruding structure within a lumen such as the post (74) within lumen (60) of Bierman does not inherently prevent the lumen from being a single lumen but rather provides an obstruction at a point of the lumen (60). The channel (60) even with the post (74) is still a single lumen that extends the length of the collar (20). Therefore, Bierman discloses the a single lumen extending from the proximal opening to the distal opening. Examiner suggests applicant add additional claim language to more narrowly describe the single lumen as a single oval shaped lumen with a uniform shape extending from the proximal opening to the distal opening.
Applicant’s arguments with respect to claim(s) 17 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.
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 O’Neil (U.S Patent No. 5364377) in view of Mogensen et al. (U.S Patent Pub. No. 20060074380 A1, “Mogensen”).
Regarding claim 7, O’Neil discloses the limitations (Claim 7) a catheter assembly (40 in Fig. 4) for organizing a catheter system (see Fig. 4 and Col.4, lines 14-34 – Fig. 4 illustrates embodiment 40 of a fluid coupling comprising several extension legs that convene into a singular tubing for supplying several fluids to a patient, the embodiment 40 comprises a movable collar for organizing the tubing), comprising:
a molded hub (42) including at least a pair of hub lumens (see Fig. 4-5 and Col.4, lines 53-60 – the connector 42 is being interpreted as the molded hub wherein the three tubes 44, 46, and 48 extend through connector 42 and are embedded therein by a resin 58, the at least pair of hub lumens being interpreted as the section of the lumens of tubes 44, 46, and 48 that extend through the connector 42 seen in Fig. 5);
a catheter tube coupled to a distal end of the molded hub (42, see annotated O’Neil drawing 1 below and see Fig. 5 and Col. 5, lines 1-17 – the distal end of the hub 42 is interpreted as the distal end of the cylindrical collar of the hub 42 as annotated below, the catheter tube being interpreted as the bonded together tubes 44, 46, and 48 that extend from said annotated end of hub 42 to the point 43 and are coupled to said annotated end of hub 42), the catheter tube including:
at least a pair of catheter tube lumens (see annotated O’Neil drawing 1 below and Col. 5, lines 1-17 – the section of the three lumens of tube 44, 46, and 48 that extend past the annotated distal end of hub 42 are interpreted as the catheter tube lumens); and
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and a distal tip (43 in Fig. 1) configured for insertion into a patient (see annotated O’Neil drawing 1 below for catheter tube, see Col.4, lines 14-17 and Col.5, lines 1-4 – the annotated catheter tube terminate at a distal tip 43 which is capable of being configured for insertion into a patient such as into their mouth or other orifice);
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a plurality of extension legs (proximal section of 44, 46, 48) each including a proximal and a distal end (see annotated O’Neil drawing 2 below, and see Col.4, lines 26-35 – the plurality of extension legs are being interpreted as the section of the tubes 44, 46, and 48 that extend proximally from hub 42), wherein the distal end of each extension leg (proximal section of 44, 46, 48) is coupled to a proximal end of the molded hub (42, see annotated O’Neil drawing 2 below and see Col.4, lines 26-35), wherein a fluid pathway is formed between the plurality of extension legs (proximal section of 44, 46, 48) and the catheter tube through the pair of hub lumens (see Fig. 4 and annotated O’Neil drawing 1 above for clarity and Col.5, lines 23-28); and
a securing mechanism configured to secure the plurality of extension legs (proximal section of 44, 46, 48) 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, see annotated O’Neil drawing 2 above and Col.4, lines 35-41 – movable collar 56 can slide over the proximal section of tubes 44, 46, and 48).
O’Neil as disclosed above teaches a hub, but is silent as to the method of manufacturing said hub. The claimed phrase “molded” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a prior art rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though O’Neil as disclosed above is silent as to the process used to form the hub, it is the examiner’s opinion that the molded hub of the claim is the same as the hub of O’Neil even if the hub of O’Neil was made by a different process since the resulting structure of the product is the same.
However, 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 of securing together multiple lengths of extension legs in the claimed invention.
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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 O’Neil 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 O’Neil discloses the catheter assembly of claim 7, as discussed above. In modified O’Neil, 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 O’Neil discloses the catheter assembly of claim 9, as discussed above. In modified O’Neil, O’Neil discloses (Claim 10) wherein the slidable collar (56 in Fig. 4) moves proximally away from the molded hub (42, see Col.4, lines 14-34).
In modified O’Neil, Mogensen discloses (Claim 10) the attachable slidable collar (10, see para. 0020-0021).
However, modified O’Neil fails to disclose (Claim 10) 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 the molded hub.
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 O’Neil 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 O’Neil discloses the catheter assembly of claim 9, as discussed above. In modified O’Neil, O’Neil discloses (Claim 11) wherein the slidable collar (56) is positioned over the plurality of extension legs (proximal section of 44, 46, 48, see annotated O’Neil drawing 2 above).
In modified O’Neil, Mogensen discloses (Claim 11) the attachable slidable collar (10, see para. 0020-0021).
Regarding claim 12, modified O’Neil discloses the catheter assembly of claim 9, as discussed above. In modified O’Neil, 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).
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Regarding claim 13, modified O’Neil discloses the catheter assembly of claim 12, as discussed above. In modified O’Neil, 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 O’Neil discloses the catheter assembly of claim 12, as discussed above. In modified O’Neil, 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 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 O’Neil discloses the catheter assembly of claim 12, as discussed above.
However, modified O’Neil 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 O’Neil 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) 16 is rejected under 35 U.S.C. 103 as being unpatentable over O’Neil in view of Mogensen as applied to claim 12 above, and further in view of Biermann et al. (U.S Patent Pub. No. 20040199122 A1, “Biermann”).
Regarding claim 16, modified O’Neil discloses the catheter assembly of claim 12, as discussed above.
In modified O’Neil, O’Neil discloses the slidable collar (56 in Fig. 4).
In modified O’Neil, Mogensen discloses the attachable slidable collar (10 in Fig. 1).
However, modified O’Neil fails to disclose (Claim 16) the proximal opening and the distal opening are oval shaped, the attachable slidable collar defines a single oval shaped lumen extending from the proximal opening to the distal opening, and the plurality of extension legs pass through the single oval shaped lumen.
Biermann teaches a securing mechanism for securing a plurality of catheter tubes, wherein Biermann teaches a collar (20 in Fig. 1), a proximal opening at proximal end (62 in Fig. 5) and a distal opening at distal end (64 in Fig. 5), and wherein the proximal opening is oval-shaped (see Fig. 5 and 8 and para. 0072 and 0074), and the collar (20) defines a single oval shaped lumen (60 in Fig. 8) extending from the proximal opening (see Fig. 5 and 8 and para. 0072, 0074 – lumen defined by the upper groove 36 and lower groove 30 as shown in Fig. 4 is a single lumen extending from the proximal end 62 to the distal end 64 with the proximal end 62 defining the oval shaped proximal opening), and the plurality of extension legs (114, 116 on Fig. 14) pass through the single oval shaped lumen (60 in Fig. 14, see para. 0082).
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 proximal and distal openings taught by modified O’Neil to have an oval-shape as taught by the proximal opening of Biermann to thus form a single oval shaped lumen extending from the proximal opening to the distal opening with the plurality of extension legs passing therethrough. In modified O’Neil, Mogensen teaches the proximal and distal openings being the same shape, and it would be obvious to make both the distal and proximal openings to have the same oval-shape taught by Biermann, as the wide-mouth, oval-shape prevents kinking in the catheter tubes that pass therethrough (see Biermann, para. 0074). Examiner notes both Mogensen and Biermann disclose collars with guiding structures within them for guiding multiple conduits therewithin (see “73” of Biermann in para. 0091 and see “12” of Mogensen in para. 0021). Modifying the openings of Mogensen to be oval-shaped would maintain the collar of Mogensen to be operable for its intended purpose.
Claim(s) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over 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 O’Neil discloses the catheter assembly of claim 12, as discussed above. In modified O’Neil, 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 O’Neil 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 O’Neil 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 O’Neil discloses the catheter assembly of claim 17, as discussed above. In modified O’Neil, 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 O’Neil discloses the catheter assembly of claim 18, as discussed above. In modified O’Neil, 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 O’Neil discloses the catheter assembly of claim 18, as discussed above. In modified O’Neil, 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’’).
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Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over 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 O’Neil 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 O’Neil 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.M.T./Examiner, Art Unit 3783 /COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783