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 (“RCE”), 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/10/2026 has been entered.
Response to Amendment
The Amendment filed 06/29/2026 has been entered.
Claims 10 and 14-20 are cancelled.
Claims 9 and 11-13 are withdrawn.
Claims 1-9, 11-13, and 21-24 remain pending in the application.
Applicant’s amendments to the Specification have overcome each and every objection previously set forth in the Non-Final Office Action mailed 04/02/2026
Claim Rejections - 35 USC § 103
Claims 1-7 and 21-24 are rejected under 35 U.S.C. 103 as being obvious, and therefore unpatentable, over U.S. Patent App. Pub. No. 2014/0228775 A1, by Burkholz et al. (“Burkholz”) in view of U.S. Patent App. Pub. No. 2004/0158208, by Hiejima (cited by Applicant; “Hiejima”).
Burkholz discloses a device substantially as claimed by Applicant, as follows and with reference to the cropped, cleaned, and annotated version of its Fig. 4 (“AnnFig”), below.
Claim 1: A catheter hub (catheter assembly 100, Fig.4), comprising:
a catheter hub (120) including body having a distal end (end towards catheter 50) having an inner wall (inner wall 128 of hub extending proximally from 24) and a proximal end (proximal end 122),
the body having a cavity (fluid pathway 26, Fig.4) opened at the proximal end (open as seen in Fig.4) and an aperture at the distal end (distal end 24 surrounding catheter 50, Fig.4),
the cavity extending from the opened proximal end (fluid pathway 26 extends from the proximal end 122) to an inside distal wall encircling the aperture at the distal end (inner surface 128 encircles the catheter right at end of distal end 24, [0055], Fig.5); and
a catheter (Fig. 5: 50+130) having a probe end at a proximal portion of the catheter (proximal portion adjacent to 132, Fig.5) and a distal tip at a distal portion of the catheter (Fig. 5, left end of catheter portion 50),
a through lumen extending along the length of the catheter to establish a fluid communication path between the probe end and the distal tip (lumen 136), the catheter fittingly extending through the aperture with a portion of the proximal portion fixedly attached to the inner wall at the distal end of the catheter hub (AnnFig: PPP) such that the distal portion of the catheter extends distally away from the catheter hub (catheter 50 extends distally past distal end 24 as seen in Figs. 4-6) and the proximal portion of the catheter not fixedly attached to the inner wall (NFA in AnnFig) extends proximally into the cavity of the catheter hub (see AnnFig).
Burkholz does not, however, describe that its “catheter” is “one piece”.
Hiejima relates to catheters having valved proximal hubs, in which a proximal portion of the catheter extends into the hub interior cavity in order to open an elastomeric valve positioned in that cavity (which describes both Applicant’s and Burkholz’s arts) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Hiejima teaches (see Figs. 12 and 13 and [0079]) that the catheter of such a device can be “one piece,” i.e., the proximal end (25) of such a catheter, which is used to actuate the valve (3), is a single piece construction with the rest of the catheter (“molded integrally”), which a person of ordinary skill in the art would understand would reduce the manufacturing steps, thus reducing rework, and reduce the cost of the device, because the entire catheter shaft could be made at one time.
It 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, to make Burkholz’s entire catheter “one piece,” because Hiejima teaches doing so in a very closely related valved catheter device, which would reduce manufacturing complexity and thus cost and rejects.
Burkholz in view of Hiejima does not, however, describe that “wherein the thickness of the circumferential wall of the proximal portion of the catheter is greater than the thickness of the circumferential wall of the distal portion of the catheter.”
Uber relates to a device for inserting a catheter into a blood vessel that uses fluid flow to aid the insertion of the catheter (which describes both Applicant’s, Burkholz’s, and Hiejima’s arts) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Uber teaches wherein the thickness of the circumferential wall of the proximal portion of the catheter is greater than the thickness of the circumferential wall of the distal portion of the catheter (“the catheter may be composed of a single material but may be designed to include a first portion at a proximal end of the catheter having a wall thickness that is greater than a distal portion of the catheter.”; see [0054]).
It 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, to make Burkholz in view of Hiejima’s thickness of the circumferential wall of the proximal portion of the catheter be greater than the thickness of the circumferential wall of the distal portion of the catheter. Doing so may allow the proximal portion of the catheter to withstand higher pressures than the distal end of the catheter, as taught by Uber (see [0054]).
Claim 2: (The catheter hub assembly of Claim 1,) wherein the proximal portion of the catheter not fixedly attached to the inner wall at the distal end of the catheter hub forms an actuator (actuator 130, Fig. 4, [0052]) inside the cavity (fluid pathway 26, Fig.4) having the probe end (probe portion 132, Fig.4) for opening a resealable (as shown through Fig.4 and 6) partition of a valve (septum 40, Fig. 4) positioned in the cavity (Fig.4) when the valve is biased distally relative to the catheter hub such that the partition (slit 42, Fig.4) comes into contact with the probe end and is opened thereby ("Upon further movement of septum 40 in distal direction 14, probe portion 132 is advanced through slit 42 of membrane 48" [0057], Fig.4), the lumen establishing a through passageway along the fluid communications path between the proximal end of the catheter hub and the distal tip of the catheter ("providing fluid communication between lumen 136 of septum actuator 130 and rearward receptacle 46 of septum 40” [0057], Figs.4-6).
Claim 3: (The catheter hub assembly of Claim 2,) wherein the actuator (septum actuator 130, Fig.4) is configured to have a rigidity and columnar strength sufficient to open the partition (proximal end 122 that defines septum actuator 130 allows slit 42 to open and close [0050], Fig. 4-6).
Claim 4: (The catheter hub assembly of Claim 1,) wherein the cavity (fluid pathway 26, Fig.5) is substantially in the shape of a cylinder (cavity 26 as seen in Fig.4) and the inside distal wall (inner surface 128, Fig.4) that forms the distal end of the cavity (forms distal end 24, Fig.4) encircling the aperture (inner surface 128 encircles catheter 50) has a counterpart configuration (Fig.4) to a given configuration of the distal end of the valve that contacts the inside distal wall (septum 40 and inner wall surface 128 can establish contact [0053], [0046], Fig.4).
Claim 5: (The catheter hub assembly of Claim 1,) wherein the proximal portion of the catheter inside the cavity has a flared cylindrical portion ("catheter assembly 100 comprises a septum actuator 130 having a probe portion 132" [0052], Fig. 4, which is flared) that includes a probe end (probe portion 132).
Claim 6: (The catheter hub assembly of Claim 1,) further comprising:
a valve positioned in the cavity (septum 40 is positioned in the cavity 26, Fig.4), the valve having a resealable partition (slit 42, [0048], Fig.4), a proximal valve end (rearward receptacle 46, [0048], Fig.4) and a distal valve end (forward receptacle 44, [0048], Fig.4), the distal valve end in contact (forward receptacle 44 proximate to membrane 48 and as seen in Fig.6) with the inside distal wall (inner wall surface 128, Fig.4) and the proximal valve end adapted to be biased by a contact end of an external device (contact of rearward receptacle 46 to external device 12 as seen in Fig.6), the partition (element in which slit 42 is formed) located proximal of the probe end of the proximal portion of the catheter that extends proximally into the cavity (probe portion 132) when the valve is in an unbiased state (slit 42 is more proximal than probe portion 132 as seen in Fig.4).
Claim 7: (The catheter hub assembly of Claim 6,) wherein when the contact end of the external device (contact end of external device 12) makes contact with the proximal valve end (external device 12 is inserted into proximal end 122, Fig.6) and moves the valve distally relative to the catheter hub (external device 12 advances septum 40 in distal direction 14 [0057], Fig.6), the partition is opened by the probe end (“probe portion 132 is advanced through slit 42 of membrane 48,” [0057], Fig.6) so that an open passageway is established through the lumen of the catheter ("providing fluid communication between lumen 136,” id.) between the proximal end of the catheter hub (proximal end 122, Fig.6) and the distal tip of the catheter (opening up passageway from proximal end 122 to distal end towards tip of the catheter, Fig.6).
Claim 21: A method of making a catheter hub assembly, comprising:
providing a catheter hub having a body including a distal end (end towards catheter 50) having an inner wall (including 128), a proximal end (proximal end 122, Fig.4), a cavity (fluid pathway 26, Fig.4) opened at the proximal end (open as seen in Fig.4) and an aperture at the distal end (distal end 24 surrounding catheter 50, Fig.4), the cavity extending from the opened proximal end (fluid pathway 26 extends from the proximal end 122) to an inside distal wall encircling the aperture at the distal end (inner surface 128 encircles the catheter right at end of distal end 24, [0055], Fig.5);
providing a catheter (50+130) having a probe end at a proximal portion of the catheter (130) and a distal tip at a distal portion of the catheter (leftmost end of 50, Fig. 5), a through lumen extending along the length of the catheter to establish a fluid communication path between the probe end and the distal tip (lumen 136);
fittingly extending the catheter through the aperture with a portion of the proximal portion fixedly attached to the inner wall at the distal end of the catheter hub (AnnFig: PPP) such that the distal portion of the catheter extends distally away from the catheter hub (catheter 50 goes past distal end 24 as seen in Figs. 4-6) and the proximal portion of the catheter not fixedly attached to the inner wall extends proximally into the cavity of the catheter hub (NFA in AnnFig).
See above concerning Claim 1 and “one piece” above, which applies equally to Claim 21.
See above concerning Claim 1 and “wherein the thickness of the circumferential wall of the proximal portion of the catheter is greater than the thickness of the circumferential wall of the distal portion of the catheter.” above, which applies equally to Claim 21.
Claim 22: (The method of Claim 21,) further comprising:
inserting a valve having a resealable partition in the cavity (septum 40 with slit 42 is within fluid pathway 26, Fig.4);
wherein the proximal portion of the catheter not fixedly attached to the inner wall at the distal end of the catheter hub forms an actuator (actuator 130, Fig.4, [0052]) inside the cavity having a probe end (probe portion 132, Fig.4) for opening the resealable partition of the valve ("probe portion 132 is advanced through slit 42 of membrane 48" [0057], Fig.4) when the valve is biased distally relative to the body (as seen by Fig. 6, [0057]) such that the partition comes into contact with the probe end and (slit 42 comes into contact with probe portion 132, [0057], Fig.6) is opened thereby to establish a through passageway between the proximal end of the body and a distal end of the catheter ("providing fluid communication between lumen 136 of septum actuator 130 and rearward receptacle 46 of septum 40" [0057], Figs.4-6).
Claim 23: (The method of Claim 21,) further comprising:
configuring the proximal portion of the catheter inside the cavity to have a flared cylindrical portion (“catheter assembly 100 comprises a septum actuator 130 having a probe portion 132,” [0052], Fig.4) that includes the probe end (probe portion 132).
Claim 24: (The method of Claim 22,) further comprising:
configuring the cavity of the body (fluid pathway 26, Fig. 4, 5) to be substantially in the shape of a cylinder (cavity 26 as seen in Fig.4 in a cylindrical and tubular shape); and
configuring the inside distal wall (inner surface 128, Fig.4) that forms the distal end of the cavity ( distal end 24, Fig.4) encircling the aperture (inner surface 128 encircles catheter 50) to have a counterpart configuration (Fig.4) to a given configuration of the distal end of the valve that contacts the inside distal wall (septum 40 and inner wall surface 128 can establish contact [0053], [0046], Fig.4).
Claim 8 is again rejected under 35 U.S.C. 103 as being unpatentable over Burkholz as applied to Claim 6, and further in view of U.S. Patent App. Pub. No. 2019/0388653, by Breindel et al. (“Breindel”).
Claim 8: Burkholz describes a catheter and hub assembly substantially as claimed by Applicant; see above. Additionally, Burkholz discusses a needle passing through the partition (“Catheter assembly 10 may further include features for use with an over-the-needle catheter assembly,” [0044]) and slidably extending through the lumen of the catheter (catheter assembly 100 with catheter 50, the needle would therefore necessarily extend through lumen 136, Figs. 4-6, and through the partition 42, 48); however, it fails to explicitly disclose that the distal tip of the needle extends beyond a distal end of the catheter when the catheter hub is in a ready-to-use position.
Breindel relates to over-the-needle catheter venipuncture devices and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Breindel teaches (see Fig. 1a and accompanying text) that the distal tip (304) of the needle (302) of such a device extends beyond a distal end of the catheter (202) when the catheter hub is in a ready-to-use position (“The catheter may then be moved distally over the needle to thread the tube of the catheter into position in the vein of the subject,” [0003]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter assembly as disclosed by Burkholz to explicitly include that the distal tip of its needle extends beyond a distal end of its catheter when the catheter hub is in a ready-to-use position, because Breindel teaches doing so in a closely-related catheter device, so that the needle can be used to puncture the patient’s vein and advance the catheter into that vein in a single step.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/29/2026, with respect to the rejection(s) of claims 1-7 and 21-24 under 35 USC 103 as being obvious over Burkholz US 2014/0228775 and Hiejima US 2004/0158208, and claim 8 as being obvious over Burkholz and Breindel US2019/0388653 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 USC 103 in view of Burkholz US 2014/0228775 and Hiejima US 2004/0158208 and Uber 20130060137.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
07/23/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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