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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 February 2026 (“Reply”) has been entered.
Response to Amendment
This Action is responsive to the RCE and Reply. As directed in the Reply:
Claims 1 and 21 have been amended;
Claims 10 and 14-20 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1-9, 11-13, and 21-24 are presently pending in this application, with Claims 9 and 11-13 having been previously withdrawn from consideration.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not persuasive.
Finality of the prior Action
Applicant’s arguments concerning the finality of the last Action are moot, because Applicant filed an RCE after that Action.
New matter objection
This application is an international application filed under the PCT; what is before the Office is the U.S. National Stage of the international application. Applicant’s comments rely on its misunderstanding of the difference between a National Stage application filed under 35 U.S.C. § 371 and a regular U.S. application filed under 35 U.S.C. § 111 with a claim for domestic priority, under 35 U.S.C. § 120, to an international application (i.e., a “PCT Bypass”), noting Applicant’s reference to “continuation/divisional applications” at the bottom of pg. 7 of the Reply. The Specification filed on 19 November 2021 is not identical to the original PCT specification, because the first paragraph of the application was added to state:
This is a US National stage application of PCT Application No. PCT/US2020/039134, filed June 23, 2020, which in turn claims priority from US Provisional application No. 62/866,951 filed June 26, 2019. The contents of the '134 and '951 applications are fully incorporated herein by reference.
The first page of this international application, as filed, begins with the following:
It is currently the Office’s policy that the incorporation by reference statements added by Applicant to the application, after its filing date, are new matter. Were this application filed as a PCT Bypass, the November 19th revision of the Specification would not be new matter in the application; it would just have an “earliest effective filing date” later than the international application to which it claims priority. Because this is, instead, a “371 application,” what Applicant filed was, indeed, an amended Specification relative to its original filed in the international phase of the application.
The balance of Applicant’s arguments concern the rejection of the claims relying on Burkholz under sec. 102; as the rejection has been changed to one under sec. 103, and Applicant presents no arguments to this point, they are moot.
Specification
The amendment filed 19 November 2021 is again objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the U.S. provisional patent application.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
Applicant has revised the claims to recite the term “one piece;” express support for the term is found in paras. [0042] and [0046]. The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
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.
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.
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”).
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783