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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 March 2026 has been entered.
Claim Rejections - 35 USC § 103
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) 1-4, 7, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0078564 (“Blanchard”) in view of U.S. Publication No. 2021/0220548 (“Kimball”).
Regarding Claim(s) 1 and 14, Blanchard discloses an integrated intravenous catheter (30 – see e.g. Fig. 2A) comprising:
A catheter adapter comprising a catheter (40) and an inlet (see at 38, 32), the catheter configured to be inserted into a patient's vasculature;
A needle free connector (inter alia 48, 64, 52, 50) comprising a first port (52), a second port (64) positioned opposite the first port, a body (48) defining a longitudinal axis extending between the first port and the second port (see Fig. 2A – i.e. the axis which lies concentric to 52 and 64), and a side port (50) positioned between the first port and the second port, wherein the needle free connector (see generally 88 – Fig. 4A; Par. 60 – re: “the connector 88 may include or correspond to the first connector 48…”) further comprises a main cavity portion (see Fig. 4A) having a tapered sidewall and a distal taper portion, and wherein the tapered sidewall gradually narrows in a direction of the distal taper portion (see below);
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intermediate tubing (42) extending between the inlet of the catheter adapter and the first port of the needle free connector (see Fig. 2A); and
extension tubing (54) extending from the side port of the needle free connector (see Fig. 2A);
wherein the distal taper portion is angled differently from the tapered sidewall (see Fig. 4A – specifically the tapered sidewall is understood to comprise either, or both, of the two tapered section with the proximal section comprising a luer taper – see Par. 48 – and the intermediate section comprising a taper which is different from the distal taper portion such that either section may be considered “angled differently” from the distal taper portion or collectively “angled differently” due to the multiple tapers versus the single taper of the distal taper portion), with the tapered sidewall gradually narrowing in the direction of the distal taper portion (see Fig. 4A).
Blanchard discloses the invention substantially as claimed except that that the side port is provide on the main cavity portion “at a location that includes the tapered sidewall” with the tapered sidewall “terminating adjacent the distal taper portion”. Rather Blanchard discloses an intermediate section into which the side port terminates which appears to be straight walled (see Fig. 4A). However, Kimball discloses a related catheter hub (100) which likewise comprises a sideport (140). Kimball discloses that this sideport can terminate into a straight walled section (160) like in Blanchard OR that this sideport can terminate into a tapered section (180) wherein terminating into a tapered section is beneficial where it may act as a contact surface against which fluid entering the housing can impinge to permit redirecting of the fluid for improving fluid flow inclusive to improved flushing (Par. 36). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the hub of Blanchard such that the section into which the side port terminates is tapered instead of straight walled, as disclosed by Kimball, in order to adjust fluid flow dynamics inclusive to improved flushing of the hub by permitting the fluids introduced through the side port to impinge against the tapered sidewall.
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Supplemental Figure: Blanchard, modified in view of Kimball, to provide a tapered intermediate segment in place of the straight walled segment into which the side port terminates.
Blanchard, as modified, discloses the invention substantially as claimed except that that the distal taper portion, in association with the remainder of the tapered sidewall, is configured to receive an constrain a distal nose of a blood draw device when advanced into the needle free connector to keep the nose aligned along the longitudinal axis of the body. Specifically, while Blanchard does disclose a distal taper portion Blanchard is silent as to its purpose. However, Examiner submits that the function of the taper, as claimed, is principally a concern of functional language directed toward the intended use of the catheter hub wherein the “blood draw device” is not specifically required by the claims and is non-descript in physical structure only circularly tied to the shape of the tapered portion of the catheter hub, i.e. the shape of the taper is tied to the corresponding shape of the blood draw device which is only particularly governed by having a shape which is suitable for interfacing with the shape of the taper of the catheter hub. As such, this limitation is not held to define and distinguish over the taper of modified Blanchard whereby the taper of Blanchard is suitable to interface and center any correspondingly designed blood draw device.
Regarding Claim 2, Blanchard discloses the needle free connector comprises a body defining a flow path extending between the first port and the second port (see generally Fig. 4A).
Regarding Claim 3, Blanchard discloses the invention substantially as claimed except that the side port is offset from a center of the flow path. However, Kimball discloses that such side ports should be offset from a center of the flow path (see Fig. 5A) because it improves fluid dynamics for flushing (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to offset the side port of modified Blanchard, as disclosed by Kimball, in order to improve fluid flow dynamics for improved flushing.
Regarding Claim 4, Blanchard discloses that the side port is not offset from a center of the flow path (see Fig. 2A, 4A).
Regarding Claim 7, Blanchard discloses a medical connector (60) positioned at an end of the extension tubing.
Regarding Claim 8, Blanchard discloses the side port extends from the body at an angle of 15-165 degrees relative to the longitudinal axis of the body (Par. 10).
Claim(s) 5, 6, 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0078564 (“Blanchard”) in view of U.S. Publication No. 2021/0220548 (“Kimball”) as applied above, and further in view of U.S. Publication No. 2020/0100716 (“Devgon”).
Regarding Claim(s) 5, 6, 15 and 16, Blanchard discloses the body of the needle free connector further comprises a lip portion extending about the proximal end of the needle free connector (see Fig. 2A, 4A). However, Blanchard does not explicitly disclose that this lip portion extends 360 degrees about the connector to provide a latching surface for engagement with clip portions of a lock of a blood draw device when coupled to the needle free connector. However, Devgon discloses a related catheter adapter and hub (2054) which comprises such a geometry in order to permit interfacing between the hub and a blood draw device (2010), the hub comprising a gap formed between the lip portion and the side port for permitting receipt of corresponding clip portions of a lock of the blood draw device (2040 – see Fig. 24). It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the hub construction of the invention of Blanchard to comprise a 360 degree lip and gap between the lip and the side port, as disclosed by Devgon, in order to provide a well-known connection interface by which ancillary devices, such as a blood draw device, can be operatively connected to the hub.
Claim(s) 9, 10, 13, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0078564 (“Blanchard”) in view of U.S. Publication No. 2021/0220548 (“Kimball”) as applied above, and further in view of U.S. Publication No. 2019/0091462 (“Bihlmaier”).
Regarding Claim 9, Blanchard discloses the invention substantially as claimed except that the main cavity portion of the needle free connector comprises an internal structure configured to redirect fluid when fluid enters the needle free connector via the side port. However, Bihlmaier discloses that in such connectors it is known to provide such main cavities with internal structures (410) configured to deflect fluid flow to improve flushing (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an internal structure in the main cavity of the invention of Blanchard of the type described by Bihlmaier in order to assist in creating a turbulent flow which helps better flush the cavity to thereby reduce the amount of residual medication, blood, or other fluids within the cavity.
Regarding Claim(s) 10 and 17, Blanchard discloses the invention substantially as claimed except that side port of the needle free connector comprises an internal structure configured to redirect fluid when fluid enters the needle free connector via the side port. However, Bihlmaier discloses that in such connectors it is known to provide such side ports (204) with various provisions useful to increase turbulence within the main cavity to improve flushing (Abstract), wherein these provision may include a fluid flow path wherein an internal surface/structure of the side port at a distal portion of the fluid flow path comprises a fluid directing ramp (210a) to redirect fluid when the fluid enters the connector via the side port, wherein the features within the side port can also be paired with features within the main cavity (410 – Abstract; Par. 45). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a fluid directing ramp of the type described by Bihlmaier into the side port of the device of Blanchard in order to assist in creating a turbulent flow which helps better flush the cavity to thereby reduce the amount of residual medication, blood, or other fluids within the cavity.
Regarding Claim(s) 13 and 20, Burkholz discloses the invention substantially as claimed except that the main cavity portion of the needle free connector comprises an internal structure configured to redirect fluid when fluid enters the needle free connector via the side port. However, Bihlmaier discloses that in such connectors it is known to provide such side ports (204) with various provisions useful to increase turbulence within the main cavity to improve flushing (Abstract), wherein these provision may include a distal portion of the fluid flow path of the side port to comprise a flow splitter (220). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a fluid directing flow splitter of the type described by Bihlmaier into the side port of the device of Blanchard in order to assist in creating a turbulent flow which helps better flush the cavity to thereby reduce the amount of residual medication, blood, or other fluids within the cavity.
Claim(s) 11-12 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2020/0078564 (“Blanchard”) in view of U.S. Publication No. 2021/0220548 (“Kimball”) and U.S. Publication No. 2019/0091462 (“Bihlmaier”) as applied above, and further in view of U.S. Publication No. 2018/0304041 (“Leeflang”).
Regarding Claim(s) 11-12 and 18-19, Bihlmaier discloses that the ramp (210a) can be formed with variations in the angle and/or height of the protrusion (Par. 27) inclusive to spiral configurations (Par. 30). In the instant case Bilhmaier fails to explicitly contemplate that any of these changes in angles and shapes necessarily result in ramps positioned on either the lower or upper internal surfaces of the side port (where lower and upper are defined based on the directions of into the plane of the page and out of the plane of the page as illustrated in Fig. 2B – Bihlmaeir). However, to the extent that Bihlmaier expressly suggests altering the various angles and shapes of these ramps, Examiner submits that arriving upon the instantly claimed shape configurations constitute an obvious design choice merely carrying forward the general concepts of the original concept provided by Bihlmaeir and wherein the resultant structures would operate only in an expected and predictable manner to achieve the intended purposes of inducing turbulent flow within the body cavity. It has been held that “mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions”, see In re Williams, 36 F.2d 436, 438 (CCPA 1929). This level of experimentation and optimization is already predicted in Bihlmaeir, particularly with further consideration to changes in the side port angle as expected by Bihlmaeir (Par. 27) and combining flow diverters with side port offsets as suggested by Bihlmaeir (Abstract; Par. 45). Further consideration is provided in view of Leeflang which share the core concept with the invention of Bihlmaeir and contemplates sideports with various diverting shapes form of ramps with various angles, shapes, and directions provided on various surfaces inclusive to the upper and lower surfaces (see Fig. 2-6; particularly configurations shown in Figs. 3 and 5 which illustrate curved ramped surfaces that are provided on the upper/lower surface).
As such, Examiner submits that locating the deflecting ramps of modified Blanchard on any of the various surfaces of the side port, inclusive to the upper and lower surfaces as defined with respect to a central plane of the main cavity portion (particularly inclusive to “spiral” configurations – see Bihlmaeir and Leeflang, particularly Figs. 3 and 5 of Leeflang) constitutes a mere obvious design choice affect a change in shape with predictable and expected results and would be arrived upon by the level of standard experimentation as set forth in the prior art.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
07/29/2026
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