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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 7, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2019/0321599 (“Burkholz”)
Regarding Claim 1, Burkholz discloses an integrated intravenous catheter (10) comprising:
A catheter adapter (12) comprising a catheter (20) and an inlet (16), the catheter configured to be inserted into a patient’s vasculature;
A needle free connector (Fig. 1J) comprising a first port (see generally at 28), a second port (see generally at 38) positioned opposite the first port, and a side port (see generally at 44) positioned between the first port and the second port (see Fig. 1J), wherein the needle free connector further comprises a main cavity portion (30) having a tapered sidewall (tapered with respect to BOTH the interior and exterior) and a distal taper portion (see Fig. 1J), and wherein the tapered sidewall gradually narrows in a direction of the distal taper portion (see Fig. 1J);
Intermediate tubing (24) extending between the inlet of the catheter adapter and the first port of the needle free connector; and
Extension tubing (44) extending from the side port of the needle free connector wherein the side port is provided on the main cavity portion at a location that includes the tapered sidewall (see Fig. 1J).
Regarding Claim 2, Burkholz discloses the needle free connector comprises a body defining a flow path extending between the first port and the second port.
Regarding Claim 4, Burkholz discloses the side port is not offset from a center of the flow path (see Fig. 1J).
Regarding Claim 7, Burkholz discloses a medical connector (53, 46) positioned at an end of the extension tubing (see Fig. 1D).
Regarding Claim 14, Burkholz discloses a needle free connector (Fig. 1J) comprising:
a body (30);
a first port (circa 28) positioned at a first end portion of the body;
a second port (circa 38) positioned at a second end portion of the body opposite the first port; and
a side port (circa 44) positioned between the first port and the second port, wherein the body comprises a main cavity portion positioned between the first port and the second port (see Fig. 1J), the main cavity portion having a tapered sidewall (note the main cavity portion sidewall is tapered in both the exterior and interior dimension) and a distal taper portion (see Fig. 1J), and wherein the tapered sidewall gradually narrows in a direction of the distal taper portion (see Fig. 1J) wherein the side port is provided on the main cavity portion at a location that includes the tapered sidewall (see Fig. 1J).
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) 3, 9, 10, 13, 17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0321599 (“Burkholz”) as applied above, and further in view of U.S. Publication No. 2019/0091462 (“Bihlmaier”).
Regarding Claim 3, Burkholz discloses the invention substantially as claimed except that that the side port is offset from a center of the flow path. However, Bihlmaier discloses that as an alternative to non-offset side ports (Fig. 1A) of the type described by Burkholz it is known to utilize offset side ports (see Fig. 3A, 3B) in order generate specific flow patterns to help minimize the amount of residual blood, medicament, or other fluids after flushing by helping to create a swirling or spiraling flow of a flushing fluid (Par. 17, 33, 35, 36). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the side port of the invention of Burkholz to be offset from a center of the flow path, as disclosed by Burkholz, in order to create a spiraling, swirling flow which will assist in the reduction of residual fluids retained in the body after flushing.
Regarding Claims 9, 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 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 Burkholz 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 10, 17, Burkholz 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 Burkholz 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 Claims 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 Burkholz 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, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0321599 (“Burkholz”) and U.S. Publication No. 2019/0091462 (“Bihlmaier”) as applied above, and further in view of U.S. Publication No. 2018/0304041 (“Leeflang”).
Regarding Claims 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 Burkholz 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.
Claim(s) 5-6, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0321599 (“Burkholz”) as applied above, and further in view of U.S. Publication No. 2020/0100716 (“Devgon”).
Regarding Claim 5-6 and 15-16, Burkholz discloses the invention substantially as claimed except for explicitly disclosing that the body of the needle free connector further comprises a lip portion extending 360 degrees around the needle free connector, and wherein the lip portion is configured 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 that extension sets (2054) with needleless connectors like those disclosed by Burkholz which provide vascular access can be used to permit the use of a blood draw device (2010) wherein in order to provide for intraoperability the body of the needle free connector further comprises a lip portion extending 360 degrees around the needle free connector (see Fig. 24), and wherein the lip portion is configured to provide a latching surface for engagement with clip portions (2040) of a lock of the blood draw device when coupled to the needle free connector, wherein the device comprises a gap formed between the lip portion and a side port in order (see Fig. 24). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the needle free connector of the invention of Burkholz to comprise a 360 degree lip portion compatible with the latching construction of the blood draw device of Devgon, in order to allow the extension set to be used for drawing blood from the patient via a known, suitable connecting interface geometry in a predictable and expected manner.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0321599 (“Burkholz”) as applied above, and further in view of U.S. Publication No. 2020/0078564 (“Blanchard”)
Regarding Claim 8, Burkholz discloses the needle free connector comprises a body (30) defining a longitudinal axis extending between the first port and the second port, and wherein the side port extends from the body at an angle (see Fig. 1J). Burkholz appears to illustrate the angle of then side port to be approximately 45 degrees (Fig. 1J) or configurations of approximately 135 degrees (see Fig. 1I), but fails to explicitly disclose the actual angle. However, Blanchard discloses a related needle free connector (49) comprises a body defining a longitudinal axis extending between the first port (64) and the second port (52), and wherein the side port (50) extends from the body at an angle of 45-90 degrees relative to the longitudinal axis of the body (see Par. 44). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the side port of the invention Burkholz to vary from 45-90 degrees (and from 90-135 degrees based on the variation shown in Fig. 1I which shows a 45 degree offset from 90 degrees), as disclosed by Blanchard (Par. 44), in order to allow the extension tubing to be positioned at various angles relative to the hub based on clinician preference and the expected utility of the extension to assist in routing the tubing to convenient locations which will not be in the way.
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. Specifically, the Burkholz reference clearly illustrates (see Fig. 1J) a configuration where the side port meets the hollow of the main cavity through tapered portion of the catheter hub (tapering both at the exterior – see Fig. 1A – and the interior – see Fig. 1J).
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.
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 12/22/2025