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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/9/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 11-13 and 15-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 has been amended to recite:
“an internal structure positioned within the flow path proximal to the flow path having a tapered diameter converging toward the internal structure, the internal structure configured to redirect fluid to the distal port when fluid enters the needle free connector via the side port, wherein the internal structure defines a diameter smaller than both (i) the tapered diameter of the flow path, and (ii) a diameter defined by the distal port”
Claim 18 has been amended to recite:
“an internal structure positioned within the flow path proximal to the flow path having a tapered diameter converging toward the internal structure, the internal structure configured to redirect fluid to the distal port when fluid enters the needle free connector via the side port, wherein the internal structure defines a diameter smaller than both (i) the tapered diameter of the flow path, and (ii) a diameter defined by the distal port”
The applicant argues in their Remarks that:
“A non-limiting example of these claimed features is illustrated in Fig. 5, shown below.
The illustrated example clearly shows the flow path (62) extending from the proximal port (26) to
the distal port (24). The internal structure (59) is positioned within the flow path (62) proximal to
the distal port (24). The flow path (62) has a tapered diameter converging toward the internal
structure (59).
In addition, Fig. 5 clearly shows that the internal structure (59) defines a diameter smaller
than both (i) the tapered diameter of the flow path (62), and (ii) a diameter defined by the distal
port (24), i.e., the internal structure (29) has a decreasing diameter in the proximal-to-distal
direction that is smaller than any diameter of the distal port (24), which increases in a proximal-
to-distal direction.”
In response, as was noted in the previous office action, while the drawings labeled a proximal port and a distal port (specifically proximal port 26 and distal port 24 as seen in Figs. 5-6), it is not fully apparent where the proximal port and distal port begin or end, and it is therefore difficult to determine where exactly one should measure “a diameter defined by the distal port”. Based off Figs. 5-6, one could say that distal port 24 possesses multiple different internal diameters, and it is unclear which one applicant refers to when they say “a diameter defined by the distal port”. There appears to a part of what might be considered the distal port including a diameter smaller than a diameter defined by internal feature 59 (see tapering portion immediately below 59 that tapers to a relatively narrow portion). Additionally, the specification and drawings are somewhat lacking regarding an actual shape/design of the “internal structure 59”. Figs. 5-6 feature the same cross-sectional view, which are not enough for one of ordinary skill in the art to understand the full structure of the internal structure 59. The instant disclosure does incorporate by reference U.S. P.G. Publication #2021/0220548 A1, however this Publication discloses multiple different things which might be interpreted as an “internal structure”. It is also not apparent whether internal structure 59 in the instant invention is a structure that can even define a diameter (i.e. if it is merely a protrusion on the inside of a channel, then this lacks the corresponding structure required to alone define a diameter). As such, it cannot be said for sure that the applicant had support, at the time the invention was filed, for the amended limitations in either claim 11 or claim 18.
New Claim 21 recites “wherein the internal structure is integrally formed by the second body portion”. Nowhere did the disclosure as previously filed state that the internal structure is integrally formed by the second body portion. Figs. 5-6 contain no cross-hatching and do not show a clear indication that internal structure 59 is integral to 64. As such, it cannot be said for sure that the applicant had support, at the time the invention was filed, for the new limitations in claim 21.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-13, 16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heflin et al. (US 5,478,331), cited previously and hereafter “Heflin”.
As to claim 11. Heflin discloses a needle free connector comprising:
a first body portion (annotated below);
a second body portion (annotated below) coupled to the first body portion;
a proximal port (annotated below) positioned at a proximal end portion of the first body portion;
a distal port (annotated below) positioned at a distal end portion of the second body portion;
a flow path (8) extending between the proximal port and the distal port (see abstract, Figs. 2, 2a);
a side port (32) positioned between the proximal port and the distal port (annotated below), wherein the side port comprises a tube receiving portion (annotated below) having a first inner diameter, an inlet portion (annotated below) having a second inner diameter smaller than the first inner diameter, and a tapered portion (annotated below) extending between the tube receiving portion and the inlet portion; and
an internal structure (22) positioned within the flow path proximal to the distal port (at least a portion of 22 seen located proximal to distal port), the flow path having a tapered diameter converging toward the internal structure (see para beginning line 3 col. 3 teaching “internal tapered surface 36”), the internal structure configured to redirect fluid to the distal port when fluid enters the needle free connector via the side port (via entrance ports 28 and secondary lumens 26), wherein the internal structure defines a diameter smaller than both (i) the tapered diameter of the flow path (see Fig. 2; 22 is clearly smaller in diameter than 36), and (ii) a diameter defined by the distal port (22 also clearly smaller in diameter of the distal port as it fits therein).
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As to claim 12, Heflin discloses the needle free connector of claim 11, wherein the first body portion and the second body portion define the flow path (8) extending between the proximal port and the distal port (see abstract, Figs. 2, 2a).
As to claim 13, Heflin discloses the needle free connector of claim 12, wherein the side port (32) is offset from a center of the flow path (Figs. 2, 2A).
As to claim 16, Heflin discloses the needle free connector of claim 11, wherein the proximal port comprises a valve member (58a, 48a; see para beginning line 51 col. 3).
As to claim 18, Heflin discloses a needle free connector (70; see Figs. 2-2A as well as annotated Fig. 2 above) comprising:
a first body portion (annotated above);
a second body portion (annotated above) coupled to the first body portion;
a proximal port (annotated above) positioned at a proximal end portion of the first body portion;
a distal port (annotated above) positioned at a distal end portion of the second body portion, wherein the first body portion and the second body portion define a flow path (8) extending between the proximal port and the distal port (see abstract, Figs. 2, 2a);
a side port (32) positioned between the proximal port and the distal port, wherein the side port comprises a primary channel portion (same as the tube receiving portion annotated above) and a tapered portion (annotated above) extending between the primary channel portion and the flow path (see annotated Fig. 2 above); and
an internal structure (22) positioned within the flow path proximal to the distal port, the flow path having a tapered diameter converging toward the internal structure (see para beginning line 3 col. 3 teaching “internal tapered surface 36”), the internal structure configured to redirect fluid to the distal port when fluid enters the needle free connector via the side port (32), wherein the internal structure defines a diameter smaller than both (i) the tapered diameter of the flow path (see Fig. 2; 22 is clearly smaller in diameter than 36), and (ii) a diameter defined by the distal port (22 also clearly smaller in diameter of the distal port as it fits therein).
As to claim 19, Heflin discloses the needle free connector of claim 18, wherein the side port comprises a luer connector on a proximal end thereof (see para beginning line 3 col. 3, para beginning line 56 col. 4).
As to claim 20, Heflin discloses the needle free connector of claim 18, wherein the side port comprises a secondary needle free connector positioned on a proximal end thereof (see para beginning line 3 col. 3, para beginning line 56 col. 4; the examiner notes that Heflin states “Side branch 30 has an infusion side port 32 configured to accept a Luer lock. Extensions, or other types of connectors, could be used as well” – Luer locks and extensions are different types of secondary needle free connectors).
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 of this title, 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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heflin in view of Burkholz et al. (US 2019/0022357, cited previously and hereafter “Burkholz”).
As to claim 15, Heflin discloses the needle free connector of claim 11 as described above, wherein the first body portion and the second body portion of the needle free connector define a longitudinal axis extending between the proximal port and the distal port (an axis is depicted in Figs. 2, 2a), but does not expressly recite wherein the side port extends from second body portion at an angle of 30-150 degrees relative to the longitudinal axis.
Burkholz teaches that a side port extends from second body portion at an angle of 30-150 degrees relative to the longitudinal axis (see para 0008, 0057).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Heflin in view of Burkholz to have a specific angle that the side port extends at from the second body portion, including values of 30-150 degrees relative to the longitudinal axis. One would have been motivated to do so to influence/control the path of a probe that is passed into the side port (see para 0008, 0057 of Burkholz).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heflin in view of Davis et al. (US 2009/0287167 A1, cited previously hereafter “Davis”).
As to claim 17, Heflin discloses the needle free connector of claim 16 as described above.
While it appears that the valve member of Burkholz may be a split septum valve, Burkholz is not explicit to such.
Davis discloses wherein a valve member (24) comprises a split septum valve (see Figs. 2, 3,
5, and para 0027, 0038).
It would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the valve member of Heflin to be in the form of a split
septum valve. One would have been motivated to do so as a way to provide a valve that remains in a
closed position until an appropriately sized structure is inserted through the valve (see Figs. 2, 3, 5,
and para 0027, 0038 of Davis).
Response to Arguments
Applicant’s Remarks submitted 9/9/26 have been considered.
Regarding the arguments concerning the previous rejections under 35 U.S.C. 112(a), the examiner notes that the claims have been amended and therefore the rejections have been changed. For the reasons given in the above rejections however, the claims remain rejected under 35 U.S.C. 112(a).
Regarding the arguments concerning the previous rejections under 35 U.S.C. 112(b), the amendments have obviated the previous rejections.
Regarding the arguments concerning the previous rejections under 35 U.S.C. §102, the arguments are not persuasive. The applicant argues that “catheter sleeve (22) is not configured to "redirect fluid to the distal port when fluid enters the needle free connector via the side port," as claimed. To the contrary, the proximal end of the sleeve (22) appears to be within the "distal port" to receive flow from the support tube (20) such that no flow whatsoever from the side port (32) is redirected by the sleeve (22)”. In response, the examiner points out that a proximal end of catheter sleeve 22 is not within the annotated distal port. Heflin discloses “Catheter sleeve 22 defines a main lumen 24 and one or more secondary lumens 26, two being shown in FIG. 1… Secondary lumens 26 have entrance ports 28 which open into axial lumen 8 adjacent a side branch 30 of body 6. Side branch 30 has an infusion side port 32 configured to accept a Luer lock. Extensions, or other types of connectors, could be used as well. Accordingly, entrance ports 28 of secondary lumens 26 are fluidly coupled to a source of fluid connected to side port 32” (para beginning line 3 col. 3). It is clear from the disclosure of Heflin, that fluid which enters side port 32 is eventually directed via the entrance ports 28 into the sleeve 22. The applicant also argues that “Moreover, since the proximal end of the sleeve (22) appears to be within the "distal port", the sleeve (22) is not "proximal to the distal port," as also claimed”. The examiner disagrees. The claim does not require that the internal feature is completely proximal to the distal port. As illustrated in the annotated Fig. above, at least a portion of 22 is located proximal to the distal port.
Regarding the arguments concerning the previous rejections under 35 U.S.C. §103, the arguments merely refer to the arguments above and therefore are also not persuasive. Regarding new claim 21 specifically, while Heflin does appear to be silent to this limitation, the claim is rejected under 35 U.S.C. §112(a) as noted above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
