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 § 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 15-20 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:
“a flow path extending between the proximal port and the distal port, the flow path having a tapered diameter converging toward the distal port; an internal structure positioned between the flow path and the distal port, the internal structure configured to redirect fluid 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”,
and claim 18 has been amended to recite:
“the flow path having a tapered diameter converging toward the distal port; an internal structure positioned between the flow path and the distal port, the internal structure configured to redirect fluid 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 has pointed out in their Remarks that “This amended subject matter was previously presented in dependent claim 14, which is now cancelled, and is further supported in the application in, at least, Figs. 5-8 and ¶¶[0058]-[0072]” (page 6, Remarks document). Previous claim 14 recited “The needle free connector of claim 11, wherein the second body portion comprises an internal structure configured to redirect fluid when fluid enters the needle free connector via the side port.” The only usage of the word “taper” in the specification as originally filed, including within ¶¶[0058]-[0072], pertained to a side port, i.e. tapered portions 57, 81, or 91 of side ports 28, 79, and 95, respectively. Additionally, while the drawings labeled a proximal port and a distal port (for example, 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 therefore difficult to determine where exactly one could measure “a diameter defined by the distal port”. Furthermore, it seems contradictory to say that the flow path is “extending between the proximal port and the distal port” while also saying that the internal structure is “positioned between the flow path and the distal port”. There was also no explicit mention of the flow path having a tapered diameter or 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. Based on these factors, it cannot be said for certain that that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention of amended claim 11 or 18.
Dependent claims inherit the deficiencies of the claims from which they depend.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 11-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the side port" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that the claim later recites “a side port” and “the side port”. The examiner further notes that claims 12 and 15 also refer to “the side port”.
Claim 12 recites “wherein the first body portion and the second body portion define a flow path extending between the proximal port and the distal port” which is unclear because claim 11 was amended to include similar limitations.
Claim 18 recites the limitation "the side port" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that the claim later recites “a side port” and “the side port”. The examiner further notes that claims 19 and 20 also refer to “the side port”.
Dependent claims inherit the deficiencies of the claims from which they depend.
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), hereafter “Heflin”.
As to claim 11, Heflin discloses a needle free connector (70; see Figs. 2-2A as well as annotated Fig. 2 below) 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), the flow path having a tapered diameter converging toward the distal port (see para beginning line 3 col. 3 teaching “internal tapered surface 36”);
an internal structure (22) positioned between the flow path and the distal port, the internal structure configured to redirect fluid when fluid enters the needle free connector via the side port (32) (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); and
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.
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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 a 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), the flow path having a tapered diameter converging toward the distal port (see para beginning line 3 col. 3 teaching “internal tapered surface 36”);
an internal structure (22) positioned between the flow path and the distal port, the internal structure configured to redirect fluid 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); and
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).
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, 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 arguments with respect to each of the claims have been considered but are moot because the arguments do not apply to the rejections being used in the current office action.
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 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
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