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 .
Election/Restrictions
Applicant's election with traverse of Group II, Claims 11-20 in the reply filed on 1/12/25 is acknowledged. The traversal is on the ground(s) that no search burden exists. This is not found persuasive because as pointed out in the Restriction, the subcombination requires additional limitations such as a first body portion; a second body portion coupled to the first body portion; a proximal port
positioned at a proximal end portion of the first body portion; a distal port positioned at a distal end portion
of the second body portion. The subcombination has separate utility such as connecting two separate
pieces of tubing or other devices besides a catheter adapter. Even if the combination and subcombination do share some common elements, the unique elements of each would require a different search as pointed out in the Restriction.
The requirement is still deemed proper and is therefore made FINAL.
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) 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US 2019/0022357 A1, hereafter “Burkholz”).
As to claim 11, Burkholz discloses a needle free connector (Fig. 19; see annotated version below) comprising: a first body portion; a second body portion coupled to the first body portion; a proximal port (proximal opening of first body portion) positioned at a proximal end portion of the first body portion (for all parts, see annotated Fig. 19 below); a distal port (distal opening of second body portion) positioned at a distal end portion of the second body portion; and a side port (extended off the first body portion) positioned between the proximal port and the distal port, wherein the side port comprises a tube receiving portion having a first inner diameter, an inlet portion having a second inner diameter smaller than the first inner diameter, and a tapered portion extending between the tube receiving portion and the inlet portion (see annotated Fig. 19 below).
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As to claim 12, Burkholz discloses the needle free connector of claim 11, wherein the first body portion and the second body portion define a flow path extending between the proximal port and the distal port (flow path opened when probe/catheter inserted therethrough – see Fig. 18 and para 0087).
As to claim 13, Burkholz discloses the needle free connector of claim 12, wherein the side port is offset from a center of the flow path (see Figs. 18-19).
As to claim 14, Burkholz discloses the needle free connector of claim 11, wherein the second body portion comprises an internal structure (interior wall of second body portion) configured to redirect fluid when fluid enters the needle free connector via the side port (fluid would contact interior wall and be redirected through extension tubing 108).
As to claim 15, Burkholz discloses the needle free connector of claim 11, wherein the first body portion and the second body portion of the needle free connector define a longitudinal axis (not depicted, but interpreted as axis extending vertically through a center of the proximal port and the distal port as annotated above) extending between the proximal port and the distal port, and wherein the side port extends from second body portion at an angle of 30-150 degrees relative to the longitudinal axis (see para 0008, 0057).
As to claim 16, Burkholz discloses the needle free connector of claim 11, wherein the proximal port comprises a valve member (not numbered, however see Fig. 18 depicting a probe inserted through a valve member located at the proximal port).
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) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Davis et al. (US 2009/0287167 A1, hereafter “Davis”).
As to claim 17, Burkholz 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 Burkholz 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).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Mottola et al. (US 2005/0261630 A1, hereafter “Mottola”).
As to claim 18, Burkholz discloses a needle free connector (Fig. 19; also see annotated version of Fig. 19 above) comprising: a first body portion; a second body portion coupled to the first body portion; a proximal port positioned at a proximal end portion of the first body portion; a distal port positioned at a distal end portion of the second body portion (all parts annotated above), wherein the first body portion and the second body portion define a flow path extending between the proximal port and the distal port (flow path opened when probe/catheter inserted therethrough – see Fig. 18 and para 0087); and a side port (annotated above) positioned between the proximal port and the distal port, wherein the side port comprises a primary channel portion (in this instance, the “primary channel portion” being interpreted as the annotated tube receiving portion above) and a tapered portion (see annotated Fig. 19 above).
However, due to the presence of the annotated inlet portion, Burkholz is silent to the tapered portion extending between the primary channel portion and the flow path (the examiner is interpreting “extending between” to mean that the tapered portion must completely extend from the primary channel portion to the flow path, similar to instant tapered portions 81 and 91 in Figs. 7-8 of the instant disclosure).
Nonetheless, Mottola discloses a tapered portion extending from a primary channel portion to a flow path (main lumen 35) (see embodiments of Figs. 7 and 9, para 0056, 0058, depicting various shapes including tapering sections extending to main lumen 35, including a statement that “a variety of types and configurations of side ports can be utilized without departing from the scope and spirit of the present invention. For example, the side port lumen can be cylindrical, non-cylindrical, curved, or any other shape or configuration that allows the side port lumen to perform its intended functions”). 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 Burkholz such that the tapered portion extends between the primary channel portion and the flow path. One would have been motivated to do so based on the intended function of the side port lumen (see Figs. 7 and 9, para 0056, 0058 of Mottola). Additionally, such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
As to claim 19, Burkholz in view of Mottola discloses the needle free connector of claim 18, wherein the side port comprises a luer connector on a proximal end thereof (“luer adapter 303” – see para 0079, 0080, Fig. 19 of Burkholz).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Mottola as applied to claim 18 above, and further in view of Harris et al. (US 2013/0158506 A1, hereafter “Harris”).
As to claim 20, Burkholz in view of Mottola discloses the needle free connector of claim 18, but does not expressly show wherein the side port comprises a secondary needle free connector positioned on a proximal end thereof (the luer adapter 303 not shown being connected to anything).
Harris discloses “the luer lock connector or other fluid supply adapter 287 maybe coupled directly to the catheter hub 220 and/or stabilization hub 240, rather than to an extension tubing 285” (para 0023).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a attached a secondary needle free connector to a proximal end of the side port. One would have been motivated to do so as an alternative to the other embodiments of Burkholz (e.g. see for example Fig. 12 showing a secondary needless connector connected via extension tubing 108), as Harris teaches that connectors can be coupled directly to a catheter hub or via extension tubing (see para 0023 of Harris).
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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/James D Ponton/Primary Examiner, Art Unit 3783