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 .
Response to Amendment
Claims 1, 2, 15, and 18 have been amended. No new matter has been entered. Claims 1-7, 9-11, and 13-21 remain pending.
Claim Objections
Claims 15 and 18 are objected to because of the following informalities:
Claims 15 and 18 are objected to where there is a typographical error causing improper antecedent basis where the claims each originally refer to “a closed distal surface at a distalmost end” and later refer to “the distal end of the distally extending solid elongate shaft” which should be amended to refer to “the distalmost end of the distally extending solid elongate shaft” to maintain proper antecedent basis.
Claim 15 is further objected to where there is a typographical error causing improper antecedent basis where the claim originally refers to “a catheter with a lumen between a distal end and a proximal end” and later refer to “located within a patient and a proximal end configured to be located outside of the patient” which should be amended to refer to “located within a patient and the proximal end configured to be located outside of the patient” to maintain proper antecedent basis.
Appropriate correction is required.
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) 1-7, 9-11, and 13-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finley et al. (US 20020082586, henceforth Finley) in view of Ziebol et al. (US 20130204231, henceforth Ziebol, previously made of record).
Regarding claim 1, Finley discloses a therapeutic delivery system (coupler 10 and conduit 24, fig. 1), the system comprising: a selectively resealable valve member (resilient resealable penetrable valve member 30, fig. 1) comprising a normally closed slit (slit 44, fig. 1), the valve member configured to seal a proximal end of a catheter (see [0027] and [0029], conduit 24 is the catheter and is sealingly engaged with tubular portion 50 which is sealed closed at its opposing end by valve member 30).
Finley does not disclose that the system is for use in performing an antimicrobial lock procedure, the system comprising: a therapeutic delivery device including one or more antimicrobial materials disposed on at least a portion of the therapeutic delivery device, a cap portion, a solid elongate shaft comprising a closed distal surface at a distalmost end, and a base portion, an outer diameter of the base portion being greater than a length of the slit, wherein the solid elongate shaft extends from a first end of the base portion and the cap portion extends from a second end of the base portion opposite the first end, wherein the cap portion is threadedly connectable and disconnectable with the valve member; wherein the valve member and the therapeutic delivery device are separate components and wherein, when in use, a portion of the solid elongate shaft of the therapeutic delivery device is configured to be inserted into the valve member by first entering through the slit, the one or more antimicrobial materials disposed at least partially on an outer surface of the portion of the solid elongate shaft inserted through the slit, and wherein, when assembled, contact between the base portion and the valve member at the slit forms a seal and the base portion remains outside the valve member, the one or more antimicrobial materials configured to be in contact with and released into a fluid in the catheter to form an antimicrobial locking solution. Ziebol teaches a system (mono packaging container system 110, fig. 2B) for use in performing an antimicrobial lock procedure (see [0006] and [0007]), the system comprising: a therapeutic delivery device (sealing cover 120, fig. 2A) including one or more antimicrobial materials (see [0066] and [0067], the sealing cover is provided with antimicrobial compositions) disposed on at least a portion of the therapeutic delivery device (see [0101], antimicrobial coating is on the central protrusion 131 and elongate member 133, fig. 2B), a cap portion (sealing cover threads 141, fig. 2A), a solid elongate shaft (elongate member 133, fig. 2A) comprising a closed distal surface at a distalmost end (see figs. 2A and 2B, the distalmost end of elongate member 133 is a half-domed shape which is closed where it has no opening), and a base portion (the portion of sealing cover 120 which is proximal to elongate member 133 excluding threads 141), wherein the solid elongate shaft extends from a first end of the base portion (see fig. 3B, the first end of the base portion is the distal end where central protrusion 131 is located, and elongate member 133 extends directly from central protrusion 131) and the cap portion extends from a second end of the base portion (see fig. 3B, the second end of the base portion is the proximal end which appears to be a continuous disc of material proximal to threads 141 and central protrusion 131, and threads 141 extend in the distal direction from this proximal most piece of the base portion) opposite the first end (see fig. 3B, the distal direction and proximal direction oppose each other), wherein the cap portion is threadedly connectable and disconnectable with a catheter (see [0100] and [0103], threads 141 provide for removable attachment to a catheter such as catheter 170 as in fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the sealing cover 120 of Ziebol to the system of Finley for killing organisms and preventing organism proliferation and biofilm formation in catheters so that organisms aren't able to exit the catheter and enter the bloodstream of a patient (Ziebol [0064]) by following the antimicrobial lock procedure of Ziebol with the system of Finley. This could be done by using the sealing cover of Ziebol similarly to the syringe and male luer fitting 14 of Finley with conduit 24 attached to tubular portion 50 in Finley clamped and configured similarly to catheter 170 and catheter hub 172, analogously, of Ziebol.
Thus, in the modified system of Finley as modified by Ziebol (henceforth Finley as modified) Finlay as modified discloses the system comprising: an outer diameter of the base portion being greater than a length of the slit (the base portion of Ziebol as called out above has an outer diameter equal to the outer diameter of threads 141, this is greater than the length of slit 44 of Finley where slit 44 is only wide enough to sealingly surround elongate portion 133 in the modified device and elongate portion 133 has a smaller outer diameter than threads 141), wherein the cap portion is threadedly connectable and disconnectable with the valve member (in the modified device, since hub 172 if Ziebol is replaced with the system of Finley for illustrative purposes as shown in fig. 4B, threads 141 would be connecting to threads 28 on attachment end 18 of coupler 10 of Finley); wherein the valve member and the therapeutic delivery device are separate components (see Ziebol fig. 2B and Finley fig. 1, the components are separate and removably connected to each other in the modified system) and wherein, when in use, a portion of the solid elongate shaft of the therapeutic delivery device is configured to be inserted into the valve member (this is how elongate member 133 of Ziebol is able to create lock solution in conduit 24 of Finley; it must enter slit 44 similarly to syringe 14 in fig. 3 of Finley) by first entering through the slit (see Finley fig. 3, this shows syringe 14 entering initially into slit 44 equivalently to how elongate member 133 would enter), the one or more antimicrobial materials disposed at least partially on an outer surface of the portion of the solid elongate shaft inserted through the slit (see Ziebol [0101] and [0102], elongate member 133 is coated with antimicrobial materials which are what enters through slit 44 of Finley in the modified device to make the locking solution as in Ziebol), and wherein, when assembled, contact between the base portion and the valve member at the slit forms a seal (see Finley [0027] and [0043], central protrusion 131 of Ziebol which would be in contact with slit 44 of Finley when sealing cover 120 is fully attached is sealed by the flaps of slit 44 as claimed) and the base portion remains outside the valve member (see Ziebol fig. 4B, the base portion including the widened proximal most end of sealing cover 120 is not insertable into a valve member because it is too large), the one or more antimicrobial materials configured to be in contact with and released into a fluid in the catheter to form an antimicrobial locking solution (see Ziebol [0067] and fig. 4B; this is what is meant to be achieved in the modified system of Finley to yield the benefits of Ziebol [0064]).
{Examiner notes that subsequent references are to Finley unless otherwise called out.}
Regarding claim 2, Finley as modified discloses the system of claim 1 comprising a medical fluid connector (coupler 10, fig. 1) having a proximal end (attachment end 18 is a proximal end, fig. 1) and a distal end (conduit end 20, fig. 1), wherein the valve member is part of the medical fluid connector (see fig. 1, valve member 30 is a part of coupler 10 as shown).
Regarding claim 3, Finley as modified discloses the system of claim 2 wherein the medical fluid connector comprises a non-tortuous fluid path (see fig. 2, the hollow interior of tubular portion 50 is a straight, or non-tortuous, path for fluid to flow through when sealing cover 120 of Ziebol is disconnected from the system).
Regarding claim 4, Finley as modified discloses the system of claim 2 wherein the medical fluid connector comprises a fluid path (the hollow interior of tubular portion 50, fig. 1) having an internal diameter (see fig. 2, the hollow interior has an internal diameter which is measured between the walls of tubular portion 40) that is substantially the same as an outlet port of a medical implement used to inject the fluid into the catheter (see fig. 3, the internal diameter of tubular portion 50 is substantially the same as an internal diameter of syringe 14 as shown in fig. 3; in the modified device, syringe 14 of Finley could be used to fill the clamped proximal end of conduit 24 to create the locking solution, see also Ziebol [0067]).
Regarding claim 5, Finley as modified discloses the system of claim 4 wherein the valve member is located at or near the proximal end of the medical fluid connector (see fig. 1, valve member 30 is at the proximal end of coupler 10 as shown where the proximal end is attachment end 18).
Regarding claim 6, Finley as modified discloses the system of claim 5 wherein the cap portion is configured to engage the proximal end of the medical fluid connector (see Ziebol fig. 4B, sealing cover 120 is configured to connect to threaded connectors such as those at the proximal attachment end 18 of Finley fig. 1) so as to press the base portion into contact with an outer surface of the valve member at the slit to form the seal (see at least Finley [0027]; the connection between attachment end 18 and threads 141 of Ziebol and the central protrusion 131 of Ziebol with slit 44 of Finley creates a seal to prevent leaking at the valve).
Regarding claim 7, Finley as modified discloses the system of claim 6 wherein the medical fluid connector is spike-less (see fig. 2, there is no spike).
Regarding claim 9, Finley as modified discloses the system of claim 7 wherein the medical fluid connector is a needle-less connector (see fig. 2, there is no needle).
Regarding claim 10, Finley as modified discloses the system of claim 1 wherein the solid elongate shaft extends distally of the base portion (see Ziebol fig. 2B, elongate member 133 extends distally of the base portion including central protrusion 131 as shown where the distal direction is the direction pointing from central protrusion 131 towards elongate member 133).
Regarding claim 11, Finley as modified discloses the system of claim 10 wherein the distal end of the solid elongate shaft is configured to open the slit (since the distalmost end of elongate member 133 of Ziebol is rounded as shown in fig. 2A, it is considered to be configured to open the slit as claimed as it would allow for the slit to be slid open smoothly).
Regarding claim 13, Finley as modified discloses the system of claim 1 wherein the portion of the solid elongate shaft with the one or more antimicrobial materials comprises an uneven surface (the distalmost end of elongate shaft 133 of Ziebol is considered to be an uneven surface where it is rounded into a half dome shape, see fig. 2A).
Regarding claim 14, Finley as modified discloses the system of claim 13 wherein the valve member comprises a more deformable and/or more resilient material than the base portion (see [0028], valve member 30 is preferably made of an elastic material; see also Ziebol [0102] which calls out that sealing cover 120 is made of a thermoplastic polymer resin; elastic materials are more deformable than plastic materials, and thus the valve member is more deformable than the base portion as claimed) such that the valve member is configured to conform around a distal and/or side surface of the base portion to form the seal (in the modified device, valve member 30 of Finley is configured to deform around central protrusion 131 of Ziebol to create the seal similar to how valve member 30 interacted with syringe 14 in Finley prior to the modification with Ziebol).
Regarding claim 21, Finley as modified discloses the system of claim 1 wherein the one or more antimicrobial materials are disposed along substantially the entire outer surface of the solid elongate shaft (see Ziebol [0065] and [0073]).
Regarding claim 15, Finley discloses a system (coupler 10 and conduit 24, fig. 1) using a catheter (conduit 24, fig. 1) with a lumen (see fig. 1, there is a lumen in conduit 24 which is the opening extending along the conduit 24) between a distal end (this is the end of the catheter which extends within the body to allow fluid to allow for fluid administration, see [0009], which must have the lumen and opening therefor extending at this end to allow for the fluid to flow from the proximal end into the body) and a proximal end (the proximal end which connects to the coupler 10 as shown in fig. 1), the distal end of the catheter configured to be located within a patient (see [0007]) and a proximal end configured to be located outside of the patient (see fig. 1, the proximal end is configured to attach to coupler 10 and not to be inserted into the patient), the locking system comprising: a medical connector (coupler 10, fig. 1) having a proximal end (attachment end 18, fig. 1) and a distal end (conduit end 20, fig. 1), the proximal end of the catheter releasably coupled to the distal end of the medical connector (see fig. 1, the elements are shown adjacent to each other as they are configured to be directly releasably connected), the medical connector comprising a valve (resilient resealable penetrable valve member 30, fig. 1) with a slit (slit 44, fig. 1) at the proximal end of the medical connector (see fig. 1, slit 44 is at attachment end 18), the slit being normally closed (see [0028], the formation of valve 44 is such that it is normally closed and sealed) to create a seal to the proximal end of the catheter (see [0028]).
Finley does not disclose the system being a locking system for applying an antimicrobial locking solution to a catheter with a lumen between a distal end and a proximal end, the distal end of the catheter configured to be located within a patient and a proximal end configured to be located outside of the patient, the locking system comprising: a medical connector having a proximal end and a distal end, the proximal end of the catheter releasably coupled to the distal end of the medical connector, the medical connector comprising a valve with a slit at the proximal end of the medical connector, the slit being normally closed to create a seal to the proximal end of the catheter; and a therapeutic delivery device separate from the medical connector and configured to be inserted into the medical connector by first entering through the slit when in use, the therapeutic delivery device comprising a cap portion and a distally extending solid elongate shaft, the distally extending solid elongate shaft comprising a closed distal surface at a distalmost end, wherein one or more antimicrobial materials are disposed on an outer surface of at least a portion of the distally extending solid elongate shaft, the distal end of the distally extending solid elongate shaft configured to open the slit to enter the medical connector, the therapeutic delivery device further comprising a base portion connecting a distally facing surface of the cap portion and a proximal end of the distally extending solid elongate shaft, an outer diameter of the base portion being greater than a length of the slit, wherein the cap portion is threadedly connectable and disconnectable with the medical connector; wherein when assembled, the distal end of the distally extending solid elongate shaft extends distally from the distal end of the medical connector and the cap portion threadedly engages the proximal end of the medical connector such that contact between the base portion and the valve at the slit forms a seal and the base portion remains outside the medical connector, the one or more antimicrobial materials configured to be in contact with and released into an injected fluid to form an antimicrobial locking solution. Ziebol teaches a locking system (mono packaging container system 110, fig. 2B) for applying an antimicrobial locking solution (see [0006] and [0007]) to a catheter (catheter 170, fig. 4B) with a lumen (see fig. 4B, the catheter has a lumen which is pinched closed), the locking system comprising: a therapeutic delivery device (sealing cover 120, fig. 2A), the therapeutic delivery device comprising a cap portion (sealing cover threads 141, fig. 2A) and a distally extending solid elongate shaft (elongate member 133, fig. 2A), the distally extending solid elongate shaft comprising a closed distal surface at a distalmost end (see figs. 2A and 2B, the distalmost end of elongate member 133 is a half-domed shape which is closed where it has no opening), wherein one or more antimicrobial materials (see [0066] and [0067], the sealing cover is provided with antimicrobial compositions) are disposed on an outer surface of at least a portion of the distally extending solid elongate shaft (see [0101], antimicrobial coating is on the central protrusion 131 and elongate member 133, fig. 2B), the therapeutic delivery device further comprising a base portion (the portion of sealing cover 120 which is proximal to elongate member 133 excluding threads 141, fig. 2B) connecting a distally facing surface of the cap portion (the distally facing surface of the cap portion is the distalmost end of threads 141, figs. 2A and 2B) and a proximal end of the distally extending solid elongate shaft (the proximal end of elongate shaft 133 is the point where it meets central protrusion 131, fig. 2B; the called out base portion connects these via the proximal part of threads 141 and the called out base portion; note also that the structures are all connected where they are integrally formed), wherein the cap portion is threadedly connectable and disconnectable with the catheter (see [0100] and [0103], threads 141 provide for removable attachment to a catheter such as catheter 170 as in fig. 4); wherein when assembled, the one or more antimicrobial materials configured to be in contact with and released into an injected fluid to form an antimicrobial locking solution (see [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the sealing cover 120 of Ziebol to the system of Finley for killing organisms and preventing organism proliferation and biofilm formation in catheters so that organisms aren't able to exit the catheter and enter the bloodstream of a patient (Ziebol [0064]) by following the antimicrobial lock procedure of Ziebol with the system of Finley. This could be done by using the sealing cover of Ziebol similarly to the syringe and male luer fitting 14 of Finley with conduit 24 attached to tubular portion 50 in Finley clamped and configured similarly to catheter 170 and catheter hub 172, analogously, of Ziebol.
Thus, in the modified system of Finley as modified by Ziebol (henceforth Finley as modified) Finlay as modified discloses the system comprising: the therapeutic delivery device separate from the medical connector (see Ziebol fig. 2B and Finley fig. 1, the components are separate and removably connected to each other in the modified system) and configured to be inserted into the medical connector (this is how elongate member 133 of Ziebol is able to create lock solution in conduit 24 of Finley; it must enter slit 44 similarly to syringe 14 in fig. 3 of Finley) by first entering through the slit when in use (see Finley fig. 3, this shows syringe 14 entering initially into slit 44 equivalently to how elongate member 133 would enter), the distal end of the distally extending solid elongate shaft configured to open the slit to enter the medical connector (since the distalmost end of elongate member 133 of Ziebol is rounded as shown in fig. 2A, it is considered to be configured to open the slit as claimed as it would allow for the slit to be slid open smoothly), an outer diameter of the base portion being greater than a length of the slit (the base portion of Ziebol as called out above has an outer diameter equal to the outer diameter of threads 141, this is greater than the length of slit 44 of Finley where slit 44 is only wide enough to sealingly surround elongate portion 133 in the modified device and elongate portion 133 has a smaller outer diameter than threads 141), the distal end of the distally extending solid elongate shaft extends distally from the distal end of the medical connector (see Ziebol [0067] and fig. 4B; this is what is meant to be achieved in the modified system of Finley to yield the benefits of Ziebol [0064] as the distal end of elongated member 133 would have to extend as claimed to allow the antimicrobial material to be in contact with the injected fluid in the clamped portion of the catheter) and the cap portion threadedly engages the proximal end of the medical connector (in the modified device, since hub 172 if Ziebol is replaced with the system of Finley for illustrative purposes as shown in fig. 4B, threads 141 would be connecting to threads 28 on attachment end 18 of coupler 10 of Finley) such that contact between the base portion and the valve at the slit forms a seal (see Finley [0027] and [0043], central protrusion 131 of Ziebol which would be in contact with slit 44 of Finley when sealing cover 120 is fully attached is sealed by the flaps of slit 44 as claimed) and the base portion remains outside the medical connector (see Ziebol fig. 4B, the base portion including the widened proximal most end of sealing cover 120 is not insertable into a valve member because it is too large).
Regarding claim 16, Finley as modified discloses the locking system of claim 15 wherein the at least a portion of the distally extending solid elongate shaft with the one or more antimicrobial materials comprises an uneven surface (the distalmost end of elongate shaft 133 of Ziebol is considered to be an uneven surface where it is rounded into a half dome shape, see fig. 2A).
Regarding claim 17, Finley as modified discloses the locking system of claim 15 wherein the one or more antimicrobial materials are disposed along substantially the entire outer surface of the distally extending solid elongate shaft (see Ziebol [0065] and [0073]).
Regarding claim 18, Finley discloses a method comprising providing a catheter (conduit 24, fig. 1) with a lumen (see fig. 1, there is a lumen in conduit 24 which is the opening extending along the conduit 24), wherein a distal end of the catheter (this is the end of the catheter which extends within the body to allow fluid to allow for fluid administration, see [0009], which must have the lumen and opening therefor extending at this end to allow for the fluid to flow from the proximal end into the body) is located within a patient ([0009]) and a proximal end of the catheter (the proximal end which connects to the coupler 10 as shown in fig. 1) is located outside of the patient (see fig. 1, the proximal end of conduit 24 is outside of the patient and connects to coupler 10 as shown), the proximal end of the catheter coupled to a distal end of a medical connector (see fig. 1, the proximal end of conduit 24 is outside of the patient and connects to coupler 10 as shown where coupler 10 is the claimed medical connector), the medical connector comprising a valve (resilient resealable penetrable valve member 30, fig. 1) with a slit (slit 44, fig. 1) at a proximal end of the medical connector (see fig. 1, slit 44 is at attachment end 18), the slit being closed to create a seal to the proximal end of the catheter (see [0028], the formation of valve 44 is such that it is normally closed and sealed).
Finley does not disclose a method of applying an antimicrobial locking solution to the catheter using a therapeutic delivery device, the method comprising: injecting a fluid into the lumen of the catheter; and inserting the therapeutic delivery device into the medical connector by first entering through the slit, the therapeutic delivery device comprising a cap portion and a distally extending solid elongate shaft, the distally extending solid elongate shaft comprising a closed distal surface at a distalmost end, wherein one or more antimicrobial materials are disposed on an outer surface of at least a portion of the distally extending solid elongate shaft, the therapeutic delivery device further comprising a base portion connecting a distally facing surface of the cap portion and a proximal end of the distally extending solid elongate shaft, such that the one or more antimicrobial materials configured to be in contact with and released into the injected fluid to form an antimicrobial locking solution. Ziebol teaches a method of applying an antimicrobial locking solution (see at least [0006] and [0007]) to a catheter (catheter 170, fig. 4B) using a therapeutic delivery device (sealing cover 120, fig. 2A), the method comprising: injecting a fluid (lock solution of [0067]) into the lumen of the catheter (see fig. 4B, the lumen of catheter 170 is shown); and inserting the therapeutic delivery device (see step e) of [0067]) into the catheter (see step e) of [0067]), the therapeutic delivery device comprising a cap portion (sealing cover threads 141, fig. 2A) and a distally extending solid elongate shaft (elongate member 133, fig. 2A), the distally extending solid elongate shaft comprising a closed distal surface at a distalmost end (see figs. 2A and 2B, the distalmost end of elongate member 133 is a half-domed shape which is closed where it has no opening), wherein one or more antimicrobial materials (see [0066] and [0067], the sealing cover is provided with antimicrobial compositions) are disposed on an outer surface of at least a portion of the distally extending solid elongate shaft (see [0101], antimicrobial coating is on the central protrusion 131 and elongate member 133, fig. 2B), the therapeutic delivery device further comprising a base portion (the portion of sealing cover 120 which is proximal to elongate member 133 excluding threads 141) connecting a distally facing surface of the cap portion (the distally facing surface of the cap portion is the distalmost end of threads 141, figs. 2A and 2B) and a proximal end of the distally extending solid elongate shaft (the proximal end of elongate shaft 133 is the point where it meets central protrusion 131, fig. 2B; the called out base portion connects these via the proximal part of threads 141 and the called out base portion; note also that the structures are all connected where they are integrally formed), such that the one or more antimicrobial materials are configured to be in contact with and released into the injected fluid to form an antimicrobial locking solution (see at least [0067], [0113], and [0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the sealing cover 120 of Ziebol to the system of Finley for killing organisms and preventing organism proliferation and biofilm formation in catheters so that organisms aren't able to exit the catheter and enter the bloodstream of a patient (Ziebol [0064]) by following the antimicrobial lock procedure of Ziebol with the system of Finley. This could be done by using the sealing cover of Ziebol similarly to the syringe and male luer fitting 14 of Finley with conduit 24 attached to tubular portion 50 in Finley clamped and configured similarly to catheter 170 and catheter hub 172, analogously, of Ziebol.
Thus, in the modified system of Finley as modified by Ziebol (henceforth Finley as modified) Finlay as modified discloses that the therapeutic delivery device is separate from the medical connector (see Ziebol fig. 2B and Finley fig. 1, the components are separate and removably connected to each other in the modified system), wherein the therapeutic delivery device comprises the cap portion which is threadedly connectable and disconnectable with the medical connector (in the modified device, since hub 172 if Ziebol is replaced with the system of Finley for illustrative purposes as shown in fig. 4B, threads 141 would be connecting to threads 28 on attachment end 18 of coupler 10 of Finley), wherein the distal end of the distally extending solid elongate shaft is configured to open and be inserted into the slit to enter the medical connector (this is how elongate member 133 of Ziebol is able to create lock solution in conduit 24 of Finley; it must open and enter slit 44 similarly to syringe 14 in fig. 3 of Finley) by first entering through the slit (see Finley fig. 3, this shows syringe 14 entering initially into slit 44 equivalently to how elongate member 133 would enter), with an outer diameter of the base portion being greater than a length of the slit (the base portion of Ziebol as called out above has an outer diameter equal to the outer diameter of threads 141, this is greater than the length of slit 44 of Finley where slit 44 is only wide enough to sealingly surround elongate portion 133 in the modified device and elongate portion 133 has a smaller outer diameter than threads 141), wherein when assembled, the distal end of the distally extending solid elongate shaft extends distally from the distal end of the medical connector (see Ziebol [0067] and fig. 4B; this is what is meant to be achieved in the modified system of Finley to yield the benefits of Ziebol [0064] as the distal end of elongated member 133 would have to extend as claimed to allow the antimicrobial material to be in contact with the injected fluid in the clamped portion of the catheter) and the cap portion threadedly engages the proximal end of the medical connector (in the modified device, since hub 172 if Ziebol is replaced with the system of Finley for illustrative purposes as shown in fig. 4B, threads 141 would be connecting to threads 28 on attachment end 18 of coupler 10 of Finley) such that contact between the base portion and the valve at the slit forms a seal (see Finley [0027] and [0043], central protrusion 131 of Ziebol which would be in contact with slit 44 of Finley when sealing cover 120 is fully attached is sealed by the flaps of slit 44 as claimed) and the base portion remains outside the medical connector (see Ziebol fig. 4B, the base portion including the widened proximal most end of sealing cover 120 is not insertable into a valve member because it is too large).
Regarding claim 19, Finley as modified discloses the method of claim 18 wherein the at least a portion of the distally extending solid elongate shaft with the one or more antimicrobial materials comprises an uneven surface (the distalmost end of elongate shaft 133 of Ziebol is considered to be an uneven surface where it is rounded into a half dome shape, see fig. 2A).
Regarding claim 20, Finley as modified discloses the method of claim 18 wherein the one or more antimicrobial materials are disposed along substantially the entire outer surface of the distally extending solid elongate shaft (see Ziebol [0065] and [0073]).
Response to Arguments
Applicant’s arguments with respect to the independent 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harding et al. (US 20080161763) is considered relevant prior art regarding a valve member similar to Finley and to Applicant’s valve member which also uses antimicrobial treatments.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783