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
The Amendments filed 11/04/2025 have been entered.
Claims 1, 11, 27-29, 36 and 37 have thereby been amended.
Claim 10 has been cancelled.
Claims 1-9, 11-13, 15, and 27-41 are being examined in this office action.
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.
Claims 1-3, 5, 10, 15, 27-29, 30-33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359).
Regarding claim 1, Urakawa discloses an introducer assembly, comprising: a syringe (42); a needle including a needle shaft and a needle tip in a distal portion of the needle shaft (41; para. [0028] of translation, needle having distal needle tip); an introducer adapter fluidly coupling the syringe and the needle together (Fig. 1: 43), the introducer adapter including: a primary conduit (Fig. 2: 431); a secondary conduit extending from a side of the primary conduit (Fig. 2: 432); and a valve (Fig. 2: 44) including an elastomeric septum (Fig. 2: 434; para. [0038] of translation, septum made from elastomeric material) sealing a proximal portion of the primary conduit or the secondary conduit (Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432; para. [0035] of translation, last two sentences, valve and septum provide seal); a guidewire-management device (Fig. 1: device 3+5+6+7) coupled to the introducer adapter (Fig. 1: 76 of 7 couples to introducer adapter at 432), the guidewire-management device including a handle having a proximal sleeve (Fig. 7: 92), a distal sleeve (Fig. 7: 71), and a gap between the proximal and distal sleeves (Fig. 7: gap between 812 and 712) including a thumbpad (Fig. 7: thumbpad 821; para. [0092], sentence 1 of translation); and an access guidewire (2) loaded in the introducer adapter and sealed therein by the valve in a ready-to-deploy state of the introducer assembly (para. [0095] of translation, a seal is maintained around the guidewire which is within the tip 76 of the introducer), a guidewire tip of the guidewire located in the needle shaft just proximal of the needle tip (paras. [0099] and [100] of translation; guidewire tip is proximal of tip of needle just before advancement and protrusion) and the septum sealed around a bare-wire portion of the access guidewire in the ready-to-deploy state of the introducer assembly (para. [0095] of translation, a seal is maintained around the guidewire which is within the tip 76 of the introducer), and the gap between the proximal and distal sleeves of the handle of the guidewire-management device configured to provide access to the access guidewire for pressing the access guidewire into the thumbpad and sliding the access guidewire across the thumbpad to advance or withdraw the access guidewire (Fig. 7: thumbpad 821 in the gap between 812 and 712; para. [0092], sentence 1 of translation). However, Urakawa fails to explicitly disclose the thumbpad as being segmented and crescent-shaped.
Matsuzawa teaches an analogous introducer assembly with an analogous guidewire-management device (Fig. 4) including a segmented crescent-shaped thumbpad (Fig. 3: thumbpad 34, crescent shape shown in Fig. 4 and angled slopes at 22a and 24b; segmented by protrusion 36) within the gap between the proximal and distal sleeves of the handle (Fig. 4: gap and crescent-shaped thumbpad between proximal sleeve at 22/22a and distal sleeve at 24). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the explicit Matsuzawa teaching of the segmented crescent-shaped thumbpad into the Urakawa handle of the guidewire-management device, in order to provide more support to the guidewire via the larger thumbpad platform and protrusion 36 of Matsuzawa, and provide a greater area for the user to contact and push the wire along the thumbpad.
Regarding claim 2, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, wherein the valve is a non-elastomeric (Urakawa: para. [0088] of translation, valve 44 is made of for example polyethylene, a non-elastomeric material) cylindrical or conical insert (Urakawa: para. [0039] of translation, first sentence, 44 being cylindrical) with the septum sealing an opening of the insert (Urakawa: Fig. 2; para. [0035] of translation, last two sentences, valve and septum provide seal), the valve disposed in the proximal portion of the primary conduit or the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432).
Regarding claim 3, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 2, as described above, wherein the septum is recessed (Urakawa: recesses 441; para. [0040] of translation, recessing being at the septum 432 at the base of recessed valve 44) in the proximal portion of the primary conduit or the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432).
Regarding claim 5, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, wherein the valve seals the proximal portion of the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432).
Regarding claim 15, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, wherein a wound-wire portion of the access guidewire distal of the bare-wire portion of the access guidewire (Urakawa: paras. [0043] and [0044] of translation, distal portion of guidewire is coiled or wound) terminates with an atraumatic 'J'-shaped guidewire tip (Urakawa: Fig. 1: 21; para. [0048]).
Regarding claim 27, Urakawa discloses a method for securing vascular access, comprising: obtaining an introducer assembly, the introducer assembly including: a syringe (42); a needle including a needle shaft and a needle tip in a distal portion of the needle shaft (41; para. [0028] of translation, needle having distal needle tip); an introducer adapter fluidly coupling the syringe and the needle together (Fig. 1: 43), the introducer adapter including: a primary conduit (Fig. 2: 431); a secondary conduit extending from a side of the primary conduit (Fig. 2: 432); and a valve (Fig. 2: 44) including an elastomeric septum (Fig. 2: 434; para. [0038] of translation, septum made from elastomeric material) sealing a proximal portion of the primary conduit or the secondary conduit (Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432; para. [0035] of translation, last two sentences, valve and septum provide seal); a guidewire-management device (Fig. 1: device 3+5+6+7) coupled to the introducer adapter (Fig. 1: 76 of 7 couples to introducer adapter at 432), the guidewire-management device including a handle having a proximal sleeve (Fig. 7: 92), a distal sleeve (Fig. 7: 71), and a gap between the proximal and distal sleeves (Fig. 7: gap between 812 and 712) including a thumbpad (Fig. 7: thumbpad 821; para. [0092], sentence 1 of translation); and an access guidewire (2) loaded in the introducer adapter and sealed therein by the septum around a bare-wire portion of the access guidewire (para. [0095] of translation, a seal is maintained around the guidewire which is within the tip 76 of the introducer); establishing a needle tract from an area of skin to a blood-vessel lumen of a patient with the needle (para. [0090] of translation); and advancing at least a guidewire tip of the access guidewire from its location in the needle shaft just proximal of the needle tip into the blood-vessel lumen for the securing of the vascular access (para. [0099] of translation), and the gap between the proximal and distal sleeves of the handle of the guidewire-management device configured to provide access to the access guidewire for pressing the access guidewire into the thumbpad and sliding the access guidewire across the thumbpad to advance or withdraw the access guidewire (Fig. 7: thumbpad 821 in the gap between 812 and 712; para. [0092], sentence 1 of translation). However, Urakawa fails to explicitly disclose the thumbpad as being segmented and crescent-shaped.
Matsuzawa teaches an analogous introducer assembly with an analogous guidewire-management device (Fig. 4) including a segmented crescent-shaped thumbpad (Fig. 3: thumbpad 34, crescent shape shown in Fig. 4 and angled slopes at 22a and 24b; segmented by protrusion 36) within the gap between the proximal and distal sleeves of the handle (Fig. 4: gap and crescent-shaped thumbpad between proximal sleeve at 22/22a and distal sleeve at 24). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the explicit Matsuzawa teaching of the segmented crescent-shaped thumbpad into the Urakawa handle of the guidewire-management device, in order to provide more support to the guidewire via the larger thumbpad platform and protrusion 36 of Matsuzawa, and provide a greater area for the user to contact and push the wire along the thumbpad.
Regarding claim 28, Urakawa in view of Matsuzawa teaches the method of claim 27, as described above, further comprising adjusting the introducer assembly such that the introducer assembly is in a ready-to-deploy state thereof if not already upon the obtaining of the introducer assembly, the ready-to-deploy state of the introducer assembly with the guidewire tip of the access guidewire just proximal of the needle tip for the advancing of the access guidewire into the blood-vessel lumen upon the establishing of the needle tract (Urakawa: paras. [0099] and [100] of translation; guidewire tip is proximal of tip of needle just before advancement and protrusion).
Regarding claim 29, Urakawa in view of Matsuzawa teaches the method of claim 28, as described above, further comprising piercing the septum with an integral septum-piercing tip of a distal portion of the distal sleeve (Urakawa: para. [0067] of translation, first sentence, piercing tip 76 and distal sleeve 71 may be integrally formed) of the guidewire-management device before the adjusting of the introducer assembly (Urakawa: para. [0093] of translation, guidewire management device is connected to secondary conduit).
Regarding claim 30, Urakawa in view of Matsuzawa teaches the method of claim 29, as described above, but does not explicitly disclose that the guidewire tip transitions from a straightened to a curved state in the blood-vessel lumen.
Matsuzawa also teaches an analogous introducer assembly with a J-tipped guidewire, wherein the advancing of the access guidewire into the blood-vessel lumen allows the guidewire tip to transition from a straightened state in the needle to a curved state in the blood-vessel lumen (Matsuzawa: page 11 of translation, second-to-last paragraph beginning with “Eventually, as shown in Fig. 12…”). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the explicit Matsuzawa teaching of the guidewire assuming its curved J-shape in the vessel lumen into the Urakawa-Matsuzawa method, as this maintains the purpose of J-tipped guidewires such that they cause minimal damage and maximal glide through the blood vessel.
Regarding claim 31, Urakawa in view of Matsuzawa teaches the method of claim 29, as described above, further comprising withdrawing the guidewire-management device from the introducer adapter after the advancing of the access guidewire into the blood-vessel lumen (Urakawa: para. [0100] of translation, access device 3 is removed after guidewire is placed in vessel), the withdrawing of the guidewire-management device from the introducer adapter leaving the septum sealed around the bare-wire portion of the access guidewire (Urakawa: para. [0100] of translation, access device 3 is removed, but the adapter and guidewire are not, thereby leaving them with the septum around the guidewire).
Regarding claim 32, Urakawa in view of Matsuzawa teaches the method of claim 31, as described above, further comprising aspirating blood with the syringe to confirm the establishing of the needle tract (para. [0091] of translation), the seal of the septum around the bare-wire portion of the access guidewire sufficient to maintain a vacuum during the aspirating of the blood with the syringe (para. [0091] of translation, the vacuum is necessary for the suction of the blood described).
Regarding claim 33, Urakawa in view of Matsuzawa teaches the method of claim 27, as described above, further comprising withdrawing the needle from the patient but leaving the access guidewire in the blood-vessel lumen (para. [0100] of translation), the withdrawing of the needle from the patient including withdrawing both the introducer adapter and the needle over a proximal portion of the access guidewire until a proximal end of the access guidewire escapes from the needle (para. [0100] of translation, adapter and needle are coupled, therefore adapter is moved proximally as needle is proximally withdrawn).
Regarding claim 36, Urakawa in view of Matsuzawa teaches the method of claim 28, as described above, further comprising piercing the septum with a septum-piercing tip coupled to a distal portion of the distal sleeve of the guidewire-management device before the adjusting of the introducer assembly (paras. [0094] and [0095] of translation, the septum must be pierced by 763 before the guidewire can be advanced distally to the needle).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Lewis (US 4935008), herein referred to as Lewis’008.
Regarding claim 4, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, the valve disposed in the proximal portion of the primary conduit or the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432), but fails to disclose that the valve is an elastomeric grommet with an integrally formed septum.
Lewis’008 teaches an analogous introducer assembly, wherein the valve is an elastomeric grommet with the septum integral therewith sealing a cavity of the grommet (Lewis‘008: 17; elastomeric material, col. 4, line 45; integral grommet and septum, col. 4, lines 48-51 and Fig. 1 showing as a singular piece). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve of the Urakawa introducer assembly by incorporating the elastomeric grommet with an integrally formed septum taught by Lewis’008 in order to make the valve a simpler and more cost-effective single piece.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Al-Ali (US 20200188650).
Regarding claim 6, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, but fails to disclose that the valve seals the primary conduit instead of the secondary conduit.
Al-Ali teaches an analogous introducer assembly, wherein the valve seals the proximal portion of the primary conduit (Al-Ali: Fig. 2: valve includes 113U + 150D + 150U in the primary conduit where instrument 140 is inserted). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the sealing valve of the Urakawa introducer assembly by incorporating the valve sealing the primary conduit as taught by Al-Ali, in order to be able to maintain a straight path for inserting the guidewire through the assembly, rather than through the angled side conduit where there is more potential for the wire to kink or become stuck.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Al-Ali (US 20200188650) in further view of Lewis (US 5735813) herein referred to as Lewis’813.
Regarding claim 8, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, but fails to disclose that the bore of the secondary conduit couples a syringe.
Al-Ali teaches an analogous introducer assembly with an introducer-adapter bore in the proximal portion of the secondary conduit couples that of a syringe tip of the syringe (Al-Ali: secondary side conduit 128 accepts syringe at bore port 124; para. [0045], second-to-last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of the syringe placement of the Urakawa introducer assembly by incorporating the syringe coupled to the secondary conduit as taught by Al-Ali, in order to be able to maintain a straight path for inserting the guidewire through the assembly, rather than through the angled side conduit where there is more potential for the wire to kink or become stuck. However, the Urakawa-Al-Ali device still fails to explicitly disclose that the secondary conduit for coupling to a syringe includes a bore with a Luer taper.
Lewis’813 teaches an analogous introducer assembly wherein the bore that accepts the syringe tip includes a Luer taper (Lewis’813: Fig. 3: opening 66 accepts the syringe tip; col. 5, lines 40-41). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe-accepting opening of the Urakawa-Al-Ali device by incorporating the specific Luer taper taught by Lewis’813 in order to have a standardized opening that can be coupled to any standard syringe tip.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Lewis (US 5735813) herein referred to as Lewis’813.
Regarding claim 7, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, wherein an introducer-adapter bore in the proximal portion of the primary conduit (Fig. 2: bore at proximal end of 437) complementing that of a syringe tip of the syringe (para. [0034] of translation, proximal end of 437 connects to syringe 42), but fails to explicitly disclose that bore having a Luer taper.
Lewis’813 teaches an analogous introducer assembly wherein the bore that accepts the syringe tip includes a Luer taper (Lewis’813: Fig. 3: opening 66 accepts the syringe tip; col. 5, lines 40-41). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe-accepting opening of the Urakawa assembly by incorporating the specific Luer taper taught by Lewis’813 in order to have a standardized opening that can be coupled to any standard syringe tip.
Regarding claim 9, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, wherein an introducer-adapter tip in a distal portion of the introducer adapter includes a taper (Fig. 2: distal end of 436 tapered inward) complementing that of a needle-hub bore of a needle hub of the needle (para. [0033] of translation), but fails to explicitly disclose that taper as being a Luer taper.
Lewis’813 teaches an analogous introducer assembly wherein the distal end of the introducer adapter includes a Luer taper for coupling a needle-hub bore (Lewis’813: Fig. 7: tapered end 382 + 326; col. 7, lines 56-59). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle-hub-accepting tip of the Urakawa assembly by incorporating the specific Luer taper taught by Lewis’813 in order to have a standardized end that can be coupled to any standard needle (Lewis’813: col. 8, lines 1-4).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Byrnes (US 20130184659).
Regarding claim 11, Urakawa in view of Matsuzawa teaches the introducer assembly of claim 1, as described above, the guidewire-management device further including a guidewire conduit coupled to the proximal sleeve (5; para. [0084] of translation, conduit 5 couples to proximal sleeve 92), the guidewire conduit configured to provide storage of the access guidewire. However, Urakawa fails to explicitly disclose that the storage of the access guidewire maintains a sterile state of the guidewire.
Byrnes teaches an analogous guidewire storage conduit configured to maintain the sterility of the guidewire (Byrnes: para. [0026], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Urakawa guidewire storage conduit by incorporating the explicit teaching of Byrnes to keep the unused guidewire sterile, in order to maintain sterility of the guidewire and safety for the patient when being handled (Byrnes: para. [0026], last sentence).
Regarding claim 12, Urakawa in view of Matsuzawa in further view of Byrnes teaches the introducer assembly of claim 11, as described above, wherein a distal portion of the distal sleeve includes an integral septum-piercing tip (Urakawa: para. [0067] of translation, first sentence, piercing tip 76 and distal sleeve 71 may be integrally formed) configured to pierce the septum of the valve and deliver the access guidewire therethrough (Urakawa: para. [0095] of translation).
Regarding claim 13, Urakawa in view Matsuzawa in further view of Byrnes teaches the introducer assembly of claim 11, as described above, the guidewire-management device further including a septum-piercing tip coupled to a distal portion of the distal sleeve (Urakawa: Fig. 5b: tip 76 and 763; para. [0067] of translation, first sentence, piercing tip 76 and distal sleeve 71 may be coupled by fusion or adhesion), the septum-piercing tip configured to pierce the septum of the valve and deliver the access guidewire therethrough (Urakawa: para. [0095] of translation).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Bian (US 20150224287).
Regarding claim 34, Urakawa in view of Matsuzawa teaches the method of claim 33, as described above, but does not explicitly disclose holding the guidewire near the skin when withdrawing the needle.
Bian teaches an analogous introducer assembly, wherein the withdrawing of the needle from the patient includes holding the access guidewire in place at or near the area of skin including the needle tract while withdrawing both the introducer adapter and the needle over the proximal portion of the access guidewire (Bian: para. [0067], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated into Urakawa the Bian teaching of holding onto the guidewire near the skin upon withdrawing the needle, in order to prevent moving and accidentally also withdrawing the guidewire.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of in further view of Lapalu et al. (The Journal of Vascular Access 2010) in further view of Adam et al. (Gastrointestinal Endoscopy Vol. 77, No 5S 2013, 1020).
Regarding claim 34, Urakawa in view of Matsuzawa teaches the method of claim 33, as described above, but fails to disclose that the syringe is disconnected prior to withdrawing the needle.
Lapalu et al. teaches the necessity of eliminating residual negative pressure preventing creation of a vacuum during the withdrawing of the needle from the patient (found in ABSTRACT: Background). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated into Urakawa the teaching of Lapalu to prevent creating a vacuum during withdraw of the needle in order to prevent reflux of the blood in the device (found in ABSTRACT: Background). However, Urakawa in view of Lapalu et al. does not explicitly teach this elimination of negative pressure achieved by disconnecting the syringe prior to needle withdrawal.
Adam et al. teaches the method of eliminating residual negative pressure in a needle by
disconnecting the syringe before the withdrawing of the needle from the patient (found in Introduction, last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Urakawa-Lapalu et al. combination by incorporating the method of the disconnection of the syringe before needle withdrawal taught by Adam et al. in order to eliminate the negative effects of residual negative pressure in the needle in a simple step without any additional techniques.
Claims 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Urakawa (JP 2004254879) in view of Matsuzawa (JP 5101359) in further view of Patton (US 4886507).
Regarding claim 37, Urakawa discloses an introducer assembly, comprising: a syringe (42); a needle including a needle shaft and a needle tip in a distal portion of the needle shaft (41; para. [0028] of translation, needle having distal needle tip); an introducer adapter fluidly coupling the syringe and the needle together (Fig. 1: 43), the introducer adapter including: a primary conduit (Fig. 2: 431); a secondary conduit extending from a side of the primary conduit (Fig. 2: 432); and a valve (Fig. 2: 44) sealing a proximal portion of the primary conduit or the secondary conduit (Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432; para. [0035] of translation, last two sentences, valve and septum provide seal); a guidewire-management device (Fig. 1: device 3+5+6+7) coupled to the introducer adapter (Fig. 1: 76 of 7 couples to introducer adapter at 432), the guidewire-management device including a handle having a proximal sleeve (Fig. 7: 92), a distal sleeve (Fig. 7: 71), and a gap between the proximal and distal sleeves (Fig. 7: gap between 812 and 712) including a thumbpad (Fig. 7: thumbpad 821; para. [0092], sentence 1 of translation); and an access guidewire (2) loaded in the introducer adapter and sealed therein by the valve in a ready-to-deploy state of the introducer assembly (para. [0095] of translation, a seal is maintained around the guidewire which is within the tip 76 of the introducer), a guidewire tip of the guidewire located in the needle shaft just proximal of the needle tip (paras. [0099] and [100] of translation; guidewire tip is proximal of tip of needle just before advancement and protrusion) and the valve sealed around a bare-wire portion of the access guidewire in the ready-to-deploy state of the introducer assembly (para. [0095] of translation, a seal is maintained around the guidewire which is within the tip 76 of the introducer), and the gap between the proximal and distal sleeves of the handle of the guidewire-management device configured to provide access to the access guidewire for pressing the access guidewire into the thumbpad and sliding the access guidewire across the thumbpad to advance or withdraw the access guidewire (Fig. 7: thumbpad 821 in the gap between 812 and 712; para. [0092], sentence 1 of translation). However, Urakawa fails to explicitly disclose the thumbpad as being segmented and crescent-shaped, or the valve including an elastomeric O-ring.
Matsuzawa teaches an analogous introducer assembly with an analogous guidewire-management device (Fig. 4) including a segmented crescent-shaped thumbpad (Fig. 3: thumbpad 34, crescent shape shown in Fig. 4 and angled slopes at 22a and 24b; segmented by protrusion 36) within the gap between the proximal and distal sleeves of the handle (Fig. 4: gap and crescent-shaped thumbpad between proximal sleeve at 22/22a and distal sleeve at 24). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the explicit Matsuzawa teaching of the segmented crescent-shaped thumbpad into the Urakawa handle of the guidewire-management device, in order to provide more support to the guidewire via the larger thumbpad platform and protrusion 36 of Matsuzawa, and provide a greater area for the user to contact and push the wire along the thumbpad. Urakawa in view of Matsuzawa fails to teach, however, the valve including an elastomeric O-ring.
Patton teaches an analogous introducer assembly wherein the valve includes an elastomeric 'O'-ring (Patton: O-ring 40 included in valve 48) such that the 'O'- ring sealed around a bare-wire portion of the access guidewire in the ready-to-deploy state of the introducer assembly (Patton: Fig. 3: O-ring 40 sealed around instrument 11). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve assembly of Urakawa-Matsuzawa by incorporating the O-ring taught by Patton in order to provide an additional sealing member to the valve and septum, to ensure the seal is maintained (Patton: col. 4, lines 31-35).
Regarding claim 38, Urakawa in view of Matsuzawa in further view of Patton teaches the introducer assembly of claim 37, as described above, wherein the valve is an integrated Touhy-Borst valve including the elastomeric 'O'-ring for sealing the valve (Patton: Fig. 3: valve 48; col. 4, lines 10-14; O-ring 40), the valve integrated into the proximal portion of the primary conduit (Patton: Fig. 2: 48 in primary conduit) or the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the Touhy-Borst valve taught by Patton as the valve of Urakawa in order to provide an adjustable sealing valve such that a seal can be maintained with smaller instruments (Patton: col. 5, lines 21-27).
Regarding claim 39, Urakawa in view of Matsuzawa in further view of Patton teaches the introducer assembly of claim 37, as described above, wherein the valve is a Touhy-Borst adapter including the elastomeric 'O'-ring for sealing the valve (Patton: Fig. 3: valve 48; col. 4, lines 10-14; O-ring 40), the Touhy-Borst adapter coupled to the proximal portion of the primary conduit (Patton: Fig. 2: 48 in primary conduit) or the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the Touhy-Borst valve taught by Patton as the valve of Urakawa in order to provide an adjustable sealing valve such that a seal can be maintained with smaller instruments (Patton: col. 5, lines 21-27).
Regarding claim 40, Urakawa in view of Matsuzawa in further view of Patton teaches the introducer assembly of claim 37, as described above, wherein the valve seals the proximal portion of the secondary conduit (Urakawa: Fig. 2: valve 44 and septum 434 in proximal portion of secondary conduit 432).
Regarding claim 41, Urakawa in view of Matsuzawa in further view of Patton teaches the introducer assembly of claim 37, as described above, wherein the valve seals the proximal portion of the primary conduit (Patton: Fig. 2: valve 48 seals proximal portion of primary conduit).
Response to Arguments
Applicant’s arguments with respect to the prior art rejections of independent claims 1, 27 and 37 have been considered but are moot because in light of the amendments to claim these claims filed 11/04/2025. The new ground of rejection no longer solely relies on the reference Urakawa to teach all the limitations of these independent claims, specifically challenged in the argument regarding the amended limitations of the crescent-shaped thumbpad. As a result in this change in scope of the claim limitations, independent claims 1, 27 and 37, as well as their respective dependent claims, is now rejected under Urakawa in view of Matsuzawa, as described above. The new ground of rejection relies on Matsuzawa to teach the crescent-shaped thumbpad in the gap between the proximal and distal sleeves of the guidewire-management handle of Urakawa, to provide increased support to the guidewire and a larger surface area for user contact.
For these reasons, Applicant’s arguments are considered moot, and claims 1-9, 11-13, 15, and 27-41 stand rejected in further view of Matsuzawa, as described above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783