DETAILED ACTION
This action is pursuant to the claims filed on December 17, 2025. Claims 1-16 are pending. A final action on the merits of claims 1-16 is as follows.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Stangenes et al. (hereinafter ‘Stangenes’, U.S. PGPub. No. 2007/0270751) in view of Smith (U.S. PGPub. No. 2010/0324488).
In regards to independent claim 1 and claims 3-5, Stangenes discloses a catheter assembly (assembly 1300 in Figs.13A-13E), comprising:
a handle (a puncture assembly hub 1306) including
a housing (casing forming the needle hub 1306) that defines a first lumen (the lumen that disposes the proximal end of the needle 1312, spring 1324 and portion of the needle unlocking mechanism 1318 as shown in Fig. 13E), the housing having a proximal end (proximal end comprising the three way valve 1320 via a flexible tube 1322 which can also be configured for other devices, [0080]) and a distal end (distal end of the hub 1306 where the needle shaft 1312 extends from);
an elongate member (needle shaft 1312) positioned within the first lumen (the proximal end of the needle shaft 1312 is disposed within the hollow lumen as shown in Fig. 13E) having a proximal end operatively controlled by the handle (the proximal end of the needle 1312 is connected to a spring 1324 so that upon unlocking the mechanism 1318, the needle assembly advances forward from a distal end of a dilator, [0079]) and a distal end having a hollow piercing tip that is extendable and retractable with respect to the distal end of the housing (the distal end of the needle 1312 is configured for piercing; and given that it is configured for delivery of fluids or other medical devices, the needle shaft 1312 is hollow);
a second lumen defined within the elongate member and defining a passageway from the handle through the hollow piercing tip ([0050]: needle assemblies includes a puncture device and a stylet; [0016], [0066]: a stylet displacement rod (not shown) is disposed within the needle hub extending through the entire needle hub and beyond the distal portion of the needle assembly which serves to prevent kinking of the needle; [0079]: fluid or other medical devices is disposed within the needle shaft 1312, therefore, the needle 920 comprises a lumen for disposing the stylet);
an engagement shaft positioned on the distal end of the housing and having a shaft interface (the distal end face of the hub 1306 comprises protrusions 1329 which cooperate or is a shaft interface with the other hub 1304 for snap-fit connection, [0078]), the engagement shaft configured to mechanically couple the handle to another catheter assembly via the shaft interface (mating of the distal face of the hub 1306 with the proximal face of the dilator hub 1304 causes a snap-fit connection, [0078]).
However, Stangenes does not necessarily disclose that the engagement shaft is circumferentially surrounding the elongate member and the structural details of the snap-fit members including the receiving lumen including a protrusion configured to engage the shaft interface, the shaft interface comprising a groove arrangement circumferentially and longitudinally on the engagement shaft.
Smith teaches a snap-fit arrangement between two members (member 104 and member 116 in Figs. 4 & 5), wherein one of the members (104) comprises annular snap fit mechanism or elongate shaft (the plurality of tabs 124 for an elongate shaft) comprising a plurality of grooves (circumferential ledges 126 in Fig. 5) arranged circumferentially along the elongate shaft and a second set of grooves (longitudinal grooves in between the circumferential ledges 126 in Fig. 5) arranged longitudinally along the elongate shaft which engages a receiving lumen comprises a protrusion (internal shelf 118 in Fig. 5) to engage with the plurality of grooves (circumferential ledges 126 in Fig. 5) for snap-fit connection. Given that Stangenes is silent as to the specific snap-fit structural details, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the snap-fit members or elongate shafts of Stangenes and incorporate the snap-fit members as taught by Smith, so that instead of two distinct protrusions, a plurality of tabs forming an annular or circumferential arrangement about the elongate member is received by a receiving lumen of the catheter assembly. The examiner notes that selection of any of the known snap-fit structures involves only routine design consideration and a predictable result of locking the catheter assembly with the housing would ensue.
In regards to claim 2, Stangenes/Su combination further discloses a second catheter assembly (combination of outer sheath 1308, sheath hub 1302, dilator 1310 and dilator hub 1304 in Figs. 13A-13D) including a second handle (hub assembly 1302 & 1304 in its connected form), an outer sheath extending from the second handle (outer sheath 126 extends distally from the connected hub assembly 1302 and 1304) and including an end cap assembly (the proximal end face of the dilator hub 1304 which abuts the distal face of the hub 1306 comprising corresponding grooves to receive the snap-fit protrusions 1328 of the hub 1306); and a receiving lumen defined within the end cap assembly, the receiving lumen configured to receive the engagement shaft (the proximal end face of the dilator hub 1304 which abuts the distal face of the hub 1306 comprising corresponding grooves to receive the snap-fit protrusions 1328 of the hub 1306, [0078]).
In regards to claim 6, Stangenes/Su combination further disclose the engagement shaft is configured to prevent rotational movement between the handle and the another catheter assembly via the shaft interface ([0078]: the snap-fit mechanism between the hubs 1304 and 1306 prevents longitudinal and rotational movement between the two).
In regards to claim 7, Stagenes further discloses wherein the handle and the another catheter assembly are configured to snap fit together ([0078]: “All three hubs are removably connected to each other through cooperating snap-fit mechanism (e.g. 1328) which serve to hold the hubs together and further to accurately position the hubs”).
In regards to claim 8, Stangenes/Su combination further discloses wherein the engagement shaft is configured to longitudinally align the handle and the another catheter assembly ([0078]: the snap-fit mechanism (e.g. 1328) along with other orientation members 1314 that are part of the distal face of the hub 1306 and proximal face of the hub 1304 all assist in accurately aligning the hubs along a longitudinal direction).
In regards to independent claim 9 and claims 11-13, Stangenes discloses a catheter assembly system (assembly 1300 in Figs. 13A-13E), comprising:
A first catheter assembly (needle hub 1306, needle 1312, three-way valve 1322 as shown in exemplary Fig. 13D) including:
a first handle (a puncture assembly hub 1306) including
a housing (casing forming the needle hub 1306) that defines a first lumen (the lumen that disposes the proximal end of the needle 1312, spring 1324 and portion of the needle unlocking mechanism 1318 as shown in Fig. 13E), the housing having a proximal end (proximal end comprising the three way valve 1320 via a flexible tube 1322 which can also be configured for other devices, [0080]) and a distal end (distal end of the hub 1306 where the needle shaft 1312 extends from);
an elongate member (needle shaft 1312) positioned within the first lumen (the proximal end of the needle shaft 1312 is disposed within the hollow lumen as shown in Fig. 13E) having a proximal end operatively controlled by the handle (the proximal end of the needle 1312 is connected to a spring 1324 so that upon unlocking the mechanism 1318, the needle assembly advances forward from a distal end of a dilator, [0079]) and a distal end having a hollow piercing tip that is extendable and retractable with respect to the distal end of the housing (the distal end of the needle 1312 is configured for piercing; and given that it is configured for delivery of fluids or other medical devices, the needle shaft 1312 is hollow);
a second lumen defined within the elongate member and defining a passageway from the handle through the hollow piercing tip ([0050]: needle assemblies includes a puncture device and a stylet; [0016], [0066]: a stylet displacement rod (not shown) is disposed within the needle hub extending through the entire needle hub and beyond the distal portion of the needle assembly which serves to prevent kinking of the needle; [0079]: fluid or other medical devices is disposed within the needle shaft 1312, therefore, the needle 920 comprises a lumen for disposing the stylet);
an engagement shaft positioned on the distal end of the housing and having a shaft interface (the distal end face of the hub 1306 comprises protrusions 1329 which cooperate or is a shaft interface with the other hub 1304 for snap-fit connection, [0078]), the engagement shaft configured to mechanically couple the handle to another catheter assembly via the shaft interface (mating of the distal face of the hub 1306 with the proximal face of the dilator hub 1304 causes a snap-fit connection, [0078]).
However, Stangenes does not necessarily disclose that the engagement shaft is circumferentially surrounding the elongate member and the structural details of the snap-fit members including the receiving lumen including a protrusion configured to engage the shaft interface, the shaft interface comprising a groove arrangement circumferentially and longitudinally on the engagement shaft.
Smith teaches a snap-fit arrangement between two members (member 104 and member 116 in Figs. 4 & 5), wherein one of the members (104) comprises annular snap fit mechanism or elongate shaft (the plurality of tabs 124 for an elongate shaft) comprising a plurality of grooves (circumferential ledges 126 in Fig. 5) arranged circumferentially along the elongate shaft and a second set of grooves (longitudinal grooves in between the circumferential ledges 126 in Fig. 5) arranged longitudinally along the elongate shaft which engages a receiving lumen comprises a protrusion (internal shelf 118 in Fig. 5) to engage with the plurality of grooves (circumferential ledges 126 in Fig. 5) for snap-fit connection. Given that Stangenes is silent as to the specific snap-fit structural details, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the snap-fit members or elongate shafts of Stangenes and incorporate the snap-fit members as taught by Smith, so that instead of two distinct protrusions, a plurality of tabs forming an annular or circumferential arrangement about the elongate member is received by a receiving lumen of the catheter assembly. The examiner notes that selection of any of the known snap-fit structures involves only routine design consideration and a predictable result of locking the catheter assembly with the housing would ensue.
In regards to claim 10, see the rejection of claim 2 above.
In regards to claim 14, see the rejection of claim 6 above.
In regards to claim 15, see the rejection of claim 7 above.
In regards to claim 16, see the rejection of claim 8 above.
Response to Arguments
Applicant’s arguments, see Remarks, filed December 17, 2025, with respect to the rejection(s) of claim(s) 1, 2, 6-10, and 14-16 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Stangenes (U.S. PGPub. No. 2007/0270751) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stangenes and Smith (U.S. PGPub. No. 2018/0324488). Smith teaches a snap-fit arrangement between two members (member 104 and member 116 in Figs. 4 & 5), wherein one of the members (104) comprises annular snap fit mechanism or elongate shaft (the plurality of tabs 124 arranged in an annular manner). Given that Stangenes is silent as to the specific snap-fit structural details, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the elongate shafts for snap-fit mechanism of Stangenes and incorporate the snap-fit members as taught by Smith, so that instead of two distinct protrusions, a plurality of tabs forming an annular or circumferential arrangement about the elongate member is received by a receiving lumen of the catheter assembly. The examiner notes that selection of any of the known snap-fit structures involves only routine design consideration and a predictable result of locking the catheter assembly with the housing would ensue.
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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 3/17/2026