DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 9, 2026 has been entered.
This action is pursuant to the claims filed on May 11, 2026. Claims 1-4, 6-12 and 14-16 are pending. Claims 5 and 13 are canceled. A first 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 1-4, 6-12 and 14-16 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 3-4, & 6-8, 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]).
Stangenes 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]).
However, Stangenes does not necessarily disclose that the engagement shaft is circumferentially surrounding the elongate member and the structural details of the connection 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 to receive the another catheter assembly.
Segal teaches a plurality of medical connector portions that can be joined together to form a complete connection ([0036]). Although Segal teaches that the medical connection is between an infusion source and a catheter, since Segal generally discloses medical connection mechanism between two medical assemblies, it is considered within the same field of art as the instant application and solves the same problem as that of the Applicant’s which is for connecting two medical assemblies. Segal teaches various alternative medical assembly connections including simple friction fit (Fig. 6A between connectors 200 and 205, [0036]), use of detent and corresponding hole for locking connection ([0037]), two protrusions for engaging to the other connector (Fig. 6C, [0038]), and radially spaced and longitudinally extending pins (160’ in Fig. 8D) and corresponding slots (165’) for receiving the radially spaced pins ([0048]). Note that the extending pins and the corresponding slots of Segal as shown in Fig. 8D are 1) configured for a snap fit connection, thus meeting claim 7, 2) prevents rotational movement between the assemblies, thus meeting claim 6, and 3) the pins and the corresponding slots allow for longitudinal alignment between the assemblies, thus meting claim 8. Given that Stangenes discloses providing two protrusions (snap-fit mechanism, e.g., 1328 in Fig. 13D) to lock to the proximal end face of another catheter assembly (1304 in Fig. 13D), it would have been obvious to one of ordinary skill in the art to before the effective filing date of the invention to modify the elongate shaft of the housing and the receiving lumen of the another catheter assembly of Stangenes and incorporate 1) an elongate shaft comprising radially spaced pins along the elongate shaft (the examiner notes that ‘grooves’ are arranged between two adjacent pins) and 2) corresponding slots on the receiving lumen for receiving the pins (the examiner notes that portions between adjacent slots form ‘protrusions’ configured to engage with the ‘grooves’ of the elongate shaft) as taught by Segal, respectively to provide a snap fit connection between the housing and the another catheter assembly, as doing so is one of various ways to form medical connection between two medical assemblies (abstract).
In regards to independent claim 9 and claims 10-12 & 14-16, 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]).
Stangenes 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]).
However, Stangenes does not necessarily disclose that the engagement shaft is circumferentially surrounding the elongate member and the structural details of the connection 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 to receive the another catheter assembly.
Segal teaches a plurality of medical connector portions that can be joined together to form a complete connection ([0036]). Although Segal teaches that the medical connection is between an infusion source and a catheter, since Segal generally discloses medical connection mechanism between two medical assemblies, it is considered within the same field of art as the instant application and solves the same problem as that of the Applicant’s which is for connecting two medical assemblies. Segal teaches various alternative medical assembly connections including simple friction fit (Fig. 6A between connectors 200 and 205, [0036]), use of detent and corresponding hole for locking connection ([0037]), two protrusions for engaging to the other connector (Fig. 6C, [0038]), and radially spaced and longitudinally extending pins (160’ in Fig. 8D) and corresponding slots (165’) for receiving the radially spaced pins ([0048]). Note that the extending pins and the corresponding slots of Segal as shown in Fig. 8D are 1) configured for a snap fit connection, thus meeting claim 15, 2) prevents rotational movement between the assemblies, thus meeting claim 14, and 3) the pins and the corresponding slots allow for longitudinal alignment between the assemblies, thus meting claim 16. Given that Stangenes discloses providing two protrusions (snap-fit mechanism, e.g., 1328 in Fig. 13D) to lock to the proximal end face of another catheter assembly (1304 in Fig. 13D), it would have been obvious to one of ordinary skill in the art to before the effective filing date of the invention to modify the elongate shaft of the housing and the receiving lumen of the another catheter assembly of Stangenes and incorporate 1) an elongate shaft comprising radially spaced pins along the elongate shaft (the examiner notes that ‘grooves’ are arranged between two adjacent pins) and 2) corresponding slots on the receiving lumen for receiving the pins (the examiner notes that portions between adjacent slots form ‘protrusions’ configured to engage with the ‘grooves’ of the elongate shaft) as taught by Segal, respectively to provide a snap fit connection between the housing and the another catheter assembly, as doing so is one of various ways to form medical connection between two medical assemblies (abstract).
Response to Arguments
Applicant’s Remarks filed on May 11, 2026 is fully acknowledged.
Applicant’s arguments, see Remarks, filed May 11, 2026, with respect to the rejection(s) of claim(s) 1-16 under 35 U.S.C. 103 as being unpatentable over Stangenes (U.S. PGPub. No. 2007/0270751) and Smith (U.S. PGPub. No. 2018/0324488) has been fully considered. Upon further consideration and an updated search, a new ground of rejection has been made in view of Stangenes and Segal et al. (U.S. PGPub. No. 2004/0201216). Segal, in teaching an interlocking mechanism as disclosed in Fig. 8D (between radially arranged pins 160’ along an elongate shaft and receiving slots 165’), aides in curing the deficiencies of Stangenes as explained in above Office action.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/17/2026
Prosecution Insights