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 .
Acknowledgment
Claims 1, 9, 42-43 are amended and filed on 7/14/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 38-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heuser et al. (US.20040147877A1).
Re Claim 1, Heuser discloses an insertion tool (¶022, 98, Figs. 1-6) for introducing a catheter (28, ¶0081) into an introducer (sheath 12, ¶0022), comprising: an attachment structure (cap 98, ¶0042) including a notch (lower valley of the thread, Fig. 4, ¶0042) at a distal tip (left end of 98) configured to engage an exterior surface of a proximal end of the introducer (100, ¶0042) and prevent the insertion tool from moving in a proximal direction away from the introducer (¶0042, the thread will prevent proximal motion of the 98), wherein a perimeter surface of the notch defines at least a first protrusion (lower half of the left edge ridges of the thread, Fig. 4) configured to secure the introducer within the notch (Fig. 5), and wherein the distal tip of the attachment structure (left end of 98) extending to a point that is proximal of a valve (94 ¶0040, Fig. 4) disposed within a lumen of the introducer (lumen for 100); and a guide channel (a guide channel of inside 106 and around 26, Fig. 4-5, ¶0042) axially aligned with the lumen of the introducer (Fig. 5) when the attachment structure is engaged to the proximal end of the introducer (Fig. 4), the guide channel configured to receive support a length of the catheter to disposed thein (Fig. 5) to maintain columnar integrity of the catheter during insertion of the catheter into the introducer ( portion around 28 within 106, ¶0040).
Re Claim 2, Heuser discloses wherein the guide channel defines an arcuate cross-section (Fig, 4) and includes a radius of curvature commensurate with a radius of curvature of an outer surface of the catheter (Fig. 5, ¶0040).
Re Claim 3, Heuser discloses wherein the guide channel extends through an arc of 30 degrees or more (more, Fig. 4).
Re Claim 4, Heuser discloses the guide channel encircles the portion of the catheter disposed therein (the guide channel encircles at a portion of the catheter Fig. 4).
Re Claim 38, Heuser discloses wherein the perimeter surface of the notch defines the first protrusion (lower half of the left edge ridges of the thread, Fig. 4) and a second protrusion (upper half of the left edge ridges of the thread, Fig. 4) , wherein the first protrusion and the second protrusion are each configured to secure the introducer within the notch (Fig. 4).
Re Claim 39, Heuser discloses wherein the first protrusion and the second protrusion disposed laterally opposite each other across a central axis (upper half of the left edge ridges of the thread, Fig. 4 and lower half of the left edge ridges of the thread are opposite each other from the axis of 98 Fig. ).
Re Claim 40, Heuser discloses wherein a lateral distance between the first protrusion and the second protrusion is less than a diameter of the introducer ( less than diameter of threads 100, Fig. 5).
Re Claim 41, Heuser discloses wherein the first protrusion and the second protrusion co- fit operate to secure the introducer (Fig. 4).
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.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser in view of King et al. (US.20120143138A1) (“ King”).
Re Claim 35, Osypka fails to disclose further including an elongate opening extending longitudinally and extending from the guide channel to an outer surface of the tool.
However, King discloses a tool (Fig.34a-37b, ¶0102) for inserting a catheter (¶0102) into an introducer (shaft 108 with hub 207), comprising: a body (body of 410) defining the guide channel defines (420) an arcuate cross-section (a circular arc that has a cut of the channel, Fig. 34a) and an elongate opening extending longitudinally and extending from the guide channel to an outer surface of the tool (side slot on the side of 410, see Fig. 34a).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide channel of Heuser to include an elongate opening extending longitudinally and extending from the guide channel to an outer surface of the tool as taught by King for the purpose of enabling removing the catheter as the sheath split (King, ¶0102).
Claim(s) 9, 11, 13-16, 19, 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US.20120143138A1) (“ King”) in view of Nardeo (US 20170333682 A1).
Re Claim 9, King discloses a tool (Fig.29a-32b, ¶0102) for inserting a catheter (¶0091) into an introducer (shaft 108 with hub 207), comprising: a body (body of 310) defining a substantially cylindrical shape (Fig. 29a); an attachment structure (lower portion that include 332 and 334 ) extending distally from a distal end of the body (lower end of 330) and configured to engage an inner surface of a connector of the introducer (245 and inner surface of the connector 206, Fig. 31, Fig, 32a), wherein the attachment structure includes at least a first ridge extending radially outward from an outer surface of the attachment structure (right half of the 334) disposed on a first side of the attachment structure (Fig. 31) and a second ridge (left half of 334) extending radially outward and disposed on a second side of the attachment structure (F opposite the first side across a longitudinal axis Fig. 31), the first ridge and the second ridge each configured to engage the inner surface of the connector providing an interference fit engagement( Fig. 32a-b, ¶0094), and wherein a distal tip of the attachment structure (315) extends to a point that is proximal of a valve (204, Fig. 32a) disposed within the introducer when the tool is engaged with the introducer (Fig. 32a); a guide channel ( channel 330 inside 320, Fig. 32a) extending from a proximal end of the body (top end of 327a) to the distal tip of the attachment structure (lower end of 315), the guide channel defining a pathway for the catheter (¶0009) and configured to maintain columnar integrity of the catheter during insertion of the catheter into the introducer (¶0090) and an elongate opening extending longitudinally from the guide channel to an outer surface of the tool (side opening of 320, Fig. 30, ¶0093), but it fails to discloses that the first ridge is extending longitudinally along a firs side and the second ridge is extending longitudinally along a second side.
However, Nardeo discloses an insertion tool (Fig.1-7) and wherein the tool has an introducer (101, 103) and body (602) and an attachment structure (604) has the first ridge (right 604, Fig. 6) is extending longitudinally along a first side (Fig. 6) and the second ridge ( left 604, Fig. 6) is extending longitudinally along a second side (Fig. 6-7, ¶0023).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the attachment structure of King so that the first ridge is extending longitudinally along a firs side and the second ridge is extending longitudinally along a second side as taught by Nardeo for the purpose of locking the introducer with the attachment structure using an art recognized locking element (Nardeo, ¶0023, Note, that the attachment structure of King is push-in ring is replaced with the system tap/cutout of Nardeo).
Re Claim 11, King discloses wherein a lateral width of the elongate opening is less than an outer diameter of the catheter (the side slot is less than the diameter of the channel that can be fit within the channel, Fig. 30).
Re Claim 13, King discloses wherein the body further includes a cylindrical segment shape (327) including a horizontal upper surface that provides a transversely shortened elongate opening (opening a side 330, Fig. 30).
Re Claim 14, King discloses wherein an outer surface of the body defines one of a concave or a bi-concave shape (concave between 328).
Re Claim 15, King discloses wherein the body includes a plurality of ribs extending radially therefrom, the plurality of ribs defining an outer perimeter of the body ( 327A, 330, Fig. 31).
Re Claim 16, King discloses wherein the guide channel defines a tapered shape progressively reducing in diameter from a first diameter ( inner diameter at 327) at a proximal end of the guide channel ( Fig. 31), to a second diameter at a distal end of the guide channel ( lower end diameter at 315, Fig. 32).
Re Claim 19, King discloses wherein the attachment structure includes a beveled tip configured to facilitate engagement with the connector (315).
Re Claim 42, King discloses wherein the attachment structure includes the first ridge (right half of 334) disposed on a first side of the attachment structure (right side) and the second ridge (left half of the 334) disposed on a second side of the attachment structure ( left side) that are each configured engage an inner surface of the connector and provide an interference fit (Fig. 32a-b).
Re Claim 43, King discloses wherein the second ridge is disposed on the second side of the attachment structure opposite the first side, across a longitudinal axis ( right and left side of 334, Fig. 32a) .
Claim(s) 10, 20, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Nardeo and further in view of Cude (US. 20140237798A1).
Re Claim 10, King discloses wherein a transverse axis of the elongate opening is laterally offset from a first side of a central axis of the guide channel from the proximal end of the body to the distal tip of the attachment structure.
However, Cude discloses an insertion tool (Fig.1-12) and wherein tool has a transverse axis of the elongate opening (a transverse axis of the elongated opening is the slit 118, Fig. 12, Fig. 4b ) is laterally offset from a first side of a central axis of the guide channel a from the proximal end of the body to the distal tip of the attachment structure (axis of the slit 118 is in an offset in first side with regards to the axis of 114, Fig. 4b, ¶0033, Fig. 12).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the elongate opening of King so that wherein a transverse axis of the elongate opening is laterally offset from a first side of a central axis of the guide channel from the proximal end of the body to the distal tip of the attachment structure as taught by Cude for the purpose of having a desired shape of the elongated opening which may need specific preferable arrangement and engagement of the catheter (Cude, ¶0033).
Re Claim 20, the embodiment of Fig. 34a of King fails to disclose wherein a longitudinal length of the attachment structure is less than a longitudinal length between a proximal surface of a hub of the introducer and the valve.
However, the embodiment of Fig. 22 of King discloses an insertion tool (Figs.22-23) and wherein a longitudinal length of the attachment structure (a length between the indentations 123 and 125) is less than a longitudinal length between a proximal surface of a hub of the introducer (left portion of 106) and the valve (104, Fig. 23).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the attachment structure of the embodiment of Fig. 34a of King so that a longitudinal length of the attachment structure is less than a longitudinal length between a proximal surface of a hub of the introducer and the valve as taught by the embodiment of Fig. 22 of King for the purpose of having a desired depth control of the attachment structure (the embodiment of Fig. 22 of King, ¶0072).
Re Claim 23, King discloses wherein the valve is one of a slit valve or a duckbill valve (404, Fig. 33, ¶0101).
Response to Arguments
Applicant’s arguments filed on 7/14/2026 with respect to claim(s) 1 have been considered and art not persuasive. The applicant argues that guide element of Heuser is not a guide channel which is the outer surface of the clamp ring. This is found not persuasive as the clamp ‘s channel is inside 106 and around the catheter 26 to guide the catheter. Note: the applicant is advised to further device the channel structurally such as “U-shaped channel” see ¶0048 of the current application.
The applicant argue that Heuser fails to have the notch at a distal tip. This is found not persuasive as the lowest thread can be called a notch that secure the attachment structure to the inserter . Note: the applicant is advised to further device the notch structurally such as the notches from an arc and has protrusions to secure a flange of introducer.
The applicant argue that the thread cannot be used to a first ridge disposed on a first side of the attachment that can have an interference fit and the thread can be called a dimensional fit or clearance fit. This is found not persuasive as ridge can be defined as a protrusion and wherein the element 334 is nubs/ protrusion that frictionally inserted to fit in the corresponding 245.
. Applicant’s arguments, with respect to the rejection(s) of claim(s) 9 under 102 using King 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 over King in view of Nardeo.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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