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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on1/28/2026 has been entered.
Acknowledgment
Claims 1, 9-11, 13 are amended and filed on 1/28/2026.
Claims 17-18 are canceled and claims 38-43 are newly added..
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 35, 38-43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, recites the limitation “a distal tip of the attachment” in lines 8-9. It is unclear if it is referring to the limitation in line 3 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1, line 3.
Claim 10, recites the limitation “a first side” in line 4. It is unclear if it is referring to the limitation in lines 7-8 of claim 9 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in lines 7-8 of claim 9.
Claim 42, recites the limitation “a first side” in line 2. It is unclear if it is referring to the limitation in lines 7-8 of claim 9 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in lines 7-8 of claim 9.
Claim 43 recites the limitation “a second side” in line 2. It is unclear if it is referring to the limitation in line 3 of claim 42 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in in line 3 of claim 42
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 a 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 106 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 support a portion of the catheter 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(s) 9, 11, 13-16, 19 , 42-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King et al. (US.20120143138A1) (“ King”).
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 315) 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 (right half of the 334) disposed on a first side of the attachment structure (Fig. 31) that is 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).
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 a 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 a second side of the attachment structure opposite the first side, across a longitudinal axis ( right and left side of 334, Fig. 32a) .
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 modify 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) 10, 20, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US.20120143138A1) (“ King”) 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 1/28/2026 with respect to claim(s) 1, 9 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 ( claim 9 used different embodiment of the King ).
Applicant’s arguments, see remark, filed 1/28/226, with respect to the rejection(s) of claim(s) 3 have been fully considered and are not persuasive.
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 . however, 334 is nubs that frictionally inserted to fit in the corresponding 245.
Also, the applicant argue King fails to discloses that the fit is interference fit. The engagement between nubs and groove as in ¶0094 can be called an interference fit which can be define as it is inserted by a friction.
Conclusion
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).
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, 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.
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.
/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights