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 .
Status of Claims
This office action is responsive to the amendment filed 21 August 2026.
Claims 8-10 are canceled.
Claims 1, 11, and 13 are amended.
Claims 1-7 and 11-14 are presently pending in this application.
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 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ishida (US Patent Publication No 20180207406 A1) in view of Burkholz et al. (US Patent Publication No. 20200023166 A1), hereinafter Burkholz.
Regarding claim 1, Ishida discloses a medical device (Ishida: Fig. 1, guidewire unit 14), comprising: an catheter (Fig. 1, comprising guidewire 80 and catheter 16) having a proximal end (Fig. 1, end of comprising guidewire 80 and catheter 16 towards operation member 84) and a distal end (Fig. 1, distal end of guidewire 80 and catheter 16); an introducer (Fig. 1, guide wire unit 14) configured to moveably receive the catheter (Fig. 1, unit 14 movably receives comprising guidewire 80 and catheter 16 and is movable relative to the unit 14; para. 0136) and having: an outer housing (Fig. 1, body portion 88) having a proximal end (Fig. 3, end of portion 88 located at 88a), a distal end (Fig. 3, end of portion 88 located at 89), and a sidewall (Fig. 3, portion 88 is shown comprising a wall between the distal and proximal ends) therebetween defining an inner volume (Fig. 3, inner volume of portion 88); and an inner housing (Fig. 3, comprising tubular members 104, 106, and 108) having a proximal end (Fig. 3, end of tubular member 104 located at 104a), a distal end (Fig. 3, end of tubular member 108 located at 112), and a sidewall therebetween (Fig. 3, each of the tubular members 104, 106 and 108 comprise sidewalls), the distal end (88 located at 89) of the outer housing (88) configured to couple the introducer (14) to an intravenous line (Fig. 5, insertion protrusion 89 at the distal end of portion 88 connects to an inner needle 20; para. 0159); and wherein the inner housing (104, 106, and 108) and outer housing (88) are displaceable relative to one another (Fig. 9 and 10, tubular members 104, 106, and 108 and portion 88 are all movable relative to one another; para. 0138) to move the catheter (80 and 16) between a first position (Fig. 9), in which the catheter (80 and 16) is disposed within the outer housing (Fig. 9, in the initial state, guide wire 80 is inside portion 88; para. 0127), and a second position (Fig. 10), in which the distal end (80 towards 90) of the catheter (80 and 16) is disposed beyond the distal end (88 located at 89) of the outer housing (88) such that at least a first portion of the catheter (Fig. 10, distal end of guide wire 80) is disposed within the intravenous line (20) when the introducer (14) is coupled to the intravenous line (Fig. 10, comprising guidewire 80 and catheter 16 is introduced into the needle 20, extending beyond portion 88), such that a length of the inner housing (104, 106, and 108) and the outer housing (88) when the catheter (80 and 16) is in the first position (Fig. 9) is greater than when the catheter (80 and 16) is in the second position (Fig. 9 and 10, when in the initial position, the length of the portion 88 and tubular members 104, 106, and 108 is greater than when in the zero protrusion length position; para. 0158).
Ishida does not expressly disclose a clamp arranged at the proximal end of the catheter, configured to selectively block fluid flow through the catheter.
Burkholz teaches a catheter (Fig. 6D, comprised of catheter 12 and tubing 78), wherein a clamp (tubing 78 may include a clamp; para. 0093) arranged at the proximal end of the catheter (Fig. 6D, tubing 78 is proximal of the system 64), configured to selectively block fluid flow through the catheter (tubing 78 may include a clamp, which selectively closes off the tubing 78 from fluid flow; para. 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of Ishida such that a clamp is arranged at the proximal end of the catheter, configured to selectively block fluid flow through the catheter as taught by Burkholz in order to selectively close off the system to prevent blood or another fluid from flowing through the system (Burkholz: para. 0093).
Regarding claim 2, Ishida in view of Burkholz discloses the device above, wherein the inner housing (104, 106, and 108) comprises a plurality of telescoping portions (Fig. 1, first, second, and third tubular members 104, 106, and 108), at least one of the telescoping portions (104, 106, and 108) configured to be received within the inner volume of the outer housing (Fig. 3 and 10, members 104-108 can be received within an inner volume of body portion 88).
Regarding claim 3, Ishida in view of Burkholz discloses the device above, wherein the inner housing (104, 106, and 108) comprises at least three telescoping portions (104, 106, and 108), a first telescoping portion (Fig. 3, member 108) being slidably received within a second telescoping portion (Fig. 3, member 108 is slidably received within member 106), and the second telescoping portion (Fig. 3, member 106) being slidably received within a third telescoping portion (Fig. 3, member 106 is slidably received within member 104).
Regarding claim 4, Ishida in view of Burkholz discloses the device above, wherein the third telescoping portion (104) is slidably received within the outer housing (Fig. 3, member 104 is slidably received within portion 88).
Regarding claim 5, Ishida teaches the device above, wherein the inner housing is rigid (cover 86 is adequately hard; para. 0148) and the outer housing (88) is collapsible longitudinally between a first configuration (Fig. 9) and a second configuration (Fig. 10), wherein a length of the outer housing (88) in the first configuration (Fig. 9) is greater than the length of the outer housing (88) in the second configuration (Fig. 9 and 10, body portion 88 is shorter when collapsed).
Regarding claim 6, Ishida in view of Burkholz discloses the device above, wherein the outer housing (88) is rigid (para. 0148) and the inner housing (104, 106, and 108) is collapsible longitudinally (Fig. 9 and 10, 104, 106, and 108 can collapse longitudinally) within the inner volume of the outer housing (Fig. 3, 9 and 10, 104, 106, and 108 can collapse into the inner volume of the portion 88) between a first configuration (Fig. 9) and a second configuration (Fig. 10), wherein a length of the inner housing (104, 106, and 108) in the first configuration (Fig. 9) is greater than the length of the inner housing (104, 106, and 108) in the second configuration (Fig. 9 and 10, when in the initial position, the tubular members 104, 106, and 108 is greater than when in the zero protrusion length position; para. 0158).
Regarding claim 7, Ishida in view of Burkholz discloses the device above, wherein the outer housing (88) comprises a lock (Fig. 5, fitting portion 90) at the distal end thereof (Fig. 5, fitting portion 90 is on the distal end of portion 88), the lock (90) configured to couple the introducer (14) to an intravenous line (fitting portion 90 can be fitted onto catheter unit 12, thus inserting protrusion 89 into an inner needle 20; para. 0132 and 0159).
Regarding claim 11, Ishida in view of Burkholz discloses the device above, wherein the catheter (Fig. 1, comprising guidewire 80 and catheter 16) comprises a connecter (Fig. 2, screw portion 30) at the proximal end thereof (proximal end of 16).
Regarding claim 12, Ishida in view of Burkholz discloses the device above.
Ishida does not expressly disclose a lubricant arranged between the inner housing and the outer housing.
Burkholz teaches a lubricant arranged between an inner housing and an outer housing (any component of the introducer 42 and/or the catheter assembly 10 may include one or more antimicrobial lubricants; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ishida such that a lubricant arranged between the inner housing and the outer housing as taught by Burkholz in order to reduce the risk of contamination of a fluid pathway of a catheter system (Burkholz: para. 0081).
Regarding claim 13, Ishida in view of Burkholz discloses the device above .
Ishida does not expressly disclose a lubricant between the catheter and the inner housing and/or the outer housing.
Burkholz teaches a lubricant between a catheter and an inner housing and/or an outer housing (any component of the introducer 42 and/or the catheter assembly 10 may include one or more antimicrobial lubricants; para. 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ishida such that a lubricant between the catheter and the inner housing and/or the outer housing as taught by Burkholz in order to reduce the risk of contamination of a fluid pathway of a catheter system (Burkholz: para. 0081).
Regarding claim 14, Ishida discloses a system (Ishida: Fig. 1, comprising catheter unit 12 and guidewire unit 14), comprising: a catheter assembly (Fig. 1, catheter unit 12) comprising: a catheter adapter (Fig. 2, catheter hub 18), comprising: a distal end (Fig. 2, end of hub 18 located at 28); a proximal end (Fig. 2, end of hub 18 located at 30); a lumen (Fig. 2, hollow portion 18a) extending between the distal end (18 located at 28) and the proximal end (18 located at 30); a catheter (Fig. 2, catheter 16) secured to the distal end (Fig. 2, catheter 16 is fixed to hub 18 distal end; para. 0092) of the catheter adapter (18) and extending distally from the catheter adapter (Fig. 2, catheter 16 extends distally from hub 18); and the medical device (14) of claim 1.
Ishida does not expressly disclose a side port arranged between a distal end and a proximal end, the side port in fluid communication with a lumen; and a fluid conduit having a proximal end coupled to the side port and a distal end, the fluid conduit in fluid communication with the side port.
Burkholz teaches a side port (Fig. 1A, second port 24) arranged between a distal end (Fig. 1A, end of catheter adapter 14 towards catheter 12) and a proximal end (Fig. 1A, end of catheter adapter 14 towards first port 22), the side port (24) in fluid communication with a lumen (Fig. 1A, lumen 20b of second portion 24 is in fluid communication with common lumen 20c; para. 0051); and a fluid conduit (Fig. 1A, extension tube 28 conducts infusion fluid through second lumen 20b; para. 0051-0052) having a proximal end (Fig. 1A, end of tube 28 connected to port 24) coupled to the side port (24) and a distal end (Fig. 1A, end of tube 28 away from port 24), the fluid conduit (28) in fluid communication with the side port (para. 0051-0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ishida such that it included a side port arranged between a distal end and a proximal end, the side port in fluid communication with a lumen; and a fluid conduit having a proximal end coupled to the side port and a distal end, the fluid conduit in fluid communication with the side port as taught by Burkholz in order to allow for selective fluid infusion/blood withdrawal through two ports, allowing for connection to a septum (Burkholz: para. 0052).
Response to Arguments
Applicant's arguments filed 21 August 2026 have been fully considered but they are not persuasive.
Applicant argues that the device of Ishida discloses two distinct devices, one of which is not a catheter and, therefore, there would be no motivation to modify Ishida in view of Burkholz. Furthermore, applicant argues that Ishida does not disclose the outer and inner housings movable relative to one another to move the catheter from a first position to a second position as claimed.
This argument is not persuasive, as the device of Ishida includes the entirety of both the catheter assembly 10A and the guidewire unit 14. The invention of Ishida requires both of these to operate and, therefore, is described as one device.
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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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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