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, 6, 7, 21, 26 are amended and field on 12/9/2025.
Claims 11-20 are canceled.
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) 1-8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri (US. 20160310702A1) in view of Kondo et al. (US. 20080255423A1) (“Kondo”).
Re Claim 1, Cabiri discloses a steerable cannula (Fig. 1-8) for a transjugular intrahepatic portosystemic shunt ("TIPS") procedure ( it is capable to be used in medical filed such as TIPS procedure, ¶0003, ¶0034, ¶0042), comprising: an elongate compound tube (14, 12) having a proximal-end portion (close to 13, Fug. 3) and a distal-end portion (close to 67, Fig. 6c), the distal-end portion including a flexible hinge (alive flexible hinges between slots, Fig. 5a-7b, opposite to the slot 16) for adjusting a cannula angle between the proximal-end portion and the distal-end portion of the compound tube adjacent the flexible hinge (Fig. 5a-7b, ¶0028, ¶0031); a lumen of the compound tube (lumen of 12, Fig. 6d) wherein a distal end of each of an inner tube (a portion of 12 at 67 ) and an outer tube of the compound tube (a portion of 14 close to 67) is fixedly attached (¶0045, at 67); and a compound hub (202, 228, 204, 206) disposed about the proximal-end portion of the compound tube (Fig. 5d); and an articulation mechanism (220, 222, ¶0042) controlled by at least a rotatable element (222) of the compound hub for adjusting the cannula angle (¶0042), the articulation mechanism configured to longitudinally move the inner tube (12) of the compound tube relative to the outer tube of the compound tube to adjust the cannula angle (14, Fig. 7a-b, ¶0042), but it fails to disclose that the cannula comprises a cannula tip coupled to a distal end of the compound tube, the cannula tip including a tip opening fluidly connected to the lumen of the compound tube and distal end of each inner tune and outer tube are fixedly connected to the cannula tip.
However, Kondo discloses a compound tube (10, Figs. 1-6) and wherein comprises a cannula tip (20) fixedly attached to each distal end of the inner tube (distal end of 16, ¶0063) and outer tube (13, 12) of the compound tube ( Fig. 4, ¶0063).
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 canula of Cabiri to include a canula tip so that the cannula comprises a cannula tip coupled to a distal end of the compound tube, the cannula tip including a tip opening fluidly connected to the lumen of the compound tube and distal end of each inner tune and outer tube are fixedly connected to the cannula tip as taught by Kondo for the purpose of performing bending operation and to smoothly guiding the insertion tools within the lumen (Kondo,¶0063, ¶0078).
Re Claim 2, Cabiri discloses wherein each tube of the inner tube and the outer tube of the compound tube includes a set of transverse cutouts (16 of 14, 16 on 12, Fig. 7b), the flexible hinge of the compound tube formed between offset sets of the transverse cutouts in at least a non-deflected state of the compound tube, Fig. 7a, ¶0032).
Re Claim 3, Cabiri discloses wherein the rotatable element of the compound hub is a rotatable handle (220, ¶0042) configured to rotate relative to a housing of the compound hub (202, ¶0042), the rotatable handle including a threaded bore (¶0042, 222 has a thread) or an insert including a threaded bore configured to drive a threaded plug (218 proximally when the rotatable handle is rotated in a first direction ( backward, ¶0041, ¶0042) or distally when the rotatable handle is rotated in a second direction ( forward, ¶0041, ¶0042).
Re Claim 4, Cabiri discloses wherein the threaded plug is fixedly attached to the inner tube of the compound tube (¶0042) such that the inner tube is driven proximally or distally in concert with the threaded plug when the rotatable handle is respectively rotated in the first direction or the second direction (¶0041, ¶00242).
Re Claim 5, Cabiri discloses wherein the outer tube of the compound tube is fixedly attached to a stationary element disposed in the housing of the compound hub (204, ¶0041), the inner tube of the compound tube passing through the stationary element (¶0041).
Re Claim 6, Cabiri discloses that the inner tube is longitudinally moved relative to the outer tube when the rotatable handle of the compound hub is rotated in the first direction or the second direction (¶0041, ¶0042).
Re Claim 7, Cabiri discloses wherein the lumen of the compound tube extends longitudinally through the compound tube (Fig. 6d, ¶0038) and is configured for disposing a needle or a catheter-and-needle assembly therein (¶0038, catheter and/other devices).
Re Claim 8, Cabiri discloses wherein the cannula angle ranges from about -90 degree to about 90 degree (Fig, 7a-7b, ¶0028).
Re Claim 10, Cabiri discloses wherein the steerable cannula is configured to stiffen a catheter assembly in support of a needle throw from the catheter assembly at the cannula angle chosen for the needle throw ( it is capable to stiffens the catheter 18, ¶0034).
Claim(s) 21-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri (US. 20160310702A1) in view of Rottenberg et al. (US. 20120235229A1) (“Rottenberg”) and further in view of Kondo et al. (US. 20080255423A1) (“Kondo”).
Re Claim 21, Cabiri discloses an access set (Fig. 1-8) for a transjugular intrahepatic portosystemic shunt ("TIPS") procedure (it is capable to be used in medical filed such as TIPS procedure, ¶0003, ¶0034, ¶0042), comprising: an introducer sheath (18, ¶0034, Fig. 2);a piercing device (¶0038, catheter or other device); and a stiffening cannula (10, ¶0034) selected from a steerable cannula (¶0034) and a fixed-curve cannula configured to support a piercing-device throw from the stiffening cannula (it is capable to guide a catheter or needle, ¶0038), the steerable cannula including an articulation mechanism (220, 222, ¶0042) configured to longitudinally move an inner tube (12) of an elongate compound tube relative to an outer tube (14) of the compound tube to adjust the piercing-device angle for the piercing-device throw (Fig. 7a-c, ¶0042); but it fails to disclose that the piercing device selected from a hinged needle, a Colapinto needle, and a trocar stylet, the hinged needle including an elongate needle tube having a flexible hinge and a pencil-point needle tip coupled to a distal end of the needle tube having a tip opening fluidly connected to a lumen of the needle tube and a distal end of each tube of the inner tune and the outer tube of the coonhound tube is fixedly attached to the cannula tip.
However, Rottenberg discloses a hinged needle (Figs. 1-8) for a transjugular intrahepatic portosystemic shunt ("TIPS") procedure ( it is capable to be used in TIPS ¶0029), comprising: a piercing device selected from a hinged needle, a Colapinto needle, and a trocar stylet (hinged needle, 10) having a proximal-end portion ( lower half portion of 10, Fig. 8) and a distal-end portion ( upper portion of 10, Fig. 8), the distal-end portion including a flexible hinge ( live hinge between the cut 23, Fig. 5, ¶0037) and a pencil-point needle tip (15) coupled to a distal end of the needle tube (Fig. 8), the needle tip including a tip opening fluidly connected to a lumen of the needle tube (16, ¶0045, ¶0030), and further discloses that proximal portion of the tube is connected with luer connector (¶0046).
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 canula of Cabiri so that the piercing device selected from a hinged needle, a Colapinto needle, and a trocar stylet, the hinged needle including an elongate needle tube having a flexible hinge and a pencil-point needle tip coupled to a distal end of the needle tube having a tip opening fluidly connected to a lumen of the needle tube as taught by Rottenberg for the purpose of using the needle for penetration tissue (Rottenberg, ¶0011).
The amended Cabiri in view of Rottenberg fails to disclose a distal end of each tube of the inner tune and the outer tube of the coonhound tube is fixedly attached to the cannula tip.
However, Kondo discloses a compound tube (10, Figs. 1-6) and wherein comprises a cannula tip (20) fixedly attached to each distal end of the inner tube (distal end of 16, ¶0063) and outer tube (13, 12) of the compound tube ( Fig. 4, ¶0063).
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 canula of Cabiri to include a canula tip so that a distal end of each tube of the inner tune and the outer tube of the coonhound tube is fixedly attached to the cannula tip as taught by Kondo for the purpose of performing bending operation and to smoothly guiding the insertion tools within the lumen (Kondo,¶0063, ¶0078).
Re Claim 22, Cabiri discloses wherein each tube of the inner tube and the outer tube of the compound tube of the steerable cannula includes a set of transverse cutouts (16 of 14 and 16 of 12, Fig. 7a-c) forming a flexible hinge of the compound tube, each set of transverse cutouts offset from the other in at least a non-deflected state of the compound tube (Fig, 7a, ¶0031).
Re Claim 23, Cabiri discloses wherein a rotatable handle (220) of a compound hub of the steerable cannula (220, 202, 228, 204, 206, ¶0042) configured to rotate relative to a housing of the compound hub (202, ¶0042), the rotatable handle including a threaded bore (¶0042, 222 has a thread) or an insert including a threaded bore configured to drive a threaded plug (218 proximally when the rotatable handle is rotated in a first direction (backward, ¶0041, ¶0042) or distally when the rotatable handle is rotated in a second direction (forward, ¶0041, ¶0042).
Re Claim 24, Cabiri discloses wherein the threaded plug is fixedly attached to the inner tube of the compound tube (¶0042) such that the inner tube is driven proximally or distally in concert with the threaded plug when the rotatable handle is respectively rotated in the first direction or the second direction (¶0041, ¶00242).
Re Claim 25, Cabiri discloses wherein the outer tube of the compound tube is fixedly attached to a stationary element disposed in the housing of the compound hub (204, ¶0041), the inner tube of the compound tube passing through the stationary element (¶0041).
Re Claim 26, Cabiri discloses that the inner tube is longitudinally moved relative to the outer tube when the rotatable handle of the compound hub is rotated in the first direction or the second direction (¶0041, ¶0042).
Re Claim 27, Cabiri fails to disclose wherein an entirety of the needle tube of the hinged needle is a metal hypotube, the flexible hinge selected from a spiral-cut portion of the hypotube, a slotted portion of the hypotube, and a nitinol portion of the hypotube.
However, Rottenberg discloses an entirety of the needle tube of the hinged needle is a metal hypotube (¶0015. ¶0035), the flexible hinge selected from a spiral-cut portion of the hypotube, a slotted portion of the hypotube, and a nitinol portion of the hypotube (¶0015, 035 ¶0035).
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 canula of Cabiri to include a needle so that an entirety of the needle tube of the hinged needle is a metal hypotube, the flexible hinge selected from a spiral-cut portion of the hypotube, a slotted portion of the hypotube, and a nitinol portion of the hypotube as taught by Rottenberg for the purpose of using the a needle for penetration tissue form desired material (Rottenberg, ¶0011¶0015, ¶0035).
Re Claim 28, the modified Cabiri discloses wherein the needle tube of the hinged needle is a hypotube coupled to a spring or braided tube as the flexible hinge (¶0015, spring of . Rottenberg)
Re Claim 29, the modified Cabiri discloses wherein the tip opening of the needle tip of the hinged needle is distal to where the needle tip is coupled to the distal end of the needle tube (16, Fig. 8 of Rottenberg).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri in view of Kondo and further in view of Hebert et al. (US. 20060004329A1) (“Hebert”).
Re Claim 9, Cabiri discloses wherein the compound hub includes a luer connector (¶0042, 228) extending through the rotatable element and into a distal-end portion of the inner tube of the compound tube (Fig 5e), the Luer connector configured to fluidly connect the lumen of the compound tube to another medical device (¶0042), but it fails to discloses that the connector is a female Luer connector.
However, Hebert discloses a needle (23, Figs. 1-6) and wherein is a female Luer connector (18 is luer lock which can be female or male luer lock, ¶0042).
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 compound tube of Cabiri so that the connector is a female Luer connector as taught by Hebert for the purpose of attaching other medical devices (Hebert, ¶0042).
Claim(s) 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri in view of Rottenberg and Kondo and further in view of Kahn et al. (US. 20130245533A1) (“Kahn”)
Re Claim 30, the modified Cabiri fails to disclose further comprising: an access device configured to create an access site in at least a jugular vein; and a first catheter configured to catheterize an inferior vena cava from the access site.
However, Kahn discloses a TIPIS procedure (Figs. 1-10) and wherein an access device configured to create an access site in at least a jugular vein (¶0052, 201) and a first catheter (204) configured to catheterize an inferior vena cava from the access site (¶0046, ¶0057).
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 set of Cabiri to include an access device configured to create an access site in at least a jugular vein; and a first catheter configured to catheterize an inferior vena cava from the access site as taught by Kahn for the purpose of ensuring that the needle is at the desired position (Kahn, ¶0057-¶0058).
Re Claim 31, the modified Cabiri fails to disclose further comprising a dilator for combination with the introducer sheath in a first assembly, the introducer sheath configured to accept the dilator in a lumen of the introducer sheath such that a distal-end portion of the dilator extends past a distal end of the introducer sheath for dilation of a piercing- device tract.
However, Kahn discloses a TIPIS procedure (Figs. 1-10) and wherein a dilator for combination with the introducer sheath in a first assembly (¶0045, outer sheath 201 with dilator), the introducer sheath configured to accept the dilator in a lumen of the introducer sheath such that a distal-end portion of the dilator extends past a distal end of the introducer sheath for dilation of a piercing- device tract (212 pass 204, Fig.2, ¶0046, ¶0057).
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 set of Cabiri to include a dilator for combination with the introducer sheath in a first assembly, the introducer sheath configured to accept the dilator in a lumen of the introducer sheath such that a distal-end portion of the dilator extends past a distal end of the introducer sheath for dilation of a piercing- device tract as taught by Kahn for the purpose of ensuring that the needle is at the desired position (Kahn, ¶0057-¶0058).
Re Claim 32, the modified Cabiri fails to disclose further comprising a second catheter for combination with the stiffening cannula in a second assembly, the second catheter configured to accept the stiffening cannula in a lumen of the second catheter and conceal a distal end of the stiffening cannula with a distal-end portion of the second catheter to protect other components of the access set from being damaged by the distal end of the stiffening cannula when advancing the second assembly in vivo.
However, Kahn discloses a TIPIS procedure (Figs. 1-19) and wherein a second catheter ( Fig. 14, catheter K) for combination with the stiffening cannula in a second assembly, the second catheter configured to accept the stiffening cannula ( j, Fig. 14) in a lumen of the second catheter and conceal a distal end of the stiffening cannula with a distal-end portion of the second catheter to protect other components of the access set from being damaged by the distal end of the stiffening cannula when advancing the second assembly in vivo (Fig.14, ¶0061, ¶0071).
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 set of Cabiri to include a second catheter for combination with the stiffening cannula in a second assembly, the second catheter configured to accept the stiffening cannula in a lumen of the second catheter and conceal a distal end of the stiffening cannula with a distal-end portion of the second catheter to protect other components of the access set from being damaged by the distal end of the stiffening cannula when advancing the second assembly in vivo as taught by Kahn for the purpose of ensuring that the needle is at the desired position (Kahn, ¶0071).
Re Claim 33, the modified Cabiri fails to disclose further comprising a third catheter for combination with the piercing device in a third assembly, the third catheter configured to accept the piercing device in a lumen of the third catheter and conceal a distal end of the piercing device with a distal-end portion of the third catheter to protect other components of the access set from being pierced by the distal end of the piercing device when advancing the third assembly in vivo.
However, Kahn discloses a TIPIS procedure (Figs. 1-19) and wherein a third catheter for combination with the piercing device in a third assembly ( Fig. 14, catheter K) ( j, Fig. 14), the third catheter configured to accept the piercing device in a lumen of the third catheter and conceal a distal end of the piercing device with a distal-end portion of the third catheter to protect other components of the access set from being pierced by the distal end of the piercing device when advancing the third assembly in vivo (Fig.13, ¶0061, ¶0071).
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 set of Cabiri to include a third catheter for combination with the piercing device in a third assembly, the third catheter configured to accept the piercing device in a lumen of the third catheter and conceal a distal end of the piercing device with a distal-end portion of the third catheter to protect other components of the access set from being pierced by the distal end of the piercing device when advancing the third assembly in vivo as taught by Kahn for the purpose of ensuring that the needle is at the desired position (Kahn, ¶0071).
Response to Arguments
Applicant’s arguments, see remark, filed 12/9/2025, with respect to the rejection(s) of claim(s) 1, 21 under 103 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 Cabiri in view of Kondo for claim 1 and further in view of Rottenberg for claim 21.
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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