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, 16 -17 are amended and filed on 11/18/2025.
Claim 2 is canceled.
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, 3-11, 16-18, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wisman (US 20200094025 A1).
Re Claim 1, Wisman discloses a cannulator (Figs. 1-9) for cannulating an arteriovenous fistula (Percutaneous vasculature access device 10, ¶0081), comprising: a compound needle (18, 16, Fig. 5) including: a needle (18, Fig. 5); a dilator (16, disposed over the needle with at least a tip of the needle (54) extending beyond a distal end of the dilator (46, Fig. 5); and a needle hub (26 and 22) around a proximal-end portion of the dilator (Fig. 6, wherein at least 26, 62 are around dilator top end, ¶0070, ¶0063), wherein the needle hub includes a housing (22, 26) enclosing a cavity (64) having a distal wall (lower wall of 22 close to 62), and each of a proximal end of the needle (top end of the needle for the guidewire to enter the needle lumen, Fig. 6, ¶0070, ¶0073, wherein lower wall of 22 is indirectly attached to a proximal end of needle 18 as needle hook 58, ¶0082) and a proximal end of the dilator coupled to the distal wall (Fig. 6, wherein at least 26, 62 are around dilator top end, ¶0070, ¶0063, wherein 22 is directly attached to dilator 16); and a compound cannula (sheath 14) including: a cannula (sheath body 36); and a cannula hub (12) around a proximal-end portion of the cannula (38, Fig, 7), the cannulator having a mated state of the compound needle and the compound cannula for at least cannulation with the cannulator (Fig. 5), the mated state including the dilator disposed in the cannula with a proximal-end portion of the cannula hub coupled to a distal-end portion of the needle hub (Fig. 5), and further disclose that each of the needle (18 is connected to 20, ¶0077) and a proximal end of the dilator coupled to hub (Fig. 6, ¶0063).
Re Claim 3, Wisman discloses the compound needle further comprising an access guidewire (56, ¶0067) disposed in the needle, the access guidewire extending from the cavity through a through hole in the distal wall of the needle hub (hole for the needle shaft so that the guidewire enter the needle, ¶0067).
Re Claim 4, Wisman discloses the compound needle further comprising a guidewire actuator (Fig. 3, 24, 70, ¶0075) configured to advance a distal end of the access guidewire beyond the tip of the needle (Fig. 6) or withdraw the distal end of the guidewire into a distal-end portion of the needle proximal of the tip of the needle (Fig. 1, ¶0073).
Re Claim 5, Wisman discloses the guidewire actuator including a slider (70) slidably disposed in a longitudinal slot of the needle hub (66, ¶0072), the slider including an extension (68, ¶0072) coupled to a proximal-end portion of the access guidewire in the cavity of the needle hub (Fig. 3, ¶0072).
Re Claim 6, Wisman discloses wherein the cannula is formed of a flexible polymeric material (¶0058) configured to increase patient comfort during a dialysis treatment procedure (it is capable to increase configured to increase patient comfort ¶0058).
Re Claim 7, Wisman discloses wherein a distal-end portion of the cannula includes a taper (lower end portion around 40, Fig. 5) configured to continue from a taper of the dilator in the mated state of the cannulator (Fig. 5).
Re Claim 8, Wisman discloses wherein the cannula hub is furcated (Fig. 3), the cannula hub including at least a primary arm (30) and a secondary arm (36).
Re Claim 9, Wisman discloses wherein the primary arm of the cannula hub includes a primary-arm lumen ( lumen of the sheath hub for insertion the needle, Fig. 3), the secondary arm of the cannula hub includes a secondary-arm lumen (side bore 36), and each lumen of the primary-arm lumen and the secondary-arm lumen is fluidly connected to a cannula lumen of the cannula (¶0054).
Re Claim 10, Wisman discloses wherein each arm of the primary arm and the secondary arm of the cannula hub terminates in a Luer connector (¶0053, leur lock or thread).
Re Claim 11, Wisman discloses wherein the proximal-end portion of the cannula hub coupled to the distal-end portion of the needle hub in the mated state of the cannulator is the Luer connector of the primary arm of the cannula hub disposed in a bore in the distal-end portion of the needle hub (Fig, 6, ¶0053, leur lock or thread).
Re Claim 16, Wisman discloses a method of cannulating a patient with a cannulator (Figs. 1-9, ¶0034, ¶0086), comprising: obtaining the cannulator, the cannulator including a compound needle (18, 16) and a compound cannula ( 14) in a mated state of the cannulator (Fig. 2); and the compound needle including: a needle (18); a dilator (16) disposed over the needle with at least a tip of the needle (54) extending beyond a distal end of the dilator (46); and a needle hub (26, 22) around a proximal-end portion of the dilator (Fig. 1, ¶0071),wherein the needle hub includes a housing (22) enclosing a cavity (64) having a distal wall (lower end of 22) each of a proximal end of the needle (top end of the needle for the guidewire to enter the needle lumen, Fig. 6, ¶0070, ¶0073, wherein lower wall of 22 is indirectly attached to a proximal end of needle 18 as needle hook 58, ¶0082) and a proximal end of the dilator coupled to the distal wall (Fig. 6, wherein at least 26, 62 are around dilator top end, ¶0070, ¶0063, wherein 22 is directly attached to dilator 16), establishing a percutaneous puncture by inserting the tip of the needle (54) of the compound needle into a blood vessel of the patient (¶0062, ¶0086); advancing a distal end of an access guidewire (56) beyond the tip of the needle (Fig. 5) and into a blood-vessel lumen with a guidewire actuator of the compound needle (¶0034, ¶0086); dilating tissue surrounding the puncture with the dilator (16) of the compound needle disposed over the needle (Fig. 5, ¶0034, ¶0062); advancing a cannula of the compound cannula over the dilator (14, ¶0070, ¶0086), the needle, and the access guidewire into the blood-vessel lumen (Fig. 5, ¶0070. ¶0086); and withdrawing the compound needle from the blood-vessel lumen leaving the compound cannula in place (¶0086) and further disclose that each of the needle (18 is connected to 20, ¶0077) and a proximal end of the dilator coupled to hub (Fig. 6, ¶0063), but it fails to specifically discloses that each of proximal end of the needle and a proximal end of the dilator coupled to the distal wall.
Re Claim 17, Wisman discloses wherein advancing the access guidewire into the blood-vessel lumen includes distally sliding a slider (24, 70, ¶0070) disposed in a longitudinal slot of the needle hub (66, ¶0072), the slider including an extension (68, Fig .3) coupled to a proximal-end portion of the access guidewire in a cavity of the needle hub (¶0072, Fig. 3).
Re Claim 18, Wisman discloses further comprising withdrawing the distal end of the guidewire into a distal-end portion of the needle proximal of the tip of the needle with the guidewire actuator before withdrawing the compound needle from the blood-vessel lumen (Fig. 1, ¶0070).
Re Claim 22, Wisman discloses wherein the blood vessel is an arteriovenous fistula (¶0081, the vessel can be any if vasculature of the patient).
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) 12-15, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Lampropoulos et al. (US. 20160331929A1)(“ Lampropoulos”).
Re Claim 12, Wisman discloses a cannulator (Figs. 1-9) for cannulating an arteriovenous fistula (Percutaneous vasculature access device 10, ¶0081), comprising: a compound needle (Figs. 5-6) including: an access guidewire (56); a needle (18) disposed over the access guidewire (Fig. 5); a dilator (16) disposed over the needle( Fig. 5) with at least a tip of the needle (54) extending beyond a distal end of the dilator (46, Fig. 5); a needle hub (26, 22) including a housing enclosing a cavity (64) having a distal wall (lower wall of 22 close to 62), each of a proximal end of the needle (top end of the needle for the guidewire to enter the needle lumen, Fig. 6, ¶0070, ¶0073) and a proximal end of the dilator coupled to the distal wall (Fig. 6, wherein at least 26, 62 are around dilator top end, ¶0070, ¶0063); and a guidewire actuator (24, 70, Fig. 6) configured to advance a distal end of the access guidewire beyond the tip of the needle (Fig. 6, ¶0070) or withdraw the distal end of the access guidewire into a distal-end portion the needle proximal of the tip of the needle (Fig. 1a, ¶0070), the guidewire actuator including a slider (70) slidably disposed in a longitudinal slot of the needle hub (66, ¶0072), the slider including an extension (68, Fig. 3, ¶0072) coupled to a proximal-end portion of the access guidewire that extends into the cavity of the needle hub through a through hole in the distal wall of the needle hub ( (hole for the needle shaft so that the guidewire enter the needle, ¶0067); and a compound cannula including: a cannula (14) ; and a cannula hub (12) around a proximal-end portion of the cannula (Fig. 3), the cannulator having a mated state of the compound needle and the compound cannula for at least cannulation with the cannulator (Fig. 5), the mated state including the dilator disposed in the cannula with a Luer connector in a proximal-end portion of the cannula hub ( 30, ¶0053, leur lock or thread) but it fails to disclose that the Luer connector is disposed in a bore of a distal-end portion of the needle hub.
However, Lampropoulos discloses a medical tubular device connections (Fig. 1-4e) and wherein the dilator/needle (410) comprises a dilator/ needle hub (410), and a bore (around 424) and introducer (430) comprises a hub (440) with Leur connector (442, 20070 ) disposed in a bore of a distal-end portion of the needle hub (Fig. 4e).
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 needle hub and the Luer connector of Wisman to include a bore so that the Luer connector is disposed in a bore of a distal-end portion of the needle hub as taught by Lampropoulos for the purpose of using a standardized connector fittings in the medical tubes (Lampropoulos, ¶0070).
Re Claim 13, Wisman discloses wherein a distal-end portion of the cannula includes a taper (close to 40, Dig. 5) configured to continue from a taper of the dilator in the mated state of the cannulator (Fig. 5).
Re Claim 14, Wisman discloses wherein the cannula hub is furcated, the cannula hub including at least a primary arm (30) and a secondary arm (side bore 36, Fig. 1, ¶0054).
Re Claim 15, Wisman discloses wherein the primary arm of the cannula hub includes a primary-arm lumen ( lumen of 12 for the cannula / guidewire), the secondary arm of the cannula hub includes a secondary-arm lumen (¶0054), and each lumen of the primary-arm lumen and the secondary-arm lumen is fluidly connected to a cannula lumen of the cannula (¶0053, leur lock or thread).
Re Claim 19, Wisman discloses further comprising ensuring the compound needle and the compound hub are properly mated with a Luer connector of a primary arm of the cannula hub (30, ¶0053, Fig. 3), but it fails to disclose that the Luer connector is disposed in a bore of a distal-end portion of the needle hub
However, Lampropoulos discloses a medical tubular device connections (Fig. 1-4e) and wherein the dilator/needle (410) comprises a dilator/ needle hub (410), and a bore (around 424) and introducer (430) comprises a hub (440) with Leur connector (442, 20070 ) disposed in a bore of a distal-end portion of the needle hub (Fig. 4e).
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 method of Wisman to include a bore so that the Luer connector is disposed in a bore of a distal-end portion of the needle hub as taught by Lampropoulos for the purpose of using a standardized connector fittings in the medical tubes (Lampropoulos, ¶0070).
Re Claim 20, Wisman discloses wherein ensuring the compound needle and the compound hub are properly mated includes ensuring a taper of a distal-end portion of the dilator continues (16, Fig. 5) along a taper of a distal-end portion of the cannula (close to 40, Fig. 5).
Re Claim 21, Wisman discloses wherein dilating the tissue surrounding the puncture further includes dilating the tissue with the distal-end portion of the cannula (Fig. 5, ¶0062).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wisman in view of Bian and further in view of Abrahamson et al. (US. 5382238)(“Abrahamson”).
Re Claim 23, Wisman fails to discloses connecting the compound cannula to a tubing set of a dialysis machine; and commencing dialysis through the compound cannula.
However, Abrahamson discloses a medical tubular device that can be connected to a dialysis unit (Fig. 1-8, Col. 1, lines 5-10) and wherein connecting the compound cannula to a tubing set of a dialysis machine; and commencing dialysis through the compound cannula (Col. 8, lines 15-30).
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 method of Wisman to include a step of connecting the compound cannula to a tubing set of a dialysis machine; and commencing dialysis through the compound cannula as taught by Abrahamson for the purpose of using the cannula in a desirable medical application such as dialysis (Abrahamson, Col. 1, lines 5-10, Col. 8, lines 15-30).
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
The applicant argues with regards to claim 1, 12, 16 that Wisman fails to discloses that the distal wall of the needle have is coupled to each of a proximal end of the needle and a proximal end of the dilator. This is found not persuasive as claimed that each proximal end is coupled to the distal wall and wherein dilator top end is attached directly to the 22 lower end (see ¶0071) and at least the needle is indirectly attached to the 22 by the needle hook 58 (see ¶0079). Note: the applicant is advised to further define the coupling of the needle/dilator with the needle hub satirically or to amend the limitation to convey a directly attachment between the distal wall and each proximal end of the needle and dilator.
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).
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