DETAILED ACTION
This action is responsive to the “AMENDMENT AND RESPONSE TO OFFICE ACTION” filed 28 January 2026. The Examiner acknowledges the amendments to claims 1-6, 11, 14-19, and 24, the cancelation of claims 7-10 and 20-23, and the addition of new claims 25-28. Claims 1-6, 11-19, and 24-28 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 11-14, 17, 19, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking (US-6726659-B1) [the Examiner notes that the presently cited Stocking reference is not the same as the previously cited Stocking reference] in view of Edwards (US-4954130-A, previously presented).
Regarding claim 1, Stocking teaches
An access system comprising:
a cannula [flexible tubular dilator 18 (Stocking Fig. 1)] comprising:
a lumen [See Stocking Fig. 1, wherein the dilator 18 is also noted as being “tubular” and defines a lumen to allow at least needle 12 to extend therethrough];
a distal opening at a distal end of the cannula that is in fluid communication with the lumen [distal end 40 of dilator 18 (Stocking Fig. 1)]; and
a proximal opening that extends through a sidewall of the cannula is in fluid communication with the lumen [A second fenestration 48 is also formed in the dilator 18 which is positioned within the cavity 24 and which communicates with the hub cavity and the sideport 26, external to the dilator (Stocking Col 3:44-47, Fig. 1); Thereafter, the blood will flow out of the passageway 46 through the dilator fenestration 48 (Stocking Col 3:64-66)];
a hub [hub 22 (Stocking Fig. 1)] comprising:
an internal chamber [interior chamber or cavity 24 (Stocking Fig. 1)];
a distal port in fluid communication with the internal chamber, the distal port being configured to couple with a base catheter system that comprises a catheter tube that is configured to be preplaced in a blood vessel of a patient [sheath 20 (Stocking Fig. 1); A hub 22 is attached to a proximal end of the sheath 20… The cavity 24 communicates both with the sheath 20, when the dilator 18 is removed, and with the sideport 26 (Stocking Col 2:64-Col 3:2, Fig. 1); insertion of the dilator and sheath into the blood vessel (Col 1:32), wherein the Examiner notes that the catheter tube being “preplaced” in a blood vessel of a patient is not recited as occurring relative to any other configurable action, such that the sheath 20 is considered to be configurable as claimed]; and
an access port in fluid communication with the internal chamber [The cavity 24 communicates… with the sideport 26 (Stocking Col 2:67-3:2, Fig. 1)],
wherein the cannula is insertable through at least a portion of the catheter tube to a collection orientation in which, when the catheter tube is within the blood vessel of the patient [wherein as depicted in Stocking Fig. 1, the dilator 18 is inserted into sheath 20]:
the distal opening of the cannula is positioned within the blood vessel of the patient and is in fluid communication with an interior of the blood vessel to permit blood to flow into the lumen of the cannula [As the needle tip 14 enters a lumen of the artery, blood will flow under pressure, into the lumen 37 of the needle 12, thence proximally along the lumen to the fenestration 16, thence along both the needle lumen and, through the fenestration 16, into and along the passageway 46. Thereafter, the blood will flow out of the passageway 46 through the dilator fenestration 48 into the surrounding hub chamber 24 and through the sideport 26 into the tube 28 (Stocking Col 3:59-66)]; and
the proximal opening of the cannula is positioned within the internal chamber of the hub to permit blood to flow from the lumen of the cannula into the internal chamber of the hub and through the access port of the hub [Stocking Col 3:44-47, 64-66, Fig. 1].
However, the current embodiment of Stocking fails to explicitly disclose a valve assembly that is configured to transition between a closed state and an open state; wherein the valve assembly is configured to prevent fluid communication between the lumen of the cannula and the access port of the hub when in the closed state and is configured to permit fluid communication between the lumen of the cannula and the access port of the hub when in the open state, and wherein the valve assembly comprises a valve member positioned in the cannula that is configured to rotate relative to the cannula to thereby transition the valve assembly from the closed state to the open state.
Stocking discloses in separate embodiments, a cannula in fluid communication with a hub via a proximal opening through a sidewall of the cannula, wherein a valve member is operable within the cannula to transition between a closed state and an open state to control fluid flow through the cannula to the hub via the proximal opening [The dilator 56 also defines a second circular fenestration 78 within the hub cavity 62, preferably in registry with the sideport 64. The needle 54 also contains a circular fenestration 80' which registers with the second dilator fenestration 78 when the needle is in its advanced operative position 54' as shown in the phantom in FIG. 2. When the needle 54 is partially retracted, as shown in full in FIG. 2, the fenestration represented by 80' would be located somewhere within the housing 66, to the right of its present position as viewed. In typical operation, the needle 54 is advanced to its initial operative position as shown at 54' and conventional blood pressure monitoring and/or other equipment is connected to the tube 65. The guidewire 68 is placed in a retracted position as shown. Under such initial conditions, the fenestration 78 and 80' register with one another. The needle 54' is inserted into a patient and into a blood vessel. Upon proper placement of the needle 54' in an artery, for example, blood will flow, under pressure, from the artery through a lumen 81 of the needle, thence through the registered needle and dilator fenestrations 80' and 78, respectively, into the surrounding hub chamber 62 and finally, into the sideport 64 and tube 65 (Stocking Col 5:23-45, Fig. 2), wherein the Examiner notes that the needle 54 being longitudinally movable within the dilator 56 is considered to read on a valve member that is operable within a cannula to transition between a closed state and an open state to control fluid flow through the cannula to a hub via a proximal opening of the cannula; the Examiner further notes that the needle 54 of the embodiment depicted in Stocking Fig. 2 is considered to be functionally and structurally similar to the needle 12 depicted in Stocking Fig. 1].
Edwards discloses systems for controlling fluid flow, wherein Edwards discloses a tubular body [catheter body 1 (Edwards Figs. 1-3)] comprising a proximal opening fluidically coupled to a lumen of the tubular body [IV port 3 (Edwards Figs. 1-3)]. Edwards further discloses a valve assembly that is configured to transition between a closed state and an open state; wherein the valve assembly is configured to prevent fluid communication through the proximal opening when in the closed state and is configured to permit fluid communication through the proximal opening when in the open state, and wherein the valve assembly comprises a valve member [plug 8 (Waters Figs. 1-4)] positioned in the tubular body that is configured to rotate relative to the tubular body to thereby transition the valve assembly from the closed state to the open state [In FIG. 3, plug 8 is depicted as rotated 180 degrees from its position in FIG. 2. In this condition, aperture 10 has been rotated away from IV port 3 and fluids are thus prevented from entering catheter body 1. In this condition, the administration of IV fluids to the patient is stopped and IV tubing 4 may be disconnected. This step is by no means irreversible since fluid administration may be recommenced by attachment to the fluid source through IV tubing 4 and rotation of plug 8 until aperture 10 is aligned with IV port 3 (Edwards Col 4:13-22, Figs. 2-3)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Stocking to employ the needle 12 of Stocking as a valve member of a valve assembly that is configured to transition between a closed state and an open state; wherein the valve assembly is configured to prevent fluid communication between the lumen of the cannula and the access port of the hub when in the closed state and is configured to permit fluid communication between the lumen of the cannula and the access port of the hub when in the open state, and wherein the valve member is positioned in the cannula and is configured to rotate relative to the cannula to thereby transition the valve assembly from the closed state to the open state, so as to allow for user control of fluid flow through the access system for the purposes of blood collection [The tube 28 can be attached to conventional blood pressure monitoring equipment, a blood sampling device and/or liquid infusion equipment, all in the usual, well known manner (Stocking Col 3:5-8)], and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for user control of fluid flow] [MPEP § 2143(I)(D)].
Regarding claim 2, Stocking in view of Edwards teaches
The access system of claim 1, further comprising a handle coupled to a proximal end of the cannula [A proximal end portion of the dilator 18 is glued or otherwise affixed in and to a central collar of the cap 30 (Stocking Col 3:22-23, Fig. 1), wherein the Examiner notes that any portion of the proximal end of the dilator 18 that can be gripped, such as the portion affixed within cap 30, may be considered to define a “handle”].
Regarding claim 3, Stocking in view of Edwards teaches
The access system of claim 2, wherein the hub comprises a sealing member through which a portion of the cannula extends [The diaphragm 38 thus seals the otherwise open proximal end of the hub cavity 24 around the dilator so that a biological liquid which may be present in the cavity 24 when the cap 30 is removed will not spill therefrom (Stocking Col 3:24-27, Fig. 1)].
Regarding claim 4, Stocking in view of Edwards teaches
The access system of claim 3, wherein the valve member extends through the portion of the cannula that extends through the sealing member [A hole in the diaphragm 38 will resiliently close and seal in a liquid tight manner when the needle 12 and the dilator 18 are withdrawn therefrom (Stocking Col 3:27-30, Fig. 1), wherein the needle 12 as modified to define the valve member, is depicted as also extending through the sealing member].
Regarding claim 5, Stocking in view of Edwards teaches
The access system of claim 1, wherein:
the valve member comprises a lumen and a port [the needle 12 may also have a second fenestration 50 (Stocking Col 4:30-31, Fig. 1); see § 103 modification of claim 1 above];
when the valve assembly is in the closed state, the port of the valve member is unaligned with the proximal port of the cannula [Edwards Col 4:13-22, Figs. 2-3]; and
when the valve assembly is in the open state, the port of the valve member is aligned with the proximal port of the cannula [Edwards Col 4:13-22, Figs. 2-3].
Regarding claim 6, Stocking in view of Edwards teaches
The access system of claim 1, wherein the valve member is rotatable about a longitudinal axis of the cannula [see § 103 modification of claim 1 above; Edwards Col 4:13-22, Figs. 2-3].
Regarding claim 11, Stocking in view of Edwards teaches
The access system of claim 1, wherein the hub comprises a proximal port in fluid communication with the internal chamber [Stocking Col 3:24-27, Fig. 1].
Regarding claim 12, Stocking in view of Edwards teaches
The access system of claim 11, wherein the proximal port of the hub comprises a sealing member that is configured to provide a fluid-tight seal against the cannula when the cannula extends therethrough [Stocking Col 3:24-27, Fig. 1].
Regarding claim 13, Stocking in view of Edwards teaches
The access system of claim 12, wherein the sealing member is configured to self-seal upon removal of the cannula therefrom [Stocking Col 3:24-30, Fig. 1].
Regarding claim 14, Stocking in view of Edwards teaches
The access system of claim 1, further comprising the base catheter system [Stocking Col 2:64-Col 3:2, Fig. 1].
Regarding claim 17, Stocking in view of Edwards teaches
The access system of claim 14, wherein an extension set comprises the hub [A flexible, hollow tube 28, preferably being constructed of a transparent or translucent plastic, has one end portion which is frictionally fitted within the sideport 26. The tube 28 can be attached to conventional blood pressure monitoring equipment, a blood sampling device and/or liquid infusion equipment, all in the usual, well known manner (Stocking Col 3:2-7, Fig. 1)].
Regarding claim 19, Stocking in view of Edwards teaches
The access system of claim 1, wherein the valve member is configured to prevent blood from flowing through the proximal opening of the cannula when the valve assembly is in the closed state and is configured to permit blood to flow through the proximal opening of the cannula when the valve assembly is in the open state [see § 103 modification of claim 1 above; Edwards Col 4:13-22, Figs. 2-3].
Regarding claim 24, Stocking in view of Edwards teaches
The access system of claim 1, further comprising a handle coupled with the valve assembly [wherein a proximal portion of the hub 22 that may be gripped is considered to read on a handle that is coupled with the valve assembly (needle 12), see Stocking Fig. 1].
Regarding claim 25, Stocking in view of Edwards teaches
The access system of claim 24, wherein the handle comprises a sealing member through which the valve member passes [Stocking Col 3:24-30, Fig. 1].
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking in view of Edwards, as applied to claim 14, in further view of Burkholz (US-20190321590-A1, previously presented).
Regarding claim 15, Stocking in view of Edwards teaches
The access system of claim 14.
However, while Stocking discloses conventional coupling to different types of equipment via tube 28 [Stocking Col 3:5-8], Stocking in view of Edwards fails to explicitly disclose wherein the base catheter system is an open catheter system.
Burkholz depicts an open catheter system for blood collection [the portion of the catheter hub 26 that extends through the slot 20 may be coupled to a blood collection device 78 (Burkholz ¶0075, Figs. 7A-B), wherein based on the Applicant’s Specification ¶0061 defining an open catheter system as comprising a connector devoid of any sealing member, the system of Burkholz may be considered to depict an open catheter system].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Stocking in view of Edwards to employ wherein the base catheter system is an open catheter system, as this modification would amount to mere simple substitution of one known element for another with similar expected results [enable coupling to a blood collection system or device] [MPEP § 2143(I)(B)].
Regarding claim 16, Stocking in view of Edwards and Burkholz teaches
The access system of claim 15.
However, Stocking in view of Edwards fails to explicitly disclose wherein the base catheter system comprises an additional hub configured to couple with the distal port, and wherein the additional hub is attached to the catheter tube.
Burkholz discloses an access system [catheter system 50 (Burkholz Figure 5A)], wherein the access systems comprises a cannula [catheter 12 and distal end 24 of catheter 12 (Burkholz Figs. 5A-C)] configured to be inserted into a catheter system [extension set 64 (Burkholz Fig. 5A)] that comprises: a hub [connector 72 (Burkholz Fig. 5A)] comprising an internal chamber [wherein as depicted in Burkholz Fig. 5A, the connector 72 is defined by an internal chamber that allows the catheter 12 to pass through]; wherein the catheter system comprises an additional hub [catheter adapter 54 (Burkholz Fig. 5A)] configured to couple with the distal port [the catheter adapter 54 may include a side port 62 (Burkholz ¶0057, Fig. 5A); In some embodiments, the distal end 68 of the extension tubing 66 may be fixed to or integrally formed with the side port 62 (Burkholz ¶0058, Fig, 5A)], wherein the additional hub is attached to the catheter tube [an intravenous catheter system 50 may include a catheter assembly 52, which may include a catheter adapter 54 and a catheter 55 (Burkholz ¶0057, Figs. 5A-B)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the access system of Stocking in view of Edwards to employ wherein the base catheter system comprises an additional hub configured to couple with the distal port, wherein the additional hub is attached to the catheter tube, as this modification amounts to mere simple substitution of one known element [portion of the hub 14 of Stocking configured to be attached to the catheter 12] for another [additional hub of Burkholz] with similar expected results of coupling a hub to a catheter for intravenous access [MPEP § 2143(I)(B)].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking in view of Edwards, as applied to claim 14, in light of Sonderegger (US-20170120012-A1, previously presented).
Regarding claim 18, Stocking in view of Edwards teaches
The access system of claim 14.
However, Stocking in view of Edwards fails to explicitly disclose wherein the catheter system is a closed intravenous catheter system.
Sonderegger discloses that a “closed” IV access device is defined by the device being configured to prevent blood from escaping the device during insertion of the catheter [When an IV access device is identified as being “closed” or “integrated,” it generally refers to the fact that the device is configured to prevent blood from escaping the device during insertion of the catheter (Sonderegger ¶0002)].
As such, Stocking in view of Edwards is considered to disclose elements of the access system that are configured to prevent blood from escaping the device during insertion of the catheter [Stocking Col 3:24-30], such that Stocking in view of Edwards is considered to teach wherein the catheter system is a closed intravenous catheter system.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stocking in view of Edwards, as applied to claim 24 above, in further view of Liegner (US-4803999-A).
Regarding claim 26, Stocking in view of Edwards teaches
The access system of claim 24.
However, while Stocking discloses that the needle 12 [see § 103 modification of claim 1 above, wherein the needle 12 is considered to read on the claimed valve member] extends proximally [The needle 12 extends through the sheath hub cavity 24 and through the center of a cap 30 which is attached over an otherwise open proximal end of the hub 22. A proximal end of the needle 12 is connected to a plastic needle hub 32 which, in turn, abuts a conventional , guidewire assembly 34 (Stocking Col 3:2-8, Fig. 1)], Stocking fails to explicitly disclose wherein the valve assembly comprises a valve body attached to the valve member, wherein the valve body is rotatably coupled to the handle.
Liegner discloses access systems, wherein Liegner discloses a valve assembly comprising a valve body [cap 37 (Liegner Fig. 1)] attached to a valve member, wherein the valve body is rotatably coupled to a handle [obturator 16 (Liegner Fig. 1); Obturator 16 preferably includes a narrow portion 35 dimensioned for a frictional sliding fit in lumen 13, a plug 39 dimensioned for a close fit in bore 24, and a cap 37, the plug 39 and cap 37 being adhesively or otherwise secured about the distal end of the narrow portion 35. Since the obturator is inserted into the blood flow path, it too should be comprised of a physiologically inert material, polytetrafluoroethylene again being preferred. The obturator 16 by its sliding fit in the lumen 13, eliminates all recesses in the blood flow path, in which blood or blood debris can accumulate. The obturator 16 also functions as a valve to open and close sideport 19 (Liegner Col 4:63-5:6); Thus, cap 37 preferably comprises an annular member 38 having internal projecting threads 42. When the obturator 16 is fully inserted in the lumen 13 and rotated, the threads 42 engage the flange 26 thereby securing the obturator in place. In this position, plug 39 is fully received in bore 24 thereby completely occluding same (Liegner Col 5:22-28)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Stocking in view of Edwards to employ wherein the valve assembly comprises a valve body attached to the valve member, wherein the valve body is rotatably coupled to the handle, so as to facilitate manual operation of the valve assembly.
Regarding claim 27, Stocking in view of Edwards and Liegner teaches
The access system of claim 26, wherein the valve member comprises an additional cannula [needle 12 (Stocking Fig. 1); see § 103 modification of claim 1 above].
Regarding claim 28, Stocking in view of Edwards and Liegner teaches
The access system of claim 27, wherein the additional cannula of the valve member comprises a lumen and an opening [the needle 12 may also have a second fenestration 50 (Stocking Col 4:30-31, Fig. 1); see § 103 modification of claim 1 above].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 28 January 2026, with respect to the previously presented claim objection(s) have been fully considered and are persuasive. The objection to claim 5 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-10, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom 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 in view of Stocking (US-6726659-B1) [the Examiner notes that the presently cited Stocking reference is not the same as the previously cited Stocking reference] in view of Edwards (US-4954130-A, previously presented).
The Applicant asserts that Stocking fails to disclose the amended limitations of claim 1 directed towards the structure and function of the amended valve assembly. The Applicant further asserts that Edwards and all other references previously applied in the previous Office Action fail to teach or render obvious the subject matter argued as not being taught by Stocking ‘914. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 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. Stocking (US-6726659-B1) [the Examiner notes that the presently cited Stocking reference is not the same as the previously cited Stocking reference] in view of Edwards (US-4954130-A, previously presented), wherein the Examiner notes that Stocking discloses embodiments directed a valve member is operable within the cannula to transition between a closed state and an open state to control fluid flow through the cannula to the hub via the proximal opening [Stocking Col 5:23-45, Fig. 2, wherein the Examiner notes that the needle 54 being longitudinally movable within the dilator 56 is considered to read on a valve member that is operable within a cannula to transition between a closed state and an open state to control fluid flow through the cannula to a hub via a proximal opening of the cannula] and Edwards discloses systems for controlling fluid flow via a rotatable valve member disposed within a tubular body [In FIG. 3, plug 8 is depicted as rotated 180 degrees from its position in FIG. 2. In this condition, aperture 10 has been rotated away from IV port 3 and fluids are thus prevented from entering catheter body 1. In this condition, the administration of IV fluids to the patient is stopped and IV tubing 4 may be disconnected. This step is by no means irreversible since fluid administration may be recommenced by attachment to the fluid source through IV tubing 4 and rotation of plug 8 until aperture 10 is aligned with IV port 3 (Edwards Col 4:13-22, Figs. 2-3)].
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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